Annual Report (ESEF) • Mar 10, 2022
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Download Source File“2021 marked Immunovia’s transition to a commercial business and another step in realizing our vision of revolutionizing blood-based diagnostics to enable increased cancer survival rates.”
Important Events During 2021 ........................................................... 4
This is Immunovia ................................................................................ 6
CEO Statement ................................................................................... 8
Market Overview ...............................................................................10
Share information .............................................................................. 20
Sustainability Report ........................................................................ 22
Auditor’s Statement on the Sustainability Report ....................... 29
Corporate Governance Report ........................................................30
The Auditor’s Examination of the Corporate Governance Statement ..................................................................... 44
Statutory Administration Report ..................................................... 45
Financial Statements ........................................................................ 48
Group Key Indicators ........................................................................ 49
Consolidated Income Statement .................................................... 50
Consolidated Statement of Comprehensive Income ...................50
Comments on the Income Statement ............................................ 50
Consolidated Balance Sheet ............................................................. 51
Comments on the Balance Sheet .................................................... 52
Consolidated Statement of Changes in Equity ............................. 52
Consolidated Cash Flow Statement ............................................... 53
Comments on the Cash Flow Statement ........................................ 53
Parent Company Income Statement ............................................... 54
Parent Company Statement of Comprehensive Income ............. 54
Parent Company Balance Sheet ......................................................55
Parent Company Statement of Changes in Equity .......................56
Parent Company Cash Flow Statement ......................................... 57
Notes .................................................................................................. 58
Board of Directors’ and Chief Executive Officer’s Certification ........................................................................................ 77
Audit Report ....................................................................................... 78
Definitions .......................................................................................... 82
Glossary ............................................................................................. 83
Shareholder information .................................................................. 85
About the report
• This information was submitted for publication March 10, 2022
• This Annual Report comprise Immunovia AB and the wholly owned subsidiaries Immunovia Inc, Immunovia GmbH, Immunovia Dx Laboratories and Immunovia Incentive AB.
Contact
Immunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund • +46 (0) 46-2756 000 • [email protected]
4 ANNUAL REPORT 2021 IMMUNOVIA EARLY DETECTION
First sales of Immunovia’s IMMray TM PanCan-d in the United States. People at high risk of developing pancreatic cancer can now receive a blood test specifically designed for the early detection of this deadly disease. The first sales of IMMray™ PanCan-d in August 2021 also marked an important transition for Immunovia from a development company to commercial business.
Immunovia reported data from a blinded validation study of IMMray TM PanCan-d. The study data demonstrated that the IMMray™ PanCan-d biomarker signature and CA 19-9 detected early stage I–II pancreatic cancers with a test specificity of 99 percent and a sensitivity of 87 percent versus familial/hereditary controls and healthy controls. All stages of pancreatic ductal adenocarcinoma (PDAC) were detected with a specificity of 99 percent and a sensitivity of 94 percent against familial/hereditary controls and healthy controls.
Immunovia Inc, Immunovia’s US subsidiary, received a clinical laboratory licensure from the Massachusetts Department of Public Health. This important milestone in August 2021 paved the way for Immunovia, Inc. to start sales of IMMray® PanCan-d as a Laboratory Developed Test in the United States.
IMMray TM PanCan-d received extensive support from key opinion leaders and pancreatic cancer patient groups. The US Pancreatic Cancer Action Network informed its membership of more than one million people of IMMray® PanCan-d’s availability as the first-ever blood test for high-risk individuals. Immunovia worked with the US National Cancer Institute, Let’s Win, the Lustgarten Foundation, ONCORE, PanSiam, Pancreatic Cancer Canada, and the Pancreatic Cancer Alliance. Thomas King, MD PhD, Immunovia, Inc.’s Medical Director, was a key speaker at the US National Cancer Institute Pancreatic Cancer Detection Consortium Steering Committee.
| 2007 - 2013 | 2015 | 2017 | 2016 |
|---|---|---|---|
| Immunovia founded in Lund, Sweden | First studies | First clinical studies published | Immunovia Inc, established in USA |
| Immunovia signs letter of intent with US National Cancer Institute |
5 ANNUAL REPORT 2021 IMMUNOVIA EARLY DETECTION
| Full year 2021 | Full year 2020 | Full year 2019 | Full year 2018 | |
|---|---|---|---|---|
| Net sales | 877 | 356 | 333 | 275 |
| Operating earnings | -1,855,928 | -1,376,376 | -1,447,278 | -829,709 |
| Earnings before tax | -1,559,988 | -1,475,366 | -1,447,547 | -855,534 |
| Net earnings | -1,559,988 | -1,475,366 | -1,447,547 | -855,534 |
| Earnings per share before dilution (SEK) | -9.87 | -9.87 | -5.88 | -7.57 |
| Earnings per share before after dilution (SEK) | -9.87 | -9.87 | -5.88 | -7.57 |
| Equity ratio (%) | 77 | 74 | 75 | 76 |
| Number of shares at the end of the period | 22,954,584 | 22,954,584 | 40,855,285 | 40,561,635 |
6 ANNUAL REPORT 2021 IMMUNOVIA EARLY DETECTION
Addressable market in the US for early detection of pancreatic cancer in risk groups
Immunovia’s vision is to revolutionize blood-based diagnostics and increase survival rates for patients with cancer. Immunovia has launched the world’s first blood test dedicated to the early detection of pancreatic cancer. By developing and commercializing non-invasive blood tests, Immunovia aims to allow for more patients to receive a timely cancer diagnosis. Immunovia’s initial area of focus is pancreatic cancer in high-risk individuals.
First commercially available blood test for pancreatic cancer. The first test that Immunovia has commercialized is IMMray® PanCan-d. This is the first time patients with hereditary and familial risk of pancreatic cancer have been given the opportunity to get continued surveillance using a simple blood test.
Pancreatic cancer is the third deadliest form of cancer and because of its non-specific symptoms, most patients receive their pancreatic cancer diagnosis too late when surgery is not an option. Early detection of pancreatic cancer is therefore crucial for increasing the survival rate of this patient group. When found at an early stage, the five-year survival rate for patients with pancreatic cancer increases tenfold.
While other diagnostic methods are expensive, invasive and require healthcare personnel with specialist knowledge, Immunovia’s cost-effective and non-invasive blood test means more high-risk individuals can benefit from continued surveillance.
US target market. Immunovia is now selling IMMray® PanCan-d in the US, the world’s largest market for non-invasive cancer tests. Using its own sales organization, Immunovia is targeting the leading university hospitals, established surveillance programs and national centers for pancreatic diseases, other large hospitals and healthcare facilities, as well as local hospitals. The addressable market in the US for the early detection of pancreatic cancer in risk groups is US$ 4 billion. Immunovia has a long-term goal of achieving a market share of 20 percent once reimbursement has been achieved.# Laboratory Developed Test
Immunovia markets the test exclusively through its subsidiary Immunovia, Inc., which has its CLIA-certified laboratory located in Marlborough, Massachusetts. The test is initially available for out-of-pocket purchases until sales with reimbursement start. In addition, Immunovia plans to expand the availability of IMMray™ PanCancer-d to other markets globally.
30% $ 4 Billion This is Immunovia
IMMUNOVIA
ANNUAL REPORT 2021
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Core competency in biomarker study design.
Immunovia’s expertise is in the identification of broad-based biomarker signatures used to develop tests to detect cancers with a significant medical need. Through its extensive experience in the design and analysis of clinical studies, Immunovia is able to translate broad-based biomarker discoveries into diagnostic assays for use in laboratories.
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2021 was a breakthrough year for Immunovia as Immunovia launched its IMMray™ PanCan-d test in the US. This marked Immunovia’s transition to a commercial business and a significant milestone in realizing our vision of revolutionizing blood-based diagnostics to enable increased cancer survival rates.
The commercial launch of IMMray™ Pan-Can-d in the US in August 2021 was a major milestone in Immunovia’s mission to change the testing paradigm and increase the survival rates for pancreatic cancer patients. In targeting pancreatic cancer, which is expected to become the second leading cause of cancer-related deaths by 2030 in the US, Immunovia is the front-runner in addressing a huge and increasing unmet medical need. With a global 5-year survival rate today of only 5%, pancreatic cancer is today the third deadliest form of cancer, taking more lives than e.g., breast cancer, prostate cancer, and leukemia. Early detection as provided by Immunovia has the potential to increase the five-year survival rate with up to 75%.
Through 2021, we initiated the build-up of Immunovia’s salesforce in the US to pave the way for the successful launch of IMMray™ PanCancer-d. The initial focus of our sales efforts has been existing surveillance centers, National Pancreatic Foundation Centers and working with patient advocacy groups such as the US Pancreatic Cancer Action Network.
IMMray™ PanCancer-d was launched at a list price of USD 995, initially for out-of-pocket purchase until reimbursement is available. We expect the volume of tests to significantly increase once insurance coverage is available, with the ambition to have initial coverage in place towards the end of 2025. Until then we see self-pay tests to continue at moderate volumes, which are no indication for the full potential of IMMray™ PanCancer-d, as seen with comparable diagnostic tests prior to reimbursement in the US.
Another important event in 2021 was the CLIA certification of Immunovia, Inc.’s laboratory by the Massachusetts Department of Public Health. IMMray™ PanCancer-d is a Laboratory Developed Test and this certification was a prerequisite for commercialization of our test.
The start of sales for IMMray™ PanCancer has been enabled by the dedication and industry-leading competence of our teams both in the US and Sweden.
for IMMray™ PanCancer-d in the US will enable an increasing population of patients with a family history of pancreatic cancer in the US to get insurance coverage for testing. During 2021 Immunovia has further refined its reimbursement plan in collaboration with Precision for Medicine Inc., a team of leading experts in the field of diagnostic reimbursement in the US. Through our extensive payer surveys and targeted research publications we feel confident about Immunovia’s ability to achieve positive reimbursement coverage decisions.
In March 2021, Immunovia reported results from a blinded validation study of IMMray™ PanCancer-d in individuals with a high familial or hereditary risk of developing pancreatic cancer. These results confirmed the revolutionary role that IMMray™ PanCancer-d can play in the early detection of pancreatic cancer in high-risk individuals and in improving patient treatment outcomes.
These results also demonstrated the differentiating of Immunovia’s IMMray™ PanCancer-d offering versus potential competition. IMMray™ PanCancer-d is the only blood test available specifically for the early detection of pancreatic cancer with unmatched performance characteristics.
The test has been very positively received by early adopters amongst both doctors and patients in the US, who see it as a highly needed addition to the diagnostic tool set for pancreatic cancer.
In September 2021, the US Pancreatic Cancer Action Network distributed information about IMMray™ PanCancer-d directly to its members and through its social media channels. We have also worked with other leading pancreatic cancer organizations including Lets Win, the Lustgarten Foundation, PO CURE, Pancreatic Cancer Canada, and the Pancreatic Cancer Alliance. In addition, Immunovia, Inc.’s Medical Director Dr. Thomas King was a keynote speaker at the National Cancer Institute’s Pancreatic Cancer Detection Consortium Steering Committee Meeting in December of 2021.
A number of Key Opinion Leader events were also held throughout the year. These provided us with the opportunity to continuously increase awareness for IMMray™ PanCancer-d as well as hear from leading pancreatic cancer specialists about the benefits of IMMray™ PanCancer-d as a tool for early detection.
2021 continued to present challenges for all parts of society as a result of the continued COVID-19 pandemic and Immunovia was not immune. In particular, it impacted the roll-out of IMMray™ PanCancer-d sales due to restrictions on visits to collect blood and the willingness of patients to visit healthcare facilities.
In summary, today Immunovia is well positioned as the frontrunner in the early detection of pancreatic cancer, and I very much look forward to working with Immunovia’s employees and its Board as well as our community including Key Opinion Leaders to make IMMray™ PanCancer-d broadly available. The company’s mission of increasing the survival rates for this lethal cancer are a highly motivating and driving force for all of us.
I also want to thank our shareholders for their trust as well as continued support.
March 2022
Philipp Mathieu
Acting CEO & President, Immunovia AB
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ANNUAL REPORT 2021
IMMUNOVIA
Pancreatic cancer is one of the deadliest forms of cancer. When diagnosed at an early stage, the five-year survival rate increases tenfold. Early detection of pancreatic cancer is critical. Pancreatic cancer is difficult to detect at an early stage when surgical treatment is still an option. Patients usually have no symptoms until the tumor has become very large or has already spread to other organs. The five-year survival rate for all people diagnosed with pancreatic cancer is 10 percent and for those diagnosed in the later stages of the disease the five-year survival rate is only 5 percent. Early detection offers the greatest potential of increasing the survival rate for people with pancreatic cancer.
Among those at risk of pancreatic cancer, Immunovia is targeting three groups. The first group is those with a familial or hereditary risk of the disease. The second group is patients with a strong suspicion of pancreatic cancer based on symptoms and the third group are those over 50 years of age with new onset diabetes type II. Between 315,000 and 350,000 individuals in the US are at high risk of developing pancreatic cancer where there is a family or hereditary link¹ . Updated guidelines from the US Preventive Services Task Force (USPSTF), the National Comprehensive Cancer Network (NCCN), the American Society of Clinical Oncology (ASCO), and the International Cancer of the Pancreas Screening (CAPS) Consortium recommended follow-up on individuals with a family history of pancreatic cancer where they have two or more first-degree relatives who have had the disease or in individuals who have a confirmed genetic predisposition.
As knowledge of the risk factors for different types of cancer increases, more people can benefit from cancer surveillance programs. The existing surveillance methods for cancers such as pancreatic cancer can include CT scans, MRI and the more invasive endoscopic ultrasound which are expensive and require healthcare personnel with specialist knowledge.
For this reason, non-invasive blood tests are becoming increasingly important tools in surveillance programs for people at high risk of developing cancer. Early detection using tests such as IMMray™ PanCancer-d means more people can benefit from early treatment and have an increased chance of survival.
| Category | Patients/Year | Price |
|---|---|---|
| New Onset Diabetes | 855,500 | $500 mn |
| Early/late symptoms | 596,000 | $400 mn |
| Familial/hereditary | 315-350,000 individuals | $3.1 bn |
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ANNUAL REPORT 2021
IMMUNOVIA
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ANNUAL REPORT 2021
IMMUNOVIA# EARLY DETECTION
A Laboratory Developed Test is the fastest way of making IMMray™ PanCan-d available to patients within the US regulatory framework. Laboratory Developed Tests (LDTs) are in vitro diagnostic tests that are designed, manufactured, and used within a single clinical laboratory that is approved to perform highly complexity testing. LDTs are regulated under guidelines established by the College of American Pathologists (CAP) which oversees clinical laboratories in the US under the Clinical Laboratory Improvement Amendments (CLIA). LDTs provide a mechanism to bring new technologies into clinical practice more quickly than through clear-ance by the US Food and Drug Administration (FDA). There are currently hundreds of LDTs available on the US market. More information is available at https://immunovia.com/category/tutorials/
Immunovia, Inc.’s headquarters in Marlborough, Massachusetts.
ANNUAL REPORT 2021 13
IMMUNOVIA
Reimbursement from public and private sector insurance plans in the US market is critical to ensuring take up of a new test or procedure. For IMMray™ PanCan-d, reimbursement means high-risk individuals will not have to pay completely from their own pocket for IMMray™ Pan- Can-d but will be reimbursed for part or all of the cost of the test by a public or private insurer.
There are two major types of insurance plans in the US, public health plans and private plans. The public plans include Medicare, which is primarily for people aged 65 and over, and Medicaid, which is for people on low incomes and people with certain disabilities. There are also more than nine hundred private insurance plans ranging from large national plans to smaller regional plans. Both public and private plans need to be considered when seeking broad reimbursement for a laboratory test.
There are several stages involved in obtaining reimbursement coverage, but the most important for people wanting to take a test is the rate. Rate refers to the level of reimbursement provided by the public or private insurer. Medicare and Medicaid publish their reimbursement rates as the Clinical Lab Fee Schedule (CLFS). Rates for private insurers must be negotiated with each individual insurer by the test supplier, although the CLFS may be used as a guide. More information is available at https://immunovia.com/category/tutorials/
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IMMUNOVIA
Immunovia’s vision is to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.
To develop and commercialize non-invasive blood tests, so that more patients can receive a timely diagnosis, that can lead to improved treatment outcomes.
Immunovia’s long-term goal is a 50 percent share of the US pancreatic cancer testing market for IMMray™ PanCan-d after reimbursement and widespread insurance coverage has been achieved.
Complete PanFAM-1. The multicenter prospective study for early detection of pancreatic cancer in individuals presenting with hereditary/familial risk factors. The main goal of the study is to provide actionable information to the clinicians regarding diagnosis of pancreatic cancer. Furthermore, the study will deliver clinical performance data for IMMray™ PanCan-d from a cohort of high-risk asymptomatic individuals compared with currently used surveillance methods i.e. imaging technologies. We have concluded sample collection across the 25 global study sites (starting December 2017 and ending April 2021) with a total of over 5,000 samples from 1,250 subjects. Currently, these samples are being analyzed at our CLIA laboratory in Marlborough and the results will be made public in mid 2022.
