Adamis Pharmaceuticals announcement – GuruFocus.com
SAN DIEGO, November 22, 2021 (GLOBE NEWSWIRE) – Adamis Pharmaceuticals Corporation (ADMP), a biopharmaceutical company that develops and markets specialty products for allergies, opioid overdoses, respiratory and inflammatory diseases, announced today hui its financial results for the nine months ended September 30, 2021 and provided a business update.
“Adamis has made significant progress over the past year,” said Dennis J. Carlo, Ph.D., President and CEO of Adamis Pharmaceuticals. “We resubmitted our NDA for ZIMHI to the FDA. We have initiated and started enrolling patients in a Phase 2/3 clinical trial to evaluate the use of Tempol for the treatment of COVID-19. Under our new business partner, we have seen significant sales growth for SYMJEPI. More importantly, in October, we received early approval for ZIMHI for the treatment of opioid overdoses, and commercial introduction is expected in the first quarter of 2022. “
Product and pipeline updates and other business developments
- On October 18, 2021, Adamis announced that the US FDA had approved the Company’s ZIMHI MT (Naloxone Hydrochloride Injection, USP) 5 mg / 0.5 mL of product.
- ZIMHI is an FDA approved high dose naloxone injection product for use in the treatment of opioid overdose.
- According to preliminary data from the CDC, overdose deaths in the United States exceeded 100,000 for the twelve months ending April 2021.
- The Company’s US business partner, US WorldMeds, is preparing to launch ZIMHI commercially in the first quarter of 2022.
- In October 2020, US WorldMeds completed the transition of control of SYMJEPI’s business operations from Sandoz, Inc.
- The U.S. epinephrine market exceeded $ 1.7 billion in annual sales for the 12-month period ending September 30, 2021, according to market data from Symphony Health.
- Despite the marketing challenges posed by the pandemic and associated bottlenecks, data from Symphony Health shows that SYMJEPI unit sales increased by approximately 98% for the nine months ending September 30, 2021, compared to the first nine months of 2020. .
- Tempol has been shown to have antiviral, anti-inflammatory and antioxidant activity.
- Recently, the National Institutes of Health (NIH) highlighted Tempol as a potential home treatment for COVID-19.
- In September, the first patient was enrolled in the company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 and the company is increasing the number of clinical study sites, including several potential sites outside of the United States.
- Adamis has licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed areas including the treatment of respiratory diseases including asthma, respiratory syncytial virus, influenza and COVID-19.
- In addition to work on COVID, the Company is exploring additional indications for the use of Tempol, including, but not limited to, the treatment of disorders related to methamphetamine use.
- In July 2021, the Company sold assets related to its human compounding pharmacy business in the United States. Pursuant to the sale, the Company expects to receive monthly payments over a 12-month period in an amount equal to one to two times the amount collected for sales of products to certain identified customers included in the sale.
- By the end of October, USC had ceased manufacturing both human and veterinary pharmaceuticals, and the employment of all USC employees had ended.
- The Company is now engaged in a process of selling or disposing of the remaining assets of the business.
The activity conducted through our subsidiary USC is treated as a discontinued operation as at September 30, 2021. Consequently, for this period, the main current assets, other assets, current liabilities and non-current liabilities have been presented as items. of total segregated assets and liabilities. of these balances from continuing operations of the company. At the same time, the results of all discontinued operations have been presented as items of net loss separate from the net loss of continuing operations. In addition, the financial statements for comparable prior periods have been reflected in accordance with the presentation of the current period as discontinued operations.
Reflecting these accounting policies for discontinued operations, revenues for the nine months ended September 30, 2021 and 2020 were approximately $ 3.4 million and $ 2.1 million, respectively. The increase in revenue is mainly attributable to the marketing initiatives of US WorldMeds for SYMJEPI.
Selling, general and administrative expenses for the nine months ended September 30, 2021 and 2020 were approximately $ 13.2 million and $ 9.6 million, respectively. The increase is mainly due to an increase in legal fees.
