Quarterly Report • Feb 17, 2021
Quarterly Report
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| Key Indicators | ||||||
|---|---|---|---|---|---|---|
| SEK thousand unless otherwise stated | 2020 Oct-Dec |
2019 Oct-Dec |
2020 Full year |
2019 Full year |
||
| Net sales | 152 | 45 | 362 | 356 | ||
| Operating earnings | -38,112 | -29,584 | -134,343 | -114,248 | ||
| Earnings before tax | -46,120 | -32,616 | -146,033 | -114,517 | ||
| Net earnings | -46,120 | -32,616 | -146,033 | -114,521 | ||
| Earnings per share before dilution (SEK) | -2.04 | -1.66 | -6.84 | -5.85 | ||
| Earnings per share after dilution (SEK) | -2.04 | -1.66 | -6.84 | -5.85 | ||
| Equity ratio (%) | 91 | 85 | 91 | 85 | ||
| Number of shares at the end of the period | 22,631,581 | 19,654,853 | 22,631,581 | 19,654,853 |
Immunovia presented the results of the verification study for IMMray™ PanCan-d at a webinar on October 26, 2020. The results showed an high accuracy of 94% when it comes to differentiating pancreatic cancer patients (Pancreatic ductal adenocarcinoma or PDAC) from healthy controls and 91% in differentiating early stages I and II of pancreatic cancer vs. all controls. The control tests included patients with non-specific but worrying symptoms, including type II diabetes and healthy people.
Immunovia's new CEO Patrik Dahlen took office on November 1. Patrik Dahlen has extensive experience from previous positions as CEO of several diagnostic companies and succeeds Mats Grahn, who over the past seven years has successfully steered the company from the development phase to becoming a commercial company.
Immunovia presented additional data from the verification study. As reported earlier, the results showed an accuracy of 94% in distinguishing stage I/II PDAC patients from healthy controls. Other test results for this comparison showed: specificity of 99%, a sensitivity of 78% and a high NPV of 99.3%. Stage I/II PDAC patients could be distinguished from all controls with 91% accuracy, with a reported specificity of 93% and a sensitivity of 78%. The analysis was performed with the signature that is now locked for clinical use commercially.
Immunovia conducted Webinar in the series on IMMray™ PanCan-d: This third webinar presented the results of the verification study for IMMray™ PanCan-d and the clinical use of the test, including feedback from experts on pancreatic cancer and pancreatic diseases.
Immunovia announced the publication of a scientific article in which the IMMRay™ platform showed good results in the differential diagnosis of hard-to-assess autoimmune diseases. Lead author Mattias Ohlsson, Professor of Computational Biology and Biological Physics at Lund University comments:
"In this study we were able to classify the included individual, IRD (Inflammatory Rheumatic Diseases) clinical states with high accuracy, We believe that this data supports the use of IMMray™ to reflect the biological complexity of autoimmune diseases."
Immunovia presented an update on the status of the company's operations and as previously reported (webinar on December 17, 2020), Immunovia will initiate the start of sales of the company's first test, IMMray™ Pan-Can-d. The test has been developed for early detection of pancreatic cancer.
Immunovia's PanFAM-1 prospective study gathers over 3000 familial hereditary pancreatic cancer risk samples and will be analysed In the second half of 2021.
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Immunovia is approaching commercial breakthrough: A sales start is planned for the first quarter of 2021. We look forward to helping patients through early detection of pancreatic cancer.
All Immunovia employees are incredibly proud of the progress we have made in 2020, especially with regard to the October 2020 milestone when we were able to document 94 percent accuracy for IMMray™ PanCan-d, the company's first blood test for the diagnosis of pancreatic cancer in the early stages of the disease when it is still possible to conduct surgery. The result opens the way for significantly improved care and survival of patients suffering from this deadly disease.
As 2020 ends, we continue to take major steps forward to launch our first diagnostic test IMMray™ PanCan-d on the U.S. market in the first quarter of 2021. We concluded the year with extraordinarily good results from the Verification Study, confirming the unique ability of our product to differentiate pancreatic cancer stages I to IV compared to clinically relevant control groups (i.e. patients with non-specific but worrying symptoms, including type II diabetes, as well as healthy individuals). Like the rest of the world, we had several challenges in 2020 due to the COVID-19 pandemic, which led to closing the Immunovia Dx laboratory in the United States for several months during the "lockdown" period. Additionally, the clinicians involved in our clinical studies have had difficulty collecting relevant samples for long periods of time. However, despite the difficulties, our staff showed strong commitment and perseverance to find solutions for achieving our milestones.
In 2020 a successful share issue was carried out. Currently, Immunovia is in a strong financial position in preparation for a crucial milestone for the business – the launch of the first commercial test, IMMray™ PanCan-d for early detection of pancreatic cancer.
Cancer diseases have recently overtaken cardiovascular diseases as the leading cause of death in the industrialized world. With the globally increased burden of cancer, the need and demand to diagnose cancer at an early stage is rapidly growing. Healthcare systems all over the world are being transformed towards applying more proactive methods, including more preventive care, early diagnosis and personalized treatments. Regulatory authorities are implementing processes for priority approvals and new value-based payment models are also being introduced.
