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Immunovia — Interim / Quarterly Report 2022
Nov 10, 2022
3061_10-q_2022-11-10_5fa3d613-2f92-478c-b19e-057fa21ae6a3.pdf
Interim / Quarterly Report
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INTERIM REPORT JANUARY – SEPTEMBER 2022
July-September 2022
- Net sales amount KSEK 358 (377) divided by sales of tests KSEK 111 and royalties KSEK 247.
- Net earnings amount MSEK -23 (-36) and earnings per share before and after dilution were SEK – 1.01 (-1.60)
- Cash Flow from operating activities amount MSEK -37 (-38).
- Cash and equivalents at the end of the period amounted to MSEK 159 (339).
- On July 5 the Company informed that a CPT PLA Code for the IMMray™ PanCan-d test was approved from the American Medical Association (AMA). The code will be effective from October 1, 2022.
- On August 11 the Company informed that the California Department of Public Health had granted Immunovia, Inc., the American subsidiary of Immunovia AB, a Clinical and Public Health Laboratory license, allowing physicians in California to order the IMMray PanCan-d test for their patients.
- On September 26 the Company announced, that the Centers for Medicare & Medicaid Services (CMS) published a preliminary payment determination implying a price of \$897 for the IMMray PanCan-d test.
Significant events after the period
- On October 12 the Company announced positive feedback from its physician experience program for the IMMray™ PanCan-d test in the U.S. The program has included 23 high risk surveillance centers around the U.S. thus far, and physicians have showed substantial interest in the use of IMMray™ PanCan-d to detect early-stage pancreatic cancer.
- On October 17 the Company announced that it enters into a strategic partnership with Proteomedix to leverage the parties joint development experience in diagnostic technologies for the detection of cancer.
- On October 19 the Company announced executive management changes to accelerate execution of strategic priorities.
- On October 20 the Company announced that the Nomination Committee for the 2023 Annual General Meeting has been determined to consist of the following persons who together represent 13.46 percent of the number of shares and votes in the company: Ranny Davidoff, Carl Borrebaeck, Peter Lindvall and Mats Leifland.
"Q3 has been a quarter focussed on commercial execution and taking further steps towards reimbursement to make our innovative IMMRay PanCan-d test, the first dedicated test for early detection of pancreatic cancer, broadly available in the US."
Philipp Mathieu, CEO and President, Immunovia AB
Key indicators
| SEK thousand unless otherwise stated | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Full year |
|---|---|---|---|---|---|
| Net sales | 358 | 377 | 643 | 539 | 844 |
| Operating earnings/loss | -41,916 | -39,938 | -140,070 | -115,752 | -166,628 |
| Earnings before tax | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 |
| Net earnings | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 |
| Earnings per share before dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 |
| Earnings per share after dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 |
| Equity ratio (%) | 82 | 88 | 82 | 88 | 88 |
| Number of shares at the end of the period | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 |
CEO's comments
Q3 has been a quarter focussed on commercial execution and taking further steps towards reimbursement to make our innovative IMMRay PanCan-d test, the first dedicated test for early detection of pancreatic cancer, broadly available in the US.
After receiving approval for a Proprietary Laboratory Analyses (PLA) code from the American Medical Association (AMA) for the IMMray™ PanCan-d test we entered the process with the Centers of Medicare & Medicaid Services (CMS) to establish payment for the test. In September, CMS followed our recommendation and published a preliminary payment determination implying a price of \$897. This rate appropriately values our innovative test. While this does not represent a coverage determination to reimburse the IMMray PanCan-d test, it is an important step in the process of securing reimbursement for our test. We anticipate CMS to finalize its basis for the payment decision during November.
The newly obtained Clinical and Public Health Laboratory license from the California Department of Public Health now allows physicians in California to order the IMMray PanCan-d test for their patients and expands the availability of our test to 49 out of 50 US states. This is another step towards increasing availability and adoption of our diagnostic test.