Achieve reimbursement in the US market. Coverage for IMMray™ PanCan-d in the US will enable an increasing population of individuals with a family history of pancreatic cancer in the US to get insurance coverage for testing. During 2021 Immunovia has further refined its reimbursement plan in collaboration with Precision for Medicine Inc., a team of leading experts in the field of diagnostic reimbursement in the US. Through our extensive payer surveys and targeted research publications we feel confident about Immunovia’s ability to achieve positive reimbursement coverage decision.
Strengthening the US organization. Immunovia aims to continue to strengthen its leadership in the US in 2022. Growth will be prioritized by looking at population densities and disease incidence. This will be achieved by engaging with the leading university hospitals, established surveillance programs and national centers for pancreatic diseases, other large hospitals and healthcare facilities, as well as local hospitals.
Seek long term opportunities. Immunovia will use its expertise in blood-based diagnostics and biomarker discovery and validation to seek long term opportunities to improve patient outcomes through the early detection of different types of cancer. In addition to the focus on the US, Immunovia will also explore opportunities to market the IMMray™ PanCan-d test in other markets around the world.
ANNUAL REPORT 2021 15
IMMUNOVIA
Ann Wennberg is sixty-one years old, lives in Columbus, Ohio, USA and is retired from a career in clinical research and regulatory affairs. She is married and involved in her community through local Meals On Wheels and a greyhound adoption charity.
My father passed away from pancreatic cancer in August of 2019. Prior to his diagnosis in February 2019, he was a robust 87 year old, recently retired from owning his own business, living in his own home, still driving and taking care of my mother who has dementia. Through my father’s illness, I learned that the lifetime risk for children of people with pancreatic cancer is much higher than the general population.
I came to know about the test through an email from the Pancreatic Cancer Action Network and requested to take the test through my physician as I am not qualified for any surveillance programs. I found the testing procedure very easy, and someone came to my house to collect the blood sample. The most complicated part was taking the form to my doctor’s office for a signature.
Peace of mind that I do not have any signs of pancreatic cancer in my blood. Pancreatic cancer is a horrible disease and kills so quickly. My father had six months between diagnosis and his death. My parents lived with us during the last stages of his illness, so I saw his progression daily. I am considering taking the test again later as pancreatic cancer is usually diagnosed in older patients.
Ann Wennberg with her husband David and their two greyhounds Apollo & Nyxie Photo: Aimee Finley
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IMMray™ PanCan-d is the world’s first non-invasive blood test for pancreatic cancer. For the first time, patients with a high hereditary and familial risk of pancreatic cancer can now receive continued surveillance using a simple blood test.
In March 2021, Immunovia released results from a blind validation study of IMMray™ PanCan-d conducted by the Immunovia, Inc. in Marlborough, Massachusetts, USA.
The study data demonstrated that IMMray™ PanCan-d biomarker signature and CA 19-9¹ detects early stage I-II pancreatic cancers with a test specificity of 99% and a sensitivity of 87% versus familial/hereditary controls² and healthy controls. All stages of pancreatic ductal adenocarcinoma³ (PDAC) were detected with a specificity of 99% and a sensitivity of 92% against familial/hereditary controls.
These results mean that IMMray™ PanCan-d can support increased survival rates and improved patient outcomes through the early detection of pancreatic cancer for people at high risk of contracting the disease based on familial and hereditary factors.
Existing surveillance methods for people at risk of pancreatic cancer include CT scans and MRI. Both these forms of imaging surveillance are time consuming, expensive and require specialized staff. Due to the simplicity and non-invasive nature of the IMMray™ PanCan-d blood test, it is the only product offering the potential for widespread and continuous surveillance of high-risk individuals. IMMray™ PanCan-d can act as a complement to endoscopic ultrasound (EUS), the leading method of pancreatic cancer diagnosis, and other diagnostic approaches.
PanFAM-1, PanSYM-1 and PanDIA-1 studies. More than 1,000 blood samples from US and Europe are included in three prospective pancreatic cancer studies. In these studies, the IMMray™ PanCan-d test is assessed focusing on the three main risk groups for pancreatic cancer: individuals with familial and hereditary pancreatic cancer (PanFAM-1), patients with non-specific but concerning symptoms and other risk factors (PanSYM-1) and patients over 50 years of age with new onset diabetes type II (PanDIA-1).
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To increase pancreatic cancer survival rates through early detection, it is important that as many high-risk individuals as possible have access to# IMMray™ PanCan-d
Executing Immunovia’s sales strategy. Immunovia has one of the world’s largest Key Opinion Leader networks in pancreatic cancer. To support the growth of IMMray™ PanCan-d and to make the test available to more high-risk individuals, Immunovia will leverage this network as well as work with patient advocacy groups to increase awareness of IMMray™ PanCan-d.
Immunovia, Inc. is a subsidiary, has a fully digital sales process for IMMray™ PanCan-d. As part of this solution, sales and payment can be made online through Immunovia, Inc.’s website. This digital solution makes accessing IMMray™ PanCan-d simpler for medical practitioners.
Immunovia, Inc. is building a strong sales and marketing team in the U.S. Once reimbursement has been achieved, it is expected that this team will be further adjusted in line with growing volumes.
The American Gastroenterological Association (AGA) clinical practice update recommends that patients with two or more first-degree relatives diagnosed with pancreatic cancer should be monitored as well as patients with certain high-risk genetic mutations.
Dr Geoffrey Burns, MD
Dr Burns is a family physician with nearly thirty years’ experience and is a Fellow of the American Academy of Family Physicians. He practices in Wellesley, Massachusetts, USA.
What are the benefits of IMMray™ PanCan-d for your patients at high risk of pancreatic cancer?
I have counselled my high-risk patients on the benefits of early identification and surveillance when they have parents or close relatives who have had pancreatic cancer and countering the perception that there is nothing that can be done if you are at risk. For those patients already in surveillance programs, this test offers a complement to existing measures and other patients now have access to a test that can detect pancreatic cancer in its early stages.
How have you and your patients found the process for ordering and testing?
The online ordering makes the process easy to do and the test is sent directly to patients who can then either attend a specialist clinic or surgery to draw blood or have Immunovia, Inc. collect the blood and manage the chain of collection and transportation at no additional cost. This provides exibility to patients as to where and how they take the blood test.
What has been the impact on the lives of your patients that have taken the IMMray™ PanCan-d test?
This test can be an important tool for surveillance and offers reassurance to patients or can provide information on risk as part of an overall view of a patient’s health. For many patients, it also lessens the overall cost of surveillance and ensures that valuable time and resources can be used for other complementary surveillance or diagnostic tools only when required.
Dr James Farrell, MD
Dr Farrell is a Professor of Medicine at Yale University School of Medicine and Director of the Yale Center for Pancreatic Diseases.
Why is early detection of pancreatic cancer so important?
Pancreatic cancer is one of the leading causes of cancer related death in the world. While there have been significant advances in the treatment of other types of cancer, the progress for the treatment of pancreatic cancer has been slow. Therefore, it is believed that early detection of this disease offers the greatest potential of increasing the currently poor survival rates associated with this disease.
How can a blood test like IMMray™ PanCan-d help people at risk of pancreatic cancer?
A blood-based test developed and validated in high-risk groups for developing pancreatic cancer is clinically needed to assist with earlier detection. These high-risk groups include people with a strong family history of the disease, a genetic predisposition to developing pancreatic cancer, pancreatic cysts, or new onset diabetes. Ultimately, the use of such a pancreatic cancer blood test in both high risk populations and the general population could have a transformational effect on this disease.
How does IMMray™ PanCan-d compare to other surveillance methods?
As a blood-based test it offers the potential of a simpler and more widely available initial surveillance option compared with the existing strategy of imaging with MRI, CT or the more invasive endoscopic ultrasound imaging. In times of limited access to hospitals, easy access to tests is even more important.
The number of registered shares amounted to 22,954,874 shares. The share’s nominal value is SEK 0.05.
| Year | Event | Total share capital (SEK) | Change (SEK) | Total no. of shares | Change in shares | Nominal value (SEK) |
|---|---|---|---|---|---|---|
| May 27, 2017 | Formation | 100,000.00 | 100,000.00 | 1,000,000 | 1,000,000 | 0.10 |
| Oct 29, 2019 | New share issue | 105,253.00 | 5,253.00 | 1,052,530 | 52,530 | 0.10 |
| Oct 27, 2020 | Share split 5:1 | 105,253.00 | - | 5,253,150 | 4,199,150 | 0.02 |
| July 5, 2021 | New share issue | 138,890.75 | 3,255.75 | 5,777,795 | 1,524,645 | 0.02 |
| May 21, 2022 | New share issue | 144,785.75 | 5,895.00 | 9,477,475 | 3,699,680 | 0.015 |
| Sep 14, 2022 | New share issue | 147,875.75 | 3,090.00 | 9,777,475 | 2,999,999 | 0.015 |
| Jun 5, 2023 | New share issue | 225,957.50 | 7,790.00 | 11,383,745 | 1,606,270 | 0.015 |
| May 24, 2024 | New share issue | 155,785.75 | 4,540.00 | 18,456,478 | 7,072,733 | 0.01 |
| Sep 14, 2024 | New share issue | 157,875.75 | 2,090.00 | 18,777,478 | 321,000 | 0.01 |
| Oct 7, 2024 | New share issue via warrants | 183,857.50 | 2,580.00 | 19,241,078 | 463,600 | 0.01 |
| Jun 8, 2025 | New share issue | 207,375.75 | 2,520.00 | 21,783,745 | 2,542,667 | 0.01 |
| Sep 14, 2025 | New share issue via warrants | 208,575.75 | 1,200.00 | 21,954,578 | 170,833 | 0.01 |
| Sep 21, 2025 | New share issue via warrants | 211,457.50 | 2,880.00 | 22,457,478 | 502,900 | 0.01 |
| Jun 7, 2026 | New share issue | 214,547.50 | 2,990.00 | 22,954,874 | 497,400 | 0.01 |
| Oct 7, 2026 | New share issue via warrants | 214,547.50 | 0.00 | 22,954,874 | 0 | 0.01 |
| At end of period | 113,1579.05 | 22,631,581 | 1,131,579,05 | 22,631,581 | 0.05 |
Immunovia has four outstanding warrant schemes comprising 5,500,000 options with the right to subscribe for 5,500,000 shares. There is no dilution effect on earnings per share as long as the Group’s earnings are negative.
For more information about the outstanding warrant schemes see Note 20.
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Carl Berrhebec | 1,709,000 | 7.5% |
| Avanza Pension | 1,387,983 | 6.1% |
| Mats Ohlin | 877,950 | 3.8% |
| Sara Andersson Ek | 877,907 | 3.8% |
| Christer Wingren | 747,525 | 3.3% |
| Vincent Salldel | 528,860 | 2.8% |
| Coelib | 513,517 | 2.2% |
| Handelsbanken Funds | 497,787 | 2.1% |
| Norden Pension Insurance | 411,309 | 1.8% |
| Ranny Davidiroffi | 307,141 | 1.4% |
| Ten largest owners | 7,938,570 | 35.1% |
| Others | 14,692,956 | 64.9% |
| Total | 22,631,581 | 100.0% |
This sustainability report refers to financial year 2021 and applies to the parent company Immunovia AB (publ) (org. no. 556730-4299) and all entities consolidated in Immunovia’s consolidated accounts for the same period. These are stated in Note 21 of the Annual Report 2021. This report has been prepared without Immunovia having any legally mandatory requirement to do so. The report is not based on any specific sustainability standard but is based on the regulations of the Annual Accounts Act. The Board of Directors and CEO have also approved the sustainability report when signing off the annual report and the consolidated accounts.
As Immunovia’s operations are expanding, a materiality analysis is carried out in which areas of sustainability will be the starting point for further sustainability work. Immunovia’s sustainability work also looks at the relevant global goals for sustainable development, adopted in 2015 by the UN General Assembly.
Immunovia’s ambition is to create value by being able to diagnose complex diseases such as cancer disorders, considerably earlier and more precisely than is currently possible.
In our therapeutic core areas cancer diseases we address several of society’s largest global health# Corporate Governance
The shares are listed for trading on Nasdaq Stockholm’s main list, which means that the company is required to comply with the Swedish Code of Corporate Governance (the “Code”). The Code is available at the website of the Swedish Corporate Governance Board, which manages the Code (www.bolagsstyrning.se). The Code is based on the principle of “follow or explain,” which means that companies applying the Code may depart from individual rules, but if so, must explain the departure.
During the 2021 financial year, Immunovia had no departure from the Code. There are two alternative, outstanding cash-based incentive schemes that, as far as practiced, meet the terms of the corresponding outstanding warrants program. The alternative cash-based incentive schemes are for participants in countries where granting of warrants is not appropriate.
The figure describes the central bodies in Immunovia’s corporate governance model and who appoints the central bodies.
Immunovia’s Articles of Association, which are the basis of governing the company’s operations, state the company’s name, registered office, the aim of business operations, the company’s shares and share capital, and also include rules governing shareholders’ meetings. The Articles of Association state no limitations in terms of how many votes each shareholder is entitled to cast at shareholder meetings, no stipulations regarding appointing and dismissing Directors, or amending the Articles of Association. The Articles of Association are stated at www.immunovia.com.
The total number of shares and votes of the company as of December 31, 2021 was 22,954,531, and the share capital was SEK 1,415,579.05. Shares in the company are all of the same class, each share carries one vote, and all shares confer equal entitlement to the company’s assets and earnings. The company had approximately 8,003 shareholders as of December 31, 2021. The company’s largest shareholders as of December 31, 2021 are listed on page 21.
According to the company’s knowledge, all other significant relationships between Immunovia and the company’s largest shareholders are listed in Note 21 titled “Transactions with related parties”.
The Board of Directors is not aware of any shareholder agreements or other agreements regarding voting rights or other shareholder rights.
The AGM is the company’s chief decision-making body. The AGM should be held within six months of the end of the financial year. The AGM elects the Board of Directors and auditors. The AGM also adopts the Income Statement and Balance Sheet, and considers matters of dividend, discharging the Directors and Chief Executive Officer from liability, and approving fees to the Board of Directors and auditors. The AGM also deals with matters that are incumbent on it pursuant to the Swedish Companies Act and the Articles of Association.
The company’s ambition is for the AGM to be a satisfactory body for shareholders, and accordingly, its objective is for the whole Board, at least one representative of the Nomination Committee, the Chief Executive Officer and other members of management, as well as the auditor, to always attend the AGM.
Extraordinary General Meetings (EGM) are convened when the Board of Directors or auditors consider this appropriate.
Pursuant to Immunovia’s Articles of Association no notices convening AGMs and EGMs are through an announcement in the Swedish Official Gazette, and by making the notice available on the company’s website. Issuance of the convening notice is announced in the Swedish daily newspaper Dagens Industri. Resolutions of meetings are published in press releases and are available on the website.
The 2022 AGM will be held at 15:00 p.m. on April 7 at Medicin Village in Lund.
All shareholders directly registered in the share register maintained by Euroclear Sweden AB five days prior to the AGM and have not notified the company of their intention to attend (with potential assistants) by no later than the date stated in the convening notice of the AGM, are entitled to attend the AGM and vote for the number of shares they hold. Shareholders can attend the AGM personally or by proxy and may also be assisted by a maximum of two people. Normally, shareholders are able to register in several different ways, as stated in the convening notice.
Shareholders that wish to have a matter considered at the AGM must submit a written request thereof to the Board. The Board should normally have received such request by no later than seven weeks prior to the AGM.
The company shall have a nomination committee with the task of preparing and submitting proposals for the AGM, and in certain cases, extraordinary general meetings, resolutions in election and remuneration issues, and, where applicable, procedural issues for the next election committee. The nomination committee shall propose:
The Nomination Committee shall, when assessing the Board’s evaluation and in its proposals, take into account the requirement on the versatility and breadth of the board and the requirement to strive for an even gender balance. Nomination Committee members, regardless of how they have been appointed, shall exercise all of the company’s shareholders’ interests.
Any changes in the composition of the Nomination Committee shall be released immediately.
The Nomination Committee, which will be appointed for the period until a new Nomination Committee has been appointed, shall consist of four members, three of whom should be appointed by the company’s largest shareholders in terms of the votes, and the fourth should be the Chairman of the Board. When evaluating which shareholder should be considered the largest shareholder of the company, calculations of participating interest should include ownersip based on groups of shareholders that collaborate in the company’s administration. As soon as possible after the end of the third quarter each year, the Chairman of the Board shall contact the three largest shareholders at this date in an appropriate manner and encourage them to designate the individual such shareholder wishes to appoint as a member of the Nomination Committee in writing within a reasonable time that does not exceed 50 days. If one of the three largest shareholders does not exercise its right to appoint a member of the Nomination Committee, the next shareholder in turn will be offered the right to appoint a member of the Nomination Committee. In cases where several shareholders decline the entitlement to appoint members of the Nomination Committee, the Chairman of the Board shall not need to contact more than eight shareholders, providing this is not necessary to compose a Nomination Committee with at least three members.
