Quarterly Report • Nov 7, 2018
Quarterly Report
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Immunovia's IMMray™ platform for blood-based biomarker signatures offers exciting new opportunities to develop accurate diagnostic tests that can detect diseases at an early stage. During the period we presented new results and identified no fewer than two new areas for strategic focus in our ongoing development activities – non-small cell lung cancer and Rheumatoid Arthritis (RA).
In August we presented the results from our first collaboration trial with a global, top-ten pharmaceutical business. The results showed that Immunovia's blood-based IMMray™ biomarker array produced very high accuracy in the diagnosis of non-small cell lung cancer. Later in August we presented the results from the latest of three completed studies within autoimmune testing. The studies represented a breakthrough, showing that IMMray™ can also have significance in the diagnosis of autoimmune rheumatoid diseases. As a consequence of the trial's exceptionally good results, we have decided to make Rheumatoid Arthritis (RA) a strategic focus area within autoimmunity.
These results for new applications clearly indicate the broad usability of the IMMray™ platform for addressing a large amount of unsolved problems within the fields of cancer, autoimmunity and other complex diseases. This means there is an opening for IMMray™ becoming a significant platform in global diagnostics for the future.
Mats Grahn CEO of Immunovia AB
As reported at the start of the quarter, new data has emerged showing that optimization of IMMray™ PanCan –d is required before the product can be launched on the market. This means a delay in the sales start until the latter part of 2019. Work on IMMray™ PanCan –d has continued during the quarter with undiminished intensity in the face of these new circumstances.
Immunovia's financial targets were updated before the previous interim report and remain in place.
| Key indicators | |||||
|---|---|---|---|---|---|
| 1 Jul–30 Sep | 1 Jul–30 Sep | 1 Jan–30 Sep | 1 Jan–30 Sep | Full year | |
| SEK thousand unless otherwise stated | 2018 | 2017 | 2018 | 2017 | 2017 |
| Net sales | 85 | 27 | 241 | 122 | 149 |
| Operating earnings | –17,344 | –11,641 | –61,952 | –30,157 | –45,520 |
| Earnings before tax | –17,403 | –11,589 | –60,876 | –29,914 | –45,232 |
| Net earnings | –17,403 | –11,589 | –60,883 | –29,914 | –45,232 |
| Earnings per share before and after dilution (SEK/share) |
–0.89 | –0.69 | –3.34 | –1.78 | –2.67 |
| Equity ratio, % | 97 | 97 | 97 | 97 | 94 |
| No. of shares at the end of the period | 19,531,353 | 17,318,059 | 19,531,353 | 17,318,059 | 17,318,059 |
| Average no. of shares before and after dilution | 19,487,025 | 16,804,059 | 18,212,275 | 16,804,059 | 16,932,559 |
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's financial targets remain in place from the previous quarter. The company expects to receive the first revenues from self-pay sales in the latter part of 2019. The following financial targets have been established:
Dear shareholders,
Immunovia's IMMray™ platform for blood-based biomarker signatures offers exciting new opportunities to develop accurate diagnostic tests that can detect diseases at an early stage. During the period we presented new results and identified no fewer than two new areas for strategic focus in our ongoing development activities – non-small cell lung cancer and Rheumatoid Arthritis (RA).
In August we presented the results from our first collaboration trial with a global, top-ten pharmaceutical company. The results showed that Immunovia's blood-based IMMray™ biomarker array produced very high accuracy in the diagnosis of non-small cell lung cancer. The trial showed that the IMMray™ platform can distinguish healthy samples in the control group from samples of non-small cell lung cancer with 95% accuracy. Since IMMray™ has previously shown similarly high accuracy (98%) in detecting pancreatic cancer, the results from this trial strengthen our belief that IMMray™ has the potential to become the central technology platform for cancer diagnosis based on blood samples. We are now really looking forward to the next phase in this collaboration.
Rheumatoid Arthritis now a strategic focus area Later in August we presented the results from the latest of three completed studies within autoimmune testing. The studies represented a breakthrough, showing that IMMray™ can also have significance in the diagnosis of autoimmune rheumatoid arthritis diseases. As a consequence of the trial's exceptionally good results, we have decided to make Rheumatoid Arthritis (RA) a strategic focus area within autoimmunity.
