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Intervacc

Intervacc

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Intervacc: Year-end report January - December 2021

08:30 / 18 February 2022 Intervacc Press release

The period in summary

January 1 - December 31, 2021

-      The European Commission granted in August a Marketing Authorisation for Strangvac within the European Union. During September the Veterinary Medicines Directorate (VMD) of the United Kingdom also granted a Marketing Authorisation for Strangvac within the UK.

-      In April Intervacc announced an exclusive distribution agreement with Dechra Pharmaceuticals PLC, to commercialize Strangvac in Europe, excluding the Nordic and Baltic countries where Intervacc will market and sell Strangvac directly.

-      Intervacc was during the autumn granted a patent in the United States for a vaccine against infections caused by Streptococcus suis.

-      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.

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

01/10/21 01/10/20 Full year Full year
-31/12/21 -31/12/20 2021 2020
Net sales 1 068 943 5 241 4 780
Operating result -8 798 -7 163 -29 393 -25 676
Result after -8 729 -7 094 -29 375 -25 601
financial items
Balance sheet total 329 393 355 282 329 393 355 282
Equity ratio 94% 95% 94% 95%

Number of shares 50160388 50 160 388 50 160 388 50160388
outstanding end of
period
Average number of 50160388 50 160 388 50 160 388 47008659
shares before
dilution
Average number of 50391330 50359877 50404133 47141055
shares after dilution
Earnings per share -0,17 -0,14 -0,59 -0,54
before dilution
Earnings per share -0,17 -0,14 -0,59 -0,54
after dilution

Net Sales

Net sales during the last quarter of 2021 amounted to SEK 1.1 million, which is on a par with the same period 2020 (0.9). For the calendar year 2021 net sales increased with approx. 0.5 million SEK from 4.7 million SEK during 2020 to 5.2 million SEK. The new products in the distribution portfolio have been established and the company will continue to launch more products, primarily in the Swedish market, and the company's first in - house developed product, Strangvac, is scheduled to be launched during first quarter 2022.

Earnings

Operating result for last quarter of 2021 amounted to SEK -8.8 million, which is 1.6 million worse compared to the same period in 2020 (-7.2). Operating result for the calendar year 2021 amounted to SEK -29.4 million, which is 3.7 million worse compared to 2020 (-25,7). 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 last quarter of 2021, SEK 6.9 million (2.5) was invested in the development of Strangvac and for calendar year 2021 the investment was SEK 22.0 million (10.4) which is mainly due to the regulatory phase with the application for approval to the European Medicines Agency, EMA. Cash flow during the last quarter of 2021 has meant that cash and cash equivalents has decreased with SEK 12.6 million and amounted to SEK 115.7 million (164.2) on the balance sheet date.

Financial position

At the end of 2021 equity amounted to SEK 308.3 million, which compared to the same date last year is a decrease with SEK 29.4 million. Approx. 52% (42%) of the group's total assets has been invested in capitalized expenditure which at end of 2021 amounts to SEK 171.3 million (149.3). Cash, which at end of 2021 amounts to SEK 115.7 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 sales launch during the first quarter of 2022 and application for approval in the U.S. submitted

We are on-track to launch Strangvac during the first quarter, with sales planned to commence in Sweden followed by our distribution partner Dechra Pharmaceuticals launching in Europe. We have succesfully produced vaccine doses and will continue to do so on an ongoing basis. During the autumn and winter we conducted a series of meetings with leading veterinarians around Europe to discuss Strangvac and how the vaccine can be used in the fight against Strangles. The interest has been great and the response fantastic. We are regularly contacted by veterinarians and horse owners who want to buy Strangvac and our own, and Dechra's, sales teams are ready and eager to go.

In February, we formally started the application process for a Permit for Sale and Distribution in the U.S. regarding Strangvac. The number of horses in the United States is estimated at 10 million. Authorization to sell and market vaccines for the use in animals in the United States are handled by the Center for Veterinary Biologics, CVB, which is part of the U.S. Department of Agriculture, USDA. The dossier is similar to what is required by EMA and we are well equipped for the process. We have help from local experts that are very experienced in the U.S. application process for veterinary vaccines. As in the European process, the authority will evaluate Strangvac on the basis of production, safety and efficacy. It is still too early for us to say how long the process will take, but we are confident that Strangvac will be approved in the U.S. as well.

