On May 9, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first three months of 2022 (Press release, Bavarian Nordic, MAY 9, 2022, View Source [SID1234613954]).
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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We have reported strong progress in our pipeline during the first quarter with additional Phase 2 results for our COVID-19 vaccine candidate, confirming its potential as a universal booster vaccine and we look forward to initiating the Phase 3 trial later this year. Furthermore, our RSV program was granted a Breakthrough Therapy Designation by the FDA, underlining the importance of the development of a vaccine to fulfil this high unmet medical need and to that end we initiated a Phase 3 program that will read out next year. In line with our RSV commercialization strategy, we were also pleased to enter a license and supply agreement covering selected Asian markets for RSV. Our rabies business demonstrated a stronger than expected performance in both US and Germany that off sets a slower than expected start of the TBE market during Q1. Based on current financial performance and current assessment of uncertainties and risks we maintain our full year financial guidance on revenue, EBITDA and cash."
Financial highlights from the first quarter
Revenue was DKK 320 million comprised of DKK 230 million from product sales, DKK 83 million in milestone payments from our RSV partner Nuance Pharma and DKK 7 million from contract work.
EBITDA was a loss of DKK 94 million.
Strong cash position of DKK 2,947 million at end of the period
Financial guidance for the full year is maintained at revenues between DKK 1,100 and 1,400 million, EBITDA with a loss between DKK -1,300 and -1,000 million and cash and cash equivalents at year-end unchanged between DKK 1,000 and 1,200 million.
* Repo pledged securities deducted.
Other highlights
In January, Bavarian Nordic announced the appointment of Russell Thirsk as new EVP and Chief Operating Officer to replace Henrik Birk, who has chosen to seek challenges outside Bavarian Nordic. Mr. Thirsk joined Bavarian Nordic in April from GSK, where he served as Head of Operations at GSK Vaccines in Belgium.
In February, the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation for the Company’s vaccine candidate, MVA-BN RSV, for the prevention of respiratory syncytial virus (RSV) in older adults. A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition.
In February, Bavarian Nordic announced additional results from the Phase 2 trial of its COVID-19 booster vaccine candidate, ABNCoV2. The results confirmed the ability of ABNCoV2 to boost neutralizing antibodies to levels reported to be highly efficacious (>90%) against SARS-CoV-21 both when used for primary vaccination and when used as a booster in subjects previously vaccinated with mRNA or Adeno-based vaccines.
In March, Bavarian Nordic entered into a license and supply agreement with Nuance Pharma on the development and commercialization of MVA-BN RSV for adults in China and selected Asian markets. Under the terms of the agreement, Bavarian Nordic could receive up to USD 225 million in upfront and milestone payments in addition to tiered, double-digit royalties. Nuance Pharma obtains rights to commercialize MVA-BN RSV in Chinese Mainland, Hong Kong, Macau, Taiwan, South Korea and Southeast Asia and will be responsible for all material costs, including development and regulatory.
Events after the reporting date
In April, Bavarian Nordic initiated a global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults. The Phase 3 trial is planned to enroll approximately 20,000 adults, aged 60 years or older across approximately 115 sites in the U.S. and Germany. The trial is designed to run through the RSV season 2022/2023 with topline results expected mid 2023, if the pre-defined number of lower-respiratory tract disease events has occurred.
In May, Bavarian Nordic reported additional Phase 2 results for 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%).
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am ET) to present the interim results followed by a Q&A session. A listen-only version of the call can be accessed via View Source To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 04 17, UK: +44 (0) 844 481 9752, USA: +1 646-741-3167. Participant code is 7179801.