Our first two studies showed that IMMray™ can identify and distinguish with excellent accuracy a number of overlapping autoimmune rheumatic diseases
that have similar symptoms, such as RA, Systemic Lupus Erythematosus (SLE), Sjögren's disease and systematic vasculitis. These results were published at the beginning of 2017 and have since been discussed with a large number of Key Opinion Leaders in the field. All of these leaders emphasized that although there is great interest in a differential diagnosis for these diseases, the greater need is for diagnostic tools that enable diagnosis of early-stage RA.
Healthcare policy recommendations with this purpose are already established. Comprehensive implementation of these guidelines is currently taking place in order to ensure early diagnosis of autoimmune rheumatic diseases in healthcare systems. There are therefore good opportunities for rapid uptake and market penetration of a new diagnostic test that can help eliminate the bottlenecks that exist, and which are also described in the recommendations.
Our third trial therefore represents a major breakthrough: the IMMray™ biomarker signature can diagnose CCP-negative patients with RA with an accuracy over 90 percent compared to healthy control samples. At present, this important patient group – 25-30%t of all RA cases – are at risk of being wrongly diagnosed due to shortcomings in today's standard methods.
These are the exceptionally good results that have prompted us to lift RA to become a strategic focus area. Our overall strategy is to solve the most important clinical needs, primarily around diagnosis of early RA. Our long-term goal is to provide doctors access to cost-effective testing for the whole patient care process, from initial diagnosis and selection of treatment to patient monitoring and measurement of treatment results. Our first step and our product development within this very large area is, as described above, a test that solves an immediate need for specialist doctors, namely to diagnose patients with advanced RA but who currently test negative in today's standard tests. This will be then followed naturally with a product that can help the healthcare system's ongoing reforms to succeed in their ambition to be able to detect RA at an earlier stage than is currently possible.
Decision to optimize IMMray™ PanCan –d At the start of the quarter new data emerged that showed that an optimization of IMMray™ PanCan –d was required ahead of the product's market introduction, which meant that the sales start was put back to the latter part of 2019. Work on IMMray™ PanCan –d
continued during the quarter with undiminished intensity in the light of these new circumstances. The background to the delay is a study that showed how sample collection procedures on a commercial basis, as for Immunovia's final validation studies, have an impact on the product's algorithms. Due to the variations in collection procedures from different biobanks, the optimization of the signature must be completed before the product can be commercialized. After the optimization, which is expected to be concluded in Q1 2019, a number of the aforementioned tests and studies must be carried out with the optimized signature, which when taken together will lead to the sales launch in the latter part of 2019. It is important to emphasize that in our own commercial business the collection procedures will be under our full control because we will manage them ourselves.
We are now fully focused on the optimization if IMMray™ PanCan –d and are doing everything necessary to maintain the tempo of the work while retaining high quality.
The prospective studies have only contributed in a small way to the delay. During the period we announced that Karolinska Institutet had decided to participate in Immunovia's PanFAM-1 prospective clinical trial for early detection of pancreatic cancer using a blood-based test.
During the period we received acknowledgements of our technology from across the scientific community. The prestigious Journal of Clinical Oncology published the results of the large retrospective clinical validation studies performed by Immunovia in collaboration with Swedish, Danish and American researchers. These studies show that the IMMray™ PanCan –d test can detect pancreatic cancer with 96% accuracy.
After the end of the period, we also achieved registration of our PanFAM-1 prospective clinical trial at ClinicalTrials.gov, the world's largest database for clinical trials. This is an online register that will make information about the PanFAM-1 trial available for patients, relatives, healthcare staff and the general public.
Immunovia's financial targets were updated prior to the previous interim report and remain in place. The company's goal is to achieve SEK 250-300 million in turnover in 2022 based on self-pay sales, and sales of SEK 800-1,000 million in 2024, which includes selfpay and reimbursed sales in Europe and the US.
All tests of the IMMray™ platform show that IMMray™ is robust and reproducible with low technical variations at all levels while being capable of finding solutions to clinical problems in addition to pancreatic cancer. This has been shown in the results for lung cancer and for the autoimmune disease, rheumatoid arthritis. Our technology creates great opportunities for Immunovia to expand, and as always, we are grateful for our shareholders' continued support.
Mats Grahn CEO, Immunovia AB
Important events in the third quarter of 2018 Karolinska Institutet participated in Immunovia's Pan-FAM-1 prospective clinical trial for early detection of pancreatic cancer using blood-based test Karolinska Institutet has a very high international reputation within oncology and complements the other clinical centres participating in PanFAM-1.
Immunovia announced that a trial carried out in collaboration with a global top-ten pharmaceutical company showed that the IMMray platform could differentiate healthy controls from non-small cell lung cancer samples with 95% accuracy.
