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Share Name | Share Symbol | Market | Type |
---|---|---|---|
VBI Vaccines Inc | NASDAQ:VBIV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.64 | 0.62 | 0.66 | 6 | 12:00:00 |
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 year ended December 31, 2023.
“Over the last 12 months, we’ve seen continued progress across all of our lead programs – with increased use of PreHevbrio and an ever-expanding access and distribution network in place, as well as positive clinical data announcements from all lead pipeline programs, we are helping to make great strides in the fight against GBM, hepatitis B, and coronaviruses,” said Jeff Baxter, VBI’s President and CEO. “In the face of a challenging financial market for biotechnology companies, we’ve taken steps to improve our financial stability, including strengthening our balance sheet through equity offerings and business development collaborations, as well as executing on a plan to significantly reduce our debt liability. With a number of near-term milestones expected, we are focused on managing our operational expenses and capital to fuel sustainable growth and value for key stakeholders – patients, healthcare providers, and shareholders.”
Recent Key Program Achievements and Projected Upcoming Milestones
PreHevbrio® [Hepatitis B Vaccine (Recombinant)]
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)
Novel mRNA-Launched eVLP (MLE) Technology Platform
VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate
Corporate Updates
Financial Results for the Twelve Months Ended December 2023
Use of Non-GAAP Financial Measures
Net Loss and Net Loss per Share, Excluding Impairment Charges and Foreign Exchange Loss, 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, 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 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 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.
GAAP to Non-GAAP Reconciliations
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.
Year Ended December 31
2023
2022
(Unaudited)
(In 000’s except share and per share amounts)
Net Loss
$
(92,836
)
$
(113,303
)
Impairment charges
24,600
-
Foreign exchange loss
6,524
27,476
Net loss, excluding impairment charges and foreign exchange loss
$
(61,712
)
$
(85,827
)
Weighted-average number of shares
15,572,494
8,608,530
Net loss per share, excluding impairment charges and foreign exchange loss
$
(3.96
)
$
(9.97
)
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/
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 Company’s ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company’s ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact 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; 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 April 16, 2024, and filed with the Canadian security authorities at sedar.com on April 16, 2024, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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
(Unaudited, In Thousands)
December 31, 2023
December 31, 2022
Assets
Cash
$
23,685
$
62,629
Accounts receivable, net
-
94
Inventory, net
8,499
6,599
Prepaid expenses and other current assets
4,047
8,368
Total current assets
36,231
77,690
Property and equipment, net
9,665
12,253
Intangible assets, net
36,499
58,345
Goodwill
1,130
2,127
Other non-current assets
3,426
4,671
Total Assets
$
86,951
$
155,086
Liabilities and stockholders’ equity
Accounts payable
$
6,431
$
12,973
Other current liabilities
69,305
23,969
Total current liabilities
75,736
36,942
Total non-current liabilities
3,688
53,981
Total liabilities
79,424
90,923
Total stockholders' equity
7,527
64,163
Total liabilities and stockholders' equity
$
86,951
$
155,086
VBI Vaccines Inc. and Subsidiaries
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited, In Thousands Except Share and Per Share Amounts)
For the Years Ended December 31
2023
2022
Revenues, net
$
8,682
$
1,082
Operating expenses
Cost of revenues
12,507
11,276
Research and development
9,343
15,506
Sales, general, and administrative
42,143
56,120
Impairment charges
24,600
-
Total operating expenses
88,593
82,902
Loss from operations
(79,911
)
(81,820
)
Interest expense, net
(6,401
)
(4,007
)
Foreign exchange loss
(6,524
)
(27,476
)
Loss before income taxes
(92,836
)
(113,303
)
Income tax benefit
-
-
Net Loss
$
(92,836
)
$
(113,303
)
Deemed dividend on certain warrants
(1,005
)
-
Net Loss Available to Common Stockholders
(93,841
)
(113,303
)
Basic and diluted net loss per share
$
(6.03
)
$
(13.16
)
Weighted-average number of shares used to compute basic and diluted net loss per share
15,572,494
8,608,539
Other comprehensive income
6,887
23,005
Comprehensive Loss
$
(85,949
)
$
(90,298
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20240416638037/en/
VBI Contact Nicole Anderson Director, Corporate Communications & IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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