Since pancreatic cancer is one of the deadliest forms of cancer and the diagnosis is often made too late, early detection is crucial. Globally, around 350, 000 people are diagnosed each year and the figure is rising rapidly. An early-stage pancreatic cancer detection test, such as IMMray™ PanCan-d, has the potential to dramatically increase the survival rate for patients. Immunovia's goal is to make early diagnosis a priority for all stake holders.
With one milestone remaining – a final validation study before the start of sales of IMMray™ PanCan-d in the first quarter of 2021, we are now stepping up the final preparations for launch. We have been successful in establishing a large network of world-renowned Key Opinion Leaders (KOL) and healthcare specialists. They have not only collaborated with us on how to use the test in practical clinical work, but also provided us with the necessary blood tests, collected in a real clinical environment, to test and validate our IMMray™technology. Immunovia's team in the United States and the laboratory in Marlborough, MA have implemented a logistics and distribution system that provides rapid test results, supporting all our US customers. We have established a scalable sales and marketing organization that caters for our top clinical customers across the United States. Collaborating with different patient organizations has also been a focus area for us, as they play an important role in creating awareness of the disease and supporting patients and their families.
As communicated thorough press releases and webinar during the third and fourth quarters, our verification study was successful. The study was conducted with signature and bioinformatics algorithms from the commercial test model study (CTMS). As reported, IMMray™ PanCan-d in combination with tumor marker CA 19-9, showed an accuracy of 94% when it comes to distinguishing stage I/II PDAC patients from healthy controls. We reported a specificity of 99% and a sensitivity of 78%, as well as a high NPV of 99.3% for this patient group.
To validate the clinical benefit of IMMray™ PanCan-d, especially important for obtaining reimbursement from insurance systems, Immunovia's three major prospective studies covering the three main risk groups for pancreatic cancer continued in 2020:
All three studies are proceeding according to plan. Interim results will be reported already in the second half of 2021
In addition to our main focus on pancreatic cancer, Immunovia conducts early projects in other cancer applications and autoimmune diseases. These are in early stages of development ("Discovery Studies") and we are establishing Key Opinion Leader collaborations to gain access to expertise on clinical needs, as well as high-quality blood tests with clinical information represents these indications. These collaborations mark the most important key activity for succeeding in subsequent studies, results of which will be crucial for deciding on investing in further development phases ("Development Studies"), leading to product development, a much larger financial commitment than "Discovery studies". Since these project are part of our discovery program we do not set timelines for them.
As the new CEO, I am honoured to start serving Immunovia at this crucial and exciting time in the company's history. I believe that Immunovia is in a position to advance into a dominant market leader for blood-based diagnosis of pancreatic cancer and I look forward to the exciting further development of the company.
I would like to underline that Immunovia continues to set its goal to reach a long-term market penetration of 30 percent after achieving reimbursement with extensive geographical coverage. The current size of the addressable market for IMMray™ PanCan-d is estimated to exceed USD 4 billion in the EU and the US, from the three risk groups targeted by the company: hereditary/familial, differential diagnosis of early symptoms and recently diagnosed type II diabetes in individuals over 50 years of age. We look forward to continuing to work with healthcare providers around the world.
On behalf of the Board of Directors and the entire Immunovia Team, I thank you for your continued support for Immunovia's efforts to contribute to a positive impact on the lives of those at risk of pancreatic cancer.
February 2021 Patrik Dahlen CEO, Immunovia AB
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| Group's performance over the period 5 | |
|---|---|
| Share information 6 | |
| Incentive scheme 7 | |
| Consolidated income statement in summary 8 | |
| Consolidated comprehensive income in summary 8 | |
| Consolidated financial position in summary 9 | |
| Change in consolidated equity in summary 10 | |
| Consolidated cash flow statement in summary 11 | |
| Consolidated key indicators 12 | |
| Definitions 13 | |
| Parent company's income statement in summary 14 | |
| Parent company's comprehensive income in summary 14 | |
| Parent company's balance sheet in summary 15 | |
| Parent company's cash flow statement in summary 16 | |
| Accounting principles 17 | |
| Glossary 20 | |
| Immunovia in brief 22 |
About the report • This information was submitted for publication February 17, 2021, kl. 16.00 (CET)
This financial statement has been produced in accordance with IFRS for the Immunovia Group Immunovia which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia Inc, Immunovia GmbH, Immunovia Dx Laboratories AB and Immunovia Incentive AB.
Contact Immunovia AB (publ),
Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden • +46 (0)46-2756 000
For further information please contact Patrik Dahlen, CEO
• Net sales for Q4 2020 amounted to SEK 152,000 (45). For the period January-December 2020, sales amounted to SEK 362,000 (356). Sales mainly consist of royalties.
