Q1 2021 PLx Pharma Inc Earnings Call

Yeah.

Good day, and thank you for standing by and welcome to the P. L X pharma Q1, 2021 earnings call.

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I would now like to hand, the conference over to Lisa Wilson Investor Relations for P. M a X.

Thank you Amit you and welcome to feel like Pharma is Q1 2021 earnings results call and this is Lisa Wilson Investor Relations for P. L Ax.

With me on today's call on 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 at P. L X pharma dot com.

Before we get started I would like 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 performance may be considered forward looking statements as defined by the private Securities Litigation Reform Act.

Forward looking statements.

And based on information available to Peel that pharmacy management as of today and involve risks and uncertainties, including those noted in our press release issued this morning, and and filings with the SEC.

Such forward looking statements are not guarantees of future performance actual results may differ materially from those projected and the forward looking statements.

<unk>, specifically disclaims any intent or obligation to update these forward looking statements, except as required by law.

And I have webcast will be available for 30 days on our website, if you like for him and Dot com.

For the benefit of those who may be listening to the replay or archived webcast. This call was held and recorded on May 14th 2021. Since then feel eczema has made announcements related to the topics discussed. So please reference the company's most recent press releases and SEC filings and with that I'll turn the call over to Peel extra CEO Natasha Giordano.

Thank you Lisa.

Good morning, everyone and thank you for joining us today as a reminder, we recently received FDA approval Bachelor of 325 milligram and 81 milligram doses this share.

First and only liquid filled aspirin capsule that can benefit millions of patients with vascular disease.

And are excited to bring back a low to market and the third quarter.

Having the patient and top of mind has always been our passion every one of US has had family or close friends, who have suffered from a heart attack or the debilitating effects of a stroke and we always wonder what its nozzle or was available to them.

Now that the FDA has approved and our vision of bringing a reliable and predictable aspirin therapy to patients at risk can be realized.

We are thrilled to launch the Adler and look forward to getting the word out to the medical community and to patients.

Aspirin and it's the most widely used drug and the world and yet there's been no innovation and the category and decades until now.

And what it delivers aspirin and a novel way and as a result, Bachelor and demonstrates fast reliable and predictable platelet inhibition, thus addressing the limitations of the current standard of care enteric coated aspirin.

It's been well established that enteric coated aspirin is a radically absorbed and the Gi tract and vascular significantly reduces the risk of stomach erosions and ulcers and immediate release aspirin as observed in our published clinical trial.

This is a large commercial opportunity with the retail market estimated at $10 billion. This market includes more than 40 million patients and two groups patients with vascular disease defined as those who have already suffered from an event like a heart attack or a stroke and those with diabetes, who are at risk at high risk.

And of having such an event does maybe candidates for aspirin therapy under the guidance of their physician.

We believe that door will transform the standard of care importantly, does the Lloyd's unique mechanism of delivery is the reason we have 58 patents extended into 2032 quite unique for and over the counter products.

And finally, our scientific Advisory Board is made up of world renowned experts and cardiology neurology and gastroenterology chaired by these steamed and extensively published doctors deep hotspot and Dominic and Julie low does.

Scientific Advisory Board appreciates the seriousness of the unmet need among this patient group and has been instrumental and guiding our strategy and understanding of what's important to clinicians who treat vascular disease I'll now turn the call over to our CFO Rita O'connor Rita. Thank you Natasha this is a busy.

And exciting time for us as we prepare to execute on our vision to bring vast alert to millions of patients and now we have the capital to launch Fazlur successfully and.

In March we closed on an underwritten public offering of $8 9 million shares of our common stock at a price of $8 gross proceeds were $71 $4 million before deducting underwriting discounts commissions and other offering expenses.

As of March 31, 2021, we had cash and cash equivalents and $84 $4 million with a cash burn of $4 9 million for the first quarter.

We paid off the balance of our term loans due in February and now have no debt on our balance sheet.

Our existing cash of $84 million should be sufficient to support our commercial activities for bad floor for at least the next two years.

On the manufacturing front, we're making excellent progress we've already manufactured a significant portion of capsules for our launch load and we're very excited to begin packaging that floor at the end of this month.

We continue to build inventory and plan to have sufficient package product ready to supply retailers across the country. This summer.

We expect cash burn to be around $6 million for the second quarter of 'twenty one.

However, cash burn will increase significantly and the third quarter as sales and marketing spend ramps up and the payments of the major portion of the inventory become due to our contract manufacturers.

And as we move closer to launch and we look forward to sharing more details around product policemen orders from retailers and sales and marketing spend with that I will turn the call back over to Natasha.

Thank you Reeta for those of you who may be new to the innovation of our vascular and let me share some of the top line highlights around this unique product its differentiators and how it addresses a real unmet need and the treatment of vascular disease and why this management team is uniquely positioned.

And so excited to launch basketball on to so many who can benefit.

And that's what capsules are filled with a liquid lipid aspirin complex that bypasses the stomach and gets rapidly absorbed and the duodenum as a result, that's what provides faster more reliable aspirin absorption and platelet inhibition compared with enteric coated aspirin. The current standard of care are clinical.

Study, a robust pharmacokinetic and Pharmacodynamic comparison of three formulations regular aspirin enteric coated aspirin and vascular was published in the journal of American College, and Cardiology, the top peer review journals. So cardiologists.

Importantly, vascular also causes fewer gastric erosions and ulcers as compared with regular aspirin or endoscopic assessment and comparison of upper Gi damage and thousands of war and regular aspirin was published and the American Journal of Gastroenterology.

Continuing our commitment to medical education and medical conferences. This weekend, we're exhibiting at the American College of Cardiology, 70th annual scientific session. The ACC is among the most prestigious cardiology conferences in the world and we're excited to participate.

