BiondVax Announces Second Quarter 2020 Financial Results

Rhea-AI Summary

BiondVax Pharmaceuticals Ltd. (BVXV) reported its Q2 2020 financial results, revealing a net loss of NIS 42 million (~$12.1 million), a decrease from NIS 47.4 million in Q2 2019. Total operating expenses fell to NIS 16 million (~$4.61 million) from NIS 19.7 million year-over-year, driven by reduced costs from a nearly completed pivotal Phase 3 trial and completion of its manufacturing facility. R&D expenses also decreased to NIS 11.9 million (~$3.4 million) from NIS 15.2 million. As of June 30, 2020, cash and cash equivalents stood at NIS 38.7 million (~$11.2 million), down from NIS 72.4 million at year-end 2019.

Positive

• Decrease in total operating expenses to NIS 16 million from NIS 19.7 million year-over-year.
• Reduced R&D expenses to NIS 11.9 million from NIS 15.2 million compared to Q2 2019.
• Completion of pivotal Phase 3 trial and manufacturing facility.

Negative

• Net loss of NIS 42 million, higher than expected.
• Cash and cash equivalents decreased significantly from NIS 72.4 million at December 31, 2019 to NIS 38.7 million.

JERUSALEM, Aug. 20, 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 second quarter financial results for the quarter ended June 30, 2020.

Second Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.466 (NIS/$US) as at June 30, 2020.

Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

• R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.
• Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.

The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 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.

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. 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			June 30,				June 30,
	2019			2019		2020		2020
	Audited			Unaudited				Unaudited
				N I S				U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents	72,467			33,916		38,752		11,181
Other receivables	656			1,258		2,467		712
	73,123			35,174		41,219		11,893
LONG–TERM ASSETS:
Property, plant and equipment	34,981			32,475		36,937		10,658
Right-of-use assets	7,136			7,610		6,662		1,922
Other long-term assets	510			510		891		257
	42,627			40,595		44,490		12,837
								-
	115,750			75,769		85,709		24,730
CURRENT LIABILITIES:
Trade payables	17,062			7,977		4,070		1,174
Operating lease liabilities	694			686		676		195
Other payables	1,203			1,348		1,609		464
	18,959			10,011		6,355		1,835
LONG–TERM LIABILITIES:
Liability in respect of government grants	14,812			14,621		12,686		3,660
Operating lease liabilities	6,809			7,076		6,457		1,863
Loan from others	123,780			110,971		122,041		35,211
Warrants	16,354			5,517		-		-
Severance pay liability, net	89			86		92		26
	161,844			138,271		141,276		40,760
SHAREHOLDERS' EQUITY:
Ordinary shares of no par value: Authorized:        600,000,000, 391,000,000 and        600,000,000 shares at June 30, 2020 and        2019 (unaudited) and December 31, 2019,        respectively; Issued and outstanding:        460,822,640, 261,419,599 and        402,351,657 shares at June 30, 2020 and        2019 (unaudited) and December 31, 2019,       respectively	*)   -			*)   -		*)   -		*)   -
Share premium	255,285			185,454		304,089		87,735
Accumulated deficit	(320,338)			(257,967)		(366,011)		(105,600)
	(65,053)			(72,513)		(61,922)		(17,865)
	115,750			75,769		85,709		24,730
*)            Represents less than NIS\USD 1.

 

 

 

STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
In thousands, except share and per share data
																		Convenience translation
		Year ended December 31,					Three months ended June 30,					Six months ended June 30,						Six months ended June 30,
		2019					2019		2020			2019			2020			2020
		Audited					Unaudited											Unaudited
		N I S																U.S. dollars
		(In thousands, except per share data)
Operating expenses:
Research and development, net of     participations			68,645			15,172			11,948				20,904			31,016		8,949
Marketing, general and administrative			9,706			4,518			4,139				5,951			5,120		1,477
Total operating expenses			78,351			19,690			16,087				26,855			36,136		10,426
																		-
Operating loss			(78,351)			(19,690)			(16,087)				(26,855)			(36,136)		(10,426)
Financial income			4			-			(11,291)				24			5,211		1,503
Financial expense			(30,847)			(27,699)			(14,600)				(19,992)			(14,748)		(4,255)
Net loss			(109,194)			(47,389)			(41,978)				(46,823)			(46,673)		(13,177)
Basic and diluted net loss per share     (NIS)			(0.33)			(0.18)			(0.10)				(0.18)			(0.11)		(0.03)
Weighted average number of shares     outstanding used to compute basic     and diluted loss per share			326,651,721			261,482,786			433,498,227				261,435,179			431,485,801		431,485,801

 

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SOURCE BiondVax Pharmaceuticals Ltd.

FAQ

What are BiondVax's Q2 2020 financial results?

BiondVax reported a net loss of NIS 42 million (~$12.1 million) and total operating expenses of NIS 16 million (~$4.61 million) for Q2 2020.

How did BiondVax's operating expenses change in Q2 2020?

Operating expenses decreased to NIS 16 million in Q2 2020 from NIS 19.7 million in Q2 2019.

What were the R&D expenses for BiondVax in Q2 2020?

R&D expenses amounted to NIS 11.9 million (~$3.4 million) in Q2 2020, down from NIS 15.2 million in Q2 2019.

What was BiondVax's cash position as of June 30, 2020?

BiondVax had cash and cash equivalents of NIS 38.7 million (~$11.2 million) as of June 30, 2020.