Quarterly Report • Apr 24, 2019
Quarterly Report
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"During the first quarter of 2019, we remained focused on our product launch strategy and continued to create value, as we reached several key objectives and took several steps towards the commercialization of IMMray™ PanCan-d, our diagnostic test for early detection of pancreatic cancer.
Another key objective that we reached in the first quarter was the addition of new participants to our PanFAM-1 study, a multicenter prospective validation study for early diagnosis of people with a high risk of hereditary pancreatic cancer. In Q1 2019 we added two additional centers, one in Sweden and one in Spain. Umeå University Hospital in Sweden and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona are now part of PanFAM-1 study.
We also took an extremely important step towards on the optimization of the algorithm during Q1. We announced in March that using blood samples that are as fresh as possible, i.e. stored for less than 24 months, increases the test performance and provides optimal results. We were able to attain the relevant samples through our large and growing network of clinical Key Opinion Leaders (KOL). It is imperative to note that we needed samples that best mirror the blood samples that will be used with our final product, finding these fresh samples and gaining access to them is quite difficult and takes time.
With the appointment of Julie Silber as Senior Investor Relations Director early this year we actualized a strategic objective in strengthening the IR role and our shareholder communication capabilities at Immunovia.
We continued to work intensely during the first quarter of 2019 on the preparations for our sales launch targeted for the beginning of 2020."
Excerpt from the CEO Mats Grahn's comment on the report.

Mats Grahn CEO of Immunovia AB
| Key indicators | ||||
|---|---|---|---|---|
| Jan-Mar | Jan-Mar | Full year | Full year | |
| SEK thousand unless otherwise stated | 2019 | 2018 | 2018 | 2017 |
| Net sales | 66 | 112 | 333 | 149 |
| Operating earnings | –27,197 | –17,377 | –87,708 | –45,520 |
| Earnings before tax | –26,381 | –17,326 | –86,531 | –45,323 |
| Net earnings | –26,384 | –17,326 | –86,538 | –45,232 |
| Earnings per share before and after dilution (SEK/share) | –1.35 | –1.00 | –4.67 | –2.67 |
| Equity ratio, % | 89 | 94 | 97 | 94 |
| No. of shares at the end of the period | 19,531,353 | 17,318,059 | 19,531,353 | 17,318,059 |
This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia Incentive AB, Immunovia Inc. and Immunovia GmbH.
Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, IMMray™, is the result of 15 years of research at CREATE Health – the Center for Translational Cancer Research at Lund University, Sweden. IMMray™ is a technology platform for the development of diagnostic tests and the company's primary test, IMMray™ PanCan–d, is the first test in the world for early diagnosis of pancreatic cancer.
The Company reiterates it's financial targets in accordance with what has previously been disclosed. The company anticipates the first revenues from self pay sales in early 2020. The following financial targets have been established:
• Immunovia's target is to achieve turnover of SEK 250-300 million by 2022 based on self-pay for IMMray™ PanCan–d.
• Immunovia's target is to achieve total turnover, including payment via self-pay and cost remuneration from insurance systems, of SEK 800-1,000 million by 2024.
Dear shareholders,
During the first quarter of 2019, we remained focused on our product launch strategy and continued to create value, as we reached several key objectives and took several steps towards the commercialization of IMMray™ PanCan-d, our diagnostic test for early detection of pancreatic cancer.
With the appointment of Julie Silber as Senior Investor Relations Director early this year we actualized a strategic objective in strengthening the IR role and our shareholder communication capabilities at Immunovia. It has also been our intent to expand our capital markets exposure throughout Europe and especially in North America and to enhance our strategic communications plan in parallel with our commercial launch.
Additionally, and to further our expanded IR initiative, we attended three investor conferences in the first quarter of 2019 and hosted many meetings with interested investors and plan to do more.
Another key objective that we reached in the first quarter was the addition of new participants to our PanFAM-1 study, a multicenter prospective validation study for early diagnosis of people with a high risk of hereditary pancreatic cancer. In Q1 2019 we added two additional centers, one in Sweden and one in Spain. Umeå University Hospital in Sweden and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona are now part of PanFAM-1 study. The participation of these new centers not only add value by expanding our network of important centers that will help in commercializing IMMrayTM PanCan-d it also creates a more diverse sample pool ethnically and genetically which provides us with a wider range of data to better validate the test.
PanFAM-1 is the largest prospective study to date that is addressing the unmet need of early diagnosis in high-risk individuals with Familial Pancreatic Cancer (FPC). The PanFAM-1 study and ongoing screening programs that will include more than 2,000 patients and is scheduled to run for three years.
