Q2 2022 Adamis Pharmaceuticals Corp Earnings Call

August 10, 2022

Greetings and welcome to the Adam Lees Pharmaceuticals second quarter, 2022 financial results conference call.

Greetings and welcome to the Adam's Pharmaceuticals second quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Robert Oll, ICR OSWIC. Please proceed. Robert, please proceed.

At this time all participants are in a listen only mode.

A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.

As a reminder, this conflict being recorded.

It is now my pleasure to introduce your host Robert who I see our our Westwood. Please proceed.

Thank you operator, welcome to the Atmos Pharmaceuticals second quarter 2022 financial results and corporate update conference call. Thank you for joining us today for the update joining me on the call will be members of the Animas executive team, including in his new role C E O David J Margulies.

Thank you, operator. Welcome to the Atomas Pharmaceuticals second quarter 2022 financial results and corporate update conference call. Thank you for joining us today for the update. Joining me on the call will be members of the Atomas executive team, including in his new role, CEO David J. Margulio, chief medical officer, Dr. Ron Moss, and chief financial officer, David Benedicto.

Oh, Chief Medical Officer, Dr. Ron Moss, and Chief Financial Officer, David Benedict.

They will share with us their various atmos updates our format for this call will consist of prepared remarks from management and following that we will open it up to Q&A.

They will share with us their various Atomus updates. Our format for this call will consist of prepared remarks from management, and following that, we will open it up to Q&A. This call is being webcast and will be available for replay in the investor section of the Atomus website at atomuspharmaceuticals.com

This call is being webcast and will be available for replay in the investor section of the Animas website at Atmos Pharmaceuticals Dot com.

In today's call, we will make certain forward looking statements regarding our business based on current expectations and current information.

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.

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 filed with the Securities and Exchange Commission and in other subsequent filings that we make with the SEC. These are available on the SEC's website.

Now please let me introduce the new CEO David Margulies.

Thank you Robert.

Now, please let me introduce the new CEO , David Margulio.

I appreciate all of you for Chilliwack today to let US update you on our second quarter and perhaps more importantly here, how long and trying to break out and this is a pattern of underperformance.

Thank you, Robert.

I appreciate all of you for tuning in today to let us update you on our second quarter and perhaps more importantly, hear how we intend to break Adamus' pattern of underperformance.

In May of this year I was appointed CEO of a company with a 45 share price. It was out of compliance with NASDAQ in the middle of a product recall part of an ongoing Doj investigation and holding a limited amount of cash.

In May of this year I became the CEO of a company with a 40 cent share price.

It was out of compliance with NASDAQ, in the middle of a product recall, part of an ongoing DOJ investigation, and holding a limited amount of cash.

Add to that a hoard of unhappy shareholders and I can understand why another candidate might've been reluctant to step up to the challenge.

Add to that a horde of unhappy shareholders and I can understand why another candidate might have been reluctant to step up to this challenge.

However, I thought beyond out of his current situations, where we can take it.

I knew the company had strong asset and it can be leveraged to unlock tremendous value.

However, I thought beyond Adamus' current situation to where we could take it.

I knew the company had strong assets and could be leveraged to unlock tremendous value.

To start we have two approved products that can compete in a large market.

We have an ongoing clinical trial for temple that if it shows efficacy.

To start, we have two approved products that can compete in large markets.

But not only potentially become a blockbuster treatment for COVID-19.

We have an ongoing clinical trial for TEMPL that shows efficacy.

Essentially they expanded to treat other respiratory diseases.

could not only potentially become a blockbuster treatment for COVID, but could potentially be expanded to treat other respiratory diseases.

But most importantly.

We have a small yet devoted team of highly qualified and experienced individuals committed to both saving patients lives and this company.

So most importantly.

We have a small yet devoted team of highly qualified and experienced individuals committed to both saving patient lives and this company.

Before accepting this role I proposed to our board what I believe to be aggressive turnaround plan.

Before accepting this role, I propose to our board what I believe to be an aggressive turnaround plan.

But at certain points could put significant strain on the company our employees and partners.

that at certain points could put significant strain on the company, our employees, and partners.

Changing the company culture.

Proving operational systems and processes.

It involves changing company culture.

And establish a corporate group.

And then individual objectives intended to put us on a path to success.

improving operational systems and processes.

and establishing corporate, group, and individual objectives intended to put us on a path to success.

The board was supportive of the plan and we are now more than two months into it.

I'd like to share with you a few of these new objective, which I believe as we execute upon them.

The board was supportive of the plan and we are now more than two months into it.

I'd like to share with you a few of these new objectives which I believe as we execute upon them.

Should positively impact the company's stock price as well as rebuilding shareholder value.

should positively impact companies stock price as well as rebuilding shareholder value.

First.

We must convert sales has been high and some getting into cash flows.

stock price as well as rebuilding shareholder value.

If we can both increase topline sales and grow margins.

We must convert sales of Zimhi and Sanjepi into cash flows.

The resulting cash flows could potentially fund the entire company.

If we can both increase top line sales and grow margins.