Immunovia AB announced that the prestigious Journal of Clinical Oncology (JCO) was publishing the results of the major retrospective clinical validation trial performed by Swedish, Danish and US researchers, showing that the IMMray™ PanCan-d serum biomarker microarray detects early pancreatic cancer with 96% accuracy.
Immunovia AB reported that new data had emerged showing that the sample-collection procedure, which will be applicable commercially and for Immunovia's final validation studies, affects the product's algorithms. Immunovia has therefore decided that a necessary stage is to optimize IMMray™ PanCan –d to safeguard the quality of the test results prior to release. This will delay the start of sales to the latter part of 2019.
Immunovia announced that a new study had confirmed that the IMMray™ blood test successfully addresses one of the major challenges in autoimmune testing. The study, performed in collaboration with Linköping University, showed that IMMray™ technology can identify patients with rheumatoid arthritis (RA), despite testing negative with antibodies against cyclic citrullinated peptides (CCP). Currently, this important group of patients – representing 25-30% of all RA cases – is missed due to a failure in the current standard method.
Registration of Immunovia's PanFAM-1 prospective clinical trial at ClinicalTrials.gov, the world's largest database for clinical trials.
After the end of the reporting period, the PanFAM-1 prospective clinical trial was registered at ClinicalTrials.gov, an online register of clinical trials. This will make information about the PanFAM-1 trial available for patients, relatives, healthcare staff and the general public.
Encouraged by the promising discovery study results previously reported, Immunovia announced that its focus in autoimmunity testing will be to develop IMMray™ blood-based biomarker signatures for the management of rheumatoid arthritis.
Net sales for the third quarter of 2018 were SEK 85 thousand (27 k). For the first nine months of 2018, net sales were SEK 241 thousand (122 k). Net sales principally comprise royalties.
Capitalization of costs for the third quarter of 2018 amounted to SEK 6,735 thousand (4,479 k). Where capitalized development costs are financed through approved and paid grants, the reported amounts are reduced by a comparable amount. During the first nine months of 2018, grants for development costs amounting to SEK 73,000 were received. Grants worth SEK 164,000 were received in the corresponding period in 2017.
The net loss for the third quarter of 2018 was SEK 17,403 thousand (–11,589 k). The loss for the first nine months of the year was SEK 60,883 thousand (–29,914 k).
The net loss for the third quarter of 2018 increased due to higher costs relating to organizational enlargement and increased marketing activity. Other external costs and personnel costs increased by a total of SEK 7,579 thousand compared with last year. For the January-September 2018 period the corresponding increase was SEK 35,348 thousand.
The total cost of research and development in the third quarter of 2018 was SEK 6,863 thousand (4,479 k), which corresponds to 28% (34%) of the Group's total operating costs.
Cash flow for the third quarter of 2018 from operating activities amounted to SEK –25,656 thousand (–13,467 k). Corresponding cash flow for the first nine months of 2018 was SEK –58,530 thousand (–29,825 k). Cash flow for financing activities in the third quarter of 2018 was SEK 1,619 thousand (5,087 k).
A new share issue was carried out in the third quarter of 2018, raising SEK 1,619 thousand net after issue costs. Liquid funds as of 30 September 2018 were SEK 415,602 thousand (215,300 k).
Shareholders' equity at the end of the period was SEK 487,749 thousand (252,113 k) and the equity ratio was 97% (97).
Management believes that there is sufficient working capital to meet working capital needs, given the current business and development plan, for more than 24 months going forward.
In the third quarter of 2018 intangible assets were acquired for SEK 7,382 thousand (4,544 k), consisting of capitalized development expenditure for SEK 6,735 thousand (4,479 k), patents for SEK 300 thousand (65 k), and other intangible assets for SEK 347 thousand (0).
In the first nine months 2018, intangible assets were acquired for a total of SEK 22,059 thousand (16,876 k), consisting of capitalized development expenditure for SEK 19,828 thousand (15,559 k), patents for SEK 1,354 thousand (1,317 k) and other intangible assets for SEK 877 thousand (0).
Investments in tangible assets in the form of inventories were made during the third quarter of 2018 amounting to SEK 181 thousand. For the corresponding period last year the total was SEK 102 thousand. In the first nine months of 2018 investment in tangible assets amounted to SEK 8,654 thousand (2,654 k).
No investment was made in financial assets the first nine months 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 the third quarter of 2018 averaged 44 (28) and at the end of the period the number of people working in full-time positions was 45.
