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Camurus

Quarterly Report Nov 9, 2023

3021_10-q_2023-11-09_358a037e-beb1-42f0-b812-03b734258742.pdf

Quarterly Report

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"Strong financial performance and launch of Brixadi™ in the US"

Q3

Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus' clinical pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit camurus.com

CAMURUS INTERIM REPORT FOR THE THIRD QUARTER 2023

Third quarter summary

July - September

  • Total revenues amounted to SEK 384 (241) million, an increase of 59% (49% at CER1 ), whereof product sales were SEK 346 (241) million, an increase of 44% (38% at CER1 )
  • Compared to previous quarter, product sales increased 13% (9% at CER1 )
  • Operating result was SEK 104 (41) million, an increase of SEK 63 million (154%)
  • Cash position at the end of the quarter was SEK 1,154 (520) million, an increase of SEK 634 million (122%)
  • Number of patients treated with Buvidal® increased to approximately 45,000
  • The European Commission issued continued marketing authorization for Buvidal with unlimited validity
  • Brixadi™ launched for the treatment of patients with opioid use disorder (OUD) in the US
  • Camurus received USD 35 million from Braeburn as a one-time payment for the US approval of Brixadi
  • Positive results were announced from the long-term Phase 3 study of CAM2029 in patients with acromegaly
  • Publication of population pharmacokinetic analyses of Buvidal in Clinical Pharmacokinetics2

January - September

  • Total revenues amounted to SEK 1,342 (688) million, an increase of 95% (86% at CER1 ), whereof product sales were SEK 933 (668) million, an increase of 40% (35% at CER1 )
  • Operating result was SEK 554 (53) million, an increase of SEK 501 million (945%)

Significant events after the period

• Financial outlook for full year 2023 revenue was raised from SEK 1,530 – 1,650 million to SEK 1,640 – 1,720 million and profit before taxes from SEK 425 – 525 million to SEK 525 – 600 million

  1. At constant exchange rate; 2.Björnsson, M., et al. Clin Pharmacokinet. 2023;62:1427-1443.
MSEK 2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Total revenues 384 241 59% 1,342 688 95% 956
whereof product sales 346 241 44% 933 668 40% 935
OPEX -253 -184 37% -703 -567 24% -789
Operating result 104 41 +63 554 53 +501 72
Result for the period 86 35 +51 447 42 +404 56
Earnings per share after dilution, SEK 1.50 0.61 +0.89 7.77 0.74 +7.03 0.97
Cash position 1,154 520 122% 1,154 520 122% 566

Third quarter 2023

Total revenues

SEK 384 M +59%

Product sales

SEK 346 M +44%

Operating result

SEK 104 M SEK +63 M

Financial analysts, investors and media are invited to attend a telephone conference and presentation of the results on 9 November at 2 pm (CET).

The conference call can also be followed by a link on camurus.com or via external link: https://financialhearings.com/event/46216

"We continued to strengthen our leading position in the opioid dependence treatment market"

Successful third quarter and US launch of Brixadi™

Camurus had an excellent third quarter with continued high sales growth in Europe and Australia, launch of Brixadi in the US, and positive interim results from a long-term Phase 3 study of CAM2029 for the treatment of acromegaly. Our US licensing partner Braeburn initiated the launch of Brixadi for the treatment of opioid use disorder which resulted in both a significant milestone payment and the first royalty revenue for Camurus. Topline revenue growth during the quarter was close to 60 percent and as a result of the positive development, we raised the financial guidance for the full year 2023.

Growing revenues and improved financial result

Camurus continued to deliver strong financial performance during the third quarter. Compared to the same quarter in 2022, revenues grew by 59 percent to SEK 384 million, while operating expenses increased by 37 percent to SEK 253 million. The revenue growth was the result of increased Buvidal product sales, and revenue of SEK 25 million related to the expiration of Braeburn's option period for Buvidal in China, Japan, Taiwan and Korea. Camurus now holds the rights to Buvidal in all markets outside North America. The increase in operating expenses was primarily due to investment in commercial activities for Buvidal in Europe, Australia and new markets, and the Phase 3 studies of CAM2029 that were ongoing during the quarter.

The operating result for the quarter increased by SEK 63 million (+154%) compared to the third quarter of 2022 to SEK 104 million, mainly attributed to increased product sales, margin improvement and positive currency effects.

At the end of the third quarter, the cash position was SEK 1,154 million, an increase of SEK 500 million since the end of the previous quarter. A significant contribution to the strong cash flow was a one-time milestone payment of USD 35 million from Braeburn received after the first commercial sale of Brixadi in the US. Camurus' strong financial position and prospects for continued growth and profitability, enables us to continue executing on our strategy to grow and diversify the business, advance our pipeline and take new innovative products to the market, and establish our own commercial organization in the US for the launch of CAM2029.

More patients in treatment with Buvidal

We continued to strengthen our leading position in the opioid dependence treatment market. Buvidal sales increased across our markets to SEK 346 million, a 44 percent increase compared to last year and 13 percent compared to the previous quarter,

including a positive currency effect of approximately 5 percent. We continued to see strong performance in the UK, which was further supported by a new report from the UK Health Select Committee highlighting the benefits of long-acting buprenorphine in the treatment of opioid dependence.1 The Nordics, Germany, Austria and Spain were other markets that performed strongly. In addition, Buvidal was launched in Italy by our distribution partner Molteni who has extensive experience in opioid dependence treatment and an established sales force.

In Australia, there have been changes during the period in the reimbursement and distribution system for treatments of opioid dependence. This includes a reduction in the co-pay for many patients which over time may contribute to more patients seeking treatment for opioid dependence. In addition to improving access, there have also been changes to the distribution system in Australia from a single customer to multiple customers which may result in quarter-on-quarter variances in channel stock that will be reflected in company sales.

In parallel with the continued success in existing markets, four regulatory applications for market authorization approvals and four price and reimbursement submissions have progressed during the quarter. New clinical and real-world evidence on Buvidal has been published and abstracts have been accepted for presentation at international conferences.

"Brixadi now available to patients with opioid use disorder in all 50 US states"

Brixadi™* launched in the US

Brixadi was launched by our license partner Braeburn on 5 September 2023 and is now available to patients with opioid use disorder in all the 50 US states, in several cases with unrestricted access through Medicaid and, increasingly, also through private payers. The product is available through a restricted program called the Brixadi REMS Program and is only intended for administration by healthcare providers.2 Product sales have started and during the quarter we reported the first royalty revenue of SEK 1.2 million for the first three weeks of sales of Brixadi in the US.

Brixadi is the only treatment for opioid use disorder that offers both weekly and monthly injections and individualized doses in accordance with current treatment guidelines for daily medication. It is also the only long-acting treatment that can be initiated on the first day of treatment, after a test dose of oral buprenorphine. In addition, Brixadi has several advantages over other products available on the US market in the form of smaller needle and dose volumes, multiple injection sites, and stability at room temperature.

Based on the large unmet medical need, the competitive product profile of Brixadi, and the sizable and focused commercial organization of Braeburn of over 100 people, there are good prospects for a continued successful launch in the US.

New positive Phase 3-data in acromegaly and progress in GEP-NET and PLD trials

After reporting positive Phase 3 results from a randomized placebo-controlled study (ACROINNOVA 1) in the second quarter of 2023, we announced in the third quarter new positive results from a long-term Phase 3 study (ACROINNOVA 2) evaluating safety and efficacy of CAM2029 octreotide subcutaneous depot in patients with acromegaly. In parallel, we entered the final stage of patient enrollment in SORENTO, the pivotal Phase 3 study of CAM2029 for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NET) and in POSITANO, our Phase 2/3 study in patients with polycystic liver disease (PLD).