We also took an extremely important step towards on the optimization of the algorithm during Q1. We announced in March that using blood samples that are as fresh as possible, i.e. stored for less than 24 months, increases the test performance and provides optimal results. We were able to attain the relevant samples through our large and growing network of clinical Key Opinion Leaders (KOL). It is imperative to note that we needed samples that best mirror the blood samples that will be used with our final product, finding these fresh samples and gaining access to them is quite difficult and takes time. Thanks to our experienced KOLs, we now have these at hand and are well on our way towards completing the optimization work. Going forward, the verification and validation process of IMMray™ PanCan-d will be conducted solely with samples collected that best conforms to general clinical conditions. This was a very important step for many reasons: not only did this confirm the need to use fresh blood samples for optimal results, it also confirmed the incredible support of our KOL network. This was a crucial step towards the commercialization of IMMray™ PanCan-d.
The completion of the optimization work will then trigger the commercial test model study, followed by Verification and Validation studies. Like we mentioned in Q1 the details on timing of these milestones will be communicated in Q2.
At Immunovia, we remain fully committed and focused on the commercialization of IMMray™ PanCan-d and continue to do everything possible to maximize efficiency while maintaining our high quality. We continued to work intensely during the first quarter of 2019 on the preparations for our sales launch targeted for the beginning of 2020.
Thank you for your continuing support of Immunovia.
Mats Grahn CEO, Immunovia AB
As Immunovia previously announced in August 2018, the combination of retrospective samples from different biobanks, with varying sample collection procedures and storage, introduced unforeseen variability in the test algorithm performance. The distorting effect caused by the variability in blood sampling was eliminated by consistent and optimal protocols. During the first quarter 2019 it was also concluded that for optimal performance of the test, the samples should be stored for a maximum of 24 months from the testing period. The step of gaining these fresh samples has pushed out the previously communicated timeline for the optimizing study by about eight weeks which will impact the start of sales early 2020.
Immunovia and University College of London have signed an agreement to extend validation studies of IMMray™ PanCan-d for early signs and symptoms. Professor Stephen Pereira and his team at the institute for Liver and Digestive Health, University College London (UCL) will extend the prospective collection of blood samples funded by Immunovia and that started with the PanSYM-1 pilot study. The pilot PanSYM-1 study at UCL that started in 2017 is scheduled for
readout in 2019 and will now support the continuation of PanSYM-1 as a prospective validation study. The continued PanSYM-1 study aims to demonstrate the diagnostic value of IMMray™ PanCan-d in detecting PDAC (pancreatic ductal adenocarcinoma) earlier than the current standard.

Net sales for the first quarter of 2019 were SEK 66 thousand (112 k). Net sales principally comprise royalties.
Capitalization of costs for the first quarter of 2019 were SEK 5.9 million (6.2 m). Capitalization development costs are financed through approved and paid grants, the reported amounts are reduced by a comparable amount. No grants for development were received during the first quarter 2019.
The net loss for the first quarter of 2019 was SEK 26.4 million (17.3 m).
The net loss for the first quarter of 2019 increased due to higher costs, relating to organizational enlargement, increased marketing activity and costs for set-up of prospective activities. Other external costs and personnel costs increased by a total of SEK 7.6 million compared with the previous year and resulting in SEK 31.0 million in the first quarter of 2019.
Research and development is going as planned. The total cost of research and development in Q1 2019 was SEK 7.6 million (6.2 m), which corresponds to 18% (26%) of the Group's total operating costs.
The decline in R&D activity is mainly due to a comparative increase in other activities, such as marketing costs and the implementation of prospective studies.
Cash flow for Q1 2019 from operating activities amounted to SEK –14.3 million (–14.9 m). Cash and cash equivalents as at 31 March 2019 amounted to SEK 359.8 million (167.8 m).
Shareholders' equity at the end of the period was SEK 434.8 million (219.4 m) and the equity ratio was 89% (94).
Management believes that there is sufficient working capital to meet working capital needs, given the current business and development plan, for approximately 2 years going forward.
In Q1 2019 intangible assets were acquired for SEK 7.1 million (7.0 m), consisting of capitalized development expenditure for SEK 5.9 million (6.2 m) and patents for SEK 1.1 million (0.7 m).
Investments in tangible assets in the form of inventories were made during the Q1 2019 amounting to SEK 3.4 million. For the corresponding period last year the total was SEK 2.8 million.
The number of employees in the Group during Q1 2019 averaged 45 (36) and at the end of the period the number of full-time employees were 46.
Since 3 April 2018, Immunovia's shares have been listed on Nasdaq Stockholm's primary market (Mid Cap) under the IMMNOV ticker.
Immunovia has four outstanding warrants schemes covering 340,650 warrants entitling to subscription of 340,650 shares. There will be no dilution as long as the Group's earnings are negative. For more information about he warrants, see page 6.