We are challenging our commercial partner to both execute on the recent commercial launch of them high as well as once we resume manufacturing continue syngas is required build check.

The resulting cash flows could potentially fund the entire company.

We are challenging our commercial partner.

to both execute on the recent commercial launch of ZIMHIE as well as once we resume manufacturing, and continue ZIMHIE's prior growth trend.

I believe we have a good capable partner and U S. All met.

I Trust they will succeed in growing sales on both parts.

I believe we have a good, capable partner in US WorldMets.

But as a closely held private company.

And I trust they will succeed in growing sales on both products.

Mirth has little interest.

Your hourly projector sales of strategies.

But as a closely held private company,

However, going forward, they're committed to regularly providing animas with talking points, which we can in turn provide you with more visibility into their commercial efforts.

U.S. World Meds has little impetus to outwardly project their sales or strategies.

However, going forward, they are committed to regularly providing Animus with talking points which we can in turn provide you with more visibility into their commercial efforts.

I will share some of those in a few moments.

To grow margins, we recently kicked off multiple projects intended to decrease the cost of our injection device.

I will share some of those in a few moments.

To grow margins, we recently kicked off multiple projects intended to decrease the cost of our injection device.

For relatively short rather modest capital investment in a relatively short timeline.

for relatively short, rather modest capital investment and a relatively short timeline.

It shouldn't materially lower the cost of goods on our products.

In the future, we will consider more expansive manufacturing improvements when sales volumes justify additional investment.

These should materially lower the cost of goods on our products.

future we will consider more expansive manufacturing improvements when sales volumes justify additional investment.

The next objective is to broaden and advance our development pipeline.

Based on our ongoing besides our ongoing work rather with on COVID-19, we continue to evaluate capital for other indications.

The next objective is to broaden and advance our development pipeline.

based on our ongoing, besides our ongoing work rather, with on COVID-19 we continue to evaluate temple for other indications.

However, while we remain capital constrained in the near term, we will not advanced new clinical programs without financial support from government or private entities.

However, while we remain capital constrained in the near term, we will not advance new clinical programs without financial support from government or private entities.

In the near term I believe data from the Covid trial, if positive will broaden both the interest and further discussions with public and private non dilutive funding.

In the near term, I believe data from the COVID trial, if positive, will broaden both the interest and further discussions with public and private non-dilutive funders.

Longer longer term, we will continue to evaluate opportunities to acquire license jointly developed or otherwise partner to expand our pipeline.

Longer term, we will continue to evaluate opportunities to acquire, license, and

The criteria for advancing any of these opportunities will be first determining if they're both accretive and strategic for the company.

jointly develop an otherwise partner to expand our pipeline.

The criteria for advancing any of these opportunities will be first, determining if they are both accretive and strategic for the company.

Objectively measuring if we have the financial and human capital to advance them.

Then objectively measuring if we have the financial and human capital to advance them.

But I I understand there's a lot of frustration and fatigue among investors.

Look folks, I understand there's a lot of frustration and fatigue among investors.

But I believe that we are a critical inflection point.

The currently challenging all of our systems and most aspects of how the company operates.

But I believe that we are at a critical inflection point.

We are currently challenging Oliver Systems.

We have established new corporate objectives, which actually execute on.

most aspects of how the company operates.

Should put us on as a second paas new levels of success.

We have established new corporate objectives which as we execute on...

I'm asking all of you to stay tune support this process and give us a bit more time to turn adding a surround regain their trust and ultimately increase shareholder value.

should put us on an ascending path to new levels of success.

I'm asking all of you to stay tuned.

Support this process and give us a bit more time to turn adamits around, regain your trust, and ultimately increase shareholder value.

Now I would like to introduce our CFO to share with US a brief update on our recently filed financials.

Now I would like to introduce our CFO to share with us a brief update on our recently filed financials.

Yeah.

This afternoon, we filed our Form 10-Q for the quarter ending June 32022, I will highlight a few parts of our financials and I sincerely encourage you to review the 10-Q for additional details and disclosures.

David? Thank you.

This afternoon we filed our form thank you for the quarter ending June 30, 2022.

I will highlight a few parts of our financials and I sincerely encourage you to review the thank you for additional details and disclosures.

First as I have mentioned on prior calls asking ourselves statements for sensation for the first for the fiscal quarter depressed from lots of theaters.

First, as I have mentioned in prior calls, archimedial statements presentation for the first, for the fifth call, quarter difference from last year's.

You saw a CLO assets relating to the U S compounding subsidiary.

Therefore revenues and expenses relating to that business and those assets and liabilities are reflected in the discontinued operations items.

due to our sale of assets relating to the US compounding subsidiary.

Therefore, revenues and expenses relating to that business and those assets and liabilities are reflected in the discontinued operations items in our income statement and our balance statement.

The income statement and our balance sheet.

That said revenues for the six months ending June 30, 2022 and 2021.

That said, revenues for the six months ending June 30, 2022 and 2021 were approximately 1.2 million and 2.6 million respectively.

Proximately, one 2 million and $2 6 million respectively.

