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Vicore Pharma Holding — Annual Report 2021
Apr 7, 2022
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Annual Report
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Annual Report 2021 Vicore Pharma Holding AB (publ)
Table of Contents
- Summary of the period ..................................3
- Vicore in brief .................................................4
- Year in brief ....................................................5
- CEO comments ..............................................7
- Moving towards a platform company ...........9
- Market overview ............................................. 11
- ATRAGs ...........................................................13
- AT2R expression and mechanisms ..............14
- Interview: Vicore's clinical trial in PAH ........................... 15
- Digital therapeutics for patients with IPF .....16
- Interview: Vicore's digital therapeutic ............................17
- Program overview ..........................................18
- Our programs .................................................19
- Interview: Vicore's commercial activities ......................22
- Intellectual property ....................................... 23
- Shareholder information ................................24
- Administration report .....................................26
- Multi-year overview ........................................33
- Financial reports, group ................................. 34
- Financial reports, parent company ...............36
- Notes, group ...................................................39
- Notes, parent company .................................57
- Board and management ................................61
- Signatures.......................................................65
- Auditor's report ...............................................66
- Corporate governance report ........................69
- Glossary ..........................................................76
- Contact information .......................................78
Summary of the Period
Important events during 2021
- In February, Vicore completed a directed share issue raising 336 MSEK. The share issue was approved at an Extraordinary General Meeting in March.
- In March, Vicore reported top-line data from the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing an improvement of blood flow in patients with SSc.
- In May, Vicore announced that the company had entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).
- In June, Vicore announced that the company had received approval from the U.S. Food and Drug Administration (FDA) to start the pivotal phase 3 trial with C21 in COVID-19.
- In August, Vicore announced a strengthened management team with three senior recruitments; Jessica Shull, Head of Digital Therapeutics, Åsa Magnusson, Chief Financial Officer, and Mats Nygård, VP Business Development.
- In September, Vicore announced that the first patients in the phase 3 trial with C21 in COVID-19 (ATTRACT-3) were dosed.
- In September, Vicore announced that the company was granted a patent in the US covering the use of C21 to treat infections caused by Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), including SARS CoV-2.
- In October, Vicore announced that the results from the phase 2 trial in COVID-19 (ATTRACT) were published in EClinicalMedicine, a sub-journal of The Lancet.
- In November, Vicore announced results from the ATTRACT phase 2 extension trial showing that C21 prevented long-term lung injury in patients with COVID-19.
Important events after the year-end
- In February, an interim analysis of the AIR phase 2 trial in idiopathic pulmonary fibrosis (IPF) showed that C21 stabilizes disease and shows an unanticipated increase in lung function in IPF patients.
- In February, Vicore announced the development of a distinct clinical entity from the VP03 program aimed at patients with atrial fibrillation. A clinical trial application (CTA) is expected to be submitted during the second quarter 2022.
- In March, Vicore announced the plan to initiate a proof-of-concept trial with C21 in pulmonary arterial hypertension (PAH).
- In March, Vicore announced the initiation of a human forearm blood flow study using the AT2R agonist C106 to start in Q2 2022.
- In March, Vicore announced that Michael Wolff Jensen resigned from the board and was replaced by Jacob Gunterberg as chairman until the annual general meeting in May 2022.
Financial calendar
- May 5, 2022: Interim report, Q1
- May 11, 2022: Annual General Meeting 2022
- August 25, 2022: Interim report, Q2
- November 3, 2022: Interim report, Q3
- February 28, 2023: Year-end report 2022
Financial reports are available on the company’s website www.vicorepharma.com from the day of publication.
Financial overview for 2021
- Net sales amounted to 0.0 MSEK (0.0)
- The operating loss was -294.8 MSEK (-149.5)
- Loss for the period amounted to -296.5 MSEK (-146.9)
- Loss per share before and after dilution was -4.25 SEK (-2.71)
- Cash, cash equivalents and short-term investments as of December 31, 2021, amounted to 371.5 MSEK (318.7)
Vicore in brief
Vicore is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe diseases where the Angiotensin II type 2 receptor (AT2R) plays an important role. The company currently has four development programs: VP01, VP02, VP03 and VP04.
- VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF), COVID-19 and pulmonary arterial hypertension (PAH).
- VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF.
- VP03 includes the development of new AT2 receptor agonists (ATRAGs).
- VP04 develops a clinically validated digital therapeutic for IPF patients.
The company's shares (VICO) are listed on Nasdaq Stockholm.
Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis ("IPF") is characterized by progressive fibrosis (scarring) in the lungs. The disease gradually causes impaired lung function leading to shortness of breath and cough. In later stages of IPF, signs of pulmonary hypertension are often seen.
Healthy alveolus
Alveolus in fibrosis
Bronchioles (small lung airways)
“Honeycombing” (clustered cystic spaces)
Fibrosis between alveoli decreases gas exchange so that less oxygen is transferred to the bloodstream
Healthy lung
Lung with IPF
Alternating areas of fibrotic and normal lung
Vicore pipeline
| Indication | Program | Preclinical | Phase 1 | Phase 2 | Phase 3 | Next event |
|---|---|---|---|---|---|---|
| COVID-19 | C21 | Phase 3 read-out | H2 2022 | |||
| IPF | C21 | Phase 2 read-out | H2 2022 | |||
| PAH | C21 | Phase 2 start | Q4/Q1 2023 | |||
| IPF anxiety | DTx | Clinical trial | 2022 | |||
| IPF cough | Inhaled | Formulation | development | |||
| Multiple indications | C106 | Phase 1 | start estimated 2022 |
"Patients with IPF have a high incidence of anxiety. The impact of untreated anxiety may synergize with the physiological burden of IPF and further decrease quality of life for these patients." – Prof. Maureen Horton, MD, PhD, Professor of Medicine, University of Pennsylvania, USA.
Worldwide prevalence of PAH: 0.5 of 100,000
Worldwide prevalence of IPF: 13-20 of 100,000
"All I know is decline, acceptance for my new reality, which is hard to do." – Patient with IPF
Year in brief
Progress in preclinical and clinical development
Topline data from the mechanistic trial in Raynaud's phenomenon in systemic sclerosis
During the first quarter, the results from the mechanistic phase 2 trial in twelve patients with systemic sclerosis (SSc) and Raynaud's phenomenon were presented. The patients received a single-dose of C21 and the aim of the trial was to shed light on the angiotensin II type 2 receptor's (AT2R) role in acute improvement of blood flow in affected tissues. The result from the trial showed a statistically significant temperature recovery as a result of dilation of peripheral vessels suggesting that C21 can increase blood flow in fibrotic tissue. The temperature recovery continued after the study measurement period. This vasodilatory effect is believed to be a benefit in the treatment of IPF.
C21 reduced long-term lung injury after COVID-19 in the ATTRACT phase 2 extension trial
The results from the extension trial, 3-6 months after treatment, including a subset of 33 patients (ATTRACT-2) showed that patients receiving C21 (n=17) displayed reduced pathological abnormalities compared to the placebo group (n=16). In the C21 group, on average 10.3 percent of the lung was affected compared to 19.2 percent in the placebo group meaning a nearly 50% reduction of pathological abnormalities in the C21 group compared with the placebo group. Radiological change was measured as ground glass opacity, a pathological characteristic following viral respiratory infection. These positive findings together with the other clinical trial results from ATTRACT suggest that C21 could accelerate recovery from COVID-19.
Start of FDA-approved, phase 3 trial (ATTRACT-3) in patients with COVID-19
Previously reported positive phase 2 trial results strongly supported further evaluation of C21 in COVID-19 and in June 2021, Vicore received approval from the U.S. Food and Drug Administration (FDA) to start a pivotal phase 3 trial with C21 in COVID-19 (ATTRACT-3) and in September the first patients in the trial were dosed. The study is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVID-19 and requiring oxygen support but not invasive mechanical ventilation. The study aims to investigate the efficacy of C21 on recovery from COVID-19.# Annual Report 2021
Vicore Pharma Holding AB (publ)
The trial has been activated in more than 50 study centers in the US, Czech Republic, the Philippines, Argentina, Brazil, Columbia and Russia. In February 2022, the trial stopped due to the conflict. Topline data from ATTRACT-3 is expected during the second half of 2022. The ongoing phase 2 AIR trial in patients with IPF presents positive interim results. The open-label, 60 patients trial in patients with IPF progressed during the year. The AIR trial is a placebo-controlled, randomized trial of C21 in patients with Idiopathic Pulmonary Fibrosis (IPF) and COVID-19, as they are particularly susceptible to respiratory diseases due to an already impaired lung function. Recruiting patients for the study has been challenging, as regular hospital visits are required and the company wants to ensure patient safety. After year-end, an interim analysis suggested that C21 stabilized disease and increased lung function in iPF patients, results that gave Vicore confidence to prepare for the next trial.
Year in Brief
2021 was a year of progress in building Vicore for the next development milestones and exploring new areas, despite the many challenges faced due to COVID-19. With a clear purpose and a highly dedicated team, Vicore is well positioned.
- Reported encouraging results showing an increase in lung function and stabilized disease, in patients with IPF from an interim analysis of the phase 2 AIR trial in IPF.
- Results from COVID-19 extension trial showed a nearly 50% reduction in lung injury with C21 compared to placebo.
- Expanded pipeline with a digital therapeutic in IPF.
- Secured the company's financing through a directed share issue of 336 MSEK.
- First drug candidate in the preclinical VP03 program ready to enter clinic.
- PAH, decided as a new indication for clinical development.
- Start of phase 3 trial in COVID-19.
Highlights during 2021 and the period thereafter:
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New AT2R agonists (ATRAGS) developed further
Throughout 2021, Vicore's efforts to develop proprietary molecules that modulate AT2R in a controlled manner was intensified. The company is in the process of establishing strong intellectual property protection around the class of AT2R stimulating drugs (ATRAGs) through patent filings. After year-end, Vicore announced that the first compound was ready for a phase 1 trial.
New addition to development pipeline
During the second quarter, Vicore expanded the pipeline with a digital therapeutic to treat anxiety in patients with IPF by the signing of an agreement with Alex Therapeutics for development and clinical validation. The agreement with Alex Therapeutics, a medtech company with expertise in artificial intelligence and digital health solutions, is to initiate a new development program focused on the development and commercialization of a clinically validated digital therapeutic (Vicore DTx) to provide cognitive behavioural therapy (CBT) to treat anxiety for people living with IPF. Under the agreement, Vicore will own all rights to VP04 in exchange for an upfront payment to Alex Therapeutics of 8.1 MSEK (1 MUSD), plus potential milestone payments and royalties on sales. During 2021, the main focus was on technical and software development. The first pilot phase investigation of the Vicore DTx received approval to start and a following pivotal investigation is estimated to start during H2 2022.
Secured patent protection covering COVID-19
Patent protection for the use of C21 in SARS CoV viruses. Vicore was granted a patent in the US covering the use of C21 to treat infections caused by Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), including SARS CoV-2(COVID-19).
Several important recruitments during the year
During 2021, Vicore strengthened the organization on several fronts, spanning from R&D, Quality Assurance to commercial functions. In August, Vicore announced a strengthened management team with three senior recruitments; Jessica Shull, Head of Digital Therapeutics, Åsa Magnusson, Director of Biostatistics and Ingrid Nygård, VP Business Development. At the end of 2021, a total of 21 employees were employed in Vicore.
Strengthened financial position
Vicore completed a successful directed share issue raising 336 MSEK during the first quarter 2021. The share issue was subscribed by Swedish and international institutional investors.
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Vital Capacity (FVC), a measure of lung function, has been measured in the AIR trial. In the first nine patients, FVC increased on average by +250 ml: over the same period, FVC in untreated patients would be expected to decline by 120 ml. Seven of those patients showed an increase in FVC, and in those patients FVC progressed further after C21 treatment. For patients, a treatment that halted the decline in IPF would be a significant improvement and potentially life-saving medicines. These interim results suggest that C21 does more than that, and actually increases lung function. We at Vicore have gained the confidence to begin planning the next trial with C21 in IPF. Over the next few months, we will be discussing the details of the trial design with our clinical collaborators and with regulators. We believe that it is our obligation to do our utmost to accelerate the development of C21 for IPF patients. The past year has been an intensive year of preparation for another part of Vicore’s offering in IPF, our digital therapeutic (Vicore DTx) designed to help patients with anxiety and depression due to their disease through cognitive behavioral therapy.
CEO Comments
Read more
2021 has been about growth and renewal. The progress we made during the year has put the company in a very optimistic position as we begin 2022. With a firm foundation in the treatment of rare lung diseases Vicore is ready to enter new therapeutic areas through the advanced development of new angiotensin II type 2 receptor agonists (ATRAGs). The first compound - C106 - from the next generation of ATRAGs, is ready to enter clinical development during 2022 and an additional three compounds are in the late stages of preclinical development. In addition, our multi-product effort in IPF was boosted by positive interim data from the AIR trial with our lead molecule, C21, and the company will be striving to advance that program into the next phase. We also plan to launch a new clinical program for C21 in the related area of Pulmonary Arterial Hypertension during Q4/Q1 2023. We began our Phase 3 trial (ATTRACT-3) with C21 in COVID-19 in the summer of 2021 following FDA approval in Q2 2021. With more than 50 centers in 10 countries now active, around half of the patients are enrolled in the study. A formal safety review implemented when 150 patients had been enrolled raised no safety concerns. As previously communicated, we expect to provide topline read-out of the results from the trial in the second half of 2022. In February 2022, when approaching half of the patients enrolled in the IPF-trial (AIR), Vicore reported data from an interim analysis of the trial. The data showed the potential of C21 to restore lung function, widely exceeding our expectations. The AIR trial measured lung function using a standard and widely accepted measure, Forced Vital Capacity (FVC).
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A pilot study involving around 20 patients is about to start at a number of leading centers for respiratory disease. The pilot study will help shape a much larger pivotal study in approximately 250 patients which is due to begin in H2 2022. The pivotal study is designed to provide the information needed for FDA clearance of the product which is estimated to 2024. Based on a variety of preclinical and clinical data that the company gathered during the years, Vicore will expand its clinical program both within rare lung disease and beyond. In one initiative, the company will build a new clinical program for C21 in pulmonary arterial hypertension (PAH). PAH is a rare disease characterized by dysfunction of the arteries of the lung. In preclinical models, C21 reverses vascular damage and significantly improves blood flow; in patients, C21 can help restore blood flow in systemic sclerosis and Raynauds phenomenon. Based on this and other evidence, we plan to begin a proof-of-concept trial with C21 in PAH in Q4 2022/ Q1 2023. Our second new clinical initiative within the VP03 program represents a greater advancement for Vicore and recognizes the broad potential of ATRAGs. C21 is the original ATRAG and, until now, the only one tested in clinical trials. In addition to the ongoing clinical work on C21 in clinical trials, the company also conducted an exhaustive discovery and preclinical development program on a series of new, proprietary ATRAGs. The first ATRAG, C106 is now ready for a phase 1 trial and Vicore expects to submit a clinical trial application in Q2 2022. An additional three ATRAGs are expected to finalize preclinical evaluation during H1 2023. ATRAGs are about repairing. The antifibrotic, repair and regenerative effects seen in many preclinical models of diseases are reflected in human disease. The recent interim data in IPF illustrate how deep that impact could be. The emergence of a pipeline of new, proprietary small molecule agonists of AT2R and the submission of the clinical trial application represents a first step in transforming Vicore from a rare lung disease company to a clinical platform company exploring a new class of drugs, the ATRAGs, in multiple indications. Vicore is on the threshold of change.
The
in COVID-19 and reinforcement of our interim data in IPF. We are also at the start of a new era of exploration of the potential of ATRAGs with our next generation of AT2R modulators.# As we plan to establish a broad platform – the ATRAG Academy - for promoting research into the use of ATRAGs to treat human disease. The idea is to provide drug plus placebo plus documentation to groups who share our ambition to accelerate ATRAGs from model studies into humans. And to the investors who support us and the companies that invest in our pipeline, we once again extend our gratitude to the investigators and patients who are part of our ongoing clinical trials, we once again extend our gratitude for their continued support.
Carl-Johan Dalsgaard, CEO
"The recent interim data in IPF illustrate how deep the impact of ATRAG's antifibrotic, repair and regenerative effects can be."
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At Vicore, we are devoted to exploiting the full potential of the angiotensin II type 2 receptor (AT2R). We are in a unique position to leverage our deep expertise in the area to bring novel therapies to patient populations with a large unmet medical need. Clinically relevant data in COVID-19, IPF and systemic sclerosis with C21 confirm the vascular and antifibrotic effects of C21 and suggest that AT2R agonists (ATRAGs) represent an important new class of drugs and bodes well for the translation also in other diseases with similar strong preclinical support.
Moving towards a platform company
The unique science behind the AT2R agonists, and a plethora of preclinical studies pointing to the disease modifying effects in several indications, there is a multitude of opportunities to explore. To prioritize among these opportunities, Vicore conducted a strategic review during 2021. Parameters including scientific rationale, medical need and commercial potential were guiding in the process that resulted in the selection of three potential new indications for AT2R agonists, pulmonary artery hypertension (PAH), diabetic nephropathy (DN) and preeclampsia (PE). Of these, PAH is first in line. Vicore has generated preclinical data in pulmonary hypertension that support the decision for a proof-of-concept trial, which is planned for 2022. In parallel with the ongoing clinical development, Vicore is running an extensive chemistry program to generate novel selective AT2R agonists with long patent life and improved properties. The aim is to generate a robust pipeline of clinical candidates, and the first new compound is planned to enter the clinic in 2022. We strongly believe that Vicore is better positioned than anyone to pursue these opportunities and feel that it is our responsibility to do so.
Read more
Vicore strategic priorities – moving towards a platform company
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Strategic priorities
Partnerships
Increase visibility and attention for Vicore’s assets and clinical programs.
Leadership position in rare lung diseases
Accelerate development of C21, a best-in-class IPF treatment.
New proprietary ATRAGs
Continued accelerated drug discovery and chemistry approach to generate novel ATRAGs with strong IP protection.
Capabilities and skills
Strengthening team capabilities to advance the clinical programs and ensure product supply.
The development of new ATRAGs in new indications.
New indications
Leverage our deep expertise in AT2R to expand the clinical pipeline to new indications supported by strong preclinical data and unmet medical need. Attract academic partners.
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Market Overview
The most advanced clinical programs in Vicore are targeting IPF and COVID-19, two therapeutic areas with large unmet medical needs and significant commercial opportunities. As the biology around AT2R agonists (ATRAGs) is being elucidated, it is becoming evident that several additional indications beyond IPF and COVID-19 may be of relevance for this new class of drugs. With a broadened spectrum of indications, the commercial opportunity will also be expanded.
IPF – a rare disease with large unmet need
It is estimated that between 80,000 and 111,000 people in the EU are currently living with idiopathic pulmonary fibrosis ("IPF"), with up to 35,000 new cases being diagnosed each year 1. In the US, approximately 100,000 people are currently living with IPF according to the National Institute of Health (NIH), with 30,000-40,000 new cases per year. Both the incidence and prevalence of IPF are increasing worldwide 2. Despite targeted treatments being available for more than ten years, mortality is still high with a median survival of approximately three years from the time of diagnosis. From the moment of diagnosis, patients will experience symptoms throughout most of their disease, with disabling dyspnea and cough that reduce quality of life. A large proportion of people with IPF also suffer from anxiety and depression.
IPF is classified as a rare disease, and the development of drugs to treat IPF can therefore be granted orphan status. Developing an orphan drug provides market exclusivity for up to seven years from approval in the US and up to ten years in the EU and Japan 3. Other benefits of orphan drug status can include tax credits for parts of the development costs or a discounted fee to the FDA in the US. In the EU, assistance with the development of the drug is possible and a discount on the fee to the European Medicines Agency (EMA) is also possible. For orphan drugs, which are aimed at a relatively fewer number of patients, the studies are often smaller, and the development phases are often combined, which can lead to a faster development timeline 3.
The IPF drug market has seen significant growth in recent years and is estimated to continue to outgrow the overall pharmaceutical market 3. There are currently two approved drugs for IPF, Esbriet (pirfenidone; Roche/Shionogi) approved since 2011/2014 and Ofev (nintedanib; Boehringer Ingelheim) approved 2014/2015 in Europe and the US. Although both drugs can slow down the progression of the deterioration of lung function, they are associated with side effects such as vomiting and diarrhea and have not yet conclusively shown that they can improve the survival or quality of life of the affected patients. The combined global sales of these drugs are estimated to approximately $4.0 billion in 2021 of which approximately 70% in US 4. IPF drug market has in recent years attracted a great deal of interest from the pharmaceutical industry due to the significant unmet medical need and a number of licensing deals and acquisitions have been completed such as the acquisition of Promedior by Roche in 2019 at a value of $1.4 billion (see table on next page).
COVID-19 – long-term need for better treatments
The COVID-19 pandemic has impacted many aspects of society and people’s lives, and in February 2022, over 354 million cases had been confirmed world-wide 5. With increasing vaccine coverage in developed countries many nations are now preparing for an endemic phase of the virus, accepting that the virus is here to stay, although at a more stable level. Many factors are pointing in this direction such as viral immune escape, waning immunity, uneven global vaccine distribution 6. The global effort to develop vaccines has been a scientific success, and novel treatments and approaches towards the reduction of disease mortality have also emerged. However, although Read more There are two drugs for IPF available on the market today. Effert and Sugg have failed to show any effect on the survival or quality of life of the patients. The combined global sales in 2021 amounted to approximately $4.0 billion
Source: Company reports from Roche and Boehringer Ingelheim
US IPF drug market was $4.5 billion in 2019 and forecasted to continue to grow
| Idiopathic Pulmonary Fibrosis (IPF) | |
|---|---|
| Prevalence (US and EU) | : 250,000 |
| Global market size | : $4.0 Bn |
| Patients not on treatment in the US | : 40% |
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new data hint at a “hidden pandemic” of long-term sequelae of severe Covid-19. Observational studies indicate that a significant proportion of patients experience long-term respiratory problems, decreased exercise tolerance, and lung tissue damage 7, 8. Thus, there is still a need for more effective treatment to reduce long-term health consequences. In an endemic situation with new viral strains, there is a need for a long-term treatment strategy also long term. Covid therapeutics sales are forecasted to reach $17 billion in 2021 and are expected to increase in 2022 and thereafter gradually go down and reach a more stable level of $4 billion annual sales from 2025 and onwards 9. However due to the changing nature of the disease and pandemic, it is difficult to forecast sales with any certainty.
Pulmonary arterial hypertension (PAH) – a rare disease with large unmet medical need
PAH is a progressive disease in which a pulmonary vascular dysfunction leads to high blood pressure in the lung arteries which ultimately leads to heart failure. The currently available treatments reduce blood pressure by dilating blood vessels but do not modify the underlying disease or improve survival. PAH is considered a rare disease and the US market for PAH treatment is estimated to $4.5 billion 10.# Digital Therapeutics Taking Off
Digital therapeutics (DTx) is a new class of medical products that has been gaining traction in the last years. To date, about 35-40 DTx products have been approved by the FDA. As the value of DTx products is becoming more evident in e.g. managing and treating chronic conditions and acceptance with regulatory bodies and payers has increased, DTx is receiving increasing attention also from investors and the pharmaceutical industry. In the last couple of years, several partnerships have been formed, e.g., Sanofi partnering with Happify Health and Boehringer Ingelheim to develop new DTx products, and several large acquisitions have also been made, e.g., ResMed’s acquisition of Propeller in 2019 (see table). This activity is expected to accelerate in the coming years. The DTx market is estimated to grow from $3.4 billion in 2021 to $13 billion in 2026.
| Year | Target/Licensor | Acquiror/Licensee | Type of deal | Development stage at transaction | Area | Total deal value (MUSD)* |
|---|---|---|---|---|---|---|
| 2021 | Aptar | Voluntis | Acquisition | DTx | 79 | |
| 2020 | Redx Pharma | AstraZeneca | License | Preclinical | Fibrosis/IPF | 377 |
| 2020 | Forbius | BMS | Acquisition | Phase I | Fibrosis/IPF | Undisclosed |
| 2020 | Curzion Pharmaceuticals | Horizon Therapeutics | Acquisition | Phase II | Fibrosis/IPF | 45 + milestones |
| 2020 | Enleofen | Boehringer Ingelheim | License | Preclinical | Fibrosis/IPF | 211 |
| 2019 | Propeller | ResMed | Acquisition | DTx | 225 | |
| 2019 | Promedior | Roche | Acquisition | Phase II | Fibrosis/IPF | 1,390 |
| 2019 | Galapagos | Gilead Sciences | License | Phase III | IPF (part of larger portfolio) | 5,000 |
| 2019 | Bridge Biotherapeutics | Boehringer Ingelheim | License | Phase I | Fibrosis/IPF | 1,300 |
| 2018 | Morphic Therapeutic | AbbVie | License | Preclinical | Fibrosis/IPF | 100 + milestones |
| 2016 | Vectra Therapeutics | BMS | License | Phase Ib | Fibrosis/IPF | Undisclosed |
| 2016 | Afferent Pharmaceuticals | Merck | Acquisition | Phase IIb | IPF cough | 1,250 |
| 2015 | Promedior | BMS | Option** | Phase II | Fibrosis/IPF | 1,250 |
| 2014 | InterMune | Roche | Acquisition | DTx | 8,300 | |
| 2014 | Galecto Biotech | BMS | Option** | Phase I/IIa | Fibrosis/IPF | 444 |
| 2012 | Stromedix | Biogen | Acquisition | Phase II | Fibrosis/IPF | 563 |
| 2011 | Amira Pharmaceuticals | BMS | Acquisition | Phase I | Fibrosis/IPF | 475 |
| 2011 | Arresto BioSciences | Gilead Sciences | Acquisition | Phase I | Fibrosis/IPF | 225 + milestones |
* Total deal values including potential milestone payments
** BMS decided not to exercise its option
Source: Corporate webpages
- European Idiopathic Pulmonary Fibrosis and Related Disorders Foundation
- The AT2R is a "repair receptor"; its role in fibrosis, inflammation, and vascular disease. J. Clin. Invest. 127, 792–798 (2017).
- EvaluatePharma, Orphan Drug Report 2019 and 2020
- Company reports; Roche, sales in 2021 (Esbriet) and Boehringer Ingelheim, estimated sales in 2021 (Ofev)
- Coronavirus (COVID-19) - Cross-Sector Impact - Global data, February 2022
- “COVID is here to stay: countries must decide how to adapt”. Nature 601, 165 (2022)
- Bazdyrev, E et al. Lung Fibrosis after COVID-19: Treatment Prospects. Pharmaceuticals 2021, 14, 807
- Wu X et al. 3-month, 6-month, 9-month, and 12-month respiratory outcomes in patients following COVID-19-related hospitalisation: a prospective study. Lancet Respir Med. 2021, 9, 747-54
- Pharmaceutical executive brief. Global data Jan 2022
- Digital Therapeutics Market Size, Share & Trends Analysis Report By Technology, By Application, By End User, By Region, And Segment Forecasts, 2022 - 2029, Global Data 2020
- Morning consult, June 2021
- Global Digital Therapeutics Market By Technology, By Application, By End-User, By Region, And Segment Forecasts, 2022 - 2029
Deals in IPF, fibrosis and DTx
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The Renin-Angiotensin System (RAS)
The AT1R (see illustration) is mainly involved in blood pressure regulation through several different mechanisms related to constriction of blood vessels and fluid retention, but also contributes to innate immunity through pro-inflammatory actions. When this system “over-shoots”, it can also contribute to the pathogenesis of diseases such as hypertension, myocardial infarction and different fibrotic conditions including idiopathic pulmonary fibrosis and chronic kidney disease. The AT2R is on the other hand an inducible system that can be seen as a mechanism responsible for resolution and regeneration following immune challenges and inflammatory processes. The natural AT2R ligands/agonists of AT2R such as Ang 1-9 and Ang 1-7 are fragments cleaved from Angiotensin I and II. Vicore’s candidate drug C21 and the new compounds within the VP03 program are AT2R agonists, i.e. they bind to and activate AT2R.
AT2R Agonists (ATRAGs)
There is strong scientific evidence for an important protective role of AT2R activation in several serious diseases related to cellular senescence, fibrosis and microvascular dysfunction. In addition to IPF, these include pulmonary arterial hypertension, different fibrotic diseases, atherosclerosis, heart failure and cognitive disorders. This is based on more than 100 preclinical studies from different research laboratories around the world. Clinical evidence is now accumulating, validating the preclinical results. In COVID-19, patients treated with the AT2R agonist C21 had a significant reduction of lung injury and fibrotic sequelae with improved oxygenation, suggesting a restoration of respiratory function by the drug. In addition, at the 3-month follow-up, treated patients had fewer pathological signs on chest computer tomographies. Vascular effects of C21 were demonstrated in systemic sclerosis patients with severe vasculopathy and fibrosis. The total body of evidence suggests that the AT2R is a relevant target far beyond COVID-19, systemic sclerosis and IPF. Vicore has during the last years built a strong position in AT2R agonist chemistry and has a platform of very promising new molecules with patent protection to at least 2040 and beyond under development. The first new AT2R agonist to follow C21 has finalized the preclinical development and is ready to enter a phase 1 trial. A clinical trial application (CTA) is expected to be submitted during the second quarter of 2022.
The renin-angiotensin system (RAS) is a hormone system that regulates several important physiological processes. The key hormone in the RAS is angiotensin II which acts via two specific receptors, the angiotensin II type 1 receptor (AT1R) and the angiotensin II type 2 receptor (AT2R).
- "The AT2R is a repair receptor"
- The AT2R is an inducible regeneration and repair receptor
- A novel target with untapped potential
- C21 is a first-in-class selective AT2R agonist
- Well established pathway targeted by ACE inhibitors (e.g. enalapril) and angiotensin receptor blockers (e.g. losartan)
- AT1R
- Well established pathway targeted by ACE inhibitors (e.g. enalapril) and angiotensin receptor blockers (e.g. losartan)
- AT2R
- A novel target with untapped potential
| The Renin-Angiotensin System (RAS) | |
|---|---|
| AT2R agonist | |
| Angiotensinogen | |
| Angiotensin II | |
| Type 2 Receptor Agonists - ATRAGs |
| 14 | Annual Report 2021 Vicore Pharma Holding AB (publ) |
|---|---|
| [³H] C21 1nM Shows binding of isotope-labeled (tritium) C21 (1 nM) to thin sections of human lung. | [³H] C21 1nM C21 0.75 μM Tissue section with no specific binding. | [¹²⁵I] Ang II 0.15 1 nM Shows binding of isotope-labeled angiotensin II (Ang II, 0.15 nM) to human lung sections. | [¹²⁵I] Ang II 0.15 1 nM C21 0.75 μM Shows binding of isotope-labeled Ang II, which illustrates that the AT2 receptor is the dominant Ang II receptor in the human lung (the binding of Ang II is not affected by AT2R antagonists). | |
|---|---|---|---|---|
AT2R expression and possible mechanisms
Vicore has recently confirmed, using so-called receptor autoradiography, that human lung tissue expresses the AT2 receptor and that C21 at very low concentrations binds specifically to AT2R in the lung tissue. (see figure below). The multimodal effects of AT2R activation are mediated by a number of possible mechanisms, including one or more of those shown in the figure to the right. (1) In the lung, the AT2R is highly expressed on alveolar epithelial cells type 2 (AEC2). These progenitor cells are involved in the repair of damaged alveoli, and they also fill a critical function in secreting surfactant which reduces alveolar surface tension and makes it easier to expand the lungs.