We further expanded our physician experience program for the IMMray PanCan-d test targeting more than 20 high risk surveillance centers around the US. Immunovia's physician experience program has been designed for providers to gain clinical experience using the IMMray PanCan-d test. Our novel test continues to be broadly adopted by physicians at those high risk surveillance centers and has contributed to more patients getting screened for early-stage pancreatic cancer. We anticipate completion of the initial physician experience program by year end.
In October, we entered into a strategic partnership with Proteomedix, a Switzerland-based proteomics-focused diagnostics company, with the purpose to leverage both companies´ substantial joint development experience in diagnostic technologies for the detection of cancer. This partnership with Proteomedix will combine leading proteomics-based researchers with state-of-the art capabilities from both companies to create an outstanding R&D platform and will enable us to focus on the commercialization of the IMMray™ PanCan-d test in the US while maximizing our R&D productivity.
On October 19 we announced executive management team changes to accelerate execution of strategic priorities.
During Q3 we continued to deliver on our previously communicated strategic priorities. Our significantly strengthened US team successfully executes the commercial US launch of IMMRay PanCan-d test. The positive feedback from physicians and patients is highly encouraging and further motivates us. We are fully committed to our mission to increase the number of patients that get diagnosed early enough to have surgical resection of their tumor and increase their survival rates.
November 10, 2022 Philipp Mathieu CEO and President Immunovia AB
Table of contents
| Share information 5 Incentive scheme 6 Consolidated income statement in summary 7 Consolidated comprehensive income in summary 7 Consolidated financial position in summary 8 Change in consolidated equity in summary9 Consolidated cash flow statement in summary 10 Consolidated key indicators 11 Definitions 12 Parent company's income statement in summary 13 Parent company's comprehensive income in summary 13 Parent company's financial position in summary 14 Parent company's cash flow statement in summary 15 Accounting principles 16 Glossary 20 Immunovia in brief 22 |
Group's performance over the period 4 | |
|---|---|---|
About the report
This information was submitted for publication on November 10, 2022, at 08:30 (CET).
This financial statement has been produced in accordance with IFRS for the Immunovia Group 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), Swedish Corporate Identity Number 556730-4299, Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden
• [email protected] • +46 46 2756 000
For further information please contact
- Philipp Mathieu, CEO and President
- [email protected]
Karin Almqvist Liwendahl, CFO
january-september 2022
The Group's performance over the period
Net sales
Net sales for Q3 amounted to kSEK 358 (377), of which kSEK 111(65) consisted of sales of tests and kSEK 247 (312) were royalties. For the period January to September of 2022, net sales amounted to kSEK 643 (539), of which kSEK 278 (65) consisted of sales of tests and kSEK 365 (474) were royalties.
Earnings
Net earnings for Q3 amounted to kSEK -22,932 (-36,131). The main difference relates to currency exchange rate effects due to a stronger USD vs SEK.
Other external costs and personnel costs increased by kSEK 3,479 during Q3 compared with the corresponding period last year and amounted to a total of kSEK 34,708. The increase is due to higher costs for sales- and marketing.
Research & Development
Total R&D cost for Q3 2022 amounted to kSEK 9,858 (8,314), which corresponded to 24 percent (22) of the Group's total operating expenses.
Financing and cash flow
Cash flow from operating activities during the Q3 2022 amounted to kSEK -37,413 (-38,288).
Cash and cash equivalents as of September 30, 2022, amounted to kSEK 158,839 (339,165).
Equity at the end of the period amounted to kSEK 296,255 (484,414) and the equity/assets ratio was 82 percent (88).
Based on the cash resources of kSEK 158,839 and the financing plans in place, the company's continued operation is secure according to the Board's assessment.
Investments
In Q3, intangible assets totalling kSEK 63 (1,813) were acquired, consisting of capitalized development expenditure of kSEK 0 (0) and patents kSEK 63 (1,813).
