Q2 2021 PLx Pharma Inc Earnings Call

August 6, 2021

[music].

Okay.

Good day and thank you for standing by welcome to the appeal of acts of format Q2, 2021earnings results call.

At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to press star 1 on your telephone. Please note that today's call is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to your speaker.

Day, Lisa Wilson. Please go ahead.

Thank you Ms. Sue welcome to Pls form of Q2.2021 earnings results call. This is Lisa Wilson Investor Relations for P of luck with me on today's call are Natasha Giordano, President and Chief Executive Officer, and Rita O'connor, Chief Financial Officer of Pls.

You can also access the webcast of this call through the investors section of the Pls website appeal of pharma Dot com before we get started I would like to remind everyone that any statements made on today's conference call that express a belief expectation projection forecast anticipation or intent regarding future events and the company's future.

<unk> may be considered forward looking statements as defined by the private Securities Litigation Reform Act.

Forward looking statements on based on information available to Pls for them as management as of today and involve risks and uncertainties, including those noted in our press release issued this morning, and our filings with the SEC such.

Such forward looking statements are not guarantees of future performance actual results may differ materially from those projected in the forward looking statements <unk>, specifically disclaims any intent or obligation to update these forward looking statements, except as required by law. The archived webcast will be available for 30 days on our website <unk> Dot com.

For the benefit of those who may be listening to the replay or archived webcast. This call was held and recorded on August 6.2021. Since then <unk> may have made announcements related to the topics discussed. So please reference the company's most recent press releases and SEC filings.

That I will turn the call over to <unk>, the CEO of Natasha Giordano.

Thank you Lisa.

Everyone and thank you for joining us today as you've seen in our recent series of press releases, we are actively executing on our commercial strategy for <unk>, the first and only FDA approved liquid filled aspirin capsule.

Our retail partners, including Walmart Walgreens Rite aid Cvs and other leaders in pharmacy like Kroger Albertsons and target are fully committed to <unk>. In fact, many of them of used attention grabbing shelf placeholders to alert customers. The vascular is coming soon.

We have extensive distribution for <unk> in more than 30 thousands of stores throughout the country. We recently deployed our cardiovascular field force to raise the awareness within the community of specialists and we of inventory ready to ship to retailers to fulfill this widespread distribution the.

This extraordinary level of distribution is unheard of for a new brand from a company our size.

As many of you know our management team has launched several prescription and OTC products, including well known names like Newson ex Lipitor neuron 10, zantac Zyrtec and Zicam.

We are looking forward to turning <unk> into a household name.

Understand what the specialists like cardiologists and neurologists require in making treatment decisions for their patients and the importance that strong clinical data can play in their understanding and appreciation for vascular novel delivery mechanism.

I'd like to spend some time today discussing why Peel ex pharma is more than just Aspen. We are about the innovative <unk> drug delivery platform and I'm looking forward to sharing more information about our plans for appeal ex guard after Reid of reviews, our financials for the quarter Rita.

Thank you Natasha this is kind of been.

A very busy few months for both financing manufacturing at Pls is Natasha mentioned upfront. We are thrilled that so many prominent retailers have made a significant commitment to <unk> and we're excited to stay our launch inventory has been manufactured and is ready for shipment to retailers across the country.

Starting in the third quarter of 2021, we expect to generate revenue from sales of both doses of the Adelaar, We will account for revenue in accordance with ASC 606, which essentially means that we will record revenue when it arrives at the customer's warehouse, which in our case is the retailer.

We will also record reductions to gross revenue for provisions for retailer promotional programs product returns prompt pay discounts and coupon redemptions by consumers. Many of you may remember those as gross to net.

Cost of sales of Cogs will include actual cost page of our contract manufacturer and packagers Cogs will also include warehousing inbound and outbound shipping and handling and storage costs at our distribution center in the Midwest the.

The gross margin for the launch here is expected to be lower until we expand manufacturing capacity and move to larger batch sizes next year.

Although we're not providing specific revenue guidance, we can share the 30000 retail stores across the country will be stocking vascular later this month.

Many of those stores will stock all 3 of Skus in the aspirin aisle plus thousands of displays and the retail price to consumers is expected to be around $25 per month supply.

Moving on to operating expenses R&D spending is expected to increase slightly for the rest of 2021 as we complete the 81 milligram PK PD study as well as feasibility work to increase manufacturing capacity combined with further development of products using our patent protected.

<unk> technology.

We also change the label for of G&A expenses, this quarter to selling marketing and administrative to properly reflect spending on our launch activities for <unk>.

As you would expect this spend will increase significantly as we will be in full launch mode, starting in the third quarter.

As a result, you can expect total operating expenses to be around $12 million to $14 million for the third quarter. The.

