On November 7, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported its interim financial results in line with guidance for the first nine months of 2019 and business progress for the third quarter of 2019 (Press release, Bavarian Nordic, NOV 7, 2019, View Source [SID1234550647]).
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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "We set out the year with a clear ambition and strategy to expand our commercial footprint, and with the recently announced acquisition of two commercial vaccines from GlaxoSmithKline (GSK), we turn to the next chapter for Bavarian Nordic to become an independent vaccine company with sustainable profitability. The company is fully focused on the integration of manufacturing of the two new vaccines and establishing the commercial operations to make this a great success. We will move ahead with our planned Phase 3 trial for RSV in 2021 that allows sufficient time to establish an improved commercial scale production and formulation to meet the demands of this blockbuster indication. The recent approval of JYNNEOS was also a tremendous milestone for the Company, offering exciting new business opportunities beyond our long-term partnership with the U.S. government to supply the national stockpile and offering clear synergies with the two acquired commercial vaccines."
TRANSFORMATIVE ACQUISITION OF TWO COMMERCIAL VACCINES FROM GLAXOSMITHKLINE
Announced on October 21, the acquisition of Rabipur/RabAvert and Encepur from GlaxoSmithKline (GSK) is a transformative transaction that will establish a leading infectious disease franchise and make Bavarian Nordic an independent and profitable vaccine company. Specifically, the transition:
Accelerates our vision by 3 years to become a leading and profitable vaccine company
Exploits significant manufacturing synergies between highly complementary technologies and builds on our expertise
Ensures strong cash flow generation, allowing us to continue progressing our promising innovative pipeline
Full details on the acquisition were published in company announcement no. 19/2019.
Closing of the acquisition is expected by December 31, 2019, conditional on antitrust approval as well as on approval of the rights issue by the Company’s shareholders. To resolve on the rights issue, an extraordinary general meeting has been convened on November 27, 2019. Details are available at www.bavarian-nordic.com/egm.
OPERATIONAL HIGHLIGHTS
Delivering our strategy
We set out for the year with a 5-year vision and four strategic imperatives that collectively build on our heritage in vaccine development and manufacturing, aiming to secure and reinforce a sustainable foundation, while also expanding the commercial opportunities. With the acquisition of two commercial vaccines from GSK, the recent approval of JYNNEOS and the advancement of several clinical programs during the year, we are on track to accomplish these targets:
MAINTAIN global leadership of our smallpox vaccine business
EXPAND and rapidly ADVANCE the pipeline of infectious disease programs
ESTABLISH a broad and deep cancer immunotherapy portfolio
EXPAND the commercial footprint and capabilities
Smallpox
In September, the U.S. Food and Drug Administration (FDA) approved JYNNEOS (MVA-BN) for protection against smallpox and monkeypox. The approval was the result of our successful, fifteen-year partnership with the U.S. government to develop a non-replicating smallpox vaccine, suitable for the entire population, presenting significant opportunities for our future business with the U.S. government beyond emergency stockpiling.
As expected, we were awarded a Priority Review Voucher along with the approval.
The additional indication for monkeypox provides new commercial opportunities to be exploited in the coming years as we expand the commercial infrastructure to accommodate sales and distribution of the vaccines acquired from GSK.
A Phase 3 lot-consistency trial, fully funded by BARDA, of the freeze-dried formulation of MVA-BN is ongoing. A prior Phase 2 study showed bioequivalence between the freeze-dried and liquid-frozen formulations of MVA-BN, and the lot-consistency trial was agreed with the FDA as the only Phase 3 study required to support licensure of the freeze-dried formulation, which is anticipated in 2022.
We are on track with the production of bulk vaccine for the current order for freeze-dried MVA-BN from the U.S. Government with the majority of the batches being invoiced in the fourth quarter of 2019 adding up to a total of USD 50 million included in our guided 2019 revenues.
Infectious diseases
The design of the Phase 3 efficacy trial, for our highly promising RSV vaccine candidate for the elderly (≥60 years old), has been finalized with the FDA. The randomized, placebo-controlled trial has an adaptive design and will enroll a total of 12,000 to 14,000 subjects over two seasons. The total number of subjects will depend on the independent analysis performed from the first 6,000 subjects enrolled for the first season. The estimated costs to determine futility after the season one will be USD 40 million and if positive, the second season will cost an additional USD 50-70 million, although after passing the first season threshold there would be approximately a 75% chance of successfully reaching the efficacy endpoint of the trial. The trial is planned to be initiated in 2021 prior to the RSV season, with the initial read out in 2022 and a potential approval in 2024.