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 395,500 warrants entitling to subscription of 395,500 shares. There will be no dilution as long as the Group's earnings are negative. For more information about he warrants, see page 7.
New share capital and number of shares During September the share capital and number of shares in Immunovia AB (publ) changed following the utilization of subscription warrants. The share capital increased by SEK 2,525.00 to SEK 976,567.65 and the number of shares increased by 50,000 to 19,531,353 shares. The subscription warrants were utilized as part of Immunovia's incentive scheme for leading decision makers, in accordance with resolutions made at the 2015 and 2016 AGMs and subscriptions issues in those years.
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 30 September 2018 | ||||||
|---|---|---|---|---|---|---|
| Name | No. of shares |
Share capital and votes |
||||
| Carl Borrebaeck | 1,709,900 | 8.75% | ||||
| Ålandsbanken i ägares ställe | 1,363,913 | 6.98% | ||||
| Sara Andersson Ek | 888,950 | 4.55% | ||||
| Christer Wingren | 888,950 | 4.55% | ||||
| Per Mats Ohlin | 888,950 | 4.55% | ||||
| Handelsbanken Svenska Småbolag | 872,375 | 4.47% | ||||
| Vincent Saldell | 782,922 | 4.01% | ||||
| Catella Småbolagsfond | 642,379 | 3.29% | ||||
| Försäkringsbolaget Avanza Pension | 594,788 | 3.05% | ||||
| Swedbank Robur Folksams LO | ||||||
| Sverige | 500,000 | 2.56% | ||||
| 10 largest owners | 9,133,127 | 46.76% | ||||
| Others | 10,398,226 | 53.24% | ||||
| 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 (150,500) 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 (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 6,175.
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 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.
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 one 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 cash flows. Most of the financial assets consist 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.
When financial assets are acquired, expected credit losses are reported continually during the ownership period, normally with consideration to the risk of credit losses within the coming 12 months. In the event that credit risks increase significantly, reserves are made for the credit losses expected throughout the full ownership period of the asset. Based on historic data for the payment patterns and payment capability of the counter party, the expected credit losses are considered to be limited.
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.
IFRS 16 – Leases will be applied from 1 January 2019. Assets and liabilities attributable to leasing agreements, with a few exceptions, will be reported on the balance sheet. The Group considers that IFRS 16 will mean that the premises rented by the Group shall be reported as an asset on the balance sheet. The current value of future rental fees will be recorded as a liability. Utilisable assets and liabilities have been assessed at SEK 14 million as of 1 January 2019, including an option period. The annual amortisation is estimated at SEK 3.0 million per year, compared with the annual rental fee of SEK 3.3 million.
New and amended standards adopted from 2018 are not expected to have a significant impact on the Group's financial position.
This quarterly report has been reviewed by the company's auditor.
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 423,146 thousand (174,930).
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.
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 33 of the 2017 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 30 September 2018 amounted to SEK 423,146 thousand (174,930 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 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
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
| 14 February 2019 | 2018 Financial statement |
|---|---|
| 24 April 2019 | Q1 2019 interim report |
| 26 April 2019 | AGM |
| 23 August 2019 | Q2 2019 interim report |
| 7 November 2019 | Q3 2019 interim report |
| 14 February 2020 | 2019 Financial statement |
7 November 2018 at 16.30 CET
SE: +46 856642662 BE: +32 24040635 CH: +41 225675548 DE: +49 69222229046 DK: +45 82333178 FR: +33 170750712 NE: +31 207168416 NO: +47 23500254 UK: +44 2030089803 US: +1 6465025116
| Page | |
|---|---|
| Consolidated income statement, summary | 11 |
| Consolidated comprehensive income, summary | 11 |
| Consolidated financial position, summary | 12 |
| Change in consolidated equity, summary | 13 |
| Consolidated key indicators | 13 |
| Consolidated cash flow statement, summary | 14 |
| Parent company's income statement, summary | 15 |
| Parent company's comprehensive income, | |
| summary | 15 |
| Parent company's financial position, summary | 16 |
| Parent company's cash flow statement, summary | 17 |
In some cases figures have been rounded off, which means tables and calculations will not always appear to be correctly totalled.