In the acromegaly program, positive interim Phase 3 results from ACROINNOVA 2 were announced during the period. * Brixadi™ is the US brand name for Camurus' product Buvidal® the basis of our upcoming marketing authorization application

"ACROINNOVA 2 showed improved treatment satisfaction and quality of life with CAM2029 compared to standard of care"

The trial evaluates long-term safety and efficacy in a total of 135 patients with acromegaly, of which 81 patients were directly enrolled in the study from a stable dose of standard of care with first-generation long-acting somatostatin receptor ligands (SRLs), octreotide LAR or lanreotide ATG. Despite treatment, most of these patients were not biochemically controlled for insulin-like growth factor-1 (IGF-1) at screening. In addition, 54 patients were transferred from 24 weeks of treatment in ACRO-INNOVA 1 to 28 weeks of extended treatment with CAM2029 in ACROINNOVA 2; 36 patients had been treated with CAM2029 and 18 received placebo.

The primary endpoint in ACROINNOVA 2 was safety and the study showed that CAM2029 was well tolerated with a safety profile like that of first-generation SRL products, with no new or unexpected adverse events. The study also assessed effectiveness as secondary endpoints, demonstrating improved biochemical control after 52 weeks of treatment with CAM2029 in non-controlled patients at baseline and maintained high and stable control for previously controlled patients from ACROINNOVA 1. All patients who lost biochemical control on placebo treatment in ACROINNOVA 1 regained control after being transferred to treatment with CAM2029 in ACROINNOVA 2.

In addition, ACROINNOVA 2 showed improved treatment satisfaction and quality of life for patients treated with CAM2029 compared to standard of care at baseline. Together with study data from ACROINNOVA 1, which met primary and key secondary endpoints, and multiple secondary endpoints, the results form

"Planned submission of the NDA for CAM2029 for the treatment of acromegaly around year end"

(NDA) to the US FDA. After the period, a pre-NDA meeting was held with the agency to discuss and align on key questions. The outcome of the meeting was positive and we are now preparing for a planned submission of the NDA for CAM2029 for treatment of acromegaly around year end.

In the GEP-NET program, we entered the final stage of patient recruitment in SORENTO, which is expected to be completed and reach the target of 302 patients during the fourth quarter. The study aims to demonstrate superiority in progression-free survival with CAM2029 compared to standard of care with lanreotide ATG or octreotide LAR. The primary outcome measure will be assessed after 194 progression events have been confirmed.

The progress of SORENTO was presented at the NANETS Annual Conference on October 4-6 in Montreal, Canada. Interest in the study and CAM2029 among the attendees was high and the feedback from participating investigators very positive.

In the PLD program, recruitment is accelerating in the randomized, placebo-controlled POSITANO study and we now have approximately 50 of the 69 planned patients randomized in the study. The study's primary and first secondary endpoints are stabilization and reduction of liver volume and reduction of disease symptoms, and the first results are expected towards the end of 2024.

We see significant commercial opportunities with CAM2029 across the three indications under development. In the US alone, the sales potential of CAM2029 is estimated to be in the order of

USD 2 billion in peak annual sales. During the third quarter, we continued to work on the establishment of our own commercial organization in the US and launch preparations for a planned NDA approval of CAM2029 in the fourth quarter of next year.

Collaborations and new projects

We have also had promising data coming out of our early development programs of innovative drug candidates and from ongoing development collaborations with international biotech and pharmaceutical companies. In addition, results from our license partner Rhythm's Phase 3 study of setmelanotide weekly depot are expected in the fourth quarter 2023. In parallel with these different programs, search and evaluation of external assets with clear synergies with Camurus' current commercial operations and development are continuing.

New headquarter and improved sustainability ratings

To support our continued expansion, during the quarter we signed an agreement to move our headquarters from its current premises to The Loop in Science Village, Lund. The property, which is under construction, will have the capacity to accommodate over 200 employees and laboratories, with occupancy towards the end of 2024. The dynamic environment, with direct proximity to the ESS and Max IV research facilities and Lund University, alongside the property's excellent sustainability profile, were important factors behind the decision to choose The Loop for our future headquarters and research laboratories.

We continue to strengthen our sustainability profile in line with our long-term strategy. As a result of our systematic work, our ESG rating has recently been raised from AA to AAA by Nordea, and the ESG risk level has improved two steps in an updated analysis by Sustainalytics, where we now rank better than the average within the pharmaceutical industry subcategory.3 We continue to work to reduce our products' environmental footprint, increase control of risks in the supply chain and ensure a good working environment for our own employees and partners.

During the quarter, a new employee survey was conducted, which resulted in very positive feedback across all categories. For example, we achieved an engagement index – an Employee Net Promoter Score (eNPS) – several times higher than benchmark.4

Strong financial performance led to raised full year 2023 guidance

Year to date, we reached revenues of SEK 1,342 million, an increase of 95 percent, and a profit before taxes of SEK 554 million. Based on the strong performance so far, and our expectations for the fourth quarter, we raised our financial guidance for the full year 2023. Our cash position increased to SEK 1,154 million at the end of the quarter, including the milestone revenue of USD 35 million received from Braeburn in September. We look forward to increasing numbers of patients getting access to Brixadi for the treatment of OUD in the US.

Camurus' growing revenues and strong financial position means that we can fully finance all activities in our strategic longterm plan. This includes taking late-stage pipeline programs to global market approvals and establishing our own commercial organization in the US.

Near-term, we plan to submit the NDA application for CAM2029 in acromegaly to the FDA and complete recruitment of patients in the SORENTO and POSITANO trials. Overall, I am very pleased with the performance so far this year and have a positive view on the continued execution on our long-range plan and value creation for patients, shareholders, and employees.

Fredrik Tiberg President and CEO

References:

  1. https://committees.parliament.uk/publications/41147/documents/203039/default/ 2. https://brixadirems.com/

    1. https://www.sustainalytics.com/esg-rating/camurus-ab/1008297536
    1. https://www.puls-solutions.se/en/puls-solutions-erm-platform-the-teams-best-friend/

Products and pipeline

Camurus has an advanced and diversified pipeline of innovative investigational and marketed medical products for the treatment of serious and chronic diseases. New products are conceived based on extensive R&D expertise and applying the company's proprietary injection depot technology, FluidCrystal®, to active substances with available positive clinical data on efficacy and safety. As a result, new proprietary medicines with improved treatment outcomes and patient benefits can be developed both in a shorter time and to a lower cost, as well as with lower risk compared to the development of new chemical substances.

Buvidal® – Treatment of opioid dependence

Buvidal (buprenorphine) prolonged-release solution for injection is used for the treatment of opioid dependence within a framework of medical, social and psychological treatment, in adults and adolescents aged 16 years and over.1 Buvidal is available as weekly and monthly formulations in multiple dose options, offering the flexibility to tailor treatment to patients' different individual needs. Buvidal provides fast onset and a long-acting release of buprenorphine, and has shown to effectively reduce illicit drug use, withdrawal and cravings.2 Buvidal has also been demonstrated to block effects of injected opioids, thereby potentially reducing the risk of relapse and overdose.3 Clinical studies and real-world experience have demonstrated significant improved patient-reported outcomes, including higher treatment satisfaction, reduced treatment burden, and improved quality of life for patients with Buvidal compared to standard treatment with daily sublingual buprenorphine.2,4,5 Furthermore, since Buvidal is administrated by healthcare professionals only, the risk for misuse and leakage is reduced compared to products that have to be taken daily.1

Commercial operations

Status Q3 2023

Commercial development

  • Product sales of SEK 346 (241) million; +44% (+38% at CER*) vs. Q3 2022 and +13% (+9% at CER*) vs. Q2 2023
  • Continued market penetration and strengthen market leadership in key markets in both community and prison settings with strong sales noted in the UK, Nordics, Germany, Austria and Spain
  • New report by the UK Health Select Committee further recognizes the value of long-acting injectable buprenorphine in context of UK Drug Strategy6
  • Expansion in Germany in prison setting with five new prisons initiating treatment with Buvidal in Q3
  • The quarter result includes orders from distributor markets. Additionally, Australian business model change by the government may result in QoQ variances in channel stock that will be reflected in company sales.
  • Buvidal launched in Italy and first order by distribution partner Molteni
  • Structural changes in treatment system in Australia has reduced co-pay for patients which presents an opportunity to encourage more patients into treatment
  • Four pricing and reimbursement submissions under review in Europe
  • Estimated 45,000 patients in treatment with Buvidal at the end of Q3
  • Brixadi™ weekly and monthly depot for the treatment of moderate to severe opioid use disorder launched in the US on 5 September by license partner Braeburn7

