PLx Pharma Inc (PLXP) 2022 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by, and welcome to PLx Pharma's First Quarter 2022 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference call will be recorded.

I would now like to hand the conference over to Janet Barth, PLx Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you. And hello, everyone, and welcome to today's conference call to discuss PLx's 2022 first quarter financial results and business updates. Before we begin, let me remind you that our 2022 first quarter earnings release can be found in the Investor Relations section of our website at www.plxpharma.com and as exhibits to the Form 8-K we filed ahead of this call.

This conference call may contain forward-looking statements, including statements about or references to our outlook regarding the company's performance, our internal models, and our long term objectives. All such statements are subject to risks and uncertainties that could cause actual results to differ materially from what we say during the call today. Please refer to our most recent periodic SEC filings for more detail on these risks and uncertainties, including the Risk Factors section in our Annual Report on Form 10-K. The company undertakes no obligation to update or revise any forward-looking statements.

Additionally, the information we will discuss today contains certain financial measures that exclude amounts or are subject to adjustments that have the effect of excluding amounts that are included in the most directly comparable measure prepared in accordance with generally accepted accounting principles. For a reconciliation to the most comparable measures presented in accordance with GAAP, please refer to the table in our earnings press release available on our website and included as an exhibit to our Form 8-K filed today.

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 13, 2022. Since then, PLx may have made announcements related to the topics discussed. So please refer to the company's most recent press releases and SEC filings.

I will now turn the call over to Natasha Giordano, PLx's President and CEO.

Thank you, Janet. Good morning, everyone. And thank you for joining our call today. We have 2 special guests joining our call this morning, both experts in their field, who will offer their unique perspectives on VAZALORE.

Our first guest is Mike Valentino, our Executive Chairman and Industry Veteran, with nearly 4 decades of experience running multiple consumer and pharmaceutical businesses. Mike is associated with the success of several major brands like Benadryl, Voltaren, [EU], and Mucinex.

Our second guest is Dr. Asif Ali, a preventative cardiologist and influencer based in Houston, who will discuss why he has adopted VAZALORE as his aspirin of choice in his practice.

To start up a call, Rita O'Connor, our Chief Financial Officer and Head of Manufacturing and Supply Chain, will review highlights of our first quarter financial performance, including an update on our cash position. Rita?

Thank you, Natasha, and hello, everyone. Overall, our first quarter financial results reflected our dual efforts to build on the sales momentum for VAZALORE and judiciously manage expenses. Quarter-over-quarter we achieved higher sales growth and lowered our operating expenses. However, we are not immune to the extraordinary macro-economic factors impacting businesses like ours, such as supply chain pressures and labor challenges. Nonetheless, we remain unwavering in our mission to drive awareness and trial of VAZALORE among consumers and healthcare professionals.

During the first quarter, we saw steady growth in VAZALORE across a number of metrics in both consumption and revenue as we continue to establish VAZALORE in the market. Beginning with revenue, we realized net sales of $2.1 million in the first quarter as compared to $1.6 million in the fourth quarter of '21, a sequential increase of approximately 31%. This brings us to over $10 million dollars in total net sales of VAZALORE since its launch 8 months ago, including the initial trade stock to 30,000 retail stores nationwide.

Our first quarter sales reflected shipments to retailers in conjunction with promotion and display support during American Heart Month in February. Net sales of the 81 milligram dose, which consists of a 12 count and 30 count SKU, represented approximately 79% of total net sales in the first quarter. In terms of retail consumption, we have seen steady growth in both units and dollars over the 13 weeks ended March 26 versus a 13-week period ended January 1 '22, according to Nielsen data.

As retail consumption of VAZALORE gains further traction, we expect more meaningful sales growth in the second half of '22. And Natasha will explain how we plan to do that in a few minutes. VAZALORE was the only product that grew within the overall Heart Health segment of the aspirin category that's experiencing decline since October of '21 when the draft aspirin guidelines were published and created confusion in the category. We're building a solid base of VAZALORE users and remain confident that we will see an inflection point in VAZALORE sales as we create the stickiness with the consumer and their repeat purchases lead to exponential growth and unit consumption, like a subscription model.

We continue to have broad retail distribution nationwide across mass drug and grocery channels and are adding 2 regional grocery chains to the mix, Publix and Harris Teeter. Trade support is positive including door count, shelf display, product signage, and other individual retailer programs designed to drive trial.

For example, during American Heart Month in February, we had strong retailer promotion and display support. And this month is National Stroke Awareness Month. And we have partnered with several retail accounts on promotional pricing to drive VAZALORE trial and conversion. Additionally, we have more retail promotional programs planned over the next several months.

As previously noted, our retail partners are committed to the success of our brand and we expect VAZALORE will continue with its broad distribution and promotional support through the end of the year. Several large retailers are featuring VAZALORE in their high visibility circular vehicles every month throughout the summer and fall.

In addition to physical retail channels, VAZALORE is gaining a solid footing in e-commerce channel, which are easy to navigate and provide expanded product information, visual assets, and consumer reviews. Amazon specifically is an important online sales, marketing, and promotion platform for VAZALORE.

Our Amazon sales metrics show a growing base for consumer trial and conversion, as evident in the study rate of growth in the Amazon Subscribe and Save feature for VAZALORE. This base of subscribers has more than doubled and now represents nearly 30% of our monthly sales on the Amazon platform. Leveraging our early success on Amazon, we have expanded our promotions on the platform to include reminder advertising, which is a very cost effective way to increase conversion and create stickiness with consumers with encouraging results so far.

