BiondVax Announces Third Quarter 2020 Financial Results & Business Update
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.
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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 68,645 16,133 12,579 37,037 43,595 12,668
participations
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 (0.33) (0.05) 0.10 (0.23) 0.02 0.006
(NIS)
Weighted average number of shares 326,651,721 377,899,911 461,046,640 290,794,601 437,381,202 437,393,465
outstanding used to compute basic
income (loss) per share
Weighted average number of shares 326,651,721 377,899,911 538,495,403 290,794,601 497,489,765 497,489,765
outstanding used to compute diluted
income (loss) per share
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SOURCE BiondVax Pharmaceuticals Ltd.