We have applied for additional protection for Strangvac in the United Kingdom, Sweden, the Netherlands, Italy, Ireland, France, Spain, Germany and Austria. A Supplementary Protection Certificate (SPC) is an intellectual property right that extends the protections provided by a patent and will, after approval, be effective up to and including May 2036. However, we do not expect anyone to receive approval for a biosimilar vaccine even after patents and supplementary protection expire. In the chemical pharmaceutical industry, generics are common, but they are much rarer for biological drugs (so-called biosimilars) and we are not aware of any approved vaccine biosimilars. Our assessment is that Strangvac will be the leading vaccine against equine Strangles globally and will continue to be so long after patents and supplementary protection have expired. There is a similar system in place in the U.S. which means that we can extend the protection there as well, after official approval of Strangvac.

In January this year, the British 'Equine Veterinary Journal' published a new comprehensive scientific study which shows that the protective antigens included in Strangvac have a very high similarity between all studied strains of Streptococcus equi. The study examined strains from outbreaks in 19 countries around the world, including outbreaks in the United States. This means that Strangvac likely protects against all known strains of equine strangles in horses. We aim to reach the global market and to make Strangvac available to the world's approximately 60 million horses. The study strengthens our position and can potentially also simplify the regulatory work when we apply for market permits for countries outside Europe. Our goal is that Strangvac becomes the leading equine strangles vaccine and the most widely used equine vaccine in the world.

Vaccines are given to prevent infectious diseases and rigorous requirements are enforced to ensure the protective effect, safety and quality of approved products. Vaccination is one of the most effective medical measures to prevent infectious diseases and works by stimulating and preparing the body's immune system. When the body is then exposed to infection, the immune system can quickly fight the infection. This does not mean that the protective effect is 100 percent, and there may still be a risk of becoming ill. It is therefore important to vaccinate a large proportion of the population to limit the spread of infection. This enables the vaccine to be beneficial in two ways, through strengthening your own immune system and by reducing the risk of being infected by others.

Vaccination with Strangvac provides good protection, especially after a re-vaccination with a so-called booster where published studies showed a very high protective effect (94% of vaccinated horses in the study did not show any symptoms). In cases where horses became infected despite vaccination, the symptoms were usually milder with, among other things, a slower onset of signs and a reduced incidence of abscesses. Therefore, vaccination with Strangvac is likely to greatly reduce the spread of equine strangles in populations where many horses are vaccinated.

Traditional infection control measures together with vaccination work together to reduce the spread of infection. Equine strangles is a highly contagious disease and it is important to use all available tools to effectively combat such a serious and contagious disease. In February 2022, the #smittfrittstall (no-contamination-stables) campaign was launched in Sweden where the state veterinary institution, SVA, together with a dozen equestrian organizations produced messages and material on how all of us who work with horses can work together to keep stables free from the common, serious and contagious equine diseases - equine strangles, virus abortion, and equine influenza. Vaccination is highlighted as one of the important measures.

We continue to make progress in our project to develop a vaccine against Staphylococcus aureus infections in dairy cows and our project to develop a vaccine against Streptococcus suis infections in swine. The projects are progress according to plan.

We are in an exciting and intense period. We have very experienced, dedicated employees and partners who make exceptional contributions. Vaccines are in focus and there are many indications that we are entering an era where vaccines will play a major role in our lives. The authorities' initiative to reduce the use of antibiotics is becoming clearer and in Europe the goal is to reduce the use of antibiotics in animal health by at least 50% during the period 2020 to 2030. On January 28th this year, the EU banned the use of antibiotics in healthy animals. It is good that antibiotic rules in animal health have now been tightened both for animal husbandry in the EU and for the food products we import. Reduced antibiotic use is necessary for antibiotics to remain an effective treatment and for the rate of development of antibiotic-resistant pathogens to decrease. With reduced antibiotic use, the need for vaccines increases further. Modern research and technology make it possible to develop vaccines against pathogens that have previously been difficult to target. Intervacc has an important role here. We are at the forefront of developing vaccines against bacterial infections and Strangvac is a shining example of this.
  • Strangvac is approved in Europe and is on-track for sales launch during the first quarter of 2022. The reception of Strangvac from leading veterinarians has been very positive.
  • The application process for market approval for Strangvac in the U.S. has begun.
  • We have a strong financial position, with over SEK 100 million in cash, no loans and good cost control.

