- PreHevbrio (Hepatitis B Vaccine [Recombinant]) global net
revenue increased 52% quarter-over-quarter from Q2 to Q3 2023
- Continued execution across earlier-stage pipeline, including:
- Initiation of Phase 2b study of VBI-1901 in recurrent
glioblastoma (GBM) patients
- Interim Phase 1 data announced for pan-coronavirus candidate,
VBI-2901
- Novel mRNA-launched eVLP platform technology announced
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 September 30,
2023.
"In Q3, we were focused on pipeline execution with continued
revenue growth for PreHevbrio, meaningful data readouts and
clinical advancements of our lead development candidates, and the
announcement of a next-generation proprietary technology that
blends the benefits of our eVLP technology with those of mRNA
platforms,” said Jeff Baxter, VBI’s President and CEO.
“Additionally, in this period of challenging financial markets for
biotechnology companies, we are intensely focused on managing our
operating expenses and capital to fuel sustainable growth and value
for key stakeholders.”
Recent Key Program Achievements and Projected Upcoming
Milestones
Hepatitis B (HBV)
PreHevbrio [Hepatitis B Vaccine (Recombinant)]
- Global net product sales increased 52% from Q2 2023 with $1.1
million earned in Q3 2023
- Net product sales are net of the provision for discounts,
chargebacks, rebates, and fees – in the aggregate, these discounts
reduced sales by $0.6 million in Q3 2023, from $1.7 million gross
sales to $1.1 million net sales
- Quarter-over-quarter momentum continues to grow, with more than
a 10% increase in total customer base in Q3 as compared to Q2
2023
- Contracting network across multiple market segments also
continues to see growth, including with retail partners, Integrated
Delivery Networks (IDNs) and large hospital systems, multiple large
military and federal facilities, prisons, and independent and
public health clinics
- July 2023: Exclusive licensing deal with Brii
Biosciences (Brii Bio) announced for the development and
commercialization of PreHevbri in the Asia Pacific region,
excluding Japan
- October 2023: Peer-reviewed publication of review of
data from studies of PreHevbrio published in Expert Review of
Vaccines
- Manuscript title: “PreHevbrio: the first approved 3-antigen
hepatitis B vaccine”
- Q4 2023: New market launches expected in additional
European Union countries through partnership with Valneva (under
brand name PreHevbri®)
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
- September 2023: Brii Bio announced topline interim
results of Phase 2 study evaluating VBI-2601 in combination with
pegylated interferon-alpha (PEG–IFNα) in chronic HBV patients
- The combination treatment elicited improved hepatitis B
S-antigen (HBsAg) loss and seroconversion vs. PEG–IFNα alone both
at the end of treatment and after 12 weeks of follow up
- November 2023: In two late-breaking poster presentations
at AASLD The Liver Meeting® 2023, Brii Bio announced new data from
Phase 2 studies of VBI-2601 (BRII-179) highlighting progress
towards achieving HBV functional cure:
- Direct evidence that BRII-179-induced functional antibody
responses can contribute to increased and sustained HBsAg loss
rate
- New insight utilizing BRII-179 to enrich patients with
intrinsic humoral immune responses for higher HBsAg loss or HBV
functional cure rates
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
- September 2023: Announcement of first patients dosed in
the randomized, controlled Phase 2b study of VBI-1901, an FDA Fast
Track and Orphan Drug Designated cancer vaccine candidate, in
recurrent GBM patients
- Around Year-End 2023: Expected initiation of VBI-1901
study arm, as part of Individualized Screening Trial of Innovative
Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial,
in combination with Agenus Inc.’s anti-PD-1, balstilimab, in
primary GBM patients
- H2 2024: Interim data analyses from Phase 2b study in
recurrent GBM patients expected, subject to speed of patient
enrollment
COVID-19 & Coronaviruses
VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate
- September 2023: Initial data from Phase 1 study of
VBI-2901 reported – the first clinical data from a pan-coronavirus
vaccine candidate
- VBI-2901 demonstrated vaccine benefit – reflected as boosting
of and/or greater durability of antibody titer maintenance:
- All participants saw boosting and/or high neutralizing antibody
responses against a panel of COVID-19 variants and two animal
coronaviruses
- Participants with lower baseline antibody titers, reflecting a
higher-risk population, saw the greatest boosting effect (5-14x
strain-dependent boosting)
