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2021-08-31

Intervacc: Interim report January - June 2021

The period in summary

First half year January 1 - June 30, 2021

  • On June 17th the Committee for Medicinal Products for Veterinary Use (CVMP) at the European Medicines Agency (EMA) adopted a positive opinion, recommending approval of Strangvac within the EU.
  • On April 12th Intervacc announced an exclusive distribution agreement with Dechra Pharmaceuticals PLC, to commercialize Intervacc's leading vaccine candidate Strangvac in Europe, excluding the Nordic and Baltic countries where Intervacc will market and sell Strangvac directly.
  • The study "Globetrotting strangles: the unbridled national and international transmission of Streptococcus equi between horses" was published in the scientific journal Microbial Genomics in the beginning of March. In the study researchers from 18 countries mapped the transmission of the bacterium Streptococcus equi with the help of DNA sequencing. The study shows how strangles spreads globally via the transport of horses that have recovered from strangles, but remain persistently infected, so-called silent carriers.
  • The contract with the Karolinska Institute, KI, was extended for three years. Thus, we will continue the very successful collaboration with KI and the Swedish University of Agriculture (SLU).

Figures in brackets indicate outcome for the corresponding period of the previous financial year. The financial information presented relates to the Group and is expressed in TSEK unless otherwise stated.

Group key ratios

01/04/ 01/04/ 01/01/ 01/01/20 Full year
21 20 21
-30/06 -30/06 -30/06 -30/06/20 2020
/21 /20 /21
Net sales 1 787 1 571 2 903 2 666 4 780
Operating result -6 -5 -12 -12 104 -25 676
145 786 297
Result after -6 -5 -12 -12 105 -25 601
financial items 152 794 330
Balance sheet total 340 367 340 367 601 355 282
973 601 973
Equity ratio 95% 96% 95% 96% 95%

Number of shares 50 50 50 50 124 463 50 160 388
outstanding end of 160 124 160
period 388 463 388
Average number of 50 44 50 43 858 327 47 008 659
shares before 160 423 160
dilution 388 964 388
Average number of 50 44 50 43 967 871 47 141 055
shares after dilution 415 533 407
427 508 007
Earnings per share -0,12 -0,13 -0,25 -0,28 -0,54
before dilution
Earnings per share -0,12 -0,13 -0,25 -0,28 -0,54
after dilution

Net Sales

Net sales during the first half year of 2021 amounted to SEK 2.9 million, which is slightly better than the same period in 2020 (2.7) and for the second quarter net sales amounted to SEK 1.8 million (1.6). The new products in the distribution portfolio have been established and the company will continue to launch more products, primarily in the Swedish market.

Earnings

Operating result for the first half year of 2021 amounted to SEK -12.3 million, which is 0.2 worse compared to the same period in 2020 (-12.1). Operating result for the second quarter 2021 amounted to SEK -6.1 million, which is 0.3 worse compared to the same period in 2020 (-5.8). The negative operating result is mainly explained by the fact that the Group does not generate sufficient funds from its own operations to finance the vaccine development.

Cash Flow

During the second quarter of 2021, SEK 5.2 million (2.6) was invested in the development of Strangvac and for the first half year the investment was SEK 9.6 million (5.9) which is mainly due to the regulatory phase with the application for approval to the European Medicines Agency, EMA. Cash flow during the second quarter of 2021 has meant that cash and cash equivalents has decreased with SEK 7.7 million and amounted to SEK 141.3 million (179.7) on the balance sheet date.

Financial position

At the end of the first half year 2021 equity amounted to SEK 325.3 million, which compared to the same date last year is a decrease with SEK 26.3 million. Approx. 47% (39%) of the group's total assets has been invested in capitalized expenditure which at end of second quarter 2021 amounts to SEK 158.9 million (144.9). Cash, which at end of second quarter 2021 amounts to SEK 141.3 million, are greatly affected by the investments made in research and development, where our new and ongoing projects become more and more essential. It also includes, for example, the upcoming regulatory process with the USDA (US Department of Agriculture). The company is well equipped for continued commercialization and vaccine development.

CEO Comments

Strangvac is approved for sale in Europe

On the 17th of June, the European Medicines Agency, EMA, gave a positive opinion on Strangvac, and just under two months later, the European Commission granted a marketing authorization. In early June, the Veterinary Medicines Directorate, VMD, in the United Kingdom also issued a positive outcome for the use of Strangvac and a formal approval from the UK is expected in September.

