Quarterly Report • Nov 9, 2023
Quarterly Report
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2023 INTERIM REPORT JANUARY – SEPTEMBER
"During the third quarter we made significant changes to streamline Immunovia and made important progress in developing our next-generation test. As we move forward, we are focused on the rapid execution of our plan to develop and validate the new product. Additionally, we are exploring strategic partnerships that will allow us to succeed in 2024 and beyond."
1
Jeff Borcherding, CEO and President, Immunovia AB
| SEK thousand unless otherwise stated | 2023 Jul-Sep |
2022 Jul-Sep |
2023 Jan-Sep |
2022 Jan-Sep |
2022 Full year |
|---|---|---|---|---|---|
| Net sales | 488 | 358 | 1,419 | 643 | 1,145 |
| Operating earnings/loss | -38,889 | -41,916 | -273,054 | -140,070 | -191,150 |
| Earnings before tax | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 |
| Net earnings | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 |
| Earnings per share before dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 |
| Earnings per share after dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 |
| Equity ratio (%) | 62 | 82 | 62 | 82 | 81 |
| Number of shares at the end of the period | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 | 22,631,581 |
INTERIM REPORT JANUARY-SEPTEMBER, 2023
During the third quarter we made significant changes to streamline Immunovia and made important progress in developing our next-generation test. As we move forward, we are focused on the rapid execution of our plan to develop and validate the new product. Additionally, we are exploring strategic partnerships that will allow us to succeed in 2024 and beyond.
Following the July announcement that we would discontinue selling the IMMray™ PanCan-d test, we moved quickly to transform Immunovia. This transformation has been significant and multi-faceted, touching nearly every part of the company. The restructuring was intended to significantly decrease spending, while focusing the company's resources on our next-generation test.
We have transformed Immunovia in important ways:
As we near the end of this transformation, the new Immunovia is a much more agile, much leaner, and more focused company. We remain true to our vision, we have unique assets, we are now cost efficient, and we are focused on our clinical mission: to save lives through early detection of pancreatic cancer with our next generation test.
As we announced, we have successfully completed the crucial discovery stage of development for our next-generation test. We found more than a dozen proteins circulating in the blood that identified patients with stage I and stage II PDAC (pancreatic ductal adenocarcinoma). Conducted using the Olink platform, the study is the most comprehensive proteomics study to date in pancreatic cancer, exploring more than 3,000 protein biomarkers.
The discovery study was completed quickly thanks to Immunovia's extensive repository of in-house blood samples from pancreatic cancer patients and controls. Immunovia's R&D partnership with Proteomedix has also proven instrumental in rapidly developing the new test.
We have already begun the model building stage of the R&D process. In this phase, we will develop reliable assays to measure the target proteins. These assays will be conducted on an ELISA platform, which will reduce costs and improve scalability.
IMMUNOVIA AB EARLY DETECTION
During the current model building stage, we will also select the final biomarkers to be used in the commercial test. By Q2 2024 we will complete a training and an initial validation study to optimize the test and assess its sensitivity and specificity. Later in 2024, Immunovia will confirm the analytical validity of the test and conduct a larger clinical validation study.
The experience, assets, and relationships Immunovia has built over the years are enabling us to develop the next generation test successfully and quickly. Our development efforts are being guided by a deep roster of expert advisors, with many of the top thought leaders in pancreatic cancer providing counsel. We have built deep realtionships with these advisors over several years and they are incredibly supportive of our efforts. We are also reaping the benefits of our industry-leading repository of pancreatic cancer blood samples. Accumulated through collaborations with pancreatic centers throughout Europe and U.S. these samples enabled us to quickly evaluate thousands of potential biomarkers in a wide range of patient types using samples we already had.
As I noted in our second quarter report, partnerships will be crucial to our success. Proteomedix continue to demonstrate their deep expertise in discovering novel biomarkers, building accurate tests, and developing commercial assays. Our collaboration strategy has enabled us to accelerate our time to market and reduce our development costs.
To generate sufficient clinical data on our new test to support reimbursement, we will partner with leading academic institutions and research consortia. These groups are conducting large clinical studies in the early detection of pancreatic cancer in high-risk individuals. By partnering with them, we can study our product in more patients, for a longer time, at a much lower cost than conducting our own proprietary studies. Conversations with these groups are progressing well and we expect to announce research partnerships in the first quarter of 2024.