The Tushar will elaborate on our plans to generate awareness among health care professionals and consumers about our innovative aspirin therapy.

As you can see theres been a few changes to our capital structure of the past few months, including the conversion of a portion of the preferred stock to 3 million common shares in.

In addition, $1.1 million warrants were exercised for $4.3 million of cash, resulting in outstanding common shares of $26.9 million as of August 3rd.

We also currently up $16.4 million potentially dilutive shares including options remaining warrants and convertible preferred stock for fully diluted shares of around $43.3 million keep.

Keep in mind that this fully diluted share count includes warrants that could be exercised for potential cash inflow of $37 million.

As of June 32021, we had cash and cash equivalents of $80.2 million and our balance sheet remains debt free as we paid off our term loan with Silicon Valley Bank back in February.

You will see this morning, we filed the shelf registration statement for <unk> $250 million, which includes a $75 million ATM facility, we elected to file the current form S..3 to replace the previous shelf registration as a matter of good housekeeping and in line with many other companies at our stage of growth.

<unk>.

While we do not have plans for additional capital in the near term these filings provide us with the maximum flexibility going forward.

As we have previously stated our existing cash should be sufficient to support our commercial activities for <unk> for at least the next 2 years.

With that I'll turn the call back to Natasha to discuss the <unk> commercial strategy and the expansion of the <unk> technology from <unk>.

Thank you Rita as a reminder, central to our vascular launch strategy is generating awareness for 3 constituent retailers professionals and consumers.

We've already discussed the widespread retailer distribution across the country and now lets discuss the strategy regarding health care professionals.

Through our market research, we've learned that the top influencer for the consumer is their physician to address the health care professional we've developed the strategy that is focused on providing scientific information about <unk>, our new innovative aspirin therapy through prestigious medical conferences.

The ACC H, a TCT publications of clinical trials and personal promotion by cardiovascular care specialists.

We continue to work with our <unk> scientific Advisory Board chaired by Dr. Deepak Bhatt, and Dominic Angelo along with strong representation from top academic institutions, such as Harvard Brigham and Women's University of Florida, Baylor Mount Sinai and tops. This.

Prominent group of cardiology, neurology, and gastroenterology specialists recognizes the unmet medical need as well as the strength of our clinical data they've played an important role in guiding our strategy and in our understanding of what's important to clinicians who treat vascular disease.

That all of our offers clinicians the completely novel approach to aspirin therapy are robust pharmacokinetic and Pharmacodynamic study comparing 3 aspirin formulations was published in the journal of the American College of Cardiology, the top peer reviewed journal for the cardiologist the.

Published the results show that value will provide fast reliable aspirin absorption and predictable platelet inhibition compared with enteric coated aspirin the current standard of care. Additionally.

Additionally, we are conducting of PK and PD 81 milligram clinical trial and should be ready with top line results later this year.

1 of the important differentiators of vascular capsules is that they are filled with a liquid lipid aspirin complex the bypassing the stomach and gets rapidly absorbed in the duodenum, thus, reducing the risk of stomach injury as compared with the regular aspirin.

Our endoscopic assessment and comparison of upper Gi damage of Boswell on regular aspirin was published in the American Journal of Gastroenterology, the top peer reviewed journals for Gastroenterologist.

Both of these studies underwent the rigor of the peer review process in order to be published in these prestigious journals.

To further raise the awareness throughout the cardiology community, we hired mainly rettig RN MSN as our executive medical director Mamie has deep cardiovascular clinical and industry experience and is a true patient advocate she's integral in our in our midst.

<unk> to reach the cardiology community and we are thrilled that she has joined the <unk> team.

Additionally to enhance our integrated multichannel commercial strategy in July we launched the cardiovascular specialty field force led by <unk> and in partnership with ever Sona, a leading provider of next generation commercial services to life science companies.

As you know vascular was developed with the <unk> drug delivery platform. The exciting aspect of where we are as the company is that POF God represents the true platform on which to build our company Peel ex pharma is more of an aspirin our innovative <unk> platform has the potential.

<unk> to enhance delivery of active pharmaceutical ingredients of.

Optimize drug absorption and reduce the acute gi injury provide new or extended patent protection for an already approved or development stage drug and utilize the 505 day, 2 NDA regulatory path that often provide the faster and lower cost FDA approval.

Used with already approved drugs.

<unk> clinically validated technology works by targeting the release of active pharmaceutical ingredients or API for various portions of the Gi tract.

We believe this platform has the potential to improve the absorption of many drugs currently on the market or in development and to reduce the risk of stomach erosion and ulcers associated with certain drugs.

The innovative <unk> drug.

Drug delivery platform utilizes a ph dependent release mechanism that relies on the chemical association of Luketic excipient with API to selectively release them to targeted portions of the Gi tract.

