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Immunovia

Quarterly Report Apr 24, 2019

3061_10-q_2019-04-24_c4181f4a-7a7f-4d43-8f38-fc2feeec306a.pdf

Quarterly Report

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Immunovia interim report January-March 2019

"During the first quarter of 2019, we remained focused on our product launch strategy and continued to create value, as we reached several key objectives and took several steps towards the commercialization of IMMray™ PanCan-d, our diagnostic test for early detection of pancreatic cancer.

Another key objective that we reached in the first quarter was the addition of new participants to our PanFAM-1 study, a multicenter prospective validation study for early diagnosis of people with a high risk of hereditary pancreatic cancer. In Q1 2019 we added two additional centers, one in Sweden and one in Spain. Umeå University Hospital in Sweden and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona are now part of PanFAM-1 study.

We also took an extremely important step towards on the optimization of the algorithm during Q1. We announced in March that using blood samples that are as fresh as possible, i.e. stored for less than 24 months, increases the test performance and provides optimal results. We were able to attain the relevant samples through our large and growing network of clinical Key Opinion Leaders (KOL). It is imperative to note that we needed samples that best mirror the blood samples that will be used with our final product, finding these fresh samples and gaining access to them is quite difficult and takes time.

With the appointment of Julie Silber as Senior Investor Relations Director early this year we actualized a strategic objective in strengthening the IR role and our shareholder communication capabilities at Immunovia.

We continued to work intensely during the first quarter of 2019 on the preparations for our sales launch targeted for the beginning of 2020."

Excerpt from the CEO Mats Grahn's comment on the report.

Mats Grahn CEO of Immunovia AB

Key indicators
Jan-Mar Jan-Mar Full year Full year
SEK thousand unless otherwise stated 2019 2018 2018 2017
Net sales 66 112 333 149
Operating earnings –27,197 –17,377 –87,708 –45,520
Earnings before tax –26,381 –17,326 –86,531 –45,323
Net earnings –26,384 –17,326 –86,538 –45,232
Earnings per share before and after dilution (SEK/share) –1.35 –1.00 –4.67 –2.67
Equity ratio, % 89 94 97 94
No. of shares at the end of the period 19,531,353 17,318,059 19,531,353 17,318,059

This financial statement has been produced in accordance with IFRS for the Immunovia Group, which comprises Immunovia AB and the wholly-owned subsidiaries Immunovia Incentive AB, Immunovia Inc. and Immunovia GmbH.

Outlook

Immunovia is focused on fundamentally transforming diagnosis of complex forms of cancer and autoimmune diseases. The antibody-based platform, IMMray™, is the result of 15 years of research at CREATE Health – the Center for Translational Cancer Research at Lund University, Sweden. IMMray™ is a technology platform for the development of diagnostic tests and the company's primary test, IMMray™ PanCan–d, is the first test in the world for early diagnosis of pancreatic cancer.

The Company reiterates it's financial targets in accordance with what has previously been disclosed. The company anticipates the first revenues from self pay sales in early 2020. The following financial targets have been established:

• Immunovia's target is to achieve turnover of SEK 250-300 million by 2022 based on self-pay for IMMray™ PanCan–d.

• Immunovia's target is to achieve total turnover, including payment via self-pay and cost remuneration from insurance systems, of SEK 800-1,000 million by 2024.

CEO's statement

Important steps toward commercialization of IMMray™ PanCan-d

Dear shareholders,

During the first quarter of 2019, we remained focused on our product launch strategy and continued to create value, as we reached several key objectives and took several steps towards the commercialization of IMMray™ PanCan-d, our diagnostic test for early detection of pancreatic cancer.

With the appointment of Julie Silber as Senior Investor Relations Director early this year we actualized a strategic objective in strengthening the IR role and our shareholder communication capabilities at Immunovia. It has also been our intent to expand our capital markets exposure throughout Europe and especially in North America and to enhance our strategic communications plan in parallel with our commercial launch.

Additionally, and to further our expanded IR initiative, we attended three investor conferences in the first quarter of 2019 and hosted many meetings with interested investors and plan to do more.

Another key objective that we reached in the first quarter was the addition of new participants to our PanFAM-1 study, a multicenter prospective validation study for early diagnosis of people with a high risk of hereditary pancreatic cancer. In Q1 2019 we added two additional centers, one in Sweden and one in Spain. Umeå University Hospital in Sweden and Catalan Institute of Oncology (ICO Hospitalet) – Bellvitge Biomedical Research Institute (IDIBELL) in Barcelona are now part of PanFAM-1 study. The participation of these new centers not only add value by expanding our network of important centers that will help in commercializing IMMrayTM PanCan-d it also creates a more diverse sample pool ethnically and genetically which provides us with a wider range of data to better validate the test.