During the period January to September 2022, investments in intangible fixed assets amounted to kSEK 292 (20,095) consisting of capitalized development expenditure of kSEK 0 (18,406) and patents kSEK 292 (2,489).
During Q2 2021, the development of the company's test for early detection of pancreatic cancer was completed, and with this the capitalized development expenditure for this project ended and depreciation of the capitalized development expenditure began.
Investments in tangible fixed assets in the form of equipment were made during Q3 2022 of kSEK 0 (1,019). For the period January to September 2022 investments in tangible fixed assets amounted to kSEK 1,256 (2,568).
No financial investments were made during the period January to September.
Employees
The average number of employees during the Q3 2022 was 64 (68) and at the end of the period the number of employees was 64 (68).
Share information
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.
| 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 | 2,948,228 | 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 |
The 10 largest shareholders on September 30, 2022
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Carl Borrebaeck | 1,709,900 | 7.56% |
| Avanza Pension | 1,543,303 | 6.82% |
| Ranny Davidoff | 1,144,936 | 5.06% |
| Per Mats Ohlin | 848,950 | 3.75% |
| Sara Andersson Ek | 848,907 | 3.75% |
| Christer Wingren | 748,525 | 3.31% |
| Vincent Saldell | 630,000 | 2.78% |
| Nordnet Pensionsförsäkring | 516,624 | 2.28% |
| Coeli | 308,835 | 1.36% |
| Handelsbanken Fonder | 216,857 | 0.96% |
| Ten largest owners | 8,516,837 | 37.63% |
| Others | 14,114,744 | 62.37% |
| Total | 22,631,581 | 100.00% |
Source: Monitor by Modular Finance AB. Compiled and processed data from Euroclear, Morningstar and the Swedish Financial Supervisory Authority, among others
Incentive schemes
Immunovia has three outstanding warrant schemes comprising 1,011,500 options with the right to subscribe for 1,011,500 shares. There is no dilution effect on earnings per share as long as the Group's earnings are negative.
Warrant scheme
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.
Alternative cash-based incentive schemes
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.
Breakdown of outstanding incentive scheme
| Number of outstanding |
Sub scription price/ |
Change in share capital at full |
Total cost of alternative cash-based incentive |
|||
|---|---|---|---|---|---|---|
| Incentive scheme | Decision date | Utilization period | warrants | share | utilization | 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 | |
| Warrant scheme 2020/2024 |
April 7, 2022 | Jun 1, 2026 -- Jun 30, 2026 | 652,000 | 88.69 | 32,600.00 | |
| 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 | |||
| Alternative cash based incentive scheme 2022/2026 |
April 7, 2022 | Jun 1, 2026 -- Jun 30, 2026 | 369,000 | |||
| Total | 1,011,500 | 50,575.00 | 1,081,000 |
Consolidated income statement, summary
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Operating income etc | |||||
| Net sales | 358 | 377 | 643 | 539 | 844 |
| Other operating income | 23 | 9 | 48 | 74 | 113 |
| Total operating income | 381 | 386 | 691 | 612 | 956 |
| Operating expenses | |||||
| Raw materials and consumables | -1,456 | -2,674 | -3,286 | -2,674 | -3,533 |
| Other external expenses | -14,583 | -16,183 | -54,954 | -65,551 | -82,607 |
| Personnel costs | -20,125 | -15,046 | -63,593 | -53,351 | -79,487 |
| Capitalized work for own account | 0 | 0 | 0 | 18,502 | 18,502 |
| Amortization and write-down of tangible and | |||||
| intangible assets | -6,134 | -6,215 | -18,682 | -12,871 | -19,063 |
| Other operating expenses | 0 | -207 | -246 | -419 | -1,397 |
| Total operating expenses | -42,297 | -40,324 | -140,761 | -116,364 | -167,584 |