The pre association of Pls guards own pharmaceutical lifted means that API won't interact with similar naturally occurring phospholipids in the stomach lining helping to prevent gastric injury and making it less likely that Apis will come in direct contact with the stomach.

Because of this technology is so novel, we have 58 strong global patents patents offering protection through 2032, which includes composition of matter methods to make and methods to treat and though we are laser focused on our imminent vascular launch.

We strongly believe in the value of our <unk> drug delivery platform.

To date, our pipeline includes the novel formulation of ibuprofen and other non steroidal anti inflammatory drugs or ansaid.

Many of you have asked about our plans beyond <unk> and since our patents extend beyond on states, where presently screening compounds, where pls guard could improve bioavailability reduce the risk of gastric injury and are commercially viable.

The 552, NDA regulatory pathway, often provides a faster and lower cost SBA approval process when used with already approved drugs as we progress in the launch of <unk> and assess product candidates for appeal Exco on platform, we will begin to describe <unk>.

Manner that represents our evolution and our ongoing growth plans so stay tuned.

With the appeal of scar junk delivery platform. We are highly confident that this management team has the depth of experience to bring products to market and achieved similar distribution like we have for value are with that I will open the call for questions. Operator. Please go ahead with the instructions.

At this time, if you would like to ask a question press star 1 on your telephone keypad again that the star and the number 1 there for.

First question comes from the lineup, Jason Butler of JMP Securities.

Hi, Thanks for taking the questions and congrats on all of the progress.

Okay.

Just a couple of on the the field force can you give us any more details around the size of the field force or.

What your targets are for.

You know the number of physicians that you want to get to how many.

Touch points, you think you need to get where the physician before they are the they start to the point the.

The patients towards the products. Thanks.

Thanks, Jason.

With the field for US our strategy is very very laser focused.

Identify the top 100 heart and stroke hospitals.

And the affiliated cardiologist to the hospitals and group practices of course.

Marketing the large msas in the country and we are very much focused on getting the iron ticket scientific information and raising awareness to the practicing clinical cardiologist. However, we will also focus on the cardiologists that on.

On the invasive cardiologist interventional cardiologists as well, although I won't comment on on size I can tell you that we've done a very sophisticated targeting and segmentation exercise, we know exactly where we want to send our reps there.

<unk> in the field as we speak.

Beginning that process, so that when bad for hits the shelves that we have some awareness within the cardiology community.

I mentioned that we hired an executive medical director as well and part of her role is to extend into that intervention cardiology community. Because it is important that they are aware since the patient is with them in the acute phase and that way we can.

Over the acute and chronic.

The maintenance of the.

This important important product.

That's helpful. Thank you Tushar and then just.

I know, it's early but can.

Can you give us any anecdotal feedback on do you feel like Youre, having successes already with physicians and I guess any any.

Reasons to believe that there are physicians ready on already to the point the their patients for the product when it's available.

Yeah I'm happy you asked that question because you've heard us talk about our market research and that the cardiologist I understand that there's an issue with the with the present current standard of care of the coated aspirin tablet, but yes, they've had they've had no other option right there's been.

No no innovation and so we know from the market research that they are open ready and willing and they find the data could be quite compelling and what we're seeing in the field right now in the last couple of weeks is an openness of receptivity.

Waiting for a new innovative aspirin product and so the there's a lot of interest being being generated.

And so in anticipation of of alcohol are hitting hitting the shelves. We wanted to make sure that we get out before that so that the cardiology community is aware of its coming.

Great and then just lot.

1 from me on the.

On the platform technology, just any more color you can give us on how you will prioritize investment into pipeline in Canada. Its obviously youre going to be laser focused on the book.

How will you think about.

Our types of investments into the pipeline.

We were prioritizing compound that could use better bioavailability, but also have the issue with potential risks to the stomach injury because of that truly is what differentiates the technology the appeal of God.

That for them. So we've already been looking at those candidates and as we continue those experiments and prioritize the the compounds will come back to you and give you progress on on what we've been doing book.

We felt it was really important especially at the time of launch this management team as the team that knows how to execute commercial launches and we are really confident and in all the the materials the resources the strategy the content the vehicles to deliver information.

Cash and everything is in place and we're really very excited to be able to bring bad for to the millions of patients who absolutely need it and can benefit from it and so we felt now was the really good time to start to talk to you all of us as you've been asking us over the last several weeks what's what's next.

And we're really excited about this platform because it really does enable us to build this company, even even beyond <unk>.

Okay, great. Thanks for thanks, again for taking the questions and congrats again on all the progress.

Thanks, Thanks, Jason.

Your next question is from Elliot Wilbur with Raymond James.