Medical affairs

  • Presentations of Buvidal data from clinical studies and clinical practice:
    • Camurus participated in the Royal College of Psychiatrists (RCPsych) International Congress 10-13 July in Liverpool, UK, and sponsored the Drink and Drug News (DDN) Conference 13 July in Birmingham, UK
    • Camurus sponsored and held symposium at the Drug and Alcohol Nurses Australasia (DANA) meeting 2-4 August in Sydney, Australia with focus on nurse practitioner led opioid dependence treatment programs
    • Abstracts accepted for poster presentations at ATHS 24-27 October in Biarritz, France and ISAM 2-4 November in Marrakesh, Morocco
  • Several new publications, including:
  • New pharmacokinetics (PK) model supporting use of Buvidal as individualized treatment for opioid dependence across different treatment stages, including initiation and switching from sublingual buprenorphine8
  • Investigator sponsored studies (ISS) on experiences with long-acting depot buprenorphine in early emergency department and use of non-prescribed substance during the first months of treatment9,10
  • Implementation of health at the margins approach for people with opioid dependence where there may be increased barriers to accessing treatment, e.g. due to sex-working11

Regulatory

  • The European Commission granted updated marketing authorization for Buvidal with unlimited validity
  • Marketing Authorization Application submitted in Serbia
  • Market Authorization Approval in Kuwait after the period
  • Four national market authorizations under review in Europe, the Middle East and North Africa regions progressed

Pipeline development

LIFE-CYCLE MANAGEMENT PROGRAMS

CAM2038 (Buvidal) – Chronic pain

There is a high unmet medical need in chronic pain, particularly among patients who have or who are at risk of developing dependency on opioids. In addition to the approved indication for the treatment of opioid dependence, CAM2038 is being developed for the treatment of chronic pain.

CAM2038 has been evaluated in a Phase 2 study in patients with chronic non-cancer pain and opioid dependence, in a randomized, double-blind, placebo-controlled 12-week Phase 3 study in opioid experienced patients with chronic low-back pain, and in a 12-month long-term efficacy and safety study also including patients with other chronic pain conditions.

Status Q3 2023

  • In Q1 2023, Camurus withdrew its applications to extend the indication for Buvidal to include chronic pain12
  • Further development under review

CAM2029 – Acromegaly, GEP-NET and PLD

CAM2029 is a novel subcutaneous octreotide depot under development for the treatment of three rare diseases: acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NET) and polycystic liver disease (PLD). Studies completed to date demonstrate that CAM2029 provides a five-fold increase of plasma exposure, with the potential for improved efficacy, compared to current standard treatments. CAM2029 is designed to enable convenient subcutaneous self-administration, using a pre-filled syringe with safety device or state-of-the-art pre-filled pen, while current standard treatments are administrated intramuscularly or deep subcutaneously with large needles, require complex handling in several steps, including reconstitution and/or conditioning, and generally are administrated by a trained healthcare professional.13,14

Acromegaly

  • Positive topline Phase 3 results in ACROINNOVA 2 announced15
    • Favorable safety profile and effective biochemical control in 52-week
  • Significant improvement of acromegaly symptoms vs. standard of care at baseline
  • Improved patient reported treatment satisfaction, convenience, and quality of life
  • Human Factors Engineering (HFE) validation studies completed during the quarter
  • Pre-NDA interaction with the US Food and Drug Administration, FDA, concerning Chemistry, Manufacturing and Control (CMC)
  • Pre-NDA meeting held after the period with the US FDA aligning on key questions, with positive outcome

GEP-NET

  • Recruitment of patients in the SORENTO16 Phase 3 study in patients with gastroenteropancreatic neuroendocrine tumors entered final stage and the target of 302 randomized patients is expected to be reached during Q4 2023
  • SORENTO study update was given at the North American Neuroendocrine Tumor Society (NANETS) congress on 4-6 October in Montreal, Canada

PLD

• Patient recruitment progressed to about 50 of the target 69 patients to be included in the randomized, placebocontrolled POSITANO17 study of CAM2029 in patients with polycystic liver disease (PLD)

READ MORE ABOUT OUR PIPELINE PROGRAMS ON www.camurus.com/science

CAM4072 – Genetic obesity disorders (Rhythm Pharmaceuticals)

CAM4072 is a weekly formulation of the MC-4 agonist setmelanotide, developed by Camurus' partner Rhythm Pharmaceuticals, for the treatment of a range of rare genetic disorders of obesity. The product candidate is based on Camurus' FluidCrystal injection depot technology and is being developed to offer patients a simpler and more convenient dosing regimen with the possibility of improved treatment adherence.

Status Q3 2023

  • Recruitment completed in Phase 3 switch study of weekly setmelanotide formulation in patients with Bardet-Biedl's syndrome (BBS) and other rare genetic obesity disorders.18
  • Topline Phase 3 pharmacokinetics results from the switch study expected in H2 2023
  • Start of a second Phase 3 study of weekly setmelanotide in patients with BBS who have not previously received treatment (de novo patients) planned in H1 2024

References:

    1. Buvidal SmPC, https://www.ema.europa.eu/en/ documents/product-information/ buvidal-eparproduct-information_en.pdf
    1. Lofwall MR, et al. JAMA Intern Med. 2018;178(6);764–773.
    1. Walsh L., et al. JAMA Psychiatry. 2017;74(9):894-902.
    1. Lintzeris N., et al. JAMA Network Open. 2021;4(5):e219041.
    1. Frost M., et al. Addiction. 2019;114:1416–1426.
    1. https://committees.parliament.uk/publications/41147/documents/203039/default/
    1. Press release 5 September, 2023: https://www.camurus.com/media/pressreleases/2023/Camurus-announces-us-launch-of-brixadi-for-the-treatment-ofmoderate-to-severe-opioid-use-disorder-by-braeburn/
    1. Björnsson, M. et al. Clin Pharmacokinet. 2023;62:1427-1443. https://doi.org/ 10.1007/s40262-023-01288-6
    1. D'Onofrio, G., et al. Acad Emerg Med. 2023 https://doi.org/10.1111/acem.14782
    1. Parkin, S., et al. Substance use & misuse. 2023;58:1696-1706. https://doi.org/ 10.1080/10826084.2023.2244064
    1. Gittins, R., et al. Front Psychiatry. 2023;14:1224376. https://doi.org/10.3389/ fpsyt.2023.1224376
    1. Press release 13 February, 2023: https://www.camurus.com/media/pressreleases/2023/camurus-withdraws-variation-application-for-cam2038-toinclude-chronic-pain/
    1. Prescribing Information SANDOSTATIN® LAR, https://www.accessdata.fda.gov/ drugsatfda_docs/label/2021/021008s041lbl.pdf
    1. Prescribing Information SOMATULINE®, https://www.accessdata.fda.gov/ drugsatfda_docs/label/2023/022074s026lbl.pdf
    1. Press release 17 July, 2023: https://www.camurus.com/media/press-releases/ 2023/camurus-announces-new-phase-3-data-reinforcing-long-term-safetyand-efficacy-of-octreotide-sc-depot-cam2029-in-patients-with-acromegaly/
    1. https://clinicaltrials.gov/ct2/show/NCT05050942
    1. https://clinicaltrials.gov/study/NCT05281328
    1. https://clinicaltrials.gov/study/NCT05194124

Corporate development

Continued growth and value creation

In addition to developing and commercializing new innovative medical products for the treatment of severe and chronic diseases, Camurus is focusing on diversification through business development and partnerships as well as strengthening of our organization and agenda for sustainable value creation.

