PLx Pharma Inc. (NASDAQ:PLXP) Q3 2022 Earnings Conference Call November 11, 2022 8:30 AM ET
Company Participants
Natasha Giordano – President, Chief Executive Officer
Rita O’Connor – Chief Financial Officer
Asif Ali – Preventative Cardiologist
Janet Barth – Vice President, Investor Relations
Conference Call Participants
Leland Gershell – Oppenheimer
Jason Butler – JMP Securities
Operator
Ladies and gentlemen, thank you for standing by and welcome to PLx Pharma’s third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. Following the presentation, there will be a question and answer session. Please be advised that today’s conference may be recorded.
I would now like to hand the conference over to Janet Barth, PLx’s Vice President of Investor Relations and Corporate Communications. Please go ahead.
Janet Barth
Thank you Liz, and welcome to today’s conference call to discuss PLx’s 2022 third quarter financial results and business update.
Before we begin, let me remind you that our 2022 third 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, which we filed yesterday afternoon due to the federal holiday and the SEC being closed today in observance of Veteran’s Day.
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 yesterday.
For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on November 11, 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.
Natasha Giordano
Thank you Janet. Good morning everyone and thank you for joining our call. It’s Veteran’s Day today, and on behalf of PLx, I want to thank all of our veterans for their service.
During the first year of Vazalore’s launch, we’ve invested in building a base of awareness among consumer and healthcare professionals. Since market acceptance and sales have taken longer to develop than anticipated, we’ve streamlined our investments with the goal of maintaining our base consumption levels. We’ve recently initiated a formal process to evaluate strategic alternatives to ensure that Vazalore can remain available for the millions of patients who need it.
Today we will review our third quarter financial performance and share some highlights of our ongoing efforts to advance adoption and use of Vazalore in the marketplace. We will also provide an update on the strategic alternatives review process, then we’ll open the call up for Q&A.
To begin, I’ll turn the call over to Rita O’Connor, our Chief Financial Officer and Head of Manufacturing and Supply Chain to share highlights of our third quarter financial results.
Rita O’Connor
Thank you Natasha, and hello everyone.
Overall, our third quarter results reflected our priorities of stringent expense management and maintaining our base business. As such, we achieved a significant reduction in operation expenses while making strategic investments to advance the awareness and trial of Vazalore in the marketplace. Keep in mind that our results in the prior year period included significantly higher sales and expenses related to the commercial launch and initial distribution of Vazalore to U.S. retail channels and the introduction of our field force and a national media television campaign.
In the third quarter, we booked net sales of $400,000, which included $300,000 of unfavorable adjustments which related to higher trade allowances and incremental sales returns reserves. The increased trade allowances are associated with trade initiatives designed to promote sell through, including promotions for the Vazalore 12-count size to drive trial and purchase.
On a sequential basis, reorders from existing trade customers were higher in the third quarter than the second quarter, which is definitely a trend in the right direction; however, total net sales were lower due to the non-recurrence of initial product stocking at Publix and Harris Teeter that occurred in the second quarter.
The macro economic pressures that were prevalent in the first half of the year have persisted in the third quarter with a tough inflationary environment continuing to adversely influence consumer purchase behavior, putting pressure on the rate of acceptance of our product in the marketplace and on our commercial resources. Retailers are feeling the effects of these macro pressures as well, and we expect retailers to continue to reduce overall inventory levels throughout their stores, prompting us to increase our sales returns reserve. To that end, we continue to support trade programs intended not only to drive sales but also move through additional retailer inventory in order to minimize further product returns.
It is our intention to maintain a broad retail distribution nationwide across mass, drug and grocery channels, and we continue to work with our trade partners to demonstrate the value of Vazalore. In a few minutes, Natasha will review some of our newer programs designed to expand our engagement with healthcare professionals and consumers to drive retail sales.
Moving to cost of sales, we recorded $1.5 million of expense in third quarter, including $1 million of incremental costs for expired packaging material and a reserve for finished goods inventory at our warehouse that has less than 12 months shelf life. Also in cost of sales this quarter were higher costs per unit for freight stemming from shipments of product cases versus large pallets in the prior year.
