On August 24, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first half of 2022 and released its financial calendar for 2023 (Press release, Bavarian Nordic, AUG 24, 2022, View Source [SID1234618611]).
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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "This year we planned to make significant investments for the future growth of Bavarian Nordic, as we moved two late-stage assets that have the potential to meet large unmet medical needs into global Phase 3 trials. While these programs remain on-track we have had to mobilize our entire organization to ensure we concentrate our efforts in the best possible way to manufacture and supply vaccines to help governments around the world combat an unprecedented outbreak of monkeypox. The magnitude of this outbreak was unexpected, however, our long-standing public-private partnership with the U.S. government has ensured that a safe and effective vaccine against monkeypox exists, enabling authorities to respond rapidly to this health crisis. We are making every effort to meet the initial worldwide demand for our monkeypox vaccine and are working diligently to further expand our manufacturing capacity through additional scale-up activities and partnerships.
Despite our heavy investments in R&D, the strong sales performance in all parts of our business during the first six months, together with our projections for the remainder of the year means that we are now nearing a break-even result for 2022, and we see a robust business for the monkeypox vaccine building up beyond 2022."
Financial highlights
Total revenue in first half year was DKK 857 million comprised of DKK 764 million from product sales, DKK 83 million in milestone payments from partners and DKK 10 million from contract work.
Revenue in second quarter totaled DKK 537 million comprised of DKK 234 million from sale of Rabipur/RabAvert, DKK 144 million from sale of Encepur, DKK 117 million from sale of JYNNEOS/IMVANEX/IMVAMUNE, DKK 38 million from sale of third-party products and DKK 4 million from contract work. The majority of the 2022 revenue from sale of JYNNEOS/IMVANEX/IMVANUNE during the second quarter will be recognized in the second half of 2022 in line with the planned deliveries.
EBITDA in first half year was a loss of DKK 212 million.
Strong cash position of DKK 2,753 million at end of first half year 2022
Financial guidance for the full year has been upgraded six times since March 2022 as result of multiple supply contracts being entered since the start of the monkeypox outbreak in May. The most recent guidance, issued on July 18, is maintained at revenues between DKK 2,700 and 2,900 million, EBITDA with a loss between DKK -300 and -100 million and cash and cash equivalents at year-end expected to exceed DKK 1,700 million.
DKK million Q2 2022 Q2 2021 H1 2022 H1 2021 2022 Guidance
Revenue 537 370 857 905 2,700 – 2,900
EBITDA (118) (9) (212) (8) (300) – (100)
Cash and cash equivalents 2,753* 2,207* 2,753* 2,207* > 1,700
* Repo pledged securities deducted.
Other highlights
Smallpox/Monkeypox
In May, the U.S. government exercised an option for manufacturing of freeze-dried JYNNEOS. The option, valued at USD 119 million, represents the first of a set of options with a total value of USD 299 million under a contract awarded in 2017 to convert bulk vaccine, already manufactured and invoiced under previous contracts, to freeze-dried doses.
In May, Bavarian Nordic entered several vaccine supply contracts with governments worldwide in response to the global monkeypox outbreak.
In June, Bavarian Nordic entered a multi-year contract with Canada, valued at USD 56 million, to deliver smallpox vaccines from 2023 and ahead. Bavarian Nordic has worked with the Canadian authorities since 2008 to ensure availability of the vaccine.
In June, the U.S. government ordered 500,000 doses of monkeypox vaccine for delivery in 2022. The vaccines will be filled using existing bulk vaccine already manufactured and invoiced under previous contracts.
In June, Bavarian Nordic entered a contract with the European Health Emergency Preparedness and Response Authority (HERA) to supply monkeypox vaccines to EU member states in 2022.
Respiratory Syncytial Virus (RSV)
In April, Bavarian Nordic initiated a global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults. The trial is planned to enroll approximately 20,000 adults ≥60 years of age and will run through the RSV season 2022/2023 with topline results expected mid-2023.
In June, the European Medicines Agency granted access to its priority medicines (PRIME) scheme for MVA-BN RSV in active immunization for the prevention of lower respiratory tract disease caused by RSV in adults ≥60 years of age. MVA-BN RSV has previously also been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).
ABNCoV2 (COVID-19)
In May, Bavarian Nordic reported additional Phase 2 results for the COVID-19 booster vaccine candidate, ABNCoV2, demonstrating that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects (87%), who were previously vaccinated with approved mRNA or adenoviral vaccines. Neutralizing antibodies reached levels reported to be associated with a high level of protection (>90%), similar to what was previously reported for ABNCoV2 with respect to other variants of concern.
In June, Bavarian Nordic announced an updated design for its Phase 3 trial for ABNCoV2, which will be a non-inferiority trial comparing ABNCoV2 to Comirnaty. The trial will start enrollment in August 2022.
Events after the reporting date
In July, the U.S. government ordered an additional 5 million doses of monkeypox vaccine for delivery in 2022 and 2023. The vaccines will be filled using existing bulk vaccine, earlier manufactured and invoiced under previous contracts with the U.S. government. A U.S. based contract manufacturer will assist in the filling of vaccines.
In July, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the European Commission approved an extension of the current marketing authorization for the Company’s smallpox vaccine, IMVANEX to include protection from monkeypox and disease caused by vaccinia virus.
In July, Bavarian Nordic received approvals from U.S. and EU regulatory authorities of the final drug manufacturing of smallpox and monkeypox vaccine, which has been transferred to the Company’s fill and finish facility in Denmark. The U.S. approval was granted after a successful inspection by FDA earlier in July and the EU approval was granted upon assessment by CHMP of an application submitted in June 2022, in supplement to the approval earlier granted by the Danish Medicines Agency after inspection of the facility.
In July and August, Bavarian Nordic received additional orders for monkeypox vaccine from several governments, including significant orders for 2023.
Conference call and webcast
The management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via https://bit.ly/3pBUllR. To join the Q&A session, please register in advance via https://bit.ly/3dS5ZGU.