Bruce in revenues was primarily due to the manufacturing hold and we call them from Japan in 2022.

The decrease in revenues was primarily due to the manufacturing hold and recall of San riba 1950s in 2022.

Offset by the product launch of somebody.

Selling general and administrative expenses for the first six months ending <unk> 'twenty to 'twenty, two and 2021 were approximately $7 6 million and $8 5 million respectively.

offset by the product launch sales of Zemhai.

selling, general and administrative expenses for the first six months ending June 30, 2022 and 2021 were approximately 7.6 million and 8.5 million respectively.

The decrease was primarily due to decreases in compensation and legal expenses.

Research and development expenses.

Or how you are the first six months of 2022 at approximately $7 5 million compared to $4 4 million in 2021. The increase was primarily related to the ongoing clinical trial for example.

Research and development expenses were higher the first six months of 2022 at approximately 7.5 million compared to 4.4 million in 2021.

The increase was primarily related to the ongoing clinical trial for TEMPL.

Net loss from the fire mentioned in discontinued operations for the six months ended June 30, 2022 and 2021 was approximately one 2 million and $3 1 million respectively.

Net loss from the fire mentioned discontinued operations for the six months ended June 30, 2022 and 2021 was approximately 0.2 million and 3.1 million respectively.

The decrease loss was primarily attributed to the safety of U S compounding operations.

The decrease in loss was primarily attributed to the cessation of U.S. compounding operations.

Cash and cash equivalents at June 32022 totaled $8 9 million.

Cash and cash equivalents at June 30, 2022, total 8.9 million.

Cash expenses for the second quarter were higher than expected due to approximately $5 2 million in disbursements.

Cash expenses for the second quarter were higher than expected due to approximately $5.2 million in disbursements relating to repayment of the second draw PPP loan.

To repayment of the second draw a PPP loan.

This will make a difference if you recall.

One of separation expenses.

expenses related to the SYNGP recall, and employment separation expenses.

We expect cash used in operations due in part to a normalized level during the second half of 2022 we also expect to receive additional proceeds during the second half of 2022 which could range from collections of approximately 2 million to $3 5 million.

We expect cash views and operations to return to a normalized level during the second half of 2022.

We also expect to receive additional proceeds during the second half of 2022. This could range from collections of approximately 2 million to 3.5 million.

Pursuant to our sale of certain USC eye starts to for growth in 2021, and some of the disposition of the remaining USC.

pursuant to our sale of certain USC assets to Fagron in 2021, and from the disposition of remaining USC assets.

Once again I encourage you to.

To review, our recently filed Form 10-Q for additional details and disclosures I will now turn it over to our Chief Medical Officer Dr. Ron.

Once again, I encourage you to subscribe to my channel.

to review our recently filed content queue for additional details and disclosures.

Ron Moss.

I will now turn it over to our Chief Medical Officer, Dr. Ron Mars.

Thank you David.

I am really pleased to share with you today that we have completed the patient enrollment needed for the next interim data safety monitoring board meeting for our phase two three clinical trial to evaluate tempo as a potential treatment for COVID-19.

Thank you, David.

I am really pleased to share with you today that we have completed the patient enrollment needed for the next interim Data Safety Monitoring Board meeting for our Phase 2-3 clinical trial to evaluate temple as a potential treatment for COVID-19.

Also within approximately 10 patients have been rolling the complete sample size of 248 patient and inform the sites to pause enrollment when the 248 patient is enrolled.

We are also within the constantly 10 patients of enrolling the complete sample size of 248 patients and have informed the sites to pause enrollment when the 248 patient is enrolled.

As a reminder, the objective of this study is to determine temples effect on clinical improvement inflammation and the rate of hospitalization and outpatients with COVID-19.

As a reminder, the objective of this study is to determine Temple's effect on clinical improvement, inflammation, and the rate of hospitalization and allocations with COVID-19.

Our trial requires individuals with moderate COVID-19 symptoms they have comorbidities, such as diabetes or heart disease is those patients typically have worse outcomes, requiring hospitalization or have prolonged symptoms.

Our trial requires individuals with moderate COVID-19 symptoms.

to have comorbidities such as diabetes or heart disease, is those patients typically have worse outcomes requiring hospitalization or have prolonged symptoms.

Thus, we are enrolling a specific subset of patients with moderate symptomatic COVID-19 with known risk factors.

As a reminder, the trial is a double blind, which means only the data safety monitoring board knows what treatment is subject maybe getting during the trial.

As a reminder, the trial is a double blind, which means only the Data Safety Monitoring Board knows what treatment a subject may be getting during the trial. The DSMB is composed of infectious disease experts who independently review the unblinded trial data and make a recommendation to the company.

The SMB is composed of infectious disease experts, who independently review the unblinded trial data and make a recommendation to the company.

As you recall the D. SMB previously met both in March and June 2022 to evaluate the clinical and safety data from the interim analysis.

As you recall, the DSMB previously met both in March and June 2022 to evaluate the clinical and safety data from the interim analysis.

All the time to recommend that the study continue without modification once a threshold for data cut off has been reached the amount of work required in preparation for a D. S M B meeting with considerable.