As we previously mentioned, we have been navigating a technical issue with Amazon relating to packaging documentation in early March. During the roughly 10 days VAZALORE was offline, there were no product orders from the Amazon website. Once restored, we recovered more than 75% of our baseline business in the first week and had fully recovered to baseline by the end of March. We believe the sales impact of being offline was immaterial to our first quarter results. One of the primary drivers of the sales recovery were the Subscribe and Save orders that had queued up while we were offline and were automatically filled as soon as our online status returned.

Moving from sales to the cost of sales and gross margin. Our gross margin was 44% in the first quarter, which was in line with the fourth quarter. We still expect to achieve improvement in our blended gross margins by the end of '22, when we complete the expansion of our manufacturing capacity for 325 milligram dose. Until then, we may have some variability in our quarterly gross margin, especially due to the macro-economic factors, I referenced earlier including higher raw material, freight, and labor costs.

Our operating expenses were $19.1 million in the first quarter of '22, driven by our investments to establish VAZALORE in the marketplace through our national TV campaign and our salesforce marketing efforts to healthcare professionals. Our disciplined spending in Q1 resulted in an 11% quarter-over-quarter decline in operating expenses, in line with our guidance of being slightly less than Q4.

On a sequential basis, our expenses declined slightly due to a strategic shift away from some of the high visibility TV program we were doing, like the NFL and college football events. We are modeling another sequential decline in operating expenses for the second quarter as we pursue more cost effective promotions and maintain a keen focus on extending our cash runway. We plan to maintain a base level of advertising network and cable news programs, and reallocate spent other priority marketing vehicles, including digital platforms.

On a GAAP basis we reported a net loss of $0.39 per diluted share in the first quarter compared to a net loss of $0.73 per diluted share in '21. Adjusting for the fair value of our warrant liability, which represented income of approximately $7.4 million, our non-GAAP net loss per diluted share was $0.66 in the first quarter of '22 compared to an adjusted net loss of $0.22 in the prior year period. And please refer to the Reg G table in our financial statements to reconcile GAAP EPS to the adjusted non-GAAP number.

Turning to the balance sheet. As of March 31 '22, we had a cash and cash equivalents balance of $52.5 million. Our cash burn of $16.9 million was primarily related to sales and marketing activities, partially offset by the timing of receivables collected from sales of VAZALORE. As we continue to mention, we are very focused on our cash runway. We will maintain a disciplined spending approach to manage expenses while still investing in strategic growth.

With Q1 as the peak, remodeling lower levels of cash burn for the remaining quarters of '22. While we still believe we have enough cash to complete our launch activities into '23, our plan is to extend that cash runway beyond that. We regularly evaluate financing options available to us to support our investments in future growth plans, including product development opportunities using our PLxGuard technology platform. We are currently reviewing various options including non-dilutive financing as we are sensitive to the potential dilution effects associated with an equity raise. We are also exploring potential business development and partnership opportunities as another source of non-dilutive capital.

To elaborate more on that subject, I will now turn the call over to our Executive Chairman, Mike Valentino, who I've had the pleasure to work with for many years, including our success at Adams Respiratory Therapeutics, where we launched Mucinex and ultimately sold it to Reckitt Benckiser for $2.3 billion. Mike will also share his perspective on our launch based on his extensive industry experience with numerous major brands.

Mike?

Thank you, Rita, and good morning everyone. For the past 10 years, I've served as Executive Chairman of PLx Pharma, and during that time, I've seen our PLxGuard technology evolved from being a novel idea discovered in the lab to becoming an innovative, FDA approved drug delivery platform for VAZALORE, protected by more than 30 U.S. patents through the year 2032.

During my nearly 40 years in the industry, I've run several major consumer and pharmaceutical businesses, including Upjohn Consumer Products, Alpharma generics, Xanodyne Pharmaceuticals, and both Novartis's North American and Global Consumer Pharmaceuticals companies. I've also had the opportunity to build a startup from the ground up called Adams Respiratory Therapeutics, makers of Mucinex.

In addition, I have launched 7 Rx-to-OTC switches, among them such well-known brands as Benadryl, Lamisil, Rogaine, Voltaren outside the U.S., and Mucinex. In addition, I've managed well over 100 brands, both domestically and internationally.

I think it's fair to say that I've seen it all from a brand point of view. Each of these brand building experiences have prepared me well, to understand the unique challenges and opportunities associated with the launch of a product like VAZALORE and I'd like to share this perspective with you today.

Let me say first that it is extremely rare for brands to come off the launch pads like a rocket ship. That's why we are all familiar with the highly unusual case histories behind such brands as Tesla, Google, and Viagra because they are few and far between. I personally have not enjoyed the pleasure of a launch like that. Yet each of the brands that I mentioned and countless others that I have worked on have all been successful. It's also very rare in spite of best efforts that you get everything right on the first try. The reality is that strong brands are developed over time as a result of continuous iteration. There is no easy way. The formula for brand building and building strong brands includes trial, learning, and adjustment. All brands go through stages of iteration to build upon and enhance what is working and make adjustments and changes based on what we've learned.

After 8 months of marketing, we've just completed this stage with VAZALORE where we have now pressure tested all of our marketing elements and are making some adjustments to strengthen our brand offering and our value proposition. You'll hear more on this from Natasha in a few minutes. But those adjustments are only half the equation. The other half requires operational excellence and precise execution, which of course, boils down to people.