• The net loss for Q4 2020 was SEK 46.12 million (-32.62). The loss for the year 2020 was SEK 146.03 million (-114,52). The net loss for Q4 2020 is greater because of increased costs, which are mainly due to increased activity with development and greater marketing and launch activities. Other external costs and personnel costs rose by SEK 32.22 million during the period January-December 2020 compared with the corresponding period last year and amounted to a total of SEK 165,12 million.
• Research and development work is going according to plan. Total R&D costs for Q4 2020 amounted to SEK 10.88 million (10.73), which corresponds to 23% (31%) of the Group's total operating expenses.
• The cash flow from operating activities for Q4 2020 amounted to SEK -35.76 million (-22.65). The corresponding cash flow for the period January-December 2020 was SEK -120.70 million (-91.95). Cash and cash equivalents as of December 31, 2020 amounted to SEK 468.46 million (263.35).
Equity at the end of the period amounted to SEK 599.40 million (357.60) and the equity/assets ratio was 91% (85%).
The management believes that there is sufficient working capital to cover working capital needs, given the current business and development plan for around 2 years ahead.
• In Q4 2020, intangible assets totaling SEK 10.10 million (9.05) were acquired, consisting of capitalized development expenditure, SEK 9.65 million (8.13), and patents SEK 455,000 (922).
During 2020, intangible assets totaling SEK 43.50 million (30,568) were acquired, consisting of capitalized development expenditure SEK 40.02 million (26.72), patents SEK 2.02 million (3,852) and other intangible assets SEK 1.45 million (0).
To the extent that the capitalized expenses are financed with decided and paid grants, a direct impairment is made of the capitalized expenses with the corresponding amount. In 2020, there were no grants received for development expenses. In the corresponding period last year SEK 291,000 was received in grants.
Investments in tangible fixed assets in the form of equipment were made during Q4 2020 of SEK 694,000, corresponding to the previous year's SEK 1.11 million. For the period January-December 2020, investments were made in tangible fixed assets of SEK 3.99 million (6.03).
No investments in financial assets were made during the year 2020.
• The average number of employees during Q4 2020 was 63 (48) and at the end of the period the number of employees was 67 (49).
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The number of registered shares amounted to 22,631,581 shares at the end of the reporting period. The share's nominal value is SEK 0.05.
| Share capital development | ||||||
|---|---|---|---|---|---|---|
| Year | Event | Total share capital (SEK |
Change (SEK) |
Total no. of shares |
Change in shares |
Nominal value (SEK) |
| May 24, 2007 | Formation | 100,000.00 | 100,000.00 | 1,000,000 | 1,000,000 | 0.10 |
| Oct 19, 2011 | New share issue | 105,263.00 | 5,263.00 | 1,052,630 | 52,630 | 0.10 |
| Oct 27, 2011 | Share split 5:1 | 105,263.00 | - | 5,263,150 | 4,210,520 | 0.02 |
| July 5, 2012 | New share issue | 108,869.92 | 3,606.92 | 5,443,496 | 180,346 | 0.02 |
| May 21, 2013 | New share issue | 122,483.76 | 13,613.84 | 6,124,188 | 680,692 | 0.02 |
| Sep 10, 2013 | New share issue | 124,899.76 | 2,416.00 | 6 ,244,988 | 120,800 | 0.02 |
| Jun 5, 2014 | New share issue | 220,924.32 | 96,024.56 | 11,046,216 | 4,801,228 | 0.02 |
| Aug 13, 2015 | Bonus issue | 552,310.80 | 331,386.48 | 11,046,216 | - | 0.05 |
| Dec 17, 2015 | New share issue | 714,560.80 | 162,250.00 | 14,291,216 | 3,245,000 | 0.05 |
| Sep 15, 2016 | New share issue | 823,728.40 | 109,167.60 | 16,474,568 | 2,183,352 | 0.05 |
| Oct 17, 2016 | New share issue | 840,202.95 | 16,474.55 | 16,804,059 | 329,491 | 0.05 |
| Oct 4, 2017 | New share issue via warrants |
865,902.95 | 25,700.00 | 17,318,059 | 514,000 | 0.05 |
| Jun 8, 2018 | New share issue | 974,042.65 | 108,139.70 | 19,480,853 | 2,162,794 | 0.05 |
| Sep 19, 2018 | New share issue via warrants |
976,567.65 | 2,525.00 | 19,531,353 | 50,500 | 0.05 |
| Sep, 9, 2019 | New share issue via warrants |
982,742.65 | 6,175.00 | 19,654,853 | 123,500 | 0.05 |
| June 4, 2020 | New share issue | 1 130,154.05 | 147,411.40 | 22,603,081 | 2,918,228 | 0.05 |
| Oct 4, 2020 | New share issue via warrants |
1 131,579.05 | 1,425.00 | 22,631,581 | 28,500 | 0.05 |
| At end of period | 1,131,579.05 | 22,631,581 | 0.05 |
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Carl Borrebaeck | 1,709,900 | 7.56% |
| Ålandsbanken i ägares ställe | 1,691,512 | 7.47% |
| Swedbank Robur Folksams LO Sverige | 980,000 | 4.33% |
| Försäkringsbolaget Avanza Pension | 907,198 | 4.01% |
| Per Mats Ohlin | 888,950 | 3.93% |
| Sara Andersson Ek | 848,907 | 3.75% |
| Christer Wingren | 748,525 | 3.31% |
| Vincent Saldell | 631,430 | 2.79% |
| State Street Bank Boston | 492,400 | 2.18% |
| Nordnet Pensionsförsäkring | 417,739 | 1.85% |
| Ten largest owners | 9,316,561 | 41.17% |
| Others | 13,315,020 | 58.83% |
| Total | 22,631,581 | 100.00% |
Immunovia has three outstanding warrant schemes comprising 685,650 options with the right to subscribe for 685,650 shares. There is no dilution effect on earnings per share as long as the Group's earnings are negative.