With regards to gross margin, we previously said that we expected to be able to expand capacity of our 325 milligram SKU, which would have yielded an improvement in our blended gross margin rate by the end of this year; however, to preserve cash and in light of our current inventory levels, we made the strategic decision to delay this project and the associated spend. We are currently working with our manufacturing partners to identify other ways to improve margin going forward.
Total operating expenses were $9.8 million in Q3, a significant sequential decline of $4.4 million or approximately 31% versus second quarter, reflecting prudent expense management particularly with less spending on TV advertising. We maintained a base level of network advertising during the quarter and also deployed a number of cost efficient marketing programs, including digital and virtual offerings.
In August, we significantly reduced our cardiovascular specialty field force which generated some cost savings in the quarter. We expect more meaningful savings from this reduction in the fourth quarter.
Turning to the balance sheet, our cash and cash equivalents balance as of September 30 was $25.8 million. Our cash burn of $9.9 million in the quarter reflected very disciplined spending, and we continue to have no debt. In light of our decision last quarter to initiate a formal process to evaluate strategic alternatives, we have committed to funding certain programs with the goal of maintaining the base business we’ve established for Vazalore, including its current broad retail distribution. In doing so, we have significantly streamlined discretionary spending to ensure that our cash runway extends into the middle of 2023.
In closing, our third quarter results reflected our two main priorities: managing our cash and maintaining our base business. Over the past year, we have invested in building a base of awareness among consumers and healthcare professionals and remain committed to making sure Vazalore remains accessible for the millions of patients who need its life-saving benefits. We believe the product is too important for the patients we serve not to be given the best chance to succeed.
Natasha, I’ll turn the call back to you.
Natasha Giordano
Thank you Rita.
Our motivation every day are the patients who need the life-saving benefits of Vazalore, an FDA approved aspirin that works predictably and is designed to help protect the stomach. Within its first full year on the market, Vazalore has achieved the number three brand position in the heart health aspirin category, while other leading legacy aspirin brands have experienced significant declines.
In the face of persistent macro economic pressures, of which we’re not immune, we remain committed to advancing Vazalore in the marketplace through medical and consumer education, along with retail trade programs and a level of advertising with the goal to maintain our base of business. In that regard, let me tell you about a few marketing programs we executed during the third quarter and another new initiative that’s just getting underway.
In an effort to retain our known business of Vazalore adopters and recommenders, we distributed samples and patient education materials to more than 1,000 healthcare professionals. These advocates from across the country have been instrumental in building our base business. We recognized Pain Awareness Month in September with a new Facebook campaign featuring legendary professional baseball pitcher and avid golfer, John Smoltz, who is a current Vazalore user and a believer in its many benefits. To date, these ads have been well received and delivered high engagement levels, beating industry benchmarks by four times.
Also in September, we initiated a new medical education program focused on a targeted group of 3,000 cardiologists and neurologists who opted in to receive Vazalore materials such as samples, education brochures, and high value coupons. We expect to receive some initial feedback from participants later this month to assess the level of engagement with our materials and the likelihood of future product recommendations.
Next, let me tell you about our recent partnerships with two major healthcare systems in Texas to incorporate Vazalore as the aspirin of choice into their Meds to Beds discharge protocol. What this means is that there’s the opportunity for patients being discharged from one of these respected healthcare systems on doctor-directed daily aspirin therapy to receive a starter pack of Vazalore plus educational materials and a high value coupon. This new initiative could advance Vazalore adoption and use by potentially hundreds of patients every week. The goal is to replicate these programs in other healthcare systems nationwide.
At this time, I’d like to welcome back Dr. Asif Ali, a preventative cardiologist and Clinical Associate Professor of Cardiovascular Medicine at the University of Texas Health Center in Houston to share some additional details and perspectives on these important initiatives. Dr. Ali continues to be a strong advocate for Vazalore and he was instrumental in facilitating these programs.
Dr. Ali?
Asif Ali
Great, thank you so much, and good morning. Thank you Natasha and the team for having me on again. Happy to be here again and delighted to talk about the Meds to Beds partnership with two of the largest healthcare systems in Texas.
