PLx Pharma Inc (PLXP) 2021 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the PLx Pharma Q2 2021 Earnings Results Call.

(Operator Instructions)

Please note that today's call is being recorded.

(Operator Instructions)

I would now like to hand the conference over to your speaker today, Lisa Wilson. Please go ahead.

Thank you, Missy. Welcome to PLx Pharma's Q2 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.

These 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 recorded on August 6, 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 you've seen in our recent series of press releases, we are actively executing on our commercial strategy for VAZALORE, the first and only FDA-approved liquid-filled aspirin capsules. Our retail partners, including Walmart, Walgreens, Rite Aid, CVS and other leaders in pharmacy like Kroger, Albertsons and Target are fully committed to VAZALORE.

In fact, many of them have used attention grabbing shelf placeholders to alert customers that VAZALORE is coming soon. We have extensive distribution for VAZALORE in more than 30,000 stores throughout the country. We recently deployed our cardiovascular field force to raise awareness within the community of specialists, and we have inventory ready to ship to retailers to fulfill this widespread distribution.

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 Mucinex, LIPITOR, Neurontin, Zantac, Zyrtec and Zicam. We are looking forward to turning VAZALORE into a household name.

We 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 VAZALORE's novel delivery mechanism.

I'd like to spend some time today discussing why PLx Pharma is more than just aspirin. We are about the innovative PLxGuard drug delivery platform, and I'm looking forward to sharing more information about our plans for PLxGuard after Rita reviews our financials for the quarter.

Rita?

Thank you, Natasha. This has been a very busy few months for both finance and manufacturing at PLx. As Natasha mentioned upfront, we are thrilled that so many prominent retailers have made a significant commitment to VAZALORE, and we're excited to say 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 VAZALORE. 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, or COGS, will include actual costs paid to our contract manufacturing packagers. COGS will also include warehousing, inbound and outbound shipping and handling in-store costs at our distribution center in the Midwest.

The gross margin for the launch year 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 that 30,000 retail stores across the country will be stocking VAZALORE later this month.

Many of those stores will stock all 3 SKUs in the aspirin aisle plus thousands of displays, and the retail price to consumers is expected to be around $25 for a month's 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 PLxGuard technology.

We also changed the label for our G&A expenses this quarter to selling, marketing and administrative to properly reflect spending on our launch activities for VAZALORE.

As you would expect, this spend will increase significantly as we'll 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, there have been a few changes to our capital structure in the past few months, including the conversion of a portion of the preferred stock to 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 3.

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

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 30, 2021, 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 a shelf registration statement for $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.

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 VAZALORE for at least the next 2 years.

With that, I'll turn the call back to Natasha to discuss VAZALORE's commercial strategy and the expansion of the PLxGuard technology. Natasha?

Thank you, Rita. As a reminder, central to our VAZALORE launch strategy is generating awareness for 3 constituents: retailers, professionals and consumers. We've already discussed the widespread retailer distribution across the country.

And now let's 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 a strategy that is focused on providing scientific information about VAZALORE, our new innovative aspirin therapy through prestigious medical conferences like ACC, AHA, TCT, publications, clinical trials and personal promotion by cardiovascular care specialists.

We continue to work with our esteemed Scientific Advisory Board chaired by Dr. Deepak Bhatt and Dominick Angiolillo, along with strong representation from top academic institutions such as Harvard, Brigham and Women's, University of Florida, Baylor, Mount Sinai and Tufts. 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. VAZALORE offers clinicians a completely novel approach to aspirin therapy, our 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 cardiologists.

The published results show that VAZALORE provides fast, reliable aspirin absorption and predictable platelet inhibition compared with enteric-coated aspirin, the current standard of care.

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

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

Our endoscopic assessment and comparison of upper GI damage of VAZALORE in regular aspirin was published in the American Journal of Gastroenterology, the top peer-reviewed journal for gastroenterologists.

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

To further raise awareness throughout the cardiology community, we hired [Maimy Redig,] RN MSN, as our Executive Medical Director. [Maimy] has deep cardiovascular, clinical and industry experience and is a true patient advocate.

She's integral in our mission to reach the cardiology community, and we are thrilled that she's joined the PLx team. Additionally, to enhance our integrated multichannel commercial strategy, in July, we launched the cardiovascular specialty field force, led by PLx and in partnership with Eversana, a leading provider of next-generation commercial services to life science companies.

As you know, VAZALORE was developed with the PLxGuard drug delivery platform. The exciting aspect of where we are as a company is that PLxGuard represents a true platform on which to build our company. PLx Pharma is more than aspirin.