And I want you all to know that I wouldn't trade our management team for any in the industry. Nearly all have been in the trenches with me before and each has enjoyed success in building brands. They are highly experienced and extremely motivated to deliver our life saving aspirin to as many patients as possible. I also want you to know that I fully support the adjustments we are making and our plans to drive trial and conversion. And I'm confident in the team's ability to execute quickly and with precision.

As an additional perspective on the launch, I want to mention that Mucinex became nearly a $500 million brand in 4-1/2 years in Adams hands and is at nearly $1 billion in sales in the U.S. as part of Reckitt Benckiser. In its first year, Mucinex sales were $14 million, but grew to more than $60 million in year 2. I think that makes the point that building a brand is a process, not a one shot event. I'm confident that we have the right product, the right thing, and the right strategy to develop VAZALORE into a major brand.

Before closing, I want to reiterate what Rita's point earlier was about our myopic focus on protecting the balance sheet and our cash runaway. This effort is multifaceted. First, as a result of the analysis I just discussed above, we now know which marketing elements have been the most efficient. By eliminating the inefficient ones and dialing up the elements that have given us the most bang for the buck, we've been able to extract some cost savings. Next, we continue to evaluate options to bring in new sources of capital including debt. And finally, we're also actively exploring business development activities as yet another way to source non-dilutive capital. We're currently engaged with several major consumer companies. And I'm personally taking lead on this project.

The range of possibilities being explored include first, licensing the technology for non-competitive categories. Second, seeking a development investment in PLx in exchange for certain future rights. And third, out-licensing ex-U.S. rights to VAZALORE. While there are no guarantees that any of these deals will get done, what I can say is that there is definite outside interest in what we have accomplished thus far, and what we are building with VAZALORE. We have and continue to build value in the brand.

Natasha, I'll now turn it back to you.

Great. Thank you, Mike. We appreciate you sharing your perspective with us today. Since launching them 8 months ago, we've analyzed our sales and marketing productivity to determine which tactics are driving the most success and where we should make some adjustments. In refining our plan, we are incorporating the learnings from market data and feedback from healthcare professionals or HCPs and consumers.

I will first discuss what we've learned from the market since launch and then what we've done to refine our plan. Like most public companies, we face our shared challenges. In addition to the struggles, the broader markets, especially the biotech markets, we're also managing macro-economic factors including inflation, and continued COVID impact.

The COVID effect is real. It has impacted where and how consumers shop and it also has affected how HCPs treat patients and receive new information. For example, medical conferences and congresses as a channel for face-to-face interactions have decreased, and in-person attendance is still low. Typically, interactions with physicians at these conferences before COVID were much more robust than they are today. Times have changed. We have been nimble in adapting our programs to address these market dynamics and remain focused on the things that we feel will build awareness and grow VAZALORE.

Another challenge impacting our category is the recent finalization of the United States Preventive Services Task Force or the USPSTF recommendations on aspirin therapy, which were first published as draft back in October of '21, and then recently finalized in April.

The media attention around this topic created confusion among consumers and HCPs alike. Physicians tell us that they still have patients calling them every day asking if they should stop taking aspirin. As a reminder, the USPSTF recommendations are not new and pertain only to the use of aspirin for the treatment of primary prevention, meaning for people who have never had a cardiac event.

However, for patients who have already had a heart attack or a clot related stroke, aspirin is the cornerstone therapy. This confusion continues to put downward pressure on the overall heart health category. Despite these market conditions and other challenges, we continue to be confident in VAZALORE, especially due to the positive feedback we've received from both HCPs and consumers. We received consumer input through various channels, including our customer care call center, online customer reviews, and through physicians.

Here are a few examples of consumer sentiment: "VAZALORE 81 milligram aspirin capsules are super small and easy to swallow. It did not upset my stomach at all." "VAZALORE 325 milligram capsules are easy to swallow and provide fast relief from minor arthritis pain." "Goes down smooth without the bitter taste of the chalky aspirin that I've been taking daily." And we've even seen some mention of consumers being able to eliminate their acid reducer.

To generate more consumer feedback, we recently deployed a 200-patient survey across major U.S. markets. Preliminary results from this study are very favorable with nearly 90% of the respondents saying they agree and the remainder saying they somewhat agree with the following: "I felt no issues with my stomach when taking VAZALORE with or without food and makes me feel like I'm doing all that I can to help support my heart health." And when asked how satisfied are you with using VAZALORE is your choice of daily aspirin therapy, and how likely are you to purchase VAZALORE, nearly 95% of the respondents said that they were either extremely or very satisfied and are likely to purchase.

We've also learned a lot through our interactions with healthcare professionals or HCPs. HCPs are beginning to recognize that there is a difference between VAZALORE and enteric-coated aspirin and that formulation matters. They stressed to us the importance of reliable and complete platelet inhibition in these high-risk patients. Early adopters are recommending VAZALORE and have told us that their patients are tolerating it well and that they are not hearing complaints.

With this feedback, we've engaged with a broader spectrum of HCP early adopters, including preventive cardiologists who are at the forefront of secondary prevention, peripheral artery disease experts, as well as practicing clinical cardiologists, pharmacists, advanced practice providers, which include nurse practitioners and physician assistants and nurses. We are delivering a stronger message of differentiation through face-to-face and virtual interactions as well as through an expansion of a cost-effective e-mail communication campaign and medical education programs.

