BiondVax announces Third Quarter 2021 Financial Results and Provides Business Update

Published: Nov. 30, 2021 at 7:05 AM EST

JERUSALEM, Nov. 30, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its third quarter financial results for the quarter ended September 30, 2021 and provided a business update.

BiondVax Pharmaceuticals Logo

Business Update

  • As recently announced, BiondVax signed a term sheet with the world-renowned Max Planck Society (MPG) and the University Medical Center Göttingen (UMG), Germany, for a broad strategic collaboration for the creation of an innovative VHH-antibody (VHH-Ab) pipeline.
  • VHH antibodies exhibit distinct advantages over monoclonal antibodies for a number of disease conditions. The collaboration with MPG and UMG would focus on large addressable markets, with known and validated drug targets (thereby shortening development timelines and lowering risk), and where the VHH-Ab advantages have the potential to capture significant market share. Scientists at MPG and UMG are among the leaders worldwide in designing VHH-Abs with superior specificity and binding affinity, traits which can increase efficacy, reduce side effects, and at a lower cost than currently available monoclonal antibodies. In addition, the small size and thermostability of VHH-Abs allows treatment through inhalation, intradermal and other favorable routes of administration and without the need for enhanced cold chain storage and transport. Together, these attributes have the potential to create significant competitive advantages.
  • Manufacturing preparations underway: To accelerate development timelines, BiondVax has initiated preparations for the manufacturing of VHH-Abs at the Company's GMP biologics manufacturing facility in Jerusalem. Furthermore, BiondVax's current and 2022 planned activities, such as setting-up equipment, developing analytical methods, and training staff, will be oriented toward all VHH-antibody production arising out of the collaboration.
  • COVID-19 variants of concern: Max Planck's currently developed VHH-Ab has demonstrated superior neutralization of all major Variants of Concern (VoC), including Delta. The COVID-19 license agreement between BiondVax and Max Planck will also include an accompanying research collaboration agreement that provides BiondVax with exclusive access to ongoing life-cycle improvements of the COVID-19 VHH-Abs for emerging VoCs including Omicron.
  • The European Investment Bank (EIB) has indicated that it supports BiondVax's new strategic turnaround plans. The parties are currently in discussions to renegotiate the terms of the EIB's €24 million loan to BiondVax in a manner that would serve both parties' long-term interests. BiondVax will update its shareholders regarding terms of such negotiations if and once the parties reach an agreement.
  • The Annual General Meeting (AGM) of Shareholders of the Company will be held on December 27, 2021. Resolutions to be voted upon at the AGM include the election to the Company's Board of Directors of Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccine business. Further information about the AGM, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/0001611747/000121390021060974/ea151013-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures.

Amir Reichman, BiondVax's CEO, stated, "The innovative VHH-antibody platform, combined with our agile manufacturing capabilities and planned ongoing collaboration with Max Planck, will enable us to respond quickly to new COVID variants of concern, including Omicron. By preparing now to manufacture batches in-house for preclinical studies, we are streamlining manufacturing for clinical and commercial batches of therapies for known and emerging COVID-19 variants, as well as for the anticipated psoriasis, asthma, macular degeneration, and psoriatic arthritis VHH-antibody therapies. BiondVax is in the process of a transformative turnaround, and we are working with urgency to bring VHH-antibody therapies with compelling commercial potential that address important healthcare needs to the market."

Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.229 (NIS/$US), the rate as of the close of business on September 30, 2021.

  • R&D expenses for the three months ended September 30, 2021 decreased to NIS 2.0 million ($0.6 million) from NIS 12.6 million for the three months ended September 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that took place during Q3 2020. As previously reported, the trial concluded in Q4 2020.
  • Marketing, general and administrative expenses for the three months ended September 30, 2021 decreased to NIS 6.2 million ($1.9 million) from NIS 7.3 million for the three months ended September 30, 2020. This decrease of NIS 1.1 million ($0.34 million) was primarily due to a decrease of NIS 0.4 million in salary and salary related expenses, decrease of NIS 1.6 million in share-based payments expenses offset with increased professional expenses of NIS 0.7 million.
  • Operating expenses for the three months ended September 30, 2021 were NIS 8.2 million ($2.5 million) compared with NIS 20.0 million for the three months ended September 30, 2020.