At the end of the reporting period the total number of shares was 19,531,353. The nominal value of each share is SEK 0.05.
| The ten largest shareholders as of 31 March 2019 | ||||
|---|---|---|---|---|
| Share | ||||
| No. of | capital | |||
| Name | shares | and votes | ||
| Carl Borrebaeck | 1,709,900 | 8.75% | ||
| Ålandsbanken, on behalf of the owner | 1,622,446 | 8.31% | ||
| Handelsbanken Svenska Småbolag | 1,050,000 | 5.38% | ||
| Sara Andersson Ek | 888,950 | 4.55% | ||
| Per Mats Ohlin | 888,950 | 4.55% | ||
| Christer Wingren | 832,825 | 4.26% | ||
| Vincent Saldell | 726,163 | 3.72% | ||
| Försäkringsbolaget Avanza Pension | 583,283 | 2.99% | ||
| Swedbank Robur Folksams LO Sverige | 500,000 | 2.56% | ||
| Mats Grahn | 413,039 | 2.11% | ||
| 10 largest owners | 9,215,556 | 47.18% | ||
| Others | 10,315,797 | 52.82% | ||
| Total | 19,531,353 | 100.00% |
| Share capital development | ||||||
|---|---|---|---|---|---|---|
| Year | Event | Total share capital (SEK) |
Change (SEK) | Total no. of shares |
Change in shares |
Nominal value (SEK) |
| 24 May 2007 | Formation | 100,000.00 | 100,000.00 | 1,000,000 | 1,000,000 | 0.10 |
| 19 Oct 2011 | New share issue | 105,263.00 | 5,263.00 | 1,052,630 | 52,630 | 0.10 |
| 27 Oct 2011 | Share split 5:1 | 105,263.00 | - | 5,263,150 | 4,210,520 | 0.02 |
| 5 July 2012 | New share issue | 108,869.92 | 3,606.92 | 5,443,496 | 180,346 | 0.02 |
| 21 May 2013 | New share issue | 122,483.76 | 13,613.84 | 6,124,188 | 680,692 | 0.02 |
| 10 Sept 2013 New share issue | 124,899.76 | 2,416.00 | 6,244,988 | 120,800 | 0.02 | |
| 5 May 2014 | New share issue | 220,924.32 | 96,024.56 | 11,046,216 | 4,801,228 | 0.02 |
| 13 Aug 2015 | Bonus issue | 552,310.80 | 331,386.48 | 11,046,216 | - | 0.05 |
| 17 Dec 2015 | New share issue | 714,560.80 | 162,250.00 | 14,291,216 | 3,245,000 | 0.05 |
| 15 Sept 2016 New share issue | 823,728.40 | 109,167.60 | 16,474,568 | 2,183,352 | 0.05 | |
| 17 Oct 2016 | New share issue | 840,202.95 | 16,474.55 | 16,804,059 | 329,491 | 0.05 |
| 4 Oct 2017 | New share issue via warrants | 865,902.95 | 25,700.00 | 17,318,059 | 514,000 | 0.05 |
| 8 June 2018 | New share issue | 974,042.65 | 108,139.70 | 19,480,853 | 2,162,794 | 0.05 |
| 19 Sept 2018 New share issue via warrants | 976,567.65 | 2,525.00 | 19,531,353 | 50,500 | 0.05 | |
| At end of period | 976,567.65 | 19,531,353 | 0.05 |
The Annual General Meeting held on 3 May 2018 resolved to offer a warrants scheme (series 2018/2021) to employees and key persons in the company. The warrants (156,150) can be used to subscribe for newly issued shares of the Company during the utilization period from 7 September 2021 to 7 October 2021. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 271.05 per share. Full utilization would increase the company's share capital by SEK 7,739.50.
The Annual General Meeting held on 25 April 2017 resolved to offer a warrants scheme (series 2017/2020) to employees and key persons in the company. The warrants (61,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2020. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 205.00 per share. Full utilization would increase the company's share capital by SEK 3,050.
The Annual General Meeting held on 30 May 2016 resolved to offer a warrants scheme (series 2016/2019) to employees and key persons in the company. The warrants (123,500) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2019. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 82.90 per share. Full utilization would increase the company's share capital by SEK 6,175.
The Annual General Meeting held on 1 June 2015 resolved to offer a warrants scheme (series 2015/2018) to employees and key persons in the company. The warrants (47,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2018. 10,000 warrants have been exercised, therefore 37,000 warrants remain for subscription. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 13.50 per share. Full utilization would increase the company's share capital by SEK 1,850.
The Annual General Meeting held on 3 May 2018 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2018/2021 scheme was not applicable for various
reasons. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2018/2021 options scheme. The total cost for the company can be at most USD 250,000.
The Annual General Meeting held on 25 April 2017 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2017/2020 scheme was not applicable for various reasons. Such an incentive scheme has been introduced for 6 key individuals and is designed so that the economic effects correspond to the terms of the 2017/202 options scheme. The total cost for the company can be at most USD 920,000.
