- PreHevbrio (Hepatitis B Vaccine [Recombinant]) global net
revenue increased 48% quarter-over-quarter from Q1 to Q2 2023 -
redefined, highly targeted commercial field team deployed at the
end of Q2
- Expanded hepatitis B collaboration with Brii Biosciences
announced in July for $15 million upfront, including a $3 million
equity investment, and up to $422 million in potential additional
milestones plus double-digit royalties
- Additional $20.5 million gross proceeds from underwritten
public offering added to balance sheet in July
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today provided a business update and
announced financial results for the quarter ended June 30,
2023.
“Q2 was a period of transition for VBI as we worked to more
efficiently align resource deployment and headcount with the
opportunities for value creation,” said Jeff Baxter, VBI’s
President and CEO. “With, (i) the expansion of our hepatitis B
partnership with Brii Biosciences, (ii) our internal workforce
reduction largely complete, (iii) the redefined, highly targeted
U.S. commercial field force now trained and deployed, and (iv) the
additional cash we brought in from our expanded partnership with
Brii and our concurrent public offering, we believe we are
well-positioned going into the second half of 2023 to execute on
our corporate strategy and drive growth and value for key
stakeholders – patients, healthcare providers, and
shareholders.”
Recent Key Program Achievements and Projected Upcoming
Milestones
Hepatitis B (HBV)
PreHevbrio [Hepatitis B Vaccine (Recombinant)]
- Global access continues to expand with:
- June & July 2023: Launches in the U.K., Netherlands,
and Belgium through our marketing and distribution partnership with
Valneva – brand name PreHevbri® [Hepatitis B Vaccine (Recombinant,
Adsorbed)]
- July 2023: Exclusive licensing deal with Brii
Biosciences (Brii Bio) announced for the development and
commercialization of PreHevbri in the Asia Pacific region (APAC),
excluding Japan
- Global net product sales increased 48% from Q1 2023 with $0.7
million earned in Q2 2023
- Net product sales are net of the provision for discounts,
chargebacks, rebates, and fees – in the aggregate, these discounts
reduced sales by $0.5 million in Q2 2023, from $1.2 million gross
sales to $0.7 million net sales
- June 2023: PreHevbrio was awarded part of the CDC 2023
Adult Vaccine contract for up to $25.4 million
- The CDC vaccine contract is established for the purchase of
vaccines by immunization programs at the local, state, and national
levels
- Through our U.S. partnership with Syneos, work has been
underway to redefine the U.S. commercial account targeting strategy
to better capitalize on the opportunities for, and access to,
PreHevbrio, today – the transition to this new model started in
February and was completed in June, with the new highly trained and
experienced team now fully deployed
- Continued increase in use reflected among accounts that have
made the switch to PreHevbrio, with a 46% increase in average order
size from Q1 to Q2 2023 among such accounts
- Contracting platform across multiple market segments continues
to grow, including with retail partners, Integrated Delivery
Networks (IDNs) and large hospital systems, military and federal
facilities, prisons, and independent and public health clinics
- U.S. coverage rates continue to be strong for
PreHevbrio-specific Current Procedural Terminology (CPT) code
across Medicare, commercial, and state Medicaid plans
- Throughout H2 2023: Additional European market launches
expected through partnership with Valneva
- H1 2024: Availability expected in Canada under brand
name PreHevbrio [3-Antigen Hepatitis B Vaccine (Recombinant)]
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate
- July 2023: Announced exclusive global licensing
agreement with Brii Bio for the development and commercialization
of VBI-2601
- This expanded partnership adds VBI-2601 to Brii Bio’s HBV
portfolio, which, through a series of strategic investments and
partnerships is among the most advanced in the chronic HBV
field
- VBI will continue to share in the success of VBI-2601, with the
potential to receive regulatory and commercial milestone payments,
in addition to potential double-digit royalties on global sales of
VBI-2601
- Additional data from the two ongoing Phase 2 studies in China
and Asia Pacific are expected to be announced by Brii Bio in H2
2023
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
- Q3 2023: First patients expected to be dosed in Phase 2b
study of VBI-1901, an FDA Fast Track and Orphan Drug Designated
cancer vaccine candidate, in recurrent GBM patients
- Q4 2023: Expected initiation of VBI-1901 study arm, as
part of the Individualized Screening Trial of Innovative
Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial,
in combination with Agenus’ anti-PD-1, balstilimab, in primary GBM
patients
COVID-19 & Coronaviruses
VBI-2901: Multivalent Coronavirus Vaccine Candidate
- Q3 2023: Interim data readout from Phase 1 study of
VBI-2901 expected – VBI-2901 is a multivalent, broad-spectrum eVLP
vaccine candidate that expresses the SARS-CoV-2 (COVID-19),
SARS-CoV-1 (SARS), and MERS-CoV (MERS) spike proteins, and was
designed to increase breadth of protection against COVID-19 and
related coronaviruses. VBI-2901 has been developed in collaboration
with the National Research Council of Canada (NRC) and is supported
by funding from the Canadian Government’s Innovation, Science and
Economic Development’s (ISED) Strategic Innovation Fund
Second Quarter 2023 Financial Results
- Cash Position: VBI ended the second quarter of 2023 with
$20.8 million in cash as compared with $62.6 million in cash as of
December 31, 2022. Cash position at June 30, 2023 does not include
$15 million upfront payment, including $3 million equity
investment, from the expanded Brii Bio partnership or $20.5 million
gross proceeds from the underwritten public offering, both of which
occurred in July 2023.