Central to our marketing strategy is raising awareness educating and informing our three key stakeholders the medical community patients and the retail trade about vast war as the first and only FDA approved liquid filled aspirin capsule its unique mechanism of delivery and ours.

Supporting published clinical data, we firmly believe that our compelling data support from the clinical community our focus on the consumer and the depth of this management team's experience represents a winning combination for a successful launch.

With the F D a Bachelor approvals and hand, the appeal X team is excited to do what we do best launch products are.

Our management team has launched many mega brands successfully and we look forward to turning back more into a household name.

Lexically, our leadership team has been involved and the successful launches of products across the prescription and OTC segment and built household names, including mucin ex lipitor Zantac and Zicam just to name a few.

This depth of experience is highly relevant to launching Bachelor successfully.

And we understand the challenges that hcp's face and clinical practice and how consumers make their buying decisions. We also have extensive experience with retail trade customers and understand the intricacies of penetrating the U S distribution channel.

And we know the markets, we know the key constituents and most importantly, we know how to build big strong recognizable brands.

With that I will open the call for questions. Operator. Please go ahead with the instructions.

And as a reminder to ask a question you will need to press Star then the number one on your telephone to withdraw your question press the pound key please standby, while we compile the Q&A roster.

Your first question comes on the line of Elliot Wilbur with Raymond James.

Thanks, Good morning, Natasha either looking forward you are looking forward to see and Bachelor or on the store shelves are relatively soon.

I guess the first question would be simple last call could you just share with us maybe any market preparation or priming efforts at the retail level that you know may lead to more visible external signs of your activity in advance of sort of the full national launch and.

And as a corollary to that anything on the publication strategy side that we should be looking for and that may enhance the visibility of our bathroom or headed into launch sure.

Morning Elliot.

And yeah, we're doing a lot in terms of preparing the market and we have all along right with our meetings and in terms of medical conferences and cardiologists getting the health care community prepared but also equally with the retail trade customers and and our.

D. P of trade sales, Steve Valentino has been and that role and a variety of companies for close to 30 years and he is well known.

He's an industry veteran and he's been having many many meetings that have gone from understanding the product the company and our strategy all the way through preparing partnering planning on how to position passed a law and the stores.

At the retail level and we are coming upon the moments when they will be providing their their commitments to us and we will talk more about that as we get closer to lunch and.

Obviously, we can't talk about it and <unk>.

Early and is now, but we will be prepared to tell you more when we get together and the next couple of months and.

And in terms of I can say this though Elliot you know we are preparing for and national launch.

And the country and as you heard Rita and and hard part of our presentation, we're manufacturing to that level as well.

Okay, and then I just had one additional question for you. It looks like the company has recently initiated a clinical trial, comparing Bachelor and 81 milligrams slipped and Tara coated aspirin I guess some of the parameters that are being looked at sort of the usual ones platelet inhibition and <unk> and <unk>, but just curious any other.

Data points or parameters that you might be looking to.

Gain insight into from that trial.

And we may not have seen and some of the earlier studies that you did with the $3 25.

Yeah, I think there's two two elements to your question. Yes, we are in the midst of of conducting a clinical trial on 81 milligram for commercial purposes, only where we are complete with our FDA approvals and in terms of both both doses and clearly.

We want to show that 81 milligram, that's allure behaves like the 325 milligrams, but also is bio equivalent to immediate release aspirin as the S. F. D. A has already determined we will be looking at pharmacokinetic and Pharmacodynamic data.

And as our primary parameters and metrics and I'm looking forward to having those results.

And the and the near future.

And that ties into your other question that I didn't answer before and that is on our publication plan. You know we are very much committed to a publication plan and strategy. Our scientific Advisory Board led by Dr. Deepak Bhatt are heavily involved and we have a pub.

Location Committee with a number of our advisors and those plans continue as we're and drafting a different manuscripts you may remember that last year, we presented a number of abstracts and posters at the at the different conferences those are now being converted into and to manage to.

Scripts, so you will be seeing and because I think it's so important for the medical community to continue to get more scientific information on on our product and as it relates to the enteric coated aspirin and tablets.

Okay. Thank you those are my questions. Thank.

Thank you Ellie and family.

Yes.

Your next question comes on the line of Jason Butler with JMP Securities.

Hi, it's Roy on for Jason and Thanks for taking our questions.

I guess a follow on to the <unk>.

Focus on the retailers I'm, just curious if you've observed and easy.

Changes in net rent receptivity or any other feedback that you've gotten there.

Since the approval of <unk>.

And it sounds like you're planning to launch maybe closer to the start of three two on the summer versus the end of three two and maybe the market's over obsess on little bit in the first quarters of launch but.

I'm just curious how robust of a launch.

And earlier either earlier in the quarter or later in the quarter. Thanks.

Yeah. Thank you so our plans are to launch and in late summer.

And the receptivity I would say by the retailers has has increased if nothing else. They're really excited now very excited they're excited to get the product on shelf and you know what day.

And I'm committed to some premium placement as well.

And unfortunately, I won't say too much and in terms of the retailers and for obvious reasons, However, where we're really excited where we're preparing for a national launch.

Cros are all the top all the top retailers.

Okay. That's great. Thank you.

Thank you.

As a reminder to ask a question you would need to press Star then the number one on your telephone.

And so withdraw your question press the pound key.

Standby, while we compile the Q&A roster.

Yeah.

At this time there are no further questions I would now like to turn the call back over to Natasha.

Thank you. Thank you for your time. This morning, we believe vascular will transform the standard of care for millions of patients at risk for vascular disease.

Thank and sincerely appreciate the support of our partners for all of the dedicated hard work and on shareholders for their continued confidence and the appeal ex management team and the promise of vascular and have a great day.

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

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