Our innovative PLxGuard platform has the potential to enhance delivery of active pharmaceutical ingredients, optimize drug absorption and reduce acute GI injury, provide new or extended patent protection for an already approved or development-stage drug and utilize the 505(b)(2) NDA regulatory path that often provides a faster and lower-cost FDA approval when used with already approved drugs.

This clinically validated technology works by targeting the release of active pharmaceutical ingredients, or API, to 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 PLx drug delivery platform utilizes a pH-dependent release mechanism that relies on the chemical association of lipidic excipients with API to selectively release them to targeted portions of the GI tract.

The preassociation of PLxGuard's owned pharmaceutical lipid 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 this technology is so novel, we have 58 strong global 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 VAZALORE launch, we strongly believe in the value of our PLxGuard drug delivery platform.

To date, our pipeline includes a novel formulation of ibuprofen and other nonsteroidal anti-inflammatory drugs or NSAIDs.

Many of you have asked about our plans beyond VAZALORE. And since our patents extend beyond NSAIDs, we're presently screening compounds where PLxGuard could improve bioavailability, reduce the risk of gastric injury and are commercially viable.

The 505(b)(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 VAZALORE and assessed product candidates for our PLxGuard platform, we will begin to describe PLx in a manner that represents our evolution and our ongoing growth plans. So stay tuned.

With the PLxGuard drug delivery platform, we are highly confident that this management team has the depth of experience to bring products to market and achieve similar distribution like we have for VAZALORE.

With that, I will open the call for questions.

Operator, please go ahead with the instructions.

(Operator Instructions)

The first question comes from the line of Jason Butler with JMP Securities.

Congrats on all the progress. Just a couple on the field force. Can you give us any more details around the size of the field force or what your targets are for the number of physicians that you want to get to? How many touch points you think you need to get with a physician before they start to point their patients towards the products?

Thanks, Jason. With the field force, our strategy is very, very laser-focused. We've identified the top 100 heart and stroke hospitals and the affiliated cardiologists to those hospitals and group practices.

Of course, we're targeting the large MSAs in the country. And we are very much focused on getting scientific information and raising awareness to the practicing clinical cardiologists. However, we will also focus on the cardiologists that are the invasive cardiologists, the interventional cardiologists as well.

Although I won't comment 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. They're actually in the field as we speak, beginning that process. So that when VAZALORE 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 interventional cardiology community because it is important that they are aware since the patient is with them in the acute phase. And that way, we cover the acute and the chronic maintenance of this important product.

That's helpful. And then just, I know it's early, but can you give us any, at least, anecdotal feedback on -- do you feel like you're having successes already with physicians?

And I guess, any reasons to believe that there are physicians ready to point their patients to the product when it's available?

Yes, I'm happy you asked that question because you've heard us talk about our market research and that the cardiologists understand that there's an issue with the present current standard of care, the coated aspirin tablet. But yet they've had no other option, right? There's been no innovation. And so we know from the market research that they're open, ready and willing and they find the data to be quite compelling.

And what we're seeing in the field right now in the last couple of weeks is an openness, a receptivity waiting for a new innovative aspirin products. And so there's a lot of interest being generated. And so in anticipation of VAZALORE 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 for me on the platform technology. Just any more color you can give us on how you'll prioritize investment into pipeline candidates? Obviously, you're going to be laser focused on the (inaudible) How will you think about prioritized investments into the pipeline?

Yes. We're prioritizing compounds that could use better bioavailability but also have the issue with potential risk to stomach injury because that truly is what differentiates the technology, the PLxGuard platform. So we've already been looking at those candidates. And as we continue those experiments and prioritize the compounds, we'll come back to you and give you progress on what we've been doing.

But we felt it was really important, especially at the time of launch. This management team is a team that knows how to execute commercial launches. And we are really confident in all the materials, the resources, the strategy, the content, the vehicles to deliver information. Everything is in place, and we're really very excited to be able to bring VAZALORE to the millions of patients who absolutely need it and can benefit from it.

And so we felt now is a really good time to start to talk to you all as you've been asking us over the last several weeks. What's next? And we're really excited about this platform because it really does enable us to build this company even beyond VAZALORE.

Your next question is from Elliot Wilbur with Raymond James.

This is actually Michael Parolari on for Elliot.

Yes. So first, kind of piggybacking on the specialty sales force. I was just wondering if this effort includes any sort of sampling or coupon strategies to get the product directly in patients' hands immediately after like any interaction with the physician?