| 1 Jul-30 Sep | 1 Jul-30 Sep | 1 Jan-30 Sep | 1 Jan-30 Sep | Full year | |
|---|---|---|---|---|---|
| SEK thousand | 2018 | 2017 | 2018 | 2017 | 2017 |
| Operating income, etc. | |||||
| Net sales | 85 | 27 | 241 | 122 | 149 |
| Capitalized work for own account | 6,735 | 4,479 | 19,828 | 15,559 | 24,041 |
| Other income | 22 | 35 | 487 | 59 | 59 |
| Total | 6,842 | 4,541 | 20,556 | 15,740 | 24,249 |
| Operating costs | |||||
| Other external costs | –11,781 | –11,959 | –47,653 | –27,472 | –39,113 |
| Personnel costs | –11,459 | –3,702 | –32,441 | –17,274 | –29,138 |
| Depreciation and amortization of tangible and | |||||
| intangible assets | –767 | –369 | –1,996 | –876 | –1,264 |
| Other operating expenses | –179 | –152 | –418 | –275 | –254 |
| Total operating expenses | –24,186 | –16,182 | –82,508 | –45,897 | –69,769 |
| Operating profit/loss | –17,344 | –11,641 | –61,952 | –30,157 | –45,520 |
| Financial items | |||||
| Financial income | 118 | 53 | 1,253 | 244 | 298 |
| Financial costs | –177 | –1 | –177 | –1 | –10 |
| Total financial items | –59 | 52 | 1,076 | 243 | 288 |
| Profit/loss after financial items | –17,403 | –11,589 | –60,876 | –29,914 | –45,232 |
| Tax | 0 | 0 | –7 | 0 | 0 |
| Profit/loss for the period | –17,403 | –11,589 | –60,883 | –29,914 | –45,232 |
| Earnings per share before and after dilution (SEK) |
–0.89 | –0.69 | –3.34 | –1.78 | –2.67 |
| Average number of shares | 19,487,025 | 16,804,059 | 18,212,275 | 16,804,059 | 16,932,559 |
| No. of shares at the end of the period | 19,531,353 | 17,318,059 | 19,531,353 | 17,318,059 | 17,318,059 |
| 1 Jul-30 Sep | 1 Jul-30 Sep | 1 Jan-30 Sep | 1 Jan-30 Sep | Full year | |
|---|---|---|---|---|---|
| SEK thousand | 2018 | 2017 | 2018 | 2017 | 2017 |
| Profit/loss for the period | –17,403 | –11,589 | –60,883 | –29,914 | –45,232 |
| Items that may be later reclassified in the income statement |
|||||
| Exchange rate differences for foreign net | |||||
| investment | 196 | 0 | –423 | 0 | 0 |
| Other comprehensive income for the period | 196 | 0 | –423 | 0 | 0 |
| Comprehensive income for the period | –17,207 | –11,589 | –61,306 | –29,914 | –45,232 |
| SEK thousand | 30-09-2018 | 30-09-2017 | 31-12-2017 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 58,627 | 36,053 | 36,791 |
| Tangible fixed assets | 14,310 | 4,922 | 7,211 |
| Financial fixed assets | 2,970 | 0 | 2,759 |
| Total fixed assets | 75,907 | 40,975 | 46,761 |
| Current assets | |||
| Current receivables | 9,919 | 3,927 | 11,584 |
| Cash and cash equivalents | 415,602 | 215,300 | 192,425 |
| Total current assets | 425,521 | 219,227 | 204,009 |
| TOTAL ASSETS | 501,428 | 260,202 | 250,770 |
| EQUITY AND LIABILITIES | |||
| Shareholders' equity | |||
| Share capital | 977 | 840 | 866 |
| Unregistered share capital | 0 | 26 | 0 |
| Other contributed capital | 626,320 | 314,170 | 314,170 |
| Translation reserve | –423 | 0 | 0 |
| Retained earnings including total comprehensive income | –139,125 | –62,923 | –78,241 |
| Total shareholders' equity | 487,749 | 252,113 | 236,795 |
| Current liabilities | |||
| Other liabilities | 13,679 | 8,089 | 13,975 |
| Total current liabilities | 13,679 | 8,089 | 13,975 |
| TOTAL EQUITY AND LIABILITIES | 501,428 | 260,202 | 250,770 |
| Retained earnings | ||||||
|---|---|---|---|---|---|---|
| Other | including total | Total | ||||
| Share | Unregistered | contributed | comprehensive | shareholders' | ||
| SEK thousand | capital | share capital | equity Reserves | income | equity | |
| Equity, 1 January 2017 | 840 | 0 | 308,800 | 0 | –33,009 | 276,631 |
| Comprehensive income for the period | 0 | –29,914 | –29,914 | |||
| Received subscription warrant premiums | 473 | 473 | ||||