PanFAM-1 is the largest prospective study to date that is addressing the unmet need of early diagnosis in high-risk individuals with Familial Pancreatic Cancer (FPC). The PanFAM-1 study and ongoing screening programs that will include more than 2,000 patients and is scheduled to run for three years.

We also took an extremely important step towards on the optimization of the algorithm during Q1. We announced in March that using blood samples that are as fresh as possible, i.e. stored for less than 24 months, increases the test performance and provides optimal results. We were able to attain the relevant samples through our large and growing network of clinical Key Opinion Leaders (KOL). It is imperative to note that we needed samples that best mirror the blood samples that will be used with our final product, finding these fresh samples and gaining access to them is quite difficult and takes time. Thanks to our experienced KOLs, we now have these at hand and are well on our way towards completing the optimization work. Going forward, the verification and validation process of IMMray™ PanCan-d will be conducted solely with samples collected that best conforms to general clinical conditions. This was a very important step for many reasons: not only did this confirm the need to use fresh blood samples for optimal results, it also confirmed the incredible support of our KOL network. This was a crucial step towards the commercialization of IMMray™ PanCan-d.

The completion of the optimization work will then trigger the commercial test model study, followed by Verification and Validation studies. Like we mentioned in Q1 the details on timing of these milestones will be communicated in Q2.

At Immunovia, we remain fully committed and focused on the commercialization of IMMray™ PanCan-d and continue to do everything possible to maximize efficiency while maintaining our high quality. We continued to work intensely during the first quarter of 2019 on the preparations for our sales launch targeted for the beginning of 2020.

Thank you for your continuing support of Immunovia.

Mats Grahn CEO, Immunovia AB

Important events

Important events in the first quarter of 2019 Immunovia has eliminated unforeseen variability in the test algorithm performance by consistent and optimal protocols.

As Immunovia previously announced in August 2018, the combination of retrospective samples from different biobanks, with varying sample collection procedures and storage, introduced unforeseen variability in the test algorithm performance. The distorting effect caused by the variability in blood sampling was eliminated by consistent and optimal protocols. During the first quarter 2019 it was also concluded that for optimal performance of the test, the samples should be stored for a maximum of 24 months from the testing period. The step of gaining these fresh samples has pushed out the previously communicated timeline for the optimizing study by about eight weeks which will impact the start of sales early 2020.

Important events after the end of the first quarter of 2019

Immunovia and University College of London have signed an agreement to extend validation studies of IMMray™ PanCan-d for early signs and symptoms. Professor Stephen Pereira and his team at the institute for Liver and Digestive Health, University College London (UCL) will extend the prospective collection of blood samples funded by Immunovia and that started with the PanSYM-1 pilot study. The pilot PanSYM-1 study at UCL that started in 2017 is scheduled for

readout in 2019 and will now support the continuation of PanSYM-1 as a prospective validation study. The continued PanSYM-1 study aims to demonstrate the diagnostic value of IMMray™ PanCan-d in detecting PDAC (pancreatic ductal adenocarcinoma) earlier than the current standard.

Consolidated financial results for January-March 2019

Net sales

Net sales for the first quarter of 2019 were SEK 66 thousand (112 k). Net sales principally comprise royalties.

Capitalization of costs for the first quarter of 2019 were SEK 5.9 million (6.2 m). Capitalization development costs are financed through approved and paid grants, the reported amounts are reduced by a comparable amount. No grants for development were received during the first quarter 2019.

Earnings

The net loss for the first quarter of 2019 was SEK 26.4 million (17.3 m).

The net loss for the first quarter of 2019 increased due to higher costs, relating to organizational enlargement, increased marketing activity and costs for set-up of prospective activities. Other external costs and personnel costs increased by a total of SEK 7.6 million compared with the previous year and resulting in SEK 31.0 million in the first quarter of 2019.

Research and development

Research and development is going as planned. The total cost of research and development in Q1 2019 was SEK 7.6 million (6.2 m), which corresponds to 18% (26%) of the Group's total operating costs.

The decline in R&D activity is mainly due to a comparative increase in other activities, such as marketing costs and the implementation of prospective studies.