The warrant schemes are aimed at employees and key personnel in the company. At the time of allotment, all warrants have been valued according to Black & Scholes' valuation model. A summary of the company's warrant schemes can be found below.
In countries where the allotment of warrant schemes is not appropriate for various reasons, it has been decided to introduce alternative cash-based incentive schemes for employees and key personnel in the company. The alternative incentive schemes are designed in such a way that their financial effect corresponds to the terms of the corresponding warrant scheme. The total cost to the company for the cash-based incentive schemes is shown in the breakdown 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 |
Sub scription price/ share |
Change in share capital at full utilization |
Total cost of alternative cash-based incentive schemes (USD) |
|---|---|---|---|---|---|---|
| Warrant scheme 2018/2021 |
May 3, 2018 | Sep 7, 2021 -- Oct 7, 2021 |
156,150 | 271.05 | 7,807.50 | |
| Warrant scheme 2019/2023 |
Apr 26, 2019 | Jun 1, 2023 -- Jun 30, 2023 |
79,500 | 342.06 | 3,975.00 | |
| Warrant scheme 2020/2024 |
Seo 23, 2020 | Jun 1, 2024 -- Jun 30, 2024 |
450,000 | 455.59 | 22,500.00 | |
| Alternative cash based incentive scheme 2018/2021 |
May 3, 2018 | Sep 7, 2021 -- Oct 7, 2021 |
250,000 | |||
| 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 |
795,000 | |||
| Total | 685,650 | 34,282.50 | 1,565,000 |
| 2020 | 2019 | 2020 | 2019 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating income etc | ||||
| Net sales | 152 | 45 | 362 | 356 |
| Other operating income | 325 | 60 | 624 | 458 |
| Total, operating income | 477 | 105 | 986 | 814 |
| Operating expenses | ||||
| Other external expenses | -21,130 | -20,354 | -91,147 | -78,321 |
| Personnel costs | -24,657 | -15,289 | -73,968 | -54,576 |
| Capitalized work for own account | 9,648 | 8,125 | 40,020 | 26,716 |
| Amortization of tangible and intangible assets | -2,450 | -2,171 | -9,763 | -8,446 |
| Other operating expenses | 0 | 0 | -471 | -435 |
| Total operating expenses | -38,589 | -29,689 | -135,329 | -115,062 |
| Operating earnings/loss | -38,112 | -29,584 | -134,343 | -114,248 |
| Profit/loss from financial items | ||||
| Financial income | 227 | 53 | 5,692 | 3,820 |
| Financial expenses | -8,235 | -3,085 | -17,382 | -4,089 |
| Total financial items | -8,008 | -3,032 | -11,690 | -269 |
| Earnings/loss after financial items | -46,120 | -32,616 | -146,033 | -114,517 |
| Income tax | 0 | 0 | 0 | -4 |
| Earnings/loss for the period | -46,120 | -32,616 | -146,033 | -114,521 |
| Earnings per share before dilution (SEK) | -2.04 | -1.66 | -6.84 | -5.85 |
| Earnings per share after dilution (SEK) | -2.04 | -1.66 | -6.84 | -5.85 |
| Average number of shares | 22,630,948 | 19,654,853 | 21,340,672 | 19,569,089 |
| Number of shares at year's end | 22,631,581 | 19,654,853 | 22,631 581 | 19,654,853 |
| 2020 | 2019 | 2020 | 2019 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Earnings/loss for the period | -46,120 | -32,616 | -146,033 | -114,521 |
| Items that may be reclassified later in the income statement |
||||
| Exchange rate differences for foreign net | ||||
| investment | 6,609 | 2,179 | 9,317 | -409 |
| Other earnings/loss for the period | 6,609 | 2,179 | 9,317 | -409 |
| Comprehensive income for the period | -39,511 | -30,437 | -136,716 | -114,930 |
| 2020 | 2019 | |
|---|---|---|
| SEK thousands | Dec 31 | Dec 31 |
| ASSETS | ||
| Fixed assets | ||
| Intangible fixed assets | 134,935 | 91,860 |
| Tangible fixed assets | 48,701 | 55,224 |
| Financial fixed assets | 2,746 | 3,124 |
| Total fixed assets | 186,382 | 150,208 |
| Current assets | ||
| Accounts receivable | 6,334 | 5,813 |
| Cash and cash equivalents | 468,462 | 263,345 |
| Total current assets | 474,796 | 269,158 |
| TOTAL ASSETS | 661,178 | 419,366 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Share capital | 1,132 | 983 |
| Other contributed capital | 1,015,291 | 636,924 |
| Translation reserve | 8,315 | -1,002 |
| Retained earnings incl. total comprehensive income | -425,334 | -279,301 |
| otal equity | 599,404 | 357,604 |
| Long-term liabilities | ||
| Interest-bearing liabilities | 27,988 | 33,121 |
| Total long-term liabilities | 27,988 | 33,121 |
| Current liabilities | ||
| Interest-bearing liabilities | 5,143 | 4,945 |
| Other liabilities | 28,643 | 23,696 |
| Total current liabilities | 33,786 | 28,641 |