All times are recommended that the study continue without modification.

Once the threshold for data cutoff has been reached, the amount of work required in preparation for a DSMB meeting is considerable.

The clinical research organization engaged in monitoring and verifying the data at all of the clinical sites and multiple statisticians and programmers prepared the analysis that will be presented to the data safety monitoring board.

The clinical research organization engaged in monitoring and verifying the data at all of the clinical sites, and multiple statisticians and programmers prepared the analysis that will be presented to the Data Safety Monitoring Board.

The blinded dataset then reviews first by Adam Metz, and then the C. O roller reviewed the data before finally, providing them to the D. F N b for their review.

The blinded data sets are then reviewed first by Atomos and then the CRO will review the data before finally providing them to the DSMB for their review.

The next meeting of the D F N B to review interim data.

Scheduled for the end of September .

The next meeting of the DSMB to review interim data is scheduled for the end of September .

At that time the D. S. M. B, we'll evaluate the primary efficacy endpoint, which is the rate of sustained clinical resolution of COVID-19 symptoms between temple and placebo as well as safety and individuals who are at high risk for disease progression.

At that time, the DSMB will evaluate the primary efficacy endpoint, which is the rate of sustained clinical resolution of COVID-19 symptoms between temple and placebo, as well as safety in individuals who are high risk for disease progression.

This will mark the first time that the DSP is evaluating efficacy using statistics and I expect there will be at least four outcomes.

This will mark the first time that the DSIB has evaluated efficacy using statistics, and I expect there will be at least four outcomes.

One possible outcome is that no efficacy as demonstrated in that case. The D. F. N. B may suggest it would be futile to continue in the company with likely stop the trial.

One possible outcome is that no efficacy is demonstrated. In that case, the DSM-B may suggest it would be futile to continue, and the company would likely stop the trial.

Second possible outcome.

Data from approximately 200 initial patients showed significant efficacy during the interim D. S. M D.

A second possible outcome is that the data from approximately 200 initial patients showed significant efficacy during the interim DSM-B meeting. Under this best case scenario, the DSM-B may recommend stopping the trial because even with a relatively small dataset, it has already demonstrated efficacy.

If that's the case scenario the D. SMB may recommend stopping the trial, because even with a relatively small dataset. It has already demonstrated efficacy.

Here, we would likely submit a clinical study report to the FDA along with our meeting request to discuss the findings and the next regulatory steps.

Here we would likely submit a clinical study report to the FDA along with a meeting request to discuss the findings.

Third possible outcome is that the efficacy transfer for example are served in the primary endpoint, but statistical significance is not yet reached in this case. The D. SMB mix may recommend that we continue to study and enroll additional patients to further powered the data in this case the DSM V with estimates.

and the next regulatory steps.

A third possible outcome is that the efficacy trends for every sample are observed in the primary endpoint, but statistical significance is not yet reached.

In this case, the DSMB may recommend that we continue the study and enroll additional patients to further power the data. In this case, the DSMB would estimate the number of additional patients needed to reach statistical significance on the primary outcome. This outcome would still be very encouraging.

A number of additional patients needed to reach statistical significance on the primary outcome.

Outcome would still be very encouraging and there's a fourth possible outcome. As you know in addition to the primary endpoint. The clinical study is reviewing secondary endpoints, including changes in inflammatory marker hospitalizations and all cause mortality there.

And there's a fourth possible outcome. As you know, in addition to the primary endpoint, the clinical study is reviewing secondary endpoints, including changes in inflammatory markers, hospitalizations, and all-cause mortality.

Therefore, another positive outcome would be if the study failed to demonstrate efficacy on the primary endpoint, but shows significant efficacy in one or more of a secondary endpoints.

Therefore, another positive outcome would be if the study fails to demonstrate efficacy on the primary endpoint, but shows significant efficacy in one or more of the secondary endpoints.

Many of the measured laboratory markers may correlate with disease progression of COVID-19 does this study could also provide additional proof of concept on temporal effect on laboratory markers of disease progression.

Many of the measured laboratory markers may correlate with disease progression of COVID-19. Thus, the study could also provide additional proof of concept on temples effect on laboratory markers of disease progression.

We are now closing in on the final enrollment for the original sample size of the study are either a modification to the trial or the CSM deal enrolling a large number of additional patients we would expect to receive topline data from this trial in the fourth quarter of this year.

We are now closing in on the final enrollment needed for the original sample size of the study. Or in either a modification to the trial or the DSMB enrolling a large number of additional patients, we would expect to receive top line data from this trial in the fourth quarter of this year.

Now if this trial ultimately proved successful.

It really could be a game changer for our company health care providers and patients as you are aware the FDA has already approved to other oral anti virals under emergency use authorization for our patients with COVID-19.

Now, if this trial ultimately proved successful...

It really could be a game changer for our company, healthcare providers and patients.

As you're aware, the FDA has already approved two other oral anti-vitals under emergency use authorization for outpatients with COVID-19.

If the data from this trial shows positive results, we will work closely with the FDA to discuss next steps and requirements for potential EUA emergency use authorization.