Commercializing our next generation test will require partnership as well. We will seek a partner with existing selling capacity and established relationships with our target clinicians. This will enable us to accelerate test adoption and bring our next-generation test to market without shouldering the full expense of our own sales organization. We can be an attractive partner to a company looking to bolster its product portfolio with an accurate test targeting a large market with significant unmet clinical needs. Securing a strategic partner is the primary focus for the remainder of 2023 and 2024.
Our transformation into a much more cost-efficient company is nearly complete and we are making excellent progress on our new test. Still, we clearly face challenges, most importantly a difficult financial market. We are working hard to outline a compelling vision for the company and to regain investor trust by delivering on our commitments. We are focused on execution, leveraging our new lean and agile structure to drive development of our next test. We will capitalize on our legacy assets, while collaborating with partners who augment our strengths. Ultimately, we plan to address the significant unmet clinical need for early detection of pancreatic cancer and to reward shareholders for their commitment and support.
November 9, 2023 Jeff Borcherding President & CEO, Immunovia AB
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| Group's performance over the period 5 | |
|---|---|
| Share information 6 | |
| Incentive scheme 8 | |
| Consolidated income statement in summary 9 | |
| Consolidated comprehensive income in summary 9 | |
| Consolidated financial position in summary 10 | |
| Change in consolidated equity in summary 11 | |
| Consolidated cash flow statement in summary 12 | |
| Consolidated key indicators 13 | |
| Definitions 14 | |
| Parent company's income statement in summary 15 | |
| Parent company's comprehensive income in summary 15 | |
| Parent company's financial position in summary 16 | |
| Parent company's cash flow statement in summary 17 | |
| Notes 18 | |
| Auditor's review report 25 | |
| Glossary 26 | |
| Immunovia in brief 28 |
This information was submitted for publication on November 9, 2023, 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.
Immunovia AB (publ), Swedish Corporate Identity Number 556730-4299, Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden
• [email protected] • +46 46 2756 000
Karin Almqvist Liwendahl, CFO
Net sales for Q3 amounted to kSEK 488 (358), of which kSEK 70 (111) consisted of sales of tests and kSEK 418 (247) were royalties. For the period January to September of 2022, net sales amounted to kSEK 1,419 (643), of which kSEK 799 (278) consisted of sales of tests and kSEK 620 (365) were royalties.
Net earnings for Q3 amounted to kSEK -38,556 (-22,932). The main difference in net earnings compared to Q3 2022 relates to currency exchange rate effects due to a stronger USD vs SEK.
Other external costs and personnel costs increased by kSEK 2,058 during Q3 compared with the corresponding period last year and amounted to a total of kSEK 36,766. The increase is due to costs reflecting discontinuation of IMMray™ PanCan-d and restructuring.
Total R&D cost for Q3 2023 amounted to kSEK 6,715 (9,858), which corresponded to 13 percent (24) of the Group's total operating expenses.
Cash flow from operating activities during the Q3 2023 amounted to kSEK -35,569 (-37,413).
Cash and cash equivalents as of September 30, 2023 amounted to kSEK 106,677 (158,839).
Equity at the end of the period amounted to kSEK 93,221 (296,255) and the equity/assets ratio was 62 percent (82).
With a cash position of MSEK 107, along with the expected effects of the ongoing reconstruction, the Board's assessment is that the company's continued operation based on current plans is financed to late 2024.
In Q3, intangible assets totalling kSEK 0 (63) were acquired, consisting of capitalized development expenditure of kSEK 0 (0) and patents kSEK 0 (63).
During the period January to September 2023, investments in intangible fixed assets amounted to kSEK 1,061 (292) consisting of capitalized development expenditure of kSEK 0 (0), patents kSEK 35 (292) and licenses 1,026 (0).
Investments in tangible fixed assets in the form of equipment were made during Q3 2023 of kSEK 0 (0). For the period January to September 2023 investments in tangible fixed assets amounted to kSEK 0 (1,256).
No financial investments were made during the period January to September 2023.
The average number of employees during the Q3 2023 was 29 (64) and at the end of the period the number of employees was 25 (64).
