On May 16, 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 quarter ending March 31, 2022 (Press release, Adamis Pharmaceuticals, MAY 16, 2022, View Source [SID1234614699]).
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Product and Pipeline Updates and Other Corporate Developments
ZIMHI
·According to the Centers for Disease Control and Prevention (CDC), drug overdoses resulted in over 108,000 deaths in the U.S. over the most recent 12 months of data. Two thirds of these involved fentanyl.
·Our U.S. commercial partner, US WorldMeds, commercially launched our high dose naloxone product, ZIMHI, at the end of March.
·We are encouraged by the early acceptance of ZIMHI in the market.
SYMJEPI
·In March, Adamis announced a voluntary recall of certain lots of SYMJEPI.
·Manufacturing of SYMJEPI has been on hold pending the results of an investigation to determine the root cause. The Company believes the investigation is nearing completion, that a root cause relating to a particular batch of syringe needles has been identified, and that corrective and preventive actions have been and will be taken.
·We anticipate a resolution and resumption of manufacturing after those issues are satisfactorily addressed, which we believe will occur during the second quarter.
TEMPOL
·The Company’s Phase 2/3 clinical trial of Tempol as a treatment for COVID-19 is continuing.
·In March, the Data Safety Monitoring Board (DSMB) overseeing the Tempol trial met to evaluate the clinical and safety data from the first planned interim analysis and, following their evaluation, recommended the study continue without modification.
·The DSMB plans to meet again, anticipated to be at the end of May or in June, to review interim data analysis for the first 124 patients.
·In addition to the work in COVID, the Company continues to explore additional indications for the use of Tempol including, but not limited to, asthma and long COVID.
Financial Results
Revenues for the quarters ending March 31, 2022 and 2021 were approximately $1.2 million and $1.4 million, respectively. Revenues for the quarter ended March 31, 2022 consisted mainly of approximately $1.1 million of sales of ZIMHI to our commercial partner US WorldMeds in anticipation of the commercial launch of ZIMHI announced at the end of March. Due to the SYMJEPI manufacturing hold and the voluntary recall of certain lots, no revenues relating to SYMJEPI were reported for the first quarter of 2022.
Selling, general and administrative expenses for the quarters ending March 31, 2022 and 2021 were approximately $3.4 million and $3.5 million, respectively. SG&A expenses in the first quarter of 2022 reflected a decrease in legal and compensation expenses, offset by an increase in accounting and finance related expenses.
Research and development expenses were approximately $4.2 million and $2.2 million for the first quarter of 2022 and 2021, respectively. The increase was primarily due to expenses relating to the ongoing clinical trial for our Tempol product candidate.
Net loss from discontinued operations for the three months ended March 31, 2022 and 2021 was approximately $165,000 and approximately $1.5 million, respectively. The decrease in loss was primarily attributable to the winding down and cessation of US Compounding’s operations.
Cash and cash equivalents at March 31, 2022, totaled approximately $17.8 million. For this year, we expect to receive additional proceeds resulting from amounts payable to us pursuant to our sale of certain 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, May 16, 2022, at 2 p.m. PT (5 p.m. ET) to discuss its financial and operating results for the first quarter 2022, 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. 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