As you are aware there is currently a huge need for new efficacious therapy for COVID-19, and we're hoping that can fulfill fat boy, regardless of what form Covid takes moving forward. We believe there will always be a medical need a large market for effective therapeutics.

As you are aware, there is currently a huge need for new application therapies for COVID-19, and we're hoping that temp fulfills that void. Regardless of what form COVID takes moving forward, we believe there will always be a medical need and large market for effective therapeutics.

Finally, we are continuing to explore other potential indications for temple and are seeking both government and nongovernment non dilutive funding to further development of temple for other indications.

Finally, we are continuing to explore other potential indications for Temple and are seeking both government and non-government, non-dilutive funding to further the development of Temple for other indications.

Such funding come through we will update you on our plans for additional clinical development at this time I will turn it back to David.

As such funding comes through, we will update you on our plans for additional clinical development. At this time, I will turn it back to David Margolio.

Thanks, Rob.

I will now provide a commercial update for both of our products.

Thanks, Rob.

As you know in March we announced a voluntary recall of four lots of congestion due to potential clogging of the needle.

We will now provide a commercial update for those of our products.

As you know, in March we announced the voluntary recall before lots of syngepi due to potential clogging of the needle.

The first step in manufacturing some Japanese completed for Adam a spike catalyst Belgium.

The first step in manufacturing this in Japan is completed for Atomos by Catalin Belgium.

And I'm oversimplifying here, but essentially sources, all the components and material necessary to formulate epinephrine sales.

And I'm oversimplifying here, but kala essentially sources all the components and material necessary to formulate epinephrine

So syringes and insert rubber stoppers before ultimately shifting the syringes to Phillips for final Assembly.

fill syringes and insert rubber stoppers before ultimately shifting the syringes to Phillips for final assembly.

During a routine inspection of the Bachelor filled syringes catalyst identified a few with clubs.

During a routine inspection of a batch of filled syringes, Cattle identified a few with clogged needles. This initiated an extensive investigation.

This initiated an extensive investigation.

After many months determined that one bad batch of stainless steel needles was the cause of the failures.

that after many months determined that one bad batch of stainless steel needles was the cause of the failures.

Working with both catalog and their syringe supplier, we have developed corrective and preventative actions that we've shared with the FDA.

Working with both Katalon and their syringe supplier, we have developed corrective and preventative actions that we've shared with the FDA.

We are committed to returning to inject into the market as soon as all stakeholders are satisfied that these corrective actions will prevent similar failures and future batches.

We are committed to returning Sanjevi to the market as soon as all stakeholders are satisfied that these corrective actions will prevent similar failures in future batches.

As these actions are still being finalized and many are outside of Animas has direct control I cannot provide a target date.

As these actions are still being finalized and many are outside of Adamus' direct control, I cannot provide a target date.

As we talk today.

But I can assure you that everyone involved from with the manufacturer from the syringe supplier to you.

as we talk today.

But I can assure you that everyone involved with the manufacturer from the syringe supplier

Well, Matt it's David So you're working to restock some jeopardy as soon as possible.

To us world met is secret to you working to restock from deputy as soon as possible

Yeah.

Let me shift now to the Zimmer high launch.

Yes, well matched began shipping zim high for wholesalers at the end of March.

Let me shift now to the ZIM-I launch.

As you May know the first year of the commercial launch of any branded pharmaceutical is focused on setting up coverage and basic groundwork to establish a foundation upon which to grow sales.

The US World Med began shipping Zim High to wholesalers at the end of March.

As you may know, the first year of a commercial launch of any branded pharmaceutical is focused on setting up coverage and basic groundwork to establish a foundation upon which to grow sales.

I am very pleased to share with you the U S. What I imagine is meeting or exceeding their goals for the first 100 days post launch.

I am very pleased to share with you that US World Meds is meeting or exceeding their goals for the first 100 days post launch.

Okay.

Feedback from the field has been very positive.

Customers have indicated they see how's been the highest higher dose and intramuscular delivery may offer significant advantages over an intranasal delivery.

Feedback from the field has been very positive.

Customers have indicated they see how Zimhi's higher dose and intramuscular delivery may offer significant advantages over intranasal delivery.

In the present environment, where 85% of overdose deaths in the U S are attributable to higher strengths synthetic opioids like that at all and its derivatives.

In the present environment where 85% of overdose deaths in the U.S. are attributable to higher strengths synthetic opioids like fentanyl and its derivatives.

A product that could more rapidly provide higher levels of naloxone and a compact easy to carry package may offer customers, a one and done solution.

A product that could more rapidly provide higher levels of naloxone in a compact, easy-to-carry package may offer customers the one and done solution.

This is especially important if a caregiver does not have immediate access to multiple naloxone devices.

This is especially important if the caregiver does not have immediate access to multiple naloxone devices.

Looking at the market.

As you would expect the larger users of naloxone devices during the non retail public interest sector. This includes emts police fire and other first responders as well as treatment centers harm reduction and other public interest community groups.