| Operating earnings/loss | -41,916 | -39,938 | -140,070 | -115,752 | -166,628 |
| Profit/loss from financial items | |||||
| Financial income | 19,371 | 4,159 | 40,514 | 10,363 | 14,459 |
| Financial expenses | -388 | -351 | -1,215 | -3,449 | -3,797 |
| Total financial items | 18,984 | -3,808 | 39,300 | 6,914 | 10,662 |
| Earnings/loss after financial items | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 |
| Earnings per share before dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 |
| Earnings per share after dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 |
| Average number of shares | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 |
| Number of shares at year's end | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 | 22,631,581 |
Consolidated comprehensive income, summary
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Earnings/loss for the period | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 |
| Items that may be reclassified later in the income state ment |
|||||
| Exchange rate differences for foreign net investment | -22,538 | -215 | -37,208 | -6,592 | -9,973 |
| Other earnings/loss for the period | -22,538 | -215 | -37,208 | -6,592 | -9,973 |
| Comprehensive income for the period | -45,470 | -36,346 | -137,978 | -115,429 | -165,939 |
Consolidated financial position, summary
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| SEK thousands | Sep 30 | Sep 30 | Dec 31 |
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 137,126 | 151,227 | 147,147 |
| Tangible fixed assets | 51,577 | 49,044 | 46,528 |
| Financial fixed assets | 3,729 | 2,948 | 3,033 |
| Total fixed assets | 192,432 | 203,219 | 196,707 |
| Current assets | |||
| Inventory | 1,273 | 1,312 | 2,150 |
| Accounts receivable | 128 | 52 | 72 |
| Other short term receivables | 8,127 | 8,051 | 7,474 |
| Cash and cash equivalents | 158,839 | 339,165 | 287,406 |
| Total current assets | 168,367 | 348,580 | 297,102 |
| TOTAL ASSETS | 360,799 | 551,799 | 493,809 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Share capital | 1,132 | 1,132 | 1,132 |
| Other contributed capital | 1,016,060 | 1,015,730 | 1,015,730 |
| Translation reserve | -38,867 | 1,723 | -1,658 |
| Retained earnings incl. total comprehensive income | -682,070 | -534,171 | -581,300 |
| Total equity | 296,255 | 484,414 | 433,903 |
| Long-term liabilities | |||
| Interest-bearing liabilities | 35,012 | 28,674 | 27,156 |
| Total long-term liabilities | 35,012 | 28,674 | 27,156 |
| Current liabilities | |||
| Interest-bearing liabilities | 4,857 | 5,861 | 6,106 |
| Other liabilities | 24,675 | 32,850 | 26,644 |
| Total current liabilities | 29,532 | 38,711 | 32,750 |
| TOTAL EQUITY AND LIABILITIES | 360,799 | 551,799 | 493,809 |
Change in consolidated equity, summary
| Share | Other contributed |
Accumulated earnings/loss for |
|||
|---|---|---|---|---|---|
| SEK thousands | capital | equity | Reserves | the period | Total equity |
| Opening balance January 1, 2021 | 1,132 | 1,015,291 | 8,315 | -425,334 | 599,004 |
| Comprehensive income for the period | -6,592 | -108,838 | -115,430 | ||
| Transactions with owners in their capacity as owners |
|||||
| Received warrants premiums | 440 | 440 | |||
| Closing balance September 30, 2021 | 1,132 | 1,015,730 | 1,723 | -534,172 | 484,414 |
| Comprehensive income for the period | -6,906 | -83,259 | -90,165 | ||
| Transactions with owners in their capacity as owners |
|||||
| Closing balance December 31, 2021 | 1,132 | 1,015,730 | -1,658 | -581,300 | 433,904 |
| Comprehensive income for the period | -37,208 | -100,770 | -137,978 | ||
| Transactions with owners in their capacity as owners |
|||||
| Received warrants premiums | 330 | 330 | |||