| New share issue | 26 | 4,897 | 4,923 | |||
| Equity, 30 September 2017 | 840 | 26 | 314,170 | 0 | –62,923 | 252,113 |
| Comprehensive income for the period | ||||||
| Registration of share capital | 0 | –15,318 | –15,318 | |||
| Equity, 31 December 2017 | 26 | –26 | 0 | |||
| Utgående balans 31 december 2017 | 866 | 0 | 314,170 | 0 | –78,241 | 236,795 |
| Comprehensive income for the period | –423 | –60,883 | –61,306 | |||
| Received subscription warrant premiums | 908 | 908 | ||||
| New share issue | 111 | 325,927 | 326,038 | |||
| Issue costs | –14,685 | –14,685 | ||||
| Equity, 30 September 2018 | 977 | 0 | 626,320 | –423 | –139,125 | 487,749 |
| 1 Jul-30 Sep 2018 |
1 Jul-30 Sep 2017 |
1 Jan-30 Sep 2018 |
1 Jan-30 Sep 2017 |
Full year 2017 |
Full year 2016 |
|
|---|---|---|---|---|---|---|
| Operating profit/loss (SEK thousand) | –17,344 | –11,641 | –61,952 | –30,157 | –45,520 | –14,978 |
| Profit/loss for the period (SEK thousand) | –17,403 | –11,589 | –60,883 | –29,914 | –45,232 | –14,723 |
| Earnings per share before and after dilution (SEK) |
–0.89 | –0.69 | –3.34 | –1.78 | –2.67 | –0.98 |
| R&D costs (SEK thousand) | –6,735 | –4,479 | –19,828 | –15,559 | –24,041 | –24,293 |
| R&D costs as percentage of operating costs (%) |
28 | 28 | 25 | 34 | 34 | 62 |
| Cash and cash equivalents at end of period (SEK thousand) |
415,602 | 215,300 | 415,602 | 215,300 | 192,425 | 259,094 |
| Cash flow from operating activities (SEK thousand) |
–25,656 | –13,467 | –58,530 | –29,825 | –46,317 | –11,867 |
| Cash flow for the period (SEK thousand) | –31,600 | –13,026 | 223,090 | –43,794 | –66,661 | 183,327 |
| Equity (SEK thousand) | 487,749 | 252,113 | 487,749 | 252,113 | 236,795 | 276,631 |
| Equity per share (SEK) | 24.97 | 14.56 | 24.97 | 14.56 | 13.67 | 16.46 |
| Equity ratio (%) | 97 | 97 | 97 | 97 | 94 | 98 |
| Average no. of employees | 44 | 28 | 41 | 28 | 30 | 16 |
| Average no. of employees in R&D | 17 | 16 | 17 | 16 | 16 | 11 |
| SEK thousand | 1 Jul-30 Sep 2018 |
1 Jul-30 Sep 2017 |
1 Jan-30 Sep 2018 |
1 Jan-30 Sep 2017 |
Full year 2017 |
|---|---|---|---|---|---|
| Operating activities | |||||
| Operating profit/loss | –17,344 | –11,641 | –61,953 | –30,157 | –45,520 |
| Adjustment for items not included in cash flow | 1,136 | 369 | 1,999 | 876 | 1,472 |
| Received interest | 118 | 53 | 235 | 244 | 298 |
| Paid interest | –177 | –1 | –177 | –1 | –10 |
| Paid tax | 0 | 0 | –7 | 0 | 0 |
| Cash flow from operating activities before | |||||
| changes in operating capital | –16,267 | –11,220 | –59,903 | –29,038 | –43,760 |
| Cash flow from changes in operating capital | |||||
| Change in operating receivables | –204 | –568 | 1,675 | –2,096 | –9,757 |
| Change in operating liabilities | –9,185 | –1,679 | –302 | 1,309 | 7,200 |
| Cash flow from operating activities | –25,656 | –13,467 | –58,530 | –29,825 | –46,317 |
| Investment activities | |||||
| Investment in intangible assets | –7,382 | –4,544 | –22,059 | –16,876 | –25,919 |
| Investment in tangible assets | –181 | –102 | –8,654 | –2,654 | –5,366 |
| Investment in financing assets | 0 | 0 | 0 | 0 | –2,861 |
| Cash flow from investing activities | –7,563 | –4,646 | –30,713 | –19,530 | –34,146 |
| Financing activities | |||||
| National and European grants for | |||||
| development costs | 0 | 164 | 73 | 164 | 8,406 |
| New share issue | 1,619 | 4,923 | 311,352 | 4,923 | 4,923 |
| Received subscription warrant premiums | 0 | 0 | 908 | 474 | 474 |
| Cash flow from financing activities | 1,619 | 5,087 | 312,333 | 5,561 | 13,803 |
| Cash flow for the period | –31,600 | –13,026 | 223,090 | –43,794 | –66,661 |
| Cash and cash equivalents at beginning of period |
447,212 | 228,326 | 192,425 | 259,094 | 259,094 |