| TOTAL EQUITY AND LIABILITIES | 661,178 | 419,366 |
| Share | Other paid | Accumulated earnings/loss |
|||
|---|---|---|---|---|---|
| SEK thousands | capital | up equityl | Reserves | for the period | Total equity |
| Opening balance January 1, 2019 | 977 | 626,348 | -593 | -164,780 | 461,953 |
| Comprehensive income for the period |
-409 | -114,521 | -114,930 | ||
| Transactions with owners in their capacity as owners |
|||||
| Warrant premium received | 344 | 344 | |||
| New share issue | 6 | 10,232 | 10,238 | ||
| Closing balance Dec. 31, 2019 | 983 | 636,924 | -1 002 | -279,301 | 357,604 |
| Comprehensive income for the period |
9,317 | -146,033 | -136,716 | ||
| Transactions with owners in their capacity as owners |
|||||
| New share issue | 149 | 403,704 | 403,853 | ||
| Share issue costs | -25,338 | -25,338 | |||
| Closing balance Dec. 31, 2020 | 1,132 | 1,015,290 | 8,315 | -425,334 | 599,403 |
| 2020 | 2019 | 2020 | 2019 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating activities | ||||
| Operating earnings/loss | -38,112 | -29,584 | -134,343 | -114,249 |
| Adjustment for items not included in cash flow | 2,666 | 2,072 | 9,945 | 8,444 |
| Interest received | 227 | 53 | 577 | 285 |
| Interest paid | -335 | -311 | -1,415 | -1,316 |
| Tax paid | 0 | 0 | 0 | -4 |
| Cash flow from operating activities before changes in working capital |
-35,554 | -27,770 | -125,236 | -106,840 |
| Cash flow from changes in working capital | ||||
| Change in operating receivables | 921 | 726 | -579 | 6,621 |
| Change in operating liabilities | -1,124 | 4,399 | 5,111 | 8,267 |
| Cash flow from operating activities | -35,757 | -22,645 | -120,704 | -91,952 |
| Investment activities | ||||
| Investment in Intangible assets | -10,103 | -9,047 | -43,497 | -30,568 |
| Investering i materiella anläggningstillgångar | -694 | -1,106 | -3,998 | -6,034 |
| Investment in financial fixed assets | 0 | 3 | 0 | 0 |
| Sale of fixed assets | 537 | 0 | 537 | 0 |
| Cash flow from investment activities | -10,260 | -10,150 | -46,958 | -36,602 |
| Financing activities | ||||
| Amortization of leasing liability | -1,245 | -1,043 | -4 936 | -5 115 |
| National and European grants for development costs |
0 | 0 | 0 | 291 |
| New share issue | 5,842 | 0 | 378,516 | 10 238 |
| Received warrants premiums | 0 | 28 | 0 | 344 |
| Cash flow from financing activities | 4,597 | -1,015 | 373,580 | 5,758 |
| Cash flow for the period | -41,420 | -33,810 | 205,918 | -122,797 |
| Cash and cash equivalents at start of period | 510,593 | 297,217 | 263,345 | 386,136 |
| Exchange rate difference in cash and cash equi valents |
-711 | -62 | -801 | 6 |
| Cash and cash equivalents at end of period | 468,462 | 263,345 | 468,462 | 263,345 |
| 2020 | 2019 | 2018 | 2017 | 2016 | |
|---|---|---|---|---|---|
| Full year | Full year | Full year | Full year | Full year | |
| Operating earnings/loss (SEK 000) | -134,343 | -114,248 | -87,709 | -45,520 | -14,978 |
| Earnings/loss for the year (SEK 000) | -146,033 | -114,521 | -86,539 | -45,232 | -14,723 |
| Earnings per share before dilution (SEK) | -6.84 | -5.85 | -4.67 | -2.67 | 0.98 |
| Earnings per share after dilution (SEK) | -6.84 | -5.85 | -4.67 | -2.67 | 0.98 |
| R&D expenses (SEK 000) | -48,078 | -34,273 | -26,048 | -24,041 | -24,239 |
| R&D expenses as percentage of operating expenses (%) |
29 | 26 | 23 | 34 | 62 |
| Cash and cash equivalents at the period's end (SEK 000) |
468,462 | 263,345 | 386,136 | 192,425 | 259,094 |
| Cash flow from operating activities (SEK 000) | -120,704 | -91,952 | -84,111 | -46,318 | -11,867 |
| Cash flow for the period (SEK 000) | 205,918 | -122,797 | 193,680 | -66,661 | 183,327 |
| Equity (SEK 000) | 599,403 | 357,604 | 461,953 | 236,795 | 276,631 |
| Equity per share (SEK) | 26.49 | 18.19 | 23.65 | 13.67 | 16.46 |
| Equity / assets ratio (%) | 91 | 85 | 97 | 94 | 98 |
| Average number of employees | 63 | 48 | 39 | 30 | 16 |
| Average number of employees in R&D | 21 | 19 | 17 | 16 | 11 |
| Key indicator | Definition | Motivation for using financial key indicator not defined pursuant to IFRS |
|---|---|---|
| Net sales | Revenues from goods and services sold, and royalties received rela-ting to the main activity during the relevant period. |
|
| Operating earnings/loss | Earnings/loss before financial items and tax. |
Operating earnings/loss provides a view of the earnings that the company's ordinary activities have generated. |
| Basic and diluted earnings per share |