This group of esteemed HCP influencers are on a mission to inform even broader groups of their peers on the value that VAZALORE could bring to their patients and specifically the difference between VAZALORE and other aspirin formulations as well as stressing the importance of aspirin therapy and the need for reliable platelet inhibition for these patients. We've also learned that many HCPs do not perceive a problem with enteric-coated aspirin, which is the most widely used formulation of low-dose aspirin in the market.

There is a general belief among these physicians that enteric-coated aspirin should work as reliably and consistently as plain aspirin and that the coatings should solve the problem of local injury to the stomach often associated with plain aspirin. The truth is, that enteric-coated aspirin has several limitations, including delayed erratic and in some cases, failed absorption. In addition, there is lack of definitive data on enteric-coated aspirin to support its claim of preventing stomach injury. By definition, enteric-coated formulations are delayed release. This delay in absorption and the coating itself may impact how much aspirin is available to be absorbed.

In addition, the FDA professional labeling states that enteric-coated aspirin products are erratically absorbed. Erratic absorption could mean that some patients may not get any aspirin absorbed at all on some days. This is an important distinction because having inconsistent absorption or variable platelet inhibition is a risk for patients being treated a secondary prevention of cardiovascular events and trying to avoid having another potential fatal event. Further, this erratic absorption may be exacerbated if the enteric-coated aspirin is taken with food or by people who are obese.

I'd now like to introduce our next guest, Dr. Asif Ali, a Preventive Cardiologist, Clinical Associate Professor of Cardiovascular Medicine at the University of Texas Health Center at Houston. He's a published author and has been featured on national and local news programs. Dr. Ali is an influencer among HCPs and has been an early adopter of VAZALORE. We are delighted to have him on the call with us today to speak about why he feels so strongly about VAZALORE as a foundational treatment for his patients. Dr. Ali?

Good morning, and thank you, Natasha and the PLx team for having me speak to you all today. I am a preventative academic and a clinical cardiologist. I've worked in the largest medical center in the United States, the Texas Medical Center. And in one of the fastest-growing cardiologist practices in Houston, Texas, I personally see thousands of new patients annually from all over the U.S.

Our goal and mission has always been patients first and creating a center of excellence, grounded in evidence-based medicine, and guideline-directed medical therapy, GDMT. I've had the privilege to work with and have mentors at the top echelon of cardiovascular care throughout the United States, both in interventional and preventative side of medicine, one of them even being a Nobel laureate winner.

In regards to aspirin, we know that aspirin remains the cornerstone therapy for secondary prevention of cardiovascular events and is needed for complete platelet inhibition to prevent clots from forming and triggering another heart attack or stroke. Yet after speaking to a number of my cardiology vascular heads of departments before and after actually the recent American College of Cardiology meeting in Washington, D.C. last month, overwhelmingly, these cardiovascular heads of departments are interested in the conversation around aspirin's efficacy and safety.

My colleagues, many of them who are chairman's of departments in cardiology, were really actually surprised about the following facts. First, that aspirin has not been tested with the rigor of an FDA approval process; #2, that the FDA states in the professional label that enteric-coated aspirin products are erratically absorbed from the GI tract. And that means our patients may get a delayed erratic and sometimes failed absorption of aspirin, which as we know, is a life-saving therapy in ASCVD. And this variable or erratic absorption may be further exacerbated by food intake, higher patient weight, diabetes, and other factors that may affect absorption. Enteric-coated aspirin has also issues of gastric erosions and gastric ulcers.

So the bottom line is if we're prescribing a medication, the assumption by healthcare professionals is that our patients are absorbing the exact dose that we intended to prescribe them. Simply put, physicians, we don't like variability. We like reliability and we like predictability. Yet the most widely used formulation of aspirin -- enteric-coated aspirin may not provide the intended protection we as doctors have come to expect.

It's very fundamental. If the drug doesn't get absorbed, then it doesn't work, then we're not doing our best for patient care. Both the consumer and the healthcare professional should be made aware of their options regarding the differences in therapeutics in a shared decision process. Both healthcare professionals and consumers should sit down and understand their options and the best therapy for their patients. I believe this is a patient health issue.

With VAZALORE, which I call Aspirin 2.0, the PK/PD data from the published study on obese diabetics show that the extent of absorption matters, and it determines the extent of aspirin responsiveness. The coding of enteric-coated aspirin tablets have a significant implications on the bioavailability of aspirin in these high-risk patients. When we treat patients in an acute hospital setting, for example, a stroke, a heart attack, or even peripheral vascular disease where we can have a critical limb; patients may be placed on 4 to 5 new medications post intervention when they leave the hospital.

With every new medication, there are potential side effects, and it is difficult to know which medicine is causing side effects when you're starting 4 to 5 medications at the same time. At least for now, at least for the aspirin component, we can have an aspirin that reduces the risk of stomach injury. Then the question is why not set our patients up for success from the get-go. I have prescribed VAZALORE to hundreds of my patients and tolerability has not been an issue.

Lastly, I don't want to take the risk of the variability of the absorption of aspirin and after discussing with my patients, neither do they. I think they have a better option in regard to their aspirin therapy now with VAZALORE.

Back to Natasha, and thank you for having me on your call today.

Thank you, Dr. Ali. Thank you for sharing your perspective with us today.