| Closing balance September 30, 2022 | 1,132 | 1,016,060 | -38,867 | -682,070 | 296,255 |
Consolidated cash flow statement, summary
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Operating activities | |||||
| Operating earnings/loss | -41,916 | -39,938 | -140,070 | -115,752 | -166,628 |
| Adjustment for items not included in cash flow | 4,189 | 6,212 | 17,877 | 12,751 | 20,048 |
| Interest received | 204 | 155 | 475 | 558 | 711 |
| Interest paid | -388 | -351 | -1,215 | -1,092 | -1,441 |
| Tax paid | 0 | 0 | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-37,911 | -33,922 | -122,933 | -103,535 | -147,310 |
| Cash flow from changes in working capital | |||||
| Change in inventory | 419 | 694 | 1,223 | -1,289 | -2,038 |
| Change in operating receivables | 142 | -2,174 | -146 | -1,641 | -1,098 |
| Change in operating liabilities | -64 | -7,234 | -2,520 | 3,297 | -2,202 |
| Cash flow from operating activities | -37,413 | -38,288 | -124,376 | -102,538 | -152,648 |
| Investment activities | |||||
| Investment in intangible assets | -63 | -1,813 | -292 | -20,905 | -21,083 |
| Investment in tangible assets | 0 | -1,019 | -1,256 | -2,568 | -3,101 |
| Investment in financial fixed assets | 0 | 0 | 0 | 0 | 0 |
| Sale of fixed assets | 0 | 0 | 0 | 186 | 358 |
| Cash flow from investment activities | -63 | -2,832 | -1,548 | -23,287 | -23,826 |
| Financing activities | |||||
| Amortization of leasing liability | -1,469 | -1,429 | -4,198 | -4,267 | -5,709 |
| New share issue | 0 | 0 | 0 | 0 | 0 |
| Received warrants premiums | 0 | 0 | 330 | 440 | 440 |
| Cash flow from financing activities | -1,469 | -1,429 | -3,868 | -3,827 | -5,269 |
| Cash flow for the period | -38,945 | -42,549 | -129,792 | -129,652 | -181,743 |
| Cash and cash equivalents at start of period | 197,447 | 381,550 | 287,406 | 468,462 | 468,462 |
| Exchange rate difference in cash and cash | |||||
| equivalents | 337 | 164 | 1,225 | 355 | 687 |
| Cash and cash equivalents at end of period | 158,839 | 339,165 | 158,839 | 339,165 | 287,406 |
Consolidated key indicators
| 2022 | 2021 | 2022 | 2021 | 2021 | 2020 | |
|---|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year | Full year | |
| Operating earnings/loss (SEK 000) | -41,916 | -39,938 | -140,070 | -115,752 | -166,628 | -134,343 |
| Earnings/loss for the year (SEK 000) | -22,932 | -36,131 | -100,770 | -108,838 | -155,966 | -146,033 |
| Earnings per share before dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 | -6.84 |
| Earnings per share after dilution (SEK) | -1.01 | -1.60 | -4.45 | -4.81 | -6.89 | -6.84 |
| R&D expenses (SEK 000) | -9,858 | -8,314 | -35,128 | -24,245 | -42,850 | -48,078 |
| R&D expenses as percentage of operating expenses (%) |
24 | 22 | 25 | 25 | 24 | 29 |
| Cash and cash equivalents at the period's end (SEK 000) |
158,839 | 339,165 | 158,839 | 339,165 | 287,406 | 468,462 |
| Cash flow from operating activities (SEK 000) | -37,413 | -38,288 | -124,376 | -102,538 | -152,648 | -120,704 |
| Cash flow for the period (SEK 000) | -38,945 | -42,,549 | -129,792 | -129,652 | -181,743 | 205,918 |
| Equity (SEK 000) | 296,255 | 484,414 | 296,255 | 484,414 | 433,903 | 599,403 |
| Equity per share (SEK) | 13,09 | 21,40 | 13,09 | 21,40 | 19.17 | 26.49 |
| Equity / assets ratio (%) | 82 | 88 | 82 | 88 | 88 | 91 |
| Average number of employees | 64 | 68 | 64 | 68 | 67 | 63 |
| Average number of employees in R&D | 18 | 22 | 20 | 22 | 23 | 21 |
Definitions
| 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 relating 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 outstanding shares in the period before and after dilution respectively. Because the group is generating a loss, there is no dilution, despite the subscrip tion price being lower than the share 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 operating expenses, which include other ex ternal expenses, personnel expen ses, depreciation and amortization. |
