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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 | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0116 | -1.90% | 0.598403 | 0.59 | 0.6004 | 0.6075 | 0.5894 | 0.6075 | 19,503 | 17:00:33 |
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)]
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate
Glioblastoma (GBM)
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
COVID-19 & Coronaviruses
VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate
Novel mRNA-Launched eVLP (MLE) Technology Platform
Third Quarter 2023 Financial Results
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
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
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