Q1 2022 Adamis Pharmaceuticals Corp Earnings Call

Good evening and welcome to the Army Adam Pharmaceuticals, first quarter 2022 financial results Conference call.

All participants will be in a listen only mode did.

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After todays presentation, there will be an opportunity to ask questions.

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Please note this event is being recorded.

I'd now like to turn the conference I thought some of the stuff like that with ICR Wesley. Please go ahead.

Thank you operator, good afternoon, everyone and welcome to the Atmos 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 animals.

Joining me today is Adam Metz, Who's President and CEO , Dr. Dennis J Carlo Chief Medical Officer, Dr. Ron Moss.

Chief Business Officer, David Martin, <unk>, and Chief Financial Officer, David been <expletive> Joe.

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 Adam is pharmaceuticals dot 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 statements made today of <unk>.

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.

Nothing that long since our last call. So todays call will be brief, but I will attempt to highlight a few important advancements.

First I'll begin with <unk>.

Some product.

Drug overdoses took more lives than ever before in 2021.

Approximately 108000 people died of drug overdoses. According to the CDC two thirds of this of these involving Sentinel.

Drug overdose remains a significant problem that affects all sectors of our society.

As we update you on our last call our commercial partner, Yes World Mitch launch them at the end of March.

In a few minutes.

Al will provide more information, but we are very pleased with the market reception of GMI and the uptake in both the retail and non retail sectors of the market.

U S World Meds has had some early wins among both commercial and government customers in the next six months you reveal the sales trajectory, we can expect towards MRI.

I'll now move on from Zim items in jeopardy.

March 'twenty, one 2022 and also announced a voluntary recall of certain lots of some of the IP epinephrine injection Europe, 115 milligrams and 0.3 milligrams pre filled single dose syringes.

In fact, it's been getting product loss lots 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 infected.

Lots is nearing its completion that a root cause relating to a particular batch of syringe needle has been identified and that corrective and preventive actions have been and will be taken.

We anticipate a resolution and the resumption of manufacturing after the.

The investigation was completed and issues are satisfactorily address we expect that this will occur in the near future.

With that I will turn it over to our CFO is the victim 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 intended to highlight the key parts of our financials and business question.

And I encourage you to thoroughly review the 10-Q for additional details and disclosures I should point out that our financial statement presentation for the following quarters is different from last year's presentation.

That is due to our sale of assets relating to or a compounding pharmacy business, formerly conducted by our U S compounding subsidiary and our decision to wind down the business and so or dispose of the remaining related assets.

Revenues and expenses related to that business and those assets and liabilities.

In the discontinued operations items.

Statement and our balance sheet.

Revenues for the quarters, ending March 31, 2022 2021 were $1 2 million and $1 4 million respectively revenues for the quarter ended March 31, 2022 consisted mainly of one 1 million of sales of Zen pie.

Partner U S World Meds in anticipation of that.

Virtual launch.

<unk> announced at the end of March.

Revenues for the quarter ended March 31, 2021 consisted mainly of some Jackie injections heroes.

Due to some differing manufacturing cold and the voluntary recall no revenues relating to some Jackie we reported for the first quarter of 2022.

Selling general and administrative expenses for the quarters, ending March 31, 2022, and 2021 what $3 4 million and $3 5 million respectively.

The selling general and administrative expenses in 2022 reflected a 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 temple.

Net loss from discontinued operations for the three months ended March 31, 'twenty to 'twenty two 2021.

<unk> hundred 65001 5 million respectively.

Decrease in loss was primarily attributable to the winding down and cessation of USD.

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 pursue what the overall scale of certain U S assets to build run and some of the disposition of the remaining U S 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 important for an additional four and upbeat.

Thank you.

Our phase II phase III clinical trial to evaluate <unk> as a treatment for COVID-19 is continuing our planned interim analysis is anticipated to occur in late May early June.

Lee confirming this statistical programs and data sets.

This trial is a double blind, which means only the data safety monitoring board or <unk> B notes with treatment of subjects getting during the trial.

As the trials interim analysis, the SMB carefully reviewed this data and can stop or continue a trial in Oakland make a recommendation to modify the trial or even request additional meetings with additional clarification is required.

The trial.

It's 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 of the integrity of the data if it's done in other clinical trials.

The time to completion of the trial depends among other factors on bulk cobain infection rates, which are increasing enrollment in the <unk> recommendations. If the trial is successful. We will also submit a clinical study report and a request a meeting with the FDA as soon as possible.

Finally, we are looking at other potential clinical uses of temple continue to see government non dilutive funding and have recently applied for government grants at this time I'd like to turn it over to David Margulies.

Thanks, Ron.

Like to provide a quick update on how the Zim high 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 etc. Zim high 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 veterinarian the veterans administration.

Many of state medical Medicaid plans.

Including several of the largest.

Blue Cross Blue Shield plans in Massachusetts, Michigan, and Tennessee, Hi.

Hi, Mark Blue Shield plans in Delaware, Ohio, Pennsylvania, and New York, and West, Virginia, and all of Humira as top commercial formularies.

Zimbabwe is available for more than 83% of physicians using electronic health Records and U S will merge is pushing to grow that number.

After loading the wholesaler distribution channel at the end of March U S. Well matched 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 science and intuitive.

Nature of the device and the overall value proposition amongst stakeholders in both the retail and non retail market sectors.

In summary, although early we are very pleased with the activity to date and the trajectory for the product both Adam and U S will merge remained bullish on zim highest 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.

Thank you.

I'll begin the question and answer session.

Good question.

So then one on your telephone keypad.

If youre using a speakerphone please pick up your handset before pressing the team.

All your question.

Okay.

At this time or pause momentarily to assemble our.

Thank you there are no questions at this time.

I'll now turn the conference back over to Mr. <unk>.

Mark.

Okay that will conclude our call today. Thank you for participating and for your interest in Atmos Pharmaceuticals have a good evening everyone.

That does conclude our conference for today.

Thank you for attending today's presentation you may now.

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