Quarterly Report • Apr 27, 2018
Quarterly Report
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"In the first quarter we reached a very important milestone for the company. Almost two years after the listing of Immunovia on Nasdaq First North, we received approval from Nasdaq to begin trading on their main market.
We have also worked intensively towards our next milestone, which is to start sales by the end of 2018.
The company has a target of achieving turnover of SEK 250-300 million by 2021 ... and total turnover of SEK 800-1,000 by 2023."
Extract from comments to the interim report by CEO Mats Grahn.
| Key indicators | ||||
|---|---|---|---|---|
| 1 Jan-31 March | 1 Jan-31 March | Full year | Full year | |
| SEK thousand unless otherwise stated | 2018 | 2017 | 2017 | 2016 |
| Net sales | 112 | 28 | 149 | 177 |
| Operating earnings | –17,377 | –7,870 | –45,520 | –14,978 |
| Earnings before tax | –17,326 | –7,771 | –45,232 | –14,723 |
| Net earnings | –17,326 | –7,771 | –45,232 | –14,723 |
| Earnings per share before dilution (SEK/share) | –1.00 | –0.46 | –2.67 | –0.98 |
| Equity ratio, % | 94 | 97 | 94 | 98 |
| No. of shares at the end of the period | 17,318,059 | 16,804,059 | 17,318,059 | 16,804,059 |
This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia 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 expects to receive the first revenues from self-pay sales in Q4 2018.
The following financial targets have been established:
IMMUNOVIA AB (PUBL) • INTERIM REPORT JANUARY-MARCH 2018 1
In the first quarter we reached a very important milestone for the company. Almost two years after the listing of Immunovia on Nasdaq First North, we received approval from Nasdaq to begin trading on their main market. We are now listed on the Mid Cap segment, where trading started on 3 April. We also worked intensively on the preparations for the next major milestone, which is our sales launch at the end of 2018.
Being listed on the main stock market further enhances our position. The change strengthens Immunovia's brand, raises awareness about the company and highlights our development and maturity. It is of great significance to us now that we are very close to commencing commercial activities.
In conjunction with the change of market listing, the Board adopted financial targets to match the start of sales. The company has a target of reaching SEK 250-300 million in revenue in 2021 based only on
self-pay sales, and a second target of achieving total turnover of SEK 800-1,000 million in 2023, including self-pay and cost reimbursement from the insurance systems in Europe and the United States.
Our target for 2021 corresponds to penetration of approximately 5 percent of the inherited risk group for pancreatic cancer, and 1 percent penetration of the market potential for use by patients with early symptoms of pancreatic cancer.
Our target for 2023 corresponds to about 20 percent market penetration in the hereditary category risk for pancreatic cancer and 9 percent market penetration within the category for early symptoms of pancreatic cancer, as well as an initial use within the area of diabetics with increased risk for pancreatic cancer.
These financial targets refer to IMMray™ PanCan –d, the first of several applications with significant market potential for the IMMray™ platform. Other areas could include autoimmune diseases and other cancers. In 2016, the company initiated, for example, a program focused on diagnosis and monitoring of autoimmune diseases.
We are very hopeful about these opportunities and I expect to report back on their development throughout the year.
Our ambition is to provide updates about our performance in relation to our financial targets for other applications in addition to pancreatic cancer as soon as we approach commercialization of new products.
We have also worked on obtaining new participants in our PanFAM-1 study, which is a multicenter prospective validation study for early diagnosis of people with a high risk of hereditary pancreatic cancer. The PanFAM-1 study now includes more than 1,000 patients and is scheduled to run for three years. Both the University Hospital in Santiago de Compostela and the Massachusetts General Hospital were included in the study during the quarter, with New York University School of Medicine, a very important center within pancreatic cancer, joining in the beginning of the second quarter.
The overall objective of the study is to show the overall benefit within health care of testing patients with hereditary pancreatic cancer. In parallel with this we will run our two other prospective studies for these risk groups, PanSYM-1, for patients with early symptoms which could be pancreatic cancer, as well PanDIA-1, for patients over 50 years of age newly diagnosed with diabetes.
As usual, I want to conclude by thanking you, our shareholders for your support. The company has never been in such an exciting stage before and I am really looking forward to advancing from being a development company to becoming a commercial diagnostics company.
Thank you for your continuing support of Immunovia!
