PLx Pharma Inc (PLXP) 2021 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the PLx Pharma Q1 2021 Earnings Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to Lisa Wilson, Investor Relations for PLx.

Thank you, Amytris. Welcome to PLx Pharma's Q1 2021 Earnings Results Call. This is Lisa Wilson, Investor Relations for PLx. With me on today's call are Natasha Giordano, President and Chief Executive Officer; and Rita O'Connor, Chief Financial Officer of PLx. You can also access the webcast of this call through the Investors section of the PLx website at plxpharma.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 performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. Forward-looking statements are based on information available to PLx Pharma's 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 forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. PLx 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, plxpharma.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 14, 2021. Since then, PLx may have 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 PLx's CEO, Natasha Giordano.

Thank you, Lisa. Good morning, everyone, and thank you for joining us today. As a reminder, we recently received FDA approval of VAZALORE 325 milligram and 81 milligram doses, the first and only liquid-filled aspirin capsule that can benefit millions of patients with vascular disease. We are excited to bring VAZALORE to market in the third quarter.

Having the patient 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 if VAZALORE was available to them? Now that the FDA has approved VAZALORE, our vision of bringing a reliable and predictable aspirin therapy to patients at risk can be realized. We are thrilled to launch VAZALORE and look forward to getting the word out to the medical community and to patients.

Aspirin is the most widely used drug in the world, and yet there's been no innovation in the category in decades until now. VAZALORE delivers aspirin in a novel way, and as a result, VAZALORE 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 erratically absorbed in the GI tract. And VAZALORE significantly reduces the risk of stomach erosions and ulcers than 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 in 2 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 of having such an event, thus may be candidates for aspirin therapy under the guidance of their physician. We believe VAZALORE will transform the standard of care. Importantly, VAZALORE's unique mechanism of delivery is the reason we have 58 patents extended into 2032, quite unique for an over-the-counter product.

And finally, our Scientific Advisory Board is made up of world-renowned experts in cardiology, neurology and gastroenterology, chaired by the esteemed and extensively published Drs. Deepak Bhatt and Dominick Angiolillo. The Scientific Advisory Board appreciates the seriousness of the unmet need among this patient group and have been instrumental in 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 VAZALORE to millions of patients, and now we have the capital to launch VAZALORE successfully.

In March, we closed on an underwritten public offering of 8.9 million shares of our common stock at a price of $8.00. 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 of $84.4 million with a cash burn of $4.9 million for the first quarter. We paid off the balance of our term loan 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 VAZALORE for at least the next 2 years.

On the manufacturing front, we are making excellent progress. We've already manufactured a significant portion of capsules for our launch load, and we are very excited to begin packaging VAZALORE at the end of this month. We continue to build inventory and plan to have sufficient packaged product ready to supply retailers across the country this summer.

We expect cash burn to be around $6 million for the second quarter of 2021. However, cash burn will increase significantly in 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. As we move closer to launch, we look forward to sharing more details around product placement, orders from retailers and sales and marketing spend.

With that, I will turn the call back over to Natasha.

Thank you, Rita. For those of you who may be new to the innovation of VAZALORE, let me share some of the top line highlights around this unique product, its differentiators, how it addresses a real unmet need in the treatment of vascular disease and why this management team is uniquely positioned and so excited to launch VAZALORE to so many who can benefit.

VAZALORE capsules are filled with a liquid lipid aspirin complex that bypasses the stomach and gets rapidly absorbed in the duodenum. As a result, VAZALORE provides faster, more reliable aspirin absorption and platelet inhibition compared with enteric coated aspirin, the current standard of care. Our clinical study, a robust pharmacokinetic and pharmacodynamic comparison of 3 formulations, regular aspirin, enteric coated aspirin and VAZALORE, was published in the Journal of the American College of Cardiology, the top peer-reviewed journal for cardiologists. Importantly, VAZALORE also causes fewer gastric erosions and ulcers as compared with regular aspirin. Our endoscopic assessment and comparison of upper GI damage of VAZALORE and regular aspirin was published in The American Journal of Gastroenterology.

We're continuing our commitment to medical education and medical conferences. This weekend, we're exhibiting at the American College of Cardiology's 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 3 key stakeholders: the medical community, patients and the retail trade about VAZALORE as the first and only FDA-approved liquid-filled aspirin capsule, its unique mechanism of delivery and our 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 represent a winning combination for a successful launch.