Unless otherwise agreed between members, the Chairman of the Nomination Committee shall represent the largest shareholder. The Chairman of the Board or other Directors may not serve as Chairman of the Nomination Committee. Employees of the Group may not be members of the Nomination Committee.
If a shareholder that has appointed a member of the Nomination Committee is no longer one of the company’s three largest shareholders in the year, the member selected by such shareholder shall leave the Nomination Committee. Instead a new shareholder from amongst the three largest shareholders will be entitled, independently and at their own discretion, to appoint a member of the Nomination Committee. However, no marginal differences in shareholding and changes to shareholdings arising later than three months prior to the AGM should cause any changes to the composition of the Nomination Committee, unless in special circumstances.
If the Chairman of the Nomination Committee leaves before the Nomination Committee has completed its assigned due to reasons other than those stated in the preceding paragraph, that shareholder that appointed such member shall be entitled, independently and at their own discretion, to appoint a replacement. If the Chairman of the Board leaves the Board of Directors, his or her replacement shall also replace the Chairman of the Board on the Nomination Committee. No fees are payable to members of the Nomination Committee. However, the company will meet expenses that the Nomination Committee considers necessary to complete its assignment.
The current Nomination Committee members are:
The composition of the Nomination Committee must be published on the company’s website no later than six months before the AGM.
The most recent AGM was held on May 5, 2021. Due to Covid-19, the AGM was conducted without a physical presence and shareholders exercised their voting rights by postal vote before the meeting.
The meeting resolved to re-elect the Directors Carl Burrédbeck, Hans Johansson, Ann-Christin Sundell, Mimmie Ekberg, Peter Hångaard Andersson and Christer Sögren and elected Martin Møller.## Board of Directors and Executive Officers
It is resolved that total remuneration of SEK 1,000,000 shall be paid, of which SEK 550,000 to the Chairman of the Board and SEK 270,000 to each of the other members of the Board and SEK 50,000 to the Chairman of the Audit Committee, SEK 50,000 to the Chairman of the Remuneration Committee and SEK 30,000 each to other members of these committees. The proposal that no dividend be paid for the financial year 2021 was approved. It was decided to elect Authorized Public Accountant Mats Andersson as Chief Auditor with Authorized Public Accountant Martin Gustafsson as Deputy Auditor, for the period up to the end of the 2022 Annual General Meeting.
Furthermore, it was decided to appoint a Nomination Committee for the next AGM, in accordance with the above section ‘Nomination Committee’.
The AGM further resolved that, to make it possible for the Board to add working capital to the com- pany and/or new owners of strategic importance for the company, and/or acquire other com- panies or businesses, to authorize the Board during the period until the next AGM on one or more occasions, to decide on a new share issue so that an increase in the share capital will be no more than twenty (20) percent based on the company’s total share capital at the 2022 AGM, with or without deviation from shareholders’ preferential rights and with or without a provision for a capital contribution.
On November 30, 2021, it was announced that Patrick Dahlliden was resigning as CEO. On January 20, 2022, Philip Mathieu was appointed acting CEO until a new CEO is appointed.
The Board of Directors is the chief decision-making body after the AGM. The responsibilities of the Board of Directors are regulated through means including the Swedish Companies Act, the company’s Articles of Association and other laws and ordinances, as well as the Board of Directors’ Rules of Procedure and other internal policies.
Pursuant to the Swedish Companies Act, the Board of Directors is responsible for the company’s ad- ministration and organization, which means that the Board is responsible for matters including setting goals and strategies, ensuring procedures and systems for evaluating established goals, continually evaluating ImmunoVia’s financial position and results of operations, as well as appraising executive management. The Board of Directors is also responsible for ensuring that the Annual Accounts and Consoli- dated Accounts, as well as interim reports, are prepared on time. The Board also appoints the CEO.
The Directors are elected by the AGM each year, or where appropriate, by an EGM, for the period until the end of the next AGM. The Chairman is elected by the AGM, or where appropriate, an EGM, and has a special responsibility to lead the work of the Board of Directors and for the work of the Board being well organized and conducted effectively.
The Board of Directors follows written Rules of Procedure, which are reviewed yearly and adopted at the Board meetings following election each year, or as necessary. The Rules of Procedure divide responsibilities for the work of the Board between the Board and its Committees, and between the Board and the CEO. Pursuant to the Articles of Association, the Board should decide on strategies and budgets, adopt the Annual Accounts and other financial statements, important policies and authoriza- tion lists, appoint the CEO and appraise the work of the CEO, adopt rules governing internal controls and monitoring how internal controls are functioning, decide on major investments and far-reaching agreements, decide on the direction of the work of the Board of Directors, appoint the Audit and Remuneration Committees, and appraise the work of the Board’s Committees.
The Chairman of the Board leads the work of the Board. The Chairman of the Board should monitor the company’s progress and ensure that the Board receives the information necessary for the Board to perform its duties.
The Board meets in accordance with an annual schedule that is approved in advance. In addition to these meetings, further meetings can be arranged to deal with issues that cannot be con- sidered at a scheduled meeting. In addition to Board meetings, the Chairman and CEO maintain an ongoing dialogue regarding management of the company.
Board meetings are prepared by the Chairman of the Board jointly with the company’s CEO. Written material is provided to the Board for each meeting. Certain matters are con- sulted with the audit committee, whose members are Christer Södergren (Chairman) and Hans Johansson. Regular issues for Board meetings include reviews of business conditions and financial reporting. The minutes of Board meetings are recorded by the company’s CFO.
Pursuant to the Articles of Association, the Board appraises its work each year. The work of the Board is evaluated yearly through a systematic and structured process that is designed to produce good sup- porting data for improvements of the Board’s own work. The appraisal is conducted partly indi- vidually, and partly through discussions at Board meetings. The aim of the appraisal is to provide the Chairman of the Board with information on how Directors perceive the efficiency and aggregated competence of the Board, and if there is a need for changes within the Board. The other Directors appraise the Chairman of the Board. The Chairman of the Board informs the Nomination Committee of the outcome of these appraisals.
In 2021, the Board held 18 meetings. During the year, the external auditors attended one meeting. Matters considered apart from scheduled items included continuous reviews of long-term strategies, review of new product alternatives, and the budget for 2022.
Pursuant to the company’s Articles of Association, where elected by the AGM, the Board should con- sist of a minimum of three and a maximum of ten Directors and a maximum of ten deputies. Otherwise, there is no stipulation in the Articles of Association regarding appointing or dismissing Directors. Pursuant to the Code, a majority of Directors elected by shareholders meetings should be independent of the com- pany and its management. At least two should also be independent of the company’s major share- holders. ImmunoVia judges that its Board satisfies the requirements of independence.
At present, the company’s Board of Directors consists of seven members elected by sharehol- ders meetings.
Professor Carl Borrebaeck (1948) is a successful entrepreneur and founder of ImmunoVia, who al- so founded Senzagen AB (Publ.) (SENZ: Nasdaq First North), BioInvent International AB (Publ.) (BINV: Nasdaq Stockholm), and PAIneR AB. In 2009, he was awarded the Åzko-Nobel Science Prize and in 2012 he received the Royal Swedish Academy of Engineering’s gold medal for his pio- neering research on bio}];markers, and in 2017 he was named BioTech Builder of the Year for his entrepreneurship.
He is a life member of the IVA (Royal Swedish Academy of Engineering Sciences), a director of C2A Health – the Strategic Center for Translational Cancer Research and former Deputy Vice-Chancellor of Lund University (responsible for its innovation systems and industrial part- nerships) and Head of the Department of Immunotechnology. He is also the Founding Mentor for NO-ME (Nordic Mentor Network for Entrepreneurship).
ImmunoVia has signed an agreement with CB Ocean Capital AB regarding services to be per- formed by Carl Borrebaeck. He will provide the company with services focused on providing sci-entific and strategic support to the company, for example at sci-entific presentations and con- ferences. The services provided do not include tasks related to board assignments. Under the agreement, CB Ocean Capital AB will receive remuneration of SEK 51,500 per quarter, excluding additional social secu- rity contribution and value added tax, for work performed by Carl Borrebaeck for the company. The agreement runs from January 1, 2022 until further notice with three months of mu- tual notice.
Chairman of SenzaGen AB and CB Ocean Capital AB. Board member of Scandion AB. Mana- ging partner of Innova Handelsbolag.
Chairman of LU Innova Invention System AB. Board member of WinterResearch AB and Clinica Laserthermia AB.
Holdings in the company as per Dec 31, 2021: 1 030 000 shares and 0 share warrants.
Ann-Christine Sundell (1964) holds an M.Sc. in biochemistry and has over 25 years’ experience of global commercial positions in the diagnostics sector. She was EVP of Genetic Screening at PerkinElmer, one of the world’s largest life science companies, for ten years, where she led one of the company’s five strategic business areas.
| Name | Assignment for the company and other material assignments | Elected to the Board | Attendance Board meetings | Attendance Remuneration Committee | Attendance Audit Committee | Dependent on the company and management | Dependent on major shareholders |
|---|---|---|---|---|---|---|---|
| Carl Borrebaeck | Chairman of the Board | 2007 | 18/18 | 5/5 | - | No | No |
| Ann-Christine Sundell | Member | 2017 | 18/18 | 5/5 | - | No | No |
| Hans Johansson | Member | 2017 | 18/18 | - | 4/4 | No | No |
| Minna Ekberg | Member | 2018 | 17/18 | - | - | No | No |
| Christer Södergren | Member | 2018 | 18/18 | - | 4/4 | No | No |
| Peter Hängaard | Member | 2021 | 15/18 | - | - | No | No |
| Mats Graah | Member (resigned 2021) | 2021 | 9/9 | - | - | No | No |
| Martin Müller | Member (elected May 2021) | 2021 | 9/9 | - | - | No | No |
The Board of Directors of Immunovia AB comprises seven directors, five of whom are independent in relation to the company and its executive management, and two of whom are independent in relation to the company’s major shareholders.
Board Members
Hans Johansson (1954) holds an M.Sc. (Eng.) in chemical engineering and has long-term experience and a broad-based contact network from previous roles in the life science and diagnostic industries, most recently as Vice President of Companion Diagnostics in Thermos Fisher Scientifics®® Speciality Diagnostics Group. Prior to that, his positions included serving as Global VP and Head of Marketing – Commercial Development for Thermos Fisher I• m m u n o- Diagnostics Division and VP of Biocartis NV. Vice Chairman of the board and chairman of nomination committee for Raisio Oy. Board member of Företags Ab Sydsvenskt Hypoteken. Holder of Aconsulat.
Previous assignments (past five years): Chairman of Oy Medi
Biohchemi Ab. Board member of Minervastit felt, Oy Medi Ab, Bueprint Genetics Oy, Serrés Oy, Ledil Group Oy, Ledil Oy and Zynonostics ApS.
Holdings in the company as per Dec 31, 2021: 1,500 shares and 0 share warrants.
Hans Johansson (1954) holds an M.Sc. (Eng.) in chemical engineering and has long-term experience and a broad-based contact network from previous roles in the life science and diagnostic industries, most recently as Vice President of Companion Diagnostics in Thermos Fisher Scientifics®® Speciality Diagnostics Group. Prior to that, his positions included serving as Global VP and Head of Marketing – Commercial Development for Thermos Fisher I• m m u n o- Diagnostics Division and VP of Biocartis NV. Vice Chairman of the board and chairman of nomination committee for Raisio Oy. Board member of Företags Ab Sydsvenskt Hypoteken. Holder of Aconsulat.
Previous assignments (past five years): Chairman of Oy Dolardiaz Ab (®® Myrtila Ab). Board member of S Ingle Techologies Ab and Upsala Innovation Centre Ab.
Holdings in the company as per Dec 31, 2021: 6,127 shares and 0 share warrants.
Christofer Sjögren (1966) has 15 years of experience from the finance industry as equity analyst at companies such as Carnégie, Danske Bank and Deutshche Bank based in Stockholm. He has also been an Investor Relations consultant at Citigate Stockholm (previously part of Huntsworth plc) and is Vice President of Trellborg Ab for ten years, and head of Trellborg Investor Relations.
Previous assignments (past five years): Board Member of Trellborg Group Treassurer.
Holdings in the company as per Dec 31, 2021: 6,723 shares and 0 share warrants.
Mimmi Ekberg (1959) has about 30 years of experience from the pharmaceutical industry and 25 years of experience within oncology. She has had various positions at both national and Nordic level with experience of successfully launching specialist pharmaceutical. She has extensive strategic and operational experience in Sales – Marketing in the field of oncology. She has over 10 years experience as business area manager from E. Merck, Ången and today serves as business area manager at Oncology Nordic at Celgene, focusing on pancreatic cancer. Since 2021, she has been working as a consultant in the pharmaceutical industry, right now focusing on solid tumors. She is a trained nurse with an academic background within medical oncology from Lund University, clinical trials at Karolinska University Hospital ’s oncology department and an Executive MBA from Stockholm University.
Previous assignments (past five years): Consultant in the Pharma Industry.
Holdings in the company as per Dec 31, 2021: 451 shares and 0 share warrants.
Peter Høngaard Andersen (1956) holds a B.Sc. in Chemistry, an M.Sc. in Biochemistry, is an M.D. and has many years’ experience and a broad network from his previous positions within the Life Science and biotech industries. Dr. Høngaard Andersen also has many years’ experience in pharmaceutical research and development from the pharmaceutical industry: 14 years at Novo Nordisk in CNS, neurologicalogy, women’s health and diabetes and 15 years at Lundbeck in CNS pharmaceutical research and early development. Dr. Høngaard Andersen has been involved in the research and development of several pharmaceuticals on the market (e.g. Norditropin SimpleX, Victoza, Trintelil® / Brintellix, Cipralex). Dr. Høngaard Andersen has been a founder or co-founder of several biotech companies, including Acadeia Pharmaceuticals, Zealand Pharma, GlyCom, Serenex, Epitherapeutics and Preston Pharmaceuticals. Dr. Høngaard Andersen was involved in the Innovative Medicine Initiative (IMI) from its inception in 2005 and served as Chairman of the industry side of IMI from 2009–2014. In addition, Dr. Høngaard V enture is a Partner in Ysios Capital and a member of the Advisory Board in Eir Venture.
Previous assignments (past five years): Founder and former CEO of In n ova t i o n Fund Den mar k, member of the Executive Committee of IC Perped (the International Consortium of Personalized Medicine) and Chairman of Prexton Therapeutics.
Holdings in the company as per Dec 31, 2021: 1,500 shares and 0 share warrants.
Martin Møller (1975) has broad and deep experience in the healthcare industry from more than 20 years at McKinsey – Company, a global management consultancy, where he was a leader in the Pharmaceuticals – Medical Products Practice until 2021. In that role, he advised companies on strategy, transformation and business development, as well as product development, launch and commercialization. Martin ’s university degree is in the humanities. He is a citizen of Denmark and the U.S.
Previous assignments (last five years): Senior Partner, McKinsey – Company. Chairman of McKinsey – Company Denmark P/S
Holdings in the company as per Dec 31, 2021: 1,059 shares and 0 share warrants.
Mimmi Ekberg
Peter Høngaard Andersen
Martin Møller
Christofer Sjögren
The Audit Committee members are Christofer Sjögren (Chairman) and Hans Johansson. The primary duty of the Committee is to assure the quality of financial reporting, which includes internal controls, reviews of material accounting and measurement issues, and reviews of the company’s external reporting. Before the AGM, the Nomination Committee would also provide the Nomination Committee with proposals regarding audit fees. The Audit Committee also determines which other services apart from auditing the company pay purchases from the company’s auditors.
The auditors meet the Board of Directors and Audit Committee each year, both with and without management in attendance.
Minutes are taken at all Audit Committee meetings and distributed to all Directors. The Committee also provides regular reports to the Board on its work through the Chairman of the Committee verbally reporting at the following Board meeting.
The Audit Committee monitors the company’s internal controls through continuous feedback and maintains regular contact with the external auditors. Business and control processes will be subject to further documentation and evaluation in 2023, through self-assessment and external appraisal.
The 2022 AGM resolved that the Chairman of the Audit Committee would receive a fee of SEK 50,000 and that other members should each receive SEK 30,000.
Ann-Christine Sundell is Chairman of the Remuneration Committee, and Carl Borrebaeck is a member of the Remuneration Committee. Its primary duty is to consult on salary, other benefits and employment terms for the CEO and other senior executives, as well as incentive schemes for each group. The Remuneration Committee should ensure compliance with the established guidelines for remunerating senior executives.
Minutes are taken at all Remuneration Committee meetings and distributed to all Directors. The Committee also provides regular reports to the Board on its work through the Chairman of the Committee verbally reporting at the following Board meeting.
The 2022 AGM resolved that the Chairman of the Remuneration Committee would receive a fee of SEK 50,000 and that other members should each receive SEK 30,000.
The 2022 AGM appointed Authoirized Public Accoun tant Mats – Kärde Andersson, HLV Audit oriet AB, as Auditor in Charge with Authoirized Public Accountant Martin Gustafsson, HLV Audit oriet AB as Deputy Auditor, for the period until the end of the AGM 2023. In addition to auditing, the company has appointed Mazars Set Revisionbygg® Oy for guidance related to the audit on accounting issues. Information on remuneration is provided in Note 9.