Financial position and cash flow

Cash flow for Q1 2019 from operating activities amounted to SEK –14.3 million (–14.9 m). Cash and cash equivalents as at 31 March 2019 amounted to SEK 359.8 million (167.8 m).

Shareholders' equity at the end of the period was SEK 434.8 million (219.4 m) and the equity ratio was 89% (94).

Management believes that there is sufficient working capital to meet working capital needs, given the current business and development plan, for approximately 2 years going forward.

Investments

In Q1 2019 intangible assets were acquired for SEK 7.1 million (7.0 m), consisting of capitalized development expenditure for SEK 5.9 million (6.2 m) and patents for SEK 1.1 million (0.7 m).

Investments in tangible assets in the form of inventories were made during the Q1 2019 amounting to SEK 3.4 million. For the corresponding period last year the total was SEK 2.8 million.

Employees

The number of employees in the Group during Q1 2019 averaged 45 (36) and at the end of the period the number of full-time employees were 46.

Share information

Since 3 April 2018, Immunovia's shares have been listed on Nasdaq Stockholm's primary market (Mid Cap) under the IMMNOV ticker.

Subscription warrants scheme

Immunovia has four outstanding warrants schemes covering 340,650 warrants entitling to subscription of 340,650 shares. There will be no dilution as long as the Group's earnings are negative. For more information about he warrants, see page 6.

Share data

At the end of the reporting period the total number of shares was 19,531,353. The nominal value of each share is SEK 0.05.

The ten largest shareholders as of 31 March 2019
Share
No. of capital
Name shares and votes
Carl Borrebaeck 1,709,900 8.75%
Ålandsbanken, on behalf of the owner 1,622,446 8.31%
Handelsbanken Svenska Småbolag 1,050,000 5.38%
Sara Andersson Ek 888,950 4.55%
Per Mats Ohlin 888,950 4.55%
Christer Wingren 832,825 4.26%
Vincent Saldell 726,163 3.72%
Försäkringsbolaget Avanza Pension 583,283 2.99%
Swedbank Robur Folksams LO Sverige 500,000 2.56%
Mats Grahn 413,039 2.11%
10 largest owners 9,215,556 47.18%
Others 10,315,797 52.82%
Total 19,531,353 100.00%
Share capital development
Year Event Total share
capital (SEK)
Change (SEK) Total no. of
shares
Change
in shares
Nominal
value (SEK)
24 May 2007 Formation 100,000.00 100,000.00 1,000,000 1,000,000 0.10
19 Oct 2011 New share issue 105,263.00 5,263.00 1,052,630 52,630 0.10
27 Oct 2011 Share split 5:1 105,263.00 - 5,263,150 4,210,520 0.02
5 July 2012 New share issue 108,869.92 3,606.92 5,443,496 180,346 0.02
21 May 2013 New share issue 122,483.76 13,613.84 6,124,188 680,692 0.02
10 Sept 2013 New share issue 124,899.76 2,416.00 6,244,988 120,800 0.02
5 May 2014 New share issue 220,924.32 96,024.56 11,046,216 4,801,228 0.02
13 Aug 2015 Bonus issue 552,310.80 331,386.48 11,046,216 - 0.05
17 Dec 2015 New share issue 714,560.80 162,250.00 14,291,216 3,245,000 0.05
15 Sept 2016 New share issue 823,728.40 109,167.60 16,474,568 2,183,352 0.05
17 Oct 2016 New share issue 840,202.95 16,474.55 16,804,059 329,491 0.05
4 Oct 2017 New share issue via warrants 865,902.95 25,700.00 17,318,059 514,000 0.05
8 June 2018 New share issue 974,042.65 108,139.70 19,480,853 2,162,794 0.05
19 Sept 2018 New share issue via warrants 976,567.65 2,525.00 19,531,353 50,500 0.05
At end of period 976,567.65 19,531,353 0.05

Incentive schemes

Warrants

The Annual General Meeting held on 3 May 2018 resolved to offer a warrants scheme (series 2018/2021) to employees and key persons in the company. The warrants (156,150) can be used to subscribe for newly issued shares of the Company during the utilization period from 7 September 2021 to 7 October 2021. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 271.05 per share. Full utilization would increase the company's share capital by SEK 7,739.50.

The Annual General Meeting held on 25 April 2017 resolved to offer a warrants scheme (series 2017/2020) to employees and key persons in the company. The warrants (61,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2020. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 205.00 per share. Full utilization would increase the company's share capital by SEK 3,050.