| Exchange rate difference in cash and cash equivalents |
–10 | 0 | 87 | 0 | –8 |
| Cash and cash equivalents at end of period | 415,602 | 215,300 | 415,602 | 215,300 | 192,425 |
| 1 Jul-30 Sep | 1 Jul-30 Sep | 1 Jan-30 Sep | 1 Jan-30 Sep | Full year | |
|---|---|---|---|---|---|
| SEK thousand | 2018 | 2017 | 2018 | 2017 | 2017 |
| Operating income, etc. | |||||
| Net sales | 85 | 27 | 241 | 122 | 149 |
| Capitalized work for own account | 6,735 | 4,479 | 19,828 | 15,559 | 24,041 |
| Other income | 22 | 35 | 487 | 59 | 59 |
| Total income | 6,842 | 4,541 | 20,556 | 15,740 | 24,249 |
| Operating costs | |||||
| Other external costs | –10,977 | –9,897 | –43,682 | –27,472 | –44,984 |
| Personnel costs | –8,106 | –5,784 | –23,298 | –17,274 | –23,343 |
| Depreciation and amortization of tangible and | |||||
| intangible assets | –561 | –369 | –1,432 | –876 | –1,264 |
| Other operating expenses | –179 | –153 | –417 | –275 | –254 |
| Total operating expenses | –19,823 | –16,203 | –68,829 | –45,897 | –69,845 |
| Operating profit/loss | –12,981 | –11,662 | –48,273 | –30,157 | –45,596 |
| Financial items | |||||
| Interest income | 289 | 73 | 1,612 | 244 | 366 |
| Interest costs | –177 | 0 | –177 | –1 | –2 |
| Total financial items | 112 | 73 | 1,435 | 243 | 364 |
| Profit/loss after financial items | –12,869 | –11,589 | –46,838 | –29,914 | –45,232 |
| Tax | 0 | 0 | 0 | 0 | 0 |
| Profit/loss for the period | –12,869 | –11,589 | –46,838 | –29,914 | –45,232 |
| Earnings per share before and after dilution (SEK) Average number of shares |
–0.66 | –0.69 | –2.57 | –1.78 | –2.67 |
| No. of shares at the end of the period | 19,487,025 | 16,804,059 | 18,212,275 | 16,804,059 | 16,932,559 |
| Antal aktier vid periodens slut | 19,531,353 | 17,318,059 | 19,531,353 | 17,318,059 | 17,318,059 |
| SEK thousand | 1 Jul-30 Sep | 1 Jul-30 Sep | 1 Jan-30 Sep | 1 Jan-30 Sep | Full year |
|---|---|---|---|---|---|
| 2018 | 2017 | 2018 | 2017 | 2017 | |
| Profit/loss for the period | –12,869 | –11,589 | –46,838 | –29,914 | –45,232 |
| Other comprehensive income for the period | 0 | 0 | 0 | 0 | 0 |
| Comprehensive income for the period | –12,869 | –11,589 | –46,838 | –29,914 | –45,232 |
| SEK thousand | 30-09-2018 | 30-09-2017 | 31-12-2017 |
|---|---|---|---|
| ASSETS | |||
| Fixed assets | |||
| Intangible fixed assets | 57,721 | 36,053 | 36,791 |
| Tangible fixed assets | 9,124 | 4,922 | 4,597 |
| Financial fixed assets | 253 | 0 | 0 |
| Total fixed assets | 67,098 | 40,975 | 41,388 |
| Current assets | |||
| Receivables from Group companies | 26,216 | 3,261 | 5,618 |
| Current receivables | 5,899 | 1,781 | 9,909 |
| Prepaid costs and accrued income | 3,754 | 1,030 | 1,533 |
| Cash and cash equivalents | 412,861 | 213,162 | 192,216 |
| Total current assets | 448,730 | 219,234 | 209,276 |
| TOTAL ASSETS | 515,828 | 260,209 | 250,664 |
| EQUITY AND LIABILITIES | |||
| Shareholder's equity | |||
| Restricted equity | |||
| Share capital | 977 | 840 | 866 |
| Unregistered share capital | 0 | 26 | 0 |
| Fund for development expenses | 36,710 | 39,381 | 16,882 |
| 37,687 | 40,247 | 17,748 | |
| Unrestricted equity | |||
| Premium fund | 311,242 | 5,691 | 4,897 |
| Retained earnings including total comprehensive income | 153,288 | 206,175 | 214,150 |
| 464,530 | 211,866 | 219,047 | |
| Total shareholders' equity | 502,217 | 252,113 | 236,795 |
| Current liabilities | |||
| Other liabilities | 13,611 | 8,096 | 13,869 |
| Total current liabilities | 13,611 | 8,096 | 13,869 |
| TOTAL EQUITY AND LIABILITIES | 515,828 | 260,209 | 250,664 |
| SEK thousandv | 1 Jan-30 Sep 2018 |
1 Jan-30 Sep 2017 |
Full year 2017 |
|---|---|---|---|
| Operating activities | |||