Looking at the market, as you would expect, the larger users of Naloxone devices are in the non-retail public interest sector.

This includes EMTs, police, fire, and other first responders, as well as treatment centers, harm reduction, and other public interest community groups.

Well imagine aggressively targeting this market.

But it is a long sales cycle. The contracts that are required often takes six months or more to finalize however, once in place. They typically result in significantly larger orders.

US World Med is just aggressively targeting this market.

But it is a long sales cycle.

The contracts that are required often take six months or more to finalize. However, once in place, they typically result in significantly larger orders.

To streamline these orders U S Y <unk> recently launched a website, which enables institutional customers to order and receive direct shipments through Zimbra high direct dot com.

To streamline these orders, US World Meds recently launched a website which enables institutional customers to order and receive direct shipments through ZimHighDirect.com.

Complementing their efforts in this sector U S worldwide is also donating quantities of them high.

Complementing their efforts in this sector, US World Meds is also donating quantities of ZIM High. This year was also informed by a new initiative on rural derelict haveinternets we built New

To positively contribute and partner with these organizations to combat the opioid epidemic.

to positively contribute and partner with these organizations to combat the opioid epidemic.

Yeah.

In the retail market for naloxone pushed.

Prescribing has accelerated over the last few years due to an increased awareness of naloxone among the general public and a growing trend among doctors of co scripting naloxone with opioid prescriptions.

In the retail market from the lock zone.

Prescribing has accelerated over the last few years due to an increased awareness of naloxone among the general public and a growing trend among doctors of co-scripting naloxone with opioid prescriptions.

In order to sell into the retail sector unless first create market access.

In order to sell into the retail sector, you must first create market access.

Primarily entails, adding your product to formularies of both payers and pharmacy benefits managers such that it is approved for reimbursement without significant restrictions Cree.

This primarily entails adding your product to formularies of both payers and pharmacy benefit managers such that it is approved for reimbursement without significant restrictions.

Creating market access is a frustratingly slow.

Often taken six to 12 months to get on many formularies.

Creating market access is a frustratingly slow process, often taking 6 to 12 months to get on many formulary's.

U S well imagine is making steady progress and recently has had significant wins with some of the largest insurers and pbms.

USOMED is making steady progress and recently has had significant wins with some of the largest insurers and PBMs.

Unfortunately, we cannot yet share the details of those wins until the Payors and Pbms publicly update their formularies.

Unfortunately, we cannot yet share the details of those wins until the payers and PBMs publicly update their formulars.

One aspect of the retail market, that's a bit you need some choose naloxone is that most states have standing orders, enabling anyone to obtain a naloxone.

One aspect of the retail market that's a bit unique to naloxone is that most states have standing orders enabling anyone to obtain a naloxone.

Product from a pharmacy without an individual prescription.

These rules differ from state to state.

product from a pharmacy without an individual prescription.

While it can be quite a long process to add a product to the standing water here again, yes. All of them have just made significant progress and I'm pleased to say that as of today, Jim Hyatt has been added to scanning orders in 25 states.

These rules differ from state to state and it can require a long process to add a product to the standing order.

Here again, US World Med has made significant progress, and I'm pleased to say that as of yesterday, Zim High has been added to the standing orders in 25 states.

While increasing market access U S. Walnuts has fielded a team of 20 sales reps detailing doctors and clinics to increase brand awareness and drive scripts.

While increasing market access, US World Med has fielded a team of 20 sales reps detailing doctors and clinics to increase brand awareness and drive script.

They intend to grow this team as Jim Hi gains more traction.

To summarize the Zimmer highest at the commercial launch is proceeding as planned.

They intend to grow this team as Zim High gains more traction.

To summarize the ZIMHI update, the commercial launch is proceeding as planned.

Market reception has been very positive and we remain bullish on the long term success of this product.

Market reception has been very positive and we remain bullish on the long-term success of this class.

Let me add some late breaking news here.

You may recall earlier I described our team's commitment to saving patients lives.

Let me add some late breaking news here.

Well and this this week U S World and I had shared with US two recent cases, which is in the highest been successfully used to resuscitate victims of what is presumed to have Fannie fentanyl overdoses.

You may recall earlier I described our team's commitment to saving patient lives.

Well, this week, US World Med shared with us two recent cases which Zimhi have been successfully used to resuscitate victims of what is presumed to have been fentanyl overdoses.

Both cases were one and done interventions, meaning that only one dose was required to resuscitate the patients.

Just as the product was designed in attendance.

My goal today was to provide you with an update it helps you understand the current state of Animas and how long you tend to change its trajectory.

just as the product was designed and intended.

My goal today was to provide you with an update that helps you understand the current state of atomists and how we intend to change its trajectory.

Between our filings with the SEC recent press releases and social media posts in our discussions today.

Between our filings with the FCC, recent press releases, social media posts, and our discussions today, our goal is to provide investors with as much transparency as we are able within the legal and regulatory requirements.

Our goal is to provide investors with as much transparency as we our April within the legal and regulatory requirements.

The last thing I'll mention is if you haven't already done so please be sure to vote their shares in it.