The CEO is appointed by the Board and has the primary responsibility for the company’s ongoing administration and daily operations. The segregation of duties between the Board and CEO is stated in the Rules of Procedure of the Board of Directors and instructions for the CEO. The CEO and group management are also responsible for preparing reports and compiling information for group management for Board meetings and present this material at Board meetings. The CEO is responsible for the company’s financial reporting, and accordingly, should ensure that the Board gathers sufficient information to enable continuous evaluation of the company’s financial## Thomas King
Mr. King has proven experience in driving life science and diagnostic product engagement into European markets. His sales experience comes from 9 years of key account management roles at both GE HealthCare and Sartorius Stedim. Marketing roles in GE HealthCare and Roche Diagnostics over a period of 10 years were used to build brand awareness, drive product life cycle management and lead creation via digital and traditional channels. Much of his experience has been gathered from commercial roles in multinational teams and organizations in Scandinavia, Europe, and the U.S.
Meagan Luipold, Sales Director NA
Cindy Callahan, Sr Marketing Director
Rob Pickles Market access and Marketing Director, Europe
Thomas King Medical Director
42 ANNUAL REPORT 2021 IMMUNOVIA EARLY DETECTION
Total remuneration and other benefits granted directly or indirectly by the company to members of Group management are stated in Note 10. The company has not issued any loans to members of group management.
The Board shall prepare proposals for new guidelines in the event of a need for significant changes to the guidelines, but at least every four years. At the 2023 AGM the Board adopted new guidelines and the guidelines apply until new guidelines have been proposed and adopted by the AGM. The AGM on May 5, 2023, resolved on the following guidelines for remuneration to senior executives, which are unchanged compared to the previous year.
Remuneration of senior executives of the company should consist of basic salary, potential variable compensation, other customary benefits and pension. Total annual remuneration should be on market terms and competitive on the labor market where the executive is stationed, and consider individual qualifications and experience, as well as reflecting exceptional performance in overall compensation. Basic salary should be subject to annual review. Senior executives means the CEO and other members of the company’s management.
Basic salary and variable compensation should relate to the executive’s responsibilities and authority. Variable compensation should be payable in cash and/or in shares/share warrants/convertible instruments or other share-based instruments and based on outcomes in relation to established targets and structured to promote shared interests between the executive and the company’s shareholders. The vesting period for entering an agreement until a share may be acquired should not be less than three years. Variable cash compensation should not exceed basic salary. The terms and conditions governing variable compensation should be structured so that in especially severe financial conditions, the Board is able to limit or refrain from paying variable compensation if such payment is considered unreasonable and irreconcilable with the company’s other responsibilities to shareholders. The annual bonus should have a capability for limitation or refraining from paying variable compensation if the Board considers that this is justified for other reasons.
If a Director renders services on behalf of the company in addition to service on the Board, consulting fees and other compensation for such work should be payable subsequent to a special decision by the Board.
As far as possible, pension benefits should be defined contribution. The CEO and other senior executives should have maximum notice periods of 18 months. Basic salary during the notice period and severance pay should not exceed an aggregated maximum amount corresponding to two years’ basic salary.
The company’s Board of Directors shall endeavor for the Group’s subsidiaries to apply these principles. The Board shall be entitled to depart from the above guidelines if the Board considers that there are special reasons justifying this in an individual case.
Questions regarding salary and other compensation to the CEO are subject to consultation by the Remuneration Committee and decided by the Board.
The Group is small, with a straightforward legal and operational structure and established governance and internal control systems. Against this background, the Board has decided not to create a dedicated internal audit.
The Board’s responsibility for internal control and governance is regulated in the Swedish Companies Act and the Annual Accounts Act, in addition to which the Code is applied. Immunovia strives to run its business as efficiently as possible. The financial reporting must be reliable and reflect the Company’s operations in a correct manner and be prepared in accordance with applicable laws and regulations. The Board determines which reports must be prepared for the Board to be able to follow the Company’s development. The quality of the financial reporting to the Board is primarily evaluated by the Audit Committee.
The Board of Directors’ responsibility for internal controls is regulated by the Swedish Companies Act and the Swedish Annual Accounts Act, which stipulate that information on the most important elements of the company’s systems for internal controls and risk management relating to financial reporting should be included in the Corporate Governance Report, as well as the Code. The Board’s duties include ensuring that the company has good internal controls and formal procedures that ensure compliance with established principles for financial reporting and internal controls, and that expedient systems for monitoring and controlling the company’s operations and the risks the company and its operations are associated with, are in place. Decision-paths, authorizations and responsibilities being clearly defined and communicated between different levels of the organization, as well as control documentation such as policies and guidelines covering all material segments, and providing guidance to different executives within the group, is an important component of the control environment.
One significant part of the Board’s work is to formulate and approve a number of fundamental policies, guidelines and frameworks. These include the Board’s Rules of Procedure, Instructions for the CEO, Corporate Communication and Finance Policies. The purposes of these policies include providing a foundation for good internal controls. All policies are subject to annual review and approval by management or the Board. Additionally, the Board shall endeavor for its organizational culture to provide clearly defined roles, responsibilities and processes that favor efficient management of the operational risks and enable targets to be achieved.
The overall purpose of internal controls is to ensure that the company is following up on its operational strategies and goals, and its owners’ investments are protected. Additionally, internal controls should ensure that there is reasonable assurance that financial reporting is reliable and prepared consistently with generally accepted accounting practice, compliant with applicable laws and ordinances and the standards applying to listed companies.
Responsibility for maintaining an effective control environment and ongoing work on internal controls over financial reporting has been delegated to the company’s CEO. The CEO provides regular reports to the Board pursuant to the established instructions for the.# ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
The Board also receives reports from the company’s auditor. Based on a control environment perceived as effective and external examination by auditors, the Board judges that there are no special circumstances in the operation, or other conditions, that would justify establishing an internal audit function.
Risk assessment includes identifying risks that may arise if the fundamental standards apply to the company’s financial reporting are not satisfied. The company’s management has identified and evaluated the risks that are relevant to the company’s operations and evaluated how these risks can be managed in a decided risk assessment document. Within the Board, the Audit Committee bears primarily responsibility for continuously evaluating the company’s risk situation, with the Board subsequently conducting an annual review of the risk situation. Important tests are conducted annually and when necessary.
Control activities limit identified risks and ensure accurate and reliable financial reporting. The Board is responsible for internal controls and monitoring management. This is conducted through internal and external control activities, and by examining and following up on the company’s control documents related to risk management.
The company has information and communication pathways intended to promote the accuracy of financial reporting and enable reporting and feedback from operations to the Board and management, through means including making control documents in the form of internal policies, guidelines, and instructions for financial reporting available and familiar to the affected staff. The Board has also adopted a Corporate Communication Policy that formalizes the company’s communication through financial information in the form of interim reports, financial statements, annual accounts and press releases in tandem with significant events that may be price sensitive. Corporate communication complies with the standards stated in Nasdaq Stockholm’s Rulebook for Issuers. The Board reviews external financial reports prior to publication. The Corporate Communication Policy also stipulates how communication can be effected, and which parties may represent the company. Information distributed through press releases is also available on the company’s website, as is other information considered relevant.
The compliance with, and effectiveness of, internal controls are subject to regular monitoring. The CEO ensures that the Board receives regular reports on the progress of the company’s operations, including the process of the company’s results of operations and financial position, and information on important events, such as research outcomes and important agreements. The CEO also reports these issues at each Board meeting.
To the general meeting of shareholders of Immunovia AB (Publ), corporate ID no. 556730-4299
The Board of Directors is responsible for that the corporate governance statement for 2021 on pages 30-44 has been prepared in accordance with the Annual Accounts Act.
My examination of the corporate governance statement is conducted in accordance with FAR’s auditing standard RevU 18 The auditor’s examination of the corporate governance statement. This means that my examination of the corporate governance statement is differently and substantially less in scope than an audit conducted in accordance with International Standards on Auditing and generally accepted auditing standards in Sweden. I believe that the examination has provided us with sufficient basis for my opinion.
A corporate governance statement has been prepared. It is consistent with the annual accounts and the consolidated accounts and is in accordance with the Annual Accounts Act.
Fund, March 14, 2022
Mats Andersson
Authorized public accountant
The Board of Directors and CEO of Immunovia AB (Publ), corporate identity number 556730- 4299, hereby submit the annual accounts and consolidated accounts for the financial year 2021. Unless otherwise stated, the information relates to the Group. Information in parentheses refers to the previous year. Amounts are stated in SEK (SEK thousands) unless otherwise stated. Rounding up differences may occur. During the period, the Parent Company’s operations essentially coincide with the Group’s. The comments on the Group’s progress therefore also apply to the Parent Company.
Immunovia AB develops new and improved methods for the diagnosis of cancer. The operations are mainly conducted in the parent company Immunovia AB, which is why the comments below apply to both the Group and the Parent Company.
The commercial launch of IMMray™ PanCan-d in the US in August 2021 was a major milestone in Immunovia’s mission to change the testing paradigm and increase the survival rates for pancreatic cancer patients. Thereby IMMray™ PanCan-d, was the first blood test for early detection of pancreatic cancer to reach the market.
Immunovia reported data from a blinded validation study of IMMray TM PanCan-d The study data demonstrated that the IMMray™ PanCan-d biomarker signature and CA 19-9 detects early stage I & II pancreatic cancers with a test specificity of 99 percent and a sensitivity of 89 percent versus familial/hereditary controls and healthy controls. All stages of pancreatic ductal adenocarcinoma (PDAC) were detected with a specificity of 99 percent and a sensitivity of 92 percent against familial/hereditary controls.
Immunovia Inc, Immunovia’s US subsidiary, received a clinical laboratory licensure from the Massachusetts Department of Public Health This important milestone in August 2021 paved the way for Immunovia, Inc. to start sales of IMM- ray™ PanCan-d as a Laboratory Developed Test in the United States.
After year-end, on January 20, 2022, Philipp Mathieu assumed the role as Acting CEO and President. He replaced Patrik Dahlen who announced his intention to step down in November 2021.
Immunovia’s operations and market are subject to a number of risks that are wholly or partly outside the company’s control, and effect, or may affect, Immunovia’s operations, financial position and results of operations. The following risk factors have been reviewed without any internal order of priority, and without any claim as to completeness:
For a review of the financial risks, please refer to Note 3.
The Group had an average of 67 (63) employees in the period, and at the end of the period, there were 65 (67) employees.
Detailed information on the company’s outstanding warrant programs is in note 10 below.
Immunovia does not conduct any operations that are hazardous to the environment that require permits or notification pursuant to the Swedish Environmental Code. Please refer to the Sustainability Report on pages 22-29.
The corporate governance report is prepared separately and can be found on pages 30-44.
The Board of Directors is proposing that no dividend is paid for the financial year 2021.
In January 2022 Phillip Mathieu assumed the role as Acting CEO and President. In February 2022 the peer-reviewed, blinded study to independently validate the clinical performance of IMMray™ PanCan-d was published in Clinical and Translational Gastroenterology. The study data demonstrated that the IMMray™ PanCan-d biomarker signature and CA 19-9 detects early stage I & II pancreatic cancers with a test specificity of 99 percent and a sensitivity of 89 percent versus familial/hereditary controls and healthy controls. All stages of pancreatic ductal adenocarcinoma (PDAC) were detected with a specificity of 99 percent and a sensitivity of 92 percent against familial/hereditary controls.
The commercial launch of IMMray™ PanCan-d in the US in August 2021 was a major milestone in Immunovia’s mission to change the testing paradigm and increase the survival rates for pancreatic cancer patients. During 2022 we will work for additional clinical validation for the test across risk groups, strengthening the US organization for commercial scale up, and continue executiong on the reimbursemement plan.# ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| 2021 Full year | 2020 Full year | 2019 Full year | 2018 Full year | 2017 Full year | |
|---|---|---|---|---|---|
| Net sales (SEK 000) | 9 987 362 | 333 149 | |||
| Earnings/loss after financial items (SEK 000) | -107 009 | -108 902 | -90 868 | -66 334 | -45 232 |
| Total assets (SEK 000) | 591 306 699 | 486 425 363 | 497 951 250 | 665 497 951 | 250 665 |
| Equity ratio (%) | 96 | 96 | 95 | 97 | 94 |
The following funds are at the disposal of the Annual General Meeting (SEK):
Profit brought forward 565 437 678
Earnings/loss for the year -106 572 082 458 865 596
The Board proposes that:
Carried forward 458 865 596 458 865 596
Group financial summary
Parent company financial summary
Proposed appropriation of the Company’s Earnings
SEK thousand unless otherwise stated
| 2021 Full year | 2020 Full year | 2019 Full year | 2018 Full year | 2017 Full year | |
|---|---|---|---|---|---|
| Net sales | 844 362 | 356 333 | 149 | ||
| Operating earnings | -166 628 | -134 343 | -114 248 | -87 709 | -45 520 |
| Earnings before tax | -155 966 | -146 033 | -114 517 | -86 531 | -45 232 |
| Net earnings | -155 966 | -146 033 | -114 521 | -86 531 | -45 232 |
| Earnings per share before dilution (SEK) | -6,89 | -6,84 | -5,85 | -4,67 | -2,67 |
| Earnings per share after dilution (SEK) | -6,89 | -6,84 | -5,85 | -4,67 | -2,67 |
| Equity ratio (%) | 88 | 91 | 85 | 97 | 94 |
| Number of shares at the end of the period | 22 631 581 | 22 631 581 | 19 654 853 | 19 531 353 | 17 318 059 |
48
ANNUAL REPORT 2021
IMMUNOVIA – EARLY DETECTION
Financial Statements .......................................................................................... 48
Group Key Indicators ......................................................................................... 49
Consolidated Income Statement ................................................................... 50
Consolidated Statement of Comprehensive Income .............................. 50
Comments on the Income Statement ......................................................... 50
Consolidated Balance Sheet ........................................................................... 51
Comments on the Balance Sheet .................................................................. 52
Consolidated Statement of Changes in Equity .......................................... 52
Consolidated Cash Flow Statement ............................................................. 53
Comments on the Cash Flow Statement .................................................... 53
Parent Company Income Statement ............................................................ 54
Parent Company Statement of Comprehensive Income ....................... 54
Parent Company Balance Sheet ...................................................................... 55
Parent Company Statement of Changes in Equity ................................... 56
Parent Company Cash Flow Statement .........................................................57
Notes ........................................................................................................................ 58
Board of Directors’ and Chief Executive Officer’s certification ............................................................................................................77
Audit Report ......................................................................................................... 78
Definitions .............................................................................................................. 82
Glossary ................................................................................................................... 83
Shareholder information ................................................................................. 85
ANNUAL REPORT 2021
49
IMMUNOVIA – EARLY DETECTION
SEK 000 unless otherwise stated
| 2021 Full year | 2020 Full year | 2019 Full year | 2018 Full year | 2017 Full year | |
|---|---|---|---|---|---|
| Operating earnings/loss | -166 628 | -134 343 | -114 248 | -87 709 | -45 520 |
| Earnings/loss for the period | -155 966 | -146 033 | -114 521 | -86 539 | -45 232 |
| Earnings per share before dilution (SEK) | -6.89 | -6.84 | -5.85 | -4.67 | -2.67 |
| Earnings per share after dilution (SEK) | -6.89 | -6.84 | -5.85 | -4,67 | -2.67 |
| R&D expenses | -42 850 | -48 078 | -34 273 | -26 048 | -24 041 |
| R&D expenses as a percentage of operating expenses (%) | 25 | 27 | 24 | 23 | 34 |
| Cash and cash equivalents at end of the period | 287 406 | 468 462 | 263 345 | 386 136 | 192 426 |
| Cash flow from operating activities | -152 648 | -120 704 | -91 952 | -84 111 | -46 318 |
| Cash flow for the period | -181 743 | 205 918 | -122 797 | 193 679 | -66 661 |
| Equity | 433 903 | 599 403 | 357 604 | 461 952 | 236 795 |
| Equity per share (SEK) | 19,17 | 26,49 | 18,19 | 23,65 | 13,67 |
| Equity ratio (%) | 88 | 91 | 85 | 97 | 94 |
| Average number of employees | 67 | 63 | 48 | 39 | 30 |
| Average number of employees in R&D | 23 | 21 | 19 | 17 | 16 |
The Group was created in 2015 with the formation of the subsidiary Immunovia Inc. In 2018, a subsidiary was established in Germany, Immunovia GmbH and in 2019 Immunovia Incentive AB and in 2020 Immunovia Dx Laboratories AB was started. The business is mainly conducted in the parent company, which is why the Group’s key figures essentially reflect the parent compa- ny’s key figures.