Your messages are clear. First, the physician's #1 concern is the health of their patients. And second, physicians don't like erratic or variable absorption. Dr. Ali in a growing list of other HCPs see the difference between VAZALORE and enteric-coated aspirin, they appreciate and understand the data and they're recommending it to their patients. Importantly, they tell us that their patients are tolerating it well.

And now I will discuss how we've refined our plans. In evaluating all the feedback, along with market research and other data, we're making some adjustments to strengthen our brand offering and value proposition for both HCPs and consumers. We are intensifying our focus to more strongly differentiate VAZALORE from the limitations of other aspirants. In refining our plan, we're implementing more effective digital and virtual offerings to broaden our consumer and physician communications and adding cost-effective multichannel programs to expand our target audience.

We're making a strategic shift in consumer marketing toward more cost-effective programs, including e-mail and online search addressing the ever present trend of online shopping. We're also maintaining a base level of television advertising, which we know reaches our target audience. In addition, we have some unique programs planned with our retail partners over the coming weeks and months to drive VAZALORE trial and conversion. Additionally, we are also exploring digital placement of product testimonials using a combination of celebrity endorsements and real patients to talk about their experience with VAZALORE.

In marketing to HCPs, we've developed an enhanced scientific narrative in collaboration with key scientific experts that supports the differentiation of VAZALORE and reinforces the value proposition versus enteric-coated aspirin for secondary prevention of cardiovascular events. These key messages include VAZALORE is fast. Enteric-coated aspirin is delayed. VAZALORE is bioequivalent to plain aspirin, enteric-coated aspirin is not. VAZALORE is predictably and reliably absorbed.

Enteric-coated aspirin is erratically absorbed as per FDA professional labeling. And finally, VAZALORE is designed to help protect the gastroduodenal lining. In contrast, aspirin has been shown to cause local stomach injury. And enteric-coated aspirin, which was developed to help reduce the stomach injury of aspirin, lacks definitive data that it does indeed prevent stomach injury.

We are driving our enhanced messages further with HCPs through thought leader led round tables at medical conferences, including showcasing VAZALORE at the upcoming Society for Cardiovascular Angiography and Interventions, the SCAI meeting later this month. Also to address the ongoing confusion among HCPs on the guidelines and the differences in aspirin formulations, PLx provided an independent educational grant to CME program earlier this week on the topic of aspirin therapy in 2022.

Dr. Michael Gibson, Professor of Medicine at Harvard Medical School was the Faculty Program Director and was joined by other esteemed faculty from medicine, from pharmacy, and from nursing. In addition, our cardiovascular care specialists are implementing new VAZALORE sampling and patient use survey programs to drive physician adoption and consumer trial. These programs involve partnering with large cardiology group practices across the U.S. to display VAZALORE, provide samples, and education materials for patients on doctor recommended aspirin therapy. We're encouraged by the broad potential of this program.

And finally, we've asked world-recognized experts to take a deep dive into the PLx data on VAZALORE as well as all the data and literature that exists on aspirin. They feel strongly that VAZALORE with its fast and reliable absorption and designed to help protect from local injury could provide significant value across multiple parameters that could lead to better outcomes for patients.

We're committed to advancing the science for VAZALORE 81 milligrams and have studies in mind for clinical development. We're in active discussions with 2 of the most reputable institutions in the country regarding a real-world evidence study on tolerance and adherence and plan to follow up with a head-to-head study versus enteric-coated aspirin. That's how confident we are in VAZALORE.

To wrap up, I'd like to leave you with some facts. As per the guidelines, aspirin is a Class Ia foundational therapy for secondary prevention of cardiovascular events and patients may remain on aspirin therapy for the rest of their lives. Aspirin is known to be tough on the stomach. The PLxGuard drug delivery platform was designed especially, to provide full bioavailability of active pharmaceutical ingredients and to help protect the gastroduodenal lining.

VAZALORE, the first and only FDA-approved liquid-filled aspirin capsules provides fast, reliable, and predictable absorption in platelet inhibition and was designed to help protect the gastroduodenal lining. We're building a solid base of VAZALORE users. We've analyzed our results to date and listened to the market feedback.

We've adjusted our tactics to strengthen our brand offering and value proposition for VAZALORE to both consumers and HCPs through cost-effective programs. We're confident in the differentiation of VAZALORE versus other aspirin formulations and are on a mission to transform the standard of aspirin therapy for secondary prevention of cardiovascular events for millions of patients. We believe we have the right team and the right strategy to make VAZALORE a winning brand.

Operator, we are now ready to move to Q&A portion of our call.

(Operator Instructions) And our first question will come from Leland Gershell of Oppenheimer.

A few questions from me. First, I mean, clearly, this -- the USPSTF guideline confusion is not helping. But you discussed it a bit on the call, but maybe what can be done further to reverse the impact of the kind of media not getting into the details until you get way down into the article about who should be on aspirin versus who maybe shouldn't be?

And also, with respect to price, if patients bring up price as a hurdle. What's your approach to advising providers with respect to talking to patients about price and counseling them on that and getting them through kind of the prices being a potential issue.

Thank you, Leland. These are 2 very interesting questions. And I think rather than me taking them on, I might ask Dr. Asif Ali, who is in the trenches with patients every day to take that on. So Dr. Ali, maybe first, talk about your impressions of the USPSTF guideline confusion and what can be done to broaden the awareness amongst HCPs?

