- Q3 marked a meaningful quarter for partnerships with a recently
announced prophylactic hepatitis B commercialization collaboration
in certain European countries with Valneva, and a clinical
collaboration in glioblastoma with Agenus
- PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], launched in
the U.S. at the end of Q1 2022, is advancing through commercial
stage gates required to enable broad access to the vaccine
- First clinical study of VBI-2901 initiated in September 2022 –
multivalent candidate designed to increase breadth of protection
against COVID-19 and coronaviruses
- Upsized and refinanced debt facility of up to $100 million with
K2 HealthVentures announced in September 2022
- $83.6 million in cash at the end of Q3 2022
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical
company driven by immunology in the pursuit of powerful prevention
and treatment of disease, today announced financial results for the
third quarter ended September 30, 2022, and provided a corporate
update.
Jeff Baxter, VBI’s President and CEO commented:
“Our second quarter of the U.S. launch of PreHevbrio saw
continued progress as our field teams worked to raise awareness of
the new CDC adult hepatitis B (HBV) vaccination recommendations and
the value proposition of our differentiated 3-antigen HBV vaccine.
The launch is proceeding as planned, and we are pleased with the
increased excitement, clinical demand, and overall reception our
field teams have received. We have continued the implementation of
critical market access and contracting infrastructure, all of which
are key pieces of the initial groundwork needed to support mid-term
commercial success.
“Outside of the U.S., we were very pleased to announce a
marketing and distribution partnership with Valneva in certain
European countries, and we look forward to working with their team
to provide access to PreHevbri in these countries beginning in
early 2023. For the rest of our pipeline, we continue to advance
our lead candidates targeting chronic HBV, glioblastoma (GBM), and
coronaviruses, and look forward to the anticipated meaningful
clinical readouts and regulatory milestones in each program.”
Recent Key Program Achievements and Projected Upcoming
Milestones
Hepatitis B (HBV)
Prophylactic Hepatitis B
Vaccine
- Notable commercial achievements for PreHevbrio in the U.S. over
the past several months include:
- 70% of Medicare-insured lives, 70% of commercially insured
lives, and 60% of lives under state Medicaid plans are estimated to
have coverage in place for the PreHevbrio specific Current
Procedural Terminology (CPT) code
- Sales have been recorded in over 90% of our target
territories
- September 2022: Following marketing authorization in the
European Union/European Economic Area and in the United Kingdom,
under the brand name PreHevbri® [Hepatitis B vaccine (recombinant,
adsorbed)], VBI and Valneva announced a marketing and authorization
partnership in select European markets – these markets initially
include the U.K., Sweden, Norway, Denmark, Finland, Belgium, and
the Netherlands
- Beginning early 2023: VBI and Valneva expect to make PreHevbri
available in certain European countries
- Regulatory filing under review by Health Canada
VBI-2601 (BRII-179): HBV Immunotherapeutic
Candidate
- Year-end 2022: Interim topline data expected from Phase 2 human
proof of concept combination study evaluating safety and efficacy
of VBI-2601 (BRII-179) with BRII-835 (VIR-2218), an HBV-targeting
siRNA
- Q3 2023: Interim topline results expected from part one of the
two-part Phase 2a/2b combination study evaluating VBI-2601
(BRII-179) as an add-on to existing pegylated interferon
(PEG-IFN-α) and nucleos(t)ide reverse transcriptase inhibitor
(Nrtl) therapy in non-cirrhotic chronic HBV patients
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic
Candidate
- Early 2023: Expected initiation of next phase of development in
recurrent GBM setting, aiming to expand the number of patients in
the ongoing Phase 1/2a study and adding a randomized control arm,
with the potential for accelerated approval based on tumor response
rates and improvement in overall survival
- Early 2023: Evaluation of VBI-1901 in combination with Agenus’
anti-PD-1, balstilimab, in the primary GBM setting expected to
initiate as part of the Individualized Screening Trial of
Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive
platform trial
COVID-19 & Coronaviruses
VBI-2901: Multivalent Coronavirus Vaccine
Candidate
- Mid-year 2023: Interim data expected from Phase 1 study of
VBI-2901, subject to speed of enrollment
Additional Corporate Updates
- Management Appointment: John Dillman appointed as VBI’s Chief
Commercial Officer in July 2022
- Debt Financing: In September 2022, VBI closed a refinanced and
upsized debt facility of up to $100 million with existing lender,
K2 HealthVentures (K2HV), adding $20 million of non-dilutive
funding to the balance sheet
Third Quarter 2022 Financial Results
- Cash Position: VBI ended the third quarter of 2022 with
$83.6 million in cash compared with $121.7 million in cash as of
December 31, 2021.