The last thing I'll mention is if you haven't already done so, please be sure to vote your shares in the upcoming annual meeting of shareholders.

It's coming annual meeting of shareholders.

What's that.

Open it up for questions.

Thank you.

We will now be conducting a question and answer session.

With that, I'll open it up for questions.

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Yeah.

Okay.

Oh, Hey, operator, this is Robert I have some questions that have come out right.

Hey, Operator, this is Robert. I have some questions that have come in.

Alright. These are these are questions that have come in via email.

From various investors. So let me just jump right into that.

Alright, these are questions that have come in via email from various investors, so let me just jump right into that.

An investor asks about what exactly is going to come out of the D. SMB meeting at the end of September I mean will you know some efficacy of temple relative to standard of care will they make some kind of numerical announcement in terms of the number of hospitalizations on temple versus the number.

An investor asks about what exactly is going to come out of the DSMB meeting at the end of September . I mean, will you know some efficacy of Temple relative to standard of care? Will they make some kind of numerical announcement in terms of the number of hospitalizations on Temple versus the number of hospitalizations for the patients not treated with Temple? So just what are you going to be able to say as a result of that analysis?

[noise] of hospitalizations for the patients not treated with temple. So just what are you going to be able to say you know as a result of that analysis.

Oh, Hi, this stock from us and so as I mentioned.

Very briefly if you tried to stop for efficacy or lack of that D. C will provide a summary information.

So as I mentioned very briefly, if the trial stops for efficacy or lack of efficacy, we'll provide summary information in the public domain. If the trial continues...

In the public domain, if it's if the trial continues.

We will provide some information, but not very detailed information as the trial needs to be blinded.

We will provide some information but not very detailed information as the trial needs to be blinded if the trial continues.

If the trial continues.

Yeah.

So when you mentioned the top line data in Q4 is at the time, when we would see something that's a little bit more revealing or or or what will that look like.

So, when you mentioned the top-line data in Q4, is that the time when we would see something that's a little bit more revealing, or what will that look like?

No actually this this next decent deleting the.

No, actually this next DSMB meeting, the statistical analysis will be done on the primary endpoint and as I mentioned before, one of four options will occur based on that statistic. So actually the meeting in late September will be very definitive for this trial.

Statistical analysis will be done on the primary endpoint and as I mentioned before one of four options will occur based on that statistic. So actually the meeting in late September we will be very definitive for this trial.

Okay perfect. Thanks, Thanks for clarifying that.

<unk> also.

Some questions about your cash balance that you reported here at the end of Q2 O. What what kind of a runway does that provide you with an I know you said you might be getting additional revenue coming in from the divestiture of the.

Okay, perfect. Thanks for clarifying that. Also, some questions about your cash balance that you reported here at the end of Q2. What kind of a runway does that provide you with? And I know you said you might be getting an additional revenue coming in from the divestiture of the...

The business from before.

So so just talk about you know what your cash will fund you that runway and what your alternatives are for perhaps some additional cash raising.

the business from before. So just talk about, you know, what your cash will fund you, the runway, and what your alternatives are for perhaps some additional cash raising.

Yeah, that's all.

I'll I'll take a swap with that and then if David B has a any other clarifications he can jump in.

Yeah, I'll...

I'll take a swab for that and then if David B. has any other clarifications, he can jump in.

So the you know I think as we mentioned in our earnings release.

So the you know, I think as we mentioned in the earnings release

We expect we had some higher than.

Budgeted expenses in Q2.

We expect, you know, we had some higher than budgeted expenses in Q2, which is sort of outside of our normal quarterly burn, and we expect that the second half of the year that we will move back to a more normalized level.

Just sort of outside of our normal.

Quarterly burn and we expect to that the second half of the year that we will move back to a more normalized level.

So.

We expect that the cash should get us through the end of the year and then as you mentioned Robert we have additional sources of capital, which we expect will also come in during that period.

So we expect that the other cash should get us through the end of the year and then as you mentioned Robert, we have additional sources of capital which we expect will also come in during that period.

To your broader question about what we intended to do for additional capital.

But to your broader question about what we intend to do for additional capital, I think that the reality is nobody wants to raise money at these levels. So the most likely outcome would be we would look ahead to

Yeah, I think the reality is none nobody wants to raise.

Raised money at these levels.

So the most likely outcome would be if you look ahead to certainly post.

In a meeting with the D SMB see what the results of that meeting are.

Certainly, post interim meeting with the DSMB, see what the results of that meeting are, the possible impact would be to the share price before determining a financing plan going forward.

Possible impact could be to the shared price before determining a financing plan going forward.

Okay, Great that's helpful.

And then also the kind of a.

Okay, great. That's helpful. And then also, kind of a little bit of the same question, but in a different way. With the really potentially very good news coming out in September for TEMPL from the DSMB, and it sounds like the ZIMHIGH launch is really starting to gain some traction, and the story about the two.

A little bit of the same question, but having a.

Different way.

With with the really potentially very good news coming out in September for temple from the D. S M B and it sounds like the zoom high launches is really starting.