Mats Grahn CEO, Immunovia AB
Net sales for the first quarter of 20178 were SEK 112 thousand (28 k). For the full year 2017 net sales were SEK 149 thousand. Net sales principally comprise royalties.
Capitalization of costs for the first quarter of 2018 amounted to SEK 6,212 thousand (5,527 k). Where capitalized development costs are financed through approved and paid grants, the reported amounts are reduced by a comparable amount.
The net loss for the first quarter of 2018 was SEK 17,326 thousand (–7,771 k). The loss for the full year was SEK 45,232. The net loss for the first quarter of 2018 was due to higher costs relating to organizational enlargement, establishing a laboratory in the US and increased marketing activity. Other operating costs and personnel costs increased by a total of SEK 10,225 thousand compared with last year to reach SEK 23,410 thousand in the first quarter of 2018.
Research and development follows established plans. The total cost of research and development in the first quarter of 2018 was SEK 6,212 thousand (5,527 k), which corresponds to 26 percent (41) of the Group's total operating costs. The decrease in the proportion of R&D activity was mainly due to the increase in activities and costs for marketing and production.
Cash flow for the first quarter of 2018 from operating activities amounted to SEK –14,884 thousand (–6,525 k). Total cash flow for 2017 amounted to SEK –46,317 thousand. Cash and cash equivalents as at 31 March 2018 amounted to SEK 167,790 thousand (246,361 k).
Shareholders' equity at the end of the period was SEK 210,365 thousand (268,860 k) and the equity ratio was 94 percent (97).
Management believes that there is sufficient working capital to meet working capital needs, given the current business and development plan, for approximately 18 months going forward.
In the first quarter of 2018 intangible assets were acquired for SEK 6,958 thousand (6,176 k), consisting of capitalized development expenditure for SEK 6,212 thousand (5,174 k) and patents for SEK 746 thousand (1,002 k).
In 2017, intangible assets were acquired for a total of SEK 25,919 thousand (28,028 k), consisting of capitalized development expenditure for SEK 23,329 thousand (24,292 k), patents for SEK 2,590 thousand (3,074 k) and other intangible assets for SEK 0 thousand (662 k).
Investments in tangible assets in the form of inventories were made during the first quarter of 2018 amounting to SEK 2,819 thousand. For the corresponding period last year the total was SEK 32 thousand. In 2017 investment in tangible assets amounted to SEK 5,268 thousand (2,781 k).
No investment was made in financial assets in the first quarter of 2018. For full year 2017, investments were made in financial assets in the form of blocked bank funds amounting to SEK 2,759 thousand.
The number of employees in the Group in the first quarter of 2018 averaged 36 (23) and at the end of the period the number of full-time positions was 38, divided across 38 individuals.
Important events in the first quarter of 2018 Immunovia approved for listing on Nasdaq Stockholm Nasdaq Stockholm's listing committee approved Immunovia AB's application for admission to trading of the company's shares on the regulated market, Nasdaq Stockholm.
The first day of trading on Nasdaq Stockholm was 3 April 2018. The share continued to be traded under the same ticker (IMMNOV) and ISIN code (SE0006091997). The share is being traded on Nasdaq Stockholm's Mid Cap segment.
"Immunovia's progress in recent years has been tremendous and the admission to trade on the main list of Nasdaq Stockholm reflects that we are transforming from a development company to a diagnostic company with product sales. We regard the move to the regulated market to be very positive as it strengthens the brand, increases the recognition of the company and confirms the progress and maturity of Immunovia," said Carl Borrebaeck, Chairman of the Board.
The Board of Directors of Immunovia AB adopted financial targets during the quarter due to the fact the company, as previously announced, will begin sales during the end of 2018. The financial targets show that the company's goal is to reach SEK 250-300 million in turnover in 2021 based on "self-pay"-sales and a turnover of SEK 800-1,000 million in 2023 including selfpay and reimbursements in Europe and the US.
The target of SEK 250-300 million in turnover in 2021, which is three years after sales start in Europe and the United States, is based on self-pay, i.e. that users themselves pay for the product. This corresponds to approximately five percent market penetration in the category of familiar or hereditary risk of pancreatic cancer and one percent market penetration in the category early symptoms of pancreatic cancer.