- Durability benefit observed regardless of baseline antibody
levels, with only about 25% reduction in geometric mean titer (GMT)
against the Wuhan strain after 5 months vs. peak responses –
compared to an approximate 77% decline in GMT against the Wuhan
strain vs. peak responses to a licensed mRNA vaccine [Gilboa M,
2022]1
- Q1 2024: Additional durability and breadth data from the
Phase 1 study expected
- Funds from existing partners, including the Canadian government
and the Coalition for Epidemic Preparedness Innovations (CEPI) are
available to fund the next phase of clinical development
Novel mRNA-Launched eVLP (MLE) Technology Platform
- October 2023: Development of a novel mRNA-launched eVLP
(MLE) technology platform announced, supported by preclinical data
that have demonstrated significant immunologic and manufacturing
benefits
- MLE technology enables the manufacture of particulate vaccines,
capable of driving polyfunctional B-cell and T-cell activation, on
accelerated timelines, similar to other mRNA vaccine production
timelines
- New platform has the potential to be leveraged across
infectious disease, cancer, and allergic and autoimmune disease
indications
Third Quarter 2023 Financial Results
- Cash Position: VBI ended the third quarter of 2023 with
$35.5 million in cash as compared with $62.6 million in cash as of
December 31, 2022.
- Revenues, net: Revenues, net for the third quarter of
2023 were $6.6 million as compared to $0.3 million for the same
period in 2022. The revenue increase was a result of an increase in
product sales of PreHevbrio in the U.S. and of PreHevbri to our
partner, Valneva, in Europe, in addition to the license revenue and
R&D services revenue associated with the HBV license agreement,
expanded in July 2023, with Brii Bio.
- Cost of Revenues: Cost of revenues was $2.5 million in
the third quarter of 2023 as compared to $2.7 million in the third
quarter of 2022. The decrease in the cost of revenues was due to
increased product sales, offset by lower direct labor costs as a
result of the recent organization changes that reduced our internal
workforce.
- Research and Development (R&D): R&D expenses for
the third quarter of 2023 were $1.5 million as compared to $5.0
million for the third quarter of 2022. R&D expenses were offset
by $2.7 million in the third quarter of 2023 and $2.4 million in
the third quarter of 2022 due to government grants and funding
arrangements.
- Sales, General, and Administrative (SG&A): SG&A
expenses for the third quarter of 2023 were $9.0 million as
compared to $14.2 million for the same period in 2022. The decrease
in SG&A expenses was mainly a result of the recent
organizational changes that reduced our internal workforce, as
announced in April 2023, the redefined deployment strategy of our
U.S. commercial field force, and a reduction in activity-based
commercial expenses related to PreHevbrio.
- Net Cash Used in Operating Activities: Net cash used in
operating activities for the nine months ended September 30, 2023,
was $48.8 million compared to $54.6 million for the same period in
2022. The decrease in cash outflows is largely a result of non-cash
reconciling items, mainly impairment charges and unrealized foreign
exchange loss, and the change in operating working capital, most
notably in inventory, other current assets, accounts payable,
deferred revenues, and other current liabilities. As announced on
April 4, 2023, VBI implemented 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 third quarter of 2023 were $20.4 million and
$1.01, respectively, compared to a net loss and net loss per share
of $25.2 million and $2.93 for the third quarter of 2022,
respectively.
- Net Loss, Excluding Impairment Charges and Foreign Exchange
Loss, and Net Loss Per Share, Excluding Impairment Charges and
Foreign Exchange Loss: Net loss, excluding impairment charges
and foreign exchange loss, and net loss per share, excluding
impairment charges and foreign exchange loss, for the third quarter
of 2023 were $8.0 million and $0.38, respectively, compared to
$22.5 million and $2.62 for the third 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 charges and foreign exchange loss for the third
quarter of 2023 were $3.6 million and $8.8 million, respectively,
as compared to none and $2.7 million for the third 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 Impairment Charges and Foreign Exchange
Loss, and Net Loss Per Share, Excluding Impairment Charges and
Foreign Exchange Loss, are non-GAAP financial measures and are
defined as Net Loss and Net Loss Per Share excluding the non-cash
impairment charges and foreign exchange loss in both calculations.