The number of registered shares amounted to 45,287,498 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 |
| April 12, 2023 | New share issue | 2,264,374.90 | 1,132,795.85 | 45,287,498 | 22,655,917 | 0.05 |
| At end of period | 2,264,374.90 | 45,287,498 | 0.05 |
| Shareholders | No. of shares | Share (capital and votes) |
|---|---|---|
| Avanza Pension | 4,777,126 | 10.55% |
| Carl Borrebaeck | 1,709,900 | 3.78% |
| Nordnet Pensionsförsäkring AB | 1,514,095 | 3.34% |
| Caceis Bank, Switzerland Branch, WBIMY | 1,319,706 | 2.91% |
| Lisa Stenqvist | 929,230 | 2.05% |
| Mats Ohlin | 848,950 | 1.87% |
| Sara Andersson Ek | 848,907 | 1.87% |
| Christer Wingren | 748,525 | 1.65% |
| Åhlandsbanken ABP (Finland), Svensk filial | 692,027 | 1.53% |
| Vincent Saldell | 624,340 | 1.38% |
| Ten largest owners | 14,012,806 | 30.94% |
| Others | 31,274,692 | 69.06% |
| Total | 45,287,498 | 100.00% |
Source: Monitor by Modular Finance AB. Compiled and processed data from Euroclear, Morningstar and the Swedish Financial Supervisory Authority, among others
Immunovia has three outstanding warrant programs comprising 656,000 options with the right to subscribe for 656,000 shares. There is no dilution effect on earnings per share 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 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 programs is 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 of the corresponding warrant program. The total cost to the company for the cash-based incentive programs is shown in the breakdown below.
All warrant programs are subject to customary recalculation terms in connection with share issues, etc.
| Incentive program | 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 pro grams (USD) |
|---|---|---|---|---|---|---|
| Warrant program 2020/2024 |
Sep 23, 2020 | Jun 1, 2024 – Jun 30, 2024 | 280,000 | 455.59 | 14,000.00 | |
| Warrant program 2020/2024 |
April 7, 2022 | Jun 1, 2026 – Jun 30, 2026 | 376,000 | 88.69 | 18,800.00 | |
| Alternative cash based incentive pro gram 2020/2024 |
Sep 23, 2020 | Jun 1, 2024 – Jun 30, 2024 | 39,812 | |||
| Total | 656,000 | 32,800.00 | 39,812 |
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Operating income etc | |||||
| Net sales | 488 | 358 | 1,419 | 643 | 1,145 |
| Other operating income | 91 | 23 | 173 | 48 | 59 |
| Total operating income | 579 | 381 | 1,592 | 691 | 1,204 |
| Operating expenses | |||||
| Raw materials and consumables | -144 | -1,456 | -6,682 | -3,286 | -4,211 |
| Other external expenses | -19,636 | -14,583 | -57,554 | -54,954 | -77,749 |
| Personnel costs | -17,130 | -20,125 | -70,714 | -63,593 | -85,222 |
| Amortization and write-down of tangible and | |||||
| intangible assets | -2,499 | -6,134 | -139,282 | -18,682 | -24,913 |
| Other operating expenses | -59 | 0 | -414 | -246 | -259 |
| Total operating expenses | -39,468 | -42,297 | -274,646 | -140,761 | -192,354 |
| Operating earnings/loss | -38,889 | -41,916 | -273,054 | -140,070 | -191,150 |
| Profit/loss from financial items | |||||
| Financial income | 968 | 19,371 | 16,928 | 40,514 | 41,259 |
| Financial expenses | -635 | -388 | -4,293 | -1,215 | -18,201 |
| Total financial items | 333 | 18,984 | 12,635 | 39,300 | 23,058 |
| Earnings/loss after financial items | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 |
| Earnings per share before dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 |
| Earnings per share after dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 |
| Average number of shares | 42,518,441 | 22,631,581 | 32,575,011 | 22,631,581 | 22,631,581 |
| Number of shares at the end of the period | 45,287,498 | 22,631,581 | 45,287,498 | 22,631,581 | 22,631,581 |