Immunovia also targets to receive reimbursement for IMMray™ PanCan –d in these segments of pancreatic cancer in 2021. Immunovia's goal of reaching SEK 800-1,000 million in total sales for self-pay and reimbursement in 2023 in Europe and the United States corresponds to approximately twenty percent market penetration in the category of hereditary risk of pancreatic cancer, nine percent penetration in the category early symptoms of pancreatic cancer, and an initial use in the area of diabetic patients with increased risk of pancreatic cancer.
The financial targets apply to IMMray™ PanCan –d, the first of several uses with significant market potential for the IMMray™ platform, such as autoimmune diseases and other cancers. The company initiated a program focusing on diagnostics and monitoring of autoimmune diseases in the beginning of 2016.
Immunovia AB announced during the first quarter that University Hospital of Santiago de Compostela is to become the latest internationally renowned participant in PanFAM-1, a multicenter prospective validation study for the early diagnosis of familiar pancreatic cancer (FPC) high risk individuals using Immunovia's innovative blood-based test, IMMray™ PanCan –d. Including more than 1,000 patients, PanFAM-1 is predicted to run for three years from the start of the study.
PanFAM-1 now includes Mount Sinai New York, Knight Cancer Institute at Oregon Health and Sciences University, Portland and Massachusetts General in the USA, University of Liverpool, UK, Ramon y Cajal Institute for Health Research, Madrid, Spain and Sahlgrenska University Hospital, Gothenburg, Sweden.
Massachusetts General Hospital joins PanFAM-1 prospective study for the early detection of pancreatic cancer in familiar risk groups Immunovia AB announced that Massachusetts General Hospital had begun participating in PanFAM-1.
Immunovia signed a letter of intent for collaboration with the Danish Center for Strategic Research into Type 2 Diabetes (DD2). The intention is that the DD2 Center will be part of the groundbreaking PanDIA-1 prospective study into new onset Type 2 diabetics over 50 and their associated risk of developing pancreatic cancer.
Since 3 April 2018, Immunovia's shares have been listed on Nasdaq Stockholm's primary market (Mid Cap) under the IMMNOV ticker.
Immunovia has three outstanding warrants schemes covering 235,000 warrants entitling to subscription of 235,000 shares. All outstanding warrants have an exercise price less than the market price on the balance sheet date. There will be no dilution as long as the Group's earnings are negative. For more information about he warrants, see page 8.
At the end of the reporting period the total number of shares was 17,318,059. The nominal value of each share is SEK 0.05.
| The ten largest shareholders as of 31 March 2018. | ||||
|---|---|---|---|---|
| Share capital | ||||
| Name | No. of shares | and votes | ||
| Carl Borrebaeck | 1,709,900 | 9.87 % | ||
| Vincent Saldell | 1,000,000 | 5.77 % | ||
| Sara Andersson Ek | 888,950 | 5.13 % | ||
| Christer Wingren | 888,950 | 5.13 % | ||
| Per Mats Ohlin | 888,950 | 5.13 % | ||
| Handelsbanken Svenska | ||||
| Småbolag | 675,556 | 3.90 % | ||
| Michael Löfman | 639,000 | 3.69 % | ||
| Ålandsbanken in ownership posoition |
533,873 | 3.14 % | ||
| Försäkringsbolaget Avanza | ||||
| Pension | 526,401 | 3.04 % | ||
| Catella Småbolagsfond | 467,302 | 2.70 % | ||
| Ten largest | 8,218,882 | 47.51 % | ||
| Others | 9,099,177 | 52.54 % | ||
| Total | 17,318,059 | 100.00 % |
| Share capital history | ||||||
|---|---|---|---|---|---|---|
| Total share | Total no. of | Change in | Nominal | |||
| Year | Event | capital (SEK) | Change (SEK) | shares | shares | 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 |
| At end of period | 865,902.95 | 17,318,059 | 0.05 |
Immunovia's financial risk exposure and risk management are described on page 51 of the 2017 annual report. Business risks are presented on page 33 of the 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 interestbearing 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 2018 amounted to SEK 174,930 thousand (246,361 k).
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 12 months.
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 41,000.
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 (137,000) 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 6,850.
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 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.
From 1 January 2018, the Group is applying IFRS 9 Financial instruments and IFRS 15 Revenues from contracts with customers. Otherwise, the applied accounting principles are consistent with those applied in the 2017 annual report.
This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting. New and amended standards adopted as of 2018 have not had any significant impact on the Group's financial position.
