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BiondVax Announces Third Quarter 2020 Financial Results & Business Update

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JERUSALEM, Jan. 28, 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 announced its third quarter financial results for the quarter ended September 30, 2020.

BiondVax Pharmaceuticals logo
BiondVax Pharmaceuticals logo

Third Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.441 (NIS/$US) as at September 30, 2020.

Total operating income for the third quarter was NIS 55.6 million (approximately $16.1 million) compared with a total operating loss of NIS 19.0 million for the third quarter of 2019.

  • R&D expenses, net of participations, for the third quarter amounted to NIS 12.6 million (approximately $ 3.7 million) compared with NIS 16.1 million for the third quarter of 2019.

  • Net profit for the third quarter was NIS 55.3 million (approximately $ 16.1 million) compared to a net loss of NIS 19.4 million for the third quarter of 2019.

As of September 30, 2020, BiondVax had cash and cash equivalents of NIS 24.8 million (approximately $7.2 million) compared to NIS 72.5 million as of December 31, 2019. At the currently anticipated burn rate going forward, BiondVax has sufficient funds to continue operations through the end of Q2 2021.

Recent Business Updates:

  • On October 23, 2020, BiondVax announced that the Phase 3 clinical trial of the Company's M–001 universal flu vaccine candidate failed to meet the trial's primary and secondary efficacy endpoints.

  • On January 21, 2021, BiondVax announced the appointment of Amir Reichman as its new CEO. Reichman currently serves as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines headquarters in Belgium.

  • In light of the Phase 3 clinical trial results, Company's management estimates that there will be no future revenues from the M-001. Therefore, most likely, there will be no future royalty payments to the Israel Innovation Authority (IIA) & European Investment Bank (EIB). The operating income and net profit noted in these Q3 2020 financial results are attributable primarily to the revaluation of the liabilities to the IIA and EIB on the Company's balance sheet in accordance with applicable IFRS standards, offset by R&D, Marketing, and G&A expenses.

  • BiondVax is currently pursuing collaborations and other opportunities in the infectious disease space, including exploring several alternatives for development of a new product pipeline.

*Tables to follow*

About BiondVax

BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention of infectious diseases and related illnesses. The Company had been developing M–001, a novel flu 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 flu 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, including exploring several alternatives for development of a pipeline of assets. For more information, please visit www.biondvax.com.

Contact Details

Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.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 the 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, that BiondVax does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern; the risk that BiondVax may not be able to secure capital on attractive terms, if at all; the risk that BiondVax is currently exploring new business strategies after its M-001 universal flu vaccine candidate failed to meet the Phase 3 trial's primary and secondary efficacy endpoints; 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; 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 us or at all; receipt, if and when provided, of regulatory approval of BiondVax's manufacturing facility in Jerusalem; the risk that drug development involves a lengthy and expensive process with uncertain outcomes; and the ability of the Company to maintain, preserve and defend its intellectual property and patents granted. 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 for the year ended December 31, 2019 and other filings filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. The Company 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,



September 30,


September 30,


2019



2019


2020


2020


Audited



Unaudited


Unaudited





N I S


U.S. dollars

CURRENT ASSETS:


















Cash and cash equivalents

72,467



75,247


24,774


7,200

Other receivables

656



1,887


2,930


851











73,123



77,134


27,704


8,051

LONG–TERM ASSETS:









Property, plant and equipment

34,981



34,324


39,889


11,592

Right-of-use assets

7,136



7,371


6,433


1,870

Other long-term assets

510



507


891


259











42,627



42,202


47,213


13,721









-


115,750



119,336


74,917


21,772










CURRENT LIABILITIES:










Trade payables

17,062



1,552


8,213


2,387


Operating lease liabilities

694



697


653


190


Other payables

1,203



820


2,289


665













18,959



3,069


11,155


3,242


LONG–TERM LIABILITIES:










Liability in respect of government grants

14,812



14,454


-


-


Operating lease liabilities

6,809



6,898


6,268


1,821


Loan from others

123,780



108,353


59,242


17,217


Warrants

16,354



6,908


-


-


Severance pay liability, net

89



87


93


27













161,844



136,700


65,603


19,065


SHAREHOLDERS' EQUITY:










Ordinary shares of no par value: Authorized:
600,000,000 shares at September 30, 2020
and 2019 (unaudited) and December 31,
2019; Issued and outstanding:
461,451,767, 460,822,640 and
402,351,657 shares at September 30, 2020
and 2019 (unaudited) and December 31,
2019, respectively

*) -



*) -


*) -


*) -


Share premium

255,285



256,889


308,855


89,757


Accumulated deficit

(320,338)



(277,322)


(310,696)


(90,292)













(65,053)



(20,433)


(1,841)


(535)













115,750



119,336


74,917


21,772














*) Represents less than NIS\USD 1.






STATEMENTS OF COMPREHENSIVE INCOME (LOSS)


In thousands, except share and per share data




























Convenience














translation














Nine months














ended




Year ended


Three months ended


Nine months ended


September




December 31,


September 30,


September 30,


30,




2019


2019


2020


2019


2020


2020




Audited


Unaudited


Unaudited




N I S


U.S. dollars


Operating expenses:














Research and development, net of
participations


68,645


16,133


12,579


37,037


43,595


12,668


Marketing, general and administrative


9,706


2,790


7,303


8,741


12,423


3,610


Other income


-


-


75,485


-


75,485


21,937
















Total operating income (expenses)


(78,351)


(18,923)


55,603


(45,778)


19,467


5,657
















Operating gain (loss)


(78,351)


(18,923)


55,603


(45,778)


19,467


5,657
















Financial income


4


169


-


193


5,034


1,463


Financial expense


(30,847)


(601)


(288)


(20,593)


(14,859)


(4,318)
















Net income (loss)


(109,194)


(19,355)


55,315


(66,178)


9,642


2,802
















Basic net income (loss) per share (NIS)


(0.33)


(0.05)


0.12


(0.23)


0.02


0.006


Diluted net income (loss) per share
(NIS)


(0.33)


(0.05)


0.10


(0.23)


0.02


0.006
















Weighted average number of shares
outstanding used to compute basic
income (loss) per share


326,651,721


377,899,911


461,046,640


290,794,601


437,381,202


437,393,465


Weighted average number of shares
outstanding used to compute diluted
income (loss) per share


326,651,721


377,899,911


538,495,403


290,794,601


497,489,765


497,489,765






















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SOURCE BiondVax Pharmaceuticals Ltd.