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Earnings/loss for the period | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 |
| Items that may be reclassified later in the income state ment |
|||||
| Exchange rate differences for foreign net investment | 507 | -22,538 | -11,406 | -37,208 | -22,647 |
| Other earnings/loss for the period | 507 | -22,538 | -11,406 | -37,208 | -22,647 |
| Comprehensive income for the period | -38,049 | -45,470 | -271,825 | -137,978 | -190,739 |
| 2023 | 2022 | 2022 | ||
|---|---|---|---|---|
| SEK thousands | Note | Sep 30 | Sep 30 | Dec 31 |
| ASSETS | ||||
| Fixed assets | ||||
| Intangible fixed assets | 3,4,5 | 2,792 | 137,126 | 133,597 |
| Tangible fixed assets | 34,207 | 51,577 | 47,877 | |
| Financial fixed assets | 3 | 3,729 | 3,500 | |
| Total fixed assets | 37,002 | 192,432 | 184,974 | |
| Current assets | ||||
| Inventory | 0 | 1,273 | 2,016 | |
| Accounts receivable | 0 | 128 | 253 | |
| Other short term receivables | 5,915 | 8,127 | 7,305 | |
| Cash and cash equivalents | 106,677 | 158,839 | 106,041 | |
| Total current assets | 112,592 | 168,367 | 115,615 | |
| TOTAL ASSETS | 149,594 | 360,799 | 300,589 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Share capital | 2,264 | 1,132 | 1,132 | |
| Other contributed capital | 1,136,480 | 1,016,060 | 1,016,369 | |
| Translation reserve | -35,712 | -38,867 | -24,306 | |
| Retained earnings incl. total comprehensive income | -1,009,811 | -682,070 | -749,392 | |
| Total equity | 93,221 | 296,255 | 243,803 | |
| Long-term liabilities | ||||
| Interest-bearing liabilities | 6 | 21,187 | 35,012 | 32,700 |
| Total long-term liabilities | 21,187 | 35,012 | 32,700 | |
| Current liabilities | ||||
| Interest-bearing liabilities | 6 | 5,101 | 4,857 | 4,874 |
| Other liabilities | 7 | 30,085 | 24,675 | 19,212 |
| Total current liabilities | 35,186 | 29,532 | 24,086 | |
| TOTAL EQUITY AND LIABILITIES | 149,594 | 360,799 | 300,589 |
| Share | Other contributed |
Accumulated earnings/loss for |
|||
|---|---|---|---|---|---|
| SEK thousands | capital | equity | Reserves | the period | Total equity |
| Opening balance January 1, 2022 | 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 |
|||||
| Recived as warrants premium | 330 | 330 | |||
| Closing balance 30 September, 2022 | 1,132 | 1,016,060 | -38,867 | -682,070 | 296,255 |
| Comprehensive income for the period | 14,561 | -67,322 | -52,761 | ||
| Transactions with owners in their capacity ac owners |
|||||
| Recived as warrants premium | 309 | 309 | |||
| Closing balance December 31, 2022 | 1,132 | 1,016,369 | -24,306 | -749,392 | 243,803 |
| Comprehensive income for the period | -11,406 | -260,419 | -271,825 | ||
| Transactions with owners in their capacity as owners |
|||||
| New share issue | 1,132 | 150,662 | 151,794 | ||
| Share issue cost | -30,551 | -30,551 | |||
| Closing balance September 30, 2023 | 2,264 | 1,136,480 | -35,712 | -1,009,811 | 93,221 |
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Operating activities | |||||
| Operating earnings/loss | -38,889 | -41,916 | -273,053 | -140,070 | -191,150 |
| Adjustment for items not included in cash flow | 2,115 | 4,189 | 138,720 | 17,877 | 23,471 |
| Interest received | 968 | 204 | 2,206 | 475 | 745 |
| Interest paid | 93 | -388 | -918 | -1,215 | -1,494 |
| Tax paid | 0 | 0 | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working capital |
-35,712 | -37,911 | -133,045 | -122,933 | -168,428 |
| Cash flow from changes in working capital | |||||
| Change in inventory | 16 | 419 | 2,036 | 1,223 | 438 |
| Change in operating receivables | 793 | 142 | 1,704 | -146 | 298 |
| Change in operating liabilities | -666 | -63 | 10,736 | -2,520 | -7,890 |