As of September 30, 2021, BiondVax had cash and cash equivalents of NIS 34.6 million ($10.7 million) as compared to NIS 39.9 million as of June 30, 2021.

Unaudited Q3 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.

About BiondVax

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms. www.biondvax.com.

Contact Details

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

Investor Relations: Kenny Green | +1 212 378 8040 | 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. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding execution of a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of VHH antibodies and agreement with EIB regarding the restructuring of the loan from EIB. 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 will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from EIB; 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 filed with the Securities and Exchange Commission on May 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,



September 30,


September 30,



2020



2020


2021


2021



Audited



Unaudited


Unaudited






N I S


U.S. dollars


CURRENT ASSETS:










Cash and cash equivalents

9,421



24,774


34,672


10,738


Other receivables

1,204



2,930


1,426


442













10,625



27,704


36,098


11,180


LONG–TERM ASSETS:










Property, plant and equipment

39,607



39,889


38,607


11,956


Right-of-use assets

6,206



6,433


5,874


1,819


Other long-term assets

473



891


446


138













46,286



47,213


44,927


13,913













56,911



74,917


81,025


25,093

CURRENT LIABILITIES:









Trade payables

1,868



8,213


3,313


1,026

Operating lease liabilities

654



653


777


241

Loan from others

60,421



-


64,488


19,972

Other payables

1,246



2,289


1,693


524











64,189



11,155


70,271


21,763

LONG–TERM LIABILITIES:









Operating lease liabilities

6,088



6,268


5,905


1,829

Loan from others

-



59,242


-


-

Other payables

1,135



-


568


176

Severance pay liability, net

95



93


95


29











7,318



65,603


6,568


2,034

SHAREHOLDERS' EQUITY:









Ordinary shares of no par value: Authorized: 1,800,000,000
shares at September 30, 2021 (unaudited) and 600,000,000
shares at September 30, 2020 (unaudited) and at December
31, 2020; Issued and outstanding: 573,285,824 shares at
September 30, 2021 (unaudited), 460,822,640 shares at
September 30, 2020 (unaudited) and 461,285,824 shares at
December 31, 2020

*)   -



*)   -


*)   -


*)   -

Share premium

310,197



308,855


358,204


110,933

Accumulated deficit

(324,793)



(310,696)


(354,018)


(109,637)











(14,596)



(1,841)


4,186


1,296


56,911



74,917


81,025


25,093

*)    Represents less than NIS\USD 1.

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data













Convenience translation




Year ended

December 31,


Three months ended

September 30,


Nine months ended

September 30,


Nine months

ended

September 30,




2020


2020


2021


2020


2021


2021




Audited


Unaudited


Unaudited




N I S


U.S. dollars




(In thousands, except per share data)


Operating expenses:













Research and development, net of participations


51,463


12,579


2,024


43,595


6,677


2,068


Marketing, general and administrative


16,687


7,303


6,201


12,423


17,208


5,329


Other income


(75,484)


(75,485)


-


(75,485)


-


-
















Total operating expenses (income)


(7,334)


(55,603)


8,225


(19,467)


23,885


7,397
















Operating income (loss)


7,334


55,603


(8,225)


19,467


(23,885)


(7,397)
















Financial income


3,843


-


1,980


5,034


2,802


868


 

Financial expense


(15,632)


(288)


(2,801)


(14,859)


(8,142)


(2,522)
















Net  Income (loss)


(4,455)


55,315


(9,046)


9,642


(29,225)


(9,051)
















Basic net income (loss) per share (NIS)


(0.01)


0.12


(0.02)


0.02


(0.05)


(0.02)


Diluted net income (loss) per share (NIS)


(0.01)


0.10


(0.02)


0.02


(0.05)


(0.02)
















Weighted average number of shares outstanding used to compute basic and diluted loss per share


443,260,878


461,046,640


573,205,607


437,381,202


559,239,052


559,239,052


 

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


443,260,878


538,495,403


573,205,607


497,489,765


559,239,052


559,239,052



The notes in the Company's quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission.





















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SOURCE BiondVax Pharmaceuticals Ltd.

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