Adamis Pharmaceuticals Corporation (ADMP) on Q1 2022 Results - Earnings Call Transcript
Operator: Good evening, and welcome to the Adamis Pharmaceuticals First Quarter 2022 Financial Results Conference Call. All participants will be in a listen-only mode. . Please note this event is being recorded. I would now like to turn the conference over to Mr. Robert Uhl with ICR Westwicke. Please go ahead.
Robert Uhl: Thank you, operator. Good afternoon, everyone, and welcome to the Adamis Pharmaceuticals first quarter 2022 financial results and corporate update conference call. Thank you for joining us today for the update. And welcome to our shareholders, analysts and anyone interested in Adamis. Joining me today is Adamis President and CEO, Dr. Dennis J. Carlo, Chief Medical Officer, Dr. Ron Moss, Chief Business Officer, David Marguglio, and Chief Financial Officer, David Benedicto. The format for this call will consist of prepared remarks for management followed by Q&A. This call is being webcast and will be available for replay in the investor section of our website adamispharmaceuticals.com. In today's call, we will make certain forward-looking statements regarding our business based on current expectations and current information. Those statements speak only as of today and except as required by law we do not assume any duty to update in the future any forward-looking statement made today. Of course, any forward-looking statements involve risks and uncertainties. And our actual results could differ materially from those anticipated by any forward-looking statements that we make today. Additional information concerning factors that could affect our business and financial results is included in our most recent annual report on Form 10-K with the Securities and Exchange Commission, and in other subsequent filings that we make with the SEC. These are available at the SEC website. With that I will now hand the call over to Dr. Dennis Carlo, President and CEO.
Dennis Carlo: Thank you, Robert. And thanks to all of you for joining us today. It's not been that long since our last call. So today's call will be brief, but I will attempt to highlight a few important advancements. First, I'll begin with ZIMHI or naloxone product. Drug overdoses took more lives than ever before in 2021. Approximately 108,000 people died of drug overdoses according to the CDC two-thirds of these involving . Drug overdose remains a significant problem that affects all sectors of our society. As we updated you on our last call our commercial partner US WorldMeds launched ZIMHI at the end of March. In a few minutes, David Marguglio will provide more information, but we are very pleased with the market reception of ZIMHI and the uptake in both the retail and non-retail sectors of the market. US WorldMeds has had some early wins among both commercial and government customers. In the next six months to reveal the sales trajectory we can expect for ZIMHI. I'll now move on from ZIMHI to SYMJEPI. On March 21, 2022, Adamis announced a voluntary recall of certain losses from Jepi epinephrine injection, 0.15 milligrams, and 0.3 milligrams prefilled the single dose syringes. Affected SYMJEPI product loss will recall due to the potential clogging of the needle presenting the dispensing of the drug product epinephrine. I'm happy to report that we believe that the investigation of the affected lots 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 the investigation is completed and issues are satisfactorily addressed. We expect that this will occur in the near future. With that I will turn it over to our CFO, David Benedicto to provide some highlights from our recently filed financials. David?