- Revenues, net: Revenues, net for the second quarter of
2023 were $0.7 million as compared to $0.3 million for the same
period in 2022. The revenue increase of 108% was a result of an
increase in product sales of PreHevbrio in the U.S., in addition to
initial European product sales of PreHevbri to our partner,
Valneva.
- Cost of Revenues: Cost of revenues was $3.5 million in
the second quarter of 2023 as compared to $2.5 million in the
second quarter of 2022. The increase in the cost of revenues was
due to increased product sales, direct labor costs, and inventory
related costs for the Company’s 3-antigen HBV vaccine.
- Research and Development (R&D): R&D expenses for
the second quarter of 2023 were $3.3 million as compared to $5.6
million for the second quarter of 2022. R&D expenses were
offset by $2.3 million in the second quarter of 2023 and $1.0
million in the second quarter of 2022 from government grants and
funding arrangements.
- Sales, General, and Administrative (SG&A): SG&A
expenses for the second quarter of 2023 were $10.9 million as
compared to $15.1 million for the same period in 2022. The decrease
in SG&A expenses, partially offset by government grants and
funding arrangements, was mainly a result of recent organizational
changes that reduced our internal workforce, as announced in April
2023, and the redefined deployment strategy of our U.S. commercial
field force and activities related to PreHevbrio.
- Net Cash Used in Operating Activities: Net cash used in
operating activities for the six months ended June 30, 2023 was
$40.9 million compared to $37.4 million for the same period in
2022. The increase in cash outflows is largely a result of an
increase in net loss, offset by non-cash reconciling items, mainly
impairment charges and unrealized foreign exchange loss and the
change in operating working capital, most notably in other current
assets, accounts payable and other current liabilities. As
announced on April 4, 2023, VBI continues to implement cost saving
measures that are expected to reduce operating expenses from normal
business in the second half of 2023 by 30-35% compared to the
second half of 2022.
- Net Loss and Net Loss Per Share: Net loss and net loss
per share for the second quarter of 2023 were $44.6 million and
$5.18, respectively, compared to a net loss and net loss per share
of $45.7 million and $5.31 for the second quarter of 2022,
respectively.
- Net Loss and Net Loss Per Share, Excluding Impairment
Charges and Foreign Exchange Loss: Net loss and net loss per
share, excluding the non-cash impairment and foreign exchange loss,
for the second quarter of 2023 were $18.7 million and $2.17,
respectively, compared to $23.8 million and $2.77 for the second
quarter of 2022, respectively. See “Non-GAAP Financial Information”
below for additional information regarding this non-GAAP financial
measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation
of this non-GAAP financial measure to net loss and net loss per
share.
- Impairment for the second quarter of 2023 was $20.0 million as
compared to $0 for the second quarter of 2022.
- Foreign exchange loss for the second quarter of 2023 was $5.9
million as compared to $21.9 million for the second quarter of
2022. Certain intercompany loans between the Company and its
subsidiaries are denominated in a currency other than the
functional currency of each entity. The primary driver of the
increase in foreign exchange loss was the impact of the relative
strengthening of the U.S. and Canadian Dollars against the New
Israeli Shekel upon translation of these intercompany loans.