Earnings/loss divided by the weighted number of shares in the period before and after dilution respectively. |
|
| Average number of shares before and after dilution |
The average number of out stan-ding shares in the period be fore and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscription price being lower than the share price price. |
|
| R&D expenses | The company's direct expenses for research and development. Expen ses for staff, materials and external services. |
The company's main activity is research and development. Management considers that R&D expenses are an important parameter to monitor as an indicator of activity levels |
| R&D expenses as a percen tage of operating expenses |
R&D expenses divided by ope-ra ting expenses, which include other external expenses, person-nel expenses, depreciation and amor tization. |
Management considers that the company's R&D expenses in relation to total expenses are an important indication of the proportion of total expenses that are used for the compa ny's main activity. |
| Cash and cash equivalents | Cash and bank balances. | |
| Cash flow from operating activities |
Cash flow before cash flow from investing activities and financing activities. |
|
| Cash flow for the period (SEK 000) |
The change in cash and cash equi-valents for the period exclu ding effective unrealized exchange rate gains and exchange rate losses. |
|
| Equity per share (SEK) | Equity divided by the number of shares.divided by the number of shares at the end of the period. |
Management follows this indicator to monitor the value of equity per share. |
| Equity/assets ratio | Equity as a percentage of total assets. |
Management follows this indicator of the company's financial stability. |
| Average number of employees |
The average number of employ ees is the total of working-hours in the period divided by scheduled working hours for the period. |
|
| Average number of employees in R&D |
The average of the number of employees in the company's re se-arch and development functions. |
| 2020 | 2019 | 2020 | 2019 | |
|---|---|---|---|---|
| SEK thousands | Oct-Dec | Oct-Dec | Full year | Full year |
| Operating income etc. | ||||
| Net sales | 152 | 45 | 362 | 356 |
| Capitalized work for own account | 9,648 | 8,125 | 40,020 | 26,716 |
| Other operating income | 143 | 64 | 451 | 458 |
| Total | 9,943 | 8,234 | 40,833 | 27 530 |
| Operating expenses | ||||
| Other external expenses | -22,105 | -22,396 | -89,134 | -79,046 |
| Personnel costs | -19,351 | -10,755 | -48,835 | -38,326 |
| Amortization of intangible and tangible | ||||
| fixed assets | -839 | -793 | -3,310 | -2,950 |
| Other operating expenses | 0 | 0 | -471 | -335 |
| Total operating expenses | -42,295 | -33,944 | -141,750 | -120,657 |
| Operating earnings/loss | -32,352 | -25,710 | -100,917 | -93,128 |
| Profit/loss from financial items | ||||
| Financial income | 1,027 | 401 | 7,982 | 4,981 |
| Financial expenses | -7,900 | -2,719 | -15,967 | -2,721 |
| Total financial items | -6,873 | -2,318 | -7,985 | 2,260 |
| Result after financial items | -39,225 | -28,028 | -108,902 | -90,868 |
| Allocations | ||||
| Group contribution | 88 | 337 | 88 | 337 |
| Total year-end appropriations | 88 | 337 | 88 | 337 |
| Earnings/loss after financial items | -39,137 | -27,691 | -108,814 | -90,531 |
| Income tax | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -39,137 | -27,691 | -108,814 | -90,531 |
| 2020 | 2019 | 2020 | 2019 | |
|---|---|---|---|---|
| SEK thousands | okt-dec | okt-dec | helår | helår |
| Earnings/loss for the period | -39 137 | -27 691 | -108 814 | -90 531 |
| Other results for the period | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -39 137 | -27 691 | -108 814 | -90 531 |
| 2020 | 2019 | |
|---|---|---|
| SEK thousands | Dec 31 | Dec 31 |
| ASSETS | ||
| Fixed assets | ||
| Intangible fixed assets | 133,550 | 90,907 |
| Tangible fixed assets | 11,384 | 12,257 |
| Financial fixed assets | 328 | 303 |
| Total fixed assets | 145,262 | 103,467 |
| Current assets | ||
| Accounts receivable | 85,556 | 53,579 |
| Current receivables | 3,850 | 3,254 |
| Prepaid expenses and accrued income | 3,088 | 3,416 |
| Cash and cash equivalents | 461,730 | 261,647 |
| Total current assets | 554,224 | 321,896 |
| TOTAL ASSETS | 699,486 | 425,363 |
| EQUITY AND LIABILITIES | ||
| Equity | ||
| Share capital | 1,132 | 983 |
| Fund for development expenses | 105,589 | 65,569 |
| Total equity and liabilities | 106,721 | 66,552 |