I’m going to cover just three points this morning, and I’ll keep my comments brief: one, what are the two healthcare systems; number two, what is the Meds to Beds program; and number three, how does Vazalore fit into the Meds to Beds program. Just to make sure people understand the rationale of what we were looking at these two healthcare systems, one is a large Tier 1 hospital system with 17 hospitals that is one of the largest in the landscape of Houston, Texas and the Texas Medical Center. Some of them are focused on what are called heart and vascular institutes – these are separate buildings that perform heart caths and open heart surgeries, and other advancements in heart failure. We have initiated now programs with two of the 17 – I believe they’re being launched next week.
The second tier is launching Meds to Beds programs with the largest independent system of freestanding healthcare centers in the nation with more than 20 centers throughout the Texas landscape. Between these two systems that really do serve a very large volume of cardiovascular patients and that are known as a center of excellence in cardiovascular care. We chose these two healthcare systems as they represent the typical access point for patients who come in with chest pain.
Now I want to transition to what Meds to Beds programs are, and to do that, let me just briefly walk you through the patient journey who presents to the emergency room. As a patient comes in with chest pain, part of the American Heart Association and American College of Cardiology guidelines, within the first 10 minutes [indiscernible] obtain vitals, EKG, 325 milligrams chewable aspirin, and an ER doctor should assess the patient. The patient may be put in an observation unit up to 24 hours for what we call chest pain rule-out. That’s the typical scenario.
The problem is when you’re discharging these patients and they’re tagged as acute [indiscernible] syndrome, unstable angina or non-[indiscernible], these are chest pain patients and they need to be discharged on medications, so typically they would receive a script and they’d need to go to their pharmacy and fill those medications, but you can understand that if someone’s had a heart attack and now we’re looking at secondary prevention, that it is utmost important that these patients don’t fall through the cracks and actually obtain their medications, and so Meds to Beds, which is the second part, what is it? It was developed by the healthcare system concerning these gaps in patient compliance and filling their medications. If they don’t fill their medications, there’s risk that their stents may occlude and they would have further damage to their heart.
The Meds to Beds program was born out of these concerns, and the patient is handed the first dose actually prior to being discharged from the hospital. They would take that dose of medication and they would be given information and materials, why they’re taking these medications, and this is known as shared decision making, which is a level 1 evidence in healthcare.
As a cardiologist or as an ER doctor who has seen a number of these chest pain patients, these patients are now being given the medication prior to discharge in the bed, and then they’re giving information on education materials about the medication that they’re being discharged, and they’re being given samples so that there is no gaps in compliance or filling their prescriptions.
Research confirms that if the medication is disseminated this way from discharge, especially when it’s coming from a specialist like a cardiologist or the ER doctor, they’re more apt to stay on the medication, but furthermore when they go to their primary care doctor, the primary care doctor is very unlikely to change the medication that the specialist or the ER doctor discharged the patient home.
How does Vazalore fit into the Meds to Beds program? I think it’s very evident and apparent that the protocols for patients who present with chest pain and after the cardiac assessment, as we described above, when the patients are being discharged, this is where Vazalore fits in. This is where the education materials, the shared decision making, and then [indiscernible] FDA approved absorption and GI protection when compared to [indiscernible] enteric coated aspirin.
Vazalore was chosen by these two large healthcare systems because the chairmen, the decision makers, the chief medical officers sat down and said, this is important for our patients. Vazalore was chosen because of its design to help protect the stomach and its absorption more predictably than enteric coated aspirin, and that Vazalore is the only aspirin that’s undergone FDA approval process.
Interesting enough, last night we had a wonderful chat with Dr. Gibson and two of the leading cardiologists in the Texas Medical Center who brought on the Meds to Beds program in two of the largest–the heart and vascular institutes, and these were the quotes that were said last night by these decision makers. One was after complex procedures where I’m putting in a stent, why wouldn’t we use this medication on all of our patients. A lot of my patients are higher risk from vascular disease and GI bleeds, why would not all of our patients be discharged on this medication. This is still the cheapest cost of all of the medications that we discharge our patients, if we’re getting better absorption and better safety, why is this not used on all of our patients. These are really quotes that were said last night from the chairs of the Meds to Beds program, and so I’m excited that the goal is the possibility to replicate these programs in other healthcare systems nationwide.
