Adamis Pharmaceuticals Corp (ADMP) 2022 Q1 法說會逐字稿

Good evening, and welcome to the Adamis Pharmaceuticals First Quarter 2022 Financial Results Conference Call. (Operator Instructions) 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.

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 from management followed by Q&A. This call is being webcast and will be available for replay in the Investors 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's website.

With that, I will now hand the call over to Dr. Dennis Carlo, President and CEO.

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, our naloxone product. Drug overdoses took more lives than ever before in 2021. Approximately 108,000 people died with drug overdoses according to the CDC, 2/3 of these involving fentanyl. Drug overdose remains a significant problem that affects all sectors of our societies. As we updated you on our last call, our commercial partner, US WorldMeds, launched ZIMHI at the end of March.

In a few minutes, Dave Marguglio will provide more information, but we are very pleased with the market reception of ZIMHI and the uptake in both the retail and nonretail sectors of the market. US WorldMeds has had some early wins among both commercial and government customers. In the next 6 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 the voluntary recall of certain lots of SYMJEPI epinephrine injection 0.15 milligrams and 0.3 milligrams prefilled single-dose syringes. Affected SYMJEPI product lots were recalled due to the potential clogging of the needle preventing the dispensing of the drug product epinephrine.

I'm happy to report that we believe that the investigation of the infected lot -- the affected lots is nearing completion. That root cause relating to a particular batch of syringe needles has been identified and that corrected and preventive actions have been and will be taken. We anticipate a resolution and resumption of manufacturing as 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, Dave Benedicto, to provide some highlights from our recently filed financials. David?

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 U.S. 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 discontinued operations items in our income statement and our balance sheet. Revenues for the quarters 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 hold and the voluntary recall, 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 $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 3 months ended March 31, 2022 and 2021 was $165,000 and $1.5 million, respectively. The decrease in loss is primarily attributable to the winding down and cessation of U.S. 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 Fagron 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 additional -- for an update on product development.

Thank you, David. Our Phase II/Phase III 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 data sets. This trial is double blind, which means only the data and safety monitoring board, or DSMB, knows what treatment is subject maybe getting during the trial.

At the trial's 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 if additional clarification is required. The trial is designed to have adequate statistical power when it reaches 248 evaluable subjects.

If the study continues, we don't anticipate releasing any data resulting from the interim analysis in order to maintain the blinding and the integrity of the data as is done in 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 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 are looking at other potential clinical uses of Tempol, continue to see government nondilutive funding and have recently applied for government grants.

At this time, I'd like to turn it over to 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 perceives 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 nonrestricted 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 HUMIRA's 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 among stakeholders in both the retail and nonretail 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 long-term value in the market.

And with that, I'll turn it over to Dennis.

Okay. Thank you, David. This will conclude our call, and we will now open it up to questions.

(Operator Instructions) Thank you. There are no questions at this time. I will now turn the conference back over to Mr. Uhl for any closing remarks.

Okay. That will conclude our call today. I thank you for participating and for your interest in Adamis Pharmaceuticals. Have a good evening, everyone.

That does conclude our conference for today. Thank you for attending today's presentation. You may now disconnect.