| Cash flow from operating activities | -35,569 | -37,413 | -118,569 | -124,376 | -175,582 |
| Investment activities | |||||
| Investment in intangible assets | 0 | -63 | -1,061 | -292 | -368 |
| Investment in tangible assets | 0 | 0 | 0 | -1,256 | -1,256 |
| Investment in financial fixed assets | 0 | 0 | 0 | 0 | 0 |
| Sale of fixed assets | 39 | 0 | 3,547 | 0 | 0 |
| Cash flow from investment activities | 39 | -63 | 2,486 | -1,548 | -1,624 |
| Financing activities | |||||
| Amortization of leasing liability | -1,663 | -1,469 | -4,857 | -4,198 | -5,746 |
| New share issue | 0 | 0 | 121,243 | 0 | 0 |
| Received warrants premiums | 0 | 0 | 0 | 330 | 639 |
| Cash flow from financing activities | -1,663 | -1,469 | 116,386 | -3,868 | -5,107 |
| Cash flow for the period | -37,193 | -38,945 | 303 | -129,792 | -182,313 |
| Cash and cash equivalents at start of period | 143,878 | 197,447 | 106,041 | 287,406 | 287,406 |
| Exchange rate difference in cash and cash | |||||
| equivalents | -8 | 337 | 333 | 1,225 | 948 |
| Cash and cash equivalents at end of period | 106,677 | 158,839 | 106,677 | 158,839 | 106,041 |
| 2023 | 2022 | 2023 | 2022 | 2022 | 2021 | |
|---|---|---|---|---|---|---|
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year | Full year | |
| Operating earnings/loss (SEK 000) | -38,889 | -41,916 | -273,054 | -140,070 | -191,150 | -166,628 |
| Earnings/loss for the year (SEK 000) | -38,556 | -22,932 | -260,419 | -100,770 | -168,092 | -155,966 |
| Earnings per share before dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 | -6.89 |
| Earnings per share after dilution (SEK) | -0.91 | -1.01 | -7.99 | -4.45 | -7.43 | -6.89 |
| R&D expenses (SEK 000) | -6,715 | -9,858 | -24,147 | -35,128 | -47,902 | -42,850 |
| R&D expenses as percentage of operating expenses (%) |
13 | 24 | 14 | 25 | 25 | 24 |
| Cash and cash equivalents at the period's end (SEK 000) |
106,677 | 158,839 | 106,677 | 158,839 | 106,041 | 287,406 |
| Cash flow from operating activities (SEK 000) | -35,569 | -37,413 | -118,569 | -124,376 | -175,582 | -152,648 |
| Cash flow for the period (SEK 000) | -37,193 | -38,945 | 303 | -129,792 | -182,313 | -181,743 |
| Equity (SEK 000) | 93,221 | 296,255 | 93,221 | 296,255 | 243,803 | 433,903 |
| Equity per share (SEK) | 2.06 | 13.09 | 2.06 | 13.09 | 10.77 | 19.17 |
| Equity / assets ratio (%) | 62 | 82 | 62 | 82 | 81 | 88 |
| Average number of employees | 32 | 64 | 38 | 64 | 64 | 67 |
| Average number of employees in R&D | 4 | 18 | 8 | 20 | 18 | 23 |
| 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. |
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Operating income etc. | |||||
| Net sales | 417 | 8,087 | 12,799 | 19,921 | 24,725 |
| Other operating income | 91 | 7 | 172 | 54 | 59 |
| Total operating income | 508 | 8,094 | 12,971 | 19,975 | 24,784 |
| Operating expenses | |||||
| Raw material and consumables | 0 | -1,063 | -3,948 | -2,703 | -3,598 |
| Other external expenses | -14,030 | -8,883 | -41,197 | -48,679 | -61,700 |
| Personnel costs | -7,178 | -10,781 | -32,949 | -38,109 | -48,376 |
| Amortization and write-down of intan | |||||
| gible and tangible fixed assets | -582 | -4,163 | -133,556 | -12,768 | -16,928 |
| Other operating expenses | -73 | -125 | -482 | -301 | -313 |
| Total operating expenses | -21,863 | -25,015 | -212,132 | -102,559 | -130,915 |
| Operating earnings/loss | -21,355 | -16,921 | -199,161 | -82,585 | -106,131 |
| Operating expenses | |||||
| Result from shares in group companies | -24,982 | 0 | -94,999 | 0 | 0 |
| Financial incomes | 3,440 | 21,005 | 20,358 | 44,694 | 47,271 |
| Financial expenses | -357 | 0 | -357 | -2 | -16,604 |