| Non-restricted equity | ||
| Premium fund | 378,367 | 10,232 |
| Retained earnings including comprehensive income | 187,070 | 325,673 |
| Total non-restricted capitall | 565,437 | 335,905 |
| Toatl equity | 672,158 | 402,457 |
| Current liabilities | ||
| Other liabilities | 27,328 | 22,906 |
| Total current liabilities | 27,328 | 22,906 |
| TOTAL EQUITY AND LIABILITIES | 699,486 | 425,363 |
| 2020 | 2019 | |
|---|---|---|
| SEK thousands | Full year | Full year |
| Operating activities | ||
| Operating earnings/loss | -100,917 | -93,128 |
| Adjustment for items not included in cash flow | 3,221 | 2,950 |
| Interest received | 576 | 270 |
| Interest paid | -3 | -2 |
| Tax paid | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-97,123 | -89,910 |
| Cash flow from changes in working capital | ||
| Change in operating receivables | -40,715 | -15,933 |
| Change in operating liabilities | 4,420 | 8,042 |
| Cash flow from operating activities | -133,418 | -97,801 |
| Investment activities | ||
| Investment in Intangible fixed assets | -42,882 | -30,568 |
| Investment in tangible fixed assets | -2,645 | -5,980 |
| Investment in financial fixed assets | -25 | -50 |
| Sale of fixed assets | 537 | 0 |
| Cash flow from investment activities | -45,015 | -36,598 |
| Financing activities | ||
| National and European grants for development expenses | 0 | 291 |
| New share issue | 378,516 | 10 238 |
| Cash flow from financing activities | 378,516 | 10 529 |
| Cash flow for the period | 200,083 | -123,870 |
| Cash and cash equivalents at start of period | 261,647 | 385,517 |
| Cash and cash equivalents at period's end | 461,730 | 261,647 |
The Group applies the Swedish Annual Accounts Act and International Financial Reporting Standards (IFRS) as adopted by the EU, and RFR 1 complementary accounting rules for Groups when preparing financial reports. The parent company applies the Swedish annual accounts act and RFR 2 Accounting for legal entities when preparing financial reports. The applied accounting principles are consistent with those applied in the 2019 annual report.
This interim report has been prepared in accordance with IAS 34 Interim New and amended standards adopted with effect from 2020 are not expected to have any significant impact on the Group's financial position.
The Group currently has no financial instruments valued at fair value. Instead, all financial assets and liabilities are valued at accrued acquisition cost. It is estimated that there are no significant differences between fair value and book value relating to financial assets and liabilities
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 assignments, but the services are aimed at providing the company with scientific and strategic support for scientific presentations and conferences, for example. This agreement runs until further notice with three months' notice for both parties and remuneration per quarter amounts to SEK 41,000
Immunovia is exposed to financial risks and business risks. Financial risk management and the financial risks are described below. The company's business risks are presented on page 39 of the 2019 annual report. In addition to the risks presented, the impact of the COVID-19 pandemic on the world's economy is currently difficult to predict, thus making it difficult to predict the general developments in Immunovia's future markets.
The Group operates both nationally and internationally, which involves exposure to fluctuations in various currencies, in particular USD and EUR. Currency risk arises from future commercial transactions and recognized assets and liabilities. The scope of the company's operations currently means that net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.
Interest risk is the risk that the value of financial instruments will fluctuate due to changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits as well as interest-bearing liabilities in the form of leasing debt for premises.
Credit risk is the risk of one party in a transaction with a financial instrument failing to meet its obligations. The maximum exposure to credit risk on financial assets as of December 31, 2020 was SEK 471.21 million (266.6).
Prudent liquidity risk management implies maintaining sufficient cash or agreed credit options to close market positions. Based on the existing business plan, there is enough liquidity for approximately 2 years.
This interim report has not been reviewed by the company's auditors.