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 October 1 - December 31, 2021

Sales launch of Intervacc vaccine against equine Strangles during Q1 2022

Intervacc announced during December that sales of the company's Strangles vaccine Strangvac is planned to begin in the first quarter of 2022. The vaccine against a widespread and common infectious disease equine strangles, which affects horses globally, was granted marketing authorization for the European Union in the autumn, followed by approvals for the United Kingdom, Norway and Iceland.

U.S. patent approval for Intervacc's vaccine against infections caused by Streptococcus suis

The United States Patent and Trademark Office has granted an approval for Intervacc's patent application in the United States for a vaccine against Streptococcus suis infections. The U.S. Patent No. 11,155,585 relates to a vaccine based on recombinant fusion proteins where patent protection is effective until 2037.

Nomination Committee appointed in respect of AGM 2022 in Intervacc

The composition of the Nomination Committee in respect of the annual general meeting 2022 was established during November. The Nomination Committee consists of the following persons who together represent approximately 21 percent of the number of shares and votes in the company based on the last known shareholder information at the end of 2021.
  • Ulrika Enhörning, appointed by Swedbank Robur Fonder
  • Lotta Sjöberg, appointed by Handelsbanken Fonder
  • Thomas Ehlin, appointed by Fjärde AP-fonden
  • Björn Sjöstrand, the Chairman of the Board

Significant events after the period

New study confirms that Strangvac is likely to be effective against all known strains of Streptococcus equi

In the largest study of its kind, published in the `Equine Veterinary Journal', scientists confirm that the antigens used in the Strangvac vaccine were highly conserved regardless of which strain of Streptococcus equi was examined from outbreaks in 19 countries around the world.

Intervacc has applied for supplementary protection certificates for Strangvac in key European markets

The European patent for Strangvac, a vaccine against equine strangles, is approved and in force until May 2031. Pending the approval of the supplementary protection certificates, the protection in Great Britain, Sweden, the Netherlands, Italy, Ireland, France, Spain, Germany and Austria will be extended until May 2036.

Intervacc applies for a Permit for Sale and Distribution of Strangvac in the U.S.

On February 16th Intervacc announced that the Company's application for a Permit for Sale and Distribution of Strangvac in the U.S. has been submitted to the U.S. Department of Agriculture (USDA).

Certified adviser

Eminova Fondkommission is Intervacc'sCertified Adviser and is responsible for the company's compliance with Nasdaq First North Growth Markets regulations.

Eminova Fondkommission AB
Biblioteksgatan 3, 3 tr.
114 46 Stockholm
Tel: +46 8 684 211 10
adviser@eminova.se

Dividend

The Board of Directors proposes that no dividend be paid.

Dates for upcoming reports

May 20, 2022 Interim report Q1 January 1 - March 31, 2022
August 31, 2022 Interim report Q2 January 1 - June 30, 2022
November 10, 2022 Interim report Q3 January 1 - September 30, 2022
February 17, 2023 Year-end report January 1 - December 31, 2022

Annual report 2021 will be published on April 6, 2022 on the company's website.

Annual General Meeting

Annual General Meeting 2022 will take place on June 14, 2022.

Contact information

Andreas Andersson, CEO

Phone: +46 (0)8 120 10601, Cell: +46 (0)73 335 99 70

E-mail: andreas.andersson@intervacc.se

The full year-end report for the period January - Deptember 2021 is attached to this press release and is available on the company's website www.intervacc.se/investors/reports.

This information is information that Intervacc AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CET on February 18, 2022.

About Intervacc

Intervacc AB is a Swedish company within animal health developing safe, effective vaccines for animals. The Company's vaccine candidates are based on research at Karolinska Institutet and Swedish University of Agricultural Research where the foundation was laid for the Company's research and development work. The Intervacc share has been listed on the Nasdaq First North Growth Market since April 2017.

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