Research and development expenses were approximately $ 9.1 million and $ 6.6 million for the nine months ending September 30, 2021 and 2020, respectively. The increase is mainly due to the development linked to ZIMHI and Tempol.
Cash and cash equivalents at September 30, 2021 were approximately $ 28.7 million. Based on the operating capital that Adamis has provided to USC over the past four quarters, we estimate that shutting down the USC business could reduce these cash expenses by approximately $ 1.2 million per quarter to beginning in the fourth quarter of 2021, excluding expenses associated with the winding-up of USC’s business. In addition, over the next four quarters, the Company estimates that it will receive additional cash amounts related to the sale of certain USC assets.
Adamis will host a conference call and live webcast today, November 22, 2021, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the nine months ending September 30, 2021, as well as only to provide an update on business developments and activities.
Call in the United States (toll free): 1-877-423-9813
International / long distance telephone number: 1-201-689-8573
Conference number: 13725311
A live audio webcast of the conference call will also be available through this link – https://viavid.webcasts.com/starthere.jsp?ei=1515468&tp_key=857fdc0361. If you cannot participate in the live call, a replay will be available shortly after the live event. To listen to the replay, please visit the events page in the Adamis Investor Relations section of the Company’s website at http://ir.adamispharmaceuticals.com/presentations.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on the development and commercialization of products in various therapeutic areas including allergies, opioid overdoses, respiratory and inflammatory diseases. The Company’s SYMJEPI (epinephrine) injectables are approved by the FDA for use in the emergency treatment of acute allergic reactions, including anaphylaxis. The company’s ZIMHI (naloxone) injection is approved for the treatment of opioid overdoses. Tempol is under development for the treatment of patients with COVID-19 and a Phase 2/3 clinical trial is underway. For more information on Adamis Pharmaceuticals, please visit www.adamispharmaceuticals.com and follow us on Twitter and LinkedIn.
Adamis forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include those which express plans, forecasts, intentions, contingencies, objectives, targets or future development and / or are not statements of historical fact. These statements relate to future events or future results of operations, including, but not limited to, the following statements: the Company’s beliefs regarding the ability of its products and product candidates to compete successfully in the market; the Company’s beliefs regarding the safety and efficacy of SYMJEPI, ZIMHI or its other products and product candidates; the Company’s ability to successfully market the products and product candidates, on its own or through marketing partners; the timing of the commercial launch of our ZIMHI product; future development and regulatory actions concerning the Company’s product candidates; the Company’s beliefs regarding the results of any future studies or clinical trials that the Company may conduct concerning Tempol or its other products or product candidates; the Company’s beliefs regarding expected clinical trial completion dates; the Company’s beliefs regarding the benefits, applicability and extent of intellectual property protection afforded by patents and patent applications that it owns or has licensed and its rights under license agreements applicable, and its ability to enforce its patents and other intellectual property rights against third parties; the Company’s expectations for future growth; expectations and statements regarding the strategies, objectives, future goals and achievements of the Company; and other statements regarding our future operations, activities and financial results. We may not meet one or more of the milestones or future targets described in the press release, either on schedule or not at all. In addition, forward-looking statements regarding our anticipated future activities assume that we have sufficient funding to support those activities and continue our planned operations and activities. Statements in this press release regarding future events depend on several factors beyond the control of the Company, including the absence of unexpected developments or delays, market conditions and the regulatory approval process. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the actual results of the Company to differ materially from the results anticipated by these forward-looking statements. We cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in forward-looking statements. You should not place undue reliance on forward-looking statements. Further, any forward-looking statement is only valid as of the date on which it is made, and except as required by applicable law, we assume no obligation to update or publicly publish the results of any review. forward-looking statements or to reflect events or circumstances occurring after the date of this press release. Certain of these additional risks and risks, uncertainties and other factors are described in more detail in documents filed periodically by Adamis with the SEC, including its annual report on Form 10-K for the year ended December 31, 2020, and the documents filed with the SEC, which Adamis strongly recommends that you read and review, all available free of charge on the SEC’s website at http://www.sec.gov.
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Pharmaceutical company Adamis
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