Q1 interim report Wednesday April 28, 2021 Q2 interim report Thursday, August 19, 2021 Q3 interim report Thursday, November 11, 2021 Financial statement 2021, Thursday, February 17, 2022
Thursday, May 6, 2021, 4.00 pm
Immunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden Tel: 046-2756 000 Email: [email protected] Web: www.immunovia.com For further information please contact: • Patrik Dahlen, VD • [email protected]
Telephone numbers: Sweden: +46 (0) 8 566 427 05 United States: +1 (0) 833 249 8404 France +33 (0) 1 707 507 21 Denmark: +45 (0) 781 501 10 Germany: +49 (0) 69 2222 203 80 Belgium: +32 (0) 24 035 851 Netherlands: +31 (0) 20 721 9496 Norway: +47 (0) 239 636 88 Switzerland: +41 (0) 22 567 5632 United Kingdom : +44 (0) 33 3300 9273
Immunovia Webcast: https://financialhearings.com/event/13667
The Board and the CEO certify that the interim report gives a true and fair view of the company's and the Group's operations, position and results, and describes significant risks and uncertainties that the company and the companies making up the Group face.
| Lund, February 17, 2021 | ||
|---|---|---|
| Carl Borrebaeck | Hans Johansson | |
| Chairmen of the board | Board member | |
| Ann-Christine Sundell | Christofer Sjögren | |
| Board member | Board member | |
| Mimmi Ekberg | Peter Høngaard Andersen | |
| Board member | Board member | |
| Mats Grahn | Patrik Dahlen | |
| Board member | CEO |
IMMUNOVIA AB EARLY DETECTION
Antigen - A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.
Antibodies – Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
Autoimmunity – Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during transplantation.
Benign – If a tumor is benign it means that the tumor is not dangerous and will not spread.
Bioinformatics – Bioinformatics is an interdisciplinary field in which algorithms are developed for the analysis of biological (especially molecular biology) data.
Biomarker – A biomarker can be defined as a biological response to a change caused by disease or foreign substance. Biomarkers can be used as early warning signs of biological changes in an organism.
Companion Diagnostics – Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.
Discovery Trial – Research carried out in order to verify a special hypothesis.
Histology – Histology is the study of biological tissue.
Invasive – Invasive means to penetrate or attack. 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.
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.
RA – Rheumatoid arthritis, one of the most common autoimmune diseases.
RA double negative – Patients who have RA, but test negative for it using the current two singlemarker standard tests, RF factor and anti-CCP.
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.
Retrospective study – A study in which the focus is on some- thing 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.
SLE (Systemic Lupus Erythematosus) – SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The disease is currently difficult to diagnose and is often confused with other autoimmune diseases.
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.
Vinnova – Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.
Immunovia AB was founded in 2007 by researchers from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. The purpose was to establish a base from which to make scientific discoveries and gain patents within the fields of human antibodies, biomarkers and antibody arrays, covering the stages from research to clinical application. Immunovia's core technology platform, IMMray™, is based on microarray analysis of biomarker antibodies. IMMray™ PanCan-d is the company's primary diagnostic tool, capable of diagnosing with a high level of sensitivity and specificity. This enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II), which is not currently possible with existing methods. Immunovia is now performing clinical validation studies to prepare for the commercialization of IMMray™ PanCan-d, which could become the first blood-based test for early diagnosis of pancreatic cancer. The antibody-based technology platform, IMMray™, is the result of 15 years of research at CREATE Health, Lund University. It is used to decode mechanisms behind the body's immune system, the first system in the body that reacts to disease. The platform can also be used for the development of diagnostic tests for autoimmune diseases.
Each year about 350,000 patients fall ill with pancreatic cancer. This form of cancer has one of the worst survival forecasts and only about 5% of diagnosed patients live more than five years, making it one of the deadliest cancers in the world. It is estimated that early detection would increase the five-year survival rate by around 50%. The initial addressable market for Immunovia consists of two high-risk pancreatic cancer groups. The market in the US and Europe for diagnosis of these groups is estimated to be worth over SEK 30 billion anually.
Immunovia's goal is to provide diagnostic tests that will enable earlier, more efficient and more accurate diagnosis of patients who run the risk of developing cancer or autoimmune disease. The aim is to make Immunovia's tests the first choice of specialist doctors and general practitioners across the world in the screening of especially high-risk groups or when there is a suspicion of the aforementioned diseases.
Immunovia's strategy is as the first company, to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases earlier and more accurately than previously possible. The focus is on unsolved problems in early diagnosis, monitoring of the course of a disease and the patient's response to treatment. These are areas where there are extensive clinical benefits for patients and the healthcare system, current solutions are lacking or insufficient, and where IMMray™ has significant competitive advantages.
Initially, the key focus for Immunovia is to bring IMMray™ PanCan-d to the market. Because early detection of pancreatic cancer constitutes a major clinical problem, Immunovia considers there to be good prospects for being the first to establish a strong position on the market.
Organization. no. 556730-4299
Immunovia has its head office in Lund, Sweden. Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm's main list (Mid Cap). For more information, please go to: www.immunovia.com
IMMray™ PanCan-d, could become the first blood-based test for early diagnosis of pancreatic cancer.
Early detection would increase the five-year survival rate by around 50%.
Scheelevägen 8, Medicon Village 223 63 Lund, Sweden Phone: 046-2756 000
www.immunovia.com
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