Net Loss, Excluding Impairment Charges and Foreign Exchange Loss,
and Net Loss Per Share, Excluding Impairment Charges and Foreign
Exchange Loss, are 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 Impairment Charges and Foreign Exchange Loss, and Net
Loss Per Share, Excluding Impairment Charges and Foreign Exchange
Loss, 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 non-cash
impairment charges, both of 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 to Net Loss Per Share, Excluding Impairment
Charges and 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 September
30
2023
2022
(Unaudited)
(In 000’s except share and per
share amounts)
Net Loss
$
(20,444)
$
(25,209)
Impairment charges
3,600
-
Foreign exchange loss
8,832
2,693
Net loss, excluding impairment charges and
foreign exchange loss
$
(8,012)
$
(22,516)
Weighted-average number of shares
21,166,818
8,608,539
Net loss per share, excluding impairment
charges and foreign exchange loss
$
(0.38)
$
(2.62)
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 – Pre-S1,
Pre-S2, and S. 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 and a proprietary mRNA-launched eVLP (“MLE”) 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/
References
- Gilboa, Mayan, Regev-Yochay, Gili, Mandelboim, Michael et al.
Durability of Immune Response After COVID-19 Booster Vaccination
and Association With COVID-19 Omicron Infection. JAMA Network Open.
September 2022
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, market, industry or
political conditions in the United States or internationally; the
impact of the COVID-19 endemic and the continuing effects of the
COVID-19 endemic 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; our ability to regain and maintain compliance with the
Nasdaq Capital Market’s listing standards; 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 Unaudited Condensed
Consolidated Balance Sheet
(In Thousands)
September 30, 2023
December 31, 2022
(Unaudited)
Assets
Cash
$
35,454
$
62,629
Accounts receivable, net
353
94
Inventory, net
7,540
6,599
Prepaid expenses and other current
assets
6,800
8,368
Total current assets
50,147
77,690
Property and equipment, net
9,423
12,253
Intangible assets, net
35,603
58,345
Goodwill
2,121
2,127
Other non-current assets
3,490
4,671
Total Assets
$
100,784
$
155,086
Liabilities and stockholders’
equity
Accounts payable
$
7,008
$
12,973
Current portion of long-term debt
50,299
-
Other current liabilities
19,887
23,969
Total current liabilities
77,194
36,942
Total non-current liabilities
3,704
53,981
Total liabilities
80,898
90,923
Total stockholders' equity
19,886
64,163
Total liabilities and stockholders'
equity
$
100,784
$
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 September
30
Nine Months Ended September
30
2023
2022
2023
2022
(Unaudited)
Revenues, net
$
6,624
$
317
$
7,829
$
789
Operating expenses
Cost of revenue
2,525
2,672
9,564
7,948
Research and development
1,532
4,983
7,975
12,988
Sales, general and administrative
9,036
14,220
33,237
40,234
Impairment charges
3,600
-
23,600
-
Total operating expenses
16,693
21,875
74,376
61,170
Loss from operations
(10,069)
(21,558)
(66,547)
(60,381)
Interest expense, net
(1,543)
(958)
(4,680)
(2,799)
Foreign exchange loss
(8,832)
(2,693)
(21,596)
(28,982)
Loss before income taxes
(20,444)
(25,209)
(92,823)
(92,162)
Income tax expense
-
-
-
-
Net Loss
$
(20,444)
$
(25,209)
$
(92,823)
$
(92,162)
Deemed dividend on certain warrants
(862)
(862)
Net Loss Available to Common
Stockholders
$
(21,306)
$
(25,209)
$
(93,685)
$
(92,162)
Basic and diluted net loss per share
(1.01)
(2.93)
(7.30)
(10.71)
Weighted-average number of shares used to
compute basic and diluted net loss per share
21,166,818
8,608,539
12,840,633
8,608,530
Other comprehensive income (loss) -
currency translation adjustments
7,753
(494)
21,022
23,845
Comprehensive Loss
$
(12,691)
$
(25,703)
$
(71,801)
$
(68,317)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231114900702/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 Sep 2024 to Oct 2024
VBI Vaccines (NASDAQ:VBIV)
Historical Stock Chart
From Oct 2023 to Oct 2024