During the period, Camurus continued preparing for the launch of CAM2029 in the US, in collaboration with a thirdparty organization. Key focus areas were set up of the distribution model, medical affairs team and commercial development activities – including market research, compliance and US organization structure.

Camurus' financial and cash position was significantly strengthened during the quarter with growing Buvidal product sales and collected milestone revenues for the FDA approval of Brixadi in the US. The company is well positioned for continued investment in sustainable growth and profitability.

Organizational update

  • An employee survey was conducted for the fourth time, with positive results across all categories and improvements from already high levels
  • Camurus announced establishment of new, sustainable headquarters and research laboratories in "The Loop", Science Village, Lund, Sweden

Sustainability

Camurus' commitment to improve the lives of patients has a clear sustainability perspective. Based on the company's ambition to contribute to a healthier world, the work includes several dimensions in the ESG area. Camurus' sustainability strategy and work is divided into four focus areas with established ambitions, goals, key figures and activities and aims to contribute to the UN's Sustainable Development Goals (SDGs).

supply chain

Status Q3 2023

  • Two step improvement of ESG rating by Sustainalytics to medium risk and better than the average in pharmaceutical subcategory
  • Sustainability Management System according to ISO 14001 developed
  • Digital platform for vendor sustainability risk management and development regarding human rights, labor rights, anti-corruption and environmental performance implemented
  • Environmental mapping of Camurus' supply chain progressed with focus on environmental performance improvement of CO2 emissions
  • Global launch of updated Code of Conduct training at Camurus' using a new e-learning platform
  • Camurus supported two campaigns aimed at reducing stigma for people with opioid dependence:
  • For the sixth year in a row, Camurus supported the organizers of the International Overdose Awareness Day (IOAD) on 31 August. The campaign aims to raise awareness around overdose, reduce stigma of opioid dependence and drug-related deaths with the message that illness and death due to illicit drug overdose can be prevented and treated.
  • Camurus' German team participated in the International Day of Remembrance for Deceased Drug Users on 21 July, the largest German nationwide day of remembrance and action within the field of illegal drug use
  • After the period, Camurus became a Nasdaq ESG Transparency Partner. The certification demonstrates Camurus' comittment to market transparency and raising environmental standards. New sustainability metrics to data included in Camurus' Annual Report 2022 is now available on https:// data.nasdaq.com/databases/NESG/overview

READ MORE ABOUT CAMURUS' SUSTAINABILITY WORK AT www.camurus.com/sustainability

12

Financial statements

Financial overview

Revenues

Total revenues during the quarter amounted to MSEK 384.0 (241.4), an increase by 59 percent (49 percent at CER1 ).

Product sales were MSEK 346.0 (240.5), corresponding to an increase of 44 percent (38 percent at CER) compared to the third quarter 2022 and 13 percent versus prior quarter.

Following FDA approval of Brixadi™ in May, Camurus recognized MSEK 25.2 revenue in the quarter related to the expiration of Braeburn´s option period for Buvidal® in China, Japan, Korea and Taiwan. Additionally, Camurus for the first time recognized royalty revenue stream for Brixadi product sales, by an amount of MSEK 1.2 in the quarter.

During January-September period, total revenues were MSEK 1,342.3 (688.3), up 95 percent compared to the same period 2022. Product sales were MSEK 933.2 (667.8), up 40 percent.

For further information, see Note 4.

Operating result

Marketing and distribution costs were MSEK 94.4 (67.0) in the quarter, and for January-September period MSEK 264.0 (195.3), an increase driven by commercial acceleration of Buvidal in Europe and Australia as well as expansion to new markets.

Administrative expenses for the quarter were MSEK 10.4 (10.5), and for the first nine months MSEK 31.8 (26.0), aligned with corporate evolution to substantiate company development.

R&D costs, including depreciation and amortization of tangible and intangible assets, were MSEK 147.7 (106.6) for the quarter and for the first nine months MSEK 407.6 (338.7). The increase compared to previous year and quarter is mainly linked to the continued progress in the three ongoing pivotal Phase 3 trials of CAM2029 for the treatment of acromegaly and neuroendochrine tumors as well as a Phase 2/3 trial in polycystic liver disease. During the quarter, ACROINNOVA 2 topline results were announced.

The operating result for the quarter was MSEK 104.0 (41.4), and for the first nine months MSEK 554.4 (53.1), driven by Buvidal revenue growth and related milestones to Brixadi approval in US by FDA.

Financial items and tax

Financial items in the period were MSEK 5.8 (0.1) and MSEK 12.9 (-0.4) for the first nine months of the year.

Tax in the quarter was MSEK -23.4 (-6.5) and MSEK -120.7 (-10.1) for the period January-September driven by company profitability.

Result for the period

The result for the period amounted to MSEK 86.4 (35.0) and MSEK 446.6 (42.5) year to date.

Earnings per share before dilution were SEK 1.56 (0.63) for the period and for the nine months SEK 8.05 (0.77). Earnings per share after dilution were SEK 1.50 (0.61) for the period and for the period January-September SEK 7.77 (0.74).

Cash flow and investment

Cash flow from operating activities, before change in working capital, amounted to MSEK 121.2 (54.8) for the quarter and year to date MSEK 613.6 (87.3). The difference compared to previous year is driven by operating result improvement and related milestones to Brixadi approval in US.

The change in working capital affected the cash flow by MSEK 364.5 (-0.8) in the quarter driven mainly by the collection of the MUSD 35 milestone related to Brixadi approval in US. For the first nine months of the year change in working capital affected the cash flow by MSEK -36.7 (-31.2), mainly driven by accounts receivable increase as revenue grows.

Cash flow from investing activities in the quarter was MSEK -1.4 (7.1) and MSEK -7.7 (5.7) year to date.

Cash flow from financing activities was MSEK 16.9 (28.6) in the quarter and relates to payments for the exercise of warrants in TO2020/2023. Year to date, cash flow from financing activities was MSEK 17.5 (42.5).

1) At constant exchange rates.

Financial position

The cash position for the group as of 30 September, 2023 was MSEK 1,153.9 (519.5).

There were no loans as of 30 September, 2023 and no loans have been taken since this date. Consolidated equity as of 30 September, 2023 was MSEK 1,488.3 (968.4). The difference compared to last year mainly relates to company profitability improvement and the exercise of warrants in the warrant program TO2019/2022 during the last quarter 2022 and TO2020/2023 during 2023.

Total assets for the group were MSEK 1,841.7 (1,233.6).

Parent company

The company's total revenue in the quarter amounted to MSEK 371.9 (222.4) and year to date MSEK 1,292.5 (654.0). The result after tax in quarter was MSEK 81.7 (30.1) and for January-September MSEK 433.7 (31.0).

On 30 September, 2023, equity in the parent company amounted to MSEK 1,393.3 (883.8) and total assets to MSEK 1,657.0 (1,076.1), of which MSEK 1,056.6 (426.0) were cash and cash equivalents.

Acquisitions and divestitures

No acquisitions nor divestitures have taken place during the quarter.

Other disclosures

Camurus' share

Camurus' share is listed on Nasdaq Stockholm.

At the end of the period, the total number of shares and votes was 55,538,818 (55,383,447). The difference compared to last year mainly relates to new shares through the exercise of warrants in the TO2019/2022 and TO2020/2023 programs.

Currently, Camurus has four long-term share-based incentive programs ongoing for the company's employees, one subscription warrant program and three employee stock option programs. During the quarter, earnings after tax were negatively impacted by MSEK 14.0, without any cash flow effect, related to the employee stock option programs and MSEK 33.8 during the first nine months of the year.

For further information about the programs, see Note 2.3.

Personnel

At the end of the period, Camurus had 204 (170) employees, of whom 104 (93) were within research and development and medical affairs, 80 (62) within business development and marketing and sales, and 19 (14) within administration. The number of employees, in terms of fulltime equivalents, amounted to 190 (157) in the quarter and 179 (149) during the first nine months.