Thank you so much for having me on today.
Natasha Giordano
Thank you Dr. Ali. As always, we value your perspective and approach to shared decision making with your patients. We too have always put the patient at the center of everything we do.
Vazalore is such an important life-saving option in the treatment and secondary prevention of cardiovascular events. The goal is to replicate these Meds to Beds programs in other healthcare systems nationwide and to ensure that Vazalore can remain available for the millions of patients who need it.
Back in August, we announced a formal process to evaluate strategic alternatives. This process is ongoing. Our primary goal is to enhance stockholder value. This could come in the form of a licensing deal or partnership, an asset sale, a financial investment, or an outright sale of the company. There has been outreach to a broad spectrum of companies, including large and small pharma companies and consumer companies, as well as private equity and potential financial partners. We will work to continue to work the process aggressively and will keep you posted.
We’re looking for a company that believes Vazalore is an innovative aspirin that could potentially address critical unmet needs for patients and that has the resources and the expertise to take Vazalore to the next level. We must continue to stay the course with a keen eye on maintaining our cash runway, selectively investing in opportunities that will bring value to the brand and to our company. Our goal is to ensure that Vazalore can remain available for the patients we serve.
We can now open the call for questions.
Question-and-Answer Session
Operator
[Operator instructions]
Our first question comes from the line of Leland Gershell of Oppenheimer. Your line is now open.
Leland Gershell
Hi, good morning. Thank you for the update.
Just wanted to maybe drill in a bit further into plans on the strategic side that you may be leaning towards, if any at this point, or perhaps it’s still early and you have kind of a broad view on the opportunities. Wondering, Natasha or Rita, if you could maybe share what you think might be of the best value for PLx’s shareholders with respect to what you might be able to do with Vazalore. Thank you.
Natasha Giordano
Thank you Leland. Of course our main goal is to bring the best value to our shareholders, that’s for sure. That’s our objective and our guiding principles. We’re certainly in the midst of an ongoing process and we’re talking to several different companies. Unfortunately I can’t give too much more details than that; however, you could see where a product like Vazalore could fit in, in any one of those options, whether it be an outright sale of the company, a licensing, a partnership, even a financial arrangement, so we continue to drive the process aggressively, and as soon as we can, we will continue to update you.
Leland Gershell
Okay, thanks. With respect to the launch, just wondering as pricing–you know, certainly there is quite a difference between the Vazalore price point and what the competitive aspirin products charge, so I’m just wondering if you have a grasp, having now been in the market for some time, of what the sensitivity is and where you may be able to gain more traction, should you reduce that price while at the same time, of course, having to preserve the ability for PLx to generate a return.
Thanks.
Natasha Giordano
Yes, thank you for pointing that out. It is quite the challenge to manage both, right, and so we do believe because the product brings so much to the patient that has cardiovascular disease, that that premium can be absorbed by the patient. You’ve heard Dr. Ali talk about on calls in the past on how he instructs his patients that this is a necessary and required treatment for them, and as you look at the other medications that they’re on, it really falls in line with those other medications in terms of price, so yes, it is quite the challenge.
We’re working with our retail partners across the country and supporting doing trade promotions, doing different programs that can help the patient in the end and drive the patient to buy Vazalore from that retailer.
Leland Gershell
Great, thanks for taking my questions.
Natasha Giordano
Thank you Leland.
Operator
Again, that is star-one-one if you’d like to ask a question.
Our next question comes from the line of Jason Butler with JMP Securities. Your line is now open.
Jason Butler
Hi, thanks for taking the questions. Just in term of the sampling program, I think you said more than 1,000 healthcare providers you’re sampling with. Can you talk about the return on that program – are you seeing prescribing or physicians that are directing their patients to go get the product, are they doing that more–are you getting more physicians to engage in the product? Any color you can give us there?
Natasha Giordano
Of course, Jason. Thank you for the question.
You know, our goal right now is to continue to maintain and retain our base business. In order to do that in our first year of launch, we have identified those 1,000 or so healthcare professionals that have adopted Vazalore into their practice, and that’s why we came up with this