The Annual General Meeting held on 30 May 2016 resolved to offer a warrants scheme (series 2016/2019) to employees and key persons in the company. The warrants (123,500) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2019. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 82.90 per share. Full utilization would increase the company's share capital by SEK 6,175.

The Annual General Meeting held on 1 June 2015 resolved to offer a warrants scheme (series 2015/2018) to employees and key persons in the company. The warrants (47,000) can be used to subscribe for newly issued shares of the Company during the period from registration of the decision until 15 October 2018. 10,000 warrants have been exercised, therefore 37,000 warrants remain for subscription. Each warrant entitles the holder to subscribe for one share at a subscription price of SEK 13.50 per share. Full utilization would increase the company's share capital by SEK 1,850.

The Annual General Meeting held on 3 May 2018 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2018/2021 scheme was not applicable for various

reasons. Such an incentive scheme has been introduced for employees and key individuals and is designed so that the economic effects correspond to the terms of the 2018/2021 options scheme. The total cost for the company can be at most USD 250,000.

The Annual General Meeting held on 25 April 2017 resolved to introduce an alternative cash-based incentive scheme for key individuals in countries where allocation of warrants in accordance with the 2017/2020 scheme was not applicable for various reasons. Such an incentive scheme has been introduced for 6 key individuals and is designed so that the economic effects correspond to the terms of the 2017/202 options scheme. The total cost for the company can be at most USD 920,000.

The warrants are subject to customary recalculation terms in connection with share issues, etc.

Accounting principles

The Group applies the Swedish annual accounts act and International Financial Reporting Standards (IFRS) as adopted by the EU, and RFR 1 complementary accounting rules for Groups when preparing financial reports. The parent company applies the Swedish annual accounts act and RFR 2 Accounting for legal entities when establishing financial reports. The applied accounting principles are in agreement with the information in the 2017 annual report. From 1 January 2019, the Group is applying IFRS 16 Leases.. Otherwise, the applied accounting principles are consistent with those applied in the 2018 annual report.

This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting.

IFRS 16 Leases

IFRS 16 Leases is effective from 1 January 2019. Immunovia has applied the simplified transition method, which means that comparatives have not been restated. The lease liability consists of the discounted remaining leasing payments as at 1 January 2019. The right-of-use asset for all leases corresponds to the lease liability adjusted for prepaid or accrued lease payments reported in the statement of financial position as at 1 January 2019.

The transition to IFRS 16 has not had any effect on equity. Immunovia applies practical expedients allowed under IFRS 16 for leases where the underlying asset has a low value and for short-term leases, which also include leases that terminate in 2019.

The most significant leases are rental agreements for office premises. The Group's total assets have increased as a result of the inclusion of right-of-use assets and lease liabilities following the introduction of IFRS 16. Under IAS 17, lease payments in the comparative year were reported as other external expenses in the income statement. These have now been replaced by depreciation of the right-of-use asset, recognized as an expense in operating profit/loss, and interest on the lease liability, recognized as a financial expense. The lease payment is apportioned between repayment of the lease liability and payment of interest.

The outstanding lease payments were measured at their present value using Immunovia's incremental borrowing rate, which was 4 percent.

The following adjustments to the Group's balance sheet as at 1 January 2019 have been made.

SEK thousands
Property, plant & equipment, right-of-use assets 36,067
Current receivables, prepaid expenses –610
35,457
Non-current interest-bearing liabilities,
lease liability 31,450
Current interest-bearing liabilities, lease liability 4,007
35,457

With regard to the existing leasing portfolio in 2019, Immunovia estimates that depreciation will increase by SEK 4,596 thousand, financial expenses will increase by SEK 1,316 thousand and profit after tax will decline by SEK 589 thousand.

Reconciliation of operating lease obligations under IAS 17 and lease liabilities under IFRS 16

Reconciliation of operating lease obligations

under IAS 17 and lease liabilities under IFRS 16 SEK thousands
-------------------------------------------------- ---------------
Lease liability recognized 35,457
Prepayments -610
Effect of present value measurement -6,325
Total 42,392
Additional extension period 21,806
31 December 2018 20,586
Operating lease obligations,

The Parent Company applies the exception allowed in RFR 2, which means that IFRS 16 is not required to be applied in a legal entity.

New and amended standards adopted with effect from 2019 are not otherwise expected to have any significant impact on the Group's financial position.