In October, we initiated a Phase 1 clinical trial of MVA-BN WEV, a trivalent prophylactic vaccine against three strains of the equine encephalitis virus: Western, Eastern (also referred to as triple E) and Venezuelan. The current program is funded by the U.S. Department of Defense. Equine encephalitis virus is an alpha virus that is spread by mosquitos from infected birds to horses and people that can result in the rare condition of encephalitis in about 5% of the people that become infected. Since October, 31 cases, including 9 deaths have been reported by the US CDC in what is the largest ever recorded outbreak of triple E. Successful Phase 1 results could lead to additional funding of clinical development towards licensure of this important emerging infectious disease.
Our Janssen partnership provides an opportunity to explore and commercialize our MVA-BN platform in three infectious disease indications; HPV, HIV and HBV. A Phase 1/2a trial of the therapeutic HPV vaccine was initiated earlier this year and the first clinical trial of the therapeutic HIV vaccine is anticipated to begin in 2020. Collectively, these programs, along with our Ebola collaboration, represent USD 1 billion in potential future milestone payments, in addition to royalties on future sales.
Ebola continues to rage in the Democratic Republic of Congo, and Janssen recently announced the donation of up to 500,000 doses of the Ad26.ZEBOV/MVA-BN Filo vaccine regimen, which will be introduced to help counter the outbreak. Neighboring countries like Rwanda and Uganda have also expressed their intent to use the vaccine as Ebola cases have been reported around the border. In Uganda, a large trial of the vaccine was initiated in healthcare workers in August. The vaccine regimen has to-date been evaluated in more than 6,500 individuals in Phase 1, 2 and 3 clinical studies, and Janssen is planning to submit a Marketing Authorization Application to the European Medicines Agency this year.
Cancer immunotherapy
In October, we updated on the development of CV301, and the study in bladder cancer, which did not meet the efficacy threshold to expanded enrollment for the second stage. While we continue to follow and support two ongoing, investigator-sponsored Phase 2 trials evaluating CV301 in combination with checkpoint inhibitors in colorectal and pancreatic cancer, the Company’s focus moves to BN-Brachyury and the intravenous and intra-tumoral applications.
BN-Brachyury is currently being evaluated in a Phase 2 trial in patients with advanced chordoma. This trial, which also uses a two-stage design, indicated clinical activity in the first stage, allowing for expansion of enrollment, which was recently completed. Conclusive data from this study are expected within 12 months.
A planned Phase 1 dose escalation study at the National Cancer Institute (NCI) investigating the safety of MVA-BN Brachyury administered intravenously into patients with brachyury positive tumors will initiate shortly.
Commercial manufacturing
Construction of our fill and finish facility is progressing according to plan, and we expect the building to be completed by end of 2019, which is the peak investment year with approximately DKK 270 million in total investments.
The addition of a large-scale fill and finish line to our existing bulk production will significantly expand our manufacturing capabilities, allowing for integration of the products from GSK, while also enabling us to continuously support our partnerships, including fulfilling our smallpox vaccine contract with the U.S. government.
To support simultaneous manufacturing of multiple products, we will invest in a new, independent clean room suite at our existing facility to be initiated in 2020.
FINANCIALS AND OUTLOOK
Financial results for the first nine months in line with expectations
Revenue generated for the nine months ending September 30, 2019 was DKK 372 million/USD 54 million (DKK 319 million/USD 47 million in the first nine months of 2018).
The income before interest and tax (EBIT) was a loss of DKK 298 million/USD 43 million (loss of DKK 261 million/USD 38 million in the first nine months of 2018).
As of September 30, 2019, the Group’s cash preparedness was DKK 1,740 million/USD 254 million (DKK 2,314 million/USD 337 million as of December 31, 2018), including unutilized credit lines of DKK 244 million/USD 36 million (DKK 244 million/USD 36 million as of December 31, 2018).