The Group classifies and values its financial assets based on the business model that manages the asset's contracted cash flows as well as the nature of the asset. The financial assets are classified in any of the following categories: financial assets valued at accrued acquisition value, financial assets valued at fair value in comprehensive income and financial assets valued at fair value in the income statement.
At present, the Group has only financial assets that are not normally sold outside the Group and where the purpose of the holding is to obtain contractual flows. Most of the financial assets consists of bank balances. All financial assets are classified as financial assets valued at accrued acquisition value.
These financial assets are included in current assets with the exception of items expired for more than 12 months after the end of the reporting period, which are classified as non-current assets. Valuation is made at accrued acquisition value using the effective interest rate method. A depreciation reserve is made when there is objective evidence that the company will not be able to receive all amounts due on the initial conditions of the receivable. The reserved amount is the difference between the asset's reported value and the present value of estimated future cash flows.
An impairment loss is recognized in the income statement as an additional external cost.
The Group only has financial liabilities that are classified and valued at accrued acquisition value using the effective interest rate method. Reporting is performed initially at fair value, net of transaction costs.
Revenues from agreements with customers are reported when the performance commitment is fulfilled when a product or a service is transferred to the customer. The Group currently only has revenues in the form of royalties which are reported as the terms of each royalty is met.
The Group currently has no financial instruments which are valued at fair value. Instead, all financial assets and liabilities are valued at accrued 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 174,930 thousand (246,361).
This quarterly report has not been reviewed by the company's auditor.
The Board and the CEO certify that the Financial Statement gives a true and fair view of the company's operations, position and results, and describes significant risks and uncertainties that the company faces.
Lund, 27 April 2018.
Carl Borrebaeck Hans Johansson Chairman Board member
Åsa Hedin Ann-Christin Malmborg Hager Board member Board member
Mats Grahn Ann-Christine Sundell CEO Board member
In some cases figures have been rounded off, which means tables and calculations will not always appear to be correctly totalled.
Tel: 00 46 46-2756 000 [email protected] www.immunovia.com
For further information, please contact: Mats Grahn, CEO, Immunovia AB E-mail: [email protected]
The company's annual report is available at the company's website: www.immunovia.com
3 May 2018 Annual general Meeting 24 August 2018 Q2 2018 interim report 7 November 2018 Q3 2018 interim report 14 February 2019 2018 Financial statement
| Telephone conference: | |
|---|---|
| 27 April 2018, 15.30 (CET) | |
| SE: +46 856642662 | |
| BE: +32 24040635 | |
| CH: +41 225675548 | |
DE: +49 69222229046 DK: +45 82333178 FR: +33 170750725 NE: +31 207168416 NO: +47 23500254
UK: +44 2030089803
US: +1 6465025116
| Contents financial section | Page |
|---|---|
| Consolidated income statement, | |
| summary | 12 |
| Consolidated comprehensive | |
| income, summary | 12 |
| Consolidated financial position, | |
| summary | 13 |
| Change in consolidated equity, | |
| summary | 14 |
| Consolidated key indicators | 14 |
| Consolidated cash flow statement, | |
| summary | 15 |
| Parent company's income statement, | |
| summary | 16 |
| Parent company's comprehensive | |
| income, summary | 16 |
| Parent company's financial position, | |
| summary | 17 |
| Parent company's cash flow | |
| statement, summary | 18 |
| SEK thousand | 1 Jan-31 Mar 2018 |
1 Jan-31 Mar 2017 |