Financial outlook for 2023

Camurus full year 2023 guidance was updated during October as follows:

  • Total revenue MSEK 1,640 to 1,720, +71-80 percent vs. 2022, including milestone revenue following NDA approval in the US of MUSD 35, compared to prior guidance MSEK 1,530 to 1,650
  • Profit before taxes MSEK 525 to 600, +618-721 percent vs. 2022, compared to prior guidance MSEK 425 to 525.

Company guidance takes into account market conditions in current macroeconomic environment as well as continuous investments to support company strategic vision 2027 shared at Camurus' Capital Markets and R&D Day.

Annual General Meeting 2024

Camurus' Annual General Meeting will be held on Wednesday 8 May 2024, at 5 pm CET, at Elite Hotel Ideon, Scheelevägen 27, 223 63 Lund, Sweden.

Audit

This report has been reviewed in summary by the company's auditor.

Forward-looking statements

This report includes forward-looking statements about expected and assumed future events, such as start of new development programs, regulatory approvals, market potential and financial performance. These events are subject to risks, uncertainties and assumptions, which may cause actual results to differ materially from previous judgements.

Financial calendar 2023-2024

Audiocast Q3 Interim Report 2023 9 November, 2023, at 2 pm CET
Full Year Report 2023 15 February, 2024
Annual Report 2023 28 March, 2024
Q1 Interim Report 2024 8 May, 2024
AGM 2024 8 May, 2024, at 5 pm CET
Q2 Interim Report 2024 16 July, 2024
Q3 Interim Report 2024 7 November, 2024

Further information

For further information, please contact: Fredrik Tiberg, President and CEO Tel. +46 46 286 46 92, e-mail: [email protected]

Lund, Sweden, 9 November, 2023 Camurus AB Board of Directors

Auditor's report

Camurus AB reg. no. 556667-9105

Introduction

We have reviewed the condensed interim financial information (interim report) of Camurus AB as of 30 September, 2023 and the nine-month period then ended. The board of directors and the CEO are responsible for the preparation and presentation of the interim financial information in accordance with IAS 34 and the Swedish Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.

Scope of the review

We conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity. A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the group, and with the Swedish Annual Accounts Act, regarding the parent company

Lund, 9 November, 2023

PricewaterhouseCoopers AB

Johan Rönnbäck Authorized Public Accountant

Consolidated statement of comprehensive income

KSEK
Note
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Total revenue
4
383,985 241,362 1,342,284 688,325 956,340
Cost of goods sold -31,995 -24,027 -89,779 -75,273 -103,265
Gross profit 351,990 217,335 1,252,505 613,052 853,075
Marketing and distribution costs -94,399 -67,035 -263,983 -195,328 -273,542
Administrative expenses -10,416 -10,468 -31,820 -26,013 -35,248
Research and development costs -147,692 -106,565 -407,613 -338,676 -473,757
Other operating income 4,564 8,104 5,353 7,029 7,697
Other operating expenses -6,987 -6,269
Operating result 104,047 41,371 554,442 53,077 71,956
Financial income 6,114 472 13,861 567 2,695
Financial expenses -326 -331 -986 -1,012 -1,526
Net financial items 5,788 141 12,875 -445 1,169
Result before tax 109,835 41,512 567,317 52,632 73,125
Income tax
9
-23,439 -6,513 -120,669 -10,146 -17,572
Result for the period1)
5
86,396 34,999 446,648 42,486 55,553
Other comprehensive income
Exchange-rate differences -2,376 1,060 1,354 3,423 3,857
Comprehensive income for the period 84,020 36,059 448,002 45,909 59,410

1) All attributable to parent company shareholders.

Earnings per share based on earnings attributable to parent company shareholders for the year (in SEK per share)

Note 2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Earnings per share before dilution, SEK 1.56 0.63 8.05 0.77 1.01
Earnings per share after dilution, SEK 1.50 0.61 7.77 0.74 0.97

For more information about calculation of earnings per share, see Note 5.

Presently, the company has four long-term share-based incentive programs active.

For further information see page 16 Camurus' share, and Note 2.3.

Consolidated balance sheet

KSEK
Note
30-09-2023 30-09-2022 31-12-2022
ASSETS
Fixed assets
Intangible assets
Capitalized development expenditure 23,195 24,043 23,597
Tangible assets
Lease assets 24,712 24,749 25,612
Equipment 14,218 9,585 9,270
Financial assets
Deferred tax receivables
9
213,651 328,709 324,667
Other long-term receivables 1,334 6,983 6,997
Total fixed assets 277,110 394,069 390,143
Current assets
Inventories
Finished goods and goods for resale 67,577 85,384 77,188
Raw materials 36,518 32,009 30,243
Total inventories 104,095 117,393 107,431
Current receivables
Trade receivables 257,495 169,338 196,863
Other receivables 21,347 19,073 21,782
Prepayments and accrued income 27,764 14,141 23,730
Total current receivables
6
306,606 202,552 242,375
Cash and cash equivalents 1,153,854 519,541 565,539
Total current assets 1,564,555 839,486 915,345
TOTAL ASSETS 1,841,665 1,233,555 1,305,488
KSEK
Note
30-09-2023 30-09-2022 31-12-2022
EQUITY AND LIABILITIES
EQUITY
Equity attributable to
parent company shareholders
Share capital 1,389 1,385 1,386
Other contributed capital 2,019,372 1,961,010 1,973,733
Retained earnings, including
comprehensive income for the period -532,446 -993,949 -980,448
Total equity
10
1,488,315 968,446 994,671
LIABILITIES
Long-term liabilities
Lease liablities 14,836 17,360 16,643
Social security fees employee stock options program 28,894 9,802 12,532
Total long-term liabilities 43,730 27,162 29,175
Short-term liabilities
Trade payables 74,565 46,467 85,548
Lease liabilities 10,456 7,772 9,574
Income taxes 9,092 5,883 9,018
Other liabilities 35,208 39,714 25,697
Accrued expenses and deferred income 180,299 138,111 151,805
Total short-term liabilities
6
309,620 237,947 281,642
TOTAL EQUITY AND LIABILITIES 1,841,665 1,233,555 1,305,488

Consolidated statement of changes in equity

KSEK Note Share
capital
Other
contri
buted
capital
Retained
earnings,
including
compr.
income for
the period
Total
equity
Opening balance 1 January, 2022 1,371 1,887,395 -1,039,858 848,908
Comprehensive income for the period 45,909 45,909
Transactions with shareholders
Exercise of warrants 14 54,862 54,876
Employee stock options program 18,805 18,805
Issuance costs, net after deferred tax -51 -51
Closing balance 30 September, 2022 1,385 1,961,010 -993,949 968,446
Opening balance 1 January, 2022 1,371 1,887,395 -1,039,858 848,908
Comprehensive income for the period 59,410 59,410
Transactions with shareholders
Exercise of warrants 15 58,777 58,792
Employee stock options program 27,799 27,799
Issuance costs, net after deferred tax -238 -238
Closing balance 31 December, 2022 1,386 1,973,733 -980,448 994,671
Opening balance 1 January, 2023 1,386 1,973,733 -980,448 994,671
Comprehensive income for the period 448,002 448,002
Transactions with shareholders
Exercise of warrants 3 19,621 19,624
Employee stock options program 26,731 26,731
Issuance costs, net after deferred tax -713 -713
Closing balance 30 September, 2023 10 1,389 2,019,372 -532,446 1,488,315

