BiondVax Announces First Quarter 2020 Financial Results

Rhea-AI Summary

BiondVax Pharmaceuticals Ltd. (BVXV) reported its financial results for Q1 2020, showing total operating expenses of NIS 20.0 million (approximately $5.6 million), a significant increase from NIS 7.1 million in Q1 2019. The company's R&D expenses rose to NIS 19 million ($5.3 million) from NIS 5.7 million year-over-year. The net loss for the quarter was NIS 3.7 million (about $1.0 million), a decline from net income of NIS 566 thousand in Q1 2019. Cash and cash equivalents fell to NIS 42.5 million ($11.9 million) from NIS 72.4 million at the end of 2019, primarily due to costs associated with its Phase 3 trial.

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• None.

Negative

• Total operating expenses increased significantly to NIS 20.0 million, up from NIS 7.1 million year-over-year.
• R&D expenses rose substantially to NIS 19 million, compared to NIS 5.7 million in Q1 2019.
• Net loss of NIS 3.7 million contrasts with net income of NIS 566 thousand in Q1 2019.
• Cash and cash equivalents decreased to NIS 42.5 million from NIS 72.4 million since the end of 2019.

JERUSALEM, June 30, 2020 /PRNewswire/ -- 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 first quarter financial results for the quarter ended March 31, 2020.

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First Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.57 (NIS/$US) as at March 31, 2020.

Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of 2019.

• R&D expenses for the first quarter amounted to NIS 19 million (approximately $5.3 million) compared with NIS 5.7 million for the first quarter of 2019.
• Net loss for the first quarter was NIS 3.7 million (approximately $1.0 million) compared to net income of NIS 566 thousand for the first quarter of 2019.

The increase in total operating expenses compared to the first quarter of 2019 was primarily due to expenses related to the ongoing Phase 3 trial and scale-up at our manufacturing facility.

As of March 31, 2020, BiondVax had cash and cash equivalents of NIS 42.5 million (approximately $11.9 million) compared to NIS 72.4 million as of December 31, 2019.

*Tables to follow*

About BiondVax

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.

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. 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.

 

BALANCE SHEETS
In thousands, except share and per share data
								Convenience
								Translation
	December 31			March 31,		March 31,
	2019			2019		2020		2020
	Audited			Unaudited		Unaudited
				N I S		U.S. dollars
CURRENT LIABILITIES:
Trade payables	17,062			15,249		3,278		919
Operating lease liabilities	694			676		684		192
Other payables	1,203			1,275		807		226
	18,959			17,200		4,769		1,337
LONG–TERM LIABILITIES:
Liability in respect of government grants	14,812			14,568		12,991		3,644
Operating lease liabilities	6,809			7,247		6,641		1,863
Loan from others	123,780			88,792		117,784		33,039
Warrants	16,354			2,059		6,861		1,925
Severance pay liability, net	89			84		90		25
	161,844			112,750		144,367		40,496
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par        value: Authorized: 600,000,000 shares at        March 31, 2020 (unaudited) and at        391,000,000 shares at March 31, 2019        (unaudited) and December 31, 2019;        Issued and outstanding: 410,213,977        shares at March 31, 2020 (unaudited),        261,419,599 shares at March 31, 2019        (unaudited) and 402,351,657 shares at        December 31, 2019	*)   -			*)   -		*)   -		*)   -
Share premium	73,867			179,987		262,729		73,697
Accumulated deficit	(92,690)			(210,578)		(324,033)		(90,893)
	(18,823)			(30,591)		(61,304)		(17,196)
	33,493			99,359		87,832		24,637

 

 

STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
In thousands, except share and per share data
							Convenience
							translation
							Three months
	Year ended		Three months ended		ended
	December 31,		March 31,		March 31,
	2019		2019		2020		2020
	Audited		Unaudited		Unaudited
	NIS		U.S. dollars
Operating expenses:
Research and development, net of       participations	68,645		5,732		19,068		5,348
Marketing, general and administrative	9,706		1,433		981		275
Total operating expenses	78,351		7,165		20,049		5,623
Operating loss	(78,351)		(7,165)		(20,049)		(5,623)
Financial income	4		9,754		16,502		4,629
Financial expense	(30,847)		(2,023)		(148)		(42)
Net income (loss) and total       comprehensive income (loss)	(109,194)		566		(3,695)		(1,036)
Basic and Diluted net income (loss)       per share	(0.33)		0.002		(0.01)		(0.002)
Weighted average number of shares       outstanding used to compute basic       and diluted income (loss) per share	326,651,721		261,419,599		408,596,752		408,596,752

 

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Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com 

 

 

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SOURCE BiondVax Pharmaceuticals Ltd.

FAQ

What were BiondVax's Q1 2020 financial results?

BiondVax reported total operating expenses of NIS 20.0 million, R&D expenses of NIS 19 million, and a net loss of NIS 3.7 million.

How did BiondVax's cash reserves change in Q1 2020?

As of March 31, 2020, BiondVax's cash and cash equivalents were NIS 42.5 million, down from NIS 72.4 million at the end of 2019.

What factors contributed to BiondVax's increased expenses in Q1 2020?

The increase in expenses was primarily due to costs related to the ongoing Phase 3 trial and scale-up at their manufacturing facility.

What impact did BiondVax's financial results have on BVXV stock?

The significant increase in losses and decline in cash reserves may negatively affect investor sentiment towards BVXV.