Full Press Release Details
BiondVax Announces Fourth Quarter and
Full Year 2019 Financial Results and Provides Business Update
Jerusalem, Israel - June 12, 2020
- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and
commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results
for the year ended December 31, 2019 and provided a business update.
Fourth Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS)
and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.
Full Year 2019 Financial Summary
As of December 31, 2019, BiondVax had cash
and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial
results are available in the Company's annual report on Form 20-F for the year ended December 31, 2019, which is being filed
with the Securities and Exchange Commission today.
2019 Highlights and Recent Corporate
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical
stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide
multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary
technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the
immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials
enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3
clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please
visit www.biondvax.com.
Joshua E. Phillipson | +972 8 930
2529 | j.phillipson@biondvax.com
Forward Looking Statements
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. 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, risks relating to the
COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent
trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy
and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy
and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property
and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis,
or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy
of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks
and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form
20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on
the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
In thousands, except share and per share data
| Convenience | ||||||||||||
| Translation | ||||||||||||
| December 31, | December 31, | |||||||||||
| 2018 | 2019 | 2019 | ||||||||||
| N I S | U.S. dollars | |||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 75,883 | 72,467 | 20,968 | |||||||||
| Other receivables | 965 | 656 | 190 | |||||||||
| 76,848 | 73,123 | 21,158 | ||||||||||
| LONG-TERM ASSETS: | ||||||||||||
| Property, plant and equipment | 28,249 | 34,981 | 10,122 | |||||||||
| Right-of-use assets | - | 7,136 | 2,065 | |||||||||
| Other long-term assets | 740 | 510 | 148 | |||||||||
| 28,989 | 42,627 | 12,335 | ||||||||||
| 105,837 | 115,750 | 33,493 | ||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 20,723 | 17,062 | 4,937 | |||||||||
| Current maturities of lease liabilities | - | 694 | 201 | |||||||||
| Other payables | 1,076 | 1,203 | 348 | |||||||||
| 21,799 | 18,959 | 5,486 | ||||||||||
| LONG-TERM LIABILITIES: | ||||||||||||
| Liability in respect of government grants | 14,643 | 14,812 | 4,286 | |||||||||
| Lease Liabilities | - | 6,809 | 1,970 | |||||||||
| Loan from others | 94,360 | 123,780 | 35,816 | |||||||||
| Warrants | 6,168 | 16,354 | 4,732 | |||||||||
| Severance pay liability, net | 82 | 89 | 26 | |||||||||
| 115,253 | 161,844 | 46,830 | ||||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||||
| Ordinary shares of NIS 0.0000001 par value: Authorized: 391,000,000 shares at December 31, 2019 and 2018; Issued and outstanding: 402,351,657 and 261,419,599, shares at of December 31, 2019 and 2018, respectively | *) - | *) - | *) - | |||||||||
| Share premium | 179,929 | 255,285 | 73,867 | |||||||||
| Accumulated deficit | (211,144 | ) | (320,338 | ) | (92,690 | ) | ||||||
| (31,215 | ) | (65,053 | ) | (18,823 | ) | |||||||
| 105,837 | 115,750 | 33,493 |
STATEMENTS OF COMPREHENSIVE
In thousands, except
share and per share data
| Convenience translation | ||||||||||||||||
| Year ended December 31, | Year ended December 31, | |||||||||||||||
| 2017 | 2018 | 2019 | 2019 | |||||||||||||
| N I S | U.S. dollars | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net of participations | 18,777 | 71,913 | 68,645 | 19,863 | ||||||||||||
| Marketing, general and administrative | 4,879 | 5,154 | 9,706 | 2,808 | ||||||||||||
| Total operating expenses | 23,656 | 77,067 | 78,351 | 22,671 | ||||||||||||
| Operating loss | (23,656 | ) | (77,067 | ) | (78,351 | ) | (22,671 | ) | ||||||||
| Financial income | 18 | 2,936 | 4 | 1 | ||||||||||||
| Financial expense | (10,913 | ) | (13,596 | ) | (30,847 | ) | (8,926 | ) | ||||||||
| Loss | (34,551 | ) | (87,727 | ) | (109,194 | ) | (31,596 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Items to be reclassified to profit or loss in subsequent periods: | ||||||||||||||||
| Loss from available-for-sale marketable securities | (6 | ) | - | - | - | |||||||||||
| Total comprehensive loss | (34,557 | ) | (87,727 | ) | (109,194 | ) | (31,596 | ) | ||||||||
| Basic and diluted loss per share | (0.17 | ) | (0.34 | ) | (0.33 | ) | (0.09 | ) | ||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 201,030,768 | 261,419,599 | 326,651,721 | 326,651,721 |