On November 22, 2021 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for allergy, opioid overdose, respiratory and inflammatory disease, reported financial results for the nine months ended September 30, 2021 and provided a business update (Press release, Adamis Pharmaceuticals, NOV 22, 2021, View Source [SID1234595942]).
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"Adamis made significant advancements over the past year," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "We resubmitted our NDA for ZIMHI to the FDA. We initiated and began enrolling patients in a Phase 2/3 clinical trial to evaluate the use of Tempol for the treatment of COVID-19. Under our new commercial partner, we have seen significant sales growth for SYMJEPI. Most significantly, in October we received an early approval for ZIMHI for the treatment of opioid overdose and commercial introduction is expected during the first quarter of 2022."
Product and Pipeline Updates and Other Corporate Developments
ZIMHI
On October 18, 2021, Adamis announced that the U.S. FDA had approved the Company’s ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL product.
ZIMHI is a high-dose naloxone injection product FDA-approved for use in the treatment of opioid overdose.
According to the preliminary data from the CDC, overdose deaths in the U.S. exceeded 100,000 for the twelve months ending April 2021.
The Company’s U.S. commercial partner, US WorldMeds is preparing to commercially launch ZIMHI in the first quarter of 2022.
SYMJEPI
In October 2020, US WorldMeds completed the transition of control of the commercial operations of SYMJEPI from Sandoz, Inc.
The U.S. market for epinephrine exceeded $1.7 billion in annual sales for the 12-month period ending September 30, 2021, according to Symphony Health market data.
Despite the marketing challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI unit sales increased approximately 98% for nine months ending September 30, 2021, versus the first nine months of 2020.
TEMPOL
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 into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 and the Company is expanding the number of clinical study sites, including several potential sites outside the U.S.
Adamis licensed exclusive worldwide rights under patents, patent applications and related know-how relating to Tempol for certain licensed fields including the treatment of respiratory diseases including asthma, respiratory syncytial virus infection, influenza and COVID-19.
In addition to the work in COVID, the Company is exploring additional indications for the use of Tempol including, but not limited to the treatment of methamphetamine use disorder.
US COMPOUNDING
In July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Under the terms of 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 pharmaceutical products and the employment of all USC employees has ended.
The Company is now engaged in a process of selling or otherwise disposing of the remaining assets of the business.
Financial Results
The business conducted through our USC subsidiary is treated as a discontinued operation as of September 30, 2021. Accordingly, for this period the major current assets, other assets, current liabilities, and noncurrent liabilities have been reported as components of total assets and liabilities separate from those balances of the continuing company operations. At the same time, the results of all discontinued operations have been reported as components of net loss separate from the net loss of continuing operations. Additionally, the financial statements of the comparable prior periods were reflected in conformity with the current period’s presentation as discontinued operations.
Reflecting these discontinued operations accounting principles, 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 was primarily attributable to US WorldMeds’ marketing initiatives for SYMJEPI.
Selling, general and administrative expenses for the nine months ending September 30, 2021 and 2020 were approximately $13.2 million and $9.6 million, respectively. The increase was primarily attributable 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 was primarily due to development related to ZIMHI and Tempol.
Cash and equivalents as of September 30, 2021 was approximately $28.7 million. Based on the operating capital that Adamis provided to USC over the last four quarters, we estimate the shutdown of the USC business may reduce those cash expenditures by approximately $1.2 million per quarter starting in the fourth quarter of 2021, excluding expenses associated with the winding down of USC’s business. Additionally, over the next four quarters, the Company estimates to receive additional cash amounts relating to the sale of certain USC assets.
Conference Call
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 provide an update on business developments and activities.
A live audio webcast of the conference call will also be available via this link – View Source;tp_key=857fdc0361. If you are unable to 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 of the Adamis investor relations section of the company website at View Source