Other information

Financial instruments

The Group currently has no financial instruments that are valued at fair value. Instead, all financial assets and liabilities are valued at accrued acquisition cost. It is estimated that there are no significant differences between fair value and book value relating to financial assets and liabilities. The reported value of financial assets on the balance sheet date amounted to SEK 365.2 million (174.9 m).

Transactions with related parties

In addition to salaries and other remuneration to company managers, and fees to Board members, as decided at the annual general meeting, the company has a consulting agreement with CB Ocean Capital AB regarding services performed by Immunovia's chairman and largest shareholder, Carl Borrebaeck. Services provided do not concern information relating to the Board role. Instead the services are to provide the company with scientific and strategic support at scientific presentations and conferences, for example. This agreement runs from 1 January 2018 until further notice with three months notice for both parties. The remuneration per quarter amounts to SEK 41.0 million.

Risks

Immunovia is exposed to financial risks and business risks. The financial risks management and the financial risks are described below. The company's business risks are presented on page 41 of the 2018 annual report. No significant changes have occurred that affect these reported risks.

Market risks

Currency 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 in cash flow

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

Credit risk is the risk that one party to a transaction with a financial instrument fails to meet its obligation. The maximum exposure to credit risk on financial assets as of 31 March 2019 amounted to SEK 365.2 million (174.9 m).

Liquidity Risk

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.

Financial reports

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:

Julie Silber, IR Director, Immunovia AB E-mail: [email protected] Tel +46(0)79 3486277

The company's annual report is available at the company's website: www.immunovia.com

Financial calendar

26 April 2019 AGM

23 August 2019 Q2 2019 interim report 8 November 2019 Q3 2019 interim report 14 February 2020 2019 Financial statement

Telephone conference

29 April at 15:00 (CET)

SE: +46 850558352 BE: +32 26200547 CH: +41 225675632 DE: +49 69222220380 DK: +45 78150109 FR: +33 170750721 NE: +31 207219495 NO: +47 23500236 UK: +44 3333009035 US: +1 6467224956

Financial reports Page
Consolidated income statement, summary 10
Consolidated comprehensive income, summary 10
Consolidated financial position, summary 11
Change in consolidated equity, summary 12
Consolidated key indicators 12
Consolidated cash flow statement, summary 13
Parent company's income statement, summary 14
Parent company's comprehensive income,
summary 14
Parent company's financial position, summary 15
Parent company's cash flow statement, summary 16

In some cases figures have been rounded off, which means tables and calculations will not always appear to be correctly totalled.

Consolidated income statement, summary

SEK thousand Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Operating income, etc.
Net sales 66 112 333
Capitalized work for own account 5,942 6,212 25,052
Other income 51 320 744
Total income 6,059 6,644 26,129
Operating costs
Other external costs –18,985 –14,531 –65,275
Personnel costs –12,057 –8,879 –45,257
Depreciation and amortization of tangible and intangible assets –2,048 –536 –2,777
Other operating expensesr –166 –75 –528
Total operating expenses –33,256 –24,021 –113,837
Operating profit/loss –27,197 –17,377 –87,708
Financial items
Financial income 1,159 51 1,178
Financial costs –343 0 –1
Total financial items 816 51 1,177
Profit/loss after financial items –26,381 –17,326 –86,531
Tax on income –3 0 –7
Profit/loss for the period –26,384 –17,326 –86,538
Earnings per share before and after dilution (SEK) –1.35 –1.00 –4.67
Average number of shares before and after dilution 19,531,353 17,318,059 18,545,795
No. of shares at the end of the period 19,531,353 17,318,059 19,531,353

Consolidated comprehensive income, summary

SEK thousand Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Profit/loss for the period –26,384 –17,326 –86,538
Items that may be later reclassified in the income statement
Exchange rate differences for foreign net investment –740 –104 –593
Other comprehensive income for the period –740 –104 –593
Comprehensive income for the period –27,124 –17,430 –87,131

