Bavarian Nordic Publishes Annual Report 2020
COPENHAGEN, Denmark, March 12, 2021 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today published its Annual Report for 2020. Below is a summary of the financial performance for the year and financial outlook for 2021. The financial performance was in line with the preliminary results announced on January 28, 2021. The full report is attached as a PDF file and can be found on the company's website, www.bavarian-nordic.com.
Strong execution and solid financial performance despite challenging markets
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: “We embarked on a commercial transition in 2020 with a strengthened product portfolio and a 2025 vision to grow Bavarian Nordic into one of the largest pure play vaccine companies, and saw strong execution in all areas supporting this vision. While our new markets in rabies and tick-borne encephalitis were challenged by the COVID-19 lock-down, we delivered results in line with or better than our original guidance, mostly due to our JYNNEOS business performing better than originally anticipated, by strong Encepur, Rabipur/RabAvert brand performance and by keeping a tight focus on profitability and cash. We remain focused on the continued execution of our commercial business, including completing the market takeover for Rabipur/RabAvert and Encepur, but 2021 will also bring exciting news from our pipeline. Based on encouraging preclinical results, we have decided to advance the clinical development of the COVID-19 vaccine candidate, which we believe has potential to address many of the challenges seen with the approved vaccines, and we will also move forward our RSV program with a human challenge trial that will provide important results ahead of the phase 3 trial, planned for next year. With the recent private placement, raising approximately DKK 1.1 billion in net proceeds, we have strengthened our capital base, allowing for executing on these exciting plans as well as providing flexibility for pursuing further opportunities for growth.”
Important events after the balance sheet date
- In March 2021, the Company announced encouraging preclinical data for ABNCoV2, the COVID-19 vaccine candidate in-licensed from AdaptVac. Subsequently, a first-in-human trial of the vaccine has been initiated.
- In March 2021, the Company announced and completed a directed issue and private placement of 5,150,000 new shares, generating gross proceeds of DKK 1,148 million. Part of the proceeds will be used to fund a phase 2 clinical study and scale-up of manufacturing to accommodate potential future clinical development to support licensure of ABNCoV2. Additionally, the proceeds will be used to secure financial flexibility to strengthen the Company’s manufacturing capabilities, ensure the strategic flexibility necessary to pursue an active M&A strategy, and to strengthen the Company’s capital base and cash preparedness for general corporate purposes.
Bavarian Nordic’s financial results for 2020 were in line with or better than the Company’s most recent guidance and are unchanged compared to the preliminary results announced on January 28, 2021.
|DKK million||USD million*|
|Securities, cash and cash equivalents||1,600||1,670||264||276|
* Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.06 per 1.00 USD, which was the exchange rate as of December 31, 2020.
Revenue for the full year was 1,852 million, comprised of DKK 1,082 million from combined sale of Rabipur/RabAvert and Encepur, DKK 704 million from US Government sale, including JYNNEOS revenue and contract work, and finally DKK 66 million from the milestone payment from Janssen (Ebola vaccine approval). COVID-19 negative impact on Encepur and Rabipur/RabAvert revenue was limited to approximately DKK 200 million by strong brand performance in key markets and largely off-set by better than originally expected JYNNEOS revenue. A USD weakening against DKK had some negative impact on RabAvert revenue in the last two months of 2020.
The operating result (EBITDA) came in slightly better than guided due to continued tight focus on cost and profitability and was DKK 740 million, including other operating income of DKK 628 million from the sale of Priority Review Voucher.
Cash position at year-end exceeded guidance due to phasing of ongoing investments and working capital movement and was DKK 1,670 million, excluding unutilized credit facilities of DKK 244 million.
For a detailed financial review, see the annual report.
Outlook for 2021
Due to the uncertainty created by COVID-19, the outlook for 2021 will be less specific than usual and until there is more visibility in the market.
|2021E (all numbers are approximate)||DKK million||USD million|
|Revenue||1,900 – 2,200||311 - 361|
|EBITDA||100 - 250||16 - 41|
|Cash and cash equivalents, year-end||1,400 – 1,600||230 - 262|
The low end of the revenue range reflects a scenario where a lockdown due to COVID-19 continues beyond Q1 in key markets like the US and Germany. The higher end of the revenue range reflects a scenario where a gradual reopening will happen in key markets during Q2 and where travel starts picking up again in Q3 and Q4 of 2021.