With the FDA VAZALORE approvals in hand, the PLx team is excited to do what we do best; launch products. Our management team has launched many mega brands successfully, and we look forward to turning VAZALORE into a household name. Collectively, our leadership team has been involved in the successful launches of products across the prescription and OTC segments and built household names, including Mucinex, LIPITOR, Zantac and Zicam, just to name a few. This depth of experience is highly relevant to launching VAZALORE successfully. We understand the challenges that HCPs face in 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 channels. 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.

(Operator Instructions) Your first question comes from the line of Elliot Wilbur with Raymond James.

Looking forward to seeing VAZALORE on store shelves relatively soon. I guess first question would be, since the last call, could you just share with us maybe any market preparation or priming efforts at the retail level that may lead to more visible external signs of your activity in advance of sort of the full national launch? And as a corollary to that, anything on the publication strategy side that we should be looking for that may enhance visibility of VAZALORE headed into launch?

Sure, Elliot. Yes. We're doing a lot in terms of preparing the market. And we have all along with our meetings in terms of medical conferences, cardiologists, getting the healthcare community prepared, but also equally with the retail trade customers. And our VP of Trade Sales, Steve Valentino, has been in that role in a variety of companies for close to 30 years. He's 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 VAZALORE in the stores at the retail level. And we are coming upon the moments when they will be providing their commitments to us, and we'll talk more about that as we get closer to launch.

Obviously, we can't talk about it as early as now, but we will be prepared to tell you more when we get together in the next couple of months. In terms of -- I can say this though, Elliot. We are preparing for a national launch in the country. And as you heard Rita in her part of our presentation, we're manufacturing to that level as well.

Okay. Then I just had one additional question for you. It looks like the company's recently initiated a clinical trial comparing VAZALORE 81 milligrams with enteric coated aspirin. I guess some of the parameters that are being looked at, sort of the usual ones -- platelet inhibition and AEs. But just curious, any other data points or parameters that you might be looking to gain insight into from that trial that we may not have seen in some of the earlier studies that you did with the 325?

Yes. I think there's two elements to your question. Yes, we are in the midst of conducting a clinical trial on 81 milligrams for commercial purposes only. We're complete with our FDA approvals in terms of both doses. And clearly, we want to show that 81 milligram VAZALORE behaves like the 325 milligrams, but also is bioequivalent to immediate release aspirin, as the FDA has already determined. We will be looking at pharmacokinetic and pharmacodynamic data as our primary parameters and metrics, and I'm looking forward to having those results in the near future. And that ties into your other question that I didn't answer before and that is on our publication plan. We are very much committed to a publication plan and strategy.

Our Scientific Advisory Board, led by Dr. Deepak Bhatt, are heavily involved. We have a publication committee with a number of our advisers. And those plans continue as we're drafting different manuscripts. You may remember that last year, we've presented a number of abstracts and posters at the different conferences. Those are now being converted into manuscripts. So you will be seeing -- because I think it's so important for the medical community to continue to get more scientific information on our product as it relates to the enteric coated aspirin tablet.

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

It's Roy on for Jason. I guess a follow-on to the focus on the retailers. I'm just curious if you've observed any changes in the receptivity or any other feedback that you've gotten since the approval of VAZALORE. And it sounds like you're planning to launch maybe closer to the start of 3Q in the summer versus the end of 3Q, that maybe the market's over obsessed a little bit in the first quarters of launch. But I'm just curious how robust of a launch you're expecting either earlier in the quarter or later in the quarter.

So our plans are to launch in late summer. The receptivity I would say by the retailers has increased, if nothing else.

Yes. They're really excited now.

They're very excited. They're excited to get the product on shelf. They've committed to some premium placement as well. Unfortunately, I won't say too much in terms of the retailers for obvious reasons, however, we're really excited. We're preparing for a national launch across all the top retailers.

(Operator Instructions) 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 VAZALORE will transform the standard of care for millions of patients at risk for vascular disease. We thank and sincerely appreciate the support of our partners for all the dedicated hard work and our shareholders for their continued confidence in the PLx management team and the promise of VAZALORE. Have a great day.

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