Consolidated financial position, summary

SEK thousand 31-03-19 31-03-18 31-12-18
ASSETS
Fixed assets
Intangible fixed assets 68,827 43,689 61,786
Tangible fixed assets 1) 51,383 9,654 14,019
Financial fixed assets 3,112 2,802 3,008
Total fixed assets 123,322 56,145 78,813
Current assets
Accounts receivable 0 34 32
Current receivables 7,587 9,795 12,401
Cash and cash equivalents 359,849 167,790 386,136
Total current assets 367,436 177,619 398,569
TOTAL ASSETS 490,758 233,764 477,382
EQUITY AND LIABILITIES
Shareholders' equity
Share capital 977 866 977
Other contributed capital 626,348 314,170 626,348
Translation reserve –1,333 –104 –593
Retained earnings including total comprehensive income –191,163 –95,567 –164,779
Total shareholders' equity 434,829 219,365 461,953
Long-term debt
Interest-bearing liabilities 2) 30,154 0 0
Total long-term debt 30,154 0 0
Current liabilities
Interest-bearing liabilities 2) 4,057 0 0
Other liabilities 21,718 14,399 15,429
Total current liabilities 25,775 14,399 15,429
TOTAL EQUITY AND LIABILITIES 490,758 233,764 477,382

1) Of which right-of-use assets SEK 36,067 thousand. 2) Refers to lease liability.

Change in consolidated equity, summary

SEK thousand Share
capital
Other
contributed
equity
Reserves Retained earnings
including total com
prehensive income
Total
shareholders'
equity
Equity, 1 January 2018 866 314,170 0 –78,241 236,795
Comprehensive income for the period –104 –17,326 –17,430
Equity 31 March 2018 866 314,170 –104 –95,567 219,365
Comprehensive income for the period –489 –69,212 –69,701
Received subscription warrant premiums 936 936
New share issue 111 325,927 326,038
Issue costs –14,685 –14,685
Equity 31 December 2018 977 626,348 –593 –164,779 461,953
Equity, 1 January 2019 977 626,348 –593 –164,779 461,953
Comprehensive income for the period –740 –26,384 –27,124
Equity 31 March 2019 977 626,348 –1,333 –191,163 434,829

Consolidated key indicators

Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Full year
2017
Full year
2016
Operating profit/loss (SEK thousand) –27,197 –17,377 –87,709 –45,520 –14,978
Profit/loss for the year (SEK thousand) –26,384 –17,326 –86,539 –45,232 –14,723
Earnings per share before and after dilution (SEK) –1.35 –1.00 –4.67 –2.67 –0.98
R&D costs (SEK thousand) –7,644 –6,212 –26,048 –24,041 –24,239
R&D costs as percentage of operating costs (%) 19 26 23 34 62
Cash and cash equivalents at end of period 359,849 386,136 192,425 259,094
(SEK thousand) 167,790
Cash flow from operating activities (SEK thousand) –14,262 –14,884 –84,111 –46,525 –11,867
Cash flow for the period (SEK thousand) –26,310 –24,662 193,680 –66,669 183,327
Equity(SEK thousand) 434,829 219,365 461,953 236,795 276,631
Equity per share (SEK) 22.26 12.67 23.65 13.67 16.46
Equity ratio (%) 89 94 97 94 98
Average no. of employees 45 36 39 30 16
Average no. of employees in R&D 17 17 17 16 11

Consolidated cash flow statement, summary

SEK thousand Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Operating activities
Operating profit/loss –27,197 –17,377 –87,709
Adjustment for items not included in cash flow 2,057 253 2,682
Received interest 94 51 319
Paid interest –343 0 –1
Paid tax –3 0 –7
Cash flow from operating activities before changes in operating capital –25,392 –17,073 –84,716
Cash flow from changes in operating capital
Change in operating receivables 4,850 1,762 –840
Change in operating liabilities 6,280 427 1,445
Cash flow from operating activities –14,262 –14,884 –84,111
Investment activities
Investment in intangible assets –7,069 –6,958 –28,230
Investment in tangible assets –3,374 –2,820 –9,056
Investment in financing assets 0 0 –2
Cash flow from investing activities –10,443 –9,778 –37,288
Financing activities
Amortization of lease liability –1,605 0 0
National and European grants for development costs 0 0 2,791
New share issue 0 0 311,352
Received subscription warrant premiums 0 0 936
Cash flow from financing activities –1,605 0 315,079
Cash flow for the period –26,310 –24,662 193,680
Cash and cash equivalents at beginning of period 386,136 192,425 192,425
Exchange rate difference in cash and cash equivalents 23 27 31
Cash and cash equivalents at end of period 359,849 167,790 386,136