Full year 2017 |
|---|---|---|---|
| Operating income, etc. | |||
| Net sales | 112 | 28 | 149 |
| Capitalized work for own account | 6,212 | 5,527 | 24,041 |
| Other income | 320 | 15 | 59 |
| Total income | 6,644 | 5,570 | 24,249 |
| Operating costs | |||
| Other external costs | –14,531 | –7,259 | –39,113 |
| Personnel costs | –8,879 | –5,926 | –29,138 |
| Depreciation and amortization of tangible and intangible assets | –536 | –240 | –1,264 |
| Other operating expenses | –75 | –15 | –254 |
| Total operating expenses | –24,021 | –13,440 | –69,769 |
| Operating profit/loss | –17,377 | –7,870 | –45,520 |
| Financial items | |||
| Financial income | 51 | 99 | 298 |
| Financial costs | 0 | 0 | –10 |
| Total financial items | 51 | 99 | 288 |
| Profit/loss after financial items | –17,326 | –7,771 | –45,232 |
| Tax on income | 0 | 0 | 0 |
| Profit/loss for the period | –17,326 | –7,771 | –45,232 |
| Earnings per share before and after dilution (SEK) Average number of shares before and after dilution No. of shares at the end of the period |
–1.00 17,318,059 17,318,059 |
–0.46 16,804,059 16,804,059 |
–2.67 16,932,559 17,318,059 |
| SEK thousand | 1 Jan-31 Mar 2018 |
1 Jan-31 Mar 2017 |
Full year 2017 |
|---|---|---|---|
| Profit/loss for the period | –17,326 | –7,771 | –45,232 |
| Items that may be later reclassified in the income statement | |||
| Exchange rate differences for foreign net investment | –104 | 0 | 0 |
| Other comprehensive income for the period | –104 | 0 | 0 |
| Comprehensive income for the period | –17,430 | –7,771 | –45,232 |
| SEK thousand | 31-03-18 | 31-03-17 | 31-12-2017 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 43,689 | 25,611 | 36,791 |
| Tangible fixed assets | 9,654 | 2,842 | 7,211 |
| Financial fixed assets | 2,802 | 0 | 2,759 |
| Total fixed assets | 56,145 | 28,453 | 46,761 |
| Current assets | |||
| Accounts receivable | 34 | 0 | 0 |
| Current receivables | 9,795 | 1,625 | 11,584 |
| Cash and cash equivalents | 167,790 | 246,361 | 192,425 |
| Total current assets | 177,619 | 247,986 | 204,009 |
| TOTAL ASSETS | 233,764 | 276,439 | 250,770 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 866 | 840 | 866 |
| Other contributed capital | 314,170 | 308,800 | 314,170 |
| Translation reserve | –104 | 0 | 0 |
| Retained earnings including total comprehensive income | –95,567 | –40,780 | –78,241 |
| Total shareholders' equity | 219,365 | 268,860 | 236,795 |
| Current liabilities | |||
| Other liabilities | 14,399 | 7,579 | 13,975 |
| Total current liabilities | 14,399 | 7,579 | 13,975 |
| TOTAL EQUITY AND LIABILITIES | 233,764 | 276,439 | 250,770 |
| SEK thousand | Share capital |
Other contributed equity |
Reserves | Retained earnings including total com prehensive income |
Total shareholders' equity |
|---|---|---|---|---|---|
| Equity, 1 January 2017 | 840 | 308,800 | 0 | –33,009 | 276,631 |
| Comprehensive income for the period | 0 | –7,771 | –7,771 | ||
| Equity 31 March 2017 | 840 | 308,800 | 0 | –40,780 | 268,860 |
| Comprehensive income for the period | 0 | –45,232 | –45,232 | ||
| Received subscription warrant premiums | 473 | 473 | |||
| New share issue | 26 | 4,897 | 4,897 | ||
| Equity 31 December 2017 | 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 |
| SEK thousand unless otherwise stated | 1 Jan-31 Mar 2018 |
1 Jan-31 Mar 2017 |
Full year 2017 |
Full year 2016 |
Full year 2015 |
|---|---|---|---|---|---|
| Operating profit/loss (SEK thousand) | –17,377 | –7,870 | –45,520 | –14,978 | –7,424 |
| Profit/loss for the year (SEK thousand) | –17,326 | –7,771 | –45,232 | –14,723 | –7,384 |
| Earnings per share before and after | |||||
| dilution (SEK) | –1.00 | –0.46 | –2.67 | –0.98 | –0.65 |
| R&D costs (SEK thousand) | –6,212 | –5,527 | –24,041 | –24,293 | –16,791 |
| R&D costs as percentage of | |||||
| operating costs (%) | 26 | 41 | 34 | 62 | 69 |
| Cash and cash equivalents at end of | |||||
| period (SEK thousand) | 167,790 | 246,391 | 192,425 | 259,094 | 75,767 |
| Cash flow from operating activities | |||||