| Operating profit/loss | –48,273 | –30,157 | –45,596 |
| Adjustment for items not included in cash flow | 2,273 | 856 | 1,264 |
| Received interest | 227 | 265 | 366 |
| Paid interest | 0 | –1 | –2 |
| Paid tax | 0 | 0 | 0 |
| Cash flow from operating activities before changes in operating capital | –45,773 | –29,037 | –43,968 |
| Cash flow from changes in operating capital | |||
| Change in operating receivables | –18,443 | –4,242 | –15,230 |
| Change in operating liabilities | –258 | 1,317 | 7,090 |
| Cash flow from operating activities | –64,474 | –31,962 | –52,108 |
| Investment activities | |||
| Investment in intangible assets | –21,181 | –16,876 | –25,919 |
| Investment in tangible assets | –5,780 | –2,654 | –2,654 |
| Investment in financing assets | –253 | 0 | 0 |
| Cash flow from investing activities | –27,214 | –19,530 | –28,573 |
| Financing activities | |||
| National and European grants for development costs | 73 | 164 | 8,406 |
| New share issue | 311,352 | 4,923 | 4,923 |
| Received subscription warrant premiums | 908 | 474 | 474 |
| Cash flow from financing activities | 312,333 | 5,561 | 13,803 |
| Cash flow for the period | 220,645 | –45,931 | –66,878 |
| Cash and cash equivalents at beginning of period | 192,216 | 259,093 | 259,094 |
| Cash and cash equivalents at end of period | 412,861 | 213,162 | 192,216 |
The Board and the CEO certify that the interim report 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, 7 November 2018.
Carl Borrebaeck Hans Johansson
Chairman Board member
Åsa Hedin Christofer Sjögren Board member Board member
Mimmi Ekberg Ann-Christine Sundell Board member Board member
Mats Grahn CEO
To the Board of Directors of Immunovia AB (publ) Org. no. 556730-4299
We have conducted a review of the summary of interim financial information (interim report) for Immunovia AB (publ) per 30-09-2018 and the ninemonth period ending at that date. The Board of Directors and the Managing Director are responsible for the preparation and fair presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
We have conducted our review in accordance with the International Standard on Review Engagements ISRE 2410, Review of financial interim information conducted by the company's chosen auditor. A review involves making inquiries, primarily to persons responsible for financial matters and accounting issues, conducting an analytical review and performing other review procedures. A review has a different focus and a significantly smaller scope than the focus and scope of a review in accordance with ISA
and with generally accepted auditing practice. The review measures taken in a review do not allow us to obtain such a full understanding that we become aware of all the important circumstances that could have been identified if an audit was carried out. Therefore, the stated conclusion based on a review does not have the assurance that an expressed conclusion based on an audit has.
Based on our review, no circumstances have arisen which give us reason to believe that the interim report has not been prepared in essence for the Group in accordance with IAS 34 and the Annual Accounts Act, as well as for the Parent Company in accordance with the Annual Accounts Act.
Lund, November 7, 2018
Mazars SET Revisionsbyrå AB
Mats-Åke Andersson Authorized Public Accountant Chief Auditor
Martin Gustafsson Authorized Public Accountant
| 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. |
PANFAM-1 Prospective trial for familiar and hereditary risk groups.
Pancreatologist Doctor specialising in diseases relating to the pancreas.
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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