Alternative Key Indicators
Of the above key indicators, only the basic and diluted earnings per share metric is obligatory and defined pursuant to IFRS. Of the other key indicators, earnings/loss for the year, cash and cash equivalents at the end of the period, cash flow from operating activities, cash flow for the period and equity are from an IFRS- defined accounting presentation. The table below indicates the calculation of mandatory IFRS key ratios: earnings per share before and after dilution, equity per share and equity ratio. The table below indicates the key ratios of R&D expenses, R&D expenses as a percentage of operating expenses, a large propor- tion of the costs in the company that are used in R&D. For defi- nitions, see the section Definitions below. The company’s opera- tions are such that it does not have a steady flow of revenue, but these come irregularly in connection with the signing of license agreements and milestones achieved. Therefore, the company complies with the key indicators of equity and equity per share attributable to the Parent Company’s shareholders, to be able to assess the company’s financial position and stability. Along with these key figures, the various measures of cash flow that follow from the consolidated cash flow report are also followed.
SEK 000 unless otherwise stated
| 2021 Full year | 2020 Full year | 2019 Full year | 2018 Full year | 2017 Full year | |
|---|---|---|---|---|---|
| Earnings/loss for the year | -155 966 | -146 033 | -114 521 | -86 539 | -45 232 |
| Average number of shares before and after dilution | 22 631 581 | 21 340 672 | 19 569 089 | 18 545 795 | 16 952 559 |
| Earnings per share before dilution (SEK) | -6.89 | -6.84 | -5.85 | -4.67 | -2.67 |
| Operating expenses | 167 584 | 135 329 | 115 062 | 88 786 | 45 727 |
| Capitalized work for own account | 18 502 | 40 020 | 26 716 | 25 052 | 24 041 |
| Administrative, marketing expenses and other operating expenses | -124 675 | -127 271 | -107 505 | -87 790 | -45 727 |
| R&D expenses | 42 850 | 48 078 | 34 273 | 26 048 | 24 041 |
| R&D expenses as a percentage of operating expenses (%) | 25 | 27 | 24 | 23 | 34 |
| Equity | 433 903 | 599 403 | 357 604 | 461 952 | 236 795 |
| Equity per share | 19,17 | 26,49 | 18,19 | 23,65 | 13,67 |
| Equity | 433 903 | 599 403 | 357 604 | 461 952 | 236 795 |
| Total assets | 493 809 | 661 178 | 419 366 | 477 383 | 250 770 |
| Equity ratio (%) | 88 | 91 | 85 | 97 | 94 |
50
ANNUAL REPORT 2021
IMMUNOVIA – EARLY DETECTION
SEK 000
| | Note | 2021 Full year | 2020 Full year |
| :-------------------------------------------------------------- | :--------- | :------------- | :------------- |
| Operating income etc | | | |
| Net sales | 5 | 844 362 | |
| Other operating income | 7 | 112 624 | |
| Total | | 956 986 | |
| Operating expenses | | | |
| Raw materials and consumables | | -3 533 0 | |
| Other external expenses | 8,9 | -82 607 | -91 147 |
| Personnel expenses | 10 | -79 487 | -73 968 |
| Capitalized work for own account | | 18 502 | 40 020 |
| Depreciation/amortization of tangible/intangible fixed assets | 15, 16, 17 | -19 063 | -9 763 |
| Other operating expenses | | -1 397 | -471 |
| Total operating expenses | | -167 584 | -135 329 |
| Operating earnings/loss | | -166 628 | -134 343 |
| Profit/loss from financial items | | | |
| Financial income | 11 | 14 459 | 5 692 |
| Financial expenses | 8, 12 | -3 797 | -17 382 |
| Total financial items | | 10 662 | -11 690 |
| Earnings/loss after financial items | | -155 966 | -146 033 |
| Tax on earnings for the year | 13 | 0 | 0 |
| Earnings/loss for the year | | -155 966 | -146 033 |
| Earnings per share before and after dilution (SEK) | | -6.89 | -6.84 |
| Average number of shares | | 22 631 581 | 21 340 672 |
| Number of shares at period’s end | | 22 631 581 | 22 631 581 |
SEK 000
| | 2021 Full year | 2020 Full year |
| :----------------------------------------------------- | :------------- | :------------- |
| Earnings/loss for the period | -155 966 | -146 033 |
| Items that may be reclassified later in the income statement | | |
| Exchange rate differences for foreign net investment | -9 973 | 9 317 |
| Other earnings/loss for the year | -9 973 | 9 317 |
| Comprehensive income for the year | -165 939 | -136 716 |
Operating income
Net sales for 2021 amounted to kSEK 844 (362). Sales consist mainly of sales of test kSEK 344 (0) and royalty income kSEK 500 (362).
Operating expenses and earnings/loss
Earnings/loss for the year was MSEK –156 (–146). The result compared with the previous year was negatively affected by the balancing of expenses being stopped and amortization of these being initiated, as well as positively by the net of financial items for the year being posi- tive. Other external costs and personnel costs decreased by a total of kSEK 3 021 compared with the previous year and amounted to MSEK 162 in 2021.
Research and development
Total R&D expenses for 2021 amounted to MSEK 43 (48), which corresponds to 25% (27%) of the Group’s total opera- ting expenses.# ANNUAL REPORT 2021 51 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Note | 2021 Dec 31 | 2020 Dec 31 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible assets | |||
| Capitalized development expenditure | 14 | 122 492 | 111 234 |
| Patents, licenses and similar rights | 15 | 24 655 | 23 701 |
| 147 134 | 134 935 | ||
| Tangible assets | |||
| Improvements on someone else’s property | 16 | 6 683 | 6 537 |
| Equipment, tools, fixtures and fittings | 17 | 6 989 | 9 069 |
| Right-of-use leasing | 18 | 32 855 | 33 095 |
| 46 527 | 48 701 | ||
| Financial assets | |||
| Other non-current receivables | 19 | 3 033 | 2 746 |
| Total assets | 196 707 | 186 382 | |
| Current assets | |||
| Inventory | 2 150 | 0 | |
| Current receivables | |||
| Accounts receivables | 72 0 | ||
| Other receivables | 4 021 | 3 895 | |
| Prepaid expenses and deferred income | 20 | 3 453 | 2 439 |
| 9 696 | 6 334 | ||
| Cash and cash equivalents | 287 406 | 468 462 | |
| Total current assets | 297 102 | 474 796 | |
| TOTAL ASSETS | 493 809 | 661 178 | |
| EQUITY AND LIABILITIES | |||
| Equity | 22 | ||
| Share capital | 1 132 | 1 132 | |
| Other paid-up capital | 1 015 730 | 1 015 290 | |
| Reserves | -1 658 | 8 315 | |
| Accumulated earnings or loss including earnings/loss for the year | -581 300 | -425 334 | |
| Total equity | 433 904 | 599 403 | |
| Long-term liabilities | |||
| Leasing liabilities | 25 | 27 156 | 27 988 |
| Total long-term liabilities | 27 156 | 27 988 | |
| Current liabilities | |||
| Leasing liabilities | 25 | 6 106 | 5 143 |
| Accounts payable | 3 067 | 4 255 | |
| Other liabilities | 3 366 | 2 441 | |
| Accrued expenses and deferred income | 23 | 20 210 | 21 948 |
| Total current liabilities | 32 749 | 33 787 | |
| TOTAL EQUITY AND LIABILITIES | 493 809 | 661 178 |
52 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
Investment
Purchases of intangible assets totaled MSEK 21 (43), divided between capitalized expenditure for development of MSEK 18 (40), patents MSEK 3 (2) and other tangible assets of MSEK 0 (1). During the second quarter of 2021, the development of the company’s test for early detection of pancreatic cancer was completed and with this, the capitalization of the development costs for this ended and the depreciation of the capitalized costs began. During the year, tangible fixed assets were acquired in the form of equipment and improvement expenses on another property for MSEK 3 corresponding to MSEK 4 in the same period last year. No investments in financial assets were made in 2021.
Equity
Equity at the end of the period totaled MSEK 434 (599) and the equity ratio was 88 percent (91 percent).
| SEK 000 | Share Capital | Other contributed equity | Reserves | Accumulated Earnings or Loss incl. earning/loss for the year | Total Equity |
|---|---|---|---|---|---|
| Opening balance January 1, 2020 | 983 | 636 924 | -1 002 | -279 300 | 357 604 |
| Comprehensive income for the year | -146 033 | -146 033 | |||
| Transactions with shareholders in their capacity as owners | |||||
| New share issue | 149 403 | 704 403 | 853 806 | ||
| Share issue cost | -25 337 | -25 337 | |||
| Translation difference | 9 317 | 9 317 | |||
| Closing balance December 31, 2020 | 1 132 | 1 015 290 | 8 315 | -425 334 | 599 403 |
| Comprehensive income for the year | -155 966 | -155 966 | |||
| Transactions with shareholders in their capacity as owners | |||||
| Deposited share warrant premiums | 440 | 440 | |||
| Translation difference | -9 973 | -9 973 | |||
| Closing balance December 31, 2021 | 1 132 | 1 015 730 | -1 658 | -581 300 | 433 904 |
53 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Note | 2021 Full year | 2020 Full year |
|---|---|---|---|
| Operating activities | |||
| Operating earnings | -166 628 | -134 343 | |
| Adjusted for non-cash flow items | 24 | 20 048 | 9 945 |
| Interest received | 711 | 577 | |
| Interest paid | -1 441 | -1 415 | |
| Tax paid | 0 | 0 | |
| Cash flow from operating activities before changes in working capital | -147 310 | -125 236 | |
| Cash flow from changes in working capital | |||
| Change in inventory | -2 038 | 0 | |
| Changes in operating receivables | -1 098 | -579 | |
| Change in operating liabilities | -2 202 | 5 111 | |
| Cash flow from operating activities | -152 648 | -120 704 | |
| Investment activities | |||
| Investment in intangible assets | -21 083 | -43 497 | |
| Investment in tangible assets | -3 101 | -3 998 | |
| Sales of tangible fixed assets | 358 | 537 | |
| Cash flow from investment activities | -23 826 | -46 958 | |
| Financing activities | |||
| Amortization of leasing liability | 25 | -5 709 | -4 935 |
| National and European subsidies of development expenses | 0 | 0 | |
| New share issue | 0 | 378 515 | |
| Deposited share warrant premiums | 440 | 0 | |
| Cash flow from financing activities | -5 269 | 373 580 | |
| Cash flow for the year | -181 743 | 205 918 | |
| Cash and cash equivalents at beginning of year | 468 462 | 263 345 | |
| Exchange rate differences in cash and cash equivalents | 687 | -801 | |
| Cash and cash equivalents at end of year | 287 406 | 468 462 |
The cash flow from operating activities for 2021 was MSEK -153 (-121) and the total cash flow was MSEK -182 (206).
Cash and Cash Equivalents
Cash and cash equivalents as of December 31, 2021 amounted to MSEK 287 (468). The company management makes the assessment that, based on the cash of MSEK 287 and the financing plans that exist, the company’s continued operations are ensured.
54 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Note | 2021 Full year | 2020 Full year |
|---|---|---|---|
| Operating revenue etc | |||
| Net sales | 6 | 5 9 987 | 362 |
| Capitalized work for own account | 18 502 | 40 020 | |
| Other operating revenue | 7 | 96 451 | |
| Total operating revenue | 28 585 | 40 833 | |
| Operating expenses | 6 | ||
| Raw materials and consumables | -2 084 | 0 | |
| Other external expenses | 8,9 | -87 841 | -89 134 |
| Personnel expenses | 10 | -48 100 | -48 835 |
| Depreciation/amortization of tangible/intangible fixed assets | 15, 16, 17 | -11 685 | -3 310 |
| Other operating expenses | -1 397 | -471 | |
| Total operating expenses | -151 107 | -141 750 | |
| Operating earnings/loss | -122 522 | -100 917 | |
| Profit/loss from financial items | |||
| Interest income and similar items | 11 | 17 869 | 7 982 |
| Interest cost and similar items | 12 | -2 356 | -15 967 |
| Total financial items | 15 513 | -7 985 | |
| Profit/loss after net financial items | -107 009 | -108 902 | |
| Appropriations | |||
| Group contribution received | 437 | 88 | |
| Total appropriations | 437 | 88 | |
| Earnings/loss before tax | -106 572 | -108 814 | |
| Tax on earnings for the year | 13 | 0 | 0 |
| Earnings/loss for the year | -106 572 | -108 814 |
| SEK 000 | 2021 Full year | 2021 Full year | |
|---|---|---|---|
| Earnings/loss for the year | -106 572 | -108 814 | |
| Other comprehensive income | |||
| Other comprehensive income for the year | 0 | 0 | |
| Total comprehensive income for the year | -106 572 | -108 814 |
55 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Note | 2021 Full year | 2020 Full year |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible assets | |||
| Capitalized development expenditure | 14 | 122 492 | 111 234 |
| Patents, licenses and similar rights | 15 | 23 286 | 22 316 |
| 145 778 | 133 550 | ||
| Tangible assets | |||
| Improvements on someone else’s property | 16 | 5 861 | 5 736 |
| Equipment, tools, fixtures and fittings | 17 | 4 324 | 5 648 |
| 10 185 | 11 384 | ||
| Financial assets | |||
| Participations in group companies | 21 | 328 | 328 |
| Total assets | 156 291 | 145 262 | |
| Current assets | |||
| Current receivables | |||
| Inventory | 1 722 | 0 | |
| Receivables from group companies | 147 557 | 85 556 | |
| Other receivables | 3 951 | 3 850 | |
| Prepaid expenses and deferred income | 20 | 2 594 | 3 088 |
| 155 824 | 92 494 | ||
| Cash and bank balances | 279 191 | 461 730 | |
| Total current assets | 435 015 | 554 224 | |
| TOTAL ASSETS | 591 306 | 699 486 | |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | |||
| Share capital | 1 132 | 1 132 | |
| Fund for development expenditure | 117 176 | 105 589 | |
| 118 308 | 106 721 | ||
| Non-restricted equity | |||
| Share premium reserve | 0 | 378 367 | |
| Accumulated earnings/loss | 553 850 | 295 884 | |
| Earnings/loss for the year | -106 572 | -108 814 | |
| 447 278 | 565 437 | ||
| Total equity | 565 586 | 672 158 | |
| Current liabilities | |||
| Accounts payable | 2 570 | 3 384 | |
| Other liabilities | 3 398 | 2 440 | |
| Accrued expenses and deferred income | 23 | 19 752 | 21 504 |
| Total current liabilities | 25 720 | 27 328 | |
| TOTAL EQUITY AND LIABILITIES | 591 306 | 699 486 |
56 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Share capital | Fund for development expenditure | Share premium reserve | Accumulated earnings/ loss | Earnings/ loss for the year | Total equity |
|---|---|---|---|---|---|---|
| Opening balance, January 1, 2020 | 983 | 65 569 | 10 232 | 416 204 | -90 531 | 402 457 |
| Transfer of previous year’s earnings/loss | -10 232 | -80 299 | -90 531 | |||
| Comprehensive income for the year | -108 814 | -108 814 | ||||
| Capitalized development expenditure for the year | 40 020 | 40 020 | ||||
| Transactions with shareholders in their capacity as owner | ||||||
| New share issue | 149 403 | 704 403 | 853 806 | |||
| Share issue cost | -25 338 | -25 338 | ||||
| Closing balance December 31, 2020 | 1 132 | 105 589 | 378 367 | 295 884 | -108 814 | 672 158 |
| Opening balance January 1, 2021 | 1 132 | 105 589 | 378 367 | 295 884 | -108 814 | 672 158 |
| Transfer of previous year’s earnings/loss | -378 367 | 269 552 | 108 814 | 0 | ||
| Comprehensive income for the year | -106 572 | -106 572 | ||||
| Capitalized development expenditure for the year | 18 502 | 18 502 | ||||
| Depreciations capitalized development expenditure | -6 915 | -6 915 | ||||
| Transactions with shareholders in their capacity as owner | ||||||
| Closing balance December 31, 2021 | 1 132 | 117 176 | 0 | 553 850 | -106 572 | 565 586 |
57 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| SEK 000 | Note | 2021 Full year | 2020 Full year |
|---|---|---|---|
| Operating activities | |||
| Operating earnings/loss | -122 522 | -100 917 | |
| Adjustments for non-cash flow items | 24 | 12 542 | 3 221 |
| Interest received | 711 | 576 | |
| Interest paid | -3 | -3 | |
| Tax paid | 0 | 0 | |
| Cash flow from operating activities before changes in working capital | -109 272 | -97 123 | |
| Cash flow from changes in working capital | |||
| Change in inventory | -1 721 | 0 | |
| Changes in operating receivables | -47 181 | -40 715 | |
| Changes in operating liabilities | -794 | 4 420 | |
| Cash flow from operating activities | -158 968 | -133 418 | |
| Investment activities | |||
| Investment in intangible assets | -21 235 | -42 882 | |
| Investment in tangible assets | -2 522 | -2 645 | |
| Investment in financial assets | 0 | -25 | |
| Försäljning av anläggningstillgångar | 186 | 537 | |
| Cash flow from investment activities | -23 571 | -45 015 | |
| Financing activities | |||
| New share issue | 0 | 378 516 | |
| Cash flow from financing activities | 0 | 378 516 | |
| Cash flow for the year | -182 539 | 200 083 | |
| Cash and cash equivalents at beginning of year | 461 730 | 261 647 | |
| Cash and cash equivalents at end of year | 279 191 | 461 730 |
58 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
Immunovia AB, with its registered office in Lund, registered in Sweden with corporate identity# Immunovia AB (publ)
number 556730-4299, is the parent company of the four wholly-owned subsidiaries Immuno- via Incentive AB, corp. ID no. 559198-2870, registered office in Lund, Immunovia Dx Labora- tories AB, corp. ID no. 559244-6503, registered office in Lund, Immunovia Inc, corp. ID no. 350589-6, registered office in Wilmington, USA and Immunovia GmbH, corp. ID no. HRB 111 597, registered office in Frankfurt am Main. These companies are collectively termed the group, or Immunovia. The address is Medicon Village, 223 63 Lund, Sweden. The group was formed in December 2015 through the incorporation of Immunovia Inc. The Group’s operations consist of the development of new and improved methods for diagnosing complex diseases within cancer. The Board of Directors approved these Consolidated Accounts for publication on March 10, 2022.
