On November 9, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results for the first nine months of 2022 and business progress for the third quarter of 2022 (Press release, Bavarian Nordic, NOV 9, 2022, View Source [SID1234623755]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "These are exciting times for Bavarian Nordic as we have continued to expand our activities to support the global response against monkeypox, while also running two global Phase 3 trials of our late-stage pipeline assets. We are highly encouraged to see how our vaccines can truly make a difference by providing comfort for the populations at-risk and helping to change the course of the monkeypox outbreak. More than 1 million people have received our vaccine since the beginning of the outbreak and the number grows day by day and we have already secured significant orders for 2023 and beyond. Deliveries were intensified over the last 3 months and will continue into the fourth quarter as we expand the supply of our smallpox/monkeypox vaccine to more than 70 countries worldwide. The increased sales of our products across the portfolio are driving all-time high revenues and we are nearing an EBITDA break-even result for 2022."

Financial highlights

Total revenue in the first nine months was DKK 1,860 million comprised of DKK 1,752 million from product sales, DKK 83 million in milestone payments from partners and DKK 25 million from contract work.
Revenue in the third quarter totaled DKK 1,004 million comprised of DKK 338 million from sale of Rabipur/RabAvert, DKK 62 million from sale of Encepur, DKK 578 million from sale of JYNNEOS/IMVANEX/IMVAMUNE, DKK 11 million from sale of third-party products and DKK 15 million from contract work.
EBITDA for the first nine months was DKK 14 million.
Cash position of DKK 2,741 million at the end of third quarter.
The most recent financial guidance for the full year, issued on September 7, is maintained at revenues between DKK 2,800 and 3,000 million, EBITDA with a loss between DKK -200 and 0 million and cash and cash equivalents at year-end expected to exceed DKK 1,700 million.

Other highlights

Monkeypox

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, manufactured and invoiced under previous contracts with the U.S. government. To expand the manufacturing footprint to increase supply, the doses will also be filled at a U.S. based contract manufacturer following the tech transfer of the manufacturing process.
In July, 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 the U.S. and EU regulatory authorities of the fill and finish manufacturing of smallpox and monkeypox vaccine at the Company’s new facility in Denmark.
In August, Bavarian Nordic entered a supply agreement with the Pan American Health Organization (PAHO) enabling access to monkeypox vaccines for countries in Latin America.
In September, Bavarian Nordic was awarded a ten-year contract valued up to USD 434 million for the supply of smallpox and monkeypox vaccine to Canada.
In September, Bavarian Nordic entered an additional contract with the European Health Emergency Preparedness and Response Authority (HERA) for the supply of monkeypox vaccines to EU Member States.
Additional orders for monkeypox vaccine were entered during the quarter with several governments, including significant orders for 2023, bringing the total number of countries with access to the vaccine to over 70.
RSV

Enrollment is proceeding as planned in the global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults.
ABNCoV2 (COVID-19)

In September, Bavarian Nordic initiated a global Phase 3 clinical trial of its COVID-19 booster vaccine candidate, ABNCoV2. The trial will assess the non-inferiority of ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against the SARS-CoV-2 (Wuhan wild type).
Other business

In September, the board of directors appointed Luc Debruyne, former President Global Vaccines at GSK, as an observer to the board with the intent to nominate him for election to the board at the ordinary general meeting in March 2023, where he, following the board’s constitution, is expected to assume the chairmanship after Gerard van Odijk, who will step down after having served for 15 years on the board.
Events after the reporting date

In October, Bavarian Nordic signed its first bilateral agreement with a country in Latin America on the supply of monkeypox vaccines, thus expanding access to the vaccine in the region beyond the availability of vaccines through PAHO.
In October, the Company furthermore entered a supply agreement for monkeypox vaccines to Switzerland. Under this agreement, Bavarian Nordic will seek regulatory approval of the vaccine with Swissmedic.
In October, Bavarian Nordic reported results from a six-month follow-up analysis of data from subjects vaccinated in the Phase 2 clinical trial of its COVID-19 booster vaccine candidate, ABNCoV2, demonstrating that six months post the booster vaccination with ABNCoV2, the neutralization antibody titers against Wuhan and the Omicron variant remained high and at levels associated with a greater than 90% efficacy.
Conference call and webcast
The management of Bavarian Nordic will host an investor/analyst call today at 2 pm CET (8 am EST) 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/3Mud65F. To join the Q&A session, please register in advance via https://bit.ly/3g5j4gR.