| Total financial items | -21,899 | 21,005 | -74,998 | 44,692 | -225,654 |
| Earnings/loss after financial items | -43,254 | 4,083 | -274,159 | -37,893 | -331,785 |
| Allocations | |||||
| Group contributions received | 0 | 0 | 0 | 0 | 638 |
| Total allocations | 0 | 0 | 0 | 0 | 638 |
| Earnings/loss before tax | -43,254 | 4,083 | -274,159 | -37,893 | -331,147 |
| Income tax | 0 | 0 | 0 | 0 | 0 |
| Earnings/loss for the period | -43,254 | 4,083 | -274,159 | -37,893 | -331,147 |
| 2023 | 2022 | 2023 | 2022 | 2022 | |
|---|---|---|---|---|---|
| SEK thousands | Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Full year |
| Earnings/loss for the period | -43,254 | 4,083 | -274,159 | -37,893 | -331,147 |
| Other earnings/loss for the period | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | -43,254 | 4,083 | -274,159 | -37,893 | -331,147 |
| 2023 | 2022 | 2022 | |
|---|---|---|---|
| SEK thousands | Sep 30 | sep 30 | Dec 31 |
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 1,728 | 135,696 | 132,335 |
| Tangible fixed assets | 5,594 | 8,215 | 7,492 |
| Financial fixed assets | 328 | 328 | 328 |
| Total fixed assets | 7,650 | 144,239 | 140,155 |
| Current assets | |||
| Inventory | 0 | 749 | 1,546 |
| Receivables from Group companies | 685 | 246,083 | 684 |
| Current receivables | 2,545 | 3,027 | 2,881 |
| Prepaid expenses and accrued income | 3,418 | 2,719 | 3,126 |
| Cash and cash equivalents | 92,647 | 153,804 | 103,953 |
| Total current assets | 99,295 | 406,382 | 112,190 |
| TOTAL ASSETS | 106,945 | 550,621 | 252,345 |
| EQUITY AND LIABILITIES | |||
| Equity | |||
| Restricted equity | 2,264 | 1,132 | 1,132 |
| Fund for development expenses | 0 | 108,286 | 105,323 |
| Total equity and liabilities | 2,264 | 109,418 | 106,455 |
| Non-restricted equity | |||
| Premium fund | 120,111 | 0 | 0 |
| Retained earnings including comprehensive income | -40,851 | 418,275 | 127,984 |
| Total non-restricted equity | 79,260 | 418,275 | 127,984 |
| Total equity | 81,524 | 527,693 | 234,439 |
| Current liabilities | |||
| Other liabilities Total current liabilities |
25,421 25,421 |
22,928 22,928 |
17,906 17,906 |
| TOTAL EQUITY AND LIABILITIES | 106,945 | 550,621 | 252,345 |
| 2023 | 2022 | 2022 | |
|---|---|---|---|
| SEK thousands | Jan-Sep | Jan-Sep | Full year |
| Operating activities | |||
| Operating earnings/loss | -199,161 | -82,585 | -106,131 |
| Adjustment for items not included in cash flow | 133,566 | 12,768 | 17,567 |
| Interest received | 2,182 | 475 | 744 |
| Interest paid | 0 | -2 | -3 |
| Tax paid | 0 | 0 | 0 |
| Cash flow from operating activities before changes in working | |||
| capital | -63,413 | -69,344 | -87,823 |
| Cash flow from changes in working capital | |||
| Change in inventory | 1,546 | 972 | 175 |
| Change in operating receivables | -77,136 | -53,507 | -78,984 |
| Change in operating liabilities | 7,515 | -2,792 | -7,814 |
| Cash flow from operating activities | -131,488 | -124,671 | -174,446 |
| Investment activities | |||
| Investment in intangible fixed assets | -1,061 | -292 | -368 |
| Investment in tangible fixed assets | 0 | -424 | -424 |
| Investment in financial fixed assets | 0 | 0 | 0 |
| Sale of fixed assets | 0 | 0 | 0 |
| Cash flow from investment activities | -1,061 | -716 | -792 |
| Financing activities | |||
| New share issue | 121,243 | 0 | 0 |
| Cash flow from financing activities | 121,243 | 0 | 0 |
| Cash flow for the period | -11,306 | -125,387 | -175,238 |
| Cash and cash equivalents at start of period | 103,953 | 279,191 | 279,191 |
| Cash and cash equivalents at period's end | 92,647 | 153,804 | 103,953 |
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 2022 annual report.