Sure. Thank you for the questions. So I'll take these both in order. In regards to the new data on primary versus secondary prevention, it's caused a lot of confusion and mudding of the water. So there definitely needs to be a much better education and awareness in regards to what is primary prevention and what is secondary prevention?

And quite simply, if you don't have the disease, aspirin may not work. If you have the disease, atherosclerotic vascular disease then aspirin works, and that's what is secondary prevention. So there hasn't been a day since that information came out that I haven't had a patient come back to me with a recent heart attack or stroke and asking me, should I still be on my aspirin. So clearly, when the data came out about primary prevention, it caused a lot of confusion in the patient population. But I think as patients are going back and talking to their healthcare providers, there is a reestablishment of what is primary versus secondary prevention and what is the importance of aspirin as a life-saving therapy in their regimen.

When we talk about cost and price, I want to come back to our base. We're talking about saving lives. We're talking about life-altering events like a stroke or a heart attack. We're talking about the #1 killer in America, which is heart attacks and the #5 killer in America, which is cerebrovascular accidents or strokes, and that's per the CDC's latest data on mortality in America. So when we talk about cost, the least expensive life-saving line item in atherosclerotic vascular disease is aspirin, especially if you look at the cost of going to the hospital with the heart attack or stroke, the diagnostics, the interventions, and the multiple therapies up to 5 medications; out of all of those 5 medications, aspirin is the least costly of those medications. Some of those medications costing thousands of dollars.

So clarifying the cost price issue, it is not an issue about -- the debate shouldn't be about the pennies that we're talking about in aspirin. We're talking about saving lives. It's not the cheapest cost of the aspirin, but simply using the drug that absorbs the best and hence, does the job it's tending to do.

Does that answer your question?

Yes. That was very helpful.

And our next question comes from Elliot Wilbur of Raymond James.

I've got a couple of questions here. First is, I think you may have just woken up the entire town of Leverkusen, Germany with your announcement that you're planning a head-to-head study against enteric-coated aspirin. Just curious sort of what the primary aim there is in terms of teasing out the relative benefit? How much is -- are you looking to show an efficacy differentiation versus safety, I'm assuming possibly both, but just wanted to confirm that. And if I could ask perhaps Dr. Ali to weigh in on that. How important do you think that data could be in terms of influencing prescriber behavior?

Yes. I'll take it on and then we'll ask Dr. Ali to offer his perspective.

I think it's important for us, given that aspirin is a life-saving drug and that millions of patients really need reliable, predictable bioavailability in order to prevent that next event that could be fatal. So our commitment to advancing the science has always been there. We have a Scientific Advisory Board that's actively working on publishing manuscripts as we speak. And so, we know that for a physician, that bioavailability is really important. Dr. Ali mentioned how they hate erratic absorption and they hate variability. And these patients are so vulnerable to having their next event. And so, many people, doctors included, are not even aware that some patients may not get any aspirin absorption at all on given days. And certainly, that puts them at high risk.

So yes, you're right, Elliot, those components will be important to us. But we also are looking at providing more information in a real-world sense and doing a study rather quickly on adherence and tolerance because that is the issue that prevents people from staying on aspirin. So we're so confident that VAZALORE is going to prove to be very, very important in the treatment of secondary prevention.

In terms of its importance to the medical community, Dr. Ali, maybe you can share a few thoughts there.

Sure. I want to point out that the issue of anticoagulation and absorption is not a new story. If you look at NOACs, which are the new oral anticoagulation in atrial fibrillation, this exact story of bioavailability, absorption, which drug absorbs the best and hence has better efficacy, it is not a new story. I think what is a new story is that physicians are actually quite shocked and they didn't realize that aspirin never -- the formulary of aspirin today did not go through the rigors of FDA approval that VAZALORE has and that there is new data now coming out about PK/PD modeling and absorption. And I think physicians as a whole, HCPs, the ones I've talked to, which are key opinion leaders, in the United States are really quite shocked actually. I would use that word. And they want to have discussions about using the drug that actually works, especially when they're doing life-saving interventions.

So this story of bioavailability absorption, I think it's great that the company is standing behind its therapy and delivery systems, and I look forward to the data coming out.

Okay. And then a follow-up question for you, Natasha. Just wanted to get perhaps some additional perspective in terms of what you may be thinking about, at least at this early stage in terms of exploring potential partnerships? Are you referring specifically to sort of more ex U.S. efforts or some type of co-promotion strategy with larger companies that may provide some additional near-term capital.

And then you talked about some new avenues or new partners on the distribution front on the retail side. But curious what you guys may be thinking about or what you may have learned recently in terms of other channels of distribution such as long-term care. I mean it's even at the Rx level, I mean that's roughly a $200 million annual market and VAZALORE looks to be -- I think it's the leading brand kind of within that channel. And I suspect that there's just -- it would be a channel that be relatively responsive to detailing promotion and would respond very well to the efficacy aspect of the product. But just wondering what you may be thinking about in terms of more direct promotion to institutional channels that weren't necessarily part of the initial marketing plan.

Yes. Thank you, Elliot. Let's take the partnership question first, and you heard from Mike, some of our activities in that regard. So let me ask Mike to provide a bit more color on that subject.

Sure. Thanks, Natasha, and thanks for the question, Ali.