The Consolidated Accounts have been prepared in accordance with the Swedish Annual Accounts Act, RFR 1 Supplementary Accounting Rules for Groups, International Financial Reporting Standards (IFRS) and interpretation statements from the IFRS Interpretations Committee (IFRS IC) as endorsed by the EU. The parent company’s Annual Accounts have been prepared in accordance with the Swedish Annual Accounts Act and RFR 2 Accounting for Legal Entities. This recommendation means that the parent company applies the same accounting policies as a group, apart from in those cases where the Swedish Annual Accounts Act or applicable tax regulation limit the scope to apply IFRS. Differences between the parent company’s and group’s accounting policies are stated under the parent company’s accounting policies below.
The Consolidated Accounts have been prepared in accordance with the cost method. The Balance Sheet items entitled current assets and current liabilities are expected to be recovered and paid within 12 months. All other Balance Sheet items are expected to be recovered or paid later. The Group’s functional reporting currency is Swedish kronor. The consolidated accounts and annual report are presented in thousands of Swedish kronor (SEK 000) unless otherwise stated.
No standards to be applied by the Group for the first time from January 1, 2021 have had, or are expected to have any impact on the Group’s accounts.
A number of new standards and interpretations come into force for fiscal years beginning after January 1, 2021 and have not been applied in the preparation of this annual report. The new stan- dards and interpretations that have not yet come into force are not expected to have any impact on the Group’s financial reports.
Subsidiaries are all companies over which the Group exerts a controlling influence. The Group controls a company when it is exposed, or has rights, to variable returns from its holding in the company, and has the possibility to affect returns through its influence in the company. Subsidiaries are included in the Consolidated Accounts effective the date when controlling influence is transferred to the group. They are derecognized from the Consolidated Accounts effective the date the controlling influence ceases. The Acquisition method is used for recognizing the Group’s business combinations.
ANNUAL REPORT 2021 59
IMMUNOVIA – EARLY DETECTION
The purchase price for the acquisition of a subsidiary consists of the fair value of the assets acquired and liabilities the group takes over from previous owners of the acquired company, and the shares issued by the Group. The purchase consideration also includes the fair value of all assets or liabilities that are a consequence of an agreement on a conditional purchase consideration. Identifiable acquired assets and liabilities taken over in a business combination are initially measured at fair value on the acquisition date. Acquisition-related costs are expensed as they arise. Intra-group transactions, Balance Sheet items and unrealized gains and losses on transactions between Group companies are eliminated. The accounting policies for subsidiaries have been amended were applicable to ensure consistent application of the group’s policies.
Items recognized in the financial statements for the different entities of the Group are measured in the currency used in the economic environment where each entity is mainly operational (func- tional currency). In the Consolidated Accounts, Swedish krona (SEK) is utilized, which is the Group’s presentation currency.
Foreign currency transactions are translated into the functional currency at the exchange rates prevailing on the transaction date or the date the items are revalued. Exchange rate gains and exchange rate losses arising from the payment of such transactions and when translating mone- tary assets and liabilities in foreign currency at the closing day rate, are reported in the income statement. The exception is when the transactions are hedges that fulfill the conditions for hedge accounting of cash flows or of net investments, when gains / losses are recognized in other compre- hensive income. Exchange rate gains and losses related to loans and cash and cash equivalents, are recognized in the income statement as financial income or expenses. All other exchange rate gains and losses are reported net in the items other operating income or other operating expenses in the income statement.
The results of operations and financial positions of all Group companies that have different functio- nal currencies than the presentation currency are translated to the Group’s as follows:
* Assets and liabilities for each balance sheet are translated at closing day rates
* Revenues and expenses for each income statement are translated at average rates of exchange
* All exchange rate differences arising are recognized in other comprehensive income
Intangible and tangible assets are recognized at cost after deductions for amortization and depre- ciation. The acquisition cost includes expenditure directly related to the acquisition of the asset. Additional expenditure is added to the asset’s carrying amount or recognized as a separate asset, whichever is appropriate, only when it is likely that the future financial benefits associated with the asset will benefit the Group and the asset’s acquisition value can be measured reliably. Expenditure for repairs and maintenance are reported as expenses in the income statement during the period in which they arise. Depreciation and amortization is on a straight-line basis as follows:
| Asset Type | Depreciation Period |
|---|---|
| Capitalized expenditure | 10 years |
| Patents | 16 years |
| Improvement to another’s property | 10 years |
| Licenses | 5 years |
| Equipment, tools, fixtures and fittings | 5 years |
For development expenses, depreciation is started as soon as the asset is completed and can be used in the intended way. Development expenditure that increases functionality and value is recognized as an intangible asset when the following criteria are satisfied:
60 ANNUAL REPORT 2021
IMMUNOVIA – EARLY DETECTION
Directly related expenditure capitalized as a portion of an intangible asset includes expenditure for employees and a reasonable share of indirect expenses. Other development expenses that do not satisfy the above criteria are expensed as they arise. Development expenses that had been pre- viously expensed are not recognized as an asset in the subsequent period. The residual values and useful lives of assets are tested at each reporting date and restated as required. The residual life of an asset is impaired to its recoverable amount immediately if the asset’s carrying amount exceeds its estimated recoverable amount.
Intangible assets that are not ready for use are not impaired, but rather subject to yearly impair- ment tests. Assets that are depreciated/amortized are subject to impairment tests whenever events or changed circumstances indicate that the carrying amount may not be recoverable. Impairment is taken at an amount whereby the asset’s carrying amount exceeds its recoverable amount. The reco- verable amount is the greater of the asset’s fair value less selling expenses and value in use. When measuring value in use, estimated future cash flows are discounted to present value by applying a discount rate before tax that reflects the current market assessment of the time value of money, and the risks associated with the asset. When conducting impairment tests, assets are grouped at the lowest level where there are essentially independent cash flows (cash-generating units). For assets that have been previously impaired, a test of reversal is conducted at each reporting date.
The Group classifies its financial assets in the following categories: financial assets measured at fair value through profit or loss, loan receivables and accounts receivable, as well as saleable financial assets. This classification depends on the purpose for which the financial asset was purchased. Ma- nagement determines the classification of financial assets on first-time recognition. At present, the Group only has financial assets in the loan receivables and accounts receivable category.
At present, the Group has only financial assets that are not normally sold outside the Group and where the purpose of the holding is to obtain contractual cash flows.# IMMUNOVIA – EARLY DETECTION
All financial assets are classified as financial assets that are valued at accrued acquisition cost using the effective interest method. Cash and cash equivalents In the balance sheet and cash flow statements, cash and cash equivalents include cash, bank balan- ces and other investments in securities, etc. with maturities within three months of the acquisition date. When acquiring financial assets, expected credit losses are reported continuously during the hol- ding period, normally taking into account credit loss risk within the next 12 months. In the event that the credit risk has increased significantly, it is reserved for the credit losses that are expected to occur during the entire term of the asset. Immunovia applies the simplified method for calcu- lating loan losses based on historical data regarding payment patterns and payment ability of the counterparty. Based on historical data, the expected loan losses are judged to be extremely limited.
Ordinary shares are classified as share capital.
Transaction expenses that are directly related to the issue of new ordinary shares or options are recognized net of tax in equity, as a deduction from the issue proceeds.
Dividends to shareholders are reported as a liability in the financial reports in the period in which the dividend is determined by the company’s shareholders.
Financial liabilities valued at accrued cost. The Group only has financial liabilities that are classified and valued at amortized cost using the effective interest method. Accounting is initially made at fair value, net after transaction costs.
The recognition of income taxes include current tax and deferred tax. Tax is recognized in the Income Statement, apart from those cases where it relates to items recognized directly in equity. In such cases, tax is also recognized in equity. Deferred tax is recognized pursuant to the balance sheet method on all temporary differences. A temporary difference exists when the book value of an asset or liability differs from its value for tax purposes. Deferred tax is measured by applying the tax rates that are enacted or substantively enacted on the reporting date, and are expected to apply when the affected tax asset is realized, or the tax liability is settled. Deferred tax assets are recognized to the extent it is likely that future taxable surpluses will exist against which the temporary differen- ces can be utilized.
Net sales consist of income from the sale of test results and royalty compensation, the distribution is stated in Note 5. Revenue from agreements with customers is reported when the performance commitment has been fulfilled and control of a product or service has been transferred to the customer. This assessment must be viewed from the customer’s perspective, taking into account indications such as transfer of ownership and risks, customer acceptance, physical access and the right to invoice. Assessment must also be made if the control is transferred at a certain time or over time. Immunovia has no customer agreements where the performance commitment falls later than twelve months after the balance sheet date.
A contract regarding the sale of a test result contains a performance commitment, which means performing tests on blood samples for a customer, ie. patients. The test result is sent to the patients immediately after the analysis has been performed. Revenue recognition takes place when the test result is transferred to the patients, ie. which in practice is the day when the test is sent by post to the patient. Revenue recognition thus takes place at a certain time. The price per test is fixed at each time. No discounts or the like are paid afterwards. The royalty compensation is reported as income according to the financial meaning in the respec- tive royalty agreement. For current agreements, this means accounting at a certain time, ie. when the conditions for receiving the compensation are met, which is mainly based on each party’s sales volumes. Interest income is reported as income over the term using the effective interest method.
The timing of revenue recognition, invoicing and payments leads to invoiced accounts receivable and uninvoiced accounts receivable. Uninvoiced accounts receivable (contract assets) are reported in the balance sheet under repaid expenses and accrued income. Invoiced but not yet provided ser- vices (contractual liabilities) are reported in the balance sheet under accrued expenses and prepaid income.
Public subsidies are recognized at fair value providing there is reasonable assurance that the terms associated with the subsidy will be satisfied, and that thereby, the subsidy will be received. Subsi- dies received to cover expenses are recognized under the heading other income in the same period as the expenses arise. Subsidies relating to an asset reduce the asset’s value in the balance sheet.
When signing new leasing agreements, a right-of-use asset and a leasing liability are reported in the balance sheet. The acquisition value consists of the discounted remaining leasing fees for non-cancellable leasing periods. Possible extension periods are included if the Group is reasonably certain that these will be used. When discounting, the company uses marginal loan interest rates, which are currently 4%. The lease may change during the lease term, whereby the lease liability and the right-of-use asset are revalued. Leasing fees are divided between amortization of the leasing liability and payment of interest. The Group’s significant leasing agreements consist of agreements regarding the leasing of office premises. The company applies the relief rules regarding leasing agreements where the underlying asset has a low value and short-term leasing agreements. These leases are recognized as an expense in the period in which the use occurs.
Liabilities for salaries and benefits and paid absence that is expected to be settled within 12 months of the end of the financial year, are recognized as current liabilities at the amount expected to be paid when the liabilities are settled, excluding discounts. All the group’s pension obligations are in defined contribution plans. In a defined contribution plan, the company pays predetermined fees to an independent pension institution. When these contributions are paid, the company has no further obligations. Benefits such as salary and pensions are recognized as an expense in the period when employees have rendered the services that the compensation relates to.
Loan expenses that are directly attributable to the purchase, construction or production of qualified assets are reported as part of the acquisition value of these assets. Qualified assets are assets that necessarily take a considerable amount of time to complete for the intended use or sale. Capitaliza- tion ceases when all activities required to complete the asset for its use or sale have been substan- tially completed. All other loan expenses are expensed as they arise.
The cash flow statement has been prepared in accordance with the indirect method, which means that net earnings/losses are restated for transactions that do not involve any payments made or received in the period, and for any revenues and expenses relating to cash flow from investment or financing activities. Cash and cash equivalents include cash and immediately available balances with banks.
The Parent Company’s accounting principles are unchanged compared with the previous year.
Participations in subsidiaries are recognized at cost after deducting for potential impairment. Cost includes acquisition-related expenses and potential additional purchase considerations. When there is an indication that participations in subsidiaries are impaired, recoverable amount is measured. If the recoverable amount is lower than the carrying amount, an impairment is taken. Impairment is recognized in the earnings/loss from participations in Group companies’ items.
The Parent Company does not apply IFRS 9 except as regards the rules for assessing and calcula- ting the need for impairment of financial assets. In the Parent Company, financial fixed assets are valued at acquisition value less any write-downs and financial current assets at the lower of acqui- sition value and fair value less costs to sell.
The parent company uses the exception regarding the application of IFRS 16 Leasing, which means that all leases are recognized as a cost on a straight-line basis over the lease period.
The parent company applies the alternative rule for group contributions and reports both paid and received group contributions as appropriations in the income statement. Shareholder contributions are entered directly against the equity of the recipient and are capitalized in shares and participa- tions, to the extent that no impairment is required.
Through its operations, the Group is exposed to various financial risks such as market risk (extensi- ve currency risk and interest risk in cash flow), credit risk and liquidity risk. The Group’s overarching risk management policy, which is adopted by the Board of Directors, is intended to minimize unfa- vorable effects on results of operations and financial position.# Market Risk
The Group operates nationally and internationally, which means exposure to fluctuations in various currencies, and then primarily, the USD and EUR. Currency risk arises through future business transactions, and reported assets and liabilities. The scope of the company’s operations means that, at present, net exposure in foreign currencies is limited. Accordingly, there is no policy prescribing hedging of this exposure. If the Swedish krona had depreciated or appreciated by 10 percent, with all other variables constant, adjusted earnings after tax as on December 31, 2021, would have been MSEK 14 (8) lower/higher, mostly as a consequence of gains and losses on the restatement of current receivables and liabilities. The corresponding impact on the parent company would have been MSEK 15 (8).
Interest risk is the risk that the value of financial instruments varies due to fluctuations in market interest rates. At present, the Group only has interest-bearing financial assets in the form of bank balances. On the basis of the financial interest-bearing assets and liabilities that accrue variable interest as of December 31, 2021, a one percentage point change in market interest rates would affect the Group’s earnings by MSEK 3 (4). For the parent company, the corresponding effect would be MSEK 3 (5).
Credit risk is the risk that a party in a transaction with a financial instrument is unable to fulfil its obligations. The maximum exposure for credit risks in financial assets as on December 31, 2021 is MSEK 291 (472). The corresponding figure for the parent company was MSEK 280 (548).
Prudence in the management of liquidity risk means holding sufficient cash and cash equivalents or contracted credit facilities to be able to close market positions. The company management makes the assessment that, based on the cash of MSEK 287 and the financing plans that exist, the company’s continued operations are ensured.
64 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
The most important assumptions regarding the future and other sources of uncertainty in estimates as of the reporting date, which involve significant risk of material restatements in the carrying amounts of assets and liabilities in the following financial years are stated below. The greatest uncertainty is within intangible assets. Capitalized development expenses that have not yet begun to be depreciated must be formally tested for impairment annually. Immunovia began depreciation of capitalized development expenses as of June 1, 2021. However, as revenue flow is still limited, the Group continues to continuously, at least annually, test the asset for impairment. Impairment tests are based on a review of recoverable amount, which is estimated on the basis of the value in use of assets. Management makes estimates of future cash flows in accordance with internal business plans and forecasts. Estimates of the discount rate and future growth rates beyond the determined budgets and forecasts are also used in this review. The carrying amount of intangible assets is MSEK 147 (135), of which capitalized development expenditure amounts to MSEK 122 (111) and MSEK 25 (24) consists of patents and licenses. Changes to the assumption management employed in impairment tests could have a material effect on the company’s results of operations and financial position. For further information see Note 14.
| SEK 000 | 2021 | 2020 |
|---|---|---|
| Total interest-bearing liabilities | 33 262 | 33 131 |
| Less: interest-bearing assets | -290 439 | -471 208 |
| Net debt | -257 177 | -438 077 |
| Total equity | 433 903 | 599 403 |
| Net debt/equity ratio (%) | -59 | -73 |
Net debt Interest-bearing liabilities less interest-bearing assets (including cash and cash equivalents).