Multiple mechanisms mediating AT2R agonist effects
| 1 | C21 | ECM | TIMP1 | MMP1 | C21 | ECM degradation | Fibroblast | Myofibroblast | Myofibroblast transformation |
|---|---|---|---|---|---|---|---|---|---|---|
| C21 | ECM, Fibrosis | Matrix secretion | TGFβ1 | Proliferation | 1 | C21 | Endothelial cells | NO | 2 |
| 3 | 4 | C21 | NO release | MMP activation | TGFβ1 inhibition | Epithelial function | Vascular remodeling and vasodilation | Fibrolysis | Alveolar integrity |
| Antifibrosis | Differentiation | Proliferation | AEC1 | AEC2 | Myofibroblast | Fibroblast | Surfactant | | |
Multiple mechanisms mediating AT2R agonist effects
| 1 | C21 | ECM | TIMP1 | MMP1 | C21 | ECM degradation | Fibroblast | Myofibroblast | Myofibroblast transformation |
|---|---|---|---|---|---|---|---|---|---|---|
| C21 | ECM, Fibrosis | Matrix secretion | TGFβ1 | Proliferation | 1 | C21 | Endothelial cells | NO | 2 |
| 3 | 4 | C21 | NO release | MMP activation | TGFβ1 inhibition | Epithelial function | Vascular remodeling and vasodilation | Fibrolysis | Alveolar integrity |
| Antifibrosis | Differentiation | Proliferation | AEC1 | AEC2 | Myofibroblast | Fibroblast | Surfactant | | |
Multiple mechanisms mediating AT2R agonist effects
| 1 | C21 | ECM | TIMP1 | MMP1 | C21 | ECM degradation | Fibroblast | Myofibroblast | Myofibroblast transformation |
|---|---|---|---|---|---|---|---|---|---|---|
| C21 | ECM, Fibrosis | Matrix secretion | TGFβ1 | Proliferation | 1 | C21 | Endothelial cells | NO | 2 |
| 3 | 4 | C21 | NO release | MMP activation | TGFβ1 inhibition | Epithelial function | Vascular remodeling and vasodilation | Fibrolysis | Alveolar integrity |
| Antifibrosis | Differentiation | Proliferation | AEC1 | AEC2 | Myofibroblast | Fibroblast | Surfactant | | |(2) AT2R
vascular endothelial cells to release nitric oxide which is a vasodilator and is an important molecule for (4) C21 also has fibrolytic activities in that it can increase matrix metalloproteinase (MMP) enzymes that degrade fibrotic changes that has already been formed. extracellular matrix, MMP1 – matrix metalloproteinase 1, TIMP1 – tissue inhibitor of metalloproteinase-1 Key sources: Sumners et al. Acta Physiologica. 2019;227(1):e13280, Peluso et al. Clin Sci. 2018;132(7):777-90, Bruce et al. Br J Pharmacology 2015;172(9);2219–2231, Rathinasabapathy et al. Front Physiol. 2018;9:180. Vicore data on file.
Multiple mechanisms mediating AT2R agonist effects
1 C21 ECM TIMP1 MMP1 C21 ECM degradation Fibroblast Myofibroblast Myofibroblast transformation C21 ECM, Fibrosis Matrix secretion TGFβ1 Proliferation 1 C21 Endothelial cells NO 2 3 4 C21 NO release MMP activation TGFβ1 inhibition Epithelial function Vascular remodeling and vasodilation Fibrolysis Alveolar integrity Antifibrosis Differentiation Proliferation AEC1 AEC2 Myofibroblast Fibroblast Surfactant
15 | Annual Report 2021
Vicore Pharma Holding AB (publ)
What is the difference between Pulmonary Hypertension and Pulmonary Arterial Hypertension, and are both of interest to Vicore?
Pulmonary Hypertension (PH) is the general term for a set of conditions in which elevated pressure in the lung blood supply can lead to progressive heart failure. Pulmonary Arterial Hypertension (PAH), is a particular severe rare require intensive care unit level care at some point in their life, and over 30% of patients with PAH die within 3 years of diagnosis. Vicore’s initial focus is on PAH because we believe our drugs will disease modifying treatment options are currently available. The way our blood vessels - means that they could also be effective more broadly in PH.
PAH is a severe lung disease, but is there a connection to your current work in IPF?
There is a connection. As mentioned, the general category of Pulmonary Hypertension encompasses several groups of diseases leading to heart failure. PH can also occur as a com- plication to many lung diseases such as IPF, where it is a strong predictor of mortality. In a World Health Organization classification, PAH is in group 1 of PH. WHO group 3 includes PH associated with already-diagnosed lung disease, which is where IPF fits.
What drove Vicore to consider PAH as a new indication?
In short, we have evidence that our drug is a clear pathway to approval. Vicore’s lead compound, C21, is a highly specific stimulator or agonist of the Angiotensin Type 2 Receptor (AT2R). A lot of animal data shows that C21 reverses vascular remodelling and improves hemod- ynamic pressure in the lungs. Quite recently, using a ‘gold standard’ animal model of Pulmonary Hypertension, we showed that C21 prevented remodelling of the blood vessels. The prevalence of orphan drug status protection in the US and Europe.
How will the trial in PAH be designed?
All clinical trial designs have to be agreed with drug regulators, but we have an outline view of the study. This is based, among other factors, on Vicore’s experience in developing medicines in PAH, and extensive inputs from Vicore’s expert clinical advisors. The plan is to conduct a ‘smart’ proof-of-concept in a relatively short period of time from will be intensive remote monitoring of patients using a smart implantable and providing a highly efficient, decentralized design.
Interview with Rohit Batta, CMO, on Vicore’s new trial in PAH
In 2022, Vicore will begin a new clinical program in Pulmonary Arterial Hypertension (PAH). "With our AT2R agonists we are addressing the vascular component of rare lung diseases."
16 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Vicore is developing a digital therapeutic to treat anxiety and depression in people living with Idiopathic Pulmonary Fibrosis (IPF).
Digital therapeutics (DTx) are clinically evaluated software, designed, built, and tested to treat a disease or condition. DTx are classified as medical There are more than 100 companies developing DTx products, and there are Belgium, and France. Some of these products treat type I or type II diabetes, there are products for Alzheimer’s, others provide a pain management, and others are in the mental health space, such as the product Vicore is developing. IPF causes scarring of the lung and dif- ficulty in breathing which is debilitating. Activities that were once possible may around a grocery store or going up stairs. The diagnosis is usually unexpected, so it can negatively impact a person’s state of mind.
The he Vicore DTx Almee™, an investigational medical device pending FDA clearance, offers a therapy for the symptoms of anxiety and depression that patients with IPF may experience and helps patients cope. The basic idea with Almee™ is to have your own personal psychologist in of sessions of Cognitive Behavioural Therapy (CBT) built specifically for people with IPF. The sessions are made up of complex interactions and psychological tools that people can a smartphone or tablet in the comfort of home rather than at a psychologist’s office, whenever the patient prefers. The sessions are built by software devel- opers, psychologists and lung disease experts and delivered through a device the patient already has. Almee™ will be validated through a Randomised Control Trial (RCT), so that potential payors and prescribers as well as patients will have evidence of its effectiveness. Throughout the design process Vicore ensured patient and physician insight was incorporated to build something that they could identify with and find useful.The ambition is that Almee™ will offer support to patients who have a rare disease and an additional resource for hospital systems that can’t provide daily counselling; the goal of the Almee™ , as with every Vicore pipeline, is to create better patient outcomes.
Digital Therapeutic for patients with IPF
17 | Annual Report 2021
Vicore Pharma Holding AB (publ)
What background do you bring to Vicore?
In 2002 I finished a master’s degree in Medical Illustration at the medical Col- lege of Georgia, which included training in Gross Anatomy, Neuropathology, and Histology as well as detailed drawing. was digital, done on computers with high-end 3D modeling software and coordination with a haptics team to create virtual surgery devices. Since health; for many years I collaborated national health systems through digital advances, and I produced digital image-based protocols during the Ebola epidemic for local populations. Now digital health has entered the personalized treatment space with digital therapeutics, and for the last four years I’ve been deeply involved in advocacy, national policy and now development of products under this new approach to healtcare.
How do you see digital therapeutics (DTx) fitting into existing healthcare practices?
I would say that a DTx needs to be con- ceptualized, designed, and continually evaluated for alignment with the patient and physician experience. We have been collaborating from day one with patient groups and specialists to ensure that this was a needed therapy, and that it wouldn’t create an extra burden on anyone. As for the patients, we need to ensure our design will have the desired effect, reducing symptoms of anxiety and depression in people with IPF.
How is a decentralized investigation for DTx different from a traditional drug trial, and what are the benefits?
With a decentralized trial for a digital therapy, we can study individual param- eters which are relevant and meaningful from a patient perspective, directly from the patients. Our decentralized trial is a randomized controlled trial (RCT) for a digital prod- uct, which is easy to deliver across a large geography. We designed the study with one central Coordinating Inves- tigator, and we will be able to accept referrals from any eligible participant, regardless of location. Being a digital product means that collecting adverse events, documenting adherence, and even participant onboarding of how to use Almee™ can be done entirely virtually. to those national regulations and standards. So while a DTx can be easily distributed and Patient Reported Outcomes (PROs) collected, there are strict requirement on the cybersecurity and privacy systems in place to protect patient data.
Where do you see the DTx industry in 10 years?
In the last five years the DTx industry industry saw deals worth $3.4 billion. It’s an impressive statement about the France are now structuring national reimbursement pathways for these Germany did in 2019. I’m an optimist, but I see DTx continuing that global trend, especially as millennials age and personalized care becomes the norm.# Interview with Jessica Shull, Director of Digital Therapeutics
"I expect to see digital therapeutics as a part of clinical guidelines in the coming years."
18 | Annual Report 2021 Vicore Pharma Holding AB (publ)
VP01 (C21) – Idiopathic pulmonary fibrosis ("IPF")
Completed phase 1 dose optimization trial in 2019, including 54 individuals. It established a safe and tolerable daily dose of 200 mg for further studies in IPF. The phase 2 trial is an open 6 month study in approximately 60 patients. In addition, patients will be given the opportunity to continue treatment for another three months. The study is currently active in the UK and India.
The study was initiated in November 2020. An interim analysis of the trial suggests that C21 stabilizes disease and increases lung function in patients with IPF. Estimated read-out of the phase 2 trial is during the second half of 2022. In parallel, preparations for the next trial is ongoing.
VP04 (DTx) – A digital therapeutic to treat anxiety in IPF
Technical development of software during 2021. COMPANION, a randomized, controlled, parallel-group clinical investigation, in two phases, evaluating the impact of our digital cognitive behavioural therapy on psychological symptom burden, in adults diagnosed with IPF, has been initiated.
The first phase will include 22 patients will be followed by a pivotal study (second phase), on approximately 250 patients in H2 2022. The pivotal study is expected to initiate in Q2 2023.
VP01 (C21) – COVID-19
Finalized phase 2 trial in 2020. The trial was a randomized, double-blind, placebo controlled study in 106 COVID-19 patients with a moderately severe disease, requiring oxygen support, but not mechanical ventilation.
Summarized, the study shows that the need for oxygen supplementation in the C21 group was decreased. The results from an extension trial, 3-6 months after treatment, including a subset of 33 patients (ATTRACT-2) showed that patients receiving C21 had a reduction of 47 percent in pathological abnormalities compared to placebo.
The phase 3 trial is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVID-19 and requiring oxygen support but not invasive mechanical ventilation. The trial has currently been activated in more than 50 study centers.
The study was initiated in September 2020 and the estimated read-out is during the second half of 2022.
Program Overview
VP01 (C21) – Pulmonary arterial hypertension (“PAH”)
A phase 2 proof-of-concept trial on patients with PAH is expected to start during 2022.
VP02 (IMiD) – IPF cough
Preclinical development. Evaluation of alternative formulations to deliver thalidomide locally to the lung ongoing.
VP03 (multiple indications)
Preclinical research is underway to develop new AT2R-agonists for multiple indications. Clinical trial application (CTA) for a phase 1 trial for C106 is expected to be submitted during Q2 2022.
Preclinical development for C106 is planned during H1 2023.
Vicore pipeline
| Indication | Program | Preclinical | Phase 1 | Phase 2 | Phase 3 | Next event |
|---|---|---|---|---|---|---|
| COVID-19 | C21 | Phase 3 | read-out in H2 2022 | |||
| IPF | C21 | Phase 2 | read-out in H2 2022 | |||
| PAH | C21 | Phase 2 | start Q4/Q1 2023 | |||
| IPF anxiety | DTx | Clinical trial 2022 | ||||
| IPF cough | Inhaled IMID | Formulation development | ||||
| Multiple indications | C106 | Phase 1 | start estimated 2022 |
19 | Annual Report 2021 Vicore Pharma Holding AB (publ)
VP01 – AT2 receptor agonist - first in class
Vicore’s drug candidate C21 (VP01 program) originates from extensive research on the Renin-Angiotensin System (RAS) and binds specifically to and activates AT2R. Vicore has shown pronounced effects with C21 in a gold-standard preclinical model considered predictive of human pulmonary hypertension (PH), the so called Sugen-Hypoxia-induced PH model. PH is a common and serious complication of interstitial lung disease, including IPF, and treatment options are extremely limited. Vicore has also shown robust effects with C21 in lung tissue from patients with idiopathic pulmonary fibrosis (IPF). Treatment with clinically relevant concentrations of C21 caused a dose-dependent reduction in fibrosis development. Recently, Vicore has also shown that human lung tissue expresses the AT2 receptor and that very low concentrations of C21 bind specifically to AT2R in the lung tissue which has been shown by so-called receptor autoradiography. C21 has previously shown very good effects in animal models with pulmonary fibrosis and is now being evaluated in a phase 2 trial in patients with IPF and a phase 3 trial in COVID-19. Vicore has received Orphan Drug Designation for C21 in IPF from the FDA and EMA. Among other benefits, eventually receiving orphan drug status provides patent exclusivity (from the date of registration of an approved drug) in Europe and seven years in the United States.
Program status
VP01 Idiopathic pulmonary fibrosis (IPF)
The phase 2 trial in IPF (AIR 1 ) has been designed in collaboration with international clinical experts in IPF and will investigate both safety and lung function. The trial aims to support the decision to initiate a confirmatory trial and is performed in the UK, India, Germany and Sweden. The trial in Germany and Sweden was stopped due to the current war situation. The study is designed as an open-label six month trial in approximately 60 patients and also offers patients the opportunity to continue treatment for an additional three months. The goal is to perform the best possible trial to answer the question if C21 can significantly slow the decline in lung function in patients with IPF. The first patient was dosed in India in November 2020. In February 2022, Vicore performed an interim analysis showing an initial stabilization of disease and then an increase in FVC up to the end of the study at 36 months. Based on the interim analysis, there were 21 evaluable patients of which 13, 9 and 7 patients reached 12, 24 and 36 months respectively. Of the 24 months. Of the 24 months, C21 treated patients had a mean FVC increase of +251 ml, a considerable difference of 371 ml compared to the historical change of -120 ml in an untreated population 2 . Five of the seven patients who completed both 24 and 36 months treatment showed continued improvement in FVC and two remained stable. Analysis of FVC trend during treatment was statistically significant (p=0.016 at 24 months; p=0.016 for change from baseline compared to mean for untreated patients. The study drug was well tolerated with no related serious adverse events related to C21 or gastrointestinal signals. The trial is estimated to read-out in H2 2022 at current recruiting plan and is being prepared for the next trial in IPF.
COVID-19
During 2020, Vicore conducted a phase 2 trial with C21 in 106 patients with COVID-19 (ATTRACT 3 ). In October 2020, the company reported that the trial was fully recruited. Top-line data was published in December 2020. The study was designed as a randomized, double-blind, placebo-controlled trial in patients with moderately severe disease and signs of acute respiratory infection but not requiring mechanical ventilation. It investigated the safety and efficacy of C21 on respiratory failure and other clinical endpoints. 80 percent of the patients received corticosteriod treatment as part of standard of care. The clinical results from the trial were positive demonstrating that C21 can restore lung function in COVID-19, suggesting that C21 can prevent disease progression. Summarized, the trial showed that the need for oxygen supplementation in the C21 group was decreased by 58 percent (p=0.026) at day 8 after start of treatment. At day 14 there was only one patient in the C21 group in need of oxygen supplementation compared to eleven patients in the placebo group (p=0.003), a reduction of more than 90 percent. There was also a clear trend for C21 reducing the number of patients needing mechanical ventilation and a trend for C21 reducing mortality. The treatment was reported safe and well tolerated. There were no treatment-related side effects. The results from an extension trial, 3-6 months after treatment, including a subset of 33 patients (ATTRACT-2 4 ) showed that patients receiving C21 (n=17) displayed reduced pathological abnormalities compared to the placebo group (n=16). In the C21 group, on average 10.3 percent of the lung was affected compared to 19.2 percent in the placebo group. The dominating radiological change was ground glass opacity, a pathological characteristic following viral respiratory infection. In June 2021, Vicore received approval from the U.S. Food and Drug Administration (FDA) to start a pivotal phase 3 trial with C21 in COVID-19 (ATTRACT-3 5 ) and in September the first patients in the trial were dosed. The study is designed as a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVID-19 and requiring oxygen support but not invasive mechanical ventilation. The primary endpoint is to evaluate the effect of C21 on recovery from COVID-19. The patients are randomized to receive 100 mg C21 or placebo twice daily on top of standard of care (SoC) for 14 days and patients will be followed for 60 days. The trial has currently been activated in more than 50 study centers in the US, China, Germany, Sweden, India, Philippines, Argentina, Brazil, Columbia and Russia. In February 2022, the trial in Germany and Sweden was stopped due to the current war situation.
20 | Annual Report 2021 Vicore Pharma Holding AB (publ)## Vicore's Pipeline
Pulmonary arterial hypertension (PAH)
In March 2022, Vicore communicated plans to commence a phase 2 trial in PAH. The tentative design is an open label trial investigating the safety and efficacy of C21 in patients with PAH, with the aim of first patient screened in Q4 2022/Q1 2023. Haemodynamics will be assessed using the Abbott remote monitoring CardioMEMS device.
VP02 – Targeting IPF and IPF-related cough
In the VP02 program, Vicore is developing a novel formulation of thalidomide, which is an existing immunomodulatory drug (IMiD), to be administered locally to the lung. It is thought that the actions of thalidomide suppress pathways involved in the cough reflex together with antifibrotic effects. Many IPF patients suffer from a chronic intractable cough which considerably affects the patients’ quality of life due to sleep disturbances, 6 . Currently, there is no established therapy for IPF-related cough and standard cough medications have little or no effect on the disease. The anti-cough mechanism of VP02 in IPF is due to structural changes in the lungs, increased sensitivity of the cough reflex, airway inflammation and/or changes in mucus production and clearance 7 .
Using IMiDs to treat IPF-related cough
The use of a systemic IMiD to treat IPF-related cough has been shown to have clinical validity. IMiDs have documented antifibrotic and anti-inflammatory attributes and may therefore be well suited for treatment of a number of interstitial lung diseases. In a clinical trial, an IMiD given orally demonstrated a significant positive effect on patients with IPF, reducing the cough and dramatically improving quality of life which is not seen in other interventional clinical trials 8 . Systemic exposure to IMiDs has limited their use due to side effects such as peripheral neuropathy, constipation and sedation. Vicore’s novel VP02 program aims to eliminate the negative aspects of systemic exposure by developing thalidomide for local administration to the lungs.
Program status VP02
VP02 The inhaled formulation for local delivery of thalidomide to treat IPF-related cough is in preclinical development. Vicore continues to evaluate alternative formulations to deliver thalidomide locally to the lung. Further details on the progress in the VP02 program will be announced in coming reports.
VP03 – New AT2R agonists
Within this program, Vicore aims to develop new patentable AT2R agonists to establish a competitive pharmaceutical products also for broader indications.
Program status VP03
The first drug candidate, C106, has completed preclinical development and a CTA for a phase 1 trial is expected during the second quarter of 2022. Three additional ATRAGs are expected to finalize preclinical development during H1 2023. The parallel development of additional ATRAGs continues in parallel.
VP04 – Digital Therapeutics – a broader perspective
The VP04-program consists of a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) to address the psychological impact of living with IPF. DTx products are clinically evaluated software, designed, built, and tested to treat a disease or condition. DTx are approved for use as medical devices in accordance with the regulations in the country of use. DTx products can be a stand-alone software, or used with a wearable sensor, or be part of a medicinal therapy protocol, depending on the intended use and target condition. Vicore is collaborating with Alex Therapeutics for the development. Alex Therapeutics is a Swedish medtech company specializing in design and development of medical device software, with expertise in technology and clinical psychology. The Vicore DTx will be evaluated through real-world pilots and clinical trials as well as secure regulatory approvals, according to national and international medical device development standards.
Program status VP04
Technical development of the software is nearing completion. In March 2022, COMPANION was approved; a randomized, controlled, parallel-group clinical investigation evaluating the impact of digital cognitive behavioural therapy on psychological symptom burden in adults diagnosed with IPF. The study will be conducted in two phases. The first phase is a pilot study with 20 patients. This will be followed by the second phase, a pivotal trial, with 250 patients in Q3 2022. The pivotal study is estimated to read-out during H1, 2023 and thereafter Vicore will offer the digital therapy to be made available to patients in 2024.
- NCT04533022
- Richeldi et al 2014; King et al 2014
- NCT04452435
- NCT04878913
- NCT04880642
- Saini et al 2011
- Vigeland et al 2017
- Horton et al 2012
Interview on our commercial activities
Åsa Magnusson joined Vicore in the fall of 2021 as Chief Commercial Officer. With an ongoing phase 3 trial in COVID-19 and an advanced patient focused program in IPF, it was time to complement the R&D focused team with a strategic commercial person.
What experiences do you bring to Vicore?
With 30 years in different commercial roles in the pharmaceutical industry, I challenge myself to stay curious, continuously learning new things and that’s why Vicore is a perfect match for me. I bring my experience of launching rare disease medicines in areas with high unmet medical need, mainly by ensuring that patients get access to these orphan medicines. Beyond the scientific evidence proving that a medicine is efficacious and safe, we offer to our partners to leverage on our unique expertise and capabilities to ensure that patients get access to these medicines. I look forward to working closely with the highly innovative team at Vicore and focus our cross-functional collaborative forces to create value for patients.
What is your key priority?
My first priority this year is to prepare for the commercialization of C21 in COVID-19. To leverage our commercial team, I have appointed Jessica Shull as our expert, to ensure that our innovative digital therapy specifically designed to treat anxiety and depression with cognitive behavioral therapy (CBT) in people with IPF gets to the patients. I have learned that there is a huge need both from the patient perspective as well as from the health care providers. Last, but not least, the commercial perspective is needed also during the planning of next steps of our of our development programs to ensure that C21 and our next generation of ATRAGs is developed and launched successfully to patients beyond efficacy and safety.
How could C21 add value to patients suffering from COVID-19?
Despite recent advances in preventing and treating COVID-19, there will be a group of patients who are hospitalized and need oxygen supplementation, and this is the patient group that we target. C21 has a unique position in therapy by addressing the alveolar damage of COVID-19. With C21 we have a first in class selective AT2R agonist (ATRAG), targeting the angiotensin II type 2 receptor. This alternate mode of action (vs. current treatments) promotes alveolar healing and reduces the need of oxygen support. In the treatment regimen C21 is clearly positioned between antivirals/antibodies and acute respiratory distress syndrome. Our ATTRACT program aims at confirming how C21 (on top of steroids and antivirals) restores respiratory function and reduces long-term lung sequelae of COVID-19. This alternate mode of action not targeting the virus per se, is expected to be effective independently of variant.
How is the value of a new product established?
Countries have different ways of evaluating the value that a new treatment brings. In general, I would say that the value is established by different parameters, ranging from the severity of the disease, how many other treatments are available and how efficacious and safe they are, as well as their price. In addition, payers in many countries would also want to see that there is a patient relevant benefit when evaluating if they are willing to reimburse a new treatment. Here patient reported outcomes and quality of life evaluations play an important role.
"My focus is to ensure that payers see the value of a product for patients, beyond its efficacy and safety"
The granted original C21 patent is in force until 2024 (see Table A). In addition to this patent, C21 is expected to be protected by different types of patents, including those directed to new formulations and methods of use. In the US a patent covering the use of C21 in the treatment of COVID-19 has been granted (Product patents, See Table B). Moreover, Vicore received the so-called orphan drug status Vicore obtained in the EU and the US for C21 regarding treatment of IPF in the VP01 program. Orphan drug designation provides for up to ten-year protection in Europe and an up to seven-year protection in the United States from the time of registration of an approved drug. If Vicore subsequently receives a marketing authorization for the use of C21 in the treatment of IPF, this treatment of IPF will also be protected by market exclusivity (ten years in Europe and five years in the US). The company also sees good opportunities to obtain orphan drug status for C21 for certain diseases other than IPF. Overall, Vicore believes that the company has strong product protection for C21 based on the development plan being followed. Vicore also develops new improved patentable AT2R agonists in the VP03 programme. The goal is to develop competitive pharmaceutical products for broader indications where it is not possible to obtain orphan drug status.# Annual Report 2021 Vicore Pharma Holding AB (publ)
The Share
As of December 31, 2021, the total number of shares outstanding was 999 MSEK. The number of shareholders amounted to 5,141. The company’s shares are issued in one class and each share carries one vote.
Capital Supply
In November 2020, Vicore acquired novel AT2R agonists from HaLaCore Pharma and decided to pay for the acquisition by issuing shares, which was registered at the Swedish Companies Registration Office during the first quarter of 2021. On February 10, 2021, Vicore completed a directed share issue of 11,200,000 shares at a subscription price of SEK 30.0 per share, raising a total amount of approximately 336 MSEK before transaction costs. The directed share issue was approved at an Extraordinary General Meeting in March 2021.
Analyst Coverage
The following analysts cover Vicore and continuously analyze the company's development:
- DNB - Øyvind Grønmyr
- SPP - Håkan Björklund
- Sjögren - Magnus Jepsen
Largest Shareholders
| Shareholder | No. of shares | % |
|---|---|---|
| HealthCap VII L.P. | 15,834,834 | 22.1% |
| Fourth Swedish National Pension Fund | 6,632,041 | 9.2% |
| HBM Healthcare Investments (Cayman) Ltd. | 4,620,302 | 6.4% |
| Protem | 4,030,340 | 5.6% |
| Jove AB/Asset Management | 3,120,425 | 4.3% |
| Unionen | 2,663,990 | 3.7% |
| Østberg Consulting | 2,644,165 | 3.7% |
| Third Swedish National Pension Fund | 2,641,425 | 3.7% |
| Avanza Pension | 2,527,370 | 3.5% |
| Infima/Hektor | 1,531,303 | 2.1% |
| Second Swedish National Pension Fund | 1,050,000 | 1.5% |
| Alexander Shaps | 685,108 | 1.0% |
| Nordnet Pension | 502,001 | 0.7% |
| Lancelot Asset Management | 500,000 | 0.7% |
| Alfred Berg Funds | 484,537 | 0.7% |
| Carl-Johan Dalsgaard | 477,981 | 0.7% |
| Kopian/Katarina/Torkel | 410,000 | 0.6% |
| Mats K Andersson | 390,000 | 0.5% |
| SEB Funds | 376,641 | 0.5% |
| Other | 20,637,830 | 28.8% |
| Total number of shares | 70,760,293 | 100.0% |
Source: Monitor by Modular Finance as of February 28, 2022
Largest shareholders in Vicore as of February 28, 2022:
Share Price Development
At the end of 2021, the share price was 13.9 SEK. The highest price paid for the share during the year was 34.6 SEK on February 16 and the lowest price paid was 12.8 SEK on December 21. The share price decreased by a total of 56 percent during 2021, and the company's market capitalization was 999 MSEK as of December 31, 2021.
Share Data
The number of registered shares on December 31, 2021 amounted to 71,760,293 ordinary shares.
Financial Targets and Dividend Policy
The target is to distribute approximately 50 percent of the company’s annual net profit as dividends when Vicore has achieved significant and stable profits. The distribution will, however, take into account the company’s present and future profit levels, investment needs, liquidity and development opportunities as well as general economic and business conditions. In accordance with the Board of Directors' dividend policy, no dividend is to be paid before the company generates significant revenue.
Development of the Share during 2021
| Year | Event | Quota value | Increase in number of shares | Increase in share capital | Total no. of shares | Total share capital |
|---|---|---|---|---|---|---|
| 2021 | Share issue | 0.5 | 11,200,000 | 5,600,000 | 71,760,293 | 35,880,147 |
| 2021 | Attt-r in köp | 0.5 | 142,054 | 71,027 | 60,560,293 | 30,280,146 |
| 2020 | Share issue | 0.5 | 10,000,000 | 5,000,000 | 60,418,239 | 30,209,119 |
| 2020 | Share issue | 0.5 | 243,525 | 121,763 | 50,418,239 | 25,209,119 |
| 2019 | Share issue | 0.5 | 7,800,000 | 3,900,000 | 50,174,714 | 25,087,357 |
| 2019 | Share issue | 0.5 | 9,414,706 | 4,707,353 | 42,374,714 | 21,187,357 |
| 2018 | Share issue | 0.5 | 8,240,002 | 4,120,001 | 32,960,008 | 16,480,004 |
| 2018 | Attt-r in köp | 0.5 | 8,851,502 | 4,425,751 | 24,720,006 | 12,360,003 |
| 2017 | Share issue | 0.5 | 1,500,000 | 750,000 | 15,868,504 | 7,934,252 |
| 2017 | Share issue | 0.5 | 2,000,000 | 1,000,000 | 14,368,504 | 7,184,252 |
| 2015 | Share issue/Listing | 0.5 | 3,248,144 | 1,624,072 | 12,368,504 | 5,684,252 |
| 2015 | Reverse split, 1:10 | 0.5 | -73,083,239 | - | 8,120,360 | 4,060,180 |
| 2015 | Share issue | 0.05 | 12,639,073 | 631,954 | 81,203,599 | 4,060,180 |
| 2013 | Share issue | 0.05 | 34,282,263 | 1,714,113 | 68,564,526 | 3,428,226 |
| 2012 | Offset issue | 0.05 | 474,498 | 23,725 | 34,282,263 | 1,714,113 |
| 2011 | Share issue | 0.05 | 10,402,389 | 520,120 | 33,807,765 | 1,690,388 |
| 2010 | Offset issue | 0.05 | 1,000,000 | 50,000 | 23,405,376 | 1,170,269 |
| 2010 | Share issue | 0.05 | 5,601,344 | 280,067 | 22,405,376 | 1,120,269 |
| 2010 | Share issue | 0.05 | 5,601,344 | 280,067 | 16,804,032 | 840,202 |
| 2008 | Share issue | 0.05 | 688 | 34 | 11,202,688 | 560,134 |
| 2008 | Split 1:2000 | 0.05 | 11,196,399 | - | 11,202,000 | 560,100 |
| 2008 | Bonus issue | 100 | 4,601 | 460,100 | 5,601 | 560,100 |
| 2005 | Formation | 100 | 1,000 | 100,000 | 1,000 | 100,000 |
Share Capital Development
| Size categories | Number of known shareholders | Number of shares | % of capital |
|---|---|---|---|
| 1 - 10,000 | 5,773 | 5,086,679 | 7.1% |
| 10,001 - 50,000 | 188 | 4,237,692 | 5.9% |
| 50,001 - 100,000 | 30 | 2,249,991 | 3.1% |
| 100,001 - 500,000 | 26 | 6,379,482 | 8.9% |
| 500,001 - 1,000,000 | 2 | 1,187,109 | 1.7% |
| 1,000,001 - 5,000,000 | 9 | 24,829,320 | 34.6% |
| 5,000,001 - | 2 | 22,466,875 | 31.3% |
| Anonymous holdings | - | 5,323,145 | 7.4% |
| Total | 6,030 | 71,760,293 | 100.0% |
Ownership distribution by holding
Ownership distribution in Vicore as of February 28, 2022:
| Shareholder category | Number of shares | % of capital |
|---|---|---|
| Swedish shareholders | 60,575,144 | 84.4% |
| International shareholders | 11,185,149 | 15.6% |
| Shareholder type | Number of shares | % of capital |
|---|---|---|
| Swedish institutional shareholders | 34,523,574 | 48.1% |
| International institutional shareholders | 4,650,951 | 6.5% |
| Swedish retail investors | 17,406,644 | 24.3% |
| Other | 9,804,694 | 13.7% |
| Anonymous holdings | 5,374,430 | 7.5% |
Shareholder categories
Shareholder categories in Vicore as of February 28, 2022:
Administration Report
The Board of Directors and the CEO of Vicore Pharma Holding AB (publ.), Corp. Reg. No. 556680-3804, hereby submit the annual report and consolidated financial statements for the 2021 fiscal year.