What I can say is that among the companies that we're talking to, all of them are very impressed with what we've accomplished thus far. And the reason for that is that they all understand how difficult it is to build a brand from the ground up. They understand that it doesn't happen overnight, that successful brands come as a result of continuous iteration and adjustment. And here's what they're impressed with. They're impressed with our science and technology. They're impressed with our vast patent estate. They're impressed with our advertising and our marketing materials on both the consumer and professional side. They're impressed with our 30,000-plus door distribution. They're impressed with the number and quality of off-shelf display activity that we've been able to achieve. And they're impressed with the potential new businesses that our technology could spawn and really so much more. Their views on our progress thus far, and this is a key point, are not at all influenced by expectations of where we should be, but rather a view of where we are after only 8 months, which, in their view, is pretty damn good. There's no doubt they're impressed, and there's no doubt that we are creating strong value in the VAZALORE franchise.

Okay. Thanks, Mike. And I'll take the question on expanding our partnerships with more direct distribution. We actually do have some plans and analysis to go to a couple of places. One is large systems that are interested in implementing potentially VAZALORE as the product of choice upon discharge for patients. We're in the beginning phase of mapping out how to execute that. But I think that's a really important and insightful question, you asked us, Elliott. You specifically mentioned -- and I'm not -- we're not going to give too much more on that because we are in the beginning phases, but I'm pretty excited about the interest that we've seen so far for that concept.

Secondly, you asked about LTC -- the LTC environment. And it is interesting because we know that there has been some interest in VAZALORE from the LTC aspect. And so, we're exploring that and how we could partner with those institutions directly. So you'll hear more about that in our next update.

Okay. And one final question, if I may, for Dr. Ali. Just curious within your subset of patients being treated for secondary prevention. Is there a particular patient profile that you think is more suited for VAZALORE than another? Or do you really think that this should be standard of care for all patients, all secondary prevention patients? And then how successful have you been in actually getting these patients on therapy and getting them to remain on therapy kind of once they go through sort of the initial first trial of VAZALORE.

And you mentioned sort of the lack of awareness among physicians in terms of the erratic absorption issue of enteric-coated aspirin. How do you think that this message should be best communicated? Or what's the best way to sort of get the word out here? Is it just more active engagement with the actual prescribers, more engagement with P&T communities or thought leaders? Just wondering from your perspective, what do you think would be helpful in terms of enhancing the messaging here?

Thank you for the question. And simply put, when you have a life-altering event, a heart attack, a stroke, change in behavior occurs very quickly, right? You have to have something that happens. And that's what secondary prevention is. So obviously, the patient has failed primary prevention, which is preventing the disease from happening. So once the disease happens, changing behaviors occur quite quickly. I mean if you're going from 0 to 5 new medications with a stent in your heart or you've been in the ICU, the Intensive Care Unit or the Cardiac Care Unit with a heart attack or a stroke and now expanding down to peripheral vascular disease because you have blood vessels from head to toe. So if the insults in the brain that's a stroke; it's in the heart, it's a heart attack; if it's in your leg, it's peripheral vascular disease. Each one of those may require hospitalization may require a procedure. So getting patients to -- that is the optimum time for patients to change the behavior, whether it's quitting smoking, losing weight, improving their diet exercise, but in addition, adding medications.

So there is a Class I indication called shared decision-making. This is per the guidelines. This is standard of care. And shared decision-making means that I and the patient have an informative discussion on their options for their treatment. And if I'm doing right for the patient, then I'm going to offer the treatments that are going to best serve that patient. So that discussion is actually fairly clear, and it's per the guidelines. We're doing shared decision-making and showing the best options for patient care.

As far as strategies to get the word out, absolutely. P&T committees, they're running a little bit of a campaign talking to chairman's who want to have much further discussions, grand rounds, looking at the data because healthcare institutions, too, are in the business for providing the best and excellence in care and they want the best and the most excellence in treatment strategies and programs. And I believe this is a healthcare issue that needs to be discussed in a much broader perspective and including speaking to organizations like the American Heart Association to clarify to patients, the difference between primary and secondary prevention and the best strategies for those patients' treatment.

Thank you, Dr. Ali.

Our next question comes from Jason Butler of JMP Securities.

I appreciate all the details you've gone into this morning. First one for Dr. Ali. I guess just how consistent is it among your peers of the appreciation of the limits of enteric-coated aspirin. And how consistent is it that it's a priority? And I guess maybe asked the other way, or do you have any peers that push back or don't view this as a priority? Or is it ultimately a situation where awareness has increases your peers or we just want to use the product VAZALORE more?

Yes. And again, I'm going to answer your question, borrowing that this is not a new conversation when we're talking about high availability. There is marketing materials in NOACs right now in Afib in obese patients. This same conversation is being played out in another anticoagulant that has nothing to do with heart attacks and strokes, it has to deal with atrial fibrillation, another clot forming disease. Again -- that's, again, an event that has happened. And NOACs are right now playing this exact scenario. And I think as physicians are listening and understanding that medication, bioavailability PK/PD is an issue. And perhaps that's why patients are still having events or have new disease that occur. One of the theories here is that you're not even absorbing the medication in some cases. And we're talking about fundamentals. These are not Class 3 or 4 or 2A or 2B. These are Class 1 indications for serious diseases.

And so, I think the fundamentals are there. It is now a campaign of educating both healthcare providers as well as patients in that shared decision model and getting this up the ladder in a broader perspective to make sure that patients are very clearly aware of their options and what the best options are for them, but we need to let them be informed of that option. And I think that information is what VAZALORE is working on, that messaging.