- Revenue: Revenue, net for the third quarter of 2022 was
$0.3 million, compared to $0.1 million for the same period in 2021.
The increase was due to an increase in U.S. product revenue related
to the launch of PreHevbrio in the U.S.
- Cost of Revenue: Cost of revenues was $2.7 million in
the third quarter of 2022 as compared to $2.5 million in the third
quarter of 2021. The increase was due primarily to manufacturing
costs for our 3-antigen HBV vaccine related to inventory build for
the U.S. market and preparation for European launches.
- Research and Development (R&D): R&D expenses for
the third quarter of 2022 were $5.0 million compared to $3.0
million for the same period in 2021. R&D expenses were offset
by $2.4 million in the third quarter of 2022 and $5.1 million in
the third quarter of 2021 due to government grants and funding
arrangements. The increase in R&D expenses was mainly driven by
the advancement of VBI-1901 as we prepare for the next clinical
studies in recurrent and primary GBM patients.
- General and Administrative (G&A): G&A expenses
for the third quarter of 2022 were $14.2 million compared to $9.7
million for the same period in 2021. The increase in G&A
expenses, partially offset by government grants and funding
arrangements, was a result of the increased commercial activities
related to PreHevbrio, most notably the deployment of our
promotional field team and development of our distribution
infrastructure. Additional increased costs include increased
insurance costs, increased professional costs, and increased labor
costs.
- Net Cash Used in Operating Activities: Net cash used in
operating activities for the nine months ended September 30, 2022
was $54.7 million, compared to $21.4 million for the same period in
2021. The increase was largely due to commercial expenses for the
launch of PreHevbrio in the U.S., a decrease in net change in
operating working capital related to purchase of inventory for
commercial production of PreHevbrio, and $18.4 million of cash
advanced from CEPI pursuant to the CEPI Funding Agreement during
the nine months ended September 30, 2021, compared to $1.0 million
cash advanced from the CEPI Funding Agreement for the same period
in 2022.
- Net Loss and Net Loss Per Share: Net loss and net loss
per share for the third quarter of 2022 were $25.2 million and
$0.10, respectively, compared to a net loss of $15.9 million and a
net loss per share of $0.06 for the third quarter of 2021.
- Net Loss and Net Loss Per Share, Excluding Foreign Exchange
Loss: Net loss and net loss per share, excluding foreign
exchange loss, for the third quarter of 2022 were $22.5 million and
$0.09, respectively, compared to a net loss and a net loss per
share, excluding foreign exchange loss, of $16.0 million and $0.06
for the third quarter of 2021. Foreign exchange loss for the third
quarter of 2022 was $2.7 million as compared to a gain of $0.2
million for the third quarter of 2021. Certain intercompany loans
between VBI Vaccines Inc. and our 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 Net Loss per Share
Excluding Foreign Exchange Loss are non-GAAP financial measures.
VBI’s management believes that the presentation of Net Loss
Excluding Foreign Exchange Loss and Net Loss per Share Excluding
Foreign Exchange Loss is 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,
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 Foreign Exchange Loss and Net Loss per Share
Excluding Foreign Exchange Loss.