Hey, guys. This is actually Michael part of Lori on for Elliot.

And thanks for taking my questions good morning, Bonnie.

Yeah. So on so first of kind of piggybacking on the specialty sales. The sales force I was just wondering if this effort includes any sort of sampling or coupon strategies.

To get the product directly in patient's hands immediately after like any interaction with the physician.

So we are applying a an integrated multichannel approach as it relates to to all our constituents not only the health care professional book, but also the the consumer.

And in partnership with the retailers. So yes, we'll be we've developed patient education tools with a.

Our high value incentive that we will be providing to the field force.

Yes, we will be including sampling for the physicians as well.

That is the the best way for physicians to start to look at end of evaluate and trial.

<unk> and so yes, we will be providing those indeed.

Okay perfect.

And then I believe you Brito referenced that some of the.

Prepared remarks.

Remarks foot on just wanted to clarify.

But you guys recognize revenue on.

On the quantities of upon shipment on that there's no requirement for pull through demand.

For reservoir.

That's correct actually 1 little clarification, we're going to record revenue when it arrives at the retailer's warehouse subsequent title transfers, so and yes, we are able to recognize revenue then because we have the ability to.

You analyze what those provisions of the gross to nets will be so GAAP allows us to record revenue when the retail of receives it.

Got it.

Alright, and then last 1 for me just wondering if you guys had any upcoming conferences or kols events, where.

Do you anticipate Boswell, we're having a high profile for for education.

Yes, we've been targeting non.

The medical conferences for the last several years and we've developed a really nice network of cardiologists that are already aware of alcohol on the benefit of it can bring to patients the.

Next.

Upcoming conferences or TCT and IHA, we just recently did a program.

The associated with ACC was the very distinguished panel Dr. Gibson Dr. <unk> Dr.

Dr Myron and got the Grainger, where they talk a lot about the adaptable trial results and also how <unk> could fit into their additional regime and we do plan to have.

Hence at TCT, nahi, as well and of course.

<unk> for 2022.

Yeah.

Perfect. Thanks, again for taking my questions and congrats on all of the progress looking forward to seeing does who are on the shelf.

That's great Michael Thank you Michael.

Your next question is from live anchor show with Oppenheimer.

Good morning from Clos.

Hey, guys. Thanks for taking the question.

Yes.

The discussions for me in addition to leveraging the majority interest.

The thing.

The papers and plenty of studies, we have on on revenue.

If the advantages once the asps that there'll be a further stream.

Of articles of maybe coming out on other work you.

We have done with the Florida.

For the content.

Back to Phil.

They're in there.

Standing with some of them.

Got it thank you guys.

And also wanted to ask in terms of.

Direct to consumer approaches if you could share.

Any thoughts for detail on any timelines or nature of the.

The deployment of clear thank you.

Thanks, Leland I believe very strongly in our publication strategy and plan and we've been working with our scientific Advisory Board.

The established the.

A publication Committee made up of our scientific Advisory Board and actually some from other very well known cardiologists in the in the country and so there is and will be a stream of papers and articles that that we are are working on and that will submit for.

For for publications you May remember last year, we presented several abstracts and posters at a variety of different cardiology conferences.

Or being converted into into manuscripts.

For publication, So, yes, I think it's really important that the medical community continues to learn more.

About that for about the category and about how how important aspirin is in the treatment of of vascular disease.

Appears on every every guideline is foundational therapy for these patients.

So we will continue our efforts there and we have Dr. <unk> on our scientific Advisory Board that is leading that effort for US right now she is a world renowned for.

Lately expert so we have a really established and world renowned team of <unk>.

I'll just working on those on the publication.

And in terms of DTC of of course, you know our marketing strategy and plan includes many different media.

Certainly have.

The program programs for for the E Commerce side of of the business, we know that the retailers over the last year and a half with with the impact of Covid has have really developed their ecommerce platform. So we will be everywhere the consumer shops for.

Certain and we will we will have on media and search and digital and as we approach and progress through the launch we'll talk more about our advertising efforts, but you can be rest assured that we are focused on the consumer as well.

Terrific.

1 last question irrespective of the on X.

Shelf filing an NDA.

Moving to pave the path for you.

We're fairly comfortable with the proof of concept that used to be.

On the black of aggressively on the.

Of that more of commercialization just wanted to kind of the thank.

So I think again of your comfort level there.

With respect to.

The launch of the next couple of years of that.

Yes.

Yeah. Great question. So you are correct, we said that we have sufficient capital to launch <unk> successfully for at least the next 2 years.

We also we filed the shelf to give us that maximum flexibility too.

Further develop some of the appeal of <unk> technology products that Natasha was elaborating on or any kind of product acquisitions or to expand capacity for of as Laura or line extensions. So we're really doing putting that up to give us the maximum flexibility to opt.