| (SEK thousand) | –14,884 | –6,525 | –46,525 | –11,867 | –6,531 |
| Cash flow for the period (SEK thousand) | –24,662 | –12,733 | –66,669 | 183,327 | 43,962 |
| Equity(SEK thousand) | 219,365 | 268,860 | 236,795 | 276,631 | 83,801 |
| Equity per share (SEK) | 12.67 | 16.00 | 13.67 | 16.46 | 5.86 |
| Equity ratio (%) | 94 | 97 | 94 | 98 | 92 |
| Average no. of employees | 36 | 23 | 30 | 16 | 11 |
| Average no. of employees in R&D | 17 | 15 | 16 | 11 | 8 |
| 1 Jan-31 Mar | 1 Jan-31 Mar | Full year | |
|---|---|---|---|
| SEK thousand | 2018 | 2017 | 2017 |
| Operating activities | |||
| Operating profit/loss | –17,377 | –7,870 | –45,520 |
| Adjustment for items not included in cash flow | 253 | 240 | 1,472 |
| Received interest | 51 | 99 | 298 |
| Paid interest | 0 | 0 | –10 |
| Paid tax | 0 | 0 | 0 |
| Cash flow from operating activities before changes in operating capital | –17,073 | –7,531 | –43,760 |
| Cash flow from changes in operating capital | |||
| Change in operating receivables | 1,762 | 206 | –9,757 |
| Change in operating liabilities | 427 | 800 | 7,200 |
| Cash flow from operating activities | –14,884 | –6,525 | –46,317 |
| Investment activities | |||
| Investment in intangible assets | –6,958 | –6,176 | –25,919 |
| Investment in tangible assets | –2,820 | –32 | –5,366 |
| Investment in financing assets | 0 | 0 | –2,861 |
| Cash flow from investing activities | –9,778 | –6,208 | –34,146 |
| Financing activities | |||
| National and European grants for development costs | 0 | 0 | 8,406 |
| New share issue | 0 | 0 | 4,923 |
| Received subscription warrant premiums | 0 | 0 | 474 |
| Cash flow from financing activities | 0 | 0 | 13,803 |
| Cash flow for the period | –24,662 | –12,733 | –66,661 |
| Cash and cash equivalents at beginning of period | 192,425 | 259,094 | 259,094 |
| Exchange rate difference in cash and cash equivalents | 27 | 0 | –8 |
| Cash and cash equivalents at end of period | 167,790 | 246,361 | 192,425 |
| SEK thousand | 1 Jan-31 Mar 2018 |
1 Jan-31 Mar 2017 |
Full year 2017 |
|---|---|---|---|
| Operating income, etc. | |||
| Net sales | 112 | 28 | 149 |
| Capitalized work for own account | 6,212 | 5,527 | 24,041 |
| Other income | 320 | 15 | 59 |
| Total income | 6,644 | 5,570 | 24,249 |
| Operating costs | |||
| Other external costs | –13,529 | –8,149 | –39,113 |
| Personnel costs | –6,639 | –5,036 | –29,138 |
| Depreciation and amortization of tangible and intangible assets | –385 | –240 | –1,264 |
| Other operating expenses | –75 | –13 | –254 |
| Total operating expenses | –20,628 | –13,438 | –69,769 |
| Operating profit/loss | –13,984 | –7,868 | –45,520 |
| Financial items | |||
| Financial income | 111 | 99 | 298 |
| Financial costs | 0 | 0 | –10 |
| Total financial items | 111 | 99 | 288 |
| Profit/loss after financial items | –13,873 | –7,769 | –45,232 |
| Tax on income | 0 | 0 | 0 |
| Profit/loss for the period | –13,873 | –7,769 | –45,232 |
| Earnings per share before and after dilution (SEK) | –0.80 | –0.46 | –2.67 |
| Average number of shares before and after dilution | 17,318,059 | 16,804,059 | 16,932,559 |
| No. of shares at the end of the period | 17,318,059 | 16,804,059 | 17,318,059 |
| SEK thousand | 1 Jan-31 Mar | 1 Jan-31 Mar | Full year |
|---|---|---|---|
| 2018 | 2017 | 2017 | |
| Profit/loss for the period | –13,873 | –7,769 | –45,232 |
| Other comprehensive income for the period | 0 | 0 | 0 |
| Comprehensive income for the period | –13,873 | –7,769 | –45,232 |
| SEK thousand | 31-03-18 | 31-03-17 | 31-12-2017 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 43,689 | 25,611 | 36,791 |
| Tangible fixed assets | 5,035 | 2,841 | 4,597 |
| Financial fixed assets | 253 | 0 | 0 |
| Total fixed assets | 48,977 | 28,452 | 41,388 |
| Current assets | |||
| Accounts receivable | 34 | 0 | 0 |
| Receivables from Group companies | 12,158 | 24 | 5,618 |
| Current receivables | 6,376 | 911 | 9,909 |
| Prepaid costs and accrued income | 3,117 | 714 | 1,533 |
| Cash and cash equivalents | 166,657 | 246,339 | 192,216 |
| Total current assets | 188,342 | 247,988 | 209,276 |