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 company'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 equivalents for the period excluding effective unrealized exchange rate gains and exchange rate losses. |
|
| Equity per share (SEK) | Equity 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 employees 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 research and development functions. |
Parent company's income statement, summary
| SEK thousands | 2022 Jul-Sep |
2021 Jul-Sep |
2022 Jan-Sep |
2021 Jan-Sep |
2021 Full year |
|---|---|---|---|---|---|
| Operating income etc. | |||||
| Net sales | 8,087 | 3,516 | 19,921 | 4,379 | 9,987 |
| Capitalized work for own account | 0 | 0 | 0 | 18,502 | 18,502 |
| Other operating income | 7 | 7 | 54 | 67 | 96 |
| Total operating income | 8,094 | 3,523 | 19,975 | 22,948 | 28,585 |
| Operating expenses | |||||
| Raw material and consumables | -1,063 | -704 | -2,703 | -867 | -2,084 |
| Other external expenses | -8,883 | -13,142 | -48,679 | -59,286 | -87,841 |
| Personnel costs | -10,781 | -8,984 | -38,109 | -34,082 | -48,100 |
| Amortization and write-down of intan gible and |
|||||
| tangible fixed assets | -4,163 | -4,336 | -12,768 | -7,386 | -11,685 |
| Other operating expenses | -125 | -207 | -301 | -419 | -1,397 |
| Total operating expenses | -25,015 | -27,373 | -102,559 | -102,040 | -151,107 |
| Operating earnings/loss | -16,921 | -23,850 | -82,585 | -79,092 | -122,522 |
| Operating expenses | |||||
| Financial incomes | 21,005 | 5,049 | 44,694 | 12,708 | 17,869 |
| Financial expenses | 0 | 0 | -2 | -2,356 | -2,356 |
| Total financial items | 21,005 | 5,049 | 44,692 | 10,352 | 15,513 |
| Earnings/loss after financial items | 4,083 | -18,801 | -37,893 | -68,739 | -107,009 |
| Allocations | |||||
| Group contributions received | 0 | 0 | 0 | 0 | 437 |
| Total allocations | 0 | 0 | 0 | 0 | 437 |
| Earnings/loss before tax | 4,083 | -18,801 | -37,893 | -68,739 | -106,572 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | 4,083 | -18,801 | -37,893 | -68,739 | -106,572 |
Parent company's comprehensive income, summary
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Earnings/loss for the period | 4,083 | -18,801 | -37,893 | -68,739 | -106,572 |
| Other earnings/loss for the period | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | 4,083 | -18,801 | -37,893 | -68,739 | -106,572 |
Parent company's balance sheet, summary
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| SEK thousands | Sep 30 | sep 30 | Dec 31 |
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 135,696 | 149,830 | 145,778 |
| Tangible fixed assets | 8,215 | 10,864 | 10,185 |
| Financial fixed assets | 328 | 328 | 328 |
| Total fixed assets | 144,239 | 161,022 | 156,291 |
| Current assets | |||
| Inventory | 749 | 1,001 | 1,722 |
| Receivables from Group companies | 246,083 | 132,251 | 147,557 |
| Current receivables | 3,027 | 2,929 | 3,951 |
| Prepaid expenses and accrued income | 2,719 | 2,718 | 2,594 |
| Cash and cash equivalents | 153,804 | 334,999 | 279,191 |
| Total current assets | 406,382 | 473,898 | 435,015 |
| TOTAL ASSETS | 550,621 | 634,920 | 591,306 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | 1,132 | 1,132 | 1,132 |
| Fund for development expenses | 108,286 | 120,140 | 117,177 |
| Total equity and liabilities | 109,418 | 121,272 | 118,309 |
| Non-restricted equity | |||
| Premium fund | 0 | 0 | 0 |
| Retained earnings including comprehensive income | 418,275 | 482,147 | 447,277 |
| Total non-restricted equity | 418,275 | 482,147 | 447,277 |
| Total equity | 527,693 | 603,419 | 565,586 |
| Current liabilities | |||
| Other liabilities | 22,928 | 31,501 | 25,720 |