Three Months Ended September
30
Nine Months Ended September
30
2022
2021
2022
2021
(Unaudited, in 000’s except share
and per share amounts)
Net Loss
$
(25,209
)
$
(15,847
)
$
(92,162
)
$
(50,970
)
Foreign exchange (loss) gain
(2,693
)
203
(28,982
)
(127
)
Net loss excluding foreign
exchange loss
$
(22,516
)
$
(16,050
)
$
(63,180
)
$
(50,843
)
Weighted-average number of
shares
258,257,494
256,360,356
258,257,229
254,055,707
Net loss per share excluding
foreign exchange loss
$
(0.09
)
$
(0.06
)
$
(0.24
)
$
(0.20
)
About PreHevbrio™
VBI’s hepatitis B vaccine is the only 3-antigen hepatitis B
vaccine, comprised of the three hepatitis B surface antigens of the
hepatitis B virus – S, pre-S1, and pre-S2. It is approved for use
in the United States, European Union/European Economic Area, United
Kingdom, and Israel. The brand names for this vaccine are:
PreHevbrio™ (US), 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 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 ongoing COVID-19 pandemic and the ongoing 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 7, 2022, and filed with the
Canadian security authorities at sedar.com on March 7, 2022, 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)
September 30, 2022
December 31, 2021
(Unaudited)
Assets
Cash and cash equivalents
$
83,550
$
121,694
Accounts receivable, net
132
8
Inventory, net
5,796
2,576
Prepaid expenses and other
current assets
6,738
6,006
Total current assets
96,216
130,284
Property and equipment, net
11,149
11,037
Intangible assets, net
57,727
62,091
Goodwill
2,104
2,261
Other non-current assets
4,814
4,603
Total Assets
$
172,010
$
210,276
Liabilities and stockholder’s
equity
Accounts payable
$
11,666
$
4,280
Other current liabilities
23,015
28,306
Total current liabilities
34,681
32,586
Total non-current liabilities
53,512
33,808
Total liabilities
88,193
66,394
Total stockholders' equity
83,817
143,882
Total liabilities and
stockholders' equity
$
172,010
$
210,276
VBI Vaccines Inc. and
Subsidiaries
Condensed Consolidated
Statement of Operations and Comprehensive Loss
(In Thousands Except Share and
Per Share Amounts)
Three Months Ended September
30
Nine Months Ended September
30
2022
2021
2022
2021
(Unaudited)
Revenues, net
$
317
$
107
$
789
$
550
Operating expenses
Cost of revenue
2,672
2,466
7,948
7,511
Research and development
4,983
2,972
12,988
14,392
General and administrative
14,220
9,693
40,234
25,807
Total operating expenses
21,875
15,131
61,170
47,710
Loss from operations
(21,558
)
(15,024
)
(60,381
)
(47,160
)
Interest income (expense),
net
(958
)
(1,026
)
(2,799
)
(3,683
)
Foreign exchange gain (loss)
(2,693
)
203
(28,982
)
(127
)
Loss before income taxes
(25,209
)
(15,847
)
(92,162
)
(50,970
)
Income tax benefit
-
-
-
-
Net Loss
$
(25,209
)
$
(15,847
)
$
(92,162
)
$
(50,970
)
Basic and diluted net loss per
share
$
(0.10
)
$
(0.06
)
$
(0.36
)
$
(0.20
)
Weighted-average number of shares
used to compute basic and diluted net loss per share
258,257,494
256,360,356
258,257,229
254,055,707
Other comprehensive income
(loss)
(494
)
(1,607
)
23,845
106
Comprehensive Loss
$
(25,703
)
$
(17,454
)
$
(68,317
)
$
(50,864
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110005335/en/
VBI Contact Nicole Anderson Director, Corporate
Communications & IR Phone: (617) 830-3031 x124 Email:
IR@vbivaccines.com
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From May 2023 to Jun 2023
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Jun 2022 to Jun 2023