Danish kroner (DKK) is the Company’s reporting currency. The USD figures provided above are based upon an assumed exchange rate of DKK 6.86 per 1.00 USD, which was the exchange rate as of September 30, 2019.
Outlook for 2019 maintained
The majority of our 2019 revenues are related to the production and release of bulk smallpox vaccine for the U.S. Government, most of which will occur in the fourth quarter of 2019. Hence, we maintain our financial expectations for 2019 as announced on March 21, 2019 with revenues of approximately DKK 600 million/USD 92 million for the full year and a loss before interest and tax (EBIT) of approximately DKK 360 million/USD 55 million. The expected cash preparedness at year-end was revised in October from approximately DKK 1,600 million/USD 246 million to approximately DKK 1,000 million/USD 154 million as a result of the announced acquisition of two vaccines from GlaxoSmithKline.
A detailed guidance for 2020 will be provided in connection with the publication of the Company’s annual report for 2019. However, pending a successful closing of the transaction with GSK, the Company is able to confirm that it will be profitable on an EBITDA basis already in 2020, exclusive of the sale of the Priority Review Voucher, which was awarded the Company by FDA upon the approval of JYNNEOS in September.
The financial expectations are based on an exchange rate of DKK 6.50 per 1.00 USD. For further details regarding assumptions behind the guidance see the Annual Report 2018.
Financial calendar 2019/2020
The date for announcement of the 2019 annual report has been changed to February 20, 2020.
November 27, 2019 Extraordinary General Meeting *
February 20, 2020 2019 Annual Report
April 21, 2020 Annual General Meeting **
May 14, 2020 First quarterly report (Q1) for the three-month period ended March 31, 2020
August 26, 2020 Half-year report (Q2) for the six-month period ended 30 June 2020
November 11, 2020 Third quarterly report (Q3) for the nine-month period ended 30 September 2020
* An extraordinary general meeting has been convened to seek shareholder approval to increase the Company’s share capital through a planned rights issue in the first half of 2020 with pre-emptive rights for the existing shareholders in order to obtain financing of costs associated with the acquisition of Rabipur/RabAvert and Encepur. See www.bavarian-nordic.com/egm for additional information.
** Pursuant to Article 12 of the Articles of Association, shareholders who wish to submit a request for proposals for consideration at the annual general meeting must lodge this with the Company no later than Wednesday, March 11, 2020.
OTHER DEVELOPMENTS
Incentive programs for employees and executive management in Bavarian Nordic
The board of directors has today decided to issue warrants to executive management and certain employees in the Bavarian Nordic Group. The decision is made in accordance with the shareholder authorization for the board of directors adopted as Article 5b of the Articles of Association and the Company’s guidelines regarding incentive programs.
The warrant program entails the issuance of 564,585 warrants in total which entitle the warrant holders to subscribe for up to 564,585 shares in total with a nominal value of DKK 10 each at an exercise price of DKK 185.4 per share. The warrants may be exercised wholly or partly during eight fixed subscription periods during 2023 and 2024.
The value of each warrant equals DKK 45.5 and is calculated on the Black-Scholes model with a risk-free interest rate of -0.69 per cent and on the historical volatility of the shares. The calculation is based on a share price of DKK 154.05.
Furthermore, the Company introduces a three-year incentive program in January 2020 for all employees in the Bavarian Nordic Group, with the exception of employees receiving warrants. The program is a cash bonus program based on the development in the Company’s share price. The incentive program will not have a dilutive effect on the shareholders.
Each employee participating in the program is awarded so-called phantom shares every month of employment until 31 December 2022. The exercise price is DKK 185.4. The phantom shares may be exercised in January 2023, only if the Company’s share price by then exceeds the exercise price by at least DKK 5. In that case, each phantom share will yield a cash bonus equivalent to DKK 1 per point the share price exceeds the exercise price.
Based on the current number of employees in the Group eligible for participating in the program, the program will comprise up to 72,288 phantom shares. The average value of each phantom share granted equals DKK 27.7 calculated on the basis of the Black-Scholes model with a risk-free interest rate of -0.69 per cent and on the historical volatility of the shares. The calculation is based on a share price of DKK 154.05.
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 80 42, UK: +44 (0) 844 571 8892, USA: +1 631-510-7495. Participant code is 8772778.