The smallpox and Ebola business are not expected to be impacted by COVID-19.
For 2021, research and development costs of approximately DKK 750 million are expected, of which approximately DKK 550 million are expected to be expensed through the P&L. The largest single project is the RSV program, for which costs for manufacturing of phase 3 material and costs for the announced human challenge trial are included. The remaining up to approximately DKK 200 million will be capitalized and relate to the COVID-19 program and include a phase 2 trial and scale-up of manufacturing in preparation for a phase 3 trial.
The outlook is based on the following assumptions on currency exchange rates of DKK 6.10 per 1 USD and DKK 7.45 per 1 EUR.
See the annual report for a full description of assumptions for the 2021 outlook.
Conference call and webcast
The management of Bavarian Nordic will host a conference call today at 2 pm CET (8 am EST) to present the annual results followed by a Q&A session. A listen-only version of the call can be accessed via https://www.bavarian-nordic.com/investor/events.aspx?event=6094. To join the Q&A session, use one of the following dial-in numbers: Denmark: +45 32 72 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 5589045.
About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccines company focused on the development, manufacture and commercialization of life-saving vaccines. We are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Strategic National Stockpile of a non-replicating smallpox vaccine, which has been approved by the FDA under the trade name JYNNEOS®, also for the protection against monkeypox. The vaccine is approved as a smallpox vaccine in Europe under the trade name IMVANEX® and in Canada under the trade name IMVAMUNE®. Our commercial product portfolio furthermore contains the market-leading vaccine Rabipur®/RabAvert® against rabies and Encepur® against tick-borne encephalitis. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates designed to save and improve lives by unlocking the power of the immune system, including an Ebola vaccine, MVABEA®, which is licensed to Janssen. For more information visit www.bavarian-nordic.com.
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, email@example.com, Tel: +1 781 686 9600
Company Announcement no. 06 / 2021
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Subscribe to releases from GlobeNewswire
Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from GlobeNewswire
Active Biotech and NeoTX announce FDA Clearance of IND for Phase II Clinical Trial of Naptumomab19.4.2021 08:30:00 CEST | Press release
Phase IIa trial in non-small cell lung cancer expected to begin enrollment in the US in the second half of 2021 Lund Sweden, April 19, 2021 - Active Biotech AB (publ) (NASDAQ STOCKHOLM: ACTI) and NeoTX today announced that they have received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of the tumor targeted superantigen naptumomab estafenatox (Naptumomab). The Phase IIa open label trial will evaluate naptumomab in combination with docetaxel in 35 patients with checkpoint inhibitor pretreated, advanced or metastatic non-small cell lung cancer. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, pharmacokinetics and pharmacodynamics. Naptumomab treatment regimens have demonstrated preliminary safety and anti-tumor activity in early-stage clinical trials in solid tumors. Naptumomab binds a genetically enginee
Active Biotech och NeoTX tillkännager IND-godkännande från FDA för klinisk fas II-studie med naptumomab19.4.2021 08:30:00 CEST | Pressemelding
En fas IIa-studie i icke-småcellig lungcancer förväntas starta rekrytering i USA under andra halvåret 2021 Lund, 19 april 2021 - Active Biotech AB (publ) (NASDAQ STOCKHOLM: ACTI) och NeoTX tillkännager idag att man har erhållit godkännande av en Investigational New Drug-ansökan (IND) från amerikanska läkemedelsverket Food and Drug Administration (FDA) för det tumörriktade superantigenet naptumomab estafenatox (naptumomab). Den öppna fas IIa-studien kommer att utvärdera naptumomab i kombination med docetaxel i 35 patienter med avancerad eller metastaserad icke-småcellig lungcancer och som är förbehandlade med checkpoint-hämmare. Det primära målet är objektiv responsfrekvens mätt med RECIST 1.1-kriterier. Studien kommer också att utvärdera säkerhet, responsduration, progressionsfri överlevnad, farmakokinetik och farmakodynamik. Behandlingsregimer för naptumomab har visat preliminär säkerhet och antitumöraktivitet i tidiga kliniska studier i patienter med solida tumörer. Naptumomab binder