| TOTAL ASSETS | 237,319 | 276,440 | 250,664 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Restricted equity | |||
| Share capital | 866 | 840 | 866 |
| Fund for development expenses | 23,095 | 29,820 | 16,882 |
| 23,961 | 30,660 | 17,748 | |
| Unrestricted equity | |||
| Premium fund | 4,897 | 207,107 | 4,897 |
| Retained earnings including total comprehensive income | 194,064 | 31,094 | 214,150 |
| 198,961 | 238,201 | 219,047 | |
| Total shareholders' equity | 222,922 | 268,861 | 236,795 |
| Current liabilities | |||
| Other liabilities | 14,397 | 7,579 | 13,869 |
| Total current liabilities | 14,397 | 7,579 | 13,869 |
| TOTAL EQUITY AND LIABILITIES | 237,319 | 276,440 | 250,664 |
| SEK thousand | 1 Jan-31 Mar 2018 |
1 Jan-31 Mar 2017 |
Full year 2017 |
|---|---|---|---|
| Operating activities | |||
| Operating profit/loss | –13,984 | –7,869 | –45,596 |
| Adjustment for items not included in cash flow | 384 | 240 | 1,264 |
| Received interest | 110 | 99 | 366 |
| Paid interest | 0 | 0 | –2 |
| Paid tax | 0 | 0 | 0 |
| Cash flow from operating activities before changes in operating capital | –13,490 | –7,530 | –43,968 |
| Cash flow from changes in operating capital | |||
| Change in operating receivables | –4,623 | 182 | –15,230 |
| Change in operating liabilities | 528 | 801 | 7,090 |
| Cash flow from operating activities | –17,585 | –6,547 | –52,108 |
| Investment activities | |||
| Investment in intangible assets | –6,958 | –6,176 | –25,919 |
| Investment in tangible assets | –763 | –32 | –2,654 |
| Investment in financing assets | –253 | 0 | 0 |
| Cash flow from investing activities | –7,974 | –6,208 | –28,573 |
| Financing activities | |||
| National and European grants for development costs | 0 | 0 | 8,406 |
| New share issue | 0 | 0 | 4,923 |
| Received subscription warrant premiums | 0 | 0 | 474 |
| Cash flow from financing activities | 0 | 0 | 13,803 |
| Cash flow for the period | –25,559 | –12,755 | –66,878 |
| Cash and cash equivalents at beginning of period | 192,216 | 259,094 | 259,094 |
| Cash and cash equivalents at end of period | 166,657 | 246,339 | 192,216 |
| Key indicator | Definition | Reason for using key indicator not defined in accordance with IFRS |
|---|---|---|
| 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. |
| Earnings per share before and after dilution |
Profit attributable to parent company shareholders divided by the weighted average number of shares during the period before and after dilution. |
|
| 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. |
|
| 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 percentage 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 important parameter to follow as an indicator of how much of the total costs is used for the company's main business. |
| Cash and cash equivalents | Cash and bank balances. | |
| Cash flow from operating activities |
Cash flow before cash flows from investing and financing activities. |
|
| Cash flow | Net change in cash and cash equivalents excluding the impact of unrealized gains and losses. |
|
| 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 indicator of the financial stability of the company. |
| Average number of employees |
The average number of employees is calculated 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 departments. |
PANDIA-1—Prospective study for the diabetes risk group of patients aged over 50 that have been recently diagnosed with type 2 diabetes.
PANFAM-1—Prospective study for the familiar and inherited risk group.
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 5-8 percent 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 up to 49 percent. The initial addressable market for Immunovia consists of three 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 main market, Mid Cap segment. For more information, visit www.immunovia.com
Scheelevägen 2, Medicon Village 223 81 Lund, SWEDEN
Tel: 00 46 46-2756 000 [email protected] www.immunovia.com
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