Net debt/equity ratio Net debt in relation to equity.
| SEK 000 | Within 3 mth | Between 3 mth. and 1 yr | Between 1 yr and 2 yr | Between 2 yr and 5 yr | Later than 5 yr |
|---|---|---|---|---|---|
| Leasing liability | 1 856 | 5 569 | 5 284 | 13 873 | 7 862 |
| Accounts payable | 3 067 | 0 | 0 | 0 | 0 |
| Accrued expenses | 12 413 | 0 | 0 | 0 | 0 |
| Total | 17 366 | 5 569 | 5 284 | 13 873 | 7 862 |
Risk The Group’s goal in terms of capital structure, defined as equity, is to secure the company’s ability to continue its operations to enable it to generate returns to shareholders and benefits to other stakeholders, and that its capital structure is optimal considering the cost of capital. Dividends to shareholders, redemption of shares, issuance of new shares or sales of assets are examples of actions the company could use to adjust its capital structure.
Financial Liabilities as on December 31, 2021 become due for payment:
65 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
Business segments are reported in a manner that is consistent with the internal reporting presented to the chief operating decision maker. The chief operating decision maker is that function responsible for allocating resources and judging the performance of operating segments. In the Group, this function has been identified as management, which consists of seven individuals including the CEO. Management has determined that the group as a whole is a single segment based on information considered in consultation with the board used as supporting data to allocate resources and evaluate performance. Of the Group’s Intangible- and tangilbe assets, MSEK 186 (174) are in Sweden, MSEK 7 (10) in the US and kSEK 0 (253) in Germany. Of the Group’s net sales, kSEK 344 consists of income from the sale of tests and kSEK 500 of royalty income. Revenues from royalty have been invoiced in full from Sweden to customers in the USA. The test results are performed for customers in the USA and invoiced from our company in the USA.
| Parent company 2021 | Parent company 2020 | The Group 2021 | The Group 2020 | |
|---|---|---|---|---|
| Share of sales relating to Group companies | 95% | 0% | ||
| Share of purchases relating to Group companies | 12% | 3% |
| Parent company 2021 | Parent company 2020 | The Group 2021 | The Group 2020 | |
|---|---|---|---|---|
| Other diverse income | 0 | 289 | 0 | 116 |
| Exchange rate gains | 113 | 335 | 96 | 335 |
| Total | 113 | 624 | 96 | 451 |
The most important assessments when reporting leasing agreements are the length of the leasing period and the discount rate to be used. The Group’s leasing agreements in the form of agreements for the use of office premises are normally signed for fixed periods between 3 and 8 years where there may be a possibility of extension. When determining the length of the lease, management considers all available information providing a financial incentive to exercise an extension option, or not to exercise an option to terminate an agreement. Options to extend an agreement are only included in the length of the leasing agreement if it is reasonably certain that the agreement will be extended. Individual assessments regarding extensions are made on an ongoing basis, contract by contract. If the Group has improvement costs relating to someone else’s property and expects them to have significant residual value, it is usually reasonably certain that the agreements will be extended. During the current financial year, there was no need for recalculation.
66 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
The Group has leasing agreements, mainly in the form of agreements for the use of office premises. The following amounts have been reported in the income statement. On December 31, 2021 the Group had obligations regarding short-term leasing agreements of SEK 0 (0). The total cash flow for leases amounted to SEK 7.3 million (6.4).
| 2021 | 2020 | |
|---|---|---|
| Operational leasing, incl rent for premises | ||
| Lease payments, expense for the year | 5 395 | 4 790 |
| Remaining lease payments become due as follows: | ||
| Within 1 year | 5 395 | 5 284 |
| Later than 1 year but within 5 years | 19 158 | 19 950 |
| Later than 5 years | 7 862 | 12 354 |
| Total | 32 415 | 37 588 |
| Amounts reported in the results | ||
| Depreciation on right-of-use assets | -6 175 | -5 490 |
| Interest expense for leasing liabilities | -1 430 | -1 415 |
| Expenses attributable to low value leasing contracts | -62 | -71 |
| Expenses attributable to variable fees not included in the valuation of the leasing liability | -23 | -62 |
Parent company
The Group
| Parent company 2021 | Parent company 2020 | The Group 2021 | The Group 2020 | |
|---|---|---|---|---|
| HLB Auditoriet AB | ||||
| Audit assignments | 350 | 335 | 350 | 335 |
| Other services | 10 | 155 | 10 | 155 |
| Total | 360 | 490 | 360 | 490 |
Parent company
The Group
ANNUAL REPORT 2021 67 IMMUNOVIA – EARLY DETECTION
| No. of employees | Of which male | No. of employees | Of which male | |
|---|---|---|---|---|
| Parent company | ||||
| Sweden | 45 | 13 | 49 | 16 |
| Subsidiaries | ||||
| USA | 20 | 7 | 13 | 5 |
| Germany | 1 | 0 | 1 | 0 |
| Total subsidiaries | 21 | 7 | 14 | 5 |
| The Group total | 66 | 20 | 63 | 21 |
| Female | Male | Female | Male | |
|---|---|---|---|---|
| 2020 | 2020 | 2021 | 2021 | |
| Average number of employees | ||||
| Gender balance, senior executives | ||||
| The Board | 2 | 5 | 2 | 5 |
| CEO and other management | 5 | 6 | 4 | 5 |
| 2020 | 2021 | 2020 | 2021 | |
| Salaries and benefits | Salaries and benefits | Social security contributions | Social security contributions | |
| Parent company | ||||
| The Board and CEO | 8 807 | 8 710 | 2 767 | 3 561 |
| (of which pension expenses) | (0) | (0) | (664) | (0) |
| Other employees | 26 052 | 26 029 | 10 475 | 9 850 |
| (of which pension expenses) | (3 257) | (2 730) | ||
| Subsidiaries | ||||
| Other employees | 20 326 | 20 688 | 2 013 | 1 919 |
| (of which pension expenses) | (596) | (561) | ||
| The Group total | 55 185 | 55 427 | 15 255 | 15 330 |
| (of which pension expenses) | (3 853) | (3 955) |
Personnel expenses Senior executives mean the individuals that make up the company’s management with the Chief Executive Officer. There are eleven people in this group. Fees are payable to the Chairman of the Board and Directors pursuant to AGM resolution. The following table illustrates compensation received. Social security contributions are not included in the costs.# ANNUAL REPORT 2021
| Name | Position | Salary & benfits/ directors’ fee | Pension expenses | Other benefits | Total |
|---|---|---|---|---|---|
| Carl Borrebaeck | Chairman | 580 | 0 | 0 | 580 |
| Hans Johansson | Director | 288 | 0 | 0 | 288 |
| Peter Høngaard Andersen | Director | 268 | 0 | 0 | 268 |
| Christofer Sjögren | Director | 290 | 0 | 0 | 290 |
| Martin Møller | Director | 160 | 0 | 0 | 160 |
| Mimmi Ekberg | Director | 240 | 0 | 0 | 240 |
| Ann-Christine Sundell | Director | 308 | 0 | 0 | 308 |
| Total, Board | 2 134 | 0 | 0 | 2 134 | |
| Patrik Dahlen | CEO | 3 199 | 0 | 0 | 3 199 |
| Other senior executives | 13 690 | 767 | 717 | 15 174 | |
| Total CEO and other senior execu- tives | 19 023 | 767 | 717 | 20 507 |
| Name | Position | Salary & benfits/ directors’ fee | Pension expenses | Other benefits | Total |
|---|---|---|---|---|---|
| Carl Borrebaeck | Chairman | 527 | 0 | 0 | 527 |
| Hans Johansson | Director | 237 | 0 | 0 | 237 |
| Peter Høngaard Andersen | Director | 160 | 0 | 0 | 160 |
| Christofer Sjögren | Director | 257 | 0 | 0 | 257 |
| Mats Grahn | Director | 65 | 0 | 0 | 65 |
| Mimmi Ekberg | Director | 211 | 0 | 0 | 211 |
| Ann-Christine Sundell | Director | 257 | 0 | 0 | 257 |
| Total Board | 1 714 | 0 | 0 | 1 714 | |
| Mats Grahn/Patrik Dahlen | CEO | 7 064 | 664 | 0 | 7 728 |
| Other senior executives | 7 569 | 823 | 1 499 | 9 891 | |
| Total CEO and other senior executives | 14 633 | 1 487 | 1 499 | 17 619 |
The CEO has a notice period of six months on resignation. A notice period of six months applies to termination by the company. Other compensation to senior executives wholly consists of invoiced fees and compensation for service in management. The Board of Directors and senior executives are members of share warrant programs, whose terms are stated below. All the group’s pension obligations are in defined contribution plans. In defined contribution plans, the company pays predetermined charges to insurance companies. Retirement age is 67.
Immunovia has four outstanding warrant schemes that comprise 359 500 warrants with the right to subscribe for 359 500 shares. There is no dilution effect as long as the Group’s earnings are negative. The warrant programs are aimed at employees and key personnel in the company. At the time of allocation, all warrants have been valued according to the Black & Scholes valuation model. A summary of the company’s warrant program can be found below.
In countries where warrant programs are not appropriate for various reasons, it has been decided to introduce alternative cash-based incentive programs for employees and key personnel in the company. The alternative incentive programs are designed in such a way that their financial effect corresponds to the terms in the corres- ponding warrant program. The total cost to the Company for the cash-based incentive programs is shown in the summary below. All warrant schemes are subject to customary recalculation terms in connection with share issues, etc.
| Incentive scheme | Decision date | Utilization period | Number of outstanding warrants | Subscription price/ share | Change in share capital at full utilization | Total cost of alternative cash-based incentive schemes (USD) |
|---|---|---|---|---|---|---|
| Warrant scheme 2019/2023 | Apr 26, 2019 | Jun 1, 2023 - Jun 30, 2023 | 79 500 | 342.06 | 3 975.00 | |
| Warrant scheme 2020/2024 | Sep 23, 2020 | Jun 1, 2024 - Jun 30, 2024 | 280 000 | 455.59 | 14 000.00 | |
| Alternative cash- based incentive scheme 2019/2023 | Apr 26, 2019 | Jun 1, 2023 - Jun 30, 2023 | 520 000 | |||
| Alternative cash- based incentive scheme 2020/2024 | Sep 23, 2020 | Jun 1, 2024 - Jun 30, 2024 | 192 000 | |||
| Total | 359 500 | 17 975.00 | 712 000 |
| 2021 | 2020 | 2021 | 2020 | |
|---|---|---|---|---|
| Interest income | ||||
| Group companies | 0 | 0 | 3 411 | 2 291 |
| Exchange rate income | 13 749 | 5 116 | 13 748 | 5 115 |
| Interest income, other | 710 | 576 | 710 | 576 |
| Total | 14 459 | 5 692 | 17 869 | 7 982 |
| 2021 | 2020 | 2021 | 2020 | |
|---|---|---|---|---|
| Exchange rate losses | -2 365 | -15 964 | -2 354 | -15 964 |
| Interest expenses for leas liabilities | -1 430 | -1 415 | 0 | 0 |
| Interest expenses other | -2 | -3 | -2 | -3 |
| Total | -3 797 | -17 382 | -2 356 | -15 967 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31,2020 | |
|---|---|---|---|---|
| Current tax | 0 | 0 | 0 | 0 |
| Deferred tax | 0 | 0 | 0 | 0 |
| Total | 0 | 0 | 0 | 0 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Theoretical tax | ||||
| Reported earnings/loss before tax | -155 966 | -146 033 | -106 572 | -108 815 |
| Tax at applicable tax rate, 20.6% (21.4%) | 32 129 | 31 251 | 21 954 | 23 286 |
| Reconciliation of reported tax | ||||
| Effect of non-deductible expenses | -26 | -69 | -26 | -69 |
| Issue expenses recognized in equity | 0 | 5 422 | 0 | 5 422 |
| Effect of loss carry-forwards that have not been measured | -32 103 | -36 604 | -21 928 | -28 639 |
| Impact attributable to previous years | 0 | 0 | 0 | 0 |
| Total | 0 | 0 | 0 | 0 |
Deductible loss carry-forwards in the Group amounted to MSEK 631.5 (475.6) as of December 31, 2021. For the parent company, deductible lost carry-forwards amounted to MSEK 501.8 (395.7) as of December 31, 2021. The majority of loss carry-forwards have no time limitation. The effect of issue expenses is reported in equity. No tax loss carry-forwards have been valued.
During the second quarter of 2021, the development of the company’s test for early detection of pancreatic can- cer was completed and with this, the capitalization of the development costs for this ended and the depreciation of the capitalized costs began. Impairment testing has been carried out for capitalized development expenditure. Significant factors in the test have been to assess cash flows for the next five years, assess growth after the forecast period and the weighted capital cost, which is calculated at 11.2 percent. The forecasts used in the impairment test are approved by the management and are based on the best assessment of the future. The growth rate beyond that forecast period is set at 2 percent, which is a conservative estimate as it is set at expected long-term inflation. A sensitivity analysis shows that an impairment requirement arises at an increased weighted capital cost of 12 percentage points or at a turnover decrease of about 2 percent and otherwise unchanged factors. A shift in sales start of about 1 year also means that an impairment need arises.
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Opening cost | 155 375 | 115 355 | 155 375 | 115 353 |
| Investment | 18 502 | 40 020 | 18 502 | 40 020 |
| Total | 173 878 | 155 375 | 173 878 | 155 375 |
| Opening amortization | 0 | 0 | 0 | 0 |
| Amortization for the year | -7 244 | 0 | -7 244 | 0 |
| Closing accumulated amortization | -7 244 | 0 | -7 244 | 0 |
| National and European subsidies of deve- lopment expenditure | ||||
| Opening balance | -44 142 | -44 142 | -44 142 | -44 142 |
| Deducted in the year | 0 | 0 | 0 | 0 |
| Total | -44 142 | -44 142 | -44 142 | -44 142 |
| Carrying amount | 122 492 | 111 234 | 122 492 | 111 234 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Opening cost | 25 451 | 22 158 | 24 067 | 21 205 |
| Investment | 2 733 | 3 477 | 2 733 | 2 862 |
| Sales and scrapping | -838 | 0 | -838 | 0 |
| Translation differences for the year | 144 | -183 | 0 | 0 |
| Closing accumulated cost | 27 491 | 25 452 | 25 961 | 24 067 |
| Opening amortization | -1 152 | -913 | -1 152 | -913 |
| Amortization for the year | -1 078 | -239 | -925 | -239 |
| Translation differences for the year | -8 | 0 | 0 | 0 |
| Closing accumulated amortization | -2 836 | -1 152 | -2 077 | -1 152 |
| Opening impairment | -599 | -599 | -599 | -599 |
| Closing accumulated impairment | -599 | -599 | -599 | -599 |
| Carrying amount | 24 655 | 23 701 | 23 286 | 22 316 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Opening cost | 7 789 | 6 422 | 6 828 | 5 329 |
| Purchase | 1 216 | 1 500 | 1 216 | 1 500 |
| Translation difference for the year | 100 | -133 | 0 | 0 |
| Closing accumulated cost | 9 105 | 7 789 | 8 044 | 6 828 |
| Opening amortization | -1 252 | -662 | -1 093 | -547 |
| Amortization for the year | -1 150 | -611 | -1 090 | -546 |
| Translation difference for the year | -20 | 21 | 0 | 0 |
| Closing accumulated amortization | -2 422 | -1 252 | -2 183 | -1 093 |
| Carrying amount | 6 683 | 6 537 | 5 861 | 5 736 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Opening cost | 20 099 | 18 314 | 14 451 | 13 306 |
| Purchases | 1 432 | 2 499 | 1 306 | 1 145 |
| Sales and scrapping | -693 | 0 | -205 | 0 |
| Reclassification | -469 | 0 | -469 | 0 |
| Translation difference for the year | 551 | -714 | 0 | 0 |
| Closing accumulated cost | 20 920 | 20 099 | 15 083 | 14 451 |
| Opening depreciation | -11 030 | -7 435 | -8 803 | -5 831 |
| Depreciation for the year | -3 410 | -3 401 | -2 425 | -2 503 |
| Sales and scrapping | 300 | 0 | ||
| Recalssification | 469 | 469 | ||
| Translation difference for the year | -260 | 275 | 0 | 0 |
| Closing accumulated depreciation | -13 931 | -11 030 | -10 759 | -8 803 |
| Carrying amount | 6 989 | 9 069 | 4 324 | 5 648 |
| Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|
| Opening cost | 43 181 | 43 181 |
| Purchases | 5 936 | 0 |
| Closing accumulated cost | 49 117 | 43 181 |
| Opening depreciation | -10 087 | -4 596 |
| Depreciation for the year | -6 175 | -5 490 |
| Closing accumulated depreciation | -16 262 | -10 087 |
| Carrying amount | 32 855 | 33 095 |
Company | Corporate ID no: | Reg. office | No.| Participa- ting interest | Dec 31, 2021 | Dec 31, 2020 |
|---|---|---|
| Immunovia Inc 350589-6 Wilmington, USA | 1,000 | 1 |
| Immunovia Incentive AB 559198-2870 Lund | 500 | 50 |
| Immunovia Dx Laboratories AB 559244-6503 Lund | 250 | 25 |
| Immunovia GmbH HRB 111 597 Frankfurt am Main | 1 | 253 |
| Carrying amount | 328 | 328 |
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Prepaid rents | 365 | 411 | 1,387 | 1,361 |
| Prepaid insurance | 455 | 226 | 209 | 62 |
| Prepaid expenses for prospective studies | 0 | 0 | 0 | 0 |
| Other prepaid expenses | 2,242 | 1,344 | 607 | 1,207 |
| Accrued income | 391 | 458 | 391 | 458 |
| Carrying amount | 3,453 | 2,439 | 2,594 | 3,088 |
The number of shares amounts to 22,631,581, each with one vote. The quotient value is SEK 0.05 per share.
| Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|
| Opening acquisition value | 2,746 | 3,125 |
| Translation difference for the year | 287 | -379 |
| Carrying amount | 3,033 | 2,746 |
| Parent company | The Group |
|---|---|
| Datum | Event |
| Jan 1, 2020 | At the beginning of the period |
| Jun 4, 2020 | New share issue |
| Oct 4, 2020 | New share of issue via warrants |
| Dec 31, 2020 | At the end of the period |
| Dec 31, 2021 | At the end of the period |
74 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
| Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | |
|---|---|---|---|---|
| Cash | 0 | 0 | 0 | 0 |
| Bank balances | 287,406 | 468,462 | 279,191 | 461,730 |
| Total cash and cash equivalents | 287,406 | 468,462 | 279,191 | 461,730 |
| Parent company | The Group |
|---|---|
| Dec 31, 2021 | |
| Personnel-related expenses | 7,798 |
| Accrued study expenses | 7,594 |
| Other Accrued expenses | 4,819 |
| Carrying amount | 20,211 |
| Parent Company | The Group |
|---|---|
| Dec 31, 2021 | |
| Depreciation | 19,063 |
| Disposal of intangible assets | 1,168 |
| Translation difference internal transac- tions | -183 |
| Total | 20,048 |
| Parent Company | The Group |
|---|---|
| Dec 31, 2021 | |
| Opening acquisition value | 33,131 |
| Additional leasing liabilities | 5,935 |
| Amortization during the year, affecting cash flow | -5,804 |
| Carrying amount | 33,262 |
The Group ANNUAL REPORT 2021 75 IMMUNOVIA – EARLY DETECTION
Financial liabilities valued at accrued acquisition value
The Group only has financial liabilities that are classified and valued at accrued acquisition value using the effec- tive interest method. Accounting is initially made at fair value, net after transaction expenses. The carrying amount on financial assets and liabilities is considered to be essentially consistent with fair value.
| Dec 31, 2020 | Dec 31, 2021 | Dec 31, 2020 | ||
|---|---|---|---|---|
| Dec 31, 2021 | Dec 31, 2020 | |||
| Financial assets valued at accrued acquisition value | ||||
| Other non-current receivables | 3,033 | 2,746 | 0 | 0 |
| Other receivables | 0 | 0 | 147,557 | 85,556 |
| Accounts receivable | 72 | 0 | 0 | 0 |
| Accrued income | 391 | 458 | 391 | 458 |
| Cash and cash equivalents | 287,406 | 468,462 | 279,191 | 461,730 |
| Total | 290,902 | 471,665 | 427,139 | 547,744 |
| Financial liabilities valued at accrued acquisition value | ||||
| Leasing liabilities | 33,262 | 33,130 | 0 | 0 |
| Accounts payable | 3,067 | 4,255 | 2,570 | 3,384 |
| Accrued expenses | 12,412 | 12,939 | 12,307 | 12,921 |
| Total | 48,741 | 50,324 | 14,877 | 16,305 |
Financial assets valued at accrued acquisition value
At present, the Group only has financial assets that are not normally sold outside the Group and where the purpose of the holding is to obtain contractual cash flows. All financial assets are classified as financial assets that are valued at amortized cost using the effective interest method. The Group applies the simplified method for calculating expected credit losses. The method means that expected losses during the entire duration of the receivables are used as a starting point for loss risk reserve. The Group is currently very limited with accounts receivable, so no loss reserve is calculated. The parent company has receivables from subsidiaries for which there is not deemed to be any significant expected loss risk.
| Parent company | The Group |
|---|---|
| 76 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION |
In January 2022 Phillip Mathieu assumed the role as Acting CEO and President. In February 2022 the peer-reviewed, blinded study to independently validate the clinical perfor- mance of IMMray™ PanCan-d was published in Clinical and Translational Gastroenterology. Resulta- ten visar att IMMray® PanCan-d kunde detektera bukspottkörtelcancer i stadium I–II med en specificitet på 99 procent och en känslighet på 89 procent mot högriskpersoner inskrivna i ett monitoreringsprogram för personer med familjär/ärftlig risk för bukspottkörtelcancer samt friska kontrollpersoner. Samtliga stadier av bukspottkörtelcancer upptäcktes med en specificitet på 99 procent och en känslighet på 92 procent.
Remuneration to the Board of Directors and senior executives is stated in Note 10. In addition to salaries and other remuneration to the executive management and board fees, according to a Resolution by the AGM, the company has also entered into a consultancy agreement with CB Ocean Capital AB for Services to be performed by Immunovia’s chairman and its largest owner Carl Borrebaeck. The services provided do not include tasks that belong to board assignme- nts, but the services are aimed at providing the company with scientific and strategic support for, for example, scientific presentations and conferences. The agreement applies from January 1, 2018 and runs until further notice with a three month mutual notice period and provides a quarterly remuneration of SEK 41,000.
Proposed appropriation of the company’s earnings
| (SEK) | |
|---|---|
| Earnings brought forward | 565,437,678 |
| Earnings/loss for the year | -106,572,082 |
| Total | 458,865,596 |
The Board of Directors proposes:
| Carried forward | 458,865,596 |
| Total | 458,865,596 |
ANNUAL REPORT 2021 77 IMMUNOVIA – EARLY DETECTION
Board of Directors’ and Chief Executive Officer’s Certification
The Consolidated Income Statement and Consolidated Balance Sheet will be presented to the Annual General Meeting on April 7, 2022 for adoption. The Board of Directors and Chief Executive Officer hereby certify that the Consolidated Accounts have been prepared in accordance with International Financial Reporting Standards, IFRS, as endorsed by the EU and give a true and fair view of the group’s financial position and results of operations. The financial statements for the parent company have been prepared in accordance with generally accepted accoun- ting practice and give a true and fair view of the parent company’s financial position and results of operations. The Statutory Administration Report of the group and parent company gives a true and fair view of the progress of the Group’s and parent company’s operations, financial position and results of operations, and states the mate- rial risks and uncertainty factors facing the parent company and companies in the Group.
Lund, Sweden March 10, 2022
Our Audit Report was presented on March 10, 2022
The consolidated income statement and consolidated balance sheet, and the parent company’s income statement and parent company’s balance sheet will be subject to adoption at the Annual General Meeting.
78 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
Audit Report
To the general meeting of the shareholders of Immunovia AB (Publ), corporate ID no. 556730-4299
Report on the annual accounts and consolidated accounts
Opinions
I have audited the annual accounts and consolidated accounts of Immunovia AB (publ) for the year 2021-01-01 - 2021-12-31. The annual accounts and consolidated accounts of the Company are included on pages 45-77 of this document.
In my opinion, the annual accounts have been prepared in accordance with the Annual Accounts Act and present fairly, in all material respects, the finan- cial position of the Parent Company as of December 31, 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 December 31, 20201and their financial performance and cash flow for the year then ended in accordance with International Financial Re- porting Standards (IFRS), as adopted by the EU, and the Annual Accounts Act. The statutory adminis- tration report is consistent with the other parts of the annual accounts and consolidated accounts. I therefore recommend that the general meeting of shareholders adopts the income statement and balance sheet for the Parent Company and the Group.
My opinions in this report on the annual accounts and the consolidated accounts are consistent with the content of the supplementary report submitted to the parent company’s audit committee in accordance with Article 11 of the audit regulation (537/2014/EU).
Basis for Opinions
I conducted my audit in accordance with International Standards on Auditing (ISA) and general- ly accepted auditing standards in Sweden. My responsibilities under those standards are further described in the Auditor’s responsibilities section.# INDEPENDENT AUDITOR'S REPORT
To the Shareholders of Immunovia AB (publ), corporate registration number 556719-1596
I am independent in my relationship with the Parent Company and the Group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled my ethical responsibilities in accordance with these requirements. This includes, based on my best knowledge and beliefs, no prohibited services referred to in Article 5 (1) (537/2014/EU) of the Auditors Regulations, the audited company or, where applicable, its parent company or its controlled companies within the EU has been provided. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinions.
Particularly important areas for the audit are the areas that, according to my professional assessment, were the most important for the audit of the annual accounts and consolidated accounts for the current period and include, among other things, the most important assessed risks for material misstatements. These areas were treated within the framework of the audit of, and in my opinion on, the annual accounts and the consolidated accounts as a whole, but I make no separate statements about these areas.
The intangible fixed assets are presented in more detail in notes 2, 4, 14 and 15. As of December 31, 2021, the Group’s carrying amount of intangible fixed assets amounts to kSEK 147 147 and constitutes a significant part of the Group’s reported assets. In accordance with applied accounting principles, certain conditions exist for the fact that capitalization of expenses can take place, see also Note 2, and partly the executive management make an annual impairment test regarding the asset. The management has performed impairment tests based on discounted cash flow. The calculations include a high degree of assessments and assumptions about future cash flows and conditions that are complex. Notes 4 and 14 contain an account of which parts have been tested, how the assessments have been made, important assumptions and the outcome of sensitivity analyses.
I have formed an understanding of the company’s operations and market, assessed the calculation model used by the management and took note of the estimates and assessments made. The management’s assumptions mainly linked to the variables that have the greatest impact on impairment testing, such as growth, margins and the discount factor have been tested by me. I have tested what effect changes in assumptions regarding the above mentioned variables have on the trials. This is to assess whether an impairment requirement exists. Assessment has been made of the accuracy of the disclosures in the annual accounts.
ANNUAL REPORT 2021 79 IMMUNOVIA – EARLY DETECTION
This document also contains other information than the annual accounts and consolidated accounts and is found on pages 2-44 and 82-85. The Board of Directors and the CEO are responsible for this other information. My opinion on the annual accounts and consolidated accounts does not cover this other information and I do not express any form of assurance conclusion regarding this other information.
In connection with my audit of the annual accounts and consolidated accounts, my 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 I also take into account our knowledge otherwise obtained in the audit and assess whether the information otherwise appears to be materially misstated. If I, based on the work performed concerning this information that we have had access to prior the date of this auditor’s report, conclude that there is a material misstatement of this other information, I am required to report that fact. I have nothing to report in this regard.
The Board of Directors and the CEO 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 CEO 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 CEO 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 CEO intends to liquidate the company, to cease operations, or has no realistic alternative but to do so.
The Board’s Audit Committee shall, without prejudice to the Board’s responsibilities and tasks in general, monitor, among other things, the Company’s financial reporting.
My objectives are 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 my 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, I exercise professional judgment and maintain professional skepticism throughout the audit. I also:
80 ANNUAL REPORT 2021 IMMUNOVIA – EARLY DETECTION
exists, I am required to draw attention in my auditor’s report to the related disclosures in the annual accounts and consolidated accounts or, if such disclosures are inadequate, to modify my opinion about the annual accounts and consolidated accounts. My conclusions are based on the audit evidence obtained up to the date of my auditor’s report. However, future events or conditions may cause a company and a group to cease to continue as a going concern.
I am responsible alone for the direction, supervision and performance of the Group audit. I remain solely responsible for my opinions. I must inform the Board of Directors of, among other matters, the planned scope and timing of the audit. I must also inform of significant audit findings during my audit, including any significant deficiencies in internal control that I identified. I must also provide the Board with a statement that I have complied with relevant professional ethical requirements regarding independence, and to address all relations and other conditions that can reasonably affect my independence, and, if applicable, associated countermeasures.
Of the areas communicated with the Board, I determine which of these areas have been the most important for the audit of the annual accounts and the consolidated accounts, including the most important assessed risks for material misstatements, and which therefore constitute the areas of particular importance to the audit. I describe these areas in the auditor’s report unless laws or other regulations prevent information about the issue or when, in extremely rare cases, I consider that an issue should not be communicated in the audit report because the negative consequences of doing so reasonably would be expected to be greater than the public interest in this communication.# Report on Other Legal and Regulatory Requirements
In addition to my audit of the annual accounts and consolidated accounts, I have also audited the administration of the Board of Directors and the CEO of Immunovia AB (Publ) for the year 2021-01-01 - 2021-12-31 and the proposed appropriations of the company’s profit or loss. I 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 CEO be discharged from liability for the financial year.
I conducted the audit in accordance with generally accepted auditing standards in Sweden. My responsibilities under those standards are further described in the Auditor’s responsibilities section. I am independent of the Parent Company and the Group in accordance with professional ethics for accountants in Sweden and have otherwise fulfilled my ethical responsibilities in accordance with these requirements. I believe that the audit evidence I have obtained is sufficient and appropriate to provide a basis for my opinions.
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 considering the requirements which the company’s and the Group’s type of operations, size and risks place on the size of the Company’s 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 CEO shall manage the ongoing administration according to the Board of Directors’ guidelines and instructions and among other matters take measures that are necessary to fulfil the company’s accounting in accordance with law and handle the management of assets in a reassuring manner.
My objective concerning the audit of the administration, and thereby my 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 CEO in any material respect:
My objective concerning the audit of the proposed appropriations of the company’s profit or loss, and thereby my 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, I 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 my professional judgment with starting point in risk and materiality. This means that I focus the examination on such actions, areas and relationships that are material for the operations and where deviations and violations would have particular importance for the company’s situation. I examine and test decisions undertaken, support for decisions, actions taken and other circumstances that are relevant to my opinion concerning discharge from liability. As a basis for my opinion on the Board of Directors’ proposed appropriations of the company’s profit or loss, I examined whether the proposal is in accordance with the Companies Act.
The company has securities admitted to trading on a regulated market and must publish its annual report and consolidated accounts in accordance with ch. 6 § 4 of the Securities Market Act. Such a company must, according to ch. 4 § 11 prepare their annual accounts and consolidated accounts in a format that enables uniform electronic reporting. At the time of submitting this audit report, no annual report and consolidated accounts have been prepared in such a format as is prescribed in ch. 4 § 11 of the Securities Market Act. I have therefore not been able to make such a statement as is required under ch. 9 § 35 b of the Swedish Companies Act.
Mats-Åke Andersson, HLB Auditoriet AB, Järnåkravägen 3, 222 25 Lund, appointed Auditor of Immunovia AB by the Annual General Meeting on May 6, 2021 and has been the company’s auditor since 6 May 2021 and has previously been the Chief Auditor of the company from April 2017.
Lund, March 10, 2022
Mats-Åke Andersson
Authorized public accountant
| Key indicator | Definition | Motivation for using financial key indicator not defined pursuant to IFRS Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation. Malignant. Malignant tumors tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumors. Metastasis. A metastasis is a tumor that has spread to other organs. Microarray. A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins. Molecular Diagnosis. A collection of technologies used to analyze biological markers at the genomic and protein levels (i.e., the genetic code of individuals and how their cells express their genes as proteins in the body), using molecular biology for medical testing. These technologies are used to diagnose and monitor disease, detect the risk of disease and to determine which treatment is likely to work best for the individual. NOD type 2. New Onset Diabetes type 2.
NPV. Negative Predicted Value. NSCLC. Non-Small Cell Lung Cancer, the most common type of lung cancer, 80-85% of all lung cancer cases. Palliative care. Palliative care is administered when the patient’s disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices. PanDIA-1. Prospective trial for the diabetes risk group of patients aged over 50 recently diagnosed with type-2 diabetes. PanFAM-1. Prospective trial for familiar and hereditary risk groups. Pancreatologist. Doctor specializing in diseases relating to the pancreas. PanSYM-1. Prospective trial for early symptom risk groups. PDAC. Pancreatic ductal adenocarcinoma, the most common form of pancreatic cancer. Prospective trial. A trial in which a group of individuals is studied and followed often for a long time to see how a particular disease develops. A prospective trial is used to study the relationship between different risk factors and a certain disease. You follow individuals with and without risk factors going forwards over time. At the end of the trial, the proportion of individuals in the two groups who developed disease is compared. Proteomics. Proteomics is a branch of biology and includes surveys of large amounts of data about proteins. Reproducibility. Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel. Resectable. Able to be removed by surgery. Retrospective study. A study in which the focus is on something that has happened in the past, i.e. using historic data. This form of study starts with the answer, i.e. it is known which individuals became ill and which did not. Screening. Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms. Self-pay customers. Patients or organizations that pay without reimbursement from insurance companies or authorities. Sensitivity. Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct. Serum. A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies. Specificity. Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.
Immunovia AB (Publ)
Medicon Village
Scheelevägen 8
223 63 Lund, Sweden
Phone: +46 46 2756 000
[email protected]
www.immunovia.com
The company’s Annual Report is available for download on the company’s website: www.immunovia.com
The shareholders of Immunovia AB (publ) are called to Annual General Meeting Thursday, April 7, 2022
Q1 interim report 2022, Thursday April 28, 2022
Q2 interim report 2022, Tuesday August 16, 2022
Q3 interim report 2022, Thursday November 10, 2022
Financial statement 2022, Thursday February 9, 2023
www.immunovia.com
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