This interim report has been prepared in accordance with IAS 34 interim finacial reporting.
New and amended standards adopted with effect from 2023 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.
Inventory is reported by applying the first-in-first-out principle (FIFO). 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.
Of this quarter's net sales, kSEK 70 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 patient. The test result is sent to the patient immediately after the analysis has been carried out. Revenue recognition takes place when the test result has been sent, i.e. transferred to the clinicians, which means that revenue recognition takes place at a certain time.
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, during 2018, a consulting agreement was entered into with CB Ocean Capital AB for services performed by Immunovia's then chairman of the board and one of the largest owner Carl Borrebaeck regarding scientific and strategic support. The agreement has provided a quarterly compensation of SEK 41 thousand and expired in Q3 2023 based on contractual notice period.
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 35 of the 2022 annual report.
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 that a party in a transaction with a financial instrument cannot fulfill its commitment. The maximum exposure to credit risks regarding financial assets amounted to kSEK 108,539 (163,060) September 30, 2023.
With a cash position of MSEK 107, along with the expected effects of the ongoing reconstruction, the Board's assessment is that the company's continued operation based on current plans is financed to late 2024.
To reflect management's view on the financial impact of market penetration and reimbursement in the US in the financial statements, it has been decided to write off the intercompany claim of 46 MSEK in Immunovia AB, to continuously write down the receivables arising from the parent company's financing to the subsidiary Immunovia Inc. The effect of the results for the financial year 2023, as of September 30, amounts to MSEK 95. Being an intercompany transaction, it will have no impact in the consolidated statements.
2022
Remaining depreciation period based on reported value Dec 31, 2022, was approximately 8.5 years.
During the second quarter of 2021, the development of the company's test for early detection of pancreatic cancer was completed, and with this also the capitalization of the development and the write-off of the capitalized costs began.
Impairment tests have been carried out continuously. Significant factors to assess have been cash flows for the next five years, growth beyond the forecast period and the weighted cost of capital.
With the decision to cease commercialization of the IMMray™ PanCan-d test, the uncertainties that existed regarding the impairment test established June 30, 2023, were confirmed. This has resulted in a full write-off of capitalized development costs.
| The Group | Parent company | |||||
|---|---|---|---|---|---|---|
| Sep 30, 2023 |
Sep 30, 2022 |
Dec 31, 2022 |
Sep 30, 2023 |
Sep 30, 2022 |
Dec 31, 2022 |
|
| Opening cost | 24,121 | 23,815 | 23,815 | 24,121 | 23,815 | 23,815 |
| Investment | 35 | 292 | 368 | 35 | 292 | 368 |
| Sales and scrapping | -22,223 | -62 | -62 | -22,223 | -62 | -62 |
| Closing accumulated cost | 1,933 | 24,045 | 24,121 | 1,933 | 24,045 | 24,121 |
| Opening amortization | -2,707 | 1,549 | -1,549 | -2,707 | 1,549 | -1,549 |
| Amortization for the year | -703 | -869 | -1,158 | -703 | -869 | -1,158 |
| Sales and disposals | 2,179 | 0 | 0 | 2,179 | 0 | 0 |
| Closing accumulated amortiza tion |
-1,230 | -2,417 | -2,707 | -1,230 | -2,417 | -2,707 |
| Opening impairment | -598 | -598 | -598 | -598 | -598 | -598 |
| Impairment for the year | 0 | 0 | 0 | 0 | 0 | 0 |
| Sales and disposals | 598 | -598 | -598 | 598 | -598 | -598 |
| Carrying amount | 702 | 21,029 | 20,816 | 702 | 21,029 | 20,816 |
For patents, the basis for depreciation is 1.9 (24.1) MSEK. Remaining patents are linked to the basis for royalty income and the remaining amortization period of 5 years is made up of the lifespan of the patent.