The warrants are subject to customary recalculation terms in connection with share issues, etc.

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 establishing financial reports. The applied accounting principles are in agreement with the information in the 2017 annual report. From 1 January 2019, the Group is applying IFRS 16 Leases.. Otherwise, the applied accounting principles are consistent with those applied in the 2018 annual report.
This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting.
IFRS 16 Leases is effective from 1 January 2019. Immunovia has applied the simplified transition method, which means that comparatives have not been restated. The lease liability consists of the discounted remaining leasing payments as at 1 January 2019. The right-of-use asset for all leases corresponds to the lease liability adjusted for prepaid or accrued lease payments reported in the statement of financial position as at 1 January 2019.
The transition to IFRS 16 has not had any effect on equity. Immunovia applies practical expedients allowed under IFRS 16 for leases where the underlying asset has a low value and for short-term leases, which also include leases that terminate in 2019.
The most significant leases are rental agreements for office premises. The Group's total assets have increased as a result of the inclusion of right-of-use assets and lease liabilities following the introduction of IFRS 16. Under IAS 17, lease payments in the comparative year were reported as other external expenses in the income statement. These have now been replaced by depreciation of the right-of-use asset, recognized as an expense in operating profit/loss, and interest on the lease liability, recognized as a financial expense. The lease payment is apportioned between repayment of the lease liability and payment of interest.
The outstanding lease payments were measured at their present value using Immunovia's incremental borrowing rate, which was 4 percent.
The following adjustments to the Group's balance sheet as at 1 January 2019 have been made.
| SEK thousands | |
|---|---|
| Property, plant & equipment, right-of-use assets | 36,067 |
| Current receivables, prepaid expenses | –610 |
| 35,457 | |
| Non-current interest-bearing liabilities, | |
| lease liability | 31,450 |
| Current interest-bearing liabilities, lease liability | 4,007 |
| 35,457 |
With regard to the existing leasing portfolio in 2019, Immunovia estimates that depreciation will increase by SEK 4,596 thousand, financial expenses will increase by SEK 1,316 thousand and profit after tax will decline by SEK 589 thousand.
Reconciliation of operating lease obligations under IAS 17 and lease liabilities under IFRS 16
Reconciliation of operating lease obligations
| under IAS 17 and lease liabilities under IFRS 16 | SEK thousands |
|---|---|
| -------------------------------------------------- | --------------- |
| Lease liability recognized | 35,457 |
|---|---|
| Prepayments | -610 |
| Effect of present value measurement | -6,325 |
| Total | 42,392 |
| Additional extension period | 21,806 |
| 31 December 2018 | 20,586 |
| Operating lease obligations, |
The Parent Company applies the exception allowed in RFR 2, which means that IFRS 16 is not required to be applied in a legal entity.
New and amended standards adopted with effect from 2019 are not otherwise expected to have any significant impact on the Group's financial position.
The Group currently has no financial instruments that are 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. The reported value of financial assets on the balance sheet date amounted to SEK 365.2 million (174.9 m).
In addition to salaries and other remuneration to company managers, and fees to Board members, as decided at the annual general meeting, the company has a consulting agreement with CB Ocean Capital AB regarding services performed by Immunovia's chairman and largest shareholder, Carl Borrebaeck. Services provided do not concern information relating to the Board role. Instead the services are to provide the company with scientific and strategic support at scientific presentations and conferences, for example. This agreement runs from 1 January 2018 until further notice with three months notice for both parties. The remuneration per quarter amounts to SEK 41.0 million.

Immunovia is exposed to financial risks and business risks. The financial risks management and the financial risks are described below. The company's business risks are presented on page 41 of the 2018 annual report. No significant changes have occurred that affect these reported risks.
The Group operates both nationally and internationally, which involves exposure to fluctuations in various currencies, especially USD and EUR. Currency risk arises from future commercial transactions and recognized assets and liabilities. The extent of the company's business currently means that the net exposure in foreign currencies is limited. The company therefore does not have a currency hedging policy.
Interest rate risk is the risk that the value of financial instruments will fluctuate because of changes in market interest rates. The Group currently only has interest-bearing financial assets in the form of bank deposits.
Credit risk is the risk that one party to a transaction with a financial instrument fails to meet its obligation. The maximum exposure to credit risk on financial assets as of 31 March 2019 amounted to SEK 365.2 million (174.9 m).
Prudent liquidity risk management implies maintaining sufficient cash or agreed credit options to close market positions. Based on the existing business plan, there is enough liquidity for around 24 months.