Starting to gain some traction in the story about the two Ah patients whose lives were saved is very compelling reason to use the product and it sounds like you're getting closer and closer on resolving some jeopardy and getting that back out. There. So you know wouldn't you think all of these things could have a positive impact on your share price in there.

patients whose lives were saved is very compelling reason to use the product and it sounds like you're getting closer and closer on resolving SimGeffy and getting that back out there. So you know wouldn't you think all of these things could have a positive impact on your share price and then that might.

That might be.

Relieve some of the pressure to do a reverse split or.

Or you know even postpone a financing until some of these positive.

relieve some of the pressure to do a reverse split, or you know even postpone a financing until some of these positive impact effects have been recognized in the share price. What's your thinking with that?

Impact effects are taken and it had been recognized in the share price, what's your thinking with that.

Oh well.

Yeah.

The answer to all of that is yes and.

I'm sorry.

Yeah, I think the answer to all of that is yes.

I believe we are.

Mentioned, either in the proxy and or in some.

I believe we mentioned either in the proxy and or in some of our

Some of our.

Communications last month.

The objective of the reverse split is beyond just.

communications last month. The objective of the reverse split is beyond just...

Trying to bring the share price back into compliance with NASDAQ certainly that is a significant motivator, but it was also in.

trying to bring the share price back into compliance with NASDAQ. And that gives a significant motivator, but it is also intended to...

Intended to.

Bringing the share price to a level that.

It can be purchased by more fundamental health care funds it might be restricted based on the present share price.

bringing the share price to a level that

It can be purchased by more fundamental healthcare funds. It might be restricted based on the present share price.

And so I feel like that.

Self puts a damper on the overall stock.

And so I feel like that in and of itself puts a damper on the overall stock, as well as the advantage of the split even in the smallest of ratios is that it opens up.

As well as the advantage of the split even in the smallest of ratios is that it opens up shares to be used to to continue to fund the company.

But certainly you know as you know.

shares to be used to continue to fund the company.

Two there is there are a number of factors on the near Horizon that you think could positively affect the share price and it's not all.

But certainly, you know, as you alluded to, there are a number of factors on the near horizon that we think could positively affect the share price. And it's not a...

Our attention to.

Makes decisions on financing or.

our intention to make decisions on financing or reverse split and possible ratio until some of those events actually transpire.

The reverse split.

Possible ratio until some of those events actually transpire.

Yeah.

Okay, Great and then.

Just just just one more came in and you talked about this a little in your prepared remarks, and that's on making future acquisitions. It sounds like there's not any you know high high desire to make any sort of near term acquisitions, but rather you'd like for some JP and Jim Hi to play out in temple as well.

Okay, great. And then...

Just one more came in, and you talked about this a little in your prepared remarks, and that's on making future acquisitions. It sounds like there's not any high desire to make any sort of near-term acquisitions, but rather you'd like for SimJepi and ZimHi to play out and Temple as well. And if those are positive, then down the road at some point, you could consider additional acquisitions or product opportunities.

And you know if those are positive then you know down the road at some point you could consider additional acquisitions or product opportunities is that.

Is that the correct message am I getting that right.

Yeah, I think that's right.

Is that the correct message? Am I getting that right?

I would add though that.

I firmly believe that it.

Yeah, I think that's right. I would add, though, that I firmly believe that...

In this industry you have to continue to innovate or die.

And you know whether that innovation is in additional indications for temple.

In this industry you have to continue to innovate or die. And whether that innovation is in additional indications for Temple or...

Sure.

In licensing or acquiring a compound that we can put in our in our already approved device.

in licensing or acquiring a compound that we can put in our already approved device.

Or other opportunities that might come down the pike that you know the.

I mentioned in my.

or other opportunities that might come down the pipe that, you know, as I mentioned in my...

In my opening comments that we felt like would be immediately accretive to the company.

In my opening comments that we felt like would be immediately accreted to the company but until You know such time that we have better visibility into where? the financing Would come from to support any new project. That's not something that we are actively working towards

Until such.

Such time that we have better visibility into where the.

The financing.

That would come from to support any new project, that's not something that we are actively working towards.

Yes.

Okay.

Great. That's that's very helpful. In clarifying so that's that's it on the questions now so.

Great, that's very helpful and clarifying. So that's it on the questions now. So with that, I think we will now conclude our call today. Once again, I would like to remind all of you that the company will be hosting its 2022 annual meeting of shareholders in two days time on August 12th at 10 a.m. Pacific time, 1 p.m. Eastern. And thank you very much for participating and for your interest in Atomos Pharmaceuticals.

With that I think we will now conclude our call today once again I would like to remind all of you that the company will be hosting its 2022 annual meeting of shareholders. In two days' time on August 12 at 10, a M Pacific time, one P M eastern and thank you very much for participating and for your interest in Atmos farm.

Masuda calls if you have additional questions. Please let us know have a good evening everyone.

Thank you. This does concludes today's teleconference. You may disconnect. Your lines at this time and thank you for your participation and have a great day.

Okay.

Q2 2022 Adamis Pharmaceuticals Corp Earnings Call

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