Year-end report January – December 2020

The period in summary

January 1 – December 31, 2020

  • Our marketing authorization application for Strangvac® was submitted to the European Medicines Agency, EMA, at the end of February 2020. After having received the Day 120 questions from EMA we have strengthened the dossier. We are on track and are planning for a positive opinion from EMA during the second quarter 2021.
  • On June 16, a directed share issue of approximately 6.5 million shares was carried out, raising gross proceeds of approximately SEK 147 million.
  • We focus on the preparations for the launch of Strangvac®, which includes a distribution partner for Europe, outside regions where we distribute ourselves.
  • We continue renewing the product portfolio within our Nordic distribution operations and launched a new product from Syva s.a. during the autumn.
  • We strengthen the organization and during the period Ed Torr and Niels Holck, both with extensive experience from the international animal health business, were elected as new members of the Board of Directors. Dr. Andrew Waller, an international leading scientist within the fields of bacterial infections and equine strangles, joined as new Chief Scientific Officer. Emma Hartman was appointed to the role as global product manager with responsibility for launching Strangvac®. Emma comes most recently from MSD Animal Health, where she worked as product manager. Astrid Larberg was recruited to the role as quality assurance manager. Astrid joins us from AstraZeneca and is not only a biologist and quality expert but also a trained veterinarian.
  • Positive results from Strangvac clinical trials were published in the journal Vaccine.

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

01/10/20

01/10/19

Full year

Full year

-31/12/20

-31/12/19

2020

2019

Net sales

943

1 079

4 780

12 139

Operating result

-7 163

-7 829

-25 676

-27 848

Result after financial items

-7 094

-7 851

-25 601

-27 892

Balance sheet total

355 282

237 067

355 282

237 067

Equity ratio

95%

93%

95%

93%

Number of shares outstanding end of period

50 160 388

43 292 690

50 160 388

43 292 690

Average number of shares before dilution

50 160 388

43 292 690

47 008 659

39 228 377

Average number of shares after dilution

50 359 877

43 524 383

47 141 055

39 336 557

Earnings per share before dilution

-0,14

-0,18

-0,54

-0,71

Earnings per share after dilution

-0,14

-0,18

-0,54

-0,71

Net Sales

Net sales during the fourth quarter of 2020 amounted to SEK 0.9 million, which is a decrease of SEK 0,1 million compared to the same period in 2019. For the fiscal year 2020 the sales decrease is approx. SEK 7.3 million, from SEK 12.1 million during 2019 to SEK 4.8 million during 2020. The lower sales are mainly due to that the new products in the distribution portfolio are in a launch and establishment phase.

Earnings

Operating result for the fourth quarter of 2020 amounted to SEK -7.2 million, which is a increase of SEK 0.6 million compared to the same period in 2019 (-7.8). For 2020 the operating result is approx. SEK -25.7 million, which is approx. SEK 2.1 million better than during last year (-27.8). 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

The directed share issue in June together with the use of employee stock options and warrants from the incentive programs from 2017 during May and July has increased available cash with net approx. SEK 143.4 million. During 2020 SEK 10.4 million have been invested in Strangvac capitalized expenditure which is a decrease with SEK 28.2 million compared to same period during 2019 (SEK 38.6 million). Cash flow during fourth quarter has meant that cash has decreased with SEK 7.4 million and amounts to SEK 164.3 at the end of 2020.

Financial position

At the end of 2020 equity amounted to SEK 337.6 million, which compared to the same date last year is an increase with SEK 117.8 million. Approx. 42% (59%) of the group’s total assets has been invested in capitalized expenditure which at end of 2020 amounts to SEK 149.3 million. Cash, which at end of 2020 amounts to SEK 164.3 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), and technology transfer for the US market. The company is well equipped for continued commercialization and vaccine development.

CEO Comments

Vaccines in the spotlight

Covid-19 has made a big impact on our daily lives and during the past year, vaccine development, the European Medicines Agency (EMA), regulatory processes and vaccine manufacturing have received a lot of attention. What we work with every day has become interesting for everyone and developing new effective vaccines is very much on the agenda!

We are in an intensive phase of preparations for the market launch of Strangvac®, our vaccine against the equine disease strangles. During the second half of 2020, we worked on the so-called day 120 questions that we received from EMA. We strengthened the dossier where needed and on 12th of January this year we submitted our answers. On January 18th, EMA confirmed that they had received our response and accepted that we had submitted them correctly and on time. The regulatory team, together with our researchers, have done a fantastic job!