Contact information: Immunovia AB (publ) Medicon Village Scheelevägen 2 223 81 Lund SWEDEN
Tel: 00 46 46-2756 000 [email protected] www.immunovia.com
Julie Silber, IR Director, Immunovia AB E-mail: [email protected] Tel +46(0)79 3486277
The company's annual report is available at the company's website: www.immunovia.com
26 April 2019 AGM
23 August 2019 Q2 2019 interim report 8 November 2019 Q3 2019 interim report 14 February 2020 2019 Financial statement
29 April at 15:00 (CET)
SE: +46 850558352 BE: +32 26200547 CH: +41 225675632 DE: +49 69222220380 DK: +45 78150109 FR: +33 170750721 NE: +31 207219495 NO: +47 23500236 UK: +44 3333009035 US: +1 6467224956
| Financial reports | Page |
|---|---|
| Consolidated income statement, summary | 10 |
| Consolidated comprehensive income, summary | 10 |
| Consolidated financial position, summary | 11 |
| Change in consolidated equity, summary | 12 |
| Consolidated key indicators | 12 |
| Consolidated cash flow statement, summary | 13 |
| Parent company's income statement, summary | 14 |
| Parent company's comprehensive income, | |
| summary | 14 |
| Parent company's financial position, summary | 15 |
| Parent company's cash flow statement, summary | 16 |
In some cases figures have been rounded off, which means tables and calculations will not always appear to be correctly totalled.
| SEK thousand | Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
|---|---|---|---|
| Operating income, etc. | |||
| Net sales | 66 | 112 | 333 |
| Capitalized work for own account | 5,942 | 6,212 | 25,052 |
| Other income | 51 | 320 | 744 |
| Total income | 6,059 | 6,644 | 26,129 |
| Operating costs | |||
| Other external costs | –18,985 | –14,531 | –65,275 |
| Personnel costs | –12,057 | –8,879 | –45,257 |
| Depreciation and amortization of tangible and intangible assets | –2,048 | –536 | –2,777 |
| Other operating expensesr | –166 | –75 | –528 |
| Total operating expenses | –33,256 | –24,021 | –113,837 |
| Operating profit/loss | –27,197 | –17,377 | –87,708 |
| Financial items | |||
| Financial income | 1,159 | 51 | 1,178 |
| Financial costs | –343 | 0 | –1 |
| Total financial items | 816 | 51 | 1,177 |
| Profit/loss after financial items | –26,381 | –17,326 | –86,531 |
| Tax on income | –3 | 0 | –7 |
| Profit/loss for the period | –26,384 | –17,326 | –86,538 |
| Earnings per share before and after dilution (SEK) | –1.35 | –1.00 | –4.67 |
| Average number of shares before and after dilution | 19,531,353 | 17,318,059 | 18,545,795 |
| No. of shares at the end of the period | 19,531,353 | 17,318,059 | 19,531,353 |
| SEK thousand | Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
|---|---|---|---|
| Profit/loss for the period | –26,384 | –17,326 | –86,538 |
| Items that may be later reclassified in the income statement | |||
| Exchange rate differences for foreign net investment | –740 | –104 | –593 |
| Other comprehensive income for the period | –740 | –104 | –593 |
| Comprehensive income for the period | –27,124 | –17,430 | –87,131 |
| SEK thousand | 31-03-19 | 31-03-18 | 31-12-18 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 68,827 | 43,689 | 61,786 |
| Tangible fixed assets 1) | 51,383 | 9,654 | 14,019 |
| Financial fixed assets | 3,112 | 2,802 | 3,008 |
| Total fixed assets | 123,322 | 56,145 | 78,813 |
| Current assets | |||
| Accounts receivable | 0 | 34 | 32 |
| Current receivables | 7,587 | 9,795 | 12,401 |
| Cash and cash equivalents | 359,849 | 167,790 | 386,136 |
| Total current assets | 367,436 | 177,619 | 398,569 |
| TOTAL ASSETS | 490,758 | 233,764 | 477,382 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 977 | 866 | 977 |
| Other contributed capital | 626,348 | 314,170 | 626,348 |
| Translation reserve | –1,333 | –104 | –593 |
| Retained earnings including total comprehensive income | –191,163 | –95,567 | –164,779 |
| Total shareholders' equity | 434,829 | 219,365 | 461,953 |
| Long-term debt | |||
| Interest-bearing liabilities 2) | 30,154 | 0 | 0 |
| Total long-term debt | 30,154 | 0 | 0 |
| Current liabilities | |||
| Interest-bearing liabilities 2) | 4,057 | 0 | 0 |
| Other liabilities | 21,718 | 14,399 | 15,429 |
| Total current liabilities | 25,775 | 14,399 | 15,429 |
| TOTAL EQUITY AND LIABILITIES | 490,758 | 233,764 | 477,382 |
1) Of which right-of-use assets SEK 36,067 thousand. 2) Refers to lease liability.