Use of Non-GAAP Financial Measures
Net Loss Excluding Foreign Exchange Loss and Impairment Charges
and Net Loss per Share Excluding Foreign Exchange Loss and
Impairment Charges are non-GAAP financial measures and are defined
as net loss excluding foreign exchange loss and impairment charges.
Net Loss and Net Loss Per Share, Excluding Impairment and Foreign
Exchange Loss is not intended to replace net loss or net loss per
share or other measures of financial performance reported in
accordance with generally accepted accounting principles (GAAP).
VBI’s management believes that the presentation of Net Loss
Excluding Foreign Exchange Loss and Impairment Charges and Net Loss
per Share Excluding Foreign Exchange Loss and Impairment Charges
are useful to investors because management does not consider
foreign exchange loss, which is primarily driven by changes in
exchange rates related to certain intercompany loans, and
impairment charges, which are non-recurring items, when evaluating
VBI’s operating performance. Non-GAAP financial measures are meant
to supplement, and to be viewed in conjunction with, GAAP financial
results. The presentation of these non-GAAP financial measures
should not be considered in isolation or as a substitute for
comparable GAAP financial measures and should be read only in
conjunction with the Company’s financial statements prepared in
accordance with GAAP. Reconciliations of the Company’s non-GAAP
measures are included below.
The following represents a reconciliation of Net Loss to Net
Loss Excluding Impairment Charges and Foreign Exchange Loss and Net
Loss per Share Excluding Foreign Exchange Loss. See “Non-GAAP
Financial Information” below for additional information regarding
this non-GAAP financial measure, and “GAAP to Non-GAAP
Reconciliation” for a reconciliation of this non-GAAP financial
measure to net loss and net loss per share.
Three Months Ended June
30
2023
2022
(Unaudited)
(In 000’s except share and per
share amounts)
Net Loss
$
(44,628)
$
(45,699)
Impairment charges
(20,000)
-
Foreign exchange loss
(5,948)
(21,895)
Net loss excluding foreign
exchange loss and impairment charges
$
(18,680)
$
(23,804)
Weighted-average number of
shares
8,608,539
8,608,539
Net loss per share excluding
foreign exchange loss and impairment charges
$
(2.17)
$
(2.77)
About PreHevbrio [Hepatitis B Vaccine
(Recombinant)]
PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised
of the three surface antigens of the hepatitis B virus – S, pre-S1,
and pre-S2. It is approved for use in the U.S., European
Union/European Economic Area, United Kingdom, Canada, and Israel.
The brand names for this vaccine are: PreHevbrio® (US/Canada),
PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).
Please visit www.PreHevbrio.com for U.S. Important Safety
Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or
please see U.S. Full Prescribing Information.
U.S. Indication
PreHevbrio is indicated for prevention of infection caused by
all known subtypes of hepatitis B virus. PreHevbrio is approved for
use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of
severe allergic reaction (e.g. anaphylaxis) after a previous dose
of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available
to manage possible anaphylactic reactions following administration
of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant
therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a
long incubation period, in individuals who have an unrecognized
hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44,
adults age 45-64, and adults age 65+ were pain and tenderness at
the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy
outcomes in women who received PreHevbrio during pregnancy. Women
who receive PreHevbrio during pregnancy are encouraged to contact
1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at
1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or
www.vaers.hhs.gov.
Please see Full Prescribing Information.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven
by immunology in the pursuit of powerful prevention and treatment
of disease. Through its innovative approach to virus-like particles
(“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform
technology, VBI develops vaccine candidates that mimic the natural
presentation of viruses, designed to elicit the innate power of the
human immune system. VBI is committed to targeting and overcoming
significant infectious diseases, including hepatitis B,
coronaviruses, and cytomegalovirus (CMV), as well as aggressive
cancers including glioblastoma (GBM). VBI is headquartered in
Cambridge, Massachusetts, with research operations in Ottawa,
Canada, and a research and manufacturing site in Rehovot,
Israel.
