On March 31, 2022 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 year ended December 31, 2021 (Press release, Adamis Pharmaceuticals, MAR 31, 2022, View Source [SID1234611297]).

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"We managed to achieve all of our internal objectives for 2021," stated Dennis J. Carlo, Ph.D., President and Chief Executive Officer of Adamis Pharmaceuticals. "Included among them, we began enrolling patients in a Phase 2/3 clinical trial evaluating Tempol as a treatment of COVID-19, resubmitted our NDA for ZIMHI and subsequently received FDA approval."

Product and Pipeline Updates and Other Corporate Developments

ZIMHI

•In October 2021, the U.S. FDA approved ZIMHI TM (naloxone HCL Injection, USP) 5 mg/0.5 mL for the treatment of opioid overdose.

•Drug overdoses are now the leading cause of death for Americans under age 50. Powerful synthetic opioids, like fentanyl and its analogues, are responsible for approximately 85% of all opioid overdose related deaths in the U.S.

•According to the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in over 100,000 deaths in the U.S. during the 12-month period ending April 2021, which was a 29% increase over the prior year.

•Earlier today, Adamis and our U.S. commercial partner, US WorldMeds, jointly announced the nationwide commercial launch of ZIMHI.

SYMJEPI

•Despite the challenges posed by the pandemic and related lockdowns, Symphony Health data indicates SYMJEPI retail scripts increased approximately 115% and total unit sales increased approximately 124% in 2021, compared to the same period of 2020.

•On March 21, 2022, Adamis announced a voluntary recall of certain lots of SYMJEPI. The recall is being conducted with the knowledge of the FDA.

•Manufacturing of SYMJEPI is on hold pending the results of an investigation currently underway to determine the root cause. The Company anticipates a resolution and resumption of manufacturing after the investigation is completed and any issues are satisfactorily addressed.

TEMPOL

•In September 2021, the first patient was enrolled into the Company’s ongoing Phase 2/3 clinical trial of Tempol as a treatment for COVID-19. As of today, 140 patients have been enrolled in the clinical trial.

•On March 11, 2022, the Data Safety Monitoring Board (DSMB) overseeing the Tempol trial met to evaluate the clinical and safety data from the first planned interim analysis. Following their evaluation, the DSMB recommended that the study continue without modification.

•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 asthma, long COVID and methamphetamine use disorder.

US COMPOUNDING

•During July 2021, the Company sold assets relating to its US Compounding human compounding pharmacy business. Adamis 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.

•The Company is continuing a process of selling or otherwise disposing of the remaining assets of US Compounding.

Financial Results

Despite the significant increase in retail scripts for, and unit sales of, SYMJEPI in 2021 compared to 2020, reported net revenues from continuing operations for the year ending December 31, 2021 were $2.2 million compared to $2.8 million in 2020, reflecting the effect and impact of a $2.0 million reserve reflected in the Company’s financial statements related to the SYMJEPI recall.

As a result of the SYMJEPI voluntary recall in March, we have reserved approximately $2.0 million as a reduction of revenue for the year ended 2021. The company may recover some or all of the cost of the recall from certain third parties under the terms our manufacturing agreements, but the amount of the cost and recovery cannot be determined at this time.

Selling, general and administrative expenses for the years ending December 31, 2021 and 2020 were $16.1 million and $20.1 million, respectively. The decrease was primarily attributable to the reduction in expenses related to legal, compensation related to employee terminations, including forfeitures of stock compensation, and depreciation and amortization.

Research and development expenses were approximately $11.3 million and $8.0 million for the years ending December 31, 2021 and 2020, respectively. The increase in R&D expense was primarily due to development costs related to ZIMHI and Tempol.

Net loss from discontinued operations for the twelve months ended December 31, 2021, and 2020 was $11.2 million and $13.5 million, respectively. The decrease in loss was primarily due to the offset by the gain from the sale of assets.

Cash and equivalents as of December 31, 2021, totaled approximately $23.2 million. In 2022, the Company expects to receive additional proceeds resulting from amounts payable to Adamis pursuant to the sale of certain of the USC assets to Fagron and from the disposition of the remaining USC assets which includes the land, the building, the machinery and the equipment.

Conference Call

Adamis will host a conference call and live webcast today, March 31, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the year ended December 31, 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