<unk> take advantage of any additional capital to further some of these projects as they come along.

Thank you very much in the.

Great to see all of the.

On the execution and look forward to seeing the.

Thank you.

Great.

Thank you Liane, we're pretty excited about that distribution that we've been able to to put out on our press releases you know it's on it's truly unheard of to have that kind of distribution for this product. So we're pretty excited and ready to launch.

There are no further questions I will now turn the call back over to Natasha for closing remarks.

Thank you Misty. So thank you for your time. This morning, we are so excited to launch <unk> and most importantly, getting back on to the hands of of millions of patients at risk for vascular disease. We will also provide updates on our plans for <unk> as we progress and I wish you. We wish you a good.

Great day, Thank you.

This concludes today's conference call you may now disconnect.

[music].

Good day and thank you for standing by welcome to the appeal of acts of format Q2, 2021earnings results call.

If you require any further assistance please press star zero.

I'd now like the hand, the conference over to your Speaker of today Lisa Wilson. Please go ahead.

Thank you Miss the welcome to Peel X form of Q2, 2021earnings results call. This is Lisa Wilson Investor Relations for P. A lot with me on today's call are Natasha Giordano, President and Chief Executive Officer, and Rita O'connor, Chief Financial Officer of Pls.

You can also access the webcast of this call through the investors section of the website appeal of pharma Dot com before we get started I would like to remind everyone that any statements made on today's conference call that express a belief expectation projection forecast anticipation or intent regarding future events on the comedies future <unk>.

<unk> may be considered forward looking statements as defined by the private Securities Litigation Reform Act.

Forward looking statements are based on information available to P. L X for mismanagement as of today and involve risks and uncertainties, including those noted in our press release issued this morning, and other filings with the SEC such.

For the benefit of those who may be listening to the replay or archived webcast. This call was held and recorded on August 6.2021 since the Pls may have made announcements related to the topics discussed. So please reference the company's most recent press releases and SEC filings.

With that I'll turn the call over to P elected the Natasha Giordano.

Thank you Lisa.

Morning, everyone and thank you for joining us today as you've seen in our recent series of press releases, we are actively executing on our commercial strategy for the war the first and only FDA approved liquid filled aspirin capsule.

Our retail partners, including Walmart Walgreens Rite aid Cvs and other leaders in pharmacy like Kroger Albertsons and target are fully committed to vascular.

Many of them abused attention grabbing shelf placeholders to alert customers the vascular is coming soon.

We have extensive distribution for basketball are in more than 30 thousands of stores throughout the country. We recently deployed our cardiovascular field force to raise the awareness within the community of specialists and we have inventory ready to ship to retailers to fulfill this widespread distribution the.

This extraordinary level of distribution is unheard of for a new brand from a company our size as.

As many of you know our management team has launched several of prescription and OTC products, including well known names like Newson ex Lipitor Neurontin Zantac Zyrtec and so I can we are looking forward to turning vascular into a household name we on.

Understand what specialists like cardiologists, and neurologists require in making treatment decisions for their patients and the importance that strong clinical data can play in their understanding and appreciation for bass, the Lord novel delivery mechanism.

I'd like to spend some time today discussing why Peel like pharma is more than just the Aspen. We are about the innovative <unk> drug delivery platform and I'm looking forward to sharing more information about our plans for appeal ex guard after Reid of reviews, our financials for the quarter Rita.

Thank you Natasha this is been a very busy few months for both financing manufacturing at P. L X isn't Natasha mentioned upfront. We are thrilled that so many prominent retailers have made a significant commitment of Adler and we're excited to stay our launch inventory has been manufactured and is ready for shipment to retailers across the country.

Starting in the third quarter of 2021, we expect to generate revenue from sales of both doses of that the Laura we will account for revenue in accordance with ASC 606, which essentially means that we will record revenue when it arrives at the customer's warehouse, which in our case is the retailer.

We will also record reductions to gross revenue for provision for retailer promotional programs product returns prompt pay discounts and coupon redemptions by consumers. Many of you may remember those as gross to net.

Cost of sales of Cogs will include actual cost paid to our contract manufacturer and packagers Cogs will also include warehousing inbound and outbound shipping and handling and storage costs at our distribution center in the Midwest. The gross margin for the launch here is expected to be lower until we expand manufacturing capacity and move to larger.

Batch sizes next year.

Although we're not providing specific revenue guidance, we can share the 30000 retail stores across the country will be stocking vascular later this month.

Many of those stores will stock all 3 of Skus in the aspirin aisle plus thousands of displays and the retail price to consumers is expected to be around $25 per month supply.

<unk> technology.