Website Home: http://www.vbivaccines.com/ News and Resources:
http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking
Information
Certain statements in this press release that are
forward-looking and not statements of historical fact are
forward-looking statements within the meaning of the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and are forward-looking information within the meaning of Canadian
securities laws (collectively, “forward-looking statements”). The
Company cautions that such forward-looking statements involve risks
and uncertainties that may materially affect the Company’s results
of operations. Such forward-looking statements are based on the
beliefs of management as well as assumptions made by and
information currently available to management. Actual results could
differ materially from those contemplated by the forward-looking
statements as a result of certain factors, including but not
limited to, the impact of general economic, industry or political
conditions in the United States or internationally; the impact of
the COVID-19 pandemic and the continuing effects of the COVID-19
pandemic on our clinical studies, manufacturing, business plan, and
the global economy; the ability to successfully manufacture and
commercialize PreHevbrio/PreHevbri; the ability to establish that
potential products are efficacious or safe in preclinical or
clinical trials; the ability to establish or maintain
collaborations on the development of pipeline candidates and the
commercialization of PreHevbrio/PreHevbri; the ability to obtain
appropriate or necessary regulatory approvals to market potential
products; the ability to obtain future funding for developmental
products and working capital and to obtain such funding on
commercially reasonable terms; the Company’s ability to manufacture
product candidates on a commercial scale or in collaborations with
third parties; changes in the size and nature of competitors; the
ability to retain key executives and scientists; and the ability to
secure and enforce legal rights related to the Company’s products.
A discussion of these and other factors, including risks and
uncertainties with respect to the Company, is set forth in the
Company’s filings with the SEC and the Canadian securities
authorities, including its Annual Report on Form 10-K filed with
the SEC on March 13, 2023, and filed with the Canadian security
authorities at sedar.com on March 13, 2023, as may be supplemented
or amended by the Company’s Quarterly Reports on Form 10-Q. Given
these risks, uncertainties and factors, you are cautioned not to
place undue reliance on such forward-looking statements, which are
qualified in their entirety by this cautionary statement. All such
forward-looking statements made herein are based on our current
expectations and we undertake no duty or obligation to update or
revise any forward-looking statements for any reason, except as
required by law.
VBI Vaccines Inc. and
Subsidiaries
Selected Condensed
Consolidated Balance Sheet
(In Thousands)
June 30, 2023
December 31, 2022
(Unaudited)
Assets
Cash
$
20,840
$
62,629
Accounts receivable, net
79
94
Inventory, net
6,861
6,599
Prepaid expenses and other
current assets
4,111
8,368
Total current assets
31,891
77,690
Property and equipment, net
10,104
12,253
Intangible assets, net
40,339
58,345
Goodwill
2,175
2,127
Other non-current assets
3,813
4,671
Total Assets
$
88,322
$
155,086
Liabilities and stockholders’
equity
Accounts payable
$
7,353
$
12,973
Other current liabilities
20,321
23,969
Total current liabilities
27,674
36,942
Total non-current liabilities
51,910
53,981
Total liabilities
79,584
90,923
Total stockholders' equity
8,738
64,163
Total liabilities and
stockholders' equity
$
88,322
$
155,086
VBI Vaccines Inc. and
Subsidiaries
Condensed Consolidated
Statement of Operations and Comprehensive Loss
(In Thousands Except Share and
Per Share Amounts)
Three Months Ended June
30
Six Months Ended June
30
2023
2022
2023
2022
(Unaudited)
Revenues, net
$
720
$
346
$
1,205
$
472
Operating expenses
Cost of revenue
3,483
2,522
7,039
5,276
Research and development
3,292
5,643
6,446
8,005
Sales, general and
administrative
10,917
15,084
24,201
26,014
Impairment charges
20,000
-
20,000
-
Total operating expenses
36,579
23,249
57,686
37,692
Loss from operations
(36,972)
(22,903)
(56,481)
(38,823)
Interest income (expense),
net
(1,708)
(901)
(3,137)
(1,841)
Foreign exchange gain (loss)
(5,948)
(21,895)
(12,761)
(26,289)
Loss before income taxes
(44,628)
(45,699)
(72,379)
(66,953)
Income tax benefit
-
-
-
-
Net Loss
$
(44,628)
$
(45,699)
$
(72,379)
$
(66,953)
Basic and diluted net loss per
share
$
(5.05)
$
(5.31)
$
(8.41)
$
(5.18)
Weighted-average number of shares
used to compute basic and diluted net loss per share
8,608,539
8,608,539
8,608,539
8,608,526
Other comprehensive income (loss)
- currency translation adjustments
6,670
19,236
13,269
24,339
Comprehensive Loss
$
(37,958)
$
(26,463)
$
(59,110)
$
(42,614)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230814872763/en/
VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
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