Parent company's income statement, summary

SEK thousand Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Operating income, etc.
Net sales 66 112 333
Capitalized work for own account 5,942 6,212 25,052
Other income 51 320 744
Total income 6,059 6,644 26,129
Operating costs
Other external costs –18,368 –13,529 –59,679
Personnel costs –8,811 –6,639 –32,003
Depreciation and amortization of tangible and intangible assets –681 –385 –1,996
Other operating expenses –166 –75 –527
Total operating expenses –28,026 –20,628 –94,205
Operating profit/loss –21,967 –13,984 –68,076
Financial items
Interest income 1,412 111 1,743
Interest costs –2 0 –1
Total financial items 1,410 111 1,742
Profit/loss after financial items –20,557 –13,873 –66,334
Tax on income 0 0 0
Profit/loss for the period –20,557 –13,873 –66,334
Earnings per share before and after dilution (SEK) –1.05 –0.80 –3.58
Average number of shares before and after dilution 19,531,353 17,318,059 18,545,795
No. of shares at the end of the period 19,531,353 17,318,059 19,531,353

Parent company's comprehensive income, summary

SEK thousand Jan-Mar Jan-Mar Full year
2019 2018 2018
Profit/loss for the period –20,557 –13,873 –66,334
Other comprehensive income for the period 0 0 0
Comprehensive income for the period –20,557 –13,873 –66,334

Parent company's financial position, summary

SEK thousand 31-03-19 31-03-18 31-12-2018
ASSETS
Fixed assets
Intangible fixed assets 67,878 43,689 60,868
Tangible fixed assets 11,741 5,035 8,989
Financial fixed assets 303 253 253
Total fixed assets 79,922 48,977 70,110
Current assets
Accounts receivable 0 34 32
Receivables from Group companies 36,754 12,158 29,984
Current receivables 4,356 6,376 8,465
Prepaid costs and accrued income 3,627 3,117 3,843
Cash and cash equivalents 358,779 166,657 385,517
Total current assets 403,516 188,342 427,841
TOTAL ASSETS 483,438 237,319 497,951
EQUITY AND LIABILITIES
Shareholders' equity
Restricted equity
Share capital 977 866 977
Fund for development expenses 45,086 23,095 39,144
Tortal restricted equity 46,063 23,961 40,120
Unrestricted equity
Premium fund 312,178 4,897 312,178
Retained earnings including total comprehensive income 103,953 194,064 130,452
Total unrestricted equity 416,130 198,961 442,630
Total shareholders' equity 462,193 222,922 482,750
Current liabilities
Other liabilities 21,244 14,397 15,201
Total current liabilities 21,244 14,397 15,201
TOTAL EQUITY AND LIABILITIES 483,437 237,319 497,951

Parent company's cash flow statement, summary

SEK thousand Jan-Mar
2019
Jan-Mar
2018
Full year
2018
Operating activities
Operating profit/loss –21,967 –13,984 –68,076
Adjustment for items not included in cash flow 681 384 2,230
Received interest 89 110 306
Paid interest –2 0 –1
Paid tax 0 0 0
Cash flow from operating activities before changes in operating capital –21,199 –13,490 –65,541
Cash flow from changes in operating capital
Change in operating receivables 204 –4,623 –23,826
Change in operating liabilities 4,751 528 1,332
Cash flow from operating activities –16,244 –17,585 –88,035
Investment activities
Investment in intangible assets –7,069 –6,958 –27,341
Investment in tangible assets –3,374 –763 –6,149
Investment in financing assets –50 –253 –253
Cash flow from investing activities –10,493 –7,974 –33,743
Financing activities
National and European grants for development costs 0 0 2,791
New share issue 0 0 311,352
Received subscription warrant premiums 0 0 936
Cash flow from financing activities 0 0 315,079
Cash flow for the period –26,737 –25,559 193,301
Cash and cash equivalents at beginning of period 385,517 192,216 192,216
Cash and cash equivalents at end of period 358,780 166,657 385,517

Board assurance

The Interim report has not been reviewed by the company's auditors.

The Board and the CEO certify that the interim report gives a true and fair view of the company's and the group's operations, position and results, and describes significant risks and uncertainties that the group faces.

Lund, 24 April 2019

Carl Borrebaeck Hans Johansson Chairman Board member

Åsa Hedin Mimmi Ekberg Board member Board member

Christofer Sjögren Ann-Christine Sundell Board member Board member

Mats Grahn CEO

Definitions

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.