Consolidated statement of cash flow

KSEK
Note
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Operating activities
Operating profit/loss before financial items 104,047 41,371 554,442 53,077 71,956
Adjustments for non-cash items
8
16,884 13,452 55,755 40,957 52,248
Interest received 6,130 472 13,878 567 2,695
Interest paid -326 -331 -986 -1,012 -1,526
Income taxes paid -5,548 -153 -9,502 -6,265 -6,535
Cashflow from operating activities before change 121,187 54,811 613,587 87,324 118,838
in working capital
Increase/decrease in inventories 2,265 5,508 3,176 -9,216 374
Increase/decrease in trade receivables 29,581 -17,150 -61,110 -30,372 -58,497
Increase/decrease in other current receivables 368,664 -1,019 -1,556 -7,362 -19,200
Increase/decrease in trade payables -6,171 6,235 -11,286 -6,729 32,118
Increase/decrease in other current operating liabilities -29,830 5,619 34,057 22,450 27,566
Cash flow from changes in working capital 364,509 -807 -36,719 -31,229 -17,639
Cash flow from operating activities 485,696 54,004 576,868 56,095 101,199
Investing activities
Acquisition/divestiture of intangible assets 7,287 -937 7,287 7,287
Acquisition of tangible assets -1,352 -172 -6,805 -1,604 -1,905
Cash flow from investing activities -1,352 7,115 -7,742 5,683 5,382
Financing activities
Amortization of lease liabilities -2,391 -1,953 -6,921 -5,309 -7,786
Share issue after issuance costs 13,065 36,829 18,729 54,811 58,492
Other long-term receivables 6,253 -6,248 5,663 -6,987 -7,001
Cash flow from financing activities 16,927 28,628 17,471 42,515 43,705
Net cash flow for the period 501,271 89,747 586,597 104,293 150,286
Cash and cash equivalents at beginning of the period 654,090 428,132 565,539 411,575 411,575
Translation difference in cash flow and liquid assets -1,507 1,662 1,718 3,673 3,678
Cash and cash equivalents at end of the period 1,153,854 519,541 1,153,854 519,541 565,539

Income statement – Parent company

KSEK
Note
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Total revenue 371,916 222,397 1,292,472 654,048 898,417
Cost of goods sold -36,636 -21,811 -91,826 -78,845 -99,250
Gross profit 335,280 200,586 1,200,646 575,203 799,167
Marketing and distribution costs
Administrative expenses
-84,824
-10,633
-61,697
-10,648
-233,554
-32,663
-181,488
-26,297
-242,700
-35,706
Research and development costs -146,643 -105,742 -404,591 -334,813 -468,515
Other operating income 4,169 15,326 3,979 13,756 14,248
Other operating expenses -6,927 -6,415
Operating result 97,349 37,825 533,817 39,434 60,079
Interest income and similar items
Interest expense and similar items
6,055
-191
460
-2
13,750
-266
555
-33
2,657
-227
Result after financial items 103,213 38,283 547,301 39,956 62,509
Result before tax 103,213 38,283 547,301 39,956 62,509
Tax on result for the period -21,525 -8,184 -113,649 -8,960 -14,038
Result for the period 81,688 30,099 433,652 30,996 48,471

Total comprehensive income is the same as result for the period, as the parent company contains no items that are recognized under other comprehensive income.

Balance sheet – Parent company

KSEK
Note
30-09-2023 30-09-2022 31-12-2022
ASSETS
Fixed assets
Tangible assets
Equipment 14,134 9,483 9,167
Financial assets
Interests in group companies 22,271 11,762 14,388
Deferred tax assets 212,932 331,433 326,404
Other financial assets 1,336 6,991 6,991
Total fixed assets 250,673 359,669 356,950
Current assets
Inventories
Finished goods and goods for resale 49,648– 69,412 66,118
Raw materials 36,518 32,009 30,243
Total inventories 86,166 101,421 96,361
Current receivables
Receivables subsidiaries 29,458 13,380
Trade receivables 226,551 135,125 157,310
Other receivables 9,813 9,807 9,245
Prepayments and accrued income 27,148 14,601 22,915
Total current receivables 263,512 188,991 202,850
Cash and bank deposit 1,056,601 425,997 495,212
Total current assets 1,406,279 716,409 794,423
TOTAL ASSETS 1,656,952 1,076,078 1,151,373
KSEK
Note
30-09-2023 30-09-2022 31-12-2022
EQUITY AND LIABILITIES
EQUITY
Restricted equity
Share capital (55,538,818 shares) 1,389 1,385 1,386
Statutory reserve 11,327 11,327 11,327
Total restricted equity 12,716 12,712 12,713
Unrestricted equity
Retained earnings -1,038,836 -1,087,307 -1,087,307
Share premium reserve 1,985,758 1,927,396 1,940,119
Result for the period 433,652 30,996 48,471
Total unrestricted equity 1,380,574 871,085 901,283
Total equity
10
1,393,290 883,797 913,996
LIABILITIES
Untaxed reserves
Depreciation/amortization in excess of plan 3,486 3,486 3,486
Total untaxed reserves 3,486 3,486 3,486
Long-term liabilities
Liabilities to subsidiaries 572 572 572
Social security fees employee stock options program 23,730 8,168 10,256
Total long-term liabilities 24,302 8,740 10,828
Short-term liabilities
Liabilities to subsidiaries 15,948
Trade payables 70,336 37,923 71,234
Other liabilities 28,779 23,064 19,192
Accrued expenses and deferred income 120,811 119,068 132,637
Total short-term liabilities 235,874 180,055 223,063
TOTAL EQUITY AND LIABILITIES 1,656,952 1,076,078 1,151,373

Key figures and definitions

Key figures, MSEK 2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Total revenue 384 241 1,342 688 956
Operating expenses -253 -184 -703 -567 -789
Operating result 104 41 554 53 72
Result for the period 86 35 447 42 56
Cash flow from operating activities 486 54 577 56 101
Cash and cash equivalents 1,154 520 1,154 520 566
Equity 1,488 968 1,488 968 995
Equity ratio in group, percent 81% 79% 81% 79% 76%
Total assets 1,842 1,234 1,842 1,234 1,305
Weighted average number of shares, before dilution 55,487,991 55,331,648 55,449,931 54,959,218 55,067,400
Weighted average number of shares, after dilution 57,494,766 57,663,176 57,504,931 57,032,020 57,170,617
Earnings per share before dilution, SEK 1.56 0.63 8.05 0.77 1.01
Earnings per share after dilution, SEK 1.50 0.61 7.77 0.74 0.97
Equity per share before dilution, SEK 26.82 17.50 26.84 17.62 18.06
Equity per share after dilution, SEK 25.89 16.79 25.88 16.98 17.40
Number of employees at end of period 204 170 204 170 176
Number of employees in R&D at end of period 104 93 104 93 95
R&D costs as a percentage of operating expenses 58% 58% 58% 60% 61%

Cash and cash equivalents Cash and cash bank balances

Equity ratio, percent Equity divided by total capital

Weighted average number of shares, before dilution Weighted average number of shares before adjustment for dilution effect of new shares

Weighted average number of shares, after dilution Weighted average number of shares adjusted for the dilution effect of new shares

Earnings per share before dilution, SEK

Result divided by the weighted average number of shares outstanding before dilution

Earnings per share after dilution, SEK

Result divided by the weighted average number of shares outstanding after dilution

Equity per share before dilution, SEK

Equity divided by the weighted number of shares at the end of period before dilution

Equity per share after dilution, SEK

Equity divided by the weighted number of shares at the end of the period after dilution

R&D costs as a percentage of operating expenses

Research and development costs divided by operating expenses (marketing and distribution costs, administrative expenses and research and development costs), excluding items affecting comparability

Note 1 General information

Camurus AB, corp. ID No. 556667-9105 is the parent company of the Camurus group and has its registered office based in Lund, Sweden, at Ideon Science Park, 223 70 Lund. Camurus AB group's interim report for the third quarter 2023 has been approved for publication by the Board of Directors and the Chief Executive Officer.

All amounts are stated in SEK thousands (KSEK), unless otherwise indicated. Figures in brackets refer to the year-earlier period.