Vicore’s Operations
Vicore is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe diseases where the Angiotensin II type 2 receptor (AT2R) plays an important role. The company currently has four development programs, VP01, VP02, VP03 and VP04. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF), COVID-19 and pulmonary arterial hypertension (PAH). VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2R-agonists. VP04 develops a clinically validated digital therapeutic for IPF patients (Vicore DTx). The company's shares (VICO) are listed on the Nasdaq Stockholm.
In the beginning of the year, Vicore completed a directed share issue raising 336 MSEK. The issue was subscribed by Swedish and international institutional investors and the intended use of the proceeds was among others, to finance the phase 3 trial in COVID-19. The share issue was approved at an Extraordinary General Meeting in March. The results from the trial with C21 in patients with systemic sclerosis and Raynaud's phenomenon was presented in March and showed vasodilating effects with C21 on peripheral resistance vessels. In May, Vicore entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) to treat anxiety in patients living with idiopathic pulmonary fibrosis (IPF). A pilot phase study on 20 patients will be followed by a pivotal study on approximately 250 patients in H2 2022. In September, the first patients in the global phase 3 trial in COVID-19 (ATTRACT-3) on 600 patients, were dosed. In September, Vicore was granted a patent in the US covering the use of C21 to treat infections caused by Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), including SARS CoV-2. In November, Vicore announced results from the phase 2 extension trial in COVID-19 (ATTRACT-2) showing a strong disease modifying effect and an improved quality of life after COVID-19. The open-label phase 2 trial in 60 patients with IPF is progressing. After year-end an interim analysis suggests that C21 stabilizes disease and increases lung function in patients with IPF. Estimated read-out of the phase 2 trial is during the second half of 2022. In parallel, preparations for the next trial is ongoing. The evaluation of alternative formulations to deliver thalidomide locally to the lung in the VP02 program continued during 2021. The VP03 program progressed well during 2021 and after year-end, Vicore announced that the first drug candidate, C106, is ready for clinical development and a phase 1 trial is expected to start during 2022. After year-end, Vicore announced the plan to initiate a proof-of-concept trial with C21 in pulmonary arterial hypertension (PAH). During 2021, Vicore strengthened the organization, spanning from R&D, Quality Assurance to commercial functions.
Intellectual Property
| Table A – Substance patents | ||||
|---|---|---|---|---|
| Project | Country | Application date (priority) | Status | Expiry year (planned) |
| VP01 (C21) | US | 31.05.2001 | Granted | 2024 |
| VP03 | National | 20.09.2019 | Pending | 2040 |
| VP03 | International | 19.03.2020 | Pending | 2041 |
| VP03 | International | 20.03.2020 | Pending | 2041 |
| VP03 | International | 01.09.2020 | Pending | 2041 |
| VP03 | International | 23.03.2021 | Pending | 2042 |
| VP03 | International | 23.03.2021 | Pending | 2042 |
| VP03 | International | 23.03.2021 | Pending | 2042 |
| VP03 | International | 09.07.2021 | Pending | 2022 |
| Table B – Other patents related to product VP01 (C21) | ||||
|---|---|---|---|---|
| Project | Country | Application date (priority) | Status | Expiry year (planned) |
| VP01 (C21) | International/US | 23.03.2020 | Granted in US/ Pending | 2040/41 |
| VP01 | International | 24.04.2020 | Pending | 2041 |
| VP01 | International/US | 24.04.2020 | Pending | 2041 |
| VP01 | International/US | 24.04.2020 | Pending | 2041 |
| VP01 | International | 14.05.2020 | Pending | 2041 |
| VP01 | Priority | 25.10.2021 | Pending | 2042 |
| VP01 | Priority/US | 10.02.2022 | Pending | 2042/43 |
| ## Vicore Pharma Holding AB (publ) |
In August, Vicore announced a strengthened management team with three senior recruitments; Jessica Shull, Head of Digital Therapeutics, Åsa Magnusson, Chief Operating Officer, and Karin Nygård, VP Business Development. At the end of 2021, a total of 21 employees were employed by Vicore.
Important events during 2021
- February: Vicore completed a directed share issue raising 336 MSEK.
- March: The share issue was approved at an Extraordinary General Meeting.
- March: Vicore reported top-line data from the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing promising results.
- May: Vicore announced that the company had entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).
- June: Vicore announced that the company had received approval from the U.S. Food and Drug Administration (FDA) to start the pivotal phase 3 trial with C21 in COVID-19.
- August: Vicore announced a strengthened management team with three senior recruitments; Jessica Shull, Head of Digital Therapeutics, Åsa Magnusson, Chief Operating Officer, and Karin Nygård, VP Business Development.
- September: Vicore announced that the first patients in the global phase 3 trial with C21 in COVID-19 (ATTRACT-3) were dosed.
- September: Vicore announced that the company was granted a patent in the US covering the use of C21 to treat infections caused by Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), including SARS CoV-2.
- October: Vicore announced that the results from the phase 2 trial in COVID-19 (ATTRACT) were published in EClinicalMedicine, a sub-journal to the Lancet.
- November: Vicore announced results from the ATTRACT phase 2 extension trial showing that C21 preserved lung function in patients with moderate COVID-19.
Important events after the year-end
- February: An interim analysis of the AIR phase 2 trial in IPF suggests that C21 stabilizes disease and shows an unanticipated increase in lung function in IPF patients.
- February: Vicore announced the establishment of a new drug candidate from the VP03 program as a standalone medicinal product. A clinical trial application (CTA) is expected to be submitted during the second quarter 2022.
- March: Vicore announced the plan to initiate a proof-of-concept trial with C21 in pulmonary arterial hypertension (PAH).
- March: Vicore announced the initiation of a human forearm blood flow study with C21 to start in Q2 2022.
- March: Vicore announced that Michael Wolff Jensen resigned from the board and was replaced by Jacob Gunterberg as chairman until the annual general meeting in May 2022.
Revenue
Net sales amounted to 0.0 MSEK (0.0) for the full year 2021.
Operating expenses
Operating expenses amounted to -295.9 MSEK (-167.7) for the full year 2021. Research and development expenses comprise a large fraction of the operating expenses. The increase in operating expenses is according to plan and is mainly attributable to increasing research and development expenses.
Administrative expenses amounted to -20.2 MSEK (-25.0) for the full year 2021. The costs for share-based incentive programs related to administrative staff amounted to +2.3 MSEK (-6.9) for the full year 2021.
Research and development expenses amounted to -271.8 MSEK (-142.0) for the full year 2021. Research and development expenses are mainly related to clinical trial costs for VP01. The costs for share-based incentive programs related to research and development staff amounted to -0.7 MSEK (-1.3) for the full year 2021.
Other operating income and expenses amounted to -1.4 MSEK (17.5) for the full year 2021. During the second quarter of 2020, Vicore received a grant of 1.5 GBP million from the British research charity LifeArc for the ATTRACT study in patients with COVID-19.
The total costs for the share-based incentive programs for the full year 2021 amounted to +1.5 MSEK (-8.2), of which +5.4 MSEK (-5.6) consisted of provisions for social security contributions and -3.9 MSEK (-2.6) were IFRS 2 classified salary costs. These costs have had no cash flow impact.
Result
The operating loss amounted to -294.8 MSEK (-149.5) for the full year 2021. The result after tax for the full year 2021 was -296.7 MSEK (-147.3).
Tax amounted to 0.3 MSEK (0.5) for the full year 2021. Tax is mainly related to a change in deferred tax liability attributable to acquired intangible assets. The group’s accumulated tax loss carryforwards as of December 31, 2021, amounted to 729.8 MSEK. The group’s tax loss carryforwards have not been measured and are not recognized as a deferred tax asset. These tax loss carryforwards will be accounted for only when the group has established a level of earnings which management with confidence estimates will lead to taxable profits.
The loss for the full year 2021 amounted to -296.5 MSEK (-146.9). The loss per share before and after dilution amounted to SEK -4.25 (-2.71) for the full year 2021.
Cash flow, investments and financial position
Cash flow from operating activities amounted to -265.2 MSEK (-119.9) for the full year 2021.
Cash flow from investing activities for the full year 2021 was -7.0 MSEK (4.0). The difference compared with the previous year is mainly attributable to the acquisition and sale of short-term interest-bearing investments.
Cash flow from financing activities amounted to 318.2 MSEK (177.0) for the full year 2021. On February 10, 2021, the company completed a directed share issue of 336 MSEK before transaction costs amounting to approximately 17.6 MSEK. The directed share issue was approved at an Extraordinary General Meeting in March 2021. The directed share issue was subscribed for by Swedish and international institutional investors. The subscription price of 30.0 SEK per share was determined through book building and corresponds to approximately 0.6 percent premium to the 10-day volume weighted average share price. The issue proceeds are mainly intended to finance the company's development programs.
As of December 31, 2021, cash and cash equivalents amounted to 294.2 MSEK (248.6) and short-term investments were 77.3 MSEK (70.1). Accordingly, cash, cash equivalents and short-term investments amounted in total to 371.5 MSEK (318.7).
The equity ratio as of December 31, 2021, was 85.0 percent (87.2 percent) and equity amounted to 383.3 MSEK (354.5). Total equity and liabilities amounted to 451.2 MSEK (406.5).
Parent company
The group ("Vicore") consists of the parent company, Vicore Pharma Holding AB (publ) and the subsidiaries Vicore Pharma AB and INIM Pharma AB. The parent company’s operations mainly consist of providing management and administrative services for the group’s operative companies. The research and development operations are conducted in the wholly owned subsidiaries Vicore Pharma AB and INIM Pharma AB.
Net sales for the parent company amounted to 38.8 MSEK (3.7) for the full year 2020. Net sales mainly consisted of re-invoiced costs and management fees to group companies.
Administrative expenses amounted to -19.9 MSEK (-24.7) for the full year 2021. The operating profit (loss) for the full year 2021 amounted to 17.1 MSEK (-22.6). The profit (loss) amounted to 17.6 MSEK (-21.8) for the full year 2021. During the full year 2021, shareholder contributions amounting to 400 MSEK were provided to the subsidiaries.
Personnel
As of December 31, 2021, the group had 21 employees, of whom 14 were women and seven men. Of the employees, 15 are active within R&D. The group also has consultants and assignments on a frequent basis.
Shareholders and the share
At the end of 2021, Vicore had 5,141 shareholders and the number of shares was 71,760,293 with a quotient value of SEK 0.5 each. There is only one class of shares. The company's shares are issued in one class and each share carries one vote at the Annual General Meeting.
On December 31, 2021, HealthCap VII L.P. was the single largest shareholder in Vicore, with a total of 15,834,834 shares, corresponding to 22.1 percent of the votes and capital. No shareholder other than HealthCap VII L.P. has a direct or indirect shareholding that represents one tenth, or more, of the voting rights for all shares in the company. Further information on shareholders and Vicore's share is presented on pages 24-25 in the 2021 annual report.
Share-based incentive programs
The purpose of share-based incentive programs is to promote the company’s long-term interests by motivating and rewarding the company’s senior management and key employees and align their interests with the interests of the shareholders.
As of December 31, 2021, Vicore has four active programs that include the management team, employees and certain board members. At the Extraordinary General Meeting on August 13, 2018, it was resolved to implement two new incentive programs: a maximum of 2,000,000 options to senior executives and employees ("Option Program LTIP 2018"); and a maximum of 475,000 share awards to board members ("Board LTIP 2018").
At the Annual General Meeting on May 20, 2020, it was resolved to implement a new incentive program for the new board members ("Board LTIP 2020") amounting to a maximum of 525,000 share awards.At the Annual General Meeting on May 11, 2021, it was resolved to implement two new incentive programs: a maximum of 73,000 share awards to certain board members (”Board LTIP 2021”). All these programs are performance-based programs entitling the holder to a maximum of one common share in Vicore per option or share award after three years. For further information about these programs, see Note 8 "Share-based payments", the minutes of the Extraordinary General Meeting 2018, the minutes of the Annual General Meeting 2020 and the minutes of the Annual General Meeting 2021, which are published on the company’s website, www.vicorepharma.com. During the third quarter of 2021, Board LTIP 2018 expired. As the share price increased by less than 50 percent during the measurement period no share awards were earned. The program is now closed. The increase in the company’s share capital, assuming full utilization and maximum goal achievement of all active incentive programs (i.e. including non-vested options that may be used as hedge for social security contributions), amounts to a maximum of SEK 2,793,387, 2022 corresponding to a dilution of 7.2 percent of the total number of shares. As of December 31, 2021, a total of 525,000 share awards have been granted in the Board LTIP 2020 program, 61,773 share awards have been granted in the Board LTIP 2021 program, and warrants to 1,325,800 shares have been granted to employees. In addition, share awards to 807,600 shares have been granted in the Board LTIP 2016.
Guidelines for executive remuneration 2021
The board of directors, the CEO and other members of the executive management fall within the provisions of these guidelines. The guidelines are applicable to remuneration agreed, and amendments to remuneration already agreed, after adoption of the guidelines by the annual general meeting 2021. These guidelines do not apply to any remuneration already decided or approved by the general meeting.
The guidelines’ promotion of the company’s business strategy, long-term interests and sustainability
In short, the company’s business strategy is the following. Vicore Pharma is a rare disease pharmaceutical company with a focus on fibrotic lung diseases and related indications. The company currently has three drug development programs, VP01, VP02 and VP03. The VP01 program aims to develop the substance C21 for the treatment of IPF and COVID- 19. The VP02 program is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). The VP02 program focuses on the underlying disease and the severe cough associated with IPF. Both VP01 and VP02 are intended for other indications within the field of fibrotic lung diseases which have a significant unmet need. The VP03 pro- gram includes follow-up molecules for C21. Vicore’s long-term goal is to obtain regulatory approvals and establish the company as a pharmaceutical company specializing in fibrotic lung disease. For more information regarding the company’s business strategy, please see Vicore Pharma’s company presentation at https://vicorepharma. com/investors/events-presentations/.
A prerequisite for the successful implementation of the company’s business strategy and safeguarding of its long-term interests, including its sustainability, is that the company is able to recruit and retain qualified personnel. To this end, it is necessary that the company offers a competitive European level remuneration. These guidelines enable the company to offer the executive management a competitive total remuneration. Variable cash remuneration covered by these guidelines shall aim at promoting the company’s business strategy and long-term interests, including its sustainability. The company also has long-term share-related incentive plans in place. The plans have been resolved by the general meeting and aim to align the interests of the board members and the personnel with those of the company’s shareholders.
Types of remuneration, etc.
The remuneration shall be market-based and may consist of the following components: fixed cash salary, variable cash remuneration, pension benefits and other benefits. Furthermore, additional variable cash remuneration may be awarded in extraordinary circumstances. Additionally, the general meeting may – irrespectively of these guidelines – resolve on, among other things, share-related or share price-related incentive programs. The satisfaction of criteria for awarding variable cash remuneration shall be measured over a period of one to several years.
The variable remuneration payable in cash may amount to a maximum of 40 percent of the annual fixed cash salary for the CEO and a maximum of 30 percent of the annual fixed cash salary to other senior executives under the measurement period for such criteria. Further variable cash remuneration may be awarded in extraordinary circumstances, provided that such extraordinary arrangements are limited in time and only made on an individual basis, either for the purpose of recruiting or retaining executives, or as remuneration for extraordinary performance or upon specific projects. Such remuneration may not exceed an amount corresponding to 50 per cent of the fixed annual cash salary and may not be paid more than once per year for each individual. Any resolution on such remuneration shall be made by the board of directors based on a proposal from the remuneration committee.
For the CEO, pension benefits, including health insurance, shall be premium defined unless otherwise required by for example collective agreements. The pension premiums for premium defined pension shall amount to not more than 30 per cent of the fixed annual cash salary. For other executives, pension benefits, including health insurance, shall be premium defined unless otherwise required by for example collective agreements. The pension premiums for premium defined pension shall amount to not more than 30 per cent of the fixed annual cash salary. Other benefits may include, for example, life insurance and medical insurance. Such benefits may not amount to more than 10 per cent of the fixed annual cash salary. For employments governed by rules other than Swedish, pension benefits shall be such as are required for compliance with mandatory rules applicable in such country, taking into account, to the extent possible, the overall purpose of these guidelines.
Termination of employment
For all executives the notice period may be up to six months if notice of termination of employment is made by the company. For the CEO, fixed cash salary during the notice period and severance pay may, in total, not exceed twelve months’ fixed salary, and for other executives, such remuneration may not correspond to an amount which exceeds six months’ fixed salary. The period of notice may be up to six months without any right to severance pay when termination is made by the executive. Additionally, remuneration may be paid upon termination of employment by the company to compensate for loss of income and shall only be paid in so far as the previously employed executive is not entitled to severance pay. The remuneration shall amount to not more than 60 per cent of the monthly income at the time of termination of employment and be paid during the time compensation for loss of income is paid, however not for more than 12 months following termination of employment.
Criteria for awarding variable cash remuneration, etc.
The variable cash remuneration shall be linked to predefined criteria. These criteria can be measurable advancements in the company’s preclinical and clinical trials and other associated activities. The criteria can be financial or non-financial. They may also be individualized, quantitative or qualitative. All criteria shall be designed so as to contribute to the company’s business strategy and long-term interests, including its sustainability, for example by aligning the incentive to the business strategy or the executive’s long-term development. The board of directors shall have the possibility, under applicable law or contractual provisions, to in whole or in part reclaim variable remuneration awarded on incorrect grounds.
To which extent the criteria for awarding variable cash remuneration have been satisfied shall be evaluated/ determined when the measurement period has ended. The remuneration committee is responsible for the evaluation so far as it concerns variable remuneration to the CEO. For variable cash remuneration to other executives, the CEO is responsible for the evaluation, with the board of directors for those executives who report directly to the CEO. For financial criteria, the evaluation shall be based on the latest financial information made public by the company.# Salary and employment conditions for employees
In the preparation of the board of directors’ proposal for these remuneration guidelines, salary and employment conditions for employees of the company have been taken into account, including information on the employees’ total income, the components of the remuneration and increase and growth rate over time, in the remuneration committee’s and the board of directors’ basis of decision when evaluating whether the guidelines and the limitations set out herein are reasonable.
The decision-making process to determine, review and implement the guidelines
The board of directors has established a remuneration committee. The committee’s assignment includes the board of directors’ proposal for these remuneration guidelines. The board of directors shall prepare a proposal for new guidelines at least every fourth year and submit it to the general meeting. The guidelines shall be in force until new guidelines are adopted by the general meeting.
The remuneration committee shall also monitor and evaluate programs for variable remuneration for the executive management, the application of the guidelines for executive remuneration as well as the current remuneration structures and compensation levels in the company. The members of the remuneration committee are independent of the company and its executive management. The CEO and other members of the executive management do not participate in the board of directors’ processing of and resolutions regarding remuneration-related matters in so far as they are affected by such matters.
Derogation from the guidelines
The board of directors may temporarily resolve to derogate from the guidelines, in whole or in part, if in a specific case there is special cause for the derogation and a derogation is necessary to serve the company’s long-term interests, including its sustainability, or to ensure the company’s financial viability. As set out above, the remuneration committee supports the board of directors’ resolutions in remuneration-related matters. This includes any resolutions to derogate from the guidelines.
Description of significant changes to the guidelines for 2022 and how the shareholders' views have been taken into account
No significant changes have been made to the proposed guidelines for 2022 compared to previously adopted guidelines. No shareholders have provided any comments.
Nomination committee for the 2022 Annual General Meeting
Vicore’s nomination committee for the 2021 Annual General Meeting consists of Staffan Lindstrand, appointed by Östersjöstaden AB, Kjell Hansson, appointed by Kvinno i Lidingö AB, and Michael Wolff Jensen, Chairman of the Board of Directors of Vicore.
30 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Risk factors
Vicore’s business is influenced by a number of factors, the effects of which on the company’s earnings and financial position, in certain respects, cannot be controlled by the company at all or in part. In an assessment of the company’s future development, it is important, alongside the possibilities for growth, to also take into account risks.
Set forth below is a description, without any internal order of priority, of risks that are of the greatest significance for the company’s business and its results. Several of these risks relate to Vicore’s operations, industry and market. Other risks relate to Vicore’s operations, for example, clinical trials and regulatory approvals, and significant third-party dependence.
Clinical trials in Russia and Ukraine
Events in Russia and Ukraine have negatively affected the availability and recruitment of potential trial participants as well as their ability to carry out non-essential hospital visits. This can lead to patients not completing a study or not returning for follow-up.
Consequently, there is a risk that studies with VP01 in IPF and COVID-19, respectively, will be delayed or need to be withdrawn, which could have a material negative impact on the company's operations, financial position and results.
COVID-19-pandemic
The COVID-19-pandemic, which has caused disruptions in the economies of many countries, including the group’s ability to carry out clinical studies. The duration and expected development of the COVID-19-pandemic are subject to considerable uncertainty, and no predictions can be made in relation to the length of present and further measures that different countries and authorities will impose to combat the crisis. However, any prolongation or exacerbated development of the pandemic may lead to e.g. the following: the availability and recruitment of potential trial participants in clinical studies as well as their possibility of carrying out non-essential hospital visits is negatively affected. This could lead to delays of the studies, greater study costs and capital need than anticipated, disruptions in the operations of third-party manufacturers, clinical research organizations, and other parties on whom Vicore relies, the availability or cost of materials, which could damage Vicore’s supply chain or otherwise limit its ability to produce Vicore’s drug candidates to be used in clinical trials, regulatory approvals or opinions for programs are delayed, commercialization of new products is hampered, and development of further candidate drugs is delayed, which can impact the company’s financial performance.
Given the evolving nature of the pandemic, the above list is by no means exhaustive, but each of these events, or any combination of them, could amplify the negative impact of the crisis on the group’s financial performance and have material adverse effect on the group’s business, financial development and shareholder value.
Research and development and the dependency of four programs
Vicore's business consists mainly of four programs (VP01, VP02, VP03 and VP04). The company's main value may be attributable to the potential of the company's respective programs. The programs are in preclinical or clinical development. Consequently, there is a risk that various programs will not develop as planned, which could have a material adverse effect on the company's value and future potential. This is especially true if any of the above would occur in the more advanced program VP01, which is currently of the greatest value to the company. For example, there is a risk that partners, institutional review bodies and / or regulatory authorities will discontinue clinical studies if the results of such studies do not demonstrate the intended treatment effect, fail to achieve an acceptable safety profile, or due to results from unwanted side effects. If a program or study is interrupted, in addition to a significant decline in the company's share price as a result of a reduced value of the company's program portfolio and a significantly impaired revenue potential for the specific program, it may cause an impairment of fixed assets.
Clinical trials and regulatory approvals
Before conducting certain clinical trials, approval must be obtained from the relevant regulatory authority and an ethics committee. The company's future products are the United States and the EU, and the relevant regulators are the US Food and Drug Administration ("FDA") and / or the European Medicines Agency ("EMA").
Consequently, there is a risk that the relevant regulatory authority and / or the ethics committee will not grant the necessary approvals for the company's ongoing or future clinical trials. Consequently, there is a risk that program approvals or opinions will be delayed or withdrawn. If the necessary approvals are not obtained, delayed or withdrawn, this could delay the relevant program or mean that it needs to be discontinued. Consequently, this could have a material adverse effect on the company's operations, financial position and results.
Delays in clinical studies
Consequently, there is a risk that clinical studies, for example, VP01, VP02, VP03 or VP04 will be delayed. Delays can occur for a variety of reasons, including difficulties in reaching agreements with clinics about participation under acceptable conditions, problems in identifying patients for studies, patients not completing a study, or not returning for follow-up. A pandemic and / or a war could negatively affect the availability and recruitment of potential trial participants as well as their possibility of carrying out non-essential hospital visits. Difficulties in adding new clinics or if a clinic withdraws from a study can also lead to delays. Consequently, there may be delays as a result of problems in the supplier route, where a delay in the delivery of an ordered substance may cause a delay in the studies. A delay in a program usually means that the program will be more expensive, since the research and development costs will run for a longer time than planned. This may result in the company having to raise additional capital to complete the program.
Development of further candidate drugs
In addition to the programs, VP01, VP02 and VP04, the company aims to identify and develop new selective AT2 receptor molecules for treatment of diseases within or outside the orphan disease area in VP03 program. Consequently, there is a risk that the company's financial resources will prove insufficient to conduct such development and that the company, as a result thereof, may be forced to discontinue development or find other sources of financing. Continuing the further development of new molecules could create a need to expand the company’s organisational resources, which could incur further costs for the company.
31 | Annual Report 2021 Vicore Pharma Holding AB (publ)There is thus a risk that any failure to obtain and defend intellectual property rights will have a negative impact on its operations, financial position and results.
Intellectual property issues
The value of Vicore is largely dependent on its ability to obtain and defend patents and its ability to protect specific know-how. Obtaining patent protection for pharmaceutical companies may be uncertain and involve complicated legal and administrative processes. There is a risk that a patent sought will not be granted for an invention, that the patent granted will not provide sufficient protection, or that the patent granted will be circumvented by competitors. Vicore holds three granted patents within the VP01 program. There is a risk that the granted patents will not constitute adequate protection. If intellectual property protection is not satisfactory, other parties can exploit this by circumventing the company's protection and conduct competing drug development. Such drug development could show higher efficacy. This may force Vicore to terminate a particular drug program for commercial reasons, or that the company's future product will not generate any revenue. Vicore has several pending patent applications within the VP01, VP02 and VP03 programs. There is a risk that patent applications or future patent applications by the company are not granted. If a patent application is not granted, it can lead to insufficient commercial protection which may result in termination of programs, or that the company's drug candidates will not be protected from generic competition or be exploited by competitors. A failure to obtain satisfactory commercial protection and a decision to terminate programs would have a material adverse effect on the company's business, financial condition and results of operations.
Orphan drug status
In addition to the company's patents, Vicore has received so-called orphan drug status for C21 for the treatment of IPF in the USA and EU, which becomes particularly relevant if Vicore succeeds in developing and launching a drug. This means that Vicore will depend on other protection than patents, such as, alternative commercial protections in the form of orphan drug status or data exclusivity. If the existing commercial and / or intellectual property protections are not adequate for Vicore's purposes, competitors may exploit this by bypassing the company's protection, and conduct competing drug development, or launching competing products. If competitors can develop competing products that show higher efficiency or are sold at a lower price than Vicore's, the company could lose significant revenue.
Market and competition
The development and commercialization of new pharmaceutical products are highly competitive and a complex process. Vicore's competitors are mainly large pharmaceutical companies, biotech companies and academic institutions. It is possible that competitors, such as large pharmaceutical companies, have greater opportunities in terms of, for example, research and development, contacts with regulatory authorities, marketing, sales and distribution networks. It is possible that competitors, who in many cases have greater resources than Vicore, may develop competing products more rapidly or that they may develop competing products that are more effective or less expensive than Vicore’s. This could lead to a decrease in the company's ability to generate revenues and the company may be forced to terminate parts of the business for commercial reasons. Furthermore, this could mean that the value of the company's program portfolio is significantly reduced.
Production
Since Vicore has no proprietary production facilities, the company is dependent on sub-suppliers for the production of pharmaceuticals. The manufacturing process for Vicore’s drugs are made in collaboration with contract manufacturers in Europe. Vicore is dependent on the quality of the manufacturing processes as well as the availability and maintenance of the production facilities. Regulatory authorities require that all manufacturing processes and methods, as well as all equipment comply with current requirements of Good Manufacturing Practice, GMP requirements and consequences for the company in the event of deficiencies in GMP requirements may lead to delays in product launches or the possibility of Vicore’s drug candidates not being approved. None of the company's current manufacturers are significant in the sense that they are not replaceable, but the company is dependent on them, since changing manufacturers can be both costly and time-consuming. There is a risk that suitable manufacturers that offer the same quality and quantity on terms acceptable to the company cannot be found.
Reliance on key individuals and employees
Vicore is highly dependent on retaining and recruiting both qualified employees and consultants as well as board members. The company's future performance is affected by its ability to attract and retain key employees. If any of the company’s key management or scientific personnel resigns and the company fails to replace him or her, this could have a negative effect on the company's operations, financial position and earnings. In order for the company to have sufficient capacity to further develop its drug candidates and conduct phase III studies, several persons must be recruited. If the recruitment is not successful, or if Vicore fails to retain key personnel, the company's drug development programs cannot be developed according to plan, which would have significant negative consequences for the company's operations and program portfolio. Such personnel deficiencies may lead to delays in the company's programs, which would be associated with significant research and development costs.
Financing and capital requirements
The company currently has no approved drugs and does not generate any revenue. It will take a long time before the company's drug candidates will be sold commercially and generate recurring cash flows. The company's ongoing and planned clinical trials entail significant costs. The company is therefore still dependent on raising capital or borrowing money to finance clinical studies. Both the extent and timing of Vicore's future capital needs will depend on a number of factors, including results from and costs for future studies. The access to, and the conditions for, additional financing, for example through new share issues, licenses or partnership agreements or loans are affected by a number of factors such as Vicore's clinical study results, the market value of its drug candidates, the company's financial position, investor confidence, the availability of equity and debt capital and Vicore's credit rating and credit capacity. Disruptions and uncertainty in the credit and capital markets could have a negative impact on the company's ability to secure additional capital. If Vicore fails to raise sufficient capital on favorable terms, or at all, it would mean that the company may have to accept a more expensive financing solution, share issues with significant discount and large dilution, or cause the company to limit its development or cease operations. For further description of the company's financial needs, see Note 25.
Currency risk
Assets, liabilities, income and expenses in foreign currency give rise to currency fluctuations. For example, a weakening of the Swedish Krona (SEK) against other currencies, such as EUR or USD, increases the reported amounts of Vicore’s assets, liabilities, income and earnings while a strengthening of the SEK against other currencies decreases these items. The company is exposed to such changes, as parts of the company’s costs are paid in EUR and other international currencies and because a part of the company’s future sales revenue may be received in international currencies. A material change in such exchange rates could have a negative impact on the company’s financial statements, which in turn could have negative effects on Vicore’s financial position and results. To reduce currency exposure in EUR, the company exchanges SEK to EUR in the range of 60-100% of expected future cash flows. See also Note 19.
Tax loss carryforwards
As a result of the business having generated significant loss, Vicore has large accumulated tax loss carryforwards. As of December 31, 2021, Vicore's tax loss carryforwards amounted to 729.8 MSEK. Changes in ownership resulting in a change of controlling influence over Vicore, or certain internal transfers described above, may impose restrictions, in whole or in part, on the possibility of utilizing such losses in the future. There is also a risk that Vicore will not be able to generate enough profits to exploit such tax losses. The possibility of utilizing the losses in the future may also be adversely affected by future changes in the applicable legislation.
Proposed appropriation of the company’s profits or loss for the 2021 financial year
The following profit/loss stated in SEK is at the disposal of the Annual General Meeting:
| Description | Amount |
|---|---|
| Share premium reserve | 1,003,761,527 |
| Loss brought forward | -60,378,841 |
| Loss of the year | 17,578,105 |
| Total | 960,960,791 |
The Board of Directors proposes that SEK 960,960,791 are to be carried forward.