| SEK thousand | Share capital |
Other contributed equity |
Reserves | Retained earnings including total com prehensive income |
Total shareholders' equity |
|---|---|---|---|---|---|
| Equity, 1 January 2018 | 866 | 314,170 | 0 | –78,241 | 236,795 |
| Comprehensive income for the period | –104 | –17,326 | –17,430 | ||
| Equity 31 March 2018 | 866 | 314,170 | –104 | –95,567 | 219,365 |
| Comprehensive income for the period | –489 | –69,212 | –69,701 | ||
| Received subscription warrant premiums | 936 | 936 | |||
| New share issue | 111 | 325,927 | 326,038 | ||
| Issue costs | –14,685 | –14,685 | |||
| Equity 31 December 2018 | 977 | 626,348 | –593 | –164,779 | 461,953 |
| Equity, 1 January 2019 | 977 | 626,348 | –593 | –164,779 | 461,953 |
| Comprehensive income for the period | –740 | –26,384 | –27,124 | ||
| Equity 31 March 2019 | 977 | 626,348 | –1,333 | –191,163 | 434,829 |
| Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
Full year 2017 |
Full year 2016 |
|
|---|---|---|---|---|---|
| Operating profit/loss (SEK thousand) | –27,197 | –17,377 | –87,709 | –45,520 | –14,978 |
| Profit/loss for the year (SEK thousand) | –26,384 | –17,326 | –86,539 | –45,232 | –14,723 |
| Earnings per share before and after dilution (SEK) | –1.35 | –1.00 | –4.67 | –2.67 | –0.98 |
| R&D costs (SEK thousand) | –7,644 | –6,212 | –26,048 | –24,041 | –24,239 |
| R&D costs as percentage of operating costs (%) | 19 | 26 | 23 | 34 | 62 |
| Cash and cash equivalents at end of period | 359,849 | 386,136 | 192,425 | 259,094 | |
| (SEK thousand) | 167,790 | ||||
| Cash flow from operating activities (SEK thousand) | –14,262 | –14,884 | –84,111 | –46,525 | –11,867 |
| Cash flow for the period (SEK thousand) | –26,310 | –24,662 | 193,680 | –66,669 | 183,327 |
| Equity(SEK thousand) | 434,829 | 219,365 | 461,953 | 236,795 | 276,631 |
| Equity per share (SEK) | 22.26 | 12.67 | 23.65 | 13.67 | 16.46 |
| Equity ratio (%) | 89 | 94 | 97 | 94 | 98 |
| Average no. of employees | 45 | 36 | 39 | 30 | 16 |
| Average no. of employees in R&D | 17 | 17 | 17 | 16 | 11 |
| SEK thousand | Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
|---|---|---|---|
| Operating activities | |||
| Operating profit/loss | –27,197 | –17,377 | –87,709 |
| Adjustment for items not included in cash flow | 2,057 | 253 | 2,682 |
| Received interest | 94 | 51 | 319 |
| Paid interest | –343 | 0 | –1 |
| Paid tax | –3 | 0 | –7 |
| Cash flow from operating activities before changes in operating capital | –25,392 | –17,073 | –84,716 |
| Cash flow from changes in operating capital | |||
| Change in operating receivables | 4,850 | 1,762 | –840 |
| Change in operating liabilities | 6,280 | 427 | 1,445 |
| Cash flow from operating activities | –14,262 | –14,884 | –84,111 |
| Investment activities | |||
| Investment in intangible assets | –7,069 | –6,958 | –28,230 |
| Investment in tangible assets | –3,374 | –2,820 | –9,056 |
| Investment in financing assets | 0 | 0 | –2 |
| Cash flow from investing activities | –10,443 | –9,778 | –37,288 |
| Financing activities | |||
| Amortization of lease liability | –1,605 | 0 | 0 |
| National and European grants for development costs | 0 | 0 | 2,791 |
| New share issue | 0 | 0 | 311,352 |
| Received subscription warrant premiums | 0 | 0 | 936 |
| Cash flow from financing activities | –1,605 | 0 | 315,079 |
| Cash flow for the period | –26,310 | –24,662 | 193,680 |
| Cash and cash equivalents at beginning of period | 386,136 | 192,425 | 192,425 |
| Exchange rate difference in cash and cash equivalents | 23 | 27 | 31 |
| Cash and cash equivalents at end of period | 359,849 | 167,790 | 386,136 |
| SEK thousand | Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
|---|---|---|---|
| Operating income, etc. | |||
| Net sales | 66 | 112 | 333 |
| Capitalized work for own account | 5,942 | 6,212 | 25,052 |
| Other income | 51 | 320 | 744 |
| Total income | 6,059 | 6,644 | 26,129 |
| Operating costs | |||
| Other external costs | –18,368 | –13,529 | –59,679 |
| Personnel costs | –8,811 | –6,639 | –32,003 |
