JERUSALEM, Jan. 28, 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 announced its
third quarter financial results for the quarter ended September 30, 2020.
Third Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience
translation to $US is provided using the exchange rate of 3.441
(NIS/$US) as at September 30,
2020.
Total operating income for the third quarter was NIS 55.6 million (approximately $16.1 million) compared with a total operating
loss of NIS 19.0 million for the
third quarter of 2019.
- R&D expenses, net of participations, for the third quarter
amounted to NIS 12.6 million
(approximately $ 3.7 million)
compared with NIS 16.1 million for
the third quarter of 2019.
- Net profit for the third quarter was NIS
55.3 million (approximately $ 16.1
million) compared to a net loss of NIS 19.4 million for the third quarter of
2019.
As of September 30, 2020, BiondVax
had cash and cash equivalents of NIS 24.8
million (approximately $7.2
million) compared to NIS 72.5
million as of December 31,
2019. At the currently anticipated burn rate going forward,
BiondVax has sufficient funds to continue operations through the
end of Q2 2021.
Recent Business Updates:
- On October 23, 2020, BiondVax
announced that the Phase 3 clinical trial of the Company's M–001
universal flu vaccine candidate failed to meet the trial's primary
and secondary efficacy endpoints.
- On January 21, 2021, BiondVax
announced the appointment of Amir
Reichman as its new CEO. Reichman currently serves as Head
of Global Vaccines Engineering Core Technologies and Asset
Management at GSK Vaccines headquarters in Belgium.
- In light of the Phase 3 clinical trial results, Company's
management estimates that there will be no future revenues from the
M-001. Therefore, most likely, there will be no future royalty
payments to the Israel Innovation Authority (IIA) & European
Investment Bank (EIB). The operating income and net profit noted in
these Q3 2020 financial results are attributable primarily to the
revaluation of the liabilities to the IIA and EIB on the Company's
balance sheet in accordance with applicable IFRS standards, offset
by R&D, Marketing, and G&A expenses.
- BiondVax is currently pursuing collaborations and other
opportunities in the infectious disease space, including exploring
several alternatives for development of a new product
pipeline.
*Tables to follow*
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a
biopharmaceutical company focused on developing, manufacturing and
ultimately commercializing products for the prevention of
infectious diseases and related illnesses. The Company had been
developing M–001, a novel flu 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 flu 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, including exploring
several alternatives for development of a pipeline of assets. 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, including statements regarding
future business strategies that BiondVax may explore. 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, that BiondVax does not have
sufficient cash to operate its business for the next 12 months,
which raises substantial doubt about its ability to continue as a
going concern; the risk that BiondVax may not be able to secure
capital on attractive terms, if at all; the risk that BiondVax is
currently exploring new business strategies after its M-001
universal flu vaccine candidate failed to meet the Phase 3 trial's
primary and secondary efficacy endpoints; 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; 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 us or at all; receipt,
if and when provided, of regulatory approval of BiondVax's
manufacturing facility in Jerusalem; the risk that drug development
involves a lengthy and expensive process with uncertain outcomes;
and the ability of the Company to maintain, preserve and defend its
intellectual property and patents granted. 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 for the year ended December 31, 2019 and other filings filed with
the U.S. Securities and Exchange Commission, or SEC, which is
available on the SEC's website, www.sec.gov. The Company 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,
|
|
|
September 30,
|
|
September
30,
|
|
2019
|
|
|
2019
|
|
2020
|
|
2020
|
|
Audited
|
|
|
Unaudited
|
|
Unaudited
|
|
|
|
|
N I
S
|
|
U.S.