| Total current liabilities | 22,928 | 31,501 | 25,720 |
| TOTAL EQUITY AND LIABILITIES | 550,621 | 634,920 | 591,306 |
Parent company's cash flow statement, summary
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| SEK thousands | Jan-Sep | Jan-Sep | Full year |
| Operating activities | |||
| Operating earnings/loss | -82 585 | -79,092 | -122,522 |
| Adjustment for items not included in cash flow | 12 768 | 7,405 | 12,542 |
| Interest received | 475 | 558 | 711 |
| Interest paid | -2 | -2 | -3 |
| Tax paid | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working | |||
| capital | -69 344 | -71,131 | -109,272 |
| Cash flow from changes in working capital | |||
| Change in inventory | 972 | -1,001 | -1,721 |
| Change in operating receivables | -53 507 | -35,606 | -47,181 |
| Change in operating liabilities | -2 792 | 4,173 | -794 |
| Cash flow from operating activities | -124 671 | -103,565 | -158,968 |
| Investment activities | |||
| Investment in intangible fixed assets | -292 | -20,991 | -21,235 |
| Investment in tangible fixed assets | -424 | -2,361 | -2,522 |
| Investment in financial fixed assets | 0 | 0 | 0 |
| Sale of fixed assets | 0 | 186 | 186 |
| Cash flow from investment activities | -716 | -23,166 | -23,571 |
| Financing activities | |||
| New share issue | 0 | 0 | 0 |
| Cash flow from financing activities | 0 | 0 | 0 |
| Cash flow for the period | -125 387 | -126,731 | -182,539 |
| Cash and cash equivalents at start of period | 279 191 | 461,730 | 461,730 |
| Cash and cash equivalents at period's end | 153 804 | 334,999 | 279,191 |
Accounting principles
Accounting principles
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 2021 annual report.
This interim report has been prepared in accordance with IAS 34 Interim.
New and amended standards adopted with effect from 2022 are not expected to have any significant impact on the Group's financial position.
OTHER INFORMATION
Financial instruments
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.
Inventory
Inventory is reported by applying the first-in-first-out principle (FIFU). Raw materials and finished and half-finished products purchased are valued at the lower out of acquisition and net sales value. Manufactured finished and half-finished products are valued at the lower of the manufacturing cost of the goods (including a reasonable share of indirect manufacturing costs) and the net sales value. When trading between Group companies, market conditions are applied. In the case of obsolescence and internal profits, the necessary provisions and eliminations are made.
Revenue recognition
Of this quarter's net sales, kSEK 111 refers to sales of test results. These contracts contain a performance commitment, which means carrying out tests on blood samples for the customers, i.e. the patients. The test result is sent to the patients immediately after the analysis has been carried out. Revenue recognition takes place when the test result has been sent, i.e. transferred to the patient, which means that revenue recognition takes place at a certain time.
Transactions with related parties
From time to time, board members undertake specific assignments outside the scope of regular board work, which are either decided by the AGM or by the Board of Directors.
In addition to salaries and other renumeration to executive management and board fees, according to a resolution by the AGM, a consulting agreement was entered into during 2018 with CB Ocean Capital AB for services performed by Immunovia's chairman of the board and its largest owner Carl Borrebaeck regarding scientific and strategic support. The agreement runs until further notice with a three-month mutual notice period and provides a quarterly compensation of SEK 41 thousand.