| Depreciation and amortization of tangible and intangible assets | –681 | –385 | –1,996 |
| Other operating expenses | –166 | –75 | –527 |
| Total operating expenses | –28,026 | –20,628 | –94,205 |
| Operating profit/loss | –21,967 | –13,984 | –68,076 |
| Financial items | |||
| Interest income | 1,412 | 111 | 1,743 |
| Interest costs | –2 | 0 | –1 |
| Total financial items | 1,410 | 111 | 1,742 |
| Profit/loss after financial items | –20,557 | –13,873 | –66,334 |
| Tax on income | 0 | 0 | 0 |
| Profit/loss for the period | –20,557 | –13,873 | –66,334 |
| Earnings per share before and after dilution (SEK) | –1.05 | –0.80 | –3.58 |
| Average number of shares before and after dilution | 19,531,353 | 17,318,059 | 18,545,795 |
| No. of shares at the end of the period | 19,531,353 | 17,318,059 | 19,531,353 |
| SEK thousand | Jan-Mar | Jan-Mar | Full year |
|---|---|---|---|
| 2019 | 2018 | 2018 | |
| Profit/loss for the period | –20,557 | –13,873 | –66,334 |
| Other comprehensive income for the period | 0 | 0 | 0 |
| Comprehensive income for the period | –20,557 | –13,873 | –66,334 |
| SEK thousand | 31-03-19 | 31-03-18 | 31-12-2018 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 67,878 | 43,689 | 60,868 |
| Tangible fixed assets | 11,741 | 5,035 | 8,989 |
| Financial fixed assets | 303 | 253 | 253 |
| Total fixed assets | 79,922 | 48,977 | 70,110 |
| Current assets | |||
| Accounts receivable | 0 | 34 | 32 |
| Receivables from Group companies | 36,754 | 12,158 | 29,984 |
| Current receivables | 4,356 | 6,376 | 8,465 |
| Prepaid costs and accrued income | 3,627 | 3,117 | 3,843 |
| Cash and cash equivalents | 358,779 | 166,657 | 385,517 |
| Total current assets | 403,516 | 188,342 | 427,841 |
| TOTAL ASSETS | 483,438 | 237,319 | 497,951 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Restricted equity | |||
| Share capital | 977 | 866 | 977 |
| Fund for development expenses | 45,086 | 23,095 | 39,144 |
| Tortal restricted equity | 46,063 | 23,961 | 40,120 |
| Unrestricted equity | |||
| Premium fund | 312,178 | 4,897 | 312,178 |
| Retained earnings including total comprehensive income | 103,953 | 194,064 | 130,452 |
| Total unrestricted equity | 416,130 | 198,961 | 442,630 |
| Total shareholders' equity | 462,193 | 222,922 | 482,750 |
| Current liabilities | |||
| Other liabilities | 21,244 | 14,397 | 15,201 |
| Total current liabilities | 21,244 | 14,397 | 15,201 |
| TOTAL EQUITY AND LIABILITIES | 483,437 | 237,319 | 497,951 |
| SEK thousand | Jan-Mar 2019 |
Jan-Mar 2018 |
Full year 2018 |
|---|---|---|---|
| Operating activities | |||
| Operating profit/loss | –21,967 | –13,984 | –68,076 |
| Adjustment for items not included in cash flow | 681 | 384 | 2,230 |
| Received interest | 89 | 110 | 306 |
| Paid interest | –2 | 0 | –1 |
| Paid tax | 0 | 0 | 0 |
| Cash flow from operating activities before changes in operating capital | –21,199 | –13,490 | –65,541 |
| Cash flow from changes in operating capital | |||
| Change in operating receivables | 204 | –4,623 | –23,826 |
| Change in operating liabilities | 4,751 | 528 | 1,332 |
| Cash flow from operating activities | –16,244 | –17,585 | –88,035 |
| Investment activities | |||
| Investment in intangible assets | –7,069 | –6,958 | –27,341 |
| Investment in tangible assets | –3,374 | –763 | –6,149 |
| Investment in financing assets | –50 | –253 | –253 |
| Cash flow from investing activities | –10,493 | –7,974 | –33,743 |
| Financing activities | |||
| National and European grants for development costs | 0 | 0 | 2,791 |
| New share issue | 0 | 0 | 311,352 |
| Received subscription warrant premiums | 0 | 0 | 936 |
| Cash flow from financing activities | 0 | 0 | 315,079 |
| Cash flow for the period | –26,737 | –25,559 | 193,301 |
| Cash and cash equivalents at beginning of period | 385,517 | 192,216 | 192,216 |
| Cash and cash equivalents at end of period | 358,780 | 166,657 | 385,517 |
The Interim report has not been reviewed by the company's auditors.
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 group faces.