Immunicum Announces Presentations at Upcoming Scientific Conferences in April and May19.4.2021 08:00:00 CEST | Press release
Press Release 19 April 2021 Immunicum Announces Presentations at Upcoming Scientific Conferences in April and May Immunicum AB (publ) today announced that it will participate and deliver multiple presentations featuring its proprietary Phase II clinical candidates, immune primer ilixadencel and cancer relapse vaccine DCP-001, at the following upcoming scientific conferences: Neoantigen Summit Europe, April 20 – 22, 2021 Alex Karlsson-Parra, Chief Scientific Officer at Immunicum, will make an oral presentation on “Harnessing the immune-priming function of allogeneic dendritic cells in neoantigen-based vaccines”, on Wednesday, April 21st at 2:45 pm CET / 8:45 am ET. Cancer Immunotherapy (CIMT) Annual Meeting, May 10 – 12, 2021. Alex Karlsson-Parra will deliver an oral presentation on “Combining intratumoral administration of inflammatory allogeneic DCs with systemic anti-CTLA-4 treatment leads to tumor eradication and is associated with peripheral expansion of CD8+ effector cells with a
Intervest starts construction works at Herentals Green Logistics19.4.2021 08:00:00 CEST | Press release
#TeamIntervest gives concrete shape to a sustainable cluster of 45.000 m² of offices and logistics. Attachment Development project Herentals
Immunicum tillkännager presentationer vid kommande vetenskapliga möten i april och maj19.4.2021 08:00:00 CEST | Pressemelding
Pressrelease 19 april 2021 Immunicum tillkännager presentationer vid kommande vetenskapliga möten i april och maj Immunicum AB (publ) meddelade idag att bolaget kommer att delta och göra ett flertal presentioner gällande sina två program i klinisk fas II-utveckling, immunprimern ilixadencel och canceråterfallsvaccinet DCP-001 vid nedanstående vetenskapliga möten: Neoantigen Summit Europe, 20 – 22 april, 2021 Alex Karlsson-Parra, Chief Scientific Officer, Immunicum håller ett anförande på temat ” “Harnessing the immune-priming function of allogeneic dendritic cells in neoantigen-based vaccines”, onsdagen den 21 april kl. 14.45 CET/8.45 ET. Cancer Immunotherapy (CIMT) Annual Meeting, 10-12 maj, 2021 Alex Karlsson-Parra, Chief Scientific Officer, Immunicum håller ett anförande på temat “Combining intratumoral administration of inflammatory allogeneic DCs with systemic anti-CTLA-4 treatment leads to tumor eradication and is associated with peripheral expansion of CD8+ effector cells with a
ABN AMRO accepted settlement offer in the anti-money laundering investigation in the Netherlands19.4.2021 07:30:00 CEST | Press release
ABN AMRO accepted settlement offer in the anti-money laundering investigation in the Netherlands Today ABN AMRO Bank N.V. (ABN AMRO) announced that it has accepted a settlement offer from the Dutch Public Prosecution Service (DPPS) in connection with the previously announced investigation by the DPPS into ABN AMRO's compliance with its obligations under the Dutch Anti-Money Laundering and Counter Terrorism Financing Act (Wet ter voorkoming van witwassenen financiering van terrorisme, AML/CTF Act) between 2014 and 2020. As part of this settlement, ABN AMRO will pay EUR 480 million. ABN AMRO fully cooperated with the DPPS throughout the investigation. Based on the investigation, the DPPS identified serious shortcomings in ABN AMRO's processes to combat money laundering in the Netherlands, such as the client acceptance, transaction monitoring and client exit processes (the so-called 'Client Life Cycle' processes) in the period between 2014 and 2020, as a result of which, in certain instan
Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States19.4.2021 07:02:32 CEST | Press release
REGULATED INFORMATION INSIDE INFORMATION Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States Mont-Saint-Guibert, Belgium – 19 April 2021 – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that it has confidentially submitted a draft Registration Statement on Form F-1 to the Securities and Exchange Commission (the "SEC") relating to the proposed public offering of its ordinary shares in the United States. The number of ordinary shares to be offered and the price for the proposed offering have not yet been determined. The public offering is expected to take place after the SEC completes its review process, subject to market and other conditions. This announcement is being made pursuant to, and in accordance with, Rule 135 under the Securities Act of 1933, as am