Financial targets and dividend policy
The target is to distribute approximately 50 percent of the company’s annual net profit as dividends when Vicore has achieved the desired financial stability, profitability and positive cash flow, subject to available profits, investment needs, liquidity and development opportunities as well as general economic and business conditions. In accordance with the Board of Directors' dividend policy, no dividend is to be paid before the company generates significant revenue.# Annual Report 2021 Vicore Pharma Holding AB (publ)
| Net sales (KSEK) | 0 | 0 | 0 |
| -296,735 | -147,315 | -93,329 | |
| Total assets (KSEK) | 451,168 | 406,515 | 341,108 |
| Equity ratio (%) | 85.0 | 87.2 | 94.3 |
| Number of employees (average) | 16 | 13 | 8 |
| 2021 | 2020 | 2019 | 2018 | |
|---|---|---|---|---|
| Net sales (KSEK) | 38,730 | 3,672 | 3,092 | 2,653 |
| 17,709 | -21,826 | -24,803 | -11,100 | |
| Total assets (KSEK) | 1,075,894 | 669,514 | 503,959 | 488,965 |
| Equity ratio (%) | 92.6 | 97.7 | 98.4 | 82.1 |
| Number of employees (average) | 4 | 4 | 3 | 3 |
Multi-year Overview
Multi-year overview, group
Multi-year overview, parent company
Consolidated statement of financial position
| KSEK | Note | 2020 Dec 31 | 2019 Dec 31 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Patents, licenses and similar rights | 15 | 67,427 | 70,755 |
| Equipment | 16 | 84 | 113 |
| Contract asset | 6 | 317 | 139 |
| Long-term investments | 17, 18 | 5,409 | 7,530 |
| Deferred tax asset | 13 | 0 | 131 |
| Total xed assets | 73,237 | 78,668 | |
| Current Assets | |||
| Other receivables | 1,417 | 5,354 | |
| Prepaid expenses and accrued income | 20 | 5,034 | 3,757 |
| Short-term investments | 21 | 77,281 | 70,118 |
| Cash and cash equivalents | 22 | 294,199 | 248,618 |
| Total current assets | 377,931 | 327,847 | |
| TOTAL ASSETS | 451,168 | 406,515 | |
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| 24 | |||
| Share capital | 35,880 | 30,209 | |
| Other contributed capital | 1,021,666 | 702,053 | |
| Retained earnings including profit (loss) for the period | -674,230 | -377,749 | |
| Total equity attributable to the parent company's shareholders | 383,316 | 354,513 | |
| LIABILITIES | |||
| Non-current liabilities | |||
| Contract liability | 6 | 320 | 0 |
| Other provisions | 25 | 600 | 2,385 |
| Deferred tax liability | 13 | 1,210 | 1,531 |
| Total non-current liabilities | 2,130 | 3,916 | |
| Current liabilities | |||
| Contract liability | 6 | 0 | 140 |
| Trade payables | 18, 19 | 23,984 | 10,943 |
| Current tax liability | 335 | 553 | |
| Other liabilities | 1,112 | 3,132 | |
| Other provisions | 25 | 152 | 3,792 |
| Accrued expenses and deferred income | 26 | 40,139 | 29,526 |
| Total current liabilities | 65,722 | 48,086 | |
| TOTAL LIABILITIES | 67,852 | 52,002 | |
| TOTAL EQUITY AND LIABILITIES | 451,168 | 406,515 |
Consolidated statement of comprehensive income
| KSEK | Note | 2021 Jan-Dec | 2020 Jan-Dec |
|---|---|---|---|
| Net sales | 0 | 0 | |
| Gross prot | 0 | 0 | |
| Administrative expenses | 4, 5 | -20,204 | -24,986 |
| Other expenses | 4 | -1,404 | 0 |
| Research and development expenses | 4 | -271,812 | -142,021 |
| Other operating income and expenses | 4, 9, 10 | -1,398 | 17,469 |
| Prot/loss from operations | -294,818 | -149,538 | |
| Financial income | 11 | 646 | 2,229 |
| Financial expenses | 12 | -2,563 | -6 |
| Net nancial income/expense | -1,917 | 2,223 | |
| Loss after nancial items | -296,735 | -147,315 | |
| Tax | 13 | 254 | 453 |
| Loss for the year attributable to the parent company´s shareholders | -296,481 | -146,862 | |
| Other comprehensive income | |||
| Other comprehensive income | 0 | 0 | |
| Other comprehensive income for the year, net of tax | 0 | 0 | |
| Total comprehensive income attributable to the parent company´s shareholders | -296,481 | -146,862 | |
| Earnings per share, before and after dilution | 14 | -4.25 | -2.71 |
Consolidated statement of cash flow
| KSEK | Note | 2021 Jan-Dec* | 2020 Jan-Dec |
|---|---|---|---|
| Operating activities | |||
| Operating profit | -294,818 | -149,538 | |
| Adjustments for non-cash items affecting profit/loss | 27 | 2,099 | 6,202 |
| Interest received | 483 | 726 | |
| Interest paid | -8 | -6 | |
| Cash ow from operating activities before changes in working capital | -292,244 | -142,616 | |
| Cash ow from changes in working capital | |||
| Change in operating receivables | -340 | -3,867 | |
| Change in operating payables | 27 | 27,413 | 26,548 |
| Cash ow from operating activities | -265,171 | -119,935 | |
| Investing activities | |||
| Acquisition of intangible assets | 29 | 0 | -3,000 |
| Acquisition of short-term investments | 21 | -77,000 | -70,000 |
| Sale of short-term investments | 21 | 70,000 | 77,000 |
| Cash ow from investing activities | -7,000 | 4,000 | |
| Financing activities | |||
| Amortization contract liability | -239 | -179 | |
| Issue of new shares | 33 | 336,000 | 187,550 |
| Issue costs | -17,578 | -10,404 | |
| Cash ow from nancing activities | 318,183 | 176,967 | |
| Cash ow for the year | 46,012 | 61,032 | |
| Cash and cash equivalents at the beginning of the year | 248,618 | 187,586 | |
| Foreign exchange difference in cash and cash equivalents | 11, 12 | -431 | 0 |
| Cash and cash equivalents at year-end | 22 | 294,199 | 248,618 |
Consolidated statement of changes in shareholders´ equity
Shareholders' equity attributable to the parent company
| KSEK | Share capital | Other contributed capital | Retained earnings including profit (loss) for the period | Total Equity |
|---|---|---|---|---|
| Jan 1, 2020 | 25,087 | 527,397 | -230,887 | 321,597 |
| Loss for the year | 0 | 0 | -146,862 | -146,862 |
| Other comprehensive income for the year | 0 | 0 | 0 | 0 |
| Total comprehensive income for the year | 0 | 0 | -146,862 | -146,862 |
| Transactions with owners: | ||||
| Issue of new shares | 5,122 | 182,428 | 0 | 187,550 |
| Issue costs | 0 | -10,404 | 0 | -10,404 |
| Long-term incentive program | 0 | 2,632 | 0 | 2,632 |
| Total transactions with owners | 5,122 | 174,656 | 0 | 179,778 |
| Equity Dec 31, 2020 | 30,209 | 702,053 | -377,749 | 354,513 |
| Equity Jan 1, 2021 | 30,209 | 702,053 | -377,749 | 354,513 |
| Loss for the year | 0 | 0 | -296,481 | -296,481 |
| Other comprehensive income for the year | 0 | 0 | 0 | 0 |
| Total comprehensive income for the year | 0 | 0 | -296,481 | -296,481 |
| Transactions with owners: | ||||
| Issue of new shares and issue in kind | 5,671 | 333,329 | 0 | 339,000 |
| Issue costs | 0 | -17,578 | 0 | -17,578 |
| Long-term incentive program | 0 | 3,862 | 0 | 3,862 |
| Total transactions with owners | 5,671 | 319,613 | 0 | 325,284 |
| Equity Dec 31, 2021 | 35,880 | 1,021,666 | -674,230 | 383,316 |
- Correction of the cash flow statement In the year-end report for the fiscal year 2021, social security contributions for share-based incentive programs were reported in the cash flow from operating activities, but have been reclassified to cash flow from financing activities to the full extent relating to the incentive programs. The correction impacts the cash flow from operating activities by -2,105 KSEK and cash flow from financing activities by +2,105 KSEK. The opening balance of cash and cash equivalents for the period is unchanged.
Parent company’s income statement
| KSEK | Note | 2021 Jan-Dec | 2020 Jan-Dec |
|---|---|---|---|
| Net sales | 2 | 38,730 | 3,672 |
| Gross prot | 38,730 | 3,672 | |
| Administrative expenses | 3, 4, 5, 6 | -19,911 | -24,663 |
| Research and development expenses | 3 | -1,686 | -1,658 |
| Other operating income and expenses | 3 | -67 | 44 |
| Prot/loss from operations | 17,066 | -22,605 | |
| Financial income including share of profit of associated companies and other companies | 7 | 645 | 815 |
| Interest expenses and similar loss items | 8 | -2 | -36 |
| Net nancial income/expense | 643 | 779 | |
| Prot/loss after nancial items | 17,709 | -21,826 | |
| Tax | 9 | -131 | 68 |
| Prot/loss for the year | 17,578 | -21,758 |
Parent company’s statement of comprehensive income
| KSEK | Note | 2021 Jan-Dec | 2020 Jan-Dec |
|---|---|---|---|
| Prot/loss for the year | 17,578 | -21,758 | |
| Other comprehensive income | |||
| Other comprehensive income | 0 | 0 | |
| Other comprehensive income for the year | 0 | 0 | |
| Comprehensive income for the year | 17,578 | -21,758 |
Parent company’s balance sheet
| KSEK | Note | 2021 Dec 31 | 2020 Dec 31 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible xed assets | |||
| Patents, licenses and similar rights | 0 | 6,000 | |
| Total intangible assets | 0 | 6,000 | |
| Tangible assets | |||
| Equipment | 0 | 0 | |
| Total tangible assets | 0 | 0 | |
| Financial assets | |||
| Participations in group companies | 10 | 796,389 | 396,303 |
| Long-term investments | 11 | 565 | 565 |
| Deferred tax asset | 9 | 0 | 131 |
| Total nancial assets | 796,954 | 396,999 | |
| Total xed assets | 796,954 | 402,999 | |
| Current assets | |||
| 12 | |||
| Receivables | |||
| Receivables from group companies | 32,386 | 0 | |
| Other receivables | 65 | 305 | |
| Prepaid expenses and accrued income | 13 | 812 | 270 |
| 33,263 | 575 | ||
| Short-term investments | 14 | 77,281 | 70,118 |
| Cash and cash equivalents | 15 | 168,396 | 195,822 |
| Total current assets | 278,940 | 266,515 | |
| TOTAL ASSETS | 1,075,894 | 669,514 | |
| EQUITY AND LIABILITIES | |||
| EQUITY | |||
| 16 | |||
| Restricted equity | |||
| Share capital | 35,880 | 30,209 | |
| Total restricted equity | 35,880 | 30,209 | |
| Non-restricted equity | |||
| Share premium reserve | 1,003,762 | 688,011 | |
| Additions to equity from profit | -60,379 | -42,483 | |
| Profit (loss) for the year | 17,578 | -21,758 | |
| Total non-restricted equity | 960,961 | 623,770 | |
| TOTAL EQUITY | 996,841 | 653,979 | |
| LIABILITIES | |||
| Provisions | |||
| Other provisions | 17 | 507 | 5,312 |
| Deferred tax liability | 184 | 120 | |
| Total provisions | 691 | 5,432 | |
| Non-current liabilities | |||
| Liabilities to group companies | 18 | 0 | 0 |
| Total non-current liabilities | 0 | 0 | |
| Current liabilities | |||
| Trade payables | 622 | 765 | |
| Liabilities to group companies | 18 | 75,000 | 0 |
| Current tax liability | 61 | 385 | |
| Other liabilities | 595 | 1,725 | |
| Accrued expenses and deferred income | 19 | 2,084 | 7,228 |
| Total current liabilities | 78,362 | 10,103 | |
| TOTAL LIABILITIES | 79,053 | 15,535 | |
| TOTAL EQUITY AND LIABILITIES | 1,075,894 | 669,514 |
The parent company’s report of changes in equity
| KSEK | Share capital | Share premium reserve | Loss brought forward | Loss for the year | Total Equity |
|---|---|---|---|---|---|
| Jan 1, 2020 | 25,087 | 515,988 | -20,376 | -24,740 | 495,959 |
| Transfer of previous year’s loss | 0 | 0 | -24,740 | 24,740 | 0 |
| Profit/loss for the year | 0 | 0 | 0 | -21,758 | -21,758 |
| Other comprehensive income for the year | 0 | 0 | 0 | 0 | 0 |
| Total comprehensive income for the year | 0 | 0 | -24,740 | 2,982 | -21,758 |
| Transactions with owners: | |||||
| Issue of new shares | 5,122 | 182,428 | 0 | 0 | 187,550 |
| Issue costs | 0 | -10,405 | 0 | 0 | -10,405 |
| Incentive programs | 0 | 0 | 2,633 | 0 | 2,633 |
| Total transaction with owners | 5,122 | 172,023 | 2,633 | 0 | 179,778 |
| Equity Dec 31, 2020 | 30,209 | 688,011 | -42,483 | -21,758 | 653,979 |
| Equity Jan 1, 2021 | 30,209 | 688,011 | -42,483 | -21,758 | 653,979 |
| Transfer of previous year’s loss | 0 | 0 | -21,758 | 21,758 | 0 |
| Profit/loss for the year | 0 | 0 | 0 | 17,578 | 17,578 |
| Other comprehensive income for the year | 0 | 0 | 0 | 0 | 0 |
| Total comprehensive income for the year | 0 | 0 | -21,758 | 39,336 | 17,578 |
| Transactions with owners: | |||||
| Issue of new shares and issue in kind | 5,671 | 333,329 | 0 | 0 | 339,000 |
| Issue costs | 0 | -17,578 | 0 | 0 | -17,578 |
| Incentive programs | 0 | 0 | 3,862 | 0 | 3,862 |
| Total transaction with owners | 5,671 | 315,751 | 3,862 | 0 | 325,284 |
| Equity Dec 31, 2021 | 35,880 | 1,003,762 | -60,379 | 17,578 | 996,841 |
The parent company’s cash flow statement
| KSEK | Note | 2021 Jan-Dec | 2020 Jan-Dec |
|---|---|---|---|
| Operating activities | |||
| Operating profit | 17,066 | -22,605 | |
| Adjustments for non-cash items affecting profit/loss | 20 | -2,215 | 2,104 |
| Interest received | 482 | 726 | |
| Interest paid | -2 | -2 | |
| Cash ow from operating activities before changes in working capital | 15,331 | -19,777 | |
| Cash ow from changes in working capital | in operating receivables -36,438 550 | ||
| Change in operating payables 2,259 1,925 | |||
| Cash flow from operating activities -18,848 -17,302 |
Investing activities
Sale/liquidation of group company 0 75
Shareholder contributions to group companies -320,000 -120,000
Proceeds from sale/liquidation of group company 14 -77,000 -70,000
Investments in group companies 14 70,000 77,000
Cash flow from investing activities -327,000 -112,925
Financing activities
Issue of new shares 336,000 187,550
Issue costs -17,578 -10,404
Cash flow from financing activities 318,422 177,146
The cash flow for the year -27,426 46,919
Cash and cash equivalents at the beginning of the year 195,822 148,903
Foreign exchange difference in cash and cash equivalents 0 0
Cash and cash equivalents at the end of the year 15 168,396 195,822
39 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 1 Accounting principles
This Annual Report and the consolidated financial statements comprise the Swedish parent company Vicore Pharma Holding AB (publ), corporate registration number 556680-3804, and its subsidiaries. The parent company is a limited liability company with its registered office in Gothenburg, Sweden. The address of the main office is Kronhusgatan 11, 411 05 Gothenburg. The main operation of the group is research and development of pharmaceutical products. On April 6, 2022, the Board of Directors approved this Annual Report and the consolidated financial statements, which will be presented for approval at the Annual General Meeting on May 11, 2022.
Applied regulations
Vicore’s consolidated accounts have been prepared in accordance with the International Financial Reporting Standards (IFRS) issued by the International Accounting Standards Board (IASB) as well as the interpretations from the IFRS Interpretation Committee (IFRS IC) as adopted by the European Union (EU). Furthermore, the group also applies the Annual Accounts Act (1995:1554) and the Swedish Financial Reporting Board’s recommendation RFR 1 ”Supplementary Accounting Rules for Groups”.
Basis for the consolidated accounts
Preparing financial statements in accordance with IFRS requires the company management to make judgments, assumptions and estimates concerning the recognition and measurement of assets and liabilities. These assessments and estimates are based on historical experiences, as well as other factors that are considered to be reasonable during the current circumstances. The actual result can deviate from these estimates and assessments.
For business combinations where the transferred remuneration exceeds the fair value of acquired assets and assumed liabilities that are reported separately, the difference is reported as goodwill. When the difference is negative, a so-called bargain purchase, this is reported directly in the profit/loss for the year. When acquiring an asset, the acquisition value is allocated to the individual identifiable assets and the debts, based on their relative fair values. Such a transaction does not give rise to goodwill.
Eliminated transactions during consolidation
Intra-group receivables and liabilities, income or expenses and unrealised gains or losses which arise from intra-group transactions between group companies are eliminated in the preparation of the consolidated accounts. Unrealised gains arising from transactions with associated companies are eliminated to the extent which corresponds to the group’s ownership in the company. Unrealised losses are eliminated in the same way, but only to the extent that there is no impairment of the asset.
Currency
Functional currency and reporting currency
Functional currency is the currency in the primary economic environments in which the companies operate. The parent company’s functional currency is SEK. In addition, the reporting currency for the parent company and the group. Unless otherwise stated, all amounts are rounded to the nearest thousand (KSEK).
Notes
Group and new and amended standards and interpretations not yet adopted by the group
Updated standards and interpretations from IASB and IFRIC interpretations that came into force during the 2021 calendar year have had no material impact on the group.
Valuation principles
Assets and liabilities have been recognised at their historical cost, except for certain financial assets that are stated at fair value. Financial assets valued at fair value consist of holdings in listed and non-listed shares.
Consolidation
Subsidiaries
Subsidiaries are all the companies over which Vicore has a controlling influence. The group controls a company when it is exposed to, or has rights to, variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. Subsidiaries are included in the consolidated accounts as of the date on which the controlling influence is transferred to the group. They are excluded from the consolidated accounts as of the date on which the controlling influence ceases. Subsidiaries are reported according to the acquisition method. The method implies that acquiring a subsidiary is considered a transaction, whereby the group indirectly acquires the subsidiary’s assets and liabilities. In the acquisition analysis, the fair value of acquired identifiable assets and assumed liabilities, as well as any holdings without controlling influence, is determined on the acquisition date. Transaction costs, excluding transaction costs attributable to the issue of equity instruments or debt instruments, which arise are reported directly in the profit/loss for the year.
Foreign currency transactions
Transactions in foreign currency are translated to the functional currency at the exchange rate as on the transaction date. Monetary assets and liabilities denominated in foreign currencies are translated to the functional currency at the exchange rate on the balance sheet date. Exchange rate differences that arise are recognized in the profit/loss for the year. Exchange gains and exchange losses on operating receivables and operating liabilities are reported in operating results, while exchange gains and exchange losses on financial receivables and liabilities are reported as financial items.
Operating segments
Operating segments are reported in a way that corresponds with internal reporting structures. The profit/loss generated by a business segment is then followed up by the company’s chief operating decision-maker. This is to obtain information about the segment’s profit/loss figures and allocating resources to the business segment. In the group, this function is identified as the company’s CEO. An operating segment is a component of the group that engages in business activities from which it may earn revenues and incur expenses, and for which discrete financial information is available. Vicore does not divide its business into different segments, instead it sees the entire business of the group as one segment. This follows the company’s internal organization and reporting structures.
Classification
Non-current assets and non-current liabilities consist in all essentials solely of amounts that are expected to be recovered or settled more than twelve months after the reporting period. Current assets and current liabilities consist in all essential solely of amounts that are expected to be recovered or settled within twelve months of the reporting period.
Revenue from contracts with customers
The group reports revenue when the group fulfils a performance obligation, i.e. when a promised product is delivered to the customer and the customer is able to use and obtain the benefits from the product. A performance obligation can be transferred over time or at a point in time. Revenue consists of the amount the company expects to receive as compensation for the transferred products or services. For the group to report revenue from contracts with customers, each customer contract is analyzed according to the five-step model included in the standard:
- Step 1: Identify a contract between at least two parties that consists of enforceable rights and obligations.
- Step 2: Identify the performance obligations in the contract.
- Step 3: Determine the transaction price, i.e. the amount of consideration that the company is expected to receive in exchange for the promised goods or services.
- Step 4: Allocate the transaction price over the identified performance obligations.
- Step 5: Recognize revenue when the performance obligations are satisfied, i.e. when control is transferred to the customer.
The group’s net sales are currently not a significant part of the business.
Government grants
Government grants are reported in the statement of financial position and the statement of comprehensive income when there is reasonable assurance that the entity will comply with the conditions attached to them and the grants will be received. The grant is recognised as income over the period necessary to match them with the related costs.
Personnel costs
Personnel costs include salaries, social security costs and pension costs. Share-based payments, such as option schemes and bonus, is expensed when the employees perform the services.
Pension obligations
The group only has defined contribution pension plans. In defined contribution plans, the group pays fixed contributions to a separate entity and has no legal or constructive obligation to pay further contributions if this entity does not have sufficient assets to pay all the remuneration to employees connected with the employees’ service during the current or prior periods. Therefore, the group has no provision for pension obligations. Any liability regarding contributions for defined contribution plans, these are reported as an expense in the consolidated profit/loss as the benefits are earned.
Incentive programs
There are four types of share-based incentive programs in the group: two option programs for employees, and two share awards programs for certain board members. The option and share awards have been granted free of charge and are settled with equity instruments. The fair value of share-based payments is accounted for as personnel costs.
40 | Annual Report 2021 Vicore Pharma Holding AB (publ)# The fair value
of options. For the share awards, the fair value is determined at the time of allocation using a Monte Carlo simulation model to calculate the fair value of the options. The cost is reported, along with a corresponding increase in equity, during the period in which the vesting conditions are fulfilled, up to and including the date when the persons concerned are fully entitled to the compensation. The accumulated cost included in each reporting period shows to what extent the vesting period has been recognised with an estimate of the number of share-related instruments that eventually will be vested. Social security contributions attributable to share-related instruments to employees as compensation for purchased services must be recognised as a cost on a systematic basis over the period until the shares are vested.
Leasing agreement
The group’s leasing portfolio consists of a few operating leases for premises, which are the two classes of leased assets presented by the group. The leasing agreements are reported as contract assets with a corresponding lease liability on the day that the leased asset is available for use by the group. Short-term leases and low value leases are excluded. Each leasing payment is divided between amortization of the lease debt and financial cost. The financial cost shall be distributed over the lease period so that each accounting period is charged with an amount corresponding to a fixed interest rate for the liability reported during each period. The leasing period is determined as the non-cancellable period together with both periods covered by an option to extend the lease if the lessee is reasonably sure to exercise that option and periods covered by an opportunity to terminate the lease if the lessee is reasonably sure not to exercise that option. The group's leasing liabilities are recognized at the present value of the group's future leasing fees. Leasing payments have been discounted with the group's marginal loan interest rate. The group's contract assets are recognized at cost and initially include the present value of the future leasing fees, related to lease payments and potential purchase options, and initial direct expenses. Recovery costs are included in the asset if a corresponding provision regarding recovery costs has been identified. The contract asset is amortized on a straight-line basis over the shorter of the asset's useful life and the duration of the lease.
Employee benefits
Short-term remuneration
Short-term remuneration to employees, such as salary, social security contributions, holiday pay, bonuses and other benefits, are expensed over the periods during which the services are performed. Short-term remuneration is recognised as a liability when it is due and payable.
Financial income and expenses
Financial income
Financial income consists of capital gains on and dividend incomes from financial fixed assets. Dividend income is recognized when the right to receive a dividend has been established. Exchange rate gains and losses are reported net.
Financial costs
Financial costs consist mainly of interest expenses on loans. Exchange rate gains and losses are reported net.
Income taxes
Income taxes consist of current tax and deferred tax. Income taxes are recognized in profit or loss for the year, except when the underlying transaction is recognized in other comprehensive income or equity, in which case the tax effect is recognized in other comprehensive income or equity.
Current tax
Current tax is the tax that must be paid or received for the current year, with the application of the tax rates that have been decided, or in practice decided, on the balance sheet date. Current tax also includes adjustments of current tax for previous periods.
Deferred tax asset/tax liability
Deferred tax is reported in its entirety, according to the balance sheet method and is based on the temporary differences between the tax base value of assets and liabilities and their carrying amounts in the balance sheet. Differences attributable to goodwill or differences attributable to participations in subsidiaries, which are not expected to be taxed in the foreseeable future. The valuation of deferred tax is based on how underlying assets or liabilities are expected to be realized or regulated. Deferred tax amounts are calculated by applying the tax rates and tax rules that have been decided or announced as of the balance sheet date and which are expected to apply when the deferred tax asset is realized or the deferred tax liability is settled. Deferred tax assets related to deductible temporary differences and loss carry forwards are only recognized to the extent it is probable that these will be utilized. The value of deferred tax assets is reduced when it is no longer probable that they will be utilized. Deferred tax assets and deferred tax liabilities are offset if there is a legal right to offset short-term tax assets against short-term tax liabilities and the deferred tax is attributable to the same entity in the group and the same tax authority.
Earnings per share
Earnings per share before dilution are calculated as profit or loss attributable to the parent company shareholders divided by the weighted average number of ordinary shares outstanding during the period. Earnings per share after dilution are calculated as profit or loss attributable to the parent company shareholders, adjusted for interest on debt or other dilutive potential ordinary shares that would be converted into ordinary shares, divided by the sum of the weighted average number of ordinary shares and potential ordinary shares that may give rise to dilution effects. A dilution effect of potential ordinary shares is recognized only if a translation into ordinary shares would lead to a reduction of earnings per share after dilution.
Intangible assets
Acquired intangible assets
Intangible assets in the group consist of patents, licenses and similar rights. They are valued at cost that is decreased by accumulated depreciation and any accumulated impairment losses. An intangible asset is recognized if it is probable that the asset will generate future economic benefits for the group, the criteria for capitalization are met and the costs can be measured reliably. An intangible asset is valued at cost when it is included for the first time in the financial report. Intangible assets with finite useful lives are reported at cost less depreciation and any impairment losses. Intangible fixed assets with finite useful lives are depreciated linearly over the asset’s estimated useful life. Intangible assets with indefinite useful lives are instead tested annually for impairment. Intangible assets with finite and indefinite useful lives are reviewed for impairment requirements in cases where there are indications that a write- down may be needed. The useful life of intangible assets is reviewed at each balance sheet date and adjusted if expectations differ from previous estimates.
Capitalization of development expenditure
The expenses that arise during the development phase are capitalized as intangible assets when, according to management’s assessment, they are probable to generate future economic benefits for the group, the criteria for capitalization are met and the costs can be measured in a reliable way. Otherwise, development expenses are expensed as normal operating expenses. The group only has acquired intangible assets.
Depreciation principles
Depreciation begins when the asset can be used, i.e. when it is in the place and in the condition required to be able to use it in the way management intends. The estimated useful life for intangible fixed assets with a finite useful life is 5 years. Depreciation is made on a straight-line basis over the estimated useful life of the asset, which coincides with the remaining patent period for the product.
Tangible fixed assets
Tangible fixed assets are reported in the group at cost after deductions for accumulated depreciation and any accumulated impairment losses. The cost includes the purchase price and any costs directly attributable to the asset to bring it in place and in condition to be utilized in accordance with the purpose of the acquisition. The carrying amount of an asset is derecognized from the balance sheet when disposing or divesting, or when no future economic benefits are expected from use or disposing/divesting of the asset. Gains or losses arising from the sale or disposal of an asset consist of the difference between the selling price and the asset’s carrying amount with the deduction of direct sales costs. Gains and losses are reported as other operating income/expenses.
Additional expenses
Additional expenses are added to the asset’s carrying amount only if it is probable that the future economic benefits associated with the asset will be leveraged by the group and that the cost of the asset can be measured reliably. All other additional expenses are reported as an expense during the period they arise. Repairs are expensed on an ongoing basis.
Depreciation principles
The depreciable amount shall be allocated on a systematic basis over the asset’s estimated useful life. Used depreciation methods, residual values and useful lives are reviewed at the end of each year. The estimated useful lives are:
| Equipment | 5 years |
|---|---|
Impairment of non-financial assets
The group’s reported assets are assessed in cases where there are indications of a decline in value of tangible or intangible assets, i.e. whenever events or changes in circumstances indicate that the fair value is not recoverable.Furthermore, the group’s impairment requirements until they are available for use. This is done regardless of whether there are indications of a decline in value or not. An impairment is recognized when an asset’s carrying amount exceeds its recoverable amount. The recoverable amount is the higher of the asset’s fair value less the cost of sale on the one hand and the value in use on the other. When assessing impairment, assets are grouped at the lowest level where there are separate identifiable cash flows (cash-generating units). When the need for impairment has been identified for a cash-generating unit (group of units), the impairment amount is distributed proportionally among the assets included in the cash-generating unit (group of units). A previously recognized impairment is reversed if the recovery amount is deemed to exceed the fair value. Reversal does not occur with an amount that is greater than what the fair value would have been recorded to if the impairment had not been recognized in previous periods. Any reversals are reported in the income statement.
Financial assets and liabilities
A financial asset or financial liability is recognized in the balance sheet when the group becomes a party according to the instrument’s contractual terms. A financial asset is removed from the balance sheet when the rights in the agreement are realized, expire or when the group loses control over them. The same applies to a part of a financial asset. A financial liability is removed from the balance sheet when the obligation in the agreement is fulfilled or otherwise extinguished. The same applies to a part of a financial debt. Acquisitions and divestments of financial assets are reported on the trade date. The trade date is the date when the group commits to acquire or divest the asset. Financial instruments are classified on initial recognition, including on the basis of what purpose the instrument was acquired and managed. This classification determines the valuation of the instruments.
42 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Classification and valuation of financial assets
The classification of financial assets that are debt instruments, is based on the group’s business model for managing the asset and the nature of the asset’s contractual cash flows. Assets are classified according to:
- Amortized cost: Assets where contractual cash flows are solely payments of principal and interest.
- Fair value through other comprehensive income
The group’s financial assets that are classified at amortized cost include accounts receivable, certain other receivables, short-term investments, and cash and cash equivalents. Financial assets classified at amortised cost are initially measured at fair value with the addition of transaction costs. After initial recognition, the assets are valued at amortized cost after a deduction of a loss reserve for expected credit losses. Assets classified at amortized cost are held according to the business model to collect contractual cash flows, which are solely payments of principal and interest on the outstanding principal amount.
The group’s financial assets that are classified at fair value through profit or loss relate to holdings in listed and non-listed shares.
Impairment of financial assets
The group’s impairment model is based on expected credit losses and is applied to financial assets or amounts due from the group. A loss reserve is made for an asset or receivable, which is due to due credit losses.
Classification and valuation of financial liabilities
The group’s financial liabilities consist of accounts payable and other current liabilities, which are all classified at amortized cost. Financial liabilities recognized at amortized cost are initially measured at fair value including transaction costs. After the initial recognition, they are valued according to the effective interest method.
Cash and cash equivalents
Cash and cash equivalents consist of cash and balances as well as immediately available credit facilities not used and held with financial institutions.
Equity
All shares in the company are ordinary shares, which are reported as equity. The share capital is reported up to its quota value and any excess part is reported as Other contributed capital. Transaction costs, directly attributable to the issue of new ordinary shares or options, are reported, net after tax, in equity as a deduction from the issue proceeds.
Contingent liabilities
A contingent liability is recognised when there is a possible commitment that arises from past events and whose existence is confirmed only by one or more uncertain future events, or when there is a commitment that is not reported as a liability or provision but where it is probable that an outflow of economic benefits will be required.