Further agreements have been made and concluded with Hongaard Consulting Aps and MM Advisory for services performed by board members Peter Høngaard Andersen and Martin Møller relating to Immunovia´s strategic planning. The assignment is concluded during the first half of 2022 and has provided compensation of in total 360 thousand SEK.
Risks
lmmunovia 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 46 of the 2021 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.
Currency risk
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 in cash flow
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
Credit risk is the risk of one party in a transaction with a financial instrument failing September 30, 2022 was MSEK 163 (343).
Liquidity risk
The company is in a situation where operational costs are not covered by generated revenues, but requires external financing. Based on the cash holding of MSEK 159 and the existing financing plans, the company's continued operations are ensured according to the Board's assessment.
INTERIM REPORT JANUARY-SEPTEMBER, 2022
18
OTHER INFORMATION
Review
This interim report has been reviewed by the company's auditors.
Financial calendar
Financial statement 2022, Thursday February 9, 2023
Contact information:
lmmunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden Tel: +46 46 275 60 00 Email: [email protected] Web: www.immunovia.com
For further information please contact
Philipp Mathieu, CEO and President
Karin Almqvist Liwendahl, CFO
The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 am CET on November 10, 2022.
Conference call
Immunovia will hold a webcast tele conference at 14:00 pm CET on November 10 with Philipp Mathieu, CEO and President, Jeff Borcherding, CEO Immunovia, Inc. and Karin Almqvist Liwendahl, CFO.
To take part of the presentation, please dial one of the numbers or watch via the web link below.
Sweden: +46 (0)8 5051 0031 United Kingdom: +44 (0) 207 107 06 13 United States: +1 (1) 631 570 56 13
Link to the webcast: https://link.edgepilot.com/s/5c6b60a2/OaUB5Q9ASkeASYHQ8QIopQ?u=http:// creo-live.creomediamanager.com/8c2be08d-5469-401d-bc5f-cb5024ef45d0
INTERIM REPORT JANUARY-SEPTEMBER, 2022
19
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 November 10, 2022
Carl Borrebaeck Chairman of the board Hans Johansson Board member
Philipp von Hugo Board member
Eric Krafft Board member
Martin Møller Board member Peter Høngaard Andersen Board member
Philipp Mathieu CEO & President
Glossary
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 immuglobulins, are a type of protein used by the body´s immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
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.
CAP - College of American Pathologists. The CAP has deemed status under CLIA to accredit laboratories performing testing on specimens from human beings or animals, using methodologies and clinical application within the expertise of the program. Laboratories must be appropriately licensed to perform testing when required by law.
CLIA - Clinical Laboratory Improvement Amendments. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to ensure quality laboratory testing. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments.
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 Predictive 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.
lmmunovia in brief
Immunovia AB is a diagnostic company with the vision to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.
Our first product, IMMray™ PanCan-d is the only blood test currently available for early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray™ PanCan-d started in August 2021 in the USA and IMMray™ PanCan-d is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc. For more information see: www.immunoviainc.com.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups globally to make this test available to all high-risk pancreatic cancer groups.
The USA, the first market in which IMMray™ PanCan-d is commercially available, is the world's largest market for the detection of pancreatic cancer with an estimated value of more than USD 4 billion annually.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
Vision
Immunovia's vision is to revolutionize blood-based diagnostics and increase survival rates for patients with cancer.
Mission
To develop and commercialise non-invasive blood tests, so that more patients can receive a timely diagnosis, that can lead to improved treatment outcomes.
IMMray™ PanCan-d enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II).
It is estimated that early detection of pancreatic cancer would increase the five-yearsurvival rate up to 50 percent.
IMMUNOVIA AB EARLY DETECTION Phone: +46 (0)46-275 60 00 [email protected] www.immunovia.com
Scheelevägen 8, Medicon Village 223 63 Lund, Sweden