Full Press Release Details
Quarter 2018 Financial Results
Israel - November 13, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company
focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for
the quarter ended September 30, 2018.
Quarter 2018 Financial Summary
are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.627 (NIS/$US) as at
of September 30, 2018, BiondVax had cash and cash equivalents of NIS 53.0 million ($14.6 million) as compared to NIS 37.1 million
as of June 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a pivotal, clinical
efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial
manufacturing facility.
note, during this third quarter a 6 million tranche was received by the Company as part of the previously announced 20
million co-financing agreement with the European Investment Bank (EIB). On October 21, 2018, after this third quarter reporting
period, an additional 8 million representing the third and final tranche of the EIB agreement was received by BiondVax,
and will be included in the Company's fourth quarter financial results.
(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-season protection against current and future, seasonal and pandemic influenza virus
strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides,
activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2
and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic.
Please visit www.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 involve certain risks and uncertainties 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 its products; 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, 2017 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 for any reason.
thousands, except share and per share data
| Convenience translation | ||||||||||||||||
| December 31, | September 30, | September 30, | ||||||||||||||
| 2017 | 2017 | 2018 | 2018 | |||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||
| N I S | U.S. dollars | |||||||||||||||
| CURRENT ASSETS: | ||||||||||||||||
| Cash and cash equivalents | 71,382 | 76,892 | 52,985 | 14,608 | ||||||||||||
| Short-term deposits | - | 1,200 | *)- | *)- | ||||||||||||
| Other receivables | 3,923 | 3,779 | 2,716 | 749 | ||||||||||||
| 75,305 | 81,871 | 55,701 | 15,357 | |||||||||||||
| LONG-TERM ASSETS: | ||||||||||||||||
| Property, plant and equipment | 5,510 | 1,308 | 24,175 | 6,665 | ||||||||||||
| Other long term assets | 880 | 515 | 888 | 245 | ||||||||||||
| 6,390 | 1,823 | 25,063 | 6,910 | |||||||||||||
| 81,695 | 83,694 | 80,764 | 22,267 | |||||||||||||
| CURRENT LIABILITIES: | ||||||||||||||||
| Trade payables | 6,223 | 792 | 1,732 | 477 | ||||||||||||
| Other payables | 660 | 2,344 | 981 | 270 | ||||||||||||
| 6,883 | 3,136 | 2,713 | 747 | |||||||||||||
| LONG-TERM LIABILITIES: | ||||||||||||||||
| Liability in respect of government grants | 10,300 | - | 12,930 | 3,565 | ||||||||||||
| Loan from others | - | - | 42,770 | 11,792 | ||||||||||||
| Warrants | 8,177 | 11,829 | 7,759 | 2,139 | ||||||||||||
| Severance pay liability, net | 83 | 81 | 81 | 22 | ||||||||||||
| 18,560 | 11,910 | 63,540 | 17,518 | |||||||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||||||||
| Ordinary shares | ||||||||||||||||
| Authorized: 600,000,000 shares as of September 30, 2018, 2017 (unaudited) and December 31, 2017; Issued and Outstanding: 261,419,599, 179,595,199 and 261,419,599 shares respectively | *)- | *)- | *)- | *)- | ||||||||||||
| Share premium | 179,669 | 179,182 | 179,871 | 49,592 | ||||||||||||
| Options | - | 533 | - | - | ||||||||||||
| Other comprehensive income | - | - | - | |||||||||||||
| Accumulated deficit | (123,417 | ) | (111,067 | ) | (165,360 | ) | (45,590 | ) | ||||||||
| 56,252 | 68,648 | 14,511 | 4,002 | |||||||||||||
| 81,695 | 83,694 | 80,764 | 22,267 |
OF COMPREHENSIVE INCOME
thousands, except share and per share data
| Convenience translation | ||||||||||||||||||||||||
| Nine months | ||||||||||||||||||||||||
| Year ended | Three months ended | Nine months ended | ended | |||||||||||||||||||||
| December 31, | September 30, | September 30, | September 30, | |||||||||||||||||||||
| 2017 | 2017 | 2018 | 2017 | 2018 | 2018 | |||||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Research and development, net of participations | 18,777 | 1,174 | 4,347 | 5,070 | 45,297 | 12,488 | ||||||||||||||||||
| Marketing, general and administrative | 4,879 | 2,036 | 1,475 | 3,699 | 3,804 | 1,049 | ||||||||||||||||||
| Total operating expenses | 23,656 | 3,210 | 5,822 | 8,769 | 49,101 | 13,537 | ||||||||||||||||||
| Operating loss | (23,656 | ) | (3,210 | ) | (5,822 | ) | (8,769 | ) | (49,101 | ) | (13,537 | ) | ||||||||||||
| Financial income | 18 | 4,558 | 3,729 | 17 | 9,817 | 2,707 | ||||||||||||||||||
| Financial expense | (10,913 | ) | (45 | ) | (157 | ) | (13,449 | ) | (2,659 | ) | (733 | ) | ||||||||||||
| Total financial income (expense), net | (10,895 | ) | 4,513 | 3,572 | (13,432 | ) | 7,158 | 1,974 | ||||||||||||||||
| Net income (loss) | (34,551 | ) | 1,303 | (2,250 | ) | (22,201 | ) | (41,943 | ) | (11,564 | ) | |||||||||||||
| Other comprehensive loss: | ||||||||||||||||||||||||
| Loss from available-for-sale financial assets | (6 | ) | (2 | ) | - | (6 | ) | - | - | |||||||||||||||
| Total comprehensive income (loss) | (34,557 | ) | 1,301 | (2,250 | ) | (22,207 | ) | (41,943 | ) | (11,564 | ) | |||||||||||||
| Earnings (loss) per share | ||||||||||||||||||||||||
| Basic (NIS) | (0.17 | ) | 0.01 | (0.01 | ) | (0.12 | ) | (0.16 | ) | (0.04 | ) | |||||||||||||
| Diluted (NIS) | (0.17 | ) | (0.01 | ) | (0.01 | ) | (0.12 | ) | (0.16 | ) | (0.04 | ) | ||||||||||||
| Weighted average number of shares used in compute earnings (loss) per share | ||||||||||||||||||||||||
| Basic | 201,030,768 | 191,521,484 | 261,419,599 | 180,680,089 | 261,419,599 | 261,419,599 | ||||||||||||||||||
| Diluted | 201,030,768 | 201,302,584 | 261,419,599 | 180,680,089 | 261,419,599 | 261,419,599 |