So we are applying an integrated multichannel approach as it relates to all our constituents, not only the health care professional but also the consumer and in partnership with the retailers. So yes, we'll be -- we've developed patient education tools with a high-value incentive that we'll be providing to the field force. And yes, we will be including sampling for the physicians as well. That is the best way for physicians to start to look at and evaluate and trial VAZALORE. And so yes, we will be providing those indeed.

Okay. Perfect. And then I believe Rita referenced this in the prepared remarks, but I just wanted to clarify that you guys recognize revenue on the quantities upon shipment and that there's no requirement for pull-through of demand for VAZALORE?

That's correct. Actually, 1 little clarification. We're going to record revenue when it arrives at the retailer's warehouse, that's when title transfers. So -- and yes, we are able to recognize revenue then because we have the ability to analyze what those provisions or the gross to nets will be. So GAAP allows us to record revenue when the retailer receives it.

Got it. All right. And then last 1 for me. Just wondering if you guys had any upcoming conferences or KOL events where you anticipate VAZALORE having a high profile 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 VAZALORE and the benefit it can bring to patients. The next upcoming conferences are TCT and AHA. We just recently did a program associated with ACC with a very distinguished panel, Dr. Gibson, Dr. Angiolillo, Dr. Mehran and Dr. Grainger, where they talked a lot about the adaptable trial results and also how VAZALORE could fit into their medicinal regime.

And we do plan to have an event at TCT and AHA as well. And of course, we're planning for 2022.

Congrats on all the progress. Looking forward to seeing VAZALORE on the shelf soon.

Yes, me too. Thank you, Michael.

Great. Michael, Thank you.

Your next question is from Leland Gershell with Oppenheimer.

Couple of questions from me. In addition to leveraging the already existing papers and scientific studies you have on VAZALORE telling its advantages. I want to ask if there'll be a further stream of articles maybe coming out on other work you may be doing or have done with a product that's actually going to add to the content with respect to physicians out there and their understanding of some of the benefits of VAZALORE?

I also wanted to ask, in terms of direct-to-consumer approaches, if you could share any possible detail on any time lines or nature of your deployments there?

Thanks, Leland. I believe very strongly in a publication strategy and plan, and we've been working with our scientific advisory board. We've established a publication committee made up of our scientific advisory board and actually some other very well-known cardiologists in the country. And so there is and will be a stream of papers and articles that we are working on and that we'll 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 manuscripts for publication. So yes, I think it's really important that the medical community continues to learn more about VAZALORE, about the category and about how important aspirin is in the treatment of vascular disease as it appears on every guideline as foundational therapy for these patients.

So we will continue our efforts there. And we have Dr. Prats on our Scientific Advisory Board that is leading that effort for us right now.

She is a world renowned platelet experts. So we have a really established and world-renowned team of cardiologists working on those publications.

In terms of DTC, of course, our marketing strategy and plan includes many different media. We certainly have developed a program -- programs for the e-commerce side of the business. We know that the retailers over the last 1.5 years, with the impact of COVID, have really developed their e-commerce platform. So we will be everywhere the consumer shops for certain, and we will have media and search and digital. And as we approach and progress through the launch, we'll talk more about our advertising efforts. But you could be rest assured that we are focused on the consumer as well.

Terrific. And then 1 last question, irrespective of the shelf filing and ETM and so forth, you've indicated in the past that you were fairly comfortable with the concept that you could be in a blast effectively on the VAZALORE commercial basis. Just wanted to kind of ask, taken again in terms of your comfort level there with respect to the launch over the next couple of years as VAZALORE makes [the shelf.]

Yes, great question. So you are correct. We said that we have sufficient capital to launch VAZALORE successfully for at least the next 2 years. We also -- we filed the shelf to give us that maximum flexibility to further develop some of the PLxGuard technology products that Natasha was elaborating on or any kind of product acquisitions, or to expand capacity for VAZALORE or line extensions. So we're really doing -- putting that up to give us the maximum flexibility to opportunistically take advantage of any additional capital to further some of these projects as they come along.

Got it. And great to see all the execution and look forward to seeing the part of the shelf soon.

Yes. Thank you. Thank you, Leland. We're pretty excited about that distribution that we've been able to put out in our press releases. 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, Missy. So thank you for your time this morning. We are so excited to launch VAZALORE. And most importantly, getting VAZALORE into the hands of of millions of patients at risk for vascular disease. We will also provide updates on our plans for PLxGuard 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.