Considering the write-down of capitalized development costs (note 3), this has resulted in write-down of related patents.
| The Group | Parent company | |||||
|---|---|---|---|---|---|---|
| Sep 30, 2023 |
Sep 30, 2022 |
Dec 31, 2022 |
Sep 30, 2023 |
Sep 30, 2022 |
Dec 31, 2022 |
|
| Opening cost | 3,911 | 3,675 | 3,675 | 2,146 | 2,146 | 2,146 |
| Investment | 1,026 | 0 | 0 | 1,026 | 0 | 0 |
| Sales and scrapping | -1,718 | 0 | 0 | -1,718 | 0 | 0 |
| Translation differences for the year | 0 | 273 | 235 | 0 | 0 | 0 |
| Closing accumulated cost | 3,219 | 3,949 | 3,911, | 1,454 | 2,146 | 2,146 |
| Opening amortization | -1,224 | -689 | -689 | -701 | -529 | -529 |
| Amortization for the year | -328 | -371 | -480 | -86 | -129 | -172 |
| Sales and disposals | 359 | 0 | 0 | 359 | 0 | 0 |
| Translation differences for the year | 63 | 29 | -33 | 0 | 0 | 0 |
| Closing accumulated amortization | -1,130 | -1,031 | -1,203 | -428 | -658 | -701 |
| Impairment for the year | 0 | 0 | 0 | 0 | 0 | 0 |
| Sales and disposals | 0 | 0 | 0 | 0 | 0 | 0 |
| Carrying amount | 2,090 | 2,918 | 2,708 | 1,026 | 1,488 | 1,445 |
| Closing amount of intangible assaets note 3-5 |
2,792 | 137,126 | 133,597 | 1,728 | 135,696 | 132,335 |
For licenses, the basis for depreciation is 3.2 (3.9) MSEK. Carrying value for licenses amounts to 2.1 MSEK and refers to the handling of patient samples. Considering the write-down of capitalized development costs (note 3), this has resulted in write-down of related licenses. The depreciation period for the remaining licenses is 3-5 years.
Interest-bearing liabilities mainly consist of leasing agreements for premises in Sweden and the US. Reduced leasing debt refers to, in addition to amortization, a re-negotiated agreement for premises in the US. The right-of-use asset (tangible fixed assets) has decreased by the corresponding amount.
Other liabilities have been affected by termination and severance pay.
This interim report has been reviewed by the company's auditors.
Financial statement 2023, Wednesday February 21, 2024.
Tuesday November 21, 2023.
Thurday April 25, 2024. Annual Report 2023 will be available from last week of March.
lmmunovia AB (publ), Medicon Village, Scheelevägen 8, 223 63 Lund, Sweden Tel: +46 46 275 60 00 Email: [email protected] Web: www.immunovia.com
Jeff Borcherding, CEO and President • [email protected]
Karin Almqvist Liwendahl, CFO • [email protected]
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 9, 2023.
Immunovia will hold a webcast teleconference at 15:00 CET on November 9, with Jeff Borcherding, CEO and President 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/d87390d6/cs4DsdYoLES9Rh7NZrIIqA?u=http:// creo-live.creomediamanager.com/10534c57-ff26-4cd2-8e58-91ffc103b244
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.
Peter Høngaard Andersen Chairman of the board
Hans Johansson Board member
Michael Löfman Board member
Martin Møller Board member
Jeff Borcherding CEO & President
I have reviewed the condensed interim financial information (interim report) of Immunovia AB (publ) as of September 30, 2023. The Board of Directors and the CEO are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Swedish Annual Accounts Act. My responsibility is to express a conclusion on this interim report based on my review.
I conducted my review in accordance with the International Standard on Review Engagements ISRE 2410, Review of Interim Report Performed by the Independent Auditor of the Entity.
A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing, ISA, and other generally accepted auditing standards in Sweden. The procedures performed in a review do not enable me to obtain assurance that would make me aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed based on a review does not give the same level of assurance as a conclusion expressed based on an audit.
Based on my review, nothing has come to my attention that causes me to believe that the interim report is not prepared, in all material respects, in accordance with IAS 34 and the Swedish Annual Accounts Act, regarding the Group, and with the Swedish Annual Accounts Act, regarding the Parent Company.
Lund November 9, 2023
Mats-Åke Andersson Authorized Public Accountant
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.
Immunovia AB is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com.
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
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