JERUSALEM, May 13, 2021 /PRNewswire/ -- BiondVax
Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical
company focused on developing, manufacturing and ultimately
commercializing products for the prevention and treatment of
infectious diseases and related illnesses, today published its
fourth quarter and full year financial results for the year ended
December 31, 2020 and provided a
business update.
Fourth Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to US$ is provided using the exchange rate of 3.215
(NIS/US$), the rate as of the close of business on December 31, 2020.
- Total operating expenses for the quarter were NIS 12.3 million ($3.2
million) compared with NIS 45.7
million for the fourth quarter of 2019.
- R&D expenses for the quarter amounted to NIS 7.8 million ($2.4
million) compared with NIS 37.6
million for the fourth quarter of 2019.
Full Year 2020 Financial Summary
- Total operating expenses for the year were NIS 68.2 million ($21.2
million) offset by other income of NIS 75.8 million ($23.4
million) due to the revaluation of the EIB loan compared
with NIS 78.3 million in
2019.
- R&D expenses for the year amounted to NIS 51.4 million ($16
million) compared with NIS 68.6
million in 2019.
As of December 31, 2020, BiondVax
had cash and cash equivalents of NIS
9.4 million ($2.9
million) compared to NIS 72.4
million as of December 31,
2019.
Following the balance sheet date, in February 2021 the Company completed a follow-on
offering on Nasdaq, providing total gross proceeds of approximately
$13.8 million and net proceeds after
fees and discounts of approximately $12.8
million. As of May 12, 2021,
the Company had cash and cash equivalents of NIS 46 million (approximately $14 million).
The complete financial results are available in
the Company's annual report on Form 20-F for the year ended
December 31, 2020, to be filed with
the Securities and Exchange Commission. A summary is included in
the tables below.
Recent Corporate Update
Following the October 23,
2020 announcement that the Phase 3 trial of M–001, our
universal influenza vaccine candidate, did not meet its efficacy
endpoints, BiondVax implemented the following actions:
- Appointed a new CEO: Mr. Amir
Reichman began serving as BiondVax's CEO on a full-time
basis March 2, 2021, taking over from
Dr. Ron Babecoff, who has continued to serve BiondVax as a senior
advisor to ensure a smooth transition. Most recently, Reichman
held senior leadership positions at the GSK Vaccine headquarters in
Belgium, including Head of Global
Vaccines Engineering Core Technologies and Asset Management, and
Senior Director Global GSK Vaccines Supply Chain.
- New Mission: As described in his March 23, 2021 CEO Letter to Shareholders,
Reichman explained that while previously BiondVax had been a one
product company, going forward the Company is implementing a
strategy to diversify its pipeline of products towards a new
mission: To help build a healthier and happier world by
developing, manufacturing and ultimately commercializing products
for the prevention and treatment of infectious diseases and related
illnesses.
- Financing: In February
2021, BiondVax completed a follow-on offering on Nasdaq with
total gross proceeds of approximately $13.8
million to strengthen the Company's balance sheet. These
additional funds will be used to support ongoing operating expenses
and implementation of the new corporate mission and strategy.
BiondVax continues to remain in close contact with its main
creditor, the European Investment Bank (EIB), to whom the Company
has a €24 million outstanding debt. The EIB is supportive of the
Company's ongoing efforts to reposition itself and to date has not
indicated an intent to recall the loan.
- Assets: The Company's highly advanced GMP vaccine
manufacturing facility in Jerusalem is being maintained by its highly
experienced staff as it seeks to expand its product asset pipeline
in the coming quarters.
Management Comment
Mr. Amir
Reichman, BiondVax's CEO, commented, "My team and the
Board are actively engaged in pursuing opportunities to diversify
our pipeline of assets in light of our new mission.
BiondVax's vaccine development, manufacturing, and clinical trial
experience, combined with our people's deep industry experience and
our highly advanced GMP vaccine manufacturing facility provide us
with an incredible untapped potential that I aim to realize over
the coming years. I look forward to leading BiondVax to the next
level."
Reichman continued, "I would like to
extend my personal appreciation and gratitude to our shareholders
for their support and belief in our new mission, vision and
strategy. Together with our employees, management, board and
others, I believe we have the capability to successfully grow
BiondVax even stronger financially while creating a diversified
portfolio of assets to both improve our offering to future
customers while reducing specific, single product risks."
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ:
BVXV) is a biopharmaceutical company focused on developing,
manufacturing and ultimately commercializing products for the
prevention and treatment of infectious diseases and related
illnesses. The Company had been developing M‑001, a novel influenza
vaccine candidate that was designed to provide multi-strain and
multi-season protection against current and future seasonal and
pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials
designed to test for immunogenicity, the Company was able to
demonstrate M-001 was effective in stimulating an immune response
to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3
clinical trial of M‑001 which failed to meet the trial's primary
and secondary efficacy endpoints. The Company is now pursuing
opportunities in the infectious disease space towards development
of a pipeline of diversified products and platforms.
Contact Details:
Company: Joshua E. Phillipson | +972 8 930 2529
| j.phillipson@biondvax.com
Investor Relations: Kenny Green (Israel) | +1 646 201 9246
| kgreen@edisongroup.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, including
statements regarding future business strategies that BiondVax may
explore. These forward-looking statements reflect 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 risk that
BiondVax may not be able to secure additional capital on attractive
terms, if at all; the risk that the European Investment Bank may
accelerate the loans under its finance contract with BiondVax; the
risk that BiondVax may not execute a strategic alternative to M-001
or implement a strategy that will diversify BiondVax's risk, and,
if executed, may not be successful; risks relating to the COVID-19
(coronavirus) pandemic; BiondVax's ability to acquire rights to
additional product opportunities; BiondVax's ability to enter into
collaborations on terms acceptable to BiondVax or at
all; timing of receipt of regulatory approval of BiondVax's
manufacturing facility in Jerusalem, if at all or when required; the
risk that the manufacturing facility will not be able to be used
for a wide variety of applications and other vaccine and treatment
technologies, and the risk that drug development involves a lengthy
and expensive process with uncertain outcomes. More detailed
information about the risks and uncertainties affecting the Company
is contained under the heading "Risk Factors" in the Company's
Annual Report on Form 20-F to be filed with the Securities and
Exchange Commission on March 13,
2021. BiondVax undertakes 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,
|
|
December
31,
|
|
|
|
|
2019
|
|
2020
|
|
2020
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
72,467
|
|
9,421
|
|
2,930
|
Other
receivables
|
|
|
|
656
|
|
1,204
|
|
375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,123
|
|
10,625
|
|
3,305
|
LONG–TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
|
|
|
34,981
|
|
39,607
|
|
12,319
|
Right-of-use
assets
|
|
|
|
7,136
|
|
6,206
|
|
1,930
|
Other long-term
assets
|
|
|
|
510
|
|
473
|
|
147
|
|
|
|
|
|
|
|
|
|
|
|
|
|
42,627
|
|
46,286
|
|
14,396
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,750
|
|
56,911
|
|
17,701
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
|
17,062
|
|
1,868
|
|
581
|
Current maturities of
lease liabilities
|
|
|
|
694
|
|
654
|
|
203
|
Loan from
others
|
|
|
|
-
|
|
60,421
|
|
18,793
|
Other
payables
|
|
|
|
1,203
|
|
1,246
|
|
388
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,959
|
|
64,189
|
|
19,965
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Liability in respect
of Government grants
|
|
|
|
14,812
|
|
-
|
|
-
|
Lease
Liabilities
|
|
|
|
6,809
|
|
6,088
|
|
1,894
|
Loan from
others
|
|
|
|
123,780
|
|
-
|
|
-
|
Warrants
|
|
|
|
16,354
|
|
-
|
|
-
|
Other
payables
|
|
|
|
-
|
|
1,135
|
|
353
|
Severance pay
liability, net
|
|
|
|
89
|
|
95
|
|
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161,844
|
|
7,318
|
|
2,276
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized: 600,000,000
shares at December 31, 2020 and 2019; Issued and
outstanding: 461,285,824 and 402,351,657, shares as of
December 31, 2020 and 2019, respectively
|
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
Share
premium
|
|
|
|
255,285
|
|
310,197
|
|
96,484
|
Accumulated
deficit
|
|
|
|
(320,338)
|
|
(324,793)
|
|
(101,024)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(65,053)
|
|
(14,596)
|
|
(4,540)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
115,750
|
|
56,911
|
|
17,701
|
*) Represents less
than 1 NISUSD
|
|
|
|
|
|
|
|
|
STATEMENTS OF
COMPREHENSIVE LOSS
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
translation
|
|
|
|
|
Year
ended
December
31,
|
|
Year
ended
December
31,
|
|
|
|
|
2018
|
|
2019
|
|
2020
|
|
2020
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
|
|
|
71,913
|
|
68,645
|
|
51,463
|
|
16,007
|
Marketing, general and
administrative
|
|
|
|
5,154
|
|
9,706
|
|
16,687
|
|
5,190
|
Other income
|
|
|
|
-
|
|
-
|
|
(75,484)
|
|
(23,479)
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses (income)
|
|
|
|
77,067
|
|
78,351
|
|
(7,334)
|
|
(2,282)
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
|
|
(77,067)
|
|
(78,351)
|
|
7,334
|
|
2,282
|
Financial
income
|
|
|
|
2,936
|
|
4
|
|
3,843
|
|
1,195
|
Financial
expense
|
|
|
|
(13,596)
|
|
(30,847)
|
|
(15,632)
|
|
(4,863)
|
|
|
|
|
|
|
|
|
|
|
|
Loss
|
|
|
|
(87,727)
|
|
(109,194)
|
|
(4,455)
|
|
(1,386)
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive
loss
|
|
|
|
(87,727)
|
|
(109,194)
|
|
(4,455)
|
|
(1,386)
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share
|
|
|
|
(0.34)
|
|
(0.33)
|
|
(0.01)
|
|
(0.003)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of shares
outstanding used to compute basic and
diluted loss per share
|
|
|
|
261,419,599
|
|
326,651,721
|
|
443,260,878
|
|
443,260,878
|
The notes in the Company's annual report on Form 20-F are an
integral part of the financial statements. The complete financial
results are available in the 20-F to be filed with the Securities
and Exchange Commission.
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SOURCE BiondVax Pharmaceuticals Ltd.