Cash flow
Cash and cash equivalents consist of available cash and bank balances and short-term investments with an original maturity of less than three months, which are exposed to insignificant value fluctuation. Incoming and outgoing payments are reported in the cash flow statement. The cash flow statement has been prepared in accordance with the indirect method.
Note 2 Judgements and accounting estimates
The preparation of the financial statements in accordance with IFRS requires company management to make judgements and accounting estimates that affect the application of the accounting policies and the carrying amounts of assets, liabilities, revenue and expenses. The actual outcome could deviate from these estimates. The accounting estimates and assumptions are evaluated continuously. Changes to the accounting estimates are recognized in the period in which the change is made if the change only has affected the period, or in the period in which the change is made and future periods if the change affects both the current period and future periods.
Sources of uncertainty in the accounting estimates
The sources of uncertainty in the accounting estimates that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next fiscal year, include impairment testing of intangible assets with indefinite useful lives.
Impairment testing of intangible assets
When impairment testing intangible assets, a number of assumptions regarding future cash flows are made which are used to calculate a recoverable amount. These assumptions are based on management and board’s best estimates, expected selling price for the company’s products in 2024, 2025 and 2026, expected development and product launches, expected revenue growth of acquired intangible assets, and intangible assets that will pass the remaining stages of development. The assumptions are based on industry- and market-related expectations, and are reviewed by the Board of Directors. For more information about impairment testing, see Note 15 "Patent, licenses and similar rights".
Other judgments and accounting estimates
Capitalization of intangible assets
Development expenditures are capitalized when they fulfill the criteria set out in IAS 38 and are expected to represent material amounts for the development initiative as a whole. Development expenditures are otherwise expensed as normal operating costs. The most important criteria for capitalization are that the end product of the development is of a technical and commercial nature, that there are sufficient resources available to complete the development, that the development is expected to generate future economic benefits or cost savings and cash flow, and that there are technical and financial preconditions to complete the development. The group only has acquired intangible assets. Since regulatory approval has not yet been obtained, no costs have been capitalized.
Research and development expenses
The company conducts research and development with external collaboration partners, such as clinical research organizations (CROs). The company estimate the timing of the costs when the development is made, as a basis for settlement with the external collaboration partner. An evaluation and update of the calculation is performed monthly and forms the basis for capitalization of accrued development costs that are expensed in accordance with the accounting principles for intangible assets.
Incentive programs
The group has four active share-based long-term incentive programs. The applicable accounting policies are described in Note 1 "Accounting principles". The cost for the remuneration that is recognized in a period is dependent on the original valuation that was made on the contract date of with the holder of the option/share award, the number of months of service required by the participant for becoming entitled to options (accruals are made over this period), the number of options that are expected to be vested by the participant under the terms of the programs and a continuous reassessment of the value of the tax benefits for the participants in the incentive programs (for determining provisions for social security contributions). Those estimates which affect the cost in a period and the corresponding increase in equity mainly refer to inputs for the valuation of the options. The models used in order to value the options are the Black-Scholes model and a Monte Carlo simulation. Significant assumptions in these valuations are described in Note 8 "Share-based payments".
43 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Tax loss carryforwards
The group’s tax loss carryforwards have not been measured and are not recognized as a deferred tax asset. These tax loss carryforwards will be measured valued only when the group has established a level of earnings which management with confidence estimate will lead to taxable profits.
Not 3 Operating segments
Vicore does not divide its business into different operating segments. Instead the group’s entire business is treated as one operating segment.This reflects the company’s internal organisation and reporting system where the group’s tangible and intangible fixed assets are attributed.
Note 4 Operating expenses by nature of expense
The total expenses classified by function are distributed in the following cost categories:
| 2021 | 2020 | |
|---|---|---|
| Other external expenses | 256,517 | 129,249 |
| Personnel expenses | 33,304 | 34,221 |
| Depreciation and amortization | 3,598 | 3,537 |
| Other operating expenses | 2,492 | 721 |
| Total | 295,911 | 167,728 |
Note 5 Audit fees
| 2021 | 2020 | |
|---|---|---|
| Audit fees* | 450 | 538 |
| Other audit related services | 92 | 47 |
| Tax consultancy services | 0 | 0 |
| Other services | 10 | 88 |
| Total | 552 | 673 |
- Audit fees refer to audit services provided in connection with the audit engagement.
Note 6 Leases
2021
| Dec 31 | 2021 | 2020 |
| :------------- | :--- | :--- |
| Contract assets| | |
| Premises | 317 | 139 |
| Total | 317 | 139 |
| Contract liabilities | | |
| Long-term | 320 | 0 |
| Short-term | 0 | 140 |
| Total | 320 | 140 |
The following amounts related to leasing contracts are reported in the consolidated statement of comprehensive income:
| 2021 | 2020 | |
|---|---|---|
| Leasing fees, short-term | 1,066 | 817 |
| Depreciation | ||
| Premises | 239 | 175 |
| Equipment | 0 | 0 |
| Interest | 6 | 3 |
| Total | 1,311 | 999 |
The total cash flow related to leasing agreements was 245 KSEK (182 KSEK) for 2021. For information on the company's exposure to risks arising from leases, see Note 22.
Note 7 Employees and personnel costs
Average number of employees
| 2021 | 2020 | |
|---|---|---|
| No. of employees | No. of employees | |
| of which men/ women | of which men/ women | |
| Parent company | 4 | 4 |
| 50%/50% | 50%/50% | |
| Subsidiaries | 12 | 9 |
| 30%/70% | 67%/33% | |
| Group total | 16 | 13 |
| 36%/64% | 62%/38% |
44 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Personnel costs for the Board of Directors, senior executives and other employees
2021
| Group | | |
| :----------------------------------------- | :--------- | :--------- |
| The Board and other senior executives | | |
| Salaries and other remuneration | 17,898 | 12,273 |
| Social security contributions | -120 | 7,364 |
| Pension costs | 3,046 | 1,690 |
| | 20,824 | 21,327 |
| Group Other employees | | |
| Salaries and other remuneration | 9,048 | 9,496 |
| Social security contributions | 744 | 1,879 |
| Pension costs | 2,239 | 1,154 |
| | 12,031 | 12,529 |
| Group Other personnel costs | 449 | 365 |
| Total personnel costs | 33,304 | 34,221 |
2020
| Group | | |
| :----------------------------------------- | :--------- | :--------- |
| The Board and other senior executives | | |
| Salaries and other remuneration | 17,898 | 12,273 |
| Social security contributions | -120 | 7,364 |
| Pension costs | 3,046 | 1,690 |
| | 20,824 | 21,327 |
| Group Other employees | | |
| Salaries and other remuneration | 9,048 | 9,496 |
| Social security contributions | 744 | 1,879 |
| Pension costs | 2,239 | 1,154 |
| | 12,031 | 12,529 |
| Group Other personnel costs | 449 | 365 |
| Total personnel costs | 33,304 | 34,221 |
Parent company
| The Board and other senior executives | | |
| :----------------------------------------- | :--------- | :--------- |
| Salaries and other remuneration | 9,813 | 10,245 |
| Social security contributions | -2,154 | 6,730 |
| Pension costs | 1,508 | 1,407 |
| | 9,167 | 18,382 |
| Parent company Other employees | | |
| Salaries and other remuneration | 906 | 592 |
| Social security contributions | 277 | 203 |
| Pension costs | 72 | 90 |
| | 1,255 | 885 |
| Parent company Other personnel costs | 226 | 90 |
| Total personnel costs | 10,648 | 19,357 |
Senior executives include members of the Board of Directors, the CEO and other senior executives.
Salaries and other remuneration
Costs related to the long-term incentive programs amounts to 3,862 KSEK (2,632 KSEK) of the payroll expenses and -5,425 KSEK (5,602 KSEK) of the social security contributions.
Pensions
All pension plans in the group are defined contribution plans. The group’s total cost for defined contribution plans amounted to 5,285 KSEK (2,844 KSEK).
Gender breakdown among senior executives
| 2021 | 2020 | |
|---|---|---|
| Group | ||
| Proportion of women on the Board | 33% | 29% |
| Proportion of men on the Board | 67% | 71% |
| Proportion of women among other senior execs. | 50% | 43% |
| Proportion of men among other senior execs. | 50% | 57% |
| Parent company | ||
| Proportion of women among other senior execs. | 25% | 33% |
| Proportion of men among other senior execs. | 75% | 67% |
Information regarding remuneration to the Board and other senior executives
2021
| Basic salary, board fee* | Pension costs | Variable remuneration | Share-based payments | Other remuneration | Total | |
|---|---|---|---|---|---|---|
| Chairman of the Board Michael Wolff Jensen | 450 | 0 | 0 | 730 | 50 | 1,230 |
| Members of the Board Jacob Gunterberg | 150 | 0 | 0 | 0 | 125 | 275 |
| Ulf Ljungdahl | 150 | 0 | 0 | 142 | 50 | 342 |
| Maarten Kraan | 150 | 0 | 0 | 142 | 75 | 367 |
| Sara Malcus | 150 | 0 | 0 | 108 | 50 | 308 |
| Heidi Hunter | 150 | 0 | 0 | 365 | 50 | 565 |
| Senior executives | ||||||
| CEO | 2,753 | 745 | 261 | 431 | 0 | 4,190 |
| Other senior executives** | 9,484 | 2,301 | 753 | 1,287 | 0 | 13,825 |
| Total | 13,437 | 3,046 | 1,014 | 3,205 | 400 | 21,102 |
- For more information, see "Remuneration for senior executives" below.
** For more information, see "Remuneration for senior executives" below.
45 | Annual Report 2021 Vicore Pharma Holding AB (publ)
2020
| Basic salary, board fee* | Pension costs | Variable remuneration | Share-based payments | Other remuneration | Total | |
|---|---|---|---|---|---|---|
| Chairman of the Board Michael Wolff Jensen | 300 | 0 | 0 | 692 | 25 | 1,017 |
| Members of the Board Jacob Gunterberg | 100 | 0 | 0 | 0 | 100 | 200 |
| Ulf Ljungdahl | 100 | 0 | 0 | 126 | 75 | 301 |
| Maarten Kraan | 100 | 0 | 0 | 126 | 75 | 301 |
| Peter Thelin | 100 | 0 | 0 | 51 | 0 | 151 |
| Sara Malcus | 100 | 0 | 0 | 51 | 50 | 201 |
| Heidi Hunter | 100 | 0 | 0 | 346 | 50 | 496 |
| Senior executives | ||||||
| CEO | 2,540 | 697 | 787 | 343 | 0 | 4,367 |
| Other senior executives** | 4,582 | 993 | 938 | 536 | 0 | 7,049 |
| Total | 8,022 | 1,690 | 1,725 | 2,272 | 375 | 14,084 |
- For more information, see "Remuneration for senior executives" below.
** For more information, see "Remuneration for senior executives" below.
Share-based payments
Share-based payments refer to share awards and options granted to independent directors, the CEO, other senior executives, and other employees. Each vested share award entitles the holder to receive one share in the company, provided that the holder is still a member of the Board of Directors of the company at the relevant time of vesting. Each option entitles the holder to acquire one share in the company for a strike price per share of SEK 0.25. The options shall be vested on the third anniversary of the granting date, provided that the holder, with some customary exceptions is still employed by the company. The participants in the programs have received the share awards / options free of charge. For further information about the incentive programs, see Note 8 "Share-based payments".
Other remuneration
Other remuneration refers to the remuneration paid to the members of the Board of Directors and other senior executives for their service.
Remuneration for senior executives
Remuneration of the CEO and other senior executives consists of, in accordance with the guidelines for remuneration decided by the shareholder's meeting in 2021, basic salary, pension benefits, bonus and share-based programs. remuneration. The executive management of the company, the CEO and the other senior executives, constitute the senior executives. The other senior executives refer to the individuals who, together with the CEO, constitute the group management. During the period January 1, 2020, to November 2, 2020, other senior executives refer to the Chief Financial Officer and Head of Business Development. Subsequently, other senior executives refer to the Chief Financial Officer, Chief Medical Officer, Chief Scientific Officer, VP Clinical Development, Head of Preclinical Development, and Chief Administrative Officer. During 2021, the group of other senior executives was expanded as follows: Head of Digital Therapeutics (July 1, 2021), Chief Commercial Officer (October 2, 2021) and Head of Business Development (November 8, 2021). The CEO has a period of notice of six months in the event the termination is made by the group or if the CEO resigns. Other senior executives have a period of notice of three to six months, in the event the termination is made by the group or if the senior executive resigns. In addition to salary during the termination period, the CEO is entitled to a termination benefit corresponding of six months’ salary in the event of termination by the company on a basis other than a breach of contract.
Note 8 Share-based payments
The purpose of share-based incentive programs is to promote the company’s long-term interests by retaining and attracting key personnel and to align the interests of the employees with the interests of the shareholders. As of December 31, 2021, Vicore has four active incentive programs that include the management team, other employees and certain board members. For more information, see below.
Long-term incentive programs 2018
The Extra General Meeting in Vicore held on August 13, 2018, resolved, in accordance with the Board of Directors’ proposal, to adopt a long-term incentive program for certain of the company’s senior management and other employees (Board LTIP 2018). Furthermore, the company’s option program 2018/2021 (CEO LTIP 2018) may be allotted to participants under the program. Of these, a total of 1,325,800 options and 475,000 share awards have been allocated. The increase in the company’s share capital in full utilization of both incentive programs amounts to a maximum of approximately SEK 1,237,500, corresponding to a dilution of approximately 3,3 percent of the total number of shares. The options and share awards have been granted to the participants of the incentive programs free of charge and the settlement is made with equity instruments.
Board LTIP 2018
Board LTIP 2018 is a program under which the participants will be granted, free of charge, share awards to the maximum of 475,000 shares. Participants in the program will be granted share awards under the condition that the participant is still employed by the company at the time of vesting. Vesting will take place on the third anniversary of the granting date. The participant may exercise their vested share awards to acquire shares at a strike price of SEK 0.25 per share, however a maximum of 475,000 shares. Board LTIP 2018 is intended for members of the Board of Directors of the company independent from the main owners.# Annual Report 2021 Vicore Pharma Holding AB (publ)
Long-term incentive program 2018 (Board LTIP 2018)
The Board of Directors of the company believes that an equity-based incentive program is a central part of an attractive and competitive remuneration package for competent members of the Board of Directors of the company, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. The share awards shall be vested by 1/3 at the end of each term until the day of publication of the interim report for the second quarter of 2021. The share awards shall be vested by 1/3 at the end of each term, provided that the participant is still a member of the Board of Directors of the company on said date. In accordance with the resolution by the Annual General Meeting, the share awards vested based on the development of the company’s share price, in accordance with the vesting conditions below.
The share awards vest based on the development of the company’s share price over the period from the date of 13 August, 2018, up to and including the date of the annual general meeting 2021. The development of the share price will be measured based on the volume weighted average price of the share price will be measured based on the volume weighted average price of the company’s share price for the 30 trading days immediately following after 17 August, 2018, and the 30 trading days immediately preceding the date of the publication of the interim report for the second quarter 2021. In the event the price of the company’s share has thereby increased by more than 150 percent, 100 percent of the share awards shall vest, and should the share price have increased by 50 percent, 25 percent of such share awards shall vest. In the event of an increase of the share price between 50 and 150 percent, vesting of the share awards will occur linearly. Should the increase of the share price be less than 50 percent, no vesting will occur. The earliest date at which accrued share awards may be exercised is the date of publication of the interim report for the second quarter of 2021. The valuation of the share awards is based on a Monte Carlo simulation in accordance with accepted valuation theory. Volatility has been based on the expected volatility of the Vicore share and other listed companies with similar operations. The risk-free interest rate used in the valuation of options amounted to an interpolation between a 2-year and 5-year government bond, respectively. The fair value of the share awards at the time of allocation amounts to SEK 4.70 per share award. In order to calculate the value of the share awards in relation to the current performance conditions, a starting value is used that corresponds to the volume-weighted average price paid for the Vicore share over a fixed period, which in this case corresponds to the value of the underlying share at the time of valuation. During the third quarter of 2021, Board LTIP 2018 expired. As the share price increased by less than 50 percent during the measurement period no share awards were earned. The program is now closed.
Co-worker LTIP 2018
For the co-workers LTIP 2018, the company has issued warrants intended for members of senior management and other key personnel, which will entitle to acquire a maximum of 2,000,000 shares in the company in total, in accordance with the terms stipulated below. The Board of Directors of the company believes that an equity-based incentive program is a central part of an attractive and competitive remuneration package for competent members of senior management and other key personnel, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders.
For the co-workers LTIP 2018, the company has issued options under which the participants will be granted options free of charge. The Board of Directors shall resolve upon the allocation of options annually or at such time as the Board of Directors can be considered as relevant to such decision (with each respective date of granting being a “granting date”). Each option entitles the holder to acquire one share in the company for a predetermined exercise price. The exercise price per share shall correspond to 150 percent of the volume weighted average price of the company’s share for the five trading days preceding the granting date. The options are subject to vesting on the third anniversary of the granting date, provided that the holder, with some customary exceptions is still employed by the company. The latest point in time at which vested options may be exercised shall be the fourth anniversary of the granting date. The options are valued according to the so-called Black-Scholes model, taking into consideration, among other things, the value of the underlying share, the options’s issue term and volatility. The risk-free interest rate was equated with the interest rate for Swedish government bonds. The volatility has been based on the expected volatility of the Vicore share and other listed companies with similar operations. The risk-free interest rate used in the valuation of the options was equated with the interest rate for Swedish government bonds. The fair value of the options at the time of allocation during 2020 amounts to SEK 7.25 per option.
Long-term incentive program 2020
The Annual General Meeting in Vicore Pharma Holding AB held on May 20, 2020, resolved, in accordance with the proposal from the Nomination Committee, to adopt a long-term incentive program for the new members of the Board of Directors (“Board LTIP 2020”) in Vicore Pharma Holding AB. A maximum of 525,000 share awards may be allotted to participants in the program Board LTIP 2020. The increase in the company’s share capital, assuming full utilization, amounts to a maximum of approximately SEK 262,500, corresponding to a dilution of 0.7% of the total number of shares. In addition to previously implemented incentive programs in the company, the maximum dilution amounts to 3.4% on a fully diluted basis.
Board LTIP 2020
Board LTIP 2020 is a program under which the participants will be granted, free of charge, share awards”) that entitle to shares in the company to be calculated in accordance with the principles stipulated below, however a maximum of 525,000 shares. Board LTIP 2020 is intended for the newly elected, main owner independent, members of the Board of Directors in the company. The Nomination Committee believes that an equity-based incentive program is a central part of a competitive remuneration package and to motivate internationally competent members of the Board of Directors, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders.
The share awards shall vest gradually over approximately three years, corresponding to three terms up to the date of, whichever is earliest, (i) the Annual General Meeting 2023 or (ii) June 1, 2023 (”vesting date”), where each term equals the period from one Annual General Meeting up until the day falling immediately prior to the next Annual General Meeting or the vesting date, as applicable (each such period a “term”). The share awards shall vest by 1/3 at the end of each term, provided that the participant is still a member of the Board of Directors of the company on said date. In addition to the vesting for the participant’s continued employment, the share awards vest based on the development of the company’s share price, in accordance with the vesting conditions below.
The share awards vest based on the development of the company’s share price over the period from the date the share awards are allocated (”grant date”) up to and including the vesting date. The development of the share price will be measured based on the volume weighted average price of the company’s share for the 10 trading days immediately following the grant date and the 30 trading days immediately preceding the vesting date, respectively. In the event the price of the company’s share has thereby increased by more than 150 percent, 100 percent of the share awards shall vest, and should the share price have increased by 50 percent, 25 percent of the share awards shall vest. In the event of an increase of the share price between 50 and 150 percent, vesting of the share awards will occur linearly. Should the increase of the share price be less than 50 percent, no vesting will occur. The earliest point in time at which vested share awards may be exercised shall be the day falling immediately after the vesting date. The valuation of the share awards is based on a Monte Carlo simulation in accordance with accepted valuation theory. Volatility has been based on the expected volatility of the Vicore share and other listed companies with similar operations. The risk-free interest rate used in the valuation of options amounted to an interpolation between a 2-year and 5-year government bond, respectively. The fair value of the share awards at the time of allocation amounts to SEK 5.18 per share award.In order to calculate the value of the share awards in relation to the current performance conditions, a starting value is used that corresponds to the volume-weighted average price paid for the Vicore share over a fixed period, which in this case corresponds to the value of the underlying share at the time of valuation.
Long-term incentive programs 2021
The Annual General Meeting in Vicore Pharma Holding AB held on May 11, 2021, resolved to implement a long-term incentive program for senior management and other key personnel in the company (“Co-worker LTIP 2021”), and a long-term performance-based incentive program for independent board members in the company who are not participants in Board LTIP 2020 (“Board LTIP 2021”). A maximum of 3,000,000 options (Co-worker LTIP 2021) and 3,000,000 warrants (Board LTIP 2021) may be allotted to participants in the programs. The increase in the company’s share capital, assuming full utilization of both incentive programs, amounts to a maximum of approximately SEK 1,530,887, corresponding to a dilution of approximately 4.1 percent of the total number of shares. However, pursuant to previously implemented incentive programs in the company, the maximum dilution amounts to approximately 7.2 percent on a fully diluted basis.
Board LTIP 2021
Board LTIP 2021 is a program under which the participants will be granted, free of charge, share awards that entitle to acquire a maximum of 61,773 shares in the company to be calculated in accordance with the principles stipulated below, however a maximum of 61,773 shares. Board LTIP 2021 is intended for independent board members in the company who are not participants in Board LTIP 2020. The Nomination Committee believes that an equity-based incentive program is a central part of a competitive remuneration structure for board members and is a tool to motivate internationally competent members of the Board of Directors, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders.
The share awards shall vest gradually over approximately three years, corresponding to three terms up to the date of, whichever is earliest, (i) the Annual General Meeting 2024 or (ii) June 1, 2024 (”vesting date”), where each term equals the period from one Annual General Meeting up until the day falling immediately prior to the next Annual General Meeting or the vesting date, as applicable (each such period a “term”). The share awards shall vest by 1/3 at the end of each term, provided that the participant is still a member of the Board of Directors of the company on said date. In addition to the time-based vesting, the share awards vest based on the development of the company’s share price, in accordance with the vesting conditions below.
The share awards vest based on the development of the company’s share price over the period from the date the share awards are allocated (”grant date”) up to and including the vesting date. The development of the share price will be measured based on the volume weighted average price of the company’s shares immediately following the grant date and the 30 trading days immediately preceding the vesting date, respectively. In the event the price of the company’s share has thereby increased by more than 80 percent, 100 percent of the share awards shall vest, and should the share price have increased by 40 percent, 25 percent of the share awards shall vest. In the event of an increase of the share price between 40 and 80 percent, vesting of the share awards will occur linearly. Should the increase of the share price be less than 40 percent, no vesting will occur. The earliest point in time at which vested share awards may be exercised shall be the day falling immediately after the vesting date.
The Board of Directors of the company believes that Board LTIP 2021 will promote an alignment of the interests of the participants and the shareholders of the company. Board LTIP 2021 is adapted to the current position and needs of the company. The Board of Directors is of the opinion that Board LTIP 2021 will strengthen the participants’ dedication to the company’s operations, improve company loyalty and strengthen the participants’ dedication to the company’s operations, improve company loyalty and incentivize the participants to contribute to long-term value creation for both the shareholders and the company.
The valuation of the share awards is based on a Monte Carlo simulation in accordance with accepted valuation theory. Volatility has been based on the expected volatility of the Vicore share and other listed companies with similar operations. The risk-free rate of interest has been equated with the interest rate for an interpolation between a 2-year and 5-year government bond, respectively. The fair value of the share awards at the time of allocation amounts to SEK 10.99 per share award. In order to calculate the value of the share awards in relation to the current performance conditions, a starting value is used that corresponds to the volume-weighted average price paid for the Vicore share over a fixed period, which in this case corresponds to the value of the underlying share at the time of valuation.
Co-worker LTIP 2021
Co-worker LTIP 2021 is a program intended for members of senior management and other key personnel in the company. Allotment of options will be resolved by the Board of Directors, and the program participants will be granted, free of charge, options to acquire shares in the company. Each option entitles to acquire a maximum of 3,000,000 shares in the company in total.
Board LTIP 2021 is a program under which the participants will be granted, free of charge, options that entitle to acquire a maximum of 3,000,000 options in total. The Board of Directors shall annually resolve upon the allocation of options no later than the day falling three years after the Annual General Meeting 2021 (with each respective date of granting being a “grant date”). Each Option entitles the holder to acquire one share in the company for a pre-determined exercise price. The exercise price shall correspond to 125 percent of the volume weighted average price for the company’s shares on Nasdaq Stockholm during the five trading days preceding the grantdate. The options shall vest over a three-year period with one third each year on the anniversary of the grant day, whereby all options shall vest on the third anniversary of the grant date, provided that the holder, with some customary exceptions, still is employed by the company. The latest point in time at which vested options may be exercised shall be the fifth anniversary of the grant date.
The options are valued according to the so-called Black-Scholes model, taking into account the following assumptions. The fair value of the options depends, among other things, on the value of the underlying share, the options’s issue price, term, volatility and the risk-free rate of interest. The volatility has been based on the expected volatility of the Vicore share and other listed companies with similar operations. The risk-free interest rate was equated with the interest rate for Swedish government bonds. The fair value of the options at the time of allocation during 2021 amounts to SEK 8.45 per option.
The following inputs have been used in the model:
| Input | 2021 |
|---|---|
| Underlying share price | 20.00 SEK |
| Excercise price | 26.48 SEK |
| Expected volatility | 50.00 % |
| Option life | 5 år |
| Expected dividends | 0 SEK |
| Risk-free interest rate | 0.10 % |
Summary of issued share awards and options 2021
| Issued share awards (Board LTIP 2018) | Average exercise price per share award | Number of share awards | Average exercise price per share award | Number of share awards |
|---|---|---|---|---|
| At January 1 | 0 | 433,333 | 0 | 475,000 |
| Forfeited/expired during the year | 0 | -433,333 | 0 | -41,667 |
| At December 31 | 0 | 0 | 0 | 433,333 |
A total of 433,333 share awards have expired during the year.
| Issued share awards (Board LTIP 2020) | Average exercise price per share award | Number of share awards | Average exercise price per share award | Number of share awards |
|---|---|---|---|---|
| At January 1 | 0 | 525,000 | 0 | 0 |
| Granted during the year | 0 | 0 | 0 | 525,000 |
| At December 31 | 0 | 525,000 | 0 | 525,000 |
No share awards have been exercised, forfeited or expired during the year.
| Issued share awards (Board LTIP 2021) | Average exercise price per share award | Number of share awards |
|---|---|---|
| At January 1 | 0 | 0 |
| Granted during the year | 0 | 61,773 |
| At December 31 | 0 | 61,773 |
No share awards have been exercised, forfeited or expired during the year.
| Issued options (Co-worker LTIP 2018) | Average exercise price per option | Number of options | Average exercise price per option | Number of options |
|---|---|---|---|---|
| At January 1 | 27.48 | 1,239,600 | 25.81 | 765,800 |
| Granted during the year | 0 | 0 | 29.25 | 560,000 |
| Forfeited during the year | 0 | 0 | 25.99 | -86,200 |
| At December 31 | 27.48 | 1,239,600 | 27.48 | 1,239,600 |
No options have been exercised, forfeited or expired during the year.
| Issued options (Co-worker LTIP 2021) | Average exercise price per option | Number of options |
|---|---|---|
| At January 1 | 0 | 0 |
| Granted during the year | 26.26 | 807,600 |
| At December 31 | 26.26 | 807,600 |
No options have been exercised, forfeited or expired during the year.# Outstanding share awards and options at year-end
Dec 31, 2021 | Dec 31, 2020
| Program | per year | Date of expiration | Exercise price | Share awards/options | Vested (%) | Share awards/options | Vested (%) |
|---|---|---|---|---|---|---|---|
| Program share awards (Board LTIP 2018) | September, 2021 | 0 | - | - | 433,333 | 92% | |
| Program share awards (Board LTIP 2020) | Annual Gen- eral Meeting 2023 | 0 | 525,000 | 78% | 525,000 | 38% | |
| Program share awards (Board LTIP 2021) | Annual Gen- eral Meeting 2024 | 0 | 61,773 | 38% | - | - | |
| Program 2018 options | September 27, 2022 | 25.26 | 283,333 | 100% | 283,333 | 93% | |
| Program 2019 options | September 27, 2023 | 26.17 | 396,267 | 92% | 396,267 | 71% | |
| Program 2020 options | September 24, 2024 | 29.25 | 560,000 | 68% | 560,000 | 15% | |
| Program 2021 options | September 16, 2026 | 26.26 | 807,600 | 15% | - | - |
The costs for social security contributions related to share-based incentive programs varies from quarter to quarter due to the change in the underlying share price. Related provisions are reported as non-current liabilities. Total IFRS 2-classified payroll expenses for the incentive programs for the entire duration of the programs amount to 9,779 KSEK. The total costs for the share-based incentive programs for each year is presented below. These costs have had no cash impact.
49 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Summary of the total cost of the incentive programs
| 2021 | 2020 | |
|---|---|---|
| Social security contributions | 3,862 | 2,632 |
| Provisions for social security contributions | -5,425 | 5,602 |
| Total | -1,563 | 8,234 |
Summary of allotted options and share awards
Program 2018 share awards (Board LTIP 2018)
| 2021 | 2020 | |
|---|---|---|
| Number outstanding at Jan 1, 2021 | Granted/ forfeited | |
| Former chairman of the Board Leif Darner | 83,333 | -83,333 |
| Member of the Board | 125,000 | -125,000 |
| Member of the Board Maarten Kraan | 125,000 | -125,000 |
| Member of the Board | 50,000 | -50,000 |
| Member of the Board Sara Malcus | 50,000 | -50,000 |
| Total | 433,333 | -433,333 |
Program 2020 share awards (Board LTIP 2020)
| 2021 | 2020 | |
|---|---|---|
| Number outstanding at Jan 1, 2021 | Granted/ forfeited | |
| Chairman of the Board Michael Wolff Jensen | 350,000 | 0 |
| Member of the Board Heidi Hunter | 175,000 | 0 |
| Total | 525,000 | 0 |
Program 2021 share awards (Board LTIP 2021)
| 2021 | |
|---|---|
| Number outstanding at Jan 1, 2021 | |
| Member of the Board | 0 |
| Member of the Board Maarten Kraan | 0 |
| Member of the Board Sara Malcus | 0 |
| Total | 0 |
Program 2018, 2019 and 2020 options (Co-wor- ker LTIP 2018)
| 2021 | 2020 | |
|---|---|---|
| Number outstanding at Jan 1, 2021 | Granted/ forfeited | |
| CEO Carl-Johan Dalsgaard | 300,000 | 0 |
| Other senior executives | 703,750 | 0 |
| Other employees | 235,850 | 0 |
| Total | 1,239,600 | 0 |
Program 2021 options (Co-wor- ker LTIP 2021)
| 2021 | |
|---|---|
| Number outstanding at Jan 1, 2021 | |
| CEO Carl-Johan Dalsgaard | 0 |
| Other senior executives | 0 |
| Other employees | 0 |
| Total | 0 |
For information about other senior executives, see Note 7 "Employees and personnel costs".