We also change the label for of G&A expenses, this quarter to selling marketing and administrative to properly reflect spending on our launch activities for <unk>.

As you would expect this spend will increase significantly as we will be in full launch mode, starting in the third quarter.

As a result, you can expect total operating expenses to be around $12 million to $14 million for the third quarter.

Natasha will elaborate on our plans to generate awareness among health care professionals and consumers about our innovative aspirin therapy.

As you can see theres been a few changes to our capital structure of the past few months, including the conversion of a portion of the preferred stock 2.3 million common shares.

In addition, $1.1 million warrants were exercised for $4.3 million of cash, resulting in outstanding common shares of $26.9 million as of August 3rd.

We also currently up $16.4 million potentially dilutive shares including options remaining warrants and convertible preferred stock for fully diluted shares of around $43.3 million keep.

Keep in mind that this fully diluted share count includes warrants that could be exercised for potential cash inflow of $37 million.

As of June 32021, we had cash and cash equivalents of $82 million and our balance sheet remains debt free as we paid off for term loan with Silicon Valley Bank back in February.

You will see this morning, we filed the shelf registration statement for $250 million, which includes a $75 million ATM facility, we elected to file of the current form S..3 to replace the previous shelf registration as a matter of good housekeeping and in line with many other companies at our stage of growth.

While we do not have plans for additional capital in the near term these filings provide us with the maximum flexibility going forward.

As we have previously stated our existing cash should be sufficient to support our commercial activities for <unk> for at least the next 2 years.

With that I'll turn the call back to Natasha to discuss the <unk> commercial strategy and the expansion of the <unk> technology Natasha. Thank you Reeta as a reminder, central to our vascular launch strategy is generating awareness for 3 constituents retailers professionals and consume.

Non.

We've already discussed the widespread retailer distribution across the country and now lets discuss the strategy regarding health care professionals.

Through our market research, we've learned that the top influencers for the consumer is their physician to address the health care professional we've developed the strategy that is focused on providing scientific information about <unk>, our new innovative aspirin therapy through prestigious medical conferences like.

The ACC H, a TCT publication of clinical trials and personal promotion by cardiovascular care specialists.

<unk> group of Cardiology, neurology, and gastroenterology specialists recognizes the unmet medical need as well as the strength of our clinical data they've played an important role in guiding our strategy and in our understanding of what's important to clinicians who treat vascular disease.

That's all of our offers clinicians the completely novel approach to aspirin therapy are robust pharmacokinetic and Pharmacodynamic study comparing 3 aspirin formulations was published in the journal of American College of Cardiology, The top peer reviewed journal for the cardiologist the.

Additionally, we are conducting of PK and PD 81 milligram clinical trial and should be ready with top line results later this year.

1 of the important differentiators of vascular capsules is that they are filled with a liquid lipid aspirin complex. The bypasses the stomach and gets rapidly absorbed in the duodenum, thus, reducing the risk of stomach injury as compared with the regular aspirin.

Our endoscopic assessment and comparison of upper Gi damage of vials of on regular aspirin was published in the American Journal of Gastroenterology, the top peer reviewed journals for Gastroenterologist.

Both of these studies underwent the rigor of the peer review process in order to be published in these prestigious journals.

To further raise the awareness throughout the cardiology community, we hired mainly rettig RN MSN as our executive medical director Mimi has deep cardiovascular clinical and industry experience and is a true patient advocate she's integral in our in our midst.

<unk> to reach the cardiology community and we are thrilled that she has joined the <unk> team.

As you know vascular was developed with the <unk> drug delivery platform. The exciting aspect of where we are as the company is that appeal of God represents the true platform on which to build our company Peel ex pharma is more of an aspirin our innovative <unk> platform has the potential.

To enhance delivery of active pharmaceutical ingredients of.

Optimize drug absorption and reduce the acute gi injury provide new or extended patent protection for an already approved or development stage drugs and utilize the 505 day 2 N D. A regulatory path that often provides of SaaS <unk> and lower cost FDA approval.

Used with already approved drugs.

This clinically validated technology works by targeting the release of active pharmaceutical ingredients or API for various portions of the Gi tract.

We believe this platform has the potential to improve the absorption of many drugs currently on the market or in development and to reduce the risk of stomach erosions and ulcers associated with certain drugs.

The innovative <unk>.

The drug delivery platform utilizes a ph dependent release mechanism that relies on the chemical association of Luketic excipient with API to selectively release them to targeted portions of the Gi tract.

Because of this technology is so novel, we have 58 strong global patent on patents offering protection through 2032, which includes composition of matter methods to make and methods to treat and though we are laser focused on our eminent vascular launch.

We strongly believe in the value of our <unk> drug delivery platform.

To date, our pipeline includes a novel formulation of ibuprofen and other non steroidal anti inflammatory drugs are unsafe.