Note 2 Summary of key accounting policies

The consolidated financial statements for the Camurus AB group ("Camurus") have been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the EU, as well as the Swedish Financial Reporting Board's Recommendation RFR 1 Supplementary Accounting Rules for groups, and the Swedish Annual Account Act.

This interim report has been drawn up in accordance with IAS 34, Interim Financial Reporting, the Swedish Annual Accounts Act and RFR 1 Supplementary Accounting Rules for groups.

The parent company statements have been prepared in accordance with the Annual Accounts Act and recommendation RFR 2 Accounting for legal entities from the Swedish Financial Reporting Board. The application of RFR 2 means that the parent company in the interim report for the legal entity shall apply all EU-approved IFRS standards and statements as far as possible within the framework of the Annual Accounts Act, the Pension Obligations Vesting Act (Tryggandelagen) and taking into consideration the relationship between accounting and taxation. The parent company's accounting policies are the same as for the group, unless otherwise stated in Note 2.2.

The most important accounting policies that are applied in the preparation of these consolidated financial statements are detailed below and are the same and consistent with those used in the preparation of the Annual Report 2022, see www.camurus.com/investors/financial-reports.

2.1 BASIS OF PREPARATION OF REPORTS

2.1.1 Changes to accounting policies and disclosures

No new or revised IFRS standards, with any material impact on the group, have come into force.

2.1.2 Derivatives

Derivatives are reported in the balance sheet on the transaction day and are valued at fair value, both initially and in subsequent revaluations at the end of each reporting period. The group does not apply hedge accounting and all changes in the fair value of derivative instruments are reported directly in the income statement as Other operating income or Other operating expenses. Derivatives are reported in the balance sheet as Other receivables and Other liabilities.

2.2 PARENT COMPANY'S ACCOUNTING POLICIES

The parent company applies accounting policies that differ from those of the group in the cases stated below.

2.2.1 Internally generated intangible assets

All expenses that relate to the development of internally generated intangible assets are recognized as expenses as they arise.

2.2.2 Interests in subsidiaries

Interests in subsidiaries are reported at cost, less any impairment losses. The cost includes acquisition-related expenses and any additional considerations. When there is an indication that interests in subsidiaries have decreased in value, a calculation is made of the recoverable amount. If this amount is lower than the reported amount, an impairment is carried out. Impairment losses are recognized under the item "Result from interest in group companies".

2.2.3 Group contributions

Group contributions paid by the parent company to subsidiaries and group contributions received from subsidiaries by the parent company are recognized as appropriations.

2.2.4 Financial instruments

IFRS 9 "Financial instruments" addresses the classification, measurement and recognition of financial assets and liabilities and is applied with the exceptions that RFR 2 allows, i.e. at amortized cost.

Derivatives with a negative fair value are reported in the balance sheet as Other liabilities and changes in the fair value of derivative instruments are reported directly in the income statement on the line Other operating income or Other operating expenses. Derivatives with a positive fair value are reported at the lower of acquisition value and fair value.

2.3 SHARE-BASED PAYMENTS

2.3.1 Subscription warrant program

Camurus has one subscription warrant program (TO) active for the company's employees. The program was adopted by the Annual General Meeting (AGM) in 2020.

The warrants are valued by an independent institute in accordance with Black & Scholes model and are acquired by the participants at market value.

As part of the program, the participants receive a threepiece stay-on bonus from the company in form of gross salary additions equivalent to the amount paid by the participant for the subscription warrants. The stay-on bonus is conditional on continued employment. Costs including social security fee, are based on how much has been earned, and are expensed over the vesting period. Expenses are recognized as personnel cost in the income statement.

2.3.2 Employee stock options programs

Camurus has three Employee Stock Options Programs (ESOP) active for the company´s employees. The programs were adopted by the Annual General Meeting (AGM) in 2021, 2022 and 2023.

The options are granted free of charge and have a term approximately between three and four years from the grant date. Once vested, the options can be exercised during the exercise period provided that the participant is still employed. Each vested option gives the holder the right to acquire one share in Camurus at a pre-defined price corresponding to 125 or 130 percent of the volume-weighted average price for the company's share on Nasdaq Stockholm during the ten trading days immediately following the respective company's AGM in which the program was adopted.

The ESOP 2021/2024 program comprises a maximum of 1,215,500 employee stock options, ESOP 2022/2026 a maximum of 1,000,000 employee stock options and the ESOP 2023/2026 program comprises a maximum of 200,000 employee stock options.

The fair value of the service that entitles to the allotment of options through the program is reported as a personnel cost with a corresponding increase in equity. The total amount to be expensed is based on the fair value of the employee stock options granted, including the share target price, and that the employee remains in the company's service during the exercise period. The total cost is reported over the vesting period. At the end of each reporting period, the company reconsiders its assessment of how many options are expected to be exercised and the difference is reported in the income statement and a corresponding adjustment is made in equity. As a basis for allocating social security contributions, a revaluation of fair value is continuously made for the employee stock options earned at the end of each reporting period. Social security contributions are reported as personnel costs and the corresponding provision is made under long- or short-term liabilities depending on the remaining term.

In total 1,860,066 employee options have been granted since programs launch, of which 102,000 to the CEO and 351,500 to other senior executives.

2.3.3 Calculation of fair value of employee stock options programs

The fair value of the options when implementing the program have been calculated using Black & Scholes' valuation model, which takes into account the exercise price, the term of the option, the share price on the allotment date and the expected volatility in the share price and risk-free interest for the option.

For further information about the programs, see the minutes from the 2021, 2022, and 2023 Annual General Meetings published on the company's website, www.camurus.com/investors/ corporategovernance/general-meetings.

2.3.4 Summary of ongoing incentive programs (number of shares)

Full exercise of allotted warrants and employee stock options as of 30 September, 2023 corresponds to a total of 1,944,866 shares and would result in a dilution of shareholders with 3.50 percent, for more information see the below summary.

If decided, but not yet granted employee options are fully exercised, a further total of 180,000, the total dilution of shareholders would increase to 3.83 percent.

Program Number
of shares
subscribed
warrants
entitles to
Potential
dilution
of the
subscribed
warrants
Subscription
period
Strike price
in SEK for
subscription
of shares
upon
exercise
Market value2) Number of
employees
participating
in the
program
TO 2020/2023 84,8001) 0.15%1) 15 May, 2023-
15 Dec, 2023
169.50 17 Aug, 2020: SEK 44.70
14 Dec, 2020: SEK 50.70
10 Mar, 2021: SEK 75.50
40
ESOP 2021/2024 928,9001) 1.67%1) 1 Jun, 2024-
16 Dec, 2024
263.50 10 Jun, 2021: SEK 61.18 116
ESOP 2022/2026 911,1661) 1.64%1) 1 Jun, 2025-
1 Mar, 2026
237.40 1 Jun, 2022: SEK 59.45 148
ESOP 2023/2026 20,000 0.04% 1 Jun, 2026-
31 Dec, 2026
346.30 1 Jun, 2023: SEK 79.75 1
Totalt 1,944,866 3.50%

1) No further allocation can be made.

2) Market valuation in accordance with Black & Scholes model. Data used in the valuation are volatility in the share, dilution effect, subscription price at exercise, interest rate and the term for the warrants.

Change in existing incentive programs Number of shares granted
instruments may entitle to
1 January, 2023 2,125,141
Change during the January-June period 2023
Returned instruments
Incentive Program 2021/2024 -34,000
Incentive Program 2022/2026 -35,500
Exercised instruments
TO 2020/2023 -35,450
Granted instruments
Incentive Program 2023/2026 20,000
Total change -84,950
Number of shares granted instruments may
entitle to as of 30 June, 2023
2,040,191
Change during the third quarter 2023
Returned instruments
Incentive Program 2021/2024 -4,500
Incentive Program 2022/2026 -10,500
Exercised instruments
TO 2020/2023 -80,325
Granted instruments
Incentive Program 2023/2026
Total change -95,325
Number of shares granted instruments may 1,944,866
entitle to as of 30 September, 2023

Note 3 Significant risks and uncertainties

The company management makes estimates and assumptions about the future. Such estimates can deviate considerably from the actual outcome, since they are based on various assumptions and experiences.