50 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 9 Other operating income
| 2021 | 2020 | |
|---|---|---|
| Exchange rate gains | 1,094 | 654 |
| Grants received | 0 | 17,536 |
| Total other operating income | 1,094 | 18,190 |
Note 10 Other operating expenses
| 2021 | 2020 | |
|---|---|---|
| Exchange rate losses | 2,492 | 721 |
| Total other operating expenses | 2,492 | 721 |
Note 11 Financial income
| 2021 | 2020 | |
|---|---|---|
| Financial assets measured at fair value through prot and loss | ||
| Change in value for long-term investments | 0 | 1,414 |
| Total | 0 | 1,414 |
| Financial assets measured at amortized cost | ||
| Interest income short-term investments | 646 | 815 |
| Total interest income calculated using the effective interest method | 646 | 815 |
| Total disclosed in net nancial income/expenses | 646 | 2,229 |
Note 12 Financial expenses
| 2021 | 2020 | |
|---|---|---|
| Financial assets measured at fair value through prot and loss | ||
| Change in value for long-term investments | -2,121 | 0 |
| Exchange rate losses currency accounts | -431 | 0 |
| Total | -2,552 | 0 |
| Financial liabilities measured at amortized cost | ||
| Interest expenses | -11 | -6 |
| Total interest expenses calculated using the effective interest method | -11 | -6 |
| Total disclosed in net nancial income/expenses | -2,563 | -6 |
Note 13 Tax
| 2021 | 2020 | |
|---|---|---|
| Current tax | 0 | 0 |
| Change in deferred tax regarding temporary differences | 254 | 453 |
| Recognized tax | 254 | 453 |
Reconciliation of effective tax rates
| 2021 | 2020 | |
|---|---|---|
| Loss before tax | -296,735 | -147,315 |
| Tax according to applicable tax rate 20.6% (21.4%) | 61,127 | 31,525 |
| Non-deductable expenses | -95 | -1,309 |
| Tax effect non-taxable income | 1,118 | 0 |
| Tax effect unrecognized tax assets | -61,896 | -30,216 |
| Change in deferred tax | 254 | 453 |
| Recognized tax | 254 | 453 |
| Effective tax rate | 0% | 0% |
The group has no tax items that are recognized in other comprehensive income, but there are issue costs related to share issues.
Information about deferred tax assets and tax liabilities
In the table below, the tax effect of the temporary differences is specified:
| Deferred tax liability | 2021 Dec 31 | 2020 Dec 31 |
|---|---|---|
| Intangible assets | 1,026 | 1,411 |
| Tax provision for pension premium | 184 | 120 |
| Carrying amount | 1,210 | 1,531 |
| Deferred tax asset | ||
|---|---|---|
| Provision for pension premium | 0 | 131 |
| Carrying amount | 0 | 131 |
Tax loss carryforwards
Tax loss carryforwards for which deferred tax assets have not been recognized in the balance sheet amounted to 729,828 KSEK (414,472 KSEK). These carryforwards have no time limit. Deferred tax assets that have not been recognized in the balance sheet are related to tax loss carryforwards that are not deemed likely to be utilized in the foreseeable future to offset future taxable profits. For further information about tax loss carryforwards, see Note 2 "Judgements and accounting estimates".
51 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 14 Earnings per share
Earnings per share before and after dilution
| 2021 | 2020 | |
|---|---|---|
| Loss before tax, attributable to the owners of the parent company | -296,480,577 | -146,861,265 |
| Average number of ordinary shares | 69,678,461 | 54,249,185 |
| Earnings per share before and after dilution | -4.25 | -2.71 |
The calculation of diluted earnings per share takes into account the dilutive effect from all potential ordinary shares. These potential ordinary shares are attributable to the options and share awards allocated to senior execu- tives, other employees and certain board members during the years 2018-2021. For further information, see Note 8 "Share-based payments". If there is a loss for the year, the options are not treated as dilutive. Neither are the options considered dilutive if the exercise rate, including the addition of the value of remaining future services to be recognized during the vesting period, exceeds the average trading price for the period. There is no dilution effect for potential ordinary shares as there was a loss for the year, as demonstrated above. For more information about the changes of the number of outstanding shares, see Note 24 "Sharehold- ers’ equity".
Note 15 Patents, licenses and similar rights
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Opening cost | 75,192 | 69,192 |
| Additions for the year | 0 | 6,000 |
| Closing accumulated cost | 75,192 | 75,192 |
| Opening amortizations | -4,437 | -1,110 |
| Amortizations for the year | -3,328 | -3,327 |
| Closing accumulated amortizations | -7,765 | -4,437 |
| Closing carrying amount | 67,427 | 70,755 |
Amortizations
Amortization refers to previously acquired intangible assets. This consists of a patent portfolio related to C21, whose main patent expires in the United States in September 2024. Amortization began in Septem- ber 2019 and is amortized over its estimated useful life, which is the remaining patent period. Amortization has not yet begun for the group's other intangible assets.
Impairment testing
Upon impairment testing of the intangible assets, the company has used a value in use model based on fair value. The value in use for VP01, VP02 and VP02 is determined by calculating the present value of future cash flows from the asset, discounted by the weighted average cost of capital. The company has not performed any impairment testing of the intangible assets and does not involve calculation of any residual value thereafter. The methodology used is an accepted one for impairment testing within the biopharmaceutical industry. The measurement is attributed to Level 3 in the fair value hierarchy and comprises the material assumptions specified below: Revenue- and cost forecasts for VP01 stretches over 7 years for the US and 10 years for the EU and Canada. The forecasts include all market potential related to the product and its potential use. Revenue is calculated using estimations based on available data of different types considered indica- tors of the market size, and the assessed price level is derived from secondary sources, accepted industry assumptions and assumptions made by Vicore. Revenue- and cost forecasts for VP02 and VP03 stretches over 20 years. Revenue is calculated using estimations based on available data of different types considered indica- tors, and the assessed price level is derived from secondary sources, accepted industry assumptions and assumptions made by Vicore.# Note 16 Equipment
| | 2021 Dec 31 | 2020 Dec 31 |
| :------------------------------------- | :---------- | :---------- |
| Opening cost | 147 | 147 |
| Additions for the year | 0 | 0 |
| Sales/disposals | 0 | 0 |
| Closing accumulated cost | 147 | 147 |
| Opening depreciations | -34 | -4 |
| Depreciations for the year | -29 | -30 |
| Sales/disposals | 0 | 0 |
| Closing accumulated depreciations | -63 | -34 |
| Closing carrying amount | 84 | 113 |
52 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 17 Long-term investments
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Opening carrying amount | 7,530 | 6,116 |
| Additions for the year | -2,121 | 1,414 |
| Closing carrying amount | 5,409 | 7,530 |
Vicore holds 91,829 shares in I-Tech AB (publ), which are classified as long-term investments.
Note 18 Financial assets and liabilities
Financial assets and liabilities at December 31, 2021
| Financial assets/ liabilities measured at fair value through profit and loss | Financial assets/ liabilities measured at amortized cost | Total carrying amount | |
|---|---|---|---|
| Financial assets | |||
| Long-term investments | 5,409 | 0 | 5,409 |
| Other current receivables | 0 | 60 | 60 |
| Accrued income | 0 | 281 | 281 |
| Short-term investments | 0 | 77,000 | 77,000 |
| Cash and cash equivalents | 0 | 294,199 | 294,199 |
| Total | 5,409 | 371,540 | 376,949 |
| Financial liablilities | |||
| Contract liability | 0 | 320 | 320 |
| Trade payables | 0 | 23,984 | 23,984 |
| Accrued expenses | 0 | 35,311 | 35,311 |
| Total | 0 | 59,615 | 59,615 |
The group has not received any pledged assets for the financial net assets.
Financial assets and liabilities at December 31, 2020
| Financial assets/ liabilities measured at fair value through profit and loss | Financial assets/ liabilities measured at amortized cost | Total carrying amount | |
|---|---|---|---|
| Financial assets | |||
| Long-term investments | 7,530 | 0 | 7,530 |
| Other current receivables | 0 | 3,783 | 3,783 |
| Accrued income | 0 | 3,151 | 3,151 |
| Short-term investments | 0 | 70,118 | 70,118 |
| Cash and cash equivalents | 0 | 248,618 | 248,618 |
| Total | 7,530 | 325,670 | 333,200 |
| Financial liablilities | |||
| Contract liability | 0 | 140 | 140 |
| Trade payables | 0 | 10,943 | 10,943 |
| Accrued expenses | 0 | 21,843 | 21,843 |
| Total | 0 | 32,926 | 32,926 |
The group has not received any pledged assets for the financial net assets.
Fair value measurement
IFRS 13, Fair Value Measurement contains a valuation hierarchy regarding inputs to the measurements. This measurement hierarchy is divided into three levels, which comprise:
- Level 1 - Quoted prices in active markets for identical assets or liabilities that the entity can access at the measurement date.
- Level 2 - Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as price quotations) or indirectly (that is, derived from price quotations)
- Level 3 - Unobservable inputs for the asset or liability (inputs that are not derived from observable market data)
Long-term investments
Investments in financial fixed assets are measured at fair value with changes in value in profit and loss. Investments in listed shares are measured at fair value according to Level 1 in the valuation hierarchy. Listed investments are measured on the basis of their share price on the closing day.
Other financial assets and liabilities
For other current receivables and liabilities, short-term investments, cash and cash equivalents, trade payables, and accrued income and expenses with a short maturity, the carrying amount is considered a reasonable estimate of the fair value.
53 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 19 Financial risks
Through its operations, Vicore is exposed to various financial risks, such as credit risks, liquidity risks and currency risks, which could have potentially unfavorable consequences for the group’s financial position and performance. The Board of Directors has overall responsibility for managing these financial risks and transactions are managed centrally by the parent company through the group’s CFO and finance department. The group's CFO is responsible for managing the group’s risk exposure and for ensuring that all payment commitments are processed at the right time, to ensure that all financial transactions are organized in a way that supports the group in achieving the desired financial position and that the risks associated with these are reduced to an acceptable level. The Board of Directors establishes written policies for the management of financial risks and the handling of excess liquidity. The group does not currently use derivatives, but allows hedging of currency in certain situations.
Credit risk
Credit risk is the risk that a counterparty of a financial instrument cannot fulfill its obligation and thereby causes a financial loss for the group. Given the nature of the group’s business, with no significant customer receivables at this stage of the company’s development.
Interest rate risk is managed through Vicore’s treasury policy.
Foreign exchange risk
Foreign exchange risk is the risk that the present value of or future cash flow from a financial instrument may vary due to changes in foreign exchange rates.
Foreign exchange risk means that fluctuations in exchange rates will have a negative impact on the group’s P&L, balance sheet or cash flow.
Transaction currency risk
The main exposure derives from the group’s expenses in foreign currencies. This exposure is referred to as transaction exposure. The company's development costs for VP01 are mainly paid in USD. At this point in time, the group has no significant cost-related transaction exposure in other currencies, such as fluctuations where the exchange rate changes from the time an agreement is entered into until its payment is to be made in accordance with the agreement. Foreign exchange hedging is decided by the Board of Directors based on cash flow forecasts. In accordance with the company's policy for financial risk, the group hedges expected flows in USD to 60-100% of expected flows. See the table below for the level of exposure in each currency.
| Foreign exchange exposure 2021 (%) | Operating income | Operating expenses |
|---|---|---|
| GBP | 100% | 7% |
| EUR | - | 52% |
| DKK | - | 2% |
| USD | - | 2% |
| SEK | - | 37% |
| Foreign exchange exposure 2020 (%) | Operating income | Operating expenses |
|---|---|---|
| GBP | 100% | 21% |
| EUR | - | 27% |
| DKK | - | 6% |
| USD | - | 1% |
| SEK | - | 45% |
Operating expenses in the table above are excluded from payroll expenses.
Financial credit risk
The financial assets that are covered by provisions for expected credit losses according to the general method consist of cash and cash equivalents. Vicore applies a rating-based method to the amortized cost of trade receivables and other receivables to measure expected credit losses. The group has defined default as when payment of the claim is 90 days overdue or more, or if other factors indicate a suspension of payment. A default in payment of the claim has not been considered to exist for any receivable or asset on the reporting date. Such assessment is based on whether payment is 30 days overdue or more, or if significant deterioration of the rating occurs, entailing a rating below investment grade. In cases where the amounts are not deemed to be insignificant, a provision for expected credit losses is also recognized for these financial instruments. The assessment has been made that there has been no impairment to the group’s financial assets. There counterparties do not have credit ratings, except for cash and cash equivalents where the counterparties have credit ratings from Moody’s.
Market risks
Market risk is the risk that the cash flows of a financial instrument will fluctuate due to changes in market rates. Market risk is divided into three types: foreign exchange risk, interest rate risk, and equity price risk.
Foreign exchange risk has the greatest impact on the group as the financing received shall cover for research and development costs mainly in foreign currencies.The group does not currently have any loans that may occur in short term cash management, and is regulated by maximum maturities. The group’s main transaction exposure consists of EUR (EUR and GBP in 2020). A 10% stronger EUR and GBP against SEK would have a negative impact on the profit after tax and shareholders’ equity by approximately 14,191 KSEK (4,112 KSEK). Refinancing risk exists when it is unavailable and that financing can only be obtained partially, not at all or at an elevated cost. Currently, the group is financed by shareholders’ equity and is therefore not exposed to refinancing risk associated with long-term financing. The board of directors is aware of the refinancing risk and aims to manage it through equity investments from Vicore’s shareholders.
Liquidity risk
Liquidity risk is the risk that the company has difficulties in fulfilling its obligations related to financial liabilities. The Board of Directors manage liquidity risk and aim to guarantee that the group always has sufficient funds to meet its payment obligations. Vicore uses rolling forecasts to ensure that the company has sufficient cash assets to meet its operational requirements. This monitoring of outcomes and forecasts are compared with the budget that is produced and approved by the Board each year. Surplus liquidity in Vicore, in excess of what is needed for current operations, is invested in interest-bearing current accounts. At the balance sheet date, Vicore had short-term investments in twelve-month fixed-rate accounts of 77,000 KSEK (70,000 KSEK). In addition to these investments, cash and cash equivalents totaled 294,199 KSEK (248,618 KSEK) at the balance sheet date.
54 | Annual Report 2021
Vicore Pharma Holding AB (publ)
The group’s contractual and undiscounted interest payments and financial liability repayments are shown in the table below. Amounts in foreign currencies have been translated into SEK at the closing rate on the reporting date. Financial instruments with a variable interest rate have been calculated using the interest rate at the reporting date. Liabilities have been included in the earliest period during which repayment may be required.
Dec 31, 2021
| Maturity analysis | <1 month | 1-3 months | >3 months |
|---|---|---|---|
| Contract liability | 21 | 42 | 257 |
| Trade payables | 23,785 | 198 | 0 |
| Accrued expenses | 0 | 13,934 | 21,377 |
| Total | 23,806 | 14,174 | 21,634 |
Dec 31, 2020
| Maturity analysis | <1 month | 1-3 months | >3 months |
|---|---|---|---|
| Contract liability | 24 | 72 | 44 |
| Trade payables | 10,919 | 24 | 0 |
| Accrued expenses | 28 | 21,815 | 0 |
| Total | 10,971 | 21,911 | 44 |
Capital management
The group’s goals regarding the capital structure are to ensure financing of the company’s development and business plan. Equity or financing related to equity is expected to be the most realistic and possible alternative in the near future. No change occurred in the group’s capital management during the year. None of the group companies have any external demands on capital.
Note 20 Prepaid expenses and accrued income
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Prepaid rental charges | 214 | 135 |
| Prepaid insurances | 591 | 0 |
| Prepaid research and development expenses | 3,123 | 0 |
| Accrued income | 0 | 3,151 |
| Other prepaid expenses | 1,106 | 471 |
| Total | 5,034 | 3,757 |
Note 21 Short-term investments
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Fixed-rate account, SBAB | 77,000 | 70,000 |
| Accrued interest income | 281 | 118 |
| Total | 77,281 | 70,118 |
Vicore has as of December 31, 2021, a total of eleven fixed-rate accounts (investment accounts) at SBAB. Each account amounts to 7 MSEK and were opened during March 2021 (fixed for 12 months). The annual interest rate per account is between 0.45% and 0.47%.
Note 22 Cash and cash equivalents
| Available balances | 2021 Dec 31 | 2020 Dec 31 |
|---|---|---|
| SEK | 232,568 | 248,618 |
| EUR | 61,631 | 0 |
| Total | 294,199 | 248,618 |
Note 23 Group companies
| Company | Principal activity | Share of equity and voting rights |
|---|---|---|
| 2021 Dec 31 | ||
| Vicore Pharma Holding AB | Own and manage shares in subsidiaries (Parent company) | 100% |
| Vicore Pharma AB | Research and development of pharmaceutical products | 100% |
| INIM Pharma AB | Research and development of pharmaceutical products | 100% |
Note 24 Shareholders’ equity
| Number of ordinary shares | Share capital | Other contributed capital | |
|---|---|---|---|
| At January 1, 2020 | 50,174,714 | 25,087,357 | 527,397,207 |
| New share issue of warrants, January 8, 2020 | 243,525 | 121,762 | 2,427,944 |
| New share issue, August 13, 2020 | 10,000,000 | 5,000,000 | 169,595,120 |
| Share-based payments | 0 | 0 | 2,632,679 |
| At December 31, 2020 | 60,418,239 | 30,209,119 | 702,052,950 |
| At January 1, 2021 | 60,418,239 | 30,209,119 | 702,052,950 |
| Exercise of options, exercise period Q1 2021 | 142,054 | 71,027 | 2,928,973 |
| New share issue, February 22, 2021, registered March 9, 2021 | 11,200,000 | 5,600,000 | 312,821,895 |
| Share-based payments | 0 | 0 | 3,861,698 |
| At December 31, 2021 | 71,760,293 | 35,880,146 | 1,021,665,516 |
55 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Share capital
At December 31, 2021, the registered share capital encompassed 71,760,293 ordinary shares. All shares have been fully paid and no shares are reserved for transfer. Each share carries one vote. The quotient value is SEK 0.50 (0.50). No shares are held by the company itself or its subsidiaries.
Other contributed capital
Other contributed capital comprises capital contributed by the owners of the company, for example share premiums when subscribing for shares.
Share-based payments
As of December 31, 2021, Vicore has four active incentive programs that include the management team, other employees and certain board members. For more information, see Note 8 "Share-based payments".
Dividend
At the Annual General Meeting in May 2022, no dividend will be proposed for the financial year 2021.
Note 25 Other provisions
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Social security contributions related to share-based incentive programs | 752 | 6,177 |
| Total | 752 | 6,177 |
For more information about incentive programs, see Note 8 "Share-based payments".
Note 26 Accrued expenses and deferred income
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Accrued personnel-related expenses | 4,644 | 1,655 |
| Accrued expenses, research and development | 35,036 | 21,843 |
| Accrued expenses, other | 459 | 6,028 |
| Total | 40,139 | 29,526 |
Note 27 Supplementary information to the cash flow statement
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Depreciations | 3,598 | 3,537 |
| Loss on disposal of equipment | 0 | 0 |
| Incentive programs, payroll expenses | 3,862 | 2,632 |
| Incentive programs, social security contributions* | -5,425 | 0 |
| Provision for payroll tax, pension premium | 64 | 0 |
| Other | 0 | 33 |
| Total | 2,099 | 6,202 |
* Social security contributions for share-based incentive programs were reported in the Annual Report for the fiscal year 2020 in the cash flow statement under “Adjustment for items not included in the cash flow” and then adjusted in the cash flow from operating activities in the amount of 5,425 KSEK.
Note 28 Related-party transactions
Related parties are defined as individuals with holdings of more than ten percent, members of the group’s senior management, meaning the Board of Directors and senior executives, as well as their immediate family members. For information about remuneration to senior executives and the Board of Directors, see Note 7 "Employees and personnel costs".
Note 29 Contingent liabilities
Below a summary of material agreements which the company has entered into during the most recent years:
Agreement with Emeriti Bio AB
Vicore Pharma AB ("Vicore Pharma") entered into a cooperation and development agreement with Emeriti Bio AB on August 24, 2016, which was expanded on November 1, 2017. The main purpose of the agreement is to develop new follow-on molecules based on C21 and other drug substances targeting the AT2 receptor (AT2R). On November 2, 2020, the parties expanded their cooperation and development agreement in connection with the acquisition of a number of new intellectual property rights as part of the development of new AT2R agonists from HaLaCore Pharma AB, where HaLaCore Pharma AB became a new party to the agreement. The agreement is valid until there is no longer any obligation to pay Emeriti Bio AB or HaLaCore Pharma AB. The agreement is based on milestone payments and royalty.
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Vicore Pharma Holding AB (publ)
Vicore Pharma pays consultancy fees, possible milestone payments and royalties on sales of predefined development goals. Vicore Pharma owns all results. The total maximum payments in the form of milestone compensation under the agreement is limited to 49.5 MSEK. In 2020, a milestone payment of 1,000 KSEK (250 KSEK) was paid to Emeriti Bio AB in connection with the filing of a patent application by Vicore Pharma. As compensation for the acquisition of intellectual property rights, HaLaCore received a one-time payment of 6 MSEK in 2020, divided between 3 MSEK in cash and 142,054 newly issued shares in Vicore, corresponding to approximately 3 MSEK.
Agreement with Nanologica AB
On May 9, 2018, INIM Pharma AB ("INIM Pharma") entered into a license agreement with Nanologica AB (publ) regarding the use of Nanologica AB’s drug delivery technology, NLAB Silica® for a unique product that INIM Pharma is developing. The agreement is valid until further notice, where INIM Pharma has a unilateral right to terminate the agreement at any time without any period of notice. All results are owned by INIM Pharma. In order to fully obtain the license, INIM Pharma is required to pay a one-time payment equivalent to 2 MSEK.This payment was completed in the fourth quarter of 2018. Furthermore, INIM Pharma is obliged to pay milestone compensations equivalent to 1 MSEK per product at a defined stage of development. INIM Pharma has an obligation to develop products within a certain period of time in order not to loose the license. However, INIM Pharma is entitled to maintain its license by issuing a new one-time payment equivalent to 2 MSEK. INIM Pharma is responsible for all development.
Note 30 Events after the balance sheet date
In February, an interim analysis of the AIR [REDACTED] IPF suggests that C21 stabilizes disease and shows an unanticipated increase in lung function in IPF patients. In February, Vicore announced the advance- [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] 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In March, Vicore announced the plan to initiate a proof-of-concept trial with C21 in pulmonary arterial hypertension (PAH). In March, Vicore announced the initiation of [REDACTED] [REDACTED] planned to start in Q2 2022. In March, Vicore announced that Michael Wolff Jensen resigned from the board and was re- placed by Jacob Gunterberg as chairman until the annual general meeting in May 2022.
57 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Notes
Parent company
Note 1 Accounting principles
The parent company's accounting principles
The parent company has prepared its financial reports in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board recommendation RFR 2 “Accounting for Legal Entities”. The differences between the group’s and the parent company’s accounting principles are described below. The accounting policies set out below for the parent company have been consistently applied for all periods as presented in the parent company’s financial statements, unless otherwise stated.
Classification and format
The parent company’s income statement and balance sheets are prepared in accordance with the Annual Accounts Act’s scheme, while the statement of comprehensive income, statement of changes in equity and the statement of cash flow are based on IAS 1 Presentation of Financial Statements and IAS 7, Statement of Cash Flow. The differences concerning the group’s statements, which are relevant to the parent company’s income statement and balance sheet consist mostly of the presentation of equity.
Subsidiary and associated companies
Participations in subsidiaries and associated companies are recognized in the parent company according to the cost method less any write-downs. This means that transaction costs are included in the carrying amount of the subsidiaries.
Financial assets and liabilities
Due to the relation between accounting and tax, the rules pertaining to the financial instruments in IFRS 9 are not applied in the parent company as a legal entity. Instead the parent company applies accounting at cost in accordance with the Annual Accounting Act. In the parent company, therefore, financial non-current assets are valued at cost and financial current assets according to the lowest value principle, with the application of impairments for expected credit losses according to IFRS 9 for assets that are debt [REDACTED]. [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
Leasing
The parent company does not apply IFRS 16 Leases. The parent company as lessee recognizes leasing fees as a linear cost over the lease period, unless another systematic way better reflects the user's economic benefit over time. The parent company only recognizes leasing fees from leasing contracts as a linear cost over the leasing period under administrative expenses. Thus, the contract asset and the contract liability are not recognized in the balance sheet.
Group contributions and shareholder contributions
Both received and paid group contributions are recognized as appropriations in accordance with the alter- native method. Shareholder contributions are recognized directly in the receiver’s equity and capitalised in shares and participations of the parent company, to the extent that impairment is not required.
Note 2 Net sales
Net sales mainly consists of reinvoiced costs and management fees to group companies.
Note 3 Operating expenses by nature of expense
The total expenses classified by function are distributed in the following cost categories:
| 2021 | 2020 | |
|---|---|---|
| Other external expenses | 10,947 | 6,970 |
| Personnel expenses | 10,648 | 19,357 |
| Depreciation and amortization | 0 | 0 |
| Other operating expenses | 69 | 10 |
| Total | 21,664 | 26,337 |
Note 4 Audit fees
| 2021 | 2020 | |
|---|---|---|
| Ernst & Young AB | ||
| Audit fees | 300 | 388 |
| Other audit related services | 92 | 47 |
| Tax consultancy services | 0 | 0 |
| Other services | 10 | 88 |
| Total | 402 | 523 |
For further information on audit fees, see Note 5 "Audit fees" for the group.
Note 5 Leases
Operating leasing costs for the year concerning operating leases mainly comprise rent for premises and office equipment and amounts to 1,066 KSEK (817 KSEK).
Future payment commitments as of December 31 for operating leases are divided up as follows:
| Future minimum lease payments | 2021 | 2020 |
|---|---|---|
| No later than 1 year | 279 | 130 |
| Between 1 and 5 years | 0 | 0 |
| Later than 5 years | 0 | 0 |
| Total | 279 | 130 |
58 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Note 6 Employees and personnel costs
For salaries and remuneration to employees and senior executives as well as information on the number of employees, see Note 7 "Employees and personnel costs" for the group. For information on employee [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED].
Note 7 Interest income and similar profit items
| 2021 | 2020 | |
|---|---|---|
| Financial assets measured at amortized cost | ||
| [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] | 645 | 815 |
| Total interest income according to the effective interest method | 645 | 815 |
| Total | 645 | 815 |
| Total in profit or loss from financial items | 645 | 815 |
Note 8 Interest expenses and similar loss items
| 2021 | 2020 | |
|---|---|---|
| Financial assets measured at amortized cost | ||
| [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] | -2 | -36 |
| Total interest expenses calculated using the effective interest method | -2 | -36 |
| Total | -2 | -36 |
| Total in profit or loss from financial items | -2 | -36 |
Note 9 Tax on profit for the year
| 2021 | 2020 | |
|---|---|---|
| Current tax | 0 | 0 |
| Change in deferred tax assets | -131 | 68 |
| Recognized tax | -131 | 68 |
Reconciliation of effective tax rates
| 2021 | 2020 | |
|---|---|---|
| Loss before tax | 17,709 | -21,826 |
| Tax according to applicable tax rate for parent company (20.6% (21.4%)) | -3,648 | 4,671 |
| Tax effect non-deductible expenses | -81 | 1,133 |
| Tax effect non-deductible income | 990 | 0 |
| Tax effect unrecognized deferred tax assets | 2,608 | -3,470 |
| Recognized tax | -131 | 68 |
| Effective tax rate | 1% | 0% |
The parent company has no tax items that are recognized in other comprehensive income or directly in equity.
Information about deferred tax assets and tax liabilities
The following table specifies the tax effect of the temporary differences:
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Deferred tax asset: | ||
| Provision for pension premium | 0 | 131 |
| Carrying amount | 0 | 131 |
Specification of change in deferred tax assets:
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Opening carrying amount | 131 | 63 |
| Change of temporary differences | -131 | 68 |
| Carrying amount deferred tax asset | 0 | 131 |
Tax loss carryforwards for which deferred tax assets have not been recognized in the balance sheet amounted to 109,689 KSEK (105,521 KSEK). These carryforwards have no time limit.
Deferred tax assets [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] [REDACTED] 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liabilities" for the group. For other current receivables and liabilities, short-term investments, cash and cash equivalents, trade payables, and accrued expenses and income with a short maturity, the carrying amount is considered a reasonable estimate of the fair value. The group has no significant amounts receivable from customers that are past due or impaired. Balances with customers that are past due are assessed for impairment. The counterparties do not constitute a significant concentration of credit risk. The carrying amount of receivables from customers, net of allowances for doubtful accounts, approximates their fair value. For a description of the expected credit loss for the cash and cash equivalents according to IFRS 9, see Note 15 "Cash and cash equivalents".
Note 13 Prepaid expenses and accrued income
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Prepaid rental charges | 181 | 126 |
| Prepaid insurances | 120 | 0 |
| Other prepaid expenses | 511 | 144 |
| Total | 812 | 270 |
60 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Note 14 Short-term investments
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Fixed-rate account, SBAB | 77,000 | 70,000 |
| Accrued interest income | 281 | 118 |
| Total | 77,281 | 70,118 |
Vicore has as of December 31, 2021, a total of eleven fixed-rate accounts (investment accounts) at SBAB. Each account amounts to 7 MSEK and were opened during March 2021 (fixed for 12 months). The annual interest rate per account is between 0.45% and 0.47%.
Not 15 Cash and cash equivalents
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Available balances | 168,396 | 195,822 |
| Total | 168,396 | 195,822 |
Note 16 Shareholders’ equity
At December 31, 2021, the registered share capital comprised 71,760,293 ordinary shares. All shares are fully paid and no shares are reserved for transfer. Each share carries one vote. The quota value amounts to 0.5 SEK (0.5 SEK). No shares are held by the company itself or its subsidiaries. The share premium reserve refers to capital from new share issues that have been issued at a price that exceeds the quotient value and includes deductions of expenditures for new share issues.
Note 17 Other provisions
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Social security contributions related to share-based incentive programs | ||
| Opening amount | 5,312 | 500 |
| Provisions for the year | -4,805 | 4,812 |
| Total | 507 | 5,312 |
For more information about incentive programs, see Note 8 "Share-based payments" for the group.
Note 18 Non-current liabilities to group companies
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Opening cost | 0 | 400 |
| Other non-current liabilities | 0 | -400 |
| Additions | 75,000 | 0 |
| Closing carrying amount | 75,000 | 0 |
Note 19 Accrued expenses and deferred income
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Accrued personnel-related expenses | 1,799 | 962 |
| Accrued consulting fees | 150 | 241 |
| Accrued expense for patents | 0 | 6,000 |
| Other | 135 | 25 |
| Total | 2,084 | 7,228 |
Note 20 Supplementary information to the cash flow statement
| 2021 Dec 31 | 2020 Dec 31 | |
|---|---|---|
| Adjustment for items not included in the cash flow | ||
| Incentive programs, salary costs | 2,526 | 2,104 |
| Incentive programs, social security contributions* | -4,805 | 0 |
| Provision payroll tax, pension premium | 64 | 0 |
| Total | -2,215 | 2,104 |
- In the year-end report for the fiscal year 2021, social security contributions for share-based incentive programs were reported in the cash flow statement as "Change in operating payables" and amounted to 4,805 KSEK, but has for the fiscal year 2021 been reclassified to the item "Other non-current liabilities" in the statement of financial position. The social security contributions for share-based incentive programs will continue to be recognized in the statement of financial position. In prior periods, these were recognized based on expected settlement.
Note 21 Pledged assets and contingent liabilities
For information about pledged assets and contingent liabilities in the parent company, see to the group’s Note 29 "Pledged assets and contingent liabilities".
Note 22 Related-party transactions
| Sales of goods or services | Purchase of goods or services | Other | Receivables on closing day | Payables on closing day | |
|---|---|---|---|---|---|
| Transactions with subsidiaries | |||||
| 2021 | 37,866 | 0 | 859 | 32,386 | 75,000 |
| 2020 | 3,672 | 0 | 56 | 0 | 0 |
Sales of goods or services relate to reinvoiced costs and management fee. For information about salaries and remuneration to employees and senior executives, see Note 7 "Employees and personnel costs" for the group. For further information on related-party transactions, see Note 28 "Related-party transactions" for the group.