Equine strangles is a dreaded infectious disease that causes great suffering to horses and forces horse owners to take resource-intensive, often costly measures in the form of isolating horses and shutting down activities for several weeks or months in the event of an outbreak. The interest and support for Strangvac throughout the equine community is fantastic and we feel a great responsibility to maximise the health benefits it can bring to the ~6 million horses in Europe.

This is the first time that a Swedish company has received EU approval for a veterinary vaccine via EMA's central procedure. In addition to the European Union Iceland, Norway, and Lichtenstein, also base their local approvals on the recommendation from EMA. It is a historic moment.

The approval of Strangvac, a vaccine based on recombinant fusion proteins, which protects against the complex bacterial infection caused by Streptococcus equi, is also great news for the technology itself. It is a breakthrough for vaccine design and highlights that the same approach can be used to develop vaccines against other complex bacterial infections.

At the beginning of the second quarter, we and Dechra Pharmaceuticals signed a distribution agreement that gives Dechra the exclusive right to sell and market Strangvac in Europe, excluding Scandinavia and the Baltics. Dechra is one of the world's ten largest companies in animal health and have a particularly strong position in the equine segment. In Europe, they are, according to our calculations, fourth in the equine pharmaceutical segment with the ambition to grow further. Dechra's growth ambitions are backed by their historic progress and fit well with our goal to establish Strangvac as one of the most widely used equine vaccines.

Horses are a very important part of many people's lives and a passion that more and more people are discovering. During the pandemic, this interest has grown further, and we have seen a corresponding increased interest in the welfare of horses. We have excellent contacts throughout the European veterinary and research community as well as with organizations who work to improve the health and well-being of horses. Ahead of its launch, we will now work to establish guidelines and recommendations for the vaccination of horses with Strangvac[®]. This is work that takes place both locally and at the European level. Together with Dechra, we will increase knowledge of Strangvac within the veterinary profession through information and training initiatives. We are confident that the vaccine is already anticipated keenly and will be very well received.

Following the announcement of approval by the European Commission, we are translating information on Strangvac into local languages and printing materials such as boxes, labels, and package leaflets. Filling of new vaccine vials was conducted during the summer by our production partner in Spain and we will send EMA data from these batches during the autumn.

Demand for critical production material for vaccine manufacturing is high and the global logistics chain is strained due to covid-19. We will undertake a responsible launch during the fourth quarter of this year where we will ensure that we can meet the demand in the countries where we first launch.

We believe that the demand for our new vaccine against equine strangles will be high and our assessment is that the use of strangles vaccines will eventually be on a par with the most widely used equine vaccines that protect against influenza virus.

We believe that Strangvac will be an important tool, which together with other infection control measures, has the potential to reduce the prevalence of this disease. One other important piece of the puzzle in the fight against equine strangles is the availability of reliable tests, and therefore we have ensured that the diagnostics market continues to have access to reliable tests for equine strangles. During the summer, we manufactured the first batch of antigens in Uppsala for use in equine strangles ELISA tests. The test kit itself is manufactured in the UK for global use. The income from producing these antigens is not very significant for Intervacc, but the availability of reliable equine strangles tests to minimise the transmission of Streptococcus equi and identify when a vaccinated horse has been protected from disease following natural exposure to this bacteria is strategically important to us.

We are also working on the regulatory side to obtain approval for Strangvac in more regions, and applications for use in the USA, Canada and Australia will follow Europe. The basis for our application to EMA is extensive and much can be reused. For the approval process in North America, we anticipate that we will need to conduct local studies.   

In parallel with everything fantastic and exciting that is happening with Strangvac, our pre-clinical research projects are generating promising results. The positive results give us reason to continue with confidence in both our project to develop a vaccine against Streptococcus suis that affects piglets and against Staphylococcus aureus infections in dairy cows that causes mastitis.

In this half-year report, you will find a copy of the European Commission's approval of Strangvac. There are very few who work with vaccines who get to experience an approval during their career, and we are very grateful to be on this fantastic journey. My copy is framed on the wall, and I expect several more framed approvals of our new vaccines, and of Strangvac in other regions, to be placed alongside over the coming years.

This is only the beginning!A big thank you to all employees, partners, and shareholders!

Feel free to follow our news on the website and via our twitter feed @intervacc_se

Andreas Andersson, CEO

Significant events during the period January 1 - June 30, 2021

Intervacc received positive CVMP opinion for Strangvac in the EU

On June 17[th] the Committee for Medicinal Products for Veterinary Use (CVMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending approval of Strangvac within the EU. Strangvac is a vaccine against equine strangles, a highly contagious infectious disease that affects horses globally....

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