Many of you have asked about our plans beyond the war and since our patents extend beyond net saves were presently screening compounds, where pls guard could improve bioavailability reduce the risk of gastric injury and are commercially viable.

The $505.2 NDA regulatory pathway, often provides a faster and lower cost FDA approval process when used with already approved drugs as we progress in the launch of <unk> and assess product candidates for appeal of squad platform, we will begin to describe <unk>.

Manner that represents of our evolution and our ongoing growth plans so stay tuned.

With the appeal of scar drug delivery platform. We are highly confident that this management team has the depth of experience to bring products to market and achieved similar distribution like we have for the <unk> with that I will open the call for questions. Operator. Please go ahead with the instructions.

At this time, if you would like to ask a question press star 1 on your telephone keypad again that let's start on the number 1 there for.

First question comes from the lineup, Jason Butler of JMP Securities.

Hi, Thanks for taking the questions and congrats on all of the progress.

Okay.

A couple on the the field force can you give us any more details around the size of the field force or.

What your targets are for you know the number of physicians that you want to get to how many.

Touch points you you think you need to get where the physician before they are they they start to the point the patients towards the products. Thanks.

Thanks, Jason.

With the field for US our strategy is is very very laser focused we've identified the top 100 heart and stroke hospitals.

On the affiliated cardiologist to the hospitals and group practices of course, where we're targeting the large msas in the country and we are very much focused on getting scientific the scientific information and raising awareness to the <unk>.

Accessing clinical cardiologist. However, we will also focus on the cardiologists that are the invasive cardiologist interventional cardiologists as well, although I won't comment on on size I can tell you that we've done a very sophisticated targeting.

And segmentation exercise, we know exactly where we want to send our reps there they're actually in the field as we speak.

Beginning that process, so that when bad for hits the shelves that we have some awareness within the cardiology community.

Cover the acute and chronic maintenance of.

This important important product.

That's helpful. Thank you Tushar and then just.

I know it's early but.

Can you give us any anecdotal feedback on how do you feel like you're having successes already with physicians and I guess any.

Any reasons to believe that there are physicians ready on the already to the point that their patients for the product when it's available.

Yeah I'm happy you asked that question because you've heard us talk about our market research and that the cardiologist I understand that there's an issue with the with the present current standard of care of the the coated aspirin tablet, but yes, they've had they've had no other option right there's been.

No no innovation and so we know from the market research that they're open ready and willing and they find the data could be quite compelling and what we're seeing in the field right now in the last couple of weeks is an openness of receptivity.

Waiting for a new innovative aspirin product and so the there's a lot of interest being being generated.

And so in anticipation of of alcohol are hitting hitting the shelves. We wanted to make sure that we get out before that so that the cardiology community is aware of its coming.

Great and then just last 1 from me on the the platform technology.

Just any more color you can give us on how you'll prioritize investment into pipeline in Canada, and its obviously youre going to be laser focused on the value.

Uh Huh, how will you think about.

For prioritizing investments of the pipeline.

Yeah, we were prioritizing compound that could use better bioavailability, but also have the issue with potential risk to the stomach injury because that truly is what differentiates the technology. The the appeal expired.

The platform. So we've already been looking at those candidates and as we continue those experiments and prioritize the the compounds will come back to you and give you progress on on what we've been doing the.

We felt it was really important especially at the time of launch you know. This this management team is is the team that knows how to execute commercial launches and we are really confident and in all the the materials the resources the strategy the content the vehicles to deliver information.

And everything is in place and we're really very excited to be able to bring back for to the millions of patients who absolutely need it and can benefit from it and so we felt now was the really good time to start to talk to you all of us as you've been asking us over the last several weeks, what's what's not.

And we're really excited about this platform because it really does enable us to build this company, even even beyond <unk>.

Okay, great. Thanks, Thanks, again for taking the questions and congrats again on all of the progress.

Thanks, Jason.

Next question is from Elliot Wilbur with Raymond James.

Hey, guys. This is actually Michael corollary on for Elliot Good morning, and thanks for taking my questions. Good morning Bonnie.

So so first of kind of piggybacking on on the specialty sales. The sales force I was just wondering if this effort includes any sort of sampling or coupon strategies to get the product directly and patients' hands.

Immediately after like any interaction with the physician.

So we are applying a and integrated multichannel approach as it relates to to all our constituents not not only the health care professional book, but also the consumer.

And in partnership with the retailers. So yes, we'll be we've developed patient education tools with.

Our high value incentives that we'll be providing 2.2 of the field force.

And yes, we will be including sampling for the physicians as well.

That is the the the best way for physicians to start to look at end of evaluate and trial the.

And so yes, we will be providing those indeed.