61 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Board of Directors and Management
Michael Wolff Jensen
Chairman of the Board since 2020 (Resigned from the board on March 23, 2022)
Michael Wolff Jensen has 20 years of experience from strategic leadership from Pharma/Biotech – as CFO, Chairman of the Board, responsible partner and as Chief Legal Officer. Michael has been responsible for four IPOs and has been responsible for several funding rounds. Michael has more than 15 years of experience as board member and as chairman, both in private and publicly traded companies.
Born: 1971
Education: Law degree from the University of Copenhagen.
Other assignments: SVP / Chief Legal Officer of Ascendis Pharma AB (publ). Chairman of Visen Pharmaceuticals and MIWO Invest ApS.
Previous assignments for the past five years: Chairman of Ascendis Pharma A/S, XSPRAY PHARMA (publ), VANX ApS and Eurocine Vaccines AB (PUBL).
Holdings in the company: 10,000 ordinary shares in the company's incentive program. Michael is chairman of Vicore's remuneration committee. Independent of the company and its senior management and independent of major shareholders of the company.
Hans Schikan
Board member since 2018
Hans Schikan has held leading positions at Xbrane Biopharma AB (publ) and previously at Genzyme (acquired by Sanofi) and Organon (acquired by Schering Plough). He has served on the Board of Directors of Wilson Therapeutics (acquired by Alexion) and Therachon (acquired by Pfizer). He is a co-founder of Pharvaris NV.
Born: 1958
Education: PharmD from the University of Utrecht.
Other assignments: Chairman of Microbiotica Ltd, InteRNA Technologies BV and Complix NV. Board member of VectivBio AG, Pharvaris NV and the Dutch Top Sector Life Sciences & Health. Advisor to various organisations in Life Sciences & Health.
Previous assignments for the past five years: Board member of Asceneuron, Hansa Medical, Sobi, Therachon and Wilson Therapeutics.
Holdings in the company: 10,000 ordinary shares in the company's incentive program. Hans is member of Vicore's remuneration committee and scientific committee. Independent of the company and its senior management and independent of major shareholders of the company.
Jacob Gunterberg
Board member since 2018 (New chairman of the board since March 23, 2022)
Jacob Gunterberg is a former partner at HealthCap and has extensive experience in venture capital investment operations and corporate finance in life science. Jacob Gunterberg has long experience as board member in both private and publicly traded companies.
Born: 1967
Education: M.Sc. in Business Administration and Economics from Lund University.
Other assignments: Chairman of Xenon Pharmaceuticals Inc. and Faron Pharmaceuticals Oy.
Previous assignments for the past five years: Board member in MIPS Helmet AB, MIPS AB, Trimb Holding AB, Trimb Healthcare AB, HealthCap Holdings GP AB, HealthCap Annex Fund I-II Bis GP AB and HealthCap Aero Holdings GP AB (which were merged in 2016), Carisma Therapeutics Inc, SynOx Therapeutics Ltd and Cenova AB. Deputy board member in BONESUPPORT AB, BONESUPPORT HOLDING AB and Wilson Therapeutics AB.
Holdings in the company: None.
Jacob is chairman of Vicore's audit committee and a member of the scientific committee. Independent of the company and its senior management and independent of major shareholders of the company.
62 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Sara Malcus
Board member since 2018
Sara Malcus has more than ten years of experience from operational management and expertise within business development and strategic responsibility within pharmaceutical companies, especially within the areas of immunology and regenerative medicine.
Born: 1975
Education: Doctor’s degree in immunology and inflammatory medicine at the University of Gothenburg.
Other assignments: Sara Malcus is the Managing Director of MetaboGen AB.
Previous assignments for the past five years: Board member of Oncorena AB, Oncorena Holding AB, Cereno Scientific AB and MetaboGen AB.
Holdings in the company: 10,000 ordinary shares in the company's incentive program.
Sara is a member of Vicore's audit committee. Independent of the company and its senior management and independent of major shareholders of the company.
Maarten Kraan
Board member since 2018
Maarten Kraan has extensive experience in biomedicine and has, among others, held a senior position at AstraZeneca AB where he was responsible for the research and development of medicines for respiratory, inflammatory and autoimmune symptoms.
Born: 1961
Education: Doctor’s degree in rheumatology at the University of Leiden.
Other assignments: CMO at AM-Pharma. Maarten Kraan is a board member of Toleranzia AB and CDS GmbH.
Previous assignments for the past five years: None.
Holdings in the company: 10,000 ordinary shares in the company's incentive program.
Maarten is chairman of Vicore’s scientific committee and a member of the remuneration committee Independent of the company and its senior management and independent of major shareholders of the company.
Heidi Hunter
Board member since 2020
Heidi Hunter (born 1958) has more than 25 years of experience from leading positions in different roles within pharmaceutical development and operations. She has held senior positions with global responsibility covering operational execution and strategic leadership within a broad spectrum of pharmaceutical development, from clinical and commercial development to launch execution.## Management
Heidi Hunter
Board member
Her leadership experience spans alliance management, business development, new business strategy development, product launch, and business sustainability.
Born: 1958
Education:
* MBA, Global Management from the School of Business, Stockholm University.
* B.A., Economics and German, Magna cum laude, The University of Michigan
Other assignments: President, Cardinal Health Specialty Solutions.
Previous assignments for the past five years: SVP, Global immunology business unit i UCB, Belgien
Holdings in the company: 65,777 shares¹³¹¹ in the company's incentive program.
Heidi is a member of Vicore's audit committee. Independent of the company and its senior management and independent of major shareholders of the company.
63 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Carl-Johan Dalsgaard
Chief Executive Officer since 2018
Carl-Johan Dalsgaard has been a Venture Partner at HealthCap since 2000, thereby he has served as CEO of several companies in which HealthCap has invested. Prior to that, he has ten years of experience from senior positions within the AstraZeneca Group, such as pre-clinical research director, therapeutic area manager of pain and anesthesia, CEO of Astra Pain Control AB and part of the Group’s research management team.
Born: 1956
Education:
* Ph.D. in neurobiology and post-doc experience from Harvard Medical School.
* Carl-Johan has also completed a specialist training in plastic surgery.
Other assignments: Board member and CEO of INIM Pharma AB and Vicore Pharma AB.
Holdings in the company: 477,981 shares and 400,000 options within the company's incentive program.
Hans Jeppsson
Chief Financial Officer since 2017
Hans Jeppsson has a cross-disciplinary background in finance and science, with experience from business development and corporate finance, as well as within preclinical research at AstraZeneca R&D.
Education:
* Ph.D. in Strategic Financial Management from the University of Gothenburg.
* After he obtained his Ph.D.-degree he conducted postdoctoral studies at the Haas School of Business at the University of California, Berkeley.
* He is currently pursuing a Ph.D. in Financial Management with a focus on biotechnology from Chalmers University of Technology.
Other assignments: Deputy board member of Vicore Pharma AB and INIM Pharma AB.
Holdings in the company: 5,000 shares and 250,000 options within the company's incentive program.
Elin Rosendahl
VP Clinical Development since 2020
Elin Rosendahl has more than 20 years’ experience of managing global biopharmaceutical development programs and leading cross-functional teams. Solid experience of all phases of clinical drug development with focus on design of innovative and patient-focused paths to market approval, and a strong track record of managing cross-functional teams and optimized collaborations with contract research organizations (CROs)
Education: M.Sc., Pharmacy from Uppsala University.
Other assignments: None.
Holdings in the company: 100,000 options within the company's incentive program.
Johanna Gräns
Head of Preclinical Development since 2015
Johanna has a Ph.D and expertise in pharmaceutical metabolism. She has extensive experience in preclinical interpretation and is responsible for the design and interpretation of in vivo and in vitro studies.
Education: Ph.D. in biology with a focus on toxicology from the University of Gothenburg.
Other assignments: None.
Holdings in the company: 7,004 shares and 143,750 options within the company's incentive program.
Åsa Magnusson
Chief Commercial Officer since 2021
Åsa has more than 20 years of experience as a commercial executive in the pharmaceutical industry with focus on development and commercialization of innovative medicines for rare disease medicines. Her previous roles include leading cross-functional teams as General Manager at Arvelle and in different senior commercial roles at Alexion, expanding innovative antibody products and heading the commercial launch of Actelion’s pulmonary arterial hypertension (PAH) pharmaceuticals.
Education:
* BBA and MBA in International Business from Lund University.
Other assignments: Board member of ImmunoLogistics AB.
Holdings in the company: 50,000 options within the company's incentive program.
64 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Johan Raud
Chief Scientific Officer since 2018
Johan Raud has many years of experience from drug research and managing the preclinical development of drug candidates.
Education:
* Ph.D. from the Karolinska Institute and Vanderbilt university, USA.
Other assignments: None.
Holdings in the company: 238,991 shares and 130,000 options within the company's incentive program.
Mikael Nygård
VP Business Development since 2021
Mikael has a profound and broad experience within Business Development in the healthcare industry. He has led M&A and Corporate Development at the care provider Intrum AB and was part of the global healthcare team at the strategy consulting firm Boston Consulting Group.
Education:
* MSc Pharmacy, Uppsala University.
* PhD Neurobiology, Karolinska Institutet.
Other assignments: None.
Holdings in the company: 4,031 shares and 41,000 options within the company's incentive program.
Rohit Batta
Chief Medical Officer since 2018
Rohit Batta has over 20 years of experience as a medical doctor with an expertise in drug development and clinical development teams whilst developing drugs for rare diseases. His previous roles include senior level positions within Cell and Gene Therapy at GlaxoSmithKline leading the clinical development and defining the clinical strategy for haemoglobinopathy gene therapy medicines. He also led the global medical and late stage clinical development teams to launch the world’s first gene therapy for patients with a paediatric rare disease.
Education:
* MBBS from Kings College London, a fellow of the Faculty of Pharmaceutical Medicine and a member of the Royal College of General Practitioners.
Other assignments: Visiting Senior Lecturer at Kings College London.
Holdings in the company: 200,000 options within the company's incentive program.
Nina Carlén
Chief Administrative Officer since 2009
Nina has more than 20 years of experience within management, project management, PR, communication in the pharmaceutical industry.
Education:
* Diploma in Marketing Management, PR, communication and graphic design at, among others, Bergh's School of Communication.
Other assignments: Deputy board member of North River AB and North River Maintenance AB.
Holdings in the company: 24,480 shares and 125,000 options within the company's incentive program.
Jessica Shull
Head of Digital Therapeutics since 2021
Jessica has more than 20 years’ experience in the field of digital technologies for healthcare including development of virtual surgical devices. She is considered an authority in HTA requirements for patient-facing software and innovation adoption in Europe and internationally. In previous positions, she has worked with best practices for the WHO and with the Digital Therapeutics Alliance she focused on digital therapeutic product integration, regulation, and policy.
Education: MA, M.Sc., Ph.D. candidate in Biomedicine.
Other assignments: None.
Holdings in the company: 50,000 options within the company's incentive program.
65 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Signatures
- Sara Malcus
- Carl-Johan Dalsgaard
- Hans Schikan
- Jacob Gunterberg
- Maarten Kraan
The undersigned give their assurance that the annual accounts have been prepared in accordance with generally accepted accounting standards in Sweden and that the consolidated financial statements have been prepared in accordance with international accounting standards, IFRS, as adopted by the EU. The annual accounts and the consolidated financial statements each provide a fair and accurate impression of the parent company’s and the group’s position and earnings. The Administration Report for the parent company and the group provides a fair and accurate overview of the parent company’s and the group’s operations, position and earnings, and risk factors and financial risks.
Gothenburg April 6, 2022
Our audit report was submitted on April 6, 2022
Ernst & Young AB
Andreas Mast
Authorized Public Accountant
Heidi Hunter
Board member
66 | Annual Report 2021
Vicore Pharma Holding AB (publ)
Auditors- Report
To the general meeting of the shareholders of Vicore Pharma Holding AB (publ), corporate identity number 556680-3804.
Report on the annual accounts and consolidated accounts
Opinions
We have audited the annual accounts and consolidated accounts of Vicore Pharma Holding AB (publ) for the year 2021. The annual accounts and consolidated accounts of the company are included on pages 26-65 in this document.
In our opinion, the annual accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the parent company as of 31 December 2021 and its financial performance and cash flow for the year then ended in accordance with the Annual Accounts Act.
The consolidated accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the financial position of the group as of 31 December 2021 and their financial performance and cash flow for the year then ended in accordance with International Financial Reporting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act.
The statutory administration report is consistent with the other parts of the annual accounts and consolidated accounts.We therefore recommend that the general meeting of shareholders adopts the income statement and balance sheet for the parent company and the group. Our opinions in this report on the annual accounts and consolidated accounts are consistent with the content of the additional report that has been submitted to the parent company's audit committee in accordance with the Audit Regulation (537/2014) Article 11.
Basis for Opinions
We conducted our audit in accordance with International Standards on Auditing (ISA) and generally accepted auditing standards in Sweden. Our responsibilities under those standards are further described in the Auditor’s Responsibilities section. We are independent of the parent company and the group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements. This includes that, based on our audit, the services referred to in the Audit Regulation (537/2014) Article 5.1 have been provided to the audited company or, where applicable, its parent company or its controlled companies within the EU. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions.
Key Audit Matters
Key audit matters of the audit are those matters that, in our professional judgment, were of most significance in our audit of the annual accounts and consolidated accounts of the current period. These matters were addressed in the context of our audit of, and in forming our opinion thereon, the annual accounts and consolidated accounts as a whole, but we do not provide a separate opinion on these matters. For each matter below, our description of how our audit addressed the matter is provided in that context. We have fulfilled the responsibilities described in the Auditor’s responsibilities for the audit of the financial statements section of our report, including in relation to these matters. Accordingly, our audit included the performance of procedures designed to respond to our assessment of the risks of material misstatement of the financial statements. The results of our audit procedures, including the procedures performed to address the matters below, provide the basis for our audit opinion on the accompanying financial statements.
Other information than the annual accounts and consolidated accounts
This document also contains other information than the annual accounts and consolidated accounts and is found on pages 1-25 and 69-78.
Key Audit Matter 1: Reporting of development costs
How our audit addressed this key audit matter
The costs of the Group's development activities amounted to SEK 71.1 m in 2021, corresponding to 92% of Vicore Pharma's total operating expenses. Most of these costs relate to the development of the product candidates VP01, VP02 and VP03 and mainly consists of costs for the clinical studies conducted. For further information, please refer to the Group's accounting policies in Note 1 and operating expenses per cost type in Note 4. In our audit, we have focused on this area as the expenses are substantial and these costs include elements of assessments involved to be able to decide whether the expense should be expensed or reported as an asset. The identification and capitalization of development costs requires a high degree of judgment.
Our review of the development costs has included, but is not limited to the following measures:
- Evaluation of the company's procedures and internal control over capitalization of development expenses.
- Testing of internal controls for approval and payment of invoices.
- Reconciled and performed detailed testing to invoice documentation, development expenses and payments.
- Substantive testing of capitalization of development costs to ensure appropriate criteria were met for capitalization in accordance with IFRS.
- We have also assessed the company's information in the annual report.
Key Audit Matter 2: Valuation of intangible assets
How our audit addressed this key audit matter
As of 31st December 2021, a substantial portion (15% or SEK 67,4 m) of the Group's total assets consists of patents and goodwill (hereinafter referred to as the assets). The company examines the assets for impairment annually and when events or changes in circumstances indicate that the carrying amount of the assets may be less than the recoverable amount. Impairment assessment involves a number of material estimates and judgments, including the estimation of future cash flows, the selection of an appropriate discount rate (e.g. weighted average cost of capital ("WACC")). For further information, please refer to the Group's accounting policies in Note 1, assessments and estimates in Note 2, as well as information on patents, licenses and similar rights in Note 15. We focused on this area as the carrying value of the assets is material and impairment testing is sensitive to changes in assumptions and is therefore a particularly important area in our audit.
- Evaluation of the company's assessment processes and the appropriateness of the chosen impairment testing model.
- Examination of the assumptions made by the company when assessing impairment requirements with a focus on the assumptions for which the result of the impairment test is most sensitive.
- We have also assessed the company's information in the annual report
67 | Annual Report 2021 Vicore Pharma Holding AB (publ)
are responsible for this other information. Our opinion on the annual accounts and consolidated accounts does not cover this other information and we do not express any form of assurance conclusion regarding this other information. In connection with our audit of the annual accounts and consolidated accounts, our responsibility is to read the information identified above and consider whether the information is materially inconsistent with the annual accounts and consolidated accounts. In this procedure we have obtained the information in the annual report and have, with the knowledge obtained in the audit and assess whether the information otherwise appears to be materially misstated. If, on the basis of the work performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. We have nothing to report in this regard.
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors and the Managing Director are responsible for the preparation of the annual accounts and consolidated accounts and that they give a fair presentation in accordance with the Annual Accounts Act and, concerning the consolidated accounts, in accordance with IFRS as adopted by the EU. The Board of Directors and the Managing Director are also responsible for such internal control as they determine is necessary to enable the preparation of annual accounts and consolidated accounts that are free from material misstatement, whether due to fraud or error.
In preparing the annual accounts and consolidated accounts, The Board of Directors and the Managing Director are responsible for the assessment of the company’s and the group’s ability to continue as a going concern. They disclose, as applicable, matters related to going concern and using the going concern basis of accounting. The going concern basis of accounting is however not applied if the Board of Directors and the Managing Director intends to liquidate the company, to cease operations, or has no realistic alternative but to do so.
The Board of Directors and the Managing Director are responsible for the oversight of the company’s financial reporting process.
Auditor’s responsibility
Our responsibility is to obtain reasonable assurance about whether the annual accounts and consolidated accounts as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinions. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and generally accepted auditing standards in Sweden will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these annual accounts and consolidated accounts.
As part of an audit in accordance with ISAs, we exercise professional judgment and maintain professional skepticism throughout the audit. We also:
- Identify and assess the risks of material misstatement of the annual accounts and consolidated accounts, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinions. If a risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control.
- Obtain an understanding of the company’s internal control relevant to our audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control.
- Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by the Board of Directors and the Managing Director.
- Conclude on the appropriateness of the Board of Directors’ and the Managing Director’s use of the going concern basis of accounting in preparing the annual accounts and consolidated accounts.We also draw a conclusion, based on the audit evidence obtained, as to whether any material uncertainty exists related to events or conditions that may cast significant doubt on the company’s and the group’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the annual accounts and consolidated accounts or, if such disclosures are inadequate, to modify our opinion about the annual accounts and consolidated accounts. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or conditions may cause a company and a group to cease to continue as a going concern.
• Evaluate the overall presentation, structure and content of the annual accounts and consolidated accounts, including the disclosures, and whether the annual accounts and consolidated accounts represent the underlying transactions and events in a manner that achieves fair presentation.
• Obtain sufficient and appropriate audit evidence regarding the financial information of the entities or business activities within the group to express an opinion on the consolidated accounts.
We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our opinions. We must inform the Board of Directors of, among other matters, the planned scope and timing of the audit. We must also inform of significant audit findings during our audit, including any significant deficiencies in internal control that we identified. We must also provide the Board of Directors with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, the safeguards applied.
From the matters communicated with the Board of Directors, we determine those matters that were of most significance in the audit of the annual accounts and consolidated accounts, and are therefore the key audit matters. We describe these matters in the auditor’s report unless law or regulation precludes disclosure about the matter.
Report on other legal and regulatory requirements
Report on the audit of the administration and the proposed appropriations of the company’s profit or loss
Opinions
In addition to our audit of the annual accounts and consolidated accounts, we have also audited the administration of the Board of Directors and the Managing Director of Vicore Pharma Holding AB (publ) for the year 2021 and the proposed appropriations of the company’s profit or loss. We recommend to the general meeting of shareholders that the profit be appropriated in accordance with the proposal in the statutory administration report and that the members of the Board of Directors and the Managing Director be discharged from liability for the financial year.
Basis for opinions
We conducted the audit in accordance with generally accepted auditing standards in Sweden. Our responsibilities under those standards are further described in the Auditor’s Responsibilities section. We are independent of the parent company and the group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinions.
68 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors is responsible for the proposal for appropriations of the company’s profit or loss. At the proposal of a dividend, this includes an assessment of whether the dividend is justifiable with regard to the company's and the group’s type of operations, size and the group’s equity, consolidation requirements, liquidity and position in general.
The Board of Directors is responsible for the company’s organization and the administration of the company’s affairs. This includes among other things continuous assessment of the company’s and the group’s financial situation and ensuring that the company's organization is designed so that the accounting, management of assets and the company’s financial affairs otherwise are controlled in a reassuring manner.
The Managing Director shall manage the ongoing administration according to the Board of Directors’ guidelines and other provisions that are necessary to fulfill the company’s accounting in accordance with law and handle the management of assets in a reassuring manner.
Auditor’s responsibility
Our audit of the Board of Directors’ administration, and thereby our opinion about discharge from liability, is to obtain audit evidence to assess with a reasonable degree of assurance whether any member of the Board of Directors or the Managing Director in any material respect:
• has acted in a way that can give rise to liability to the company, or any omission which can give rise to liability to the company, or
• in any other way has acted in contravention of the Companies Act, the Annual Accounts Act or the Articles of Association.
Our audit of the Board of Directors’ proposed appropriations of the company’s profit or loss, and thereby our opinion about this, is to assess with reasonable degree of assurance whether the proposal is in accordance with the Companies Act.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with generally accepted auditing standards in Sweden will always detect actions or omissions that can give rise to liability to the company, or that the proposed appropriations of the company’s profit or loss are not in accordance with the Companies Act.
As part of an audit in accordance with generally accepted auditing standards in Sweden, we exercise professional judgment and maintain professional skepticism throughout the audit.
The examination of the administration and the proposed appropriations of the company’s profit or loss is based primarily on the audit of the accounts. Additional audit procedures performed are based on our assessment of the relevance and importance of selected areas and the need for further audit work to fulfill our opinion. The auditor’s examination of the ESEF report
Opinion
In addition to our audit of the annual accounts and consolidated accounts, we have also examined that the Board of Directors and the Managing Director have prepared the annual accounts and consolidated accounts in a format that enables uniform electronic reporting (the Esef report) pursuant to Chapter 16, Section 4(a) of the EU Regulation 2019/815 on the European Single Electronic Format (ESEF) applicable to Vicore Pharma Holding AB for the financial year 2021. Our examination and our opinion relate only to the statutory requirements.
We confirm that the ESEF report has been prepared in a format that, in all material respects, enables uniform electronic reporting.
Basis for opinion
We have performed the examination in accordance with FAR’s recommendation RevR 18 Examination of the ESEF report. Our responsibility under this recommendation is described in more detail in the Auditors’ responsibility section. We are independent of Vicore Pharma Holding AB in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled our ethical responsibilities in accordance with these requirements. We believe that the evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Responsibilities of the Board of Directors and the Managing Director
The Board of Directors and the Managing Director are responsible for the preparation of the Esef report in accordance with Chapter 16, Section 4(a) of the EU Regulation 2019/815 on the European Single Electronic Format (ESEF) and for such internal control that the Board of Directors and the Managing Director determine is necessary to prepare the Esef report without material misstatements, whether due to fraud or error.
Auditor’s responsibility
Our responsibility is to obtain reasonable assurance whether the Esef report is in all material respects prepared in a format that meets the requirements of Chapter 16, Section 4(a) of the EU Regulation 2019/815 on the European Single Electronic Format (ESEF) based on the procedures performed. RevR 18 requires us to plan and execute procedures to achieve reasonable assurance that the Esef report is prepared in a format that meets these requirements.
Reasonable assurance is a high level of assurance, but it is not a guarantee that an engagement carried out according to RevR 18 and generally accepted auditing standards in Sweden will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the Esef report.The audit firm applies ISQC 1 Quality Control for Firms that Perform Audits and Reviews of Financial Statements, and other Assurance and Related Services Engagements and accordingly maintains a comprehensive system of quality control, including documented policies and procedures regarding compliance with professional ethical requirements, professional standards and legal and regulatory requirements. The examination involves obtaining evidence, through various procedures, that the ESEF report has been prepared in a format that enables uniform electronic reporting of the annual and consolidated accounts. The procedures selected depend on the auditor’s judgment, with the objective of obtaining sufficient appropriate audit evidence to provide a basis for an opinion. In making those judgments the auditor considers the risks of material misstatement of the ESEF report, whether due to fraud or error. In carrying out this audit, the auditor considers those elements of internal control that are relevant to the preparation of the ESEF report by the Board of Directors and the Managing Director, but not for the purpose of expressing an opinion on the effectiveness of those internal controls. The examination also includes an evaluation of the appropriateness and reasonableness of assumptions made by the Board of Directors and the Managing Director. The procedures mainly include a technical validation of the ESEF report, i.e. if the file containing the ESEF report meets the technical specification set out in the Commission’s Delegated Regulation (EU) 2019/815 and a reconciliation of the ESEF report with the audited annual accounts and consolidated accounts. Furthermore, the procedures also include an assessment of whether the ESEF report has been prepared in accordance with the requirements of the Commission’s Delegated Regulation (EU) 2019/815, and if it contains a complete machine-readable version of the consolidated statement of financial performance, financial position, changes in equity and cash flow. Ernst & Young AB, with Andreas Mast as auditor is the appointed auditor of Vicore Pharma Holding by the general meeting of the shareholders on the 11th of May, 2021 and has been the company’s auditor since the 10th of October 2018.
Gothenburg the 6th of April
Ernst & Young AB
Andreas Mast
Authorized Public Accountant
69 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Corporate Governance Report
Introduction
The Board of Directors of Vicore Pharma Holding AB (publ), company reg. no. 556680-3804 (“Vicore” or the “company”) hereby submits the 2021 corporate governance report in accordance with the requirements of the Swedish Annual Accounts Act) (Sw. årsredovisningslagen) and the Swedish Code of Corporate Governance (the “Code”; see the Swedish Corporate Governance Board website at www.bolagsstyrning.se).
The company's shares have been listed on Nasdaq Stockholm since March 2017 (previously, since December 2015, listed on the Spotlight Stock Market AB). The company’s corporate governance is mainly regulated by the provisions of the company’s articles of association, the Swedish Companies Act (2005:551) (Sw. Aktiebolagslagen) and, to some extent, the Swedish Corporate Governance Code.
The corporate governance report has been reviewed by the company’s auditors in accordance with the Swedish Annual Accounts Act. It does not constitute a part of the formal annual report documents.
The group comprises the parent company Vicore Pharma Holding AB ("Vicore") and the subsidiaries Vicore Pharma AB ("Vicore Pharma") and INIM Pharma AB ("INIM Pharma"). The company's research and development operations are conducted in Vicore Pharma and INIM Pharma.
There are no deviations from the Swedish Corporate Governance Code (the “Code”) to report for the financial year of 2021. No infringements of Nasdaq Stockholm’s rules of the listed companies or of good practice on the securities market has been sanctioned by the exchange’s disciplinary committee or the Swedish Securities Council during the financial year.
Corporate governance within Vicore
The purpose of Vicore’s corporate governance is to create a clear allocation of roles and responsibilities among the shareholders, the Board of Directors and management. Corporate governance, management and control of Vicore are allotted among the general meeting, the Board of Directors, its elected committees and the CEO.
Important external and internal regulations and policies that affect corporate governance:
Significant external regulations:
* Swedish Companies Act
* Swedish Accounting Act
* Swedish Annual Accounts Act
* International standards for audits and ISQC1
* Nasdaq Stockholm’s Rulebook for Issuers
* Swedish Code of Corporate Governance
* Other applicable rules and recommendations
Significant internal regulations and policies:
* Articles of association
* Rules of procedure for the Board of Directors
* Instruction for the CEO, including responsibilities for financial reporting
* Finance policy
* Internal control policy
* Information policy
* Insider policy
* IT policy
Shareholders and the share
At the end of 2021, Vicore had 5,140 shareholders and the number of shares was 71,760,293 with a quotient value of SEK 0.5 each. There is only one class of shares. The company's shares are issued in one class and each share carries one vote at the AGM.
On December 31, 2021, HealthCap VII L.P. was the single largest shareholder in Vicore, with a total of 15,834,834 shares, corresponding to 22.1 percent of the votes and capital. No shareholder other than HealthCap VII L.P. has a direct or indirect shareholding that represents one tenth, or more, of the voting rights for all shares in the company.
Further information on shareholders and Vicore's share is presented on pages 24-25 in the 2021 annual report.
General meetings of shareholders
According to the Companies Act (2005:551), the General Meetings of Shareholders is the company's highest decision-making body. At the General Meetings, the shareholders exercise their voting rights in the company. The Annual General Meeting shall be held within six (6) months from the end of the financial year. At the Annual General Meeting, the shareholders decide, among other things, on the Board of Directors and, where applicable, auditors, how the Nomination Committee is to be appointed and on discharge from liability for the Board of Directors and the CEO for the past year. Decisions are also made on the adoption of Annual Report, the appropriation of profit or loss, fees for the Board of Directors and auditors, guidelines for remuneration to the CEO and other senior executives as well as the remuneration report.
The Articles of Association stipulate that the Annual General Meeting shall be held in Stockholm.
Shareholders who wish to attend General Meetings, in person or through a representative, must be included in the share register kept by Euroclear Sweden AB, and notify the company in accordance with the notice. Notice of General Meetings is made through advertising and via the company's website (www.vicorepharma.com).
2021 AGM
The Annual General Meeting 2021 was held through advance voting (postal voting), pursuant to temporary legislation, on May 11, 2021. At the AGM, approximately 52.1 percent of the total votes were represented. Michael Wolff Jensen was elected chairman of the meeting.
- Nomination Committee
- Remuneration Committee
- Board of Directors
- Audit Committee
- Scientific Committee
- CEO and Management team
- Shareholders
- Annual General Meeting
- External Auditors
70 | Annual Report 2021 Vicore Pharma Holding AB (publ)
At the AGM the following principal resolutions were passed:
- Jacob Gunterberg, Maarten Kraan, Lars Eric Lindström, Michael Wolff Jensen and Heidi Hunter were re-elected as board members. Michael Wolff Jensen was elected Chairman of the Board.
- EY AB with principal auditor Andreas Mast was re-elected as auditor.
- Remuneration to the Chairman of the Board and the Board's members elected by the Annual General Meeting and the auditor were established.
- Resolution on adoption of a long-term performance-based incentive program (Board LTIP 2021) of a maximum 73,000 options to three board members.
- Resolution on adoption of a long-term performance-based incentive program (Management LTIP 2021) for a maximum 3.000.000 options to senior management, within the scope of directors.
- Proposed guidelines for remuneration to senior executives were approved.
- Resolution on adoption of remuneration report 2020.
- Resolution on adoption of articles of association with increased margins in number of shares and share capital.
- Resolution on adoption of balance sheet and income statement.
- No dividend will be paid for 2020 and the company's earnings shall be carried forward.
- Discharge from liability of the Board and CEO for the fiscal year 2020.
Full minutes and information from the AGM are available on Vicore's website (www.vicorepharma.com).
AGM 2022
The 2022 Annual General Meeting will be held on Wednesday, May 11, 2022. The meeting will held through postal voting and with no opportunity to attend in person or by proxy. Information on the decisions made at the Annual General Meeting will be published on 11 May 2022 as soon as the outcome of the voting is finally compiled. For the right to participate and more information, see Vicore's website (www.vicorepharma.com). The minutes of the Annual General Meeting will be available on Vicore's website (www.vicorepharma.com).
Nomination Committee
The Nomination Committee for the AGM 2022 consists of Staffan Lindstrand (Chairman) appointed by HealthCap VII L.P., Carl-Johan Hedqvist appointed by Fleria AB and Ulrik Svärd appointed by Stiftelsen Silviahemmet. Staffan Lindstrand is chairman of the Nomination Committee.The Committee also includes the Chairman of the Board, Michael Wolff Jensen, as convenor. The committee is to prepare and present proposals for the number of board members to be elected by the AGM, the election of a Chairman and other members of the Board of Directors, board fees and, if applicable, proposals for rules for the appointment of a Nomination Committee for the next annual general meeting. The proposals will be published at the latest four weeks prior to the Annual General Meeting, and will include election of a Chairman to the Annual General Meeting, election of auditors (if applicable) and auditors fees (if applicable) and proposals for rules for the appointment of a Nomination Commit- tee for the next annual general meeting. The proposals will be published at the latest four weeks prior to the AGM 2022.