Lund, 24 April 2019
Carl Borrebaeck Hans Johansson Chairman Board member
Åsa Hedin Mimmi Ekberg Board member Board member
Christofer Sjögren Ann-Christine Sundell Board member Board member
Mats Grahn CEO
| Key indicator | Definition | Reason for using key indicator not defined in accordance with IFRS |
|---|---|---|
| Average number of employees The average number of employees is calcu lated as the sum of hours worked during the period divided by the normal working hours for the period. |
||
| Average number of employees in R & D |
The average number of employees in the company's research and development depart ments. |
|
| Average number of shares before and after dilution |
Average number of shares outstanding during the period before and after dilution. As the Group's performance is negative, there is no dilution although the issue price is lower than the market price. |
|
| Cash and cash equivalents | Cash and bank balances. | |
| Cash flow for the period | Net change in cash and cash equivalents excluding the impact of unrealized gains and losses. |
|
| Cash flow from operating activities |
Cash flow before cash flows from investing and financing activities. |
|
| Earnings per share before and after dilution |
Profit attributable to parent company share holders divided by the weighted average number of shares during the period before and after dilution. |
|
| Equity per share | Equity divided by number of shares at period end. |
Management monitors this number to monitor how much value is equity per share. |
| Equity ratio | Equity as a percentage of total assets. | Management monitors this ratio as an indica tor of the financial stability of the company. |
| Net sales | Revenues for goods and services sold in the main activity during the current period. |
|
| Operating profit | Profit before financial items and tax. | Operating income provides a picture of the results that the company's regular operations have generated. |
| R & D costs | The Company's direct costs for research and development. Refers to the costs of personnel, materials and external services. |
The company's main activity is research and development. Management believes that its R & D costs is an important parameter to follow as an indicator of the level of activity of the company. |
| R & D expenses as a percent age of operating expenses |
R & D expenses divided by operating expenses, which include other external costs, personnel costs and depreciation. |
Management believes that the company's R & D expenses in relation to total costs is an import ant parameter to follow as an indicator of how much of the total costs is used for the compa ny's main business. |
Immunovia is a Swedish molecular diagnostic company with a strong financial position in a commercial phase. The company develops and commercialises diagnostic tools for complex forms of cancer and autoimmune diseases.
Immunovia AB was founded in 2007 by researchers from the Department of Immunotechnology at Lund University and CREATE Health, the Center for Translational Cancer Research in Lund, Sweden. The purpose was to establish a base from which to make scientific discoveries and gain patents within the fields of human antibodies, biomarkers and antibody arrays, covering the stages from research to clinical application.
Immunovia's core technology platform, IMMray™, is based on microarray analysis of biomarker antibodies. IMMray™ PanCan-d is the company's primary diagnostic tool, capable of diagnosing with a high level of sensitivity and specificity. This enables diagnosis of patients with pancreatic cancer before symptoms are noted (stages I and II), which is not currently possible with existing methods. Immunovia is now performing clinical validation studies to prepare for the commercialization of IMMray™ PanCan-d, which could become the first blood-based test for early diagnosis of pancreatic cancer.
The antibody-based technology platform, IMMray™, is the result of 15 years of research at CREATE Health, Lund University. It is used to decode mechanisms behind the body's immune system, the first system in the body that reacts to disease. The platform can also be used for the development of diagnostic tests for autoimmune diseases.
Each year about 338,000 patients fall ill with pancreatic cancer. This form of cancer has one of the worst survival forecasts and only about 5% of diagnosed patients live more than five years, making it one of the deadliest cancers in the world. It is estimated that early detection would increase the five-year survival rate by around 50%. The initial addressable
Scheelevägen 2, Medicon Village 223 81 Lund SWEDEN
Tel: 00 46 46-2756 000 [email protected] www.immunovia.com
market for Immunovia consists of two high-risk pancreatic cancer groups. The market in the US and Europe for diagnosis of these groups is estimated to be worth over SEK 30 billion per year.
Immunovia's goal is to provide diagnostic tests that will enable earlier, more efficient and more accurate diagnosis of patients who run the risk of developing cancer or autoimmune disease. The aim is to make Immunovia's tests the first choice of specialist doctors and general practitioners across the world in the screening of specially high-risk groups or when there is a suspicion of the aforementioned diseases.
As the first company, Immunovia's strategy is to decipher the wealth of information in blood and translate it into clinically useful tools to diagnose complex diseases earlier and more accurately than previously possible. The focus is on unsolved problems in early diagnosis, monitoring of the course of a disease and the patient's response to treatment. These are areas where there are extensive clinical benefits for patients and the healthcare system, current solutions are lacking or insufficient, and where IMMray™ has significant competitive advantages.
Initially, the key focus for Immunovia is to bring IMMray™ PanCan-d to the market. Because early detection of pancreatic cancer constitutes a major clinical problem, Immunovia considers there to be good prospects for being the first to establish a strong position on the market.
Organization. no. 556730-4299
Immunovia has its head office in Lund, Sweden. Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm First North. The Certified Advisor is Wildeco. For more information, visit www.immunovia.com

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