That's helpful. Natasha, I don't think you're making any changes to your trial sample and coupon program. Is that -- should we infer from that is working well as intended? Or are there any changes that you're considering there?

And then just one for Rita. Can you give us any sense of how retailer inventory levels are changing or maintaining versus the end of the fourth quarter?

Okay. In terms of sampling and couponing, I think, was your question and how we're approaching it. we actually are making some adjustments on our sampling program. We've partnered with large cardiology group practices across the country right now that have adopted VAZALORE as an important piece in their regimen in treating secondary prevention. And so, we're providing heavier sampling there with coupons, with patient education materials as well. And we're taking a step further. I mentioned earlier, we're doing a 200-patient survey with a very specific objective to get real data back from patients on how they perceive VAZALORE, how they tolerate VAZALORE, how they feel about it in terms of protecting their risk for cardiovascular disease or a fatal event. And we're providing sampling and couponing there. We know that our consumer is responsive to that approach. We've seen the data that validates that. So we're being very focused in programs that we think will yield broader and faster success and uptake in conversion specifically to VAZALORE.

And I'll let Rita, address your second question.

Sure. Thanks, Jason. Yes, real quick. So as you know, for heart month in February, we actually did a lot of display promotions. So the retail inventory levels were there, and we're just starting to see them come down. And including in May, we're doing some promotion that shelf to draw down that inventory, so that we're expecting some significant growth in the back half of the year as we work down those displays and execute those promotions.

And our next question comes from a follow-up of Leland Gershell of Oppenheimer.

Sorry, I think my second question has gotten cut off. If you could maybe with respect to the management team, maybe discuss what counseling approaches you take in terms of patients who take issue with the more expensive price obviously of VAZALORE versus just regular aspirin?

And then I also have a second question, but please go ahead.

Your question on price for -- and cost for the patient from -- and how HCPs should have that discussion with them. Is that your question you're circling back to?

Yes, that's right, Natasha.

Okay. Maybe I'll ask Dr. Ali again, to ask your opinion, maybe briefly summarize how you get your patient to, if there is a challenge in terms of price and cost, how do you handle that conversation? You talked a lot about the shared decision-making process between a physician and a patient. How would you handle that? How do you handle that since you have hundreds of patients on VAZALORE with that patient? How do you get them through that?

Yes. I mean it's just quite simply you have a new stent in your heart, your life saved. So we got through the acute process. Now we really need to focus on secondary prevention processes. And when we look at data from different medications, so you look at different trials, you look at different differences in absorption as we talked about. I'm putting these patients on 5 medications, right? One, we look at dual antiplatelet therapy. So it's usually aspirin plus another medication that would also help with inhibition and making sure that, that stent stays open. And for example, if it's in your heart, a coronary stent.

And the discussion so far has been very -- quite simple that there's a lot of variability in the regular aspirin that you're getting, that you may not absorb any aspirin in the aspirin that you may have been discharged from the hospital. I'm going to switch you over to VAZALORE. I have samples in my closet. I have a savings coupon. And this is the medication that has better absorption. So it's not a very difficult conversation when we talk about shared decision-making with the patient, especially when this medication is the least expensive line item out of the other medications that could cost hundreds of dollars a month.

So yes, I think that's the answer. I mean, this is out of all the medications, the therapies, the diagnostics, the hospital stay; this is going to be the lowest line item cost. I want to make sure, though, that whatever I'm giving you that it's being absorbed and it's being efficacious and that you're being protected. And so, it's not a -- this really is a 10-second conversation. Won't you be on the best formulation for you to keep that stent open and to prevent further other atherosclerotic vascular disease.

And Dr. Ali, with respect to patients who may need to -- need to take, let's say, a put on pump inhibitor or some other adjunctive agent to help them with the GI tolerability issues of regular aspirin. I mean do you see that as kind of a special sweet spot population for VAZALORE? Or is it really just kind of VAZALORE is simply a better aspirin and whether you are trying to ameliorate that side effect or not, if one should simply be on VAZALORE referral with various benefits as a part of?

Right. So inherent in your question right there, you're saying that, look, there are patients on aspirin who now need to take an additional medication because they're having GI issues. So now I'm adding more cost. I mean that's -- inherent in your question was, look, they're taking an aspirin, now they have to be on another medication just to be able to take the aspirin. So that's a whole issue there. And by the way, proton pump inhibitors, if you read in the CDC and NIH guidelines have their own issues with renal and cardiac issues as well. So now we're having to add additional costs and additional medications. So that's what I was saying earlier. Why not set the patient up from the get-go with a medication that has much better data on bioavailability, so that was the efficacy. Now you're talking about safety. So when we talk about safety, we're seeing less GI ulcers, GI irritation, and we have a better formulation.

So that's also another conversation I have with the patient, like why? And so, I think that's a niche area that you're talking about, but it's a good point. And I have actually gone through my own database in my office to see how many patients are on regular aspirin and who are having to take an H2 blocker, and a PPI. I think it's preliminary to give you any reporting on that, but it just makes inherent sense to set the patient up for success from the get-go rather than adding additional medications so they can tolerate another medication.

And I'm showing no further questions. I would now like to turn the call back to Janet Barth for closing remarks.

Thank you, LaTonya, and thank you all for participating in our call today. Please feel free to contact me with any additional questions you may have. Have a great day.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. You may now disconnect.