Glossary

  • Actionable information Information that is sufficiently authoritative and specific to be used in clinical decision making.
  • Antibodies Antibodies, or immunoglobulins, are a type of protein used by the body's immune system to detect and identify foreign substances such as viruses, bacteria or parasites.
  • Antigen A foreign body substance that elicits a reaction of the immune system in contact with the organism. The substance may be a chemical substance, a protein or a carbohydrate.
  • Autoimmunity Autoimmunity is the immune system's harmful attack on the body's own tissue, which can take the form of disease or rejection of organs during transplantation.
  • Benign If a tumour is benign it means that the tumour is not dangerous and will not spread.
  • Bioinformatics Bioinformatics is an interdisciplinary field in which algorithms are developed for the analysis of biological (especially molecular biology) data.
  • Biomarker A biomarker can be defined as a biological response to a change caused by disease or foreign substance. Biomarkers can be used as early warning signs of biological changes in an organism.
  • Companion Diagnostics Diagnostics tools aimed at identifying which groups of patients will respond well to a particular treatment and thus ruling out ineffective treatments.
  • Discovery Trial Research carried out in order to verify a special hypothesis.
  • Histology Histology is the study of biological tissue.
  • Invasive Invasive means to penetrate or attack. Invasive medical examinations refer to examinations that include any form of penetration through a hole in the body or surgical operation.
  • Malignant Malignant tumours tend to worsen and become mortal. They are termed cancer, and thus differ from benign tumours.
  • Metastasis A metastasis is a tumour that has spread to other organs.
  • Microarray A microarray is a molecular biology test format for simultaneously measuring the relative concentrations of proteins.
  • Molecular Diagnosis A collection of technologies used to analyze biological markers at the genomic and protein levels (ie, the genetic code of individuals and how their cells express their genes as proteins in the body), using molecular biology for medical testing. These technologies are used to diagnose and monitor disease, detect the risk of disease and to determine which treatment is likely to work best for the individual.
  • NSCLC Non Small Cell Lung Cancer, the most common type of lung cancer, 80-85% of all lung cancer cases.
  • Palliative care Palliative care is administered when the patient's disease is beyond the ability to cure. The purpose of palliative care is to provide support to patients and families using both psychological and medical practices.
  • PANDIA-1 Prospective trial for the diabetes risk group of patients aged over 50 recently diagnosed with type-2 diabetes.
  • PANFAM-1 Prospective trial for familiar and hereditary risk groups.
  • Pancreatologist Doctor specialising in diseases relating to the pancreas.
  • PANSYM-1 Prospective trial for early symptom risk groups. Prospective trial – A trial in which a group of individuals is studied and followed often for a long time to see how a particular disease develops. A prospective trial is used to study the relationship between different risk factors and a certain disease. You follow individuals with and without risk factors going forwards over time. At the end of the trial, the proportion of individuals in the two groups who developed disease is compared.
  • Proteomics Proteomics is a branch of biology and includes surveys of large amounts of data about proteins.
  • RA Rheumatoid arthritis, one of the most common autoimmune diseases.
  • RA double negative Patients who have RA, but test negative for it using the current two single-marker standard tests, RF factor and anti-CCP.
  • Reproducibility Within the field of statistics, reproducibility is described as the correlation between results from repeated measurements performed by different observers with different instruments of the same type, which measurements are performed in order to reject any measurement error due to materials and personnel.
  • Retrospective study A study in which the focus is on something that has happened in the past, i.e. using historic data. This form of study starts with the answer, i.e. it is known which individuals became ill and which did not.
  • Screening Screening refers to medical examinations to identify a disease. It is normally carried out before the patient has exhibited obvious symptoms.
  • Self-pay customers Patients or organizations that pay without reimbursement from insurance companies or authorities.
  • Sensitivity Sensitivity is a statistical measure of the reliability of a binary diagnostic test and the probability that a generated positive result is correct.
  • Serum A serum is a transparent yellowish liquid obtained by allowing the blood to clot, and then removing the blood cells and the coagulation proteins. Serum contains proteins, including antibodies.
  • SLE (Systemic Lupus Erythematosus) SLE is an autoimmune inflammatory disease which means that the immune system attacks the body. The symptoms come and go in cycles, sometimes the patient is sick and sometimes has no sickness at all. Usually it is the joints, skin, blood and kidneys which become inflamed, but also the nervous system, lungs and heart can be affected. The disease is currently difficult to diagnose and is often confused with other autoimmune diseases.
  • Specificity Specificity is a statistical measure of the reliability of a binary diagnostic test and the probability that the generated negative result is de facto negative.
  • Vinnova Vinnova is a Swedish government agency under the Ministry of Industry which aims to promote sustainable growth by improving conditions for innovation and by funding needs-driven research.

Immunovia in brief

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.

Pancreatic cancer

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.

Goals

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.

Strategy

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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