David Benedicto: Thank you, Dennis. This afternoon we were pleased to file our Form 10-Q for the quarter ending March 31, 2022. I only intend to highlight a few parts of our financials in this discussion. And I encourage you to thoroughly review the 10-Q for additional details and disclosures. I should point out that our financial statements presentation for the fiscal quarters is different from last year's presentation. That is due to our sale of assets relating to our compounding pharmacy business, formerly conducted by our US compounding subsidiary, and our decision to wind down that business and sell or dispose of the remaining related assets. As a result, revenues and expenses related to that business. And those assets and liabilities are reflected in the continued operations items in our income statement and our balance sheet. Revenues for the quarter ending March 31, 2022 and 2021 were 1.2 million and 1.4 million respectively. Revenues for the quarter ended March 31, 2022 consisted mainly of 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. Revenues for the quarter ended March 31, 2021 consisted mainly of SYMJEPI injection sales. Due to SYMJEPI manufacturing code and the voluntary recall, no revenues relating to SYMJEPI were reported for the first quarter of 2022. Selling, general and administrative expenses for the quarter ending March 31, 2022, and 2021 were 3.4 million and 3.5 million respectively. The selling, general and administrative expenses in 2022 reflected the decrease in legal and compensation expenses, offset by an increase in accounting and finance related expenses. Research and development expenses were 4.2 million and 2.2 million for the first quarter of 2022 and 2021, respectively. The increase was primarily due to increased expenses relating to the ongoing clinical trial of Tempol. Net loss from discontinued operations for the three months ended March 31, 2022 and 2021 was 165,000 and 1.5 million respectively. The decrease in loss was primarily attributable to the winding down and cessation of US compounding operations. Cash and cash equivalents at March 31, 2022, totaled 17.8 million. This year, we expect to receive additional proceeds resulting from amounts payable to us pursuant to our sale of certain USC assets to and from the disposition of the remaining USC assets, which includes the land, the building, and the machinery and equipment. Once again, please see our Form 10-Q for the quarter ended March 31, 2022 for additional details and disclosures. I will now turn it over to our Chief Medical Officer, Dr. Ron Moss for an update on product development.
Ron Moss: Thank you, David. Our Phase 2, Phase 3 clinical trial to evaluate Tempol as a treatment for COVID-19 is continuing, our planned interim analysis is anticipated to occur in late May or early June as we're currently confirming the statistical programs and datasets. This trial is double blind, which means only the Data Safety Monitoring Board, DSMB knows what treatment that subject may be getting during the trial. As the trials interim analysis, the DSMB carefully reviews this data and can stop or continue a trial and also make a recommendation to modify the trial or even request additional meetings of additional clarification is required. The trial is designed to have adequate statistical power when it reaches 248 of valuable subjects. If the study continues, we don't anticipate releasing any data resulting from the interim analysis in order to maintain the blinding and integrity of the data as it is done and other clinical trials. The time to completion of the trial depends among other factors on both COVID infection rates, which are increasing enrollment in the DSMB's recommendations. If the trial is successful, we will also submit a clinical study report and request a meeting with the FDA as soon as possible. Finally, we're looking at other potential clinical uses of Tempol, continue to seek government non-dilutive funding and have recently applied for government grants. At this time, I'd like to turn it over to David Marguglio.
David Marguglio: Thanks, Ron. I'd like to provide a quick update on how the ZIMHI commercial launch is proceeding. As with any launch, there's a ton of work going on behind the scenes that precedes any significant uptick in sales and that includes establishing brand awareness, market access, contracting, et cetera. ZIMHI has been undergoing formulary review by commercial, federal and state formularies. And it has already been added to many plans as either non-restricted or as a preferred brand. A few of those plans include the Veterans Administration, many of state medical or Medicaid plans, including several of the largest Blue Cross Blue Shield plans in Massachusetts, Michigan and Tennessee, Highmark Blue Shield plans in Delaware, Ohio, Pennsylvania, New York and West Virginia and all of top commercial formularies. ZIMHI is available for more than 83% of physicians using electronic health records and US WorldMeds is pushing to grow that number. After loading the wholesaler distribution channel at the end of March, US WorldMeds began direct promotion to health care practitioners with a team of 20 plus regional account managers. Although we are still just weeks into this launch feedback from the commercial team has been quite favorable for the product, the size and intuitive nature of the device and the overall value proposition amongst stakeholders in both the retail and non-retail market sectors. So, in summary, although early we are very pleased with the activity to-date, and the trajectory for the product, both Adamis and US WorldMeds remain bullish on ZIMHI’s as long-term value in the market. And with that, I'll turn it over to Dennis.
Dennis Carlo: Good. Thank you, David. This will conclude our call and we will now open it up to questions.
Operator: Q - Unidentified Analyst A - Dennis Carlo
Robert Uhl: Okay. That will conclude our call today. I thank you for participating and for your interest Adamis Pharmaceuticals. Have a good evening everyone.
Operator: That does conclude our conference for today. Thank you for attending today's presentation. You may now disconnect.
