Full Press Release Details
Announces Fourth Quarter and Full Year 2018 Financial Results and Update
Israel - April 30, 2018 -
Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing and commercializing M-001, a universal
flu vaccine candidate currently undergoing a pivotal clinical efficacy Phase 3 trial, today announced its fourth quarter and full
year financial results for the year ended December 31, 2018 and provided a business update.
Quarter 2018 Financial Summary
are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.748(NIS/$US) as at
Year 2018 Financial Summary
of December 31, 2018, BiondVax had cash and cash equivalents and short-term investments of NIS 75.8 million ($20.24m) as compared
to NIS 71.38 million as of December 31, 2017.
Highlights and Recent Corporate Update
financial results are available in the Company's annual report on Form 20-F for the year ended December 31, 2018, which
was filed with the Securities and Exchange Commission on April 30, 2019.
(NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The proprietary technology
of the vaccine candidate, called M-001, utilizes a unique combination of conserved and common influenza virus peptides designed
to provide multi-season and multi-strain protection against current and future, seasonal and pandemic influenza. In a total of
6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated,
and immunogenic. An additional Phase 2 trial is being conducted by the NIH/NIAID is the US. As well, BiondVax is currently conducting
a large pivotal clinical efficacy Phase 3 trial in Europe. Please visit www.biondvax.com.
E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
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, the prosecution
and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval
of the new manufacturing facility; 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 United
States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and
the ability to raise 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, 2018
filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov,
and in the Company's periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement
thousands, except share and per share data
| Convenience | ||||||||||||
| Translation | ||||||||||||
| December 31, | December 31, | |||||||||||
| 2017 | 2018 | 2018 | ||||||||||
| N I S | U.S. dollars | |||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 71,382 | 75,883 | 20,246 | |||||||||
| Other receivables | 3,923 | 965 | 258 | |||||||||
| 75,305 | 76,848 | 20,504 | ||||||||||
| LONG-TERM ASSETS: | ||||||||||||
| Property, plant and equipment | 5,510 | 28,249 | 7,537 | |||||||||
| Other long term assets | 880 | 740 | 197 | |||||||||
| 6,390 | 28,989 | 7,734 | ||||||||||
| 81,695 | 105,837 | 28,238 | ||||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 6,223 | 20,723 | 5,529 | |||||||||
| Other payables | 660 | 1,076 | 287 | |||||||||
| 6,883 | 21,799 | 5,816 | ||||||||||
| LONG-TERM LIABILITIES: | ||||||||||||
| Liability in respect of government grants | 10,300 | 14,643 | 3,907 | |||||||||
| Loan from others | - | 94,360 | 25,176 | |||||||||
| Warrants | 8,177 | 6,168 | 1,645 | |||||||||
| Severance pay liability, net | 83 | 82 | 22 | |||||||||
| 18,560 | 115,253 | 30,750 | ||||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||||
| Ordinary shares of NIS 0.0000001 par value: | ||||||||||||
| Authorized: 391,000,000 shares as of December 31, 2018 and 2017; Issued and Outstanding: 261,419,599, shares as of December 31, 2018 and 2017 | *)- | *)- | *)- | |||||||||
| Share premium | 179,669 | 179,929 | 48,007 | |||||||||
| Accumulated deficit | (123,417 | ) | (211,144 | ) | (56,335 | ) | ||||||
| 56,252 | (31,215 | ) | (8,328 | ) | ||||||||
| 81,695 | 105,837 | 28,238 |
OF COMPREHENSIVE INCOME
thousands, except per share data
| Convenience translation | ||||||||||||||||
| Year ended December 31, | Year ended December 31, | |||||||||||||||
| 2016 | 2017 | 2018 | 2018 | |||||||||||||
| N I S | U.S. dollars | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net of participations | 7,794 | 18,777 | 71,913 | 19,187 | ||||||||||||
| Marketing, general and administrative | 4,106 | 4,879 | 5,154 | 1,375 | ||||||||||||
| Total operating expenses | 11,900 | 23,656 | 77,067 | 20,562 | ||||||||||||
| Operating loss | (11,900 | ) | (23,656 | ) | (77,067 | ) | (20,562 | ) | ||||||||
| Financial income | 3,019 | 18 | 2,936 | 783 | ||||||||||||
| Financial expense | (303 | ) | (10,913 | ) | (13,596 | ) | (3,628 | ) | ||||||||
| Loss | (9,184 | ) | (34,551 | ) | (87,727 | ) | (23,407 | ) | ||||||||
| Other comprehensive loss: | ||||||||||||||||
| Items to be reclassified to profit or loss in subsequent periods: | ||||||||||||||||
| Loss from available-for-sale marketable securities | (6 | ) | (6 | ) | - | - | ||||||||||
| Total comprehensive loss | (9,190 | ) | (34,557 | ) | (87,727 | ) | (23,407 | ) | ||||||||
| Basic and diluted loss per share | (0.07 | ) | (0.17 | ) | (0.34 | ) | (0.09 | ) | ||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 135,097,367 | 201,030,768 | 261,419,599 | 261,419,599 |