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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.

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 | [email protected]  

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 NISUSD 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.

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