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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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.0021 | 0.35% | 0.602 | 0.5851 | 0.61 | 0.6298 | 0.5786 | 0.623 | 109,132 | 22:29:13 |
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 second quarter ending June 30, 2022 and provided a corporate update.
Jeff Baxter, VBI’s President and CEO commented:
“Since the U.S. launch of PreHevbrio, our field teams have been extremely productive, raising awareness of the persistent burden of hepatitis B, the new, recently implemented CDC guidelines for a universal HBV vaccine recommendation for adults aged 19 to 59 years, and of course, the differentiation and value proposition of PreHevbrio. Over recent months:
As we advance through these initial commercial stage gates to establish our target network of distribution partners, we believe that as a differentiated 3-antigen HBV vaccine, PreHevbrio will be a meaningful new tool for healthcare providers as they work to tackle hepatitis B.
In addition to the U.S. launch of PreHevbrio, we continue to meet our clinical and regulatory milestones as we advance our lead pipeline candidates against chronic HBV, GBM, and COVID-19, with three new clinical studies expected to start and new therapeutic HBV Phase 2 data expected before the end of 2022. As VBI’s pipeline now includes both commercial and developmental stage assets, we rigorously prioritize our human and financial capital with efficient and well-managed program execution to maximize the impact of our programs in the medical and public health space, and to drive shareholder value.”
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: Trivalent Pan-Coronavirus Vaccine Candidate
Second Quarter 2022 Financial Results
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 June 30
Six Months Ended June 30
2022
2021
2022
2021
(Unaudited, in 000's except share and per share amounts)
Net Loss
$
(45,699)
$
(17,476)
$
(66,953)
$
(35,123)
Foreign exchange loss
(21,895)
(190)
(26,289)
(328)
Net loss excluding foreign exchange loss
$
(23,804)
$
(17,286)
$
(40,664)
$
(34,795)
Weighted-average number of shares
258,257,494
255,142,550
258,257,095
252,884,284
Net loss per share excluding foreign exchange loss
$
(0.09)
$
(0.07)
$
(0.16)
$
(0.14)
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 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)
June 30, 2022
December 31, 2021
(Unaudited)
Assets
Cash and cash equivalents
$
82,414
$
121,694
Accounts receivable, net
135
8
Inventory, net
4,050
2,576
Prepaid expenses and other current assets
6,153
6,006
Total current assets
92,752
130,284
Property and equipment, net
11,015
11,037
Intangible assets, net
61,379
62,091
Goodwill
2,237
2,261
Other non-current assets
4,778
4,603
Total Assets
$
172,161
$
210,276
Liabilities and stockholders’ equity
Accounts payable
$
5,617
$
4,280
Current portion of long-term debt
8,780
-
Current liabilities, other
26,135
28,306
Total current liabilities
40,532
32,586
Total non-current liabilities
26,071
33,808
Total liabilities
66,603
66,394
Total stockholders' equity
105,558
143,882
Total liabilities and stockholders' equity
$
172,161
$
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 June 30
Six Months Ended June 30
2022
2021
2022
2021
(Unaudited)
Revenues
$
346
$
142
$
472
$
443
Operating expenses
Cost of revenue
2,522
2,634
5,276
5,046
Research and development
5,643
4,582
8,005
11,421
General and administrative
15,084
9,367
26,014
16,114
Total operating expenses
23,249
16,583
39,295
32,581
Loss from operations
(22,903)
(16,441)
(38,823)
(32,138)
Interest income (expense), net
(901)
(845)
(1,841)
(2,657)
Foreign exchange gain (loss)
(21,895)
(190)
(26,289)
(328)
Loss before income taxes
(45,699)
(17,476)
(66,953)
(35,123)
Income tax benefit
-
-
-
-
Net Loss
$
(45,699)
$
(17,476)
$
(66,953)
$
(35,123)
Basic and diluted net loss per share
$
(0.18)
$
(0.07)
$
(0.26)
$
(0.14)
Weighted-average number of shares used to compute basic and diluted net loss per share
258,257,494
255,142,550
258,257,095
252,884,284
Other comprehensive income (loss) - currency translation adjustments
19,236
1,370
24,339
1,713
Comprehensive Loss
$
(26,463)
$
(16,106)
$
(42,614)
$
(33,410)
View source version on businesswire.com: https://www.businesswire.com/news/home/20220808005136/en/
VBI Contact Nicole Anderson Director, Corporate Communications & IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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