External auditors
The external audit of the accounts of the parent company and the group, as well as of the management by the Board of Directors and the CEO, is carried out in accordance with generally accepted accounting standards in Sweden. The auditor participates in at least one board meeting per year, going through the accounts for the year and leading a discussion with the Board of Directors without the CEO or any other senior executive present. Pursuant to the articles of association, Vicore must have an authorized public accountant or a registered accounting firm as its external auditor. Since the AGM 2010, the accounting firm EY AB has been auditor of the company. As of the 2019 AGM, certified public accountant Andreas Mast is the auditor in charge. Andreas Mast is member of the Swedish Institute of Authorized Public Accountants. For information regarding fees paid to the auditors, please refer to Note 5 of the 2021 Annual Report.
The Board of Directors
The Board of Directors is the company's governing body and is elected by the Annual General Meeting. According to the Companies Act, the Board of Directors is responsible for the company's management and organization, which means that the Board of Directors is responsible for, among other things, setting goals and strategies, ensuring routines and systems for evaluating established goals, continuously evaluating the company's results and financial position and evaluating the operational management. The Board of Directors is also responsible for ensuring that the annual accounts and interim reports are prepared in a timely manner. In addition, the Board of Directors appoints the company's CEO. Board members are normally elected by the AGM for the period until the end of the next AGM. According to the Code, the Chairman of the Board must be elected by the Annual General Meeting and have a special responsibility for the management of the Board of Directors and for ensuring that the Board of Directors’ work is well organized and implemented in an efficient manner. The Board of Directors adheres to written rules of procedure that are reviewed annually and are determined at the statutory board meeting each year. The rules of procedure govern, among other things, the practices for the Board of Directors' meetings, the Chairman’s duties and the allocation of responsibilities between the Board of Directors and the CEO. Instructions for financial reporting and instructions for the CEO are also determined in connection with the statutory board meeting. The Board of Directors meets in accordance with a yearly schedule and essentially follows an annual cycle determined by the Board of Directors, which is decided at the statutory board meeting, with the aim of preparing for the Annual General Meeting. If necessary, special decisions are made such as acquisi- tions or divestments, other investment decisions, financing decisions and decisions on structural or organizational issues. In 2021, the Board of Directors held 13 board meetings, of which 6 were ordinary meetings. At the board meetings, the company's CEO and CFO were also present when needed.
Board of Directors
According to the Articles of Association, Vicore's Board of Directors shall consist of a minimum of three and a maximum of nine members. The Company's Board of directors currently consists of seven people without deputies. The assignment for all members runs until the end of the upcoming AGM. On page 61-62 is a presentation of the Board of Directors with information on year of birth, year of inclusion in the Board of Directors, previous and current assignments in the company, other significant assignments and their respective direct and indirect holdings in the company as of March 31, 2021. Ownership in the company includes personal and / or related parties' holding.
Board of Directors’ work 2021
During 2021, the Board of Directors held 13 board meetings, including the inaugural meeting, of which 13 through digital channels. In addition, the Board of Directors has made decisions per capsulam on 2 occasions during 2021. The issues that the Board of Directors dealt with in 2021 are mainly: decision to carry out a new share issue, preclinical, clinical studies and organizational issues. At the board meetings held during the financial year 2021, the members have been present as shown below.
Evaluation of the Board of Directors’ work
Pursuant to the Code, the Board of Directors’ work is to be evaluated annually using a systematic and structured process, with the aim of developing the Board of Directors and its work and ensuring that the Board of Directors’ effectiveness is continuously improved. The Board of Directors has been evaluated by having the board members anonymously answer a number of questions about the Board of Directors' activities. The results of the evaluation have been compiled and reported orally to the members of the Board of Directors and the Nomina- tion Committee.
| Board member | Function | Elected | Independent in relation to the company and its management | Independent in relation to Major shareholders | Board fees (KSEK 1)) | Remuneration Committee (KSEK 2)) | Audit Committee (KSEK 2)) | Scientific committee (KSEK 2)) | Total (KSEK 2)) | Attendance 3) |
|---|---|---|---|---|---|---|---|---|---|---|
| Michael Wolff Jensen | Chairman | 2020 | Yes | Yes | 450 | 50 | - | 50 | 500 | 12/13 |
| Heidi Hunter | Board member | 2020 | Yes | Yes | 150 | 50 | 200 | - | 400 | 10/13 |
| Lars Österberg | Board member | 2018 | Yes | Yes | 150 | 25 | - | 25 | 200 | 13/13 |
| Jacob Gunterberg | Board member | 2018 | Yes | No | 150 | - | 100 | 25 | 275 | 12 4) /13 |
| Maarten Kraan | Board member | 2018 | Yes | Yes | 150 | 25 | - | 50 | 225 | 12/13 |
| Sara Malcus | Board member | 2018 | Yes | Yes | 150 | - | 50 | - | 200 | 12/13 |
| Anders Ström | Board member | 2015 | Yes | Yes | - | - | - | - | - | 7/13 |
Reporting period January 1 – December 31, 2021
1) Fee set by the AGM, excluding social security contributions, for the May 2021 to May 2022 financial year
2) Figures in table show the total number of meetings attended/total number of meetings
3) Excluding per capsulam meetings
4) Absence due to conflict of interest on one occasion
5) Anders Ström's resignation from the Board of Directors took place on May 17, 2021. His duties as member of the Board of Directors and the Scientific Committee ceased on that date.
Board committees
Remuneration Committee
The Remuneration Committee is appointed by the company's Board of Directors and consists of three members: Michael Wolff Jensen (Chairman), Lars Österberg and Maarten Kraan. The Remuneration Committee shall perform duties regarding the remuneration policy according to the Code. The Remuneration Committee shall prepare and present to the Board of Directors any remuneration for senior management and monitor and evaluate the application of the guidelines for remuneration adopted by the annual general meeting, as well as applicable remu- neration structures and levels for the company. The Remuneration Committee's main duties are: Prepare decisions for the Board of Directors regarding remuneration principles, remuneration and other employment terms and conditions for senior management. Monitor and evaluate any programs pending or adopted during the year for variable compensation for senior management. monitor and evaluate the applica- tion of the guidelines for remunera- tion adopted by the annual general meeting, as well as applicable remu- neration structures and levels for the company. In 2021, the Remuneration Committee held four meetings.
Audit Committee
The Audit Committee is appointed by the Board of Directors and consists of Jacob Gunterberg (Chairman), Heidi Hunter and Sara Malcus. Primary duties of the Audit Committee: The Audit Committee shall, without impact on the responsibilities and duties of the Board of Directors in other respects, among other things, monitor the company's reporting, monitor the effectiveness of the company’s internal control, risk management and internal auditing, review and discuss the company's annual accounts and the consolidated accounts, review and monitor the auditor’s impartiality and indepen- dence and in this case pay special attention to whether the auditor provides the company with services other than audit services, and assist in the preparation of proposals for the general meeting’s election of auditor. In 2021, the Audit Committee held six meetings.
Scientific Committee
The Scientific Committee shall consist of at least three non-employed board members with a broad scientific and medical understanding and experience in the field concerned. The Board of Directors shall appoint the members of the Scientific Committee, including the Chairman. Vicore's Scientific Committee consists of Maarten Kraan (chairman), Anders Ström and Lars Österberg. The Committee’s duties are: Reviewing and discussing the company's preclinical and clinical product portfolio, including its com- plementary composition and studies, as well as studies and development projects. Reviewing and discussing the com- pany's R&D strategy and reviewing and assessing R&D projects that the company considers are of great importance. Providing strategic advice and rec- ommendations for the company's ongoing R&D program. To review the (quality of) R&D capacity of the company and its organization, including the product development process. To review and discuss the compa- ny's intellectual property strategies.# Remuneration
In 2021, the Scientific Committee held three meetings.
Remuneration to the Board of Directors
At the Annual General Meeting on May 11, 2021, it was resolved that the remuneration to the members of the Board of Directors for the period up to the end of the 2022 Annual General Meeting shall be paid with SEK 450,000 to the Chairman of the Board and SEK 150,000 to each of the other board members. At the same meeting, it was decided that the Chairman of the Audit Committee should receive SEK 100,000 and the other members of the Audit Committee SEK 50,000 each. Furthermore, it was decided that the Chairman of the Remuneration Committee should receive SEK 50,000 and the other members of the Remuneration Committee SEK 25,000 each. The Chairman of the Scientific Committee shall receive SEK 50,000 and the other members of the Scientific Committee SEK 25,000 each. The table on page 4, shows the fees paid to members elected by the AGM in 2021.
Remuneration to management
Remuneration issues for senior executives are dealt with by the Board of Directors Remuneration Committee. The Board of Directors decides on the CEO's remuneration on a proposal from the Remuneration Committee. Remuneration and terms for senior executives aim to attract and retain senior executives and consist of a balanced mix of fixed salary, variable remuneration, pension benefits and terms of notice. Salaries and other remuneration for the 2021 financial year were paid to the CEO and other senior executives in accordance with what is stated in note 7 "Employees and Personnel costs" in the Annual Report 2021.
Guidelines on remuneration to senior executives and Board of Directors 2021
This is a summary of the guidelines for executive remuneration. The complete guidelines are available in the annual report 2021 and on the company's website. At the 2021 AGM, guidelines were adopted that are valid up to the 2025 AGM as follows. Vicore shall offer remuneration in accordance with market practice to support recruitment and retention of internationally qualified senior executives. Remunerations within Vicore shall be based on principles of performance, competitiveness and fairness. Senior executives refer to the CEO and the other members of the executive management. The guidelines shall apply to employment agreements concluded after the annual general meeting’s resolution to adopt these guidelines, as well as when changes are made to existing agreements thereafter. The remuneration to senior executives consists of fixed remuneration, variable remuneration, share and share-price related incentive programs, pension and other benefits. The Board of Directors is entitled to deviate from the guidelines if the Board of Directors, in a certain case, deems that there are good reasons for the deviation.
Fixed salary
The fixed salary should take into account the individual's responsibilities and experience. The fixed salary should be reviewed annually.
Variable salary
Variable remuneration paid in cash may amount to a maximum of 40 per cent of the annual fixed remuneration of the CEO and a maximum of 30 per cent of the annual fixed remuneration to other senior executives. Variable remuneration is based on established and measurable criteria, designed to promote the company's long-term value creation.
Share- and share price-based remuneration
Share- and share price-based incentive programs shall, if applicable, be decided by the AGM. Already decided incentive programs are described on page 74-75.
Pension
Pension should, where possible, be premium-based. For the CEO and other senior executives, the premium, in cases where a premium-based pension is applicable, can amount to up to 30 percent of the fixed salary. The Board of Directors has the right to, based on the above, to offer other solutions that are equivalent in cost to the above.
Severance pay etc.
A notice period of up to six months between the company and the CEO shall apply if notice is given by the company. If notice is given by the company, the Board of Directors may decide that the CEO shall be entitled to severance pay of up to twelve months' salary. In the event of termination by the CEO, a notice period of up to six months shall apply. Other senior executives shall have a notice period of three to six months. During the notice period, normal salary shall be paid.
Other benefits
Senior executives may be awarded customary other benefits such as occupational health care, etc. Such other benefits shall not constitute a significant part of the total remuneration.
Vetting and decision processes
The CEO's remuneration shall be vetted by the Remuneration Committee and decided by the Board of Directors. The remuneration of other senior executives shall be vetted by the CEO and the Remuneration Committee, which shall submit a proposal for approval to the Board of Directors. The Board of Directors has the right to deviate from the above guidelines when there are special reasons for the deviation in an individual case.
At the end of 2021, Vicore has four active programs that include the company's management and staff, and certain board members. In 2018, two long-term incentive programs were set up: "Co-worker LTIP 2018” and "Board LTIP 2018” (expired in 2021). In 2020, a long-term incentive program, "Board LTIP 2020", for the two new board members was introduced. In 2021, two long-term incentive programs were set up: "Co-worker LTIP 2021” and "Board LTIP 2021”. The increase in the company’s share capital, assuming full utilization and maximum goal achievement of all active incentive programs (i.e. including shares issued to cover social security contributions and warrants that may be used as hedge for social security contributions), amounts to a maximum of SEK 2,793,387, corresponding to a dilution of 7.2 percent of the total number of shares. Below is a description of the various programs. For other information about the incentive programs, see Note 8 in the Annual Report 2021.
Long-term incentive program 2018
The Extraordinary General Meeting of Vicore Pharma Holding AB on August 13, 2018 resolved, in accordance with the Board of Directors proposal to adopt a long-term incentive program for senior employees and board members. Two separate programs were adopted: the employee-focused "Co-worker LTIP 2018” and a performance-based long-term incentive plan for certain directors ("Board LTIP 2018”) in Vicore Pharma Holding AB. A maximum of 2,000,000 shares (Co-worker LTIP 2018) and 475,000 share rights (Board LTIP 2018) may be granted to participants in the programs. The increase in the company's share capital upon full utilization of both incentive programs amounts to a maximum of around SEK 1,237,500, which corresponds to a dilution of approximately 3.3 percent with respect to the total number of shares. The participants in the programs have received the share rights / options free of charge and settlements is made with equity instruments.
Board LTIP 2018
Board LTIP 2018 is a program under which the participants will be granted, free of charge, share awards that entitle to shares in the company to be calculated in accordance with the principles stipulated below, however a maximum of 475,000 shares. Board LTIP 2018 is intended for members of the Board of Directors of the company independent from the main owners. The main owners believe that an equity-based incentive program is a central part of an attractive and competitive remuneration for board members, in order to attract, retain and motivate internationally competent members of the Board of Directors of the company, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. The share awards shall vest gradually over approximately three years and are conditional on the development of the company’s share price over the period from the date the share awards are allocated up to and including the vesting date. The development of the share price will be measured based on the volume weighted average price of the company's share price for the 30 trading days immediately following after 17 August, 2018, and the 30 trading days immediately preceding the date of the publication of the Q2 report 2021. In the event the price of the company’s share has thereby increased by more than 150 percent, 100 percent of the share awards shall vest, and should the share price have increased by 50 percent, 25 percent of such share awards shall vest. In the event of an increase of the share price between 50 and 150 percent, vesting of the share awards will occur linearly. Should the increase of the share price be less than 50 percent, no vesting will occur. The earliest date at which accrued share rights may be exercised is the date of publication of the Q2 report 2021. During the third quarter of 2021, Board LTIP 2018 expired. As the share price increased by less than 50 percent during the measurement period no share awards were earned. The program is now closed.
Co-worker LTIP 2018
Co-worker LTIP 2018 is a program intended for members of personnel and other key personnel in the company. According to the program, participants will be granted, free of charge, share options that entitle to acquire a maximum of 2,000,000 shares in the company in total. The exercise price per share shall correspond to 150 percent of the volume weighted average price of the company’s share for the five trading days preceding the granting date. The latest point in time at which vested options may be exercised shall be the fourth anniversary of the granting date.# Long-term incentive program
The Board of Directors of the company believes that an equity-based incentive program is a central part of an attractive and competitive remuneration strategy to motivate competent members of senior management and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. As of December 31, 2021, options corresponding to 1,325,800 shares have been granted under the Employee LTIP 2014.
Long-term incentive program 2020
The Annual General Meeting in Vicore Pharma Holding AB held on May 20, 2020, resolved, in accordance with the proposal from the Nomination Committee, to adopt a long-term incentive program for the new members of the Board of Directors (“Board LTIP 2020”) in Vicore Pharma Holding AB. A maximum of 525,000 share awards may be allotted to participants in the program Board LTIP 2020. The increase in the company’s share capital, assuming full utilization, amounts to a maximum of approximately SEK 262,500, corresponding to a dilution of 0.7 percent of the total number of shares.
Board LTIP 2020
Board LTIP 2020 is a program under which the participants will be granted, subject to performance vesting that entitle to shares in the company to be calculated in accordance with the principles stipulated below, however a maximum of 525,000 shares. The share awards shall vest gradually over approximately three years following the grant date, with vesting based on the development of the company’s share price over the period from the date the share awards are allocated up to and including the vesting date. Board LTIP 2020 is intended for the newly elected, main owner independent, members of the Board of Directors in the company. The Nomination Committee believes that an equity-based incentive program is a central part of a competitive remuneration strategy in order to attract, retain and motivate internationally competent members of the Board of Directors, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. As of December 31, 2021, a total of 525,000 share awards have been granted in Board LTIP 2020.
74 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Long-term incentive program 2021
The Annual General Meeting in Vicore Pharma Holding AB held on May 11, 2021, resolved to implement a long-term incentive program for employees in the company and to implement a long-term performance-based incentive program for independent board members in the company who are not participants in Board LTIP 2020 (“Board LTIP 2021”). A maximum of 3,000,000 options (Employee LTIP 2021) and 61,773 share awards (Board LTIP 2021) may be allotted to participants in the programs. The increase in the company’s share capital, assuming full utilization of both incentive programs, amounts to a maximum of approximately SEK 1,530,887, corresponding to a dilution of approximately 4.1 percent of the total number of shares. However, also the shares which may be issued pursuant to previously implemented incentive programs in the company, the maximum dilution amounts to approximately 7.2 percent on a fully diluted basis.
Board LTIP 2021
Board LTIP 2021 is a program under which the participants will be granted, subject to performance vesting that entitle to shares in the company to be calculated in accordance with the principles stipulated below, however a maximum of 61,773 shares. The share awards are subject to performance vesting over three years following the grant date, with vesting based on the development of the company’s share price over the period from the date the share awards are allocated up to and including the vesting date. Board LTIP 2021 is intended for independent board members in the company who are not participants in Board LTIP 2020. The Nomination Committee believes that an equity-based incentive program is a central part of a competitive remuneration strategy in order to attract, retain and motivate internationally competent members of the Board of Directors, and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. As of December 31, 2021, a total of 61,773 share awards have been granted in Board LTIP 2021.
Co-worker LTIP 2018
Employee LTIP 2018 is an incentive program intended for members of management and staff in the company. According to the program, participants will be granted, subject to three-year vesting that entitle to acquire a maximum of 3,000,000 shares in the company in total. The exercise price per share shall correspond to 125 percent of the volume weighted average price of the company’s share for the five trading days preceding the granting date. The latest point in time at which vested options may be exercised shall be the fifth anniversary of the granting date. The Board of Directors of the company believes that an equity-based incentive program is a central part of an attractive and competitive remuneration strategy to motivate competent members of senior management and to focus the participants on delivering exceptional performance which contributes to value creation for all shareholders. As of December 31, 2021, options corresponding to 807,600 shares have been granted under the Employee LTIP 2018.
Internal control and risk management regarding the financial reporting
Introduction
According to the Companies Act and the Annual Accounts Act, the Board of Directors are responsible for internal control. The purpose of internal control is to achieve efficient and effective operations, to ensure reliable financial reporting and information about the business, and to comply with applicable laws, regulations, policies and guidelines. Vicore's internal control is based on principles developed by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) which consists of five consecutive components:
- Control environment
- Risk assessment
- Control activities
- Information and communication
- Monitoring including monitoring and evaluation
Internal control of financial reporting
Internal control over financial reporting aims to provide reasonable reliability and security in financial reporting and to ensure that financial external reporting is conducted in accordance with applicable laws and accounting standards. The Board of Directors are ultimately responsible for internal control and continuously evaluates, via the Audit Committee, the work on internal control and risk management. Vicore ensures internal control of financial reporting through a qualitative and quantitative analysis of the balance sheet and income statement for the Group. The purpose of the quantitative analysis is to highlight significant and transaction-intensive items. The qualitative analysis aims to identify significant and irregularities. Based on the results of the analysis, significant financial processes are reviewed. Vicore has designed procedures and activities to follow up on financial reporting and to ensure that any errors are detected and corrected. Key controls have been designed and followed up as part of the effort to maintain good internal control.
Internal audit
The Board of Directors has evaluated the need for an internal audit function and decided that it is not necessary at present in view of the scope of the business and that the Board's follow-up of internal control is deemed sufficient to ensure that internal control is effective. The Board reexamines the need, when changes occur that can lead to re-examination and at least once a year.
Control environment and risk assessment
The control environment within Vicore contributes to the ethical tone and culture that the Company's Board and management communicate to the organization. In order to ensure effective internal control, the Company has adopted a series of internal guidelines, policies and instructions, to governing documents such as the Board's rules of procedure, instructions for the CEO with associated instructions for delegation and attestation. The Board has also established an Audit Committee to monitor the Company's financial position, the effectiveness of the Company's internal control, to be informed of the audit of the annual accounts and the consolidated accounts, and to review and monitor the auditor's impartiality and independence. Responsibility for internal control of the financial reporting has been delegated to the Company's CEO and CFO. In addition to the abovementioned controls, the company has standardized procedures that govern the control and quality of drug development. Vicore's group management shall continuously assess the risk of strategic, operational, legal and financial risks that affect the company and potential problem areas and assessing the risk that the company from achieving its vision and goals, for example if the basic requirements for financial reporting in the company are not met. Within the scope of the Group, the risk management process involves assessing consequences and probabilities, and proposes measures.The Audit Committee is responsible for continuously evaluating its work and for assisting the Board of Directors with proposals regarding the management 75 | Annual Report 2021 Vicore Pharma Holding AB (publ) of the company’s operations, the Board of Directors has appointed individuals with the responsibility to manage and monitor the internal control of the company. Control activities Up to date, the company has established and maintained a system for the internal control of the company’s operations, the Board of Directors has implemented a system for internal control, which is in line with the requirements of the Swedish Companies Act. The Board of Directors continuously works with improving internal control in Vicore. Ultimately, it is the Board of Directors’ responsibility to ensure that the company’s internal control is adequate and that the work on internal control is carried out in a satisfactory way. The situation must be evaluated annually, after which an action plan will be drawn up. Vicore base its control environment on the COSO framework and has established a systematic assessment process. The company has also appointed process owners who are responsible for individual processes. The CEO and other senior executives are all responsible for ensuring that the company’s internal control is compliant with the Board of Directors’ instructions and that the internal control system is implemented and adhered to. Vicore has designed procedures and activities to follow up on financial reporting and to ensure that any errors are detected and corrected. These activities include, among other things, follow-up and comparison of earnings performance or items, account reconciliations and balance sheet specifications, as well as approval of cash flow, investment decisions, agreements, proxy and authorization instructions, and accounting and valuation principles. The company’s CFO is responsible for following up the company's financial reporting and results. Authorizations to IT systems are limited according to powers, responsibilities and roles. Information and communication The company also has internal control functions for information and commu- nication that aim to ensure that correct financial and other company informa- tion is communicated to employees and stakeholders. The company's internal instructions and policies are available to all employees and provide detailed information on current routines in all parts of the company and describe the control functions and how they are implemented. Monitoring including follow-up and evaluation Compliance and effectiveness regarding internal controls are regularly monitored. The CEO ensures that the Board of Directors receives regular reports on the development of the company's operations, including the development of the company's earnings and financial position and information on important events, such as research results and important agreements and contracts. The CEO reports on these issues at each board meeting. The company's compliance with applicable policies and governance documents and the effectiveness of internal control are documented annually. The results of these evaluations are compiled by the company's CEO and reported to the Board of Directors annually. The Board of Directors handles all interim reports and annual reports before they are published and follows up the audit of the internal control via the Audit Committee. The Audit Committee supports the Board of Directors by preparing questions and provides the Board of Directors with information regarding the Board of Directors’ responsibilities in the areas of internal control and accounting and to assure the quality of Vicore's financial reporting. Management The Board of Directors appoints the CEO to lead the company. The management team consists of 10 people: CEO Carl-Johan Dalsgaard Chief Financial Officer Hans Jeppsson Head of Preclinical Development VP Business Development Director of Digital Therapeutics The management team holds monthly meetings to discuss the group's results and financial position, follow-up of budgets and forecasts, status in projects, administration, HR and organization, IR and strategy. The CEO's responsibility The CEO is subordinate to the Board of Directors and is responsible for the company's day-to-day management and operations of the company. The division of duties between the Board of Directors and CEO is specified in the rules of pro- cedure for the Board of Directors and the CEO's instructions. The CEO shall ensure that the company's accounting is in order and that the business is conducted in accordance with relevant regulations, laws and the Swedish Corporate Governance Code. The CEO shall ensure that the Board of Directors is continuously informed of the development of the company's operations, the company's earnings and financial position, liquidity and credit situ- ation, important business events and any other event, circumstances or conditions that may be of material importance to the company's shareholders. The CEO is also responsible for pro- ducing reports and necessary documen- tation to facilitate decisions for board meetings and is the main presenter of the material at board meetings. Management team Vicore's management team currently consist of ten individuals; CEO Carl-Jo- han Dalsgaard; Chief Financial Officer Hans Jeppsson; CMO Rohit Batta, CSO Johan Raud, VP Clinical Development Elin Rosendahl, Head of Preclinical Administrative Officer Nina Carlén, Chief Commercial Officer Åsa Magnusson, VP and Director of Digital Therapeutics Jessica Shull. For further information about Vicore's management team, including name, position, year of employment, education, responsibilities outside the company and holdings (own and / or related parties) in Vicore on March 31, 2022, see page 63-64. 76 | Annual Report 2021 Vicore Pharma Holding AB (publ) Glossary Agonist A drug that has affinity for, and stimu- lates physiological activity, via cellular receptors that are normally stimulated by naturally occurring substances. Antagonist A substance that tends to nullify the action of another; in pharmaceutical terms, a drug that binds to a receptor without eliciting a biological response. Angiotensin Peptides and hormonal substances within the renin-angiotensin system. Angiotensin II, which may bind to two different receptors; the AT1 receptor and the AT2 receptor. Stimulation of the AT1 receptor via Angiotensin II provides inter alia a contraction of the blood vessels and increases the blood pressure. AT1 receptor Stimulation of the AT1 receptor (AT1R) via Angiotensin II provides, among other things, a contraction of the blood vessels and raised blood pressure AT2 receptor (AT2R) The Angiotensin II type 2 receptor or AT2 receptor is regarded as the “protective” receptor of the Renin-Angiotensin sys- tem. Many effects seen after stimulation of the AT2 receptor counteracts effects mediated via the AT1 receptor thus counter- acting detrimental effects and healing The AT2 receptor belongs to a family of G protein-coupled receptors. In contrast to the ubiquitous AT1 receptor, the AT2 receptor is predominantly expressed during embryonic development. In adults, however, it is mainly expressed after tissue damage and in certain disease states. Clinical studies Phase 1 is the first time that the drug is tested on humans. This is usually done on a small group (10-30) of healthy volun- teers with normal weight who are men. This is because women’s reproductive capacity is more sensitive if it should prove that the substance is toxic. In the phase I study the safety of the drug is assessed and its effects on the body and its effects. In the phase I study the dose is usually a fraction of the amount that is given to experimen- tal animals, because the effect on people is significantly higher. Phase 2 is carried out on a larger group of patients suffering from a disease (20- 3,000) to study how effective the drug is to treat the disease. During phase II, dose studies are also usually conducted to arrive at the right dose to be given to patients in the future. This dose is used later in the phase III studies. Phase II studies can be divided into early phase (IIa) and late phase (IIb). Phase 3 is carried out in a large population (300-30,000) to conclusively define how suitable the drug is to treat the disease. This patient group should as far as possible mimic the population of which the finished product is to be used on, e.g. weight, age, gender, etc. Comparisons are made to the current standard treatment or placebo (sugar pill) if there is no standard treatment for the disease. Phase III may also be divided into two subgroups phase IIIa and phase IIIb. In phase IIIa, the drug has not come into the market yet and its areas of use for it are tested. Phase 4 comes after the drug has been approved by the authorities and is put on the market. Phase IV can be seen as a monitoring of what is happening. Monitoring of new unusual side effects can be discovered. 77 | Annual Report 2021 Vicore Pharma Holding AB (publ) Interstitial lung disease (ILD) Term used for a group of lung diseases. Idiopathic pulmonary fibrosis (IPF) IPF is a chronic and ultimately fatal disease char- acterized by a progressive decline in lung function. The term pulmonary fibrosis means scarring of lung tissue and is the cause of worsening dyspnoea (shortness of breath). Fibrosis is usually associated with a poor prognosis. IPF usually occurs in adult individuals of between 50 and 70 years of age, and affects more men than women. IMiD (Immunomodulatory drugs) Is a class of drugs that affect the immune response and contains an imide group. The IMiD class includes thalidomide. Preclinical research Preclinical research is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected.The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product’s safety profile.
Pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by high blood pressure in the lung arteries caused by narrowing and obstruction in the arteries of the lung.
RAS or Renin-Angiotensin System
The Renin-Angiotensin System (RAS) or the Renin-Angiotensin-Aldosterone System (RAAS) is a hormone system that regulates blood pressure and fluid and electrolyte balance, and is a major determinant of blood pressure and cardiovascular homeostasis. Drugs targeting the RAS pathway have been widely used clinically to treat high blood pressure, and for reducing mortality of patients with myocardial infarction and heart failure patients. With these drugs, the negative effects of Angiotensin II are reduced.
Receptor
A specific molecule on the surface or within the cytoplasm of a cell that recognizes and binds with other specific molecules, such as the cell molecules that bind with hormone or neurotransmitter molecules and react with other molecules that respond in a specific way.
Regulatory
Regulatory authorities’ formal requirements regarding, for example, pharmaceutical registration.
Raynaud's phenomenon
Raynaud's phenomenon expresses itself in that fingers or toes whitens. This is due to decreased blood flow due to temporary cramps in the blood vessels of the fingers. You distinguish between primary form, which is idiopathic and has no known cause, and the secondary form which is often caused by damage in connection with arteriosclerosis, SLE, previous diseases or in connection with cold. It is a side effect that occurs in the use of some drugs. In the primary form of the disease there are some hereditary relationships.
Systemic sclerosis (SSc)
Systemic sclerosis (SSc) is a rheumatic disease characterized by abnormal growth of connective tissue in the skin and internal organs, and is characterized by the thickening and hardening of the skin. The disease affects connective tissue and blood vessels, and causes skin tightening and itching, particularly in the fingers and toes (Raynaud's phenomenon) are also affected. Systemic sclerosis is a so-called chronic autoimmune disease, which means that the body responds to its own tissues in a similar way that it responds to foreign substances. The disease usually debuts in the ages between 30 and 50 years. There are two types of the disease. One is called diffuse cutaneous systemic sclerosis (dcSSc) and the other type is limited cutaneous systemic sclerosis (lcSSc).
Orphan drugs
The regulatory authorities can grant a drug candidate Orphan Drug Designation (ODD). Orphan drug status is a way of encouraging research and development of drugs for the treatment of rare diseases. In the US and Europe, about 60 million people are estimated to suffer from one of the 7,000 identified rare diseases. In total, some 350 million people around the world are estimated to suffer from one of the rare diseases identified.
The definition of rare disease for different markets:
* USA: <200,000 patients per indication
* Japan: <50,000 patients per indication
* Europe: <5 per 10,000 inhabitants (approximately 250,000 patients per indication)
78 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Adress
Vicore Pharma Holding AB
Kronhusgatan 11
SE-411 05 Gothenburg, Sweden
Contact Information
- Contact
Carl-Johan Dalsgaard, CEO
Tel: +46 70 975 98 63
[email protected] - Contact
Hans Jeppsson, CFO
Tel: +46 70 553 14 65
[email protected]
Vicore Pharma Holding AB
Kornhamnstorg 53
111 27 Stockholm
Sweden
Tel: + 46 31 788 05 60
Org.no.: 556680-3804
www.vicorepharma.com
79 | Annual Report 2021 Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB
Kronhusgatan 11, 411 05 Gothenburg, Sweden | +46 (0)31-788 05 60 | vicorepharma.com
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