Okay perfect.

And then I believe you agree to the referenced this on the prepared remarks.

Remarks, but I'll just wanted to clarify.

But you guys recognize revenue on.

On the quantities of upon shipment on that there's no requirement for pull through demand.

For reservoir.

The analyzed what those provisions of the gross to nets will be so GAAP allows us to record revenue when the retailer receives it.

Got it.

Alright, and then last 1 for me just wondering if you guys had any upcoming conferences or kols events, where.

You anticipate reservoir of having a high profile for for education.

Yes, we've been targeting.

Medical conferences for the last several years and we've developed a really nice network of cardiologists that are already aware of alcohol on the benefit of it can bring to patients the next.

Upcoming conferences or TCT and say, we just recently did a program.

The associated with ACC was the very distinguished panel Dr. Gibson Dr. <unk> Dr.

Dr Myron and Dr Granger, where they talk a lot about the adaptable trial results and also how vast the law could fit into their additional regime and we do plan to have on events at TCT nahi as well and of course, where we're.

<unk> for 2022.

Perfect. Thanks, again for taking my questions and congrats on all of the progress looking forward to seeing does who are on the shelf.

Yes, Michael Thank you Michael.

Your next question is from live anchor show with Oppenheimer.

Good morning from Boston.

Hey, guys. Thank you for the necessity.

<unk>.

Couple of questions from me in addition to leveraging the already existing.

There is some funding of studies you have on revenue.

If the advantages once the asps that there'll be a towards the screen.

Of articles of maybe coming out on other work you may be seeing there have done with the product that's actually kind of bad for the content.

With respect to.

The physicians out there and they're they're on.

Understanding of the.

The benefits of <unk>.

And also wanted to ask the concerns of.

Direct to consumer approaches if you could share.

Any any thoughtful detail on any timelines on nature of your deployments there. Thank you.

Thanks Leland.

I believe very strongly in our publication strategy and plan and we've been working with our scientific Advisory Board.

We've established the of.

Publication Committee made up of our scientific Advisory Board and actually some some other very well known cardiologists in the in the country and so there is and will be a stream of papers and articles that that we are are working on and that will submit for.

Publications, you May remember last year, we presented several abstracts and posters at a variety of different cardiology conferences.

Those are being converted into into manuscripts for.

For publication, so yeah, I think it's really important that the medical community continues to learn more about that for about the category.

And about how how important aspirin is in the treatment of of vascular disease.

Appears on every every guideline is foundational therapy for these patients.

We will continue our efforts there and we have Dr. <unk> on our scientific Advisory Board that is leading that effort for US right. Now she is a world renown platelet expert so we have a really.

Stablish and World, we know the team of cardiologists working on those on the publication.

In terms of DTC of of course, you know, our our marketing strategy and plan includes many different media.

Certainly have developed a program programs for for the E Commerce side of of the business, we know that the retailers over the last year and a half with with the impact of Covid has have really developed their ecommerce platform. So we will be everywhere the consumer shops for search.

And we will we will have of media and <unk> and.

Search and digital and as we approach and progress through the launch we'll talk more about our our advertising efforts, but you can be rest assured that we are focused on the consumer as well.

Terrific.

1 last question irrespective of the.

The shelf filing in detail again.

You indicated in the past that you're fairly comfortable with the proof of concept that you could be.

And from the black effectively on the debt.

As more of a commercialization.

Just wanted to kind of that type of again in terms of your comfort level there with respect to.

The launch of the next couple of years of that mortgage book.

Yeah. Great question. So you are correct, we said that we have sufficient capital to launch Bachelor successfully for at least the next 2 years.

We also we filed the shelf to give us that maximum flexibility too.

Further develop some of the <unk> technology products that Natasha was elaborating on or any kind of product acquisitions or to expand capacity for of as Laura or line extension. So we're really doing putting that up to give us the maximum flexibility to opt.

For Tunis Stickley take advantage of any additional capital to further some of these projects as they come along.

Got it thank you very much and the.

Great to see all of the.

On the excuse me in the forward to seeing the parts of the field Kim Thank you.

Great. Yeah. Thank you. Thank you will and we're pretty excited about that distribution that we've been able to to put out on our press releases you know it's on it's truly unheard of to have that kind of distribution for this product. So we're pretty excited and ready to launch.

There are no further questions I will now turn the call back over to Natasha for closing remarks.

Thank you Misty.

Thank you for your time. This morning, we are so excited to launch back lore, and most importantly, getting back on to the hands of of millions of patients at risk for vascular disease. We will also provide updates on our plans for appeal ex guard as we progress and I wish you. We wish you a great day. Thank you.

This concludes today's conference call you may now disconnect.

Q2 2021 PLx Pharma Inc Earnings Call

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