The estimates and assumptions that may lead to the risk of significant adjustments to reported amounts for assets and liabilities relate mainly to measurement and allocation of revenues and costs in connection with licensing agreements and deferred tax receivables. Risks in ongoing development projects comprise technical and manufacturing related risks (including products failing to meet set specifications post manufacturing), safety and effect-related risks that can arise in clinical trials, regulatory risks relating to non-approval or delays of clinical trial applications and market approvals, and commercial risks relating to the sale of proprietary and competing products and their development on the market, as well as IP risks relating to approval of patent applications and patent protection. In addition, there are risks relating to the development, strategy and management decisions of Camurus' partners. There is also a risk that differences of opinion will arise between Camurus and its partners or that such partners do not meet their contractual commitments.

Camurus pursues operations and its business on the international market and the company is therefore exposed to currency risks, since revenues and costs arise in different currencies, mainly AUD, EUR, GBP, NOK, SEK, and USD.

The group reports a deferred tax asset of MSEK 213.7 as of 30 September, 2023. The deferred tax asset is calculated on the basis that Camurus AB's entire losses carried forward will be utilized against taxable surpluses in the future. The basic circumstance leading the company to make this assessment is that the company, for the development of new drug candidates, utilizes its own proprietary and regulatory validated long-acting FluidCrystal® injection depot. By combining this technology with already existing active drug substances whose efficacy and safety profile previously has been documented, new proprietary drugs with improved properties and treatment results can be developed in shorter time, at a lower cost and risk compared to the development of completely new drugs.

Accounting for deferred tax assets according to IFRS requires that it is probable that taxable surpluses will be generated in the future which the losses carried forward can be used against. In addition, a company that has reported losses in recent periods must be able to demonstrate convincing factors that taxable profits will be generated. The progress made in the commercialization of CAM2038 plus the development of CAM2029 at the time the company reached its first profitable year in 2022 is what convincingly suggests that the company will be able to utilize its losses carried forward.

Future revenues will mainly be generated from Camurus' own sales organization in markets where Camurus has own commercialization capabilities, and through partnerships for markets where Camurus has outlicensed FluidCrystal and/or product candidates or products, such as Buvidal.

Losses carried forward are only reported in Sweden and without any due dates based on current tax legislation in Sweden.

A more detailed description of the group's risk exposure is included in Camurus Annual Report 2022 (The Director's Report).

The Board of Directors has not changed its outlook about future risk and uncertainties development in relation to their outlook published in the Annual Report 2022.

Note 4 Segment information

The highest executive decision maker is the function responsible for allocating resources and assessing the operating segments results. In the group this function is identified as the CEO based on the information he manages. As the operations in the group, i.e. the development of pharmaceutical products based on Camurus' technology platform, is organized as an integrated unit, with similar risks and opportunities for the products and services produced, the entire group's business constitutes one operating segment. The operating segment is monitored in a manner consistent with the internal reporting provided to the chief operating decision maker. In the internal reporting to the CEO, only one segment is used.

Group-wide information

To follow is a breakdown of revenues from all products and services.

Revenues allocated by
products and services
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Sales of development related
goods and services 380 856 1,761 11,573 12,439
Licensing revenues and
milestone payments 36,428 406,120 8,920 8,920
Royalties 1,180 6 1,185 6 7
Product sale1) 345,997 240,500 933,218 667,826 934,974
Total 383,985 241,362 1,342,284 688,325 956,340
1) Related to Buvidal and episil.
Revenues allocated by
geographical area
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Europe 218,182 148,129 592,007 391,823 545,297
(whereof Sweden) (18,701) (15,450) (60,074) (44,113) (68,250)
North America 37,695 194 406,944 20,089 20,720
Asia including Oceania 128,108 93,039 343,333 276,413 390,323
Total 383,985 241,362 1,342,284 688,325 956,340

Revenues during the quarter of approximately MSEK 113.2 (91.8) relate to one single external customer.

99.9 (99.8) percent of the group's fixed assets are located in Sweden.

Note 5 Earnings per share

a) Before dilution

Earnings per share before dilution is calculated by dividing the result attributable to shareholders of the parent company by a weighted average number of ordinary shares outstanding during the period. During the period, no shares held as treasury shares by the parent company have been repurchased.

b) After dilution

In order to calculate earnings per share after dilution, the number of existing ordinary shares is adjusted for the dilutive effect of the weighted average number of outstanding ordinary shares. The parent company has one category of ordinary shares with anticipated dilution effect in the form of warrants and options. For this category, a calculation is made of the number of shares that could have been purchased at fair value (calculated as the average market price for the year for the parent company's shares), at an amount corresponding to the monetary value of the subscription rights linked to outstanding warrants and options. The number of shares calculated as above are compared to the number of shares that would have been issued assuming the warrants and options are exercised.

2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Result attributable to
parent company
shareholders
Weighted average number
of ordinary shares
outstanding (thousands)
86,396
55,488
34,999
55,332
446,648
55,450
42,486
54,959
55,553
55,067
2023
Jul-Sep
2022
Jul-Sep
2023
Jan-Sep
2022
Jan-Sep
2022
Jan-Dec
Result attributable to
parent company
shareholders
Weighted average number
86,396 34,999 446,648 42,486 55,553
of ordinary shares
outstanding (thousands)
55,488 55,332 55,450 54,959 55,067
Adjustment for warrants
and options (thousands)
2,007 2,332 2,055 2,073 2,103
Weighted average number
of ordinary shares used in
calculation of earnings per
share after dilution
(thousands)
57,495 57,663 57,505 57,032 57,171

Note 6 Financial instruments – Fair value of financial assets and liabilities

All of the group's financial instruments that are measured at amortized cost are short-term and expire within one year. The fair value of these instruments is deemed to correspond to their reported amounts, since discounting effects are minimal.

Financial assets and liabilities in the group that are reported at fair value consist of derivatives (currency futures). All derivatives are included in level 2 when valuing at fair value, which means that fair value is determined using valuation techniques that are based on market information as much as possible, while company-specific information is used as little as possible. All significant input data required for the fair value measurement of an instrument is observable. The fair value of forward exchange contracts is determined as the present value of future cash flows based on exchange rates for forward exchange contracts on the balance sheet date.

Balance sheet assets, KSEK 30-09-2023 30-09-2022 31-12-2022
Trade receivables 257,495 169,338 196,863
Derivatives - currency futures (part of Other receivables) 1,368
Cash and cash equivalents 1,153,854 519,541 565,539
Total 1,412,717 688,879 762,402
Balance sheet liabilities, KSEK 30-09-2023 30-09-2022 31-12-2022
Trade payables 74,565 46,467 85,548
Derivatives - currency forwards (part of Other liabilities) 3,934 4,195
Other liabilities 190 190 190
Total 78,689 50,852 85,738

Note 7 Related party transaction

There were no related party transactions outside of the Camurus group during the period. No receivables or liabilities existed as of 30 September, 2023.

Note 8 Information on cash flow

Adjustment for non-cash items:

KSEK 2023 2022 2023 2022 2022
Jul-Sep Jul-Sep Jan-Sep Jan-Sep Jan-Dec
Depreciation 3,478 2,910 10,096 9,174 12,936
Derivatives - currency futures -4,428 -3,234 2,566 4,195
Employee stock options 17,834 13,776 43,093 27,588 39,312
Total 16,884 13,452 55,755 40,957 52,248

Note 9 Tax

Tax for the quarter amounted to MSEK -23.4 (-6.5), an income tax driven by the positive result.

This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the Chief Executive Officer, 07.00 am (CET) on 9 November, 2023.

Note 10 Equity

The change in equity during the quarter is mainly attributable to the result during the period and second window of program TO2020/2023 which led to the issuance of 80,325 new shares.

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