On January 19th, the clock re-started at day 121 in the evaluation process. The next stop is day 180, when we expect further constructive interactions with EMA. We are on-track for a positive opinion from EMA during the second quarter of this year after which, the European Commission has up to 67 days to give its formal approval. With that comes the market launch of Strangvac® in Europe. The work of choosing a distribution partner for the countries in Europe where we do not distribute ourselves is steadily progressing. In November, we recruited Emma Hartman in the role of global product manager with responsibility for launching Strangvac®. Emma comes most recently from MSD Animal Health, where she worked as product manager for equine and cattle, and her experience from having worked for one of the largest global suppliers of equine vaccines is very valuable for us. We have been working closely with important key opinion leaders for a long time and through the recruitment of Dr Andrew Waller this summer that network was further strengthened. We have a product, a network, and a team to deliver success!

In parallel with the regulatory work towards approval of Strangvac® in Europe, we are also working to obtain approval to sell Strangvac® in the USA, a market that is approximately 50% larger than the European market. Together with local expertise, we are developing a plan to be shared with the Centre for Veterinary Biologics (CVB), which is part of the United States Department of Agriculture (USDA). The dialogue with CVB will clarify the extent of local studies needed in the US approval process, but it is clear that this process will benefit greatly from the trials and regulatory work we have already completed for our application to EMA.

We already have almost 60,000 doses produced for the launch of Strangvac® and we are planning for further production together with our partners Liof Pharma and 3P Biopharmaceuticals in Spain. An important part of the preparations for vaccine production and distribution is the recruitment of Astrid Larberg in the role of quality assurance manager. She joins us from AstraZeneca and is not only a biologist and quality expert but is also a trained veterinarian. Astrid starts on the first of March and we look forward to welcoming her into the team and the role!

We are making progress in our preclinical trials for new vaccines in addition to Strangvac®. The vaccine projects that are most advanced target infections caused by Streptococcus suis in piglets following weaning, and Staphylococcus aureus which, among other diseases, is an important cause of mastitis in dairy cows. In both projects, we are conducting small-scale trials in the target animal.

The transition of our Nordic distribution operations to new products in strategic segments continues. The pharmaceutical product from Syva that we launched during the autumn in the cattle and pig segments has got off to a good start. The drug for the treatment of hypocalcemia and hypomagnesemia conditions in cattle, for which we are the Market Authorization Holder (MAH), also shows good growth in both Sweden and Denmark. The business is still relatively small, but with good conditions for growth it forms a solid foundation for sales of our in-house developed vaccines. In February 2021, we launched two new products from the AnimalCare Group, both in the dog and cat segment.

Our veterinary laboratory in bacteriology, where we offer services to veterinary clinics around Sweden, showed over 35% growth during the full year. The growth came mainly in the equine segment, which is strategically important to us. The Veterinary Laboratory gives us proximity to our customers, and thanks to the influx of samples we have a direct and reliable source of information to understand how various bacterial infectious diseases develop in animals in Sweden and the potential impact of new vaccines towards improving the health of animals.

2020 was a fantastic year for Intervacc and 2021 will be the year when we launch our first proprietary vaccine, Strangvac®. This is something we are all looking forward to and I would like to take this opportunity to thank all employees, partners and shareholders.

Andreas Andersson CEO

Significant events during the period October 1 – December 31, 2020

Intervacc appointed Emma Hartman as Global Product Manager for Strangvac

Emma Hartman was appointed to the role as global product manager for Strangvac®, a vaccine that is expected to become a game-changer in the fight against the global equine disease strangles. Emma Hartman has a DVM degree and most recently comes from MSD Animal Health, where she held the position as Nordic product manager for equine and ruminant products.

Significant events after the period

Intervacc has submitted Responses to EMA Day 120 Questions

On January 12th Intervacc submitted the responses to the Day 120 questions regarding the Company’s Marketing Authorization Application (MAA) for Strangvac to the European Medicines Agency (EMA). Intervacc is seeking approval for Strangvac® as a vaccine against equine strangles, a highly contagious infectious disease that affects horses globally.

On January 18th EMA accepted the submission and after reviewing the responses, a second list of questions and outstanding issues is expected from the Committee for Medicinal Products for Veterinary Use (CVMP). The Company estimates that it is on track for a positive opinion from the CVMP during Q2 2021.

Certified adviser

Eminova Fondkommission is Intervacc’s Certified 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 21, 2021 Interim report Q1 January 1 – March 31, 2021
September 3, 2021 Interim report Q2 January 1 – June 30, 2021
November 11, 2021 Interim report Q3 January 1 – September 30, 2021
February 18, 2022 Year-end report January 1 – December 31, 2021

 

Annual report 2020 will be published on March 31, 2021 on the company’s website.

Annual General Meeting

Annual General Meeting 2021will take place on June 9, 2021.

Contact information
Andreas Andersson, CEO
Phone: +46 (0)8 120 10 601, Cell: +46 (0)73 335 99 70
E-mail: andreas.andersson@intervacc.se

The full year-end report for the period January – Deptember 2020 is attached to this press release and is available on the company’s website www.intervacc.se.

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, 2021.

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.