dollars
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
72,467
|
|
|
75,247
|
|
24,774
|
|
7,200
|
Other
receivables
|
656
|
|
|
1,887
|
|
2,930
|
|
851
|
|
|
|
|
|
|
|
|
|
|
73,123
|
|
|
77,134
|
|
27,704
|
|
8,051
|
LONG–TERM
ASSETS:
|
|
|
|
|
|
|
|
|
Property, plant and
equipment
|
34,981
|
|
|
34,324
|
|
39,889
|
|
11,592
|
Right-of-use
assets
|
7,136
|
|
|
7,371
|
|
6,433
|
|
1,870
|
Other long-term
assets
|
510
|
|
|
507
|
|
891
|
|
259
|
|
|
|
|
|
|
|
|
|
|
42,627
|
|
|
42,202
|
|
47,213
|
|
13,721
|
|
|
|
|
|
|
|
|
-
|
|
115,750
|
|
|
119,336
|
|
74,917
|
|
21,772
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
17,062
|
|
|
1,552
|
|
8,213
|
|
2,387
|
|
Operating lease
liabilities
|
694
|
|
|
697
|
|
653
|
|
190
|
|
Other
payables
|
1,203
|
|
|
820
|
|
2,289
|
|
665
|
|
|
|
|
|
|
|
|
|
|
|
|
18,959
|
|
|
3,069
|
|
11,155
|
|
3,242
|
|
LONG–TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
|
Liability in respect of
government grants
|
14,812
|
|
|
14,454
|
|
-
|
|
-
|
|
Operating lease
liabilities
|
6,809
|
|
|
6,898
|
|
6,268
|
|
1,821
|
|
Loan from
others
|
123,780
|
|
|
108,353
|
|
59,242
|
|
17,217
|
|
Warrants
|
16,354
|
|
|
6,908
|
|
-
|
|
-
|
|
Severance pay
liability, net
|
89
|
|
|
87
|
|
93
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
161,844
|
|
|
136,700
|
|
65,603
|
|
19,065
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
|
|
|
|
|
|
|
Ordinary shares of no
par value: Authorized:
600,000,000 shares at September 30,
2020
and 2019 (unaudited) and December
31,
2019; Issued and
outstanding:
461,451,767, 460,822,640
and
402,351,657 shares at September 30,
2020
and 2019 (unaudited) and December
31,
2019, respectively
|
*)
-
|
|
|
*)
-
|
|
*)
-
|
|
*)
-
|
|
Share
premium
|
255,285
|
|
|
256,889
|
|
308,855
|
|
89,757
|
|
Accumulated
deficit
|
(320,338)
|
|
|
(277,322)
|
|
(310,696)
|
|
(90,292)
|
|
|
|
|
|
|
|
|
|
|
|
|
(65,053)
|
|
|
(20,433)
|
|
(1,841)
|
|
(535)
|
|
|
|
|
|
|
|
|
|
|
|
|
115,750
|
|
|
119,336
|
|
74,917
|
|
21,772
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*)
Represents less than NISUSD 1.
|
|
|
|
|
|
STATEMENTS OF
COMPREHENSIVE INCOME (LOSS)
|
|
In thousands,
except share and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convenience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine
months
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ended
|
|
|
|
Year
ended
|
|
Three months
ended
|
|
Nine months
ended
|
|
September
|
|
|
|
December
31,
|
|
September
30,
|
|
September
30,
|
|
30,
|
|
|
|
2019
|
|
2019
|
|
2020
|
|
2019
|
|
2020
|
|
2020
|
|
|
|
Audited
|
|
Unaudited
|
|
Unaudited
|
|
|
|
N I
S
|
|
U.S.
dollars
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development, net of
participations
|
|
68,645
|
|
16,133
|
|
12,579
|
|
37,037
|
|
43,595
|
|
12,668
|
|
Marketing, general
and administrative
|
|
9,706
|
|
2,790
|
|
7,303
|
|
8,741
|
|
12,423
|
|
3,610
|
|
Other
income
|
|
-
|
|
-
|
|
75,485
|
|
-
|
|
75,485
|
|
21,937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
income (expenses)
|
|
(78,351)
|
|
(18,923)
|
|
55,603
|
|
(45,778)
|
|
19,467
|
|
5,657
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating gain
(loss)
|
|
(78,351)
|
|
(18,923)
|
|
55,603
|
|
(45,778)
|
|
19,467
|
|
5,657
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
income
|
|
4
|
|
169
|
|
-
|
|
193
|
|
5,034
|
|
1,463
|
|
Financial
expense
|
|
(30,847)
|
|
(601)
|
|
(288)
|
|
(20,593)
|
|
(14,859)
|
|
(4,318)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
|
(109,194)
|
|
(19,355)
|
|
55,315
|
|
(66,178)
|
|
9,642
|
|
2,802
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per share (NIS)
|
|
(0.33)
|
|
(0.05)
|
|
0.12
|
|
(0.23)
|
|
0.02
|
|
0.006
|
|
Diluted net income
(loss) per share
(NIS)
|
|
(0.33)
|
|
(0.05)
|
|
0.10
|
|
(0.23)
|
|
0.02
|
|
0.006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of shares
outstanding used to compute
basic
income (loss) per share
|
|
326,651,721
|
|
377,899,911
|
|
461,046,640
|
|
290,794,601
|
|
437,381,202
|
|
437,393,465
|
|
Weighted average
number of shares
outstanding used to compute
diluted
income (loss) per share
|
|
326,651,721
|
|
377,899,911
|
|
538,495,403
|
|
290,794,601
|
|
497,489,765
|
|
497,489,765
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE BiondVax Pharmaceuticals Ltd.