BiondVax Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update

JERUSALEM, May 13, 2021 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately…

JERUSALEM, May 13, 2021 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its fourth quarter and full year financial results for the year ended December 31, 2020 and provided a business update.

BiondVax Pharmaceuticals Logo

Fourth Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.215 (NIS/US$), the rate as of the close of business on December 31, 2020.  

  • Total operating expenses for the quarter were NIS 12.3 million ($3.2 million) compared with NIS 45.7 million for the fourth quarter of 2019.
  • R&D expenses for the quarter amounted to NIS 7.8 million ($2.4 million) compared with NIS 37.6 million for the fourth quarter of 2019.

 Full Year 2020 Financial Summary 

  • Total operating expenses for the year were NIS 68.2 million ($21.2 million) offset by other income of NIS 75.8 million ($23.4 million) due to the revaluation of the EIB loan compared with NIS 78.3 million in 2019.
  • R&D expenses for the year amounted to NIS 51.4 million ($16 million) compared with NIS 68.6 million in 2019.

As of December 31, 2020, BiondVax had cash and cash equivalents of NIS 9.4 million ($2.9 million) compared to NIS 72.4 million as of December 31, 2019.

Following the balance sheet date, in February 2021 the Company completed a follow-on offering on Nasdaq, providing total gross proceeds of approximately $13.8 million and net proceeds after fees and discounts of approximately $12.8 million. As of May 12, 2021, the Company had cash and cash equivalents of NIS 46 million (approximately $14 million).

The complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2020, to be filed with the Securities and Exchange Commission. A summary is included in the tables below.

Recent Corporate Update

Following the October 23, 2020 announcement that the Phase 3 trial of M–001, our universal influenza vaccine candidate, did not meet its efficacy endpoints, BiondVax implemented the following actions:

  • Appointed a new CEO: Mr. Amir Reichman began serving as BiondVax’s CEO on a full-time basis March 2, 2021, taking over from Dr. Ron Babecoff, who has continued to serve BiondVax as a senior advisor to ensure a smooth transition. Most recently, Reichman held senior leadership positions at the GSK Vaccine headquarters in Belgium, including Head of Global Vaccines Engineering Core Technologies and Asset Management, and Senior Director Global GSK Vaccines Supply Chain.
  • New Mission: As described in his March 23, 2021 CEO Letter to Shareholders, Reichman explained that while previously BiondVax had been a one product company, going forward the Company is implementing a strategy to diversify its pipeline of products towards a new mission: To help build a healthier and happier world by developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses.
  • Financing: In February 2021, BiondVax completed a follow-on offering on Nasdaq with total gross proceeds of approximately $13.8 million to strengthen the Company’s balance sheet. These additional funds will be used to support ongoing operating expenses and implementation of the new corporate mission and strategy. BiondVax continues to remain in close contact with its main creditor, the European Investment Bank (EIB), to whom the Company has a €24 million outstanding debt. The EIB is supportive of the Company’s ongoing efforts to reposition itself and to date has not indicated an intent to recall the loan.
  • Assets: The Company’s highly advanced GMP vaccine manufacturing facility in Jerusalem is being maintained by its highly experienced staff as it seeks to expand its product asset pipeline in the coming quarters.

Management Comment

Mr. Amir Reichman, BiondVax’s CEO, commented, «My team and the Board are actively engaged in pursuing opportunities to diversify our pipeline of assets in light of our new mission. BiondVax’s vaccine development, manufacturing, and clinical trial experience, combined with our people’s deep industry experience and our highly advanced GMP vaccine manufacturing facility provide us with an incredible untapped potential that I aim to realize over the coming years. I look forward to leading BiondVax to the next level.«

Reichman continued, «I would like to extend my personal appreciation and gratitude to our shareholders for their support and belief in our new mission, vision and strategy.  Together with our employees, management, board and others, I believe we have the capability to successfully grow BiondVax even stronger financially while creating a diversified portfolio of assets to both improve our offering to future customers while reducing specific, single product risks.«

About BiondVax

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space towards development of a pipeline of diversified products and platforms.

Contact Details:

Company:
 Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com  

Investor Relations: Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as «expect,» «believe,» «intend,» «plan,» «continue,» «may,» «will,» «anticipate,» and similar expressions are intended to identify forward-looking statements, including statements regarding future business strategies that BiondVax may explore. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading «Risk Factors» in the Company’s Annual Report on Form 20-F to be filed with the Securities and Exchange Commission on March 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

BALANCE SHEETS

In thousands, except share and per share data









Convenience









Translation














December 31,


December 31,





2019


2020


2020





N I S


U.S. dollars

CURRENT ASSETS:









Cash and cash equivalents




72,467


9,421


2,930

Other receivables




656


1,204


375














73,123


10,625


3,305

LONG–TERM ASSETS:









Property, plant and equipment




34,981


39,607


12,319

Right-of-use assets




7,136


6,206


1,930

Other long-term assets




510


473


147














42,627


46,286


14,396














115,750


56,911


17,701

CURRENT LIABILITIES:









Trade payables




17,062


1,868


581

Current maturities of lease liabilities




694


654


203

Loan from others





60,421


18,793

Other payables




1,203


1,246


388














18,959


64,189


19,965

LONG–TERM LIABILITIES:









Liability in respect of Government grants




14,812



Lease Liabilities




6,809


6,088


1,894

Loan from others




123,780



Warrants




16,354



Other payables





1,135


353

Severance pay liability, net




89


95


29














161,844


7,318


2,276

SHAREHOLDERS’ EQUITY:









Ordinary shares of no par value: Authorized: 600,000,000

shares at December 31, 2020 and 2019; Issued and

outstanding: 461,285,824 and 402,351,657, shares as of

December 31, 2020 and 2019, respectively




*)   –


*)   –


*)   –

Share premium




255,285


310,197


96,484

Accumulated deficit




(320,338)


(324,793)


(101,024)














(65,053)


(14,596)


(4,540)














115,750


56,911


17,701

*) Represents less than 1 NIS\USD









 

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data














Convenience

translation

 





Year ended

December 31,


Year ended

December 31,





2018


2019


2020


2020





N I S


U.S. dollars

Operating expenses:











Research and development, net of

participations




71,913


68,645


51,463


16,007

Marketing, general and administrative




5,154


9,706


16,687


5,190

Other income






(75,484)


(23,479)












Total operating expenses (income)




77,067


78,351


(7,334)


(2,282)












Operating income (loss)




(77,067)


(78,351)


7,334


2,282

Financial income




2,936


4


3,843


1,195

Financial expense




(13,596)


(30,847)


(15,632)


(4,863)












Loss




(87,727)


(109,194)


(4,455)


(1,386)












Total comprehensive loss




(87,727)


(109,194)


(4,455)


(1,386)












Basic and diluted loss per share




(0.34)


(0.33)


(0.01)


(0.003)












Weighted average number of shares

outstanding used to compute basic and

diluted loss per share




261,419,599


326,651,721


443,260,878


443,260,878

The notes in the Company’s annual report on Form 20-F are an integral part of the financial statements. The complete financial results are available in the 20-F to be filed with the Securities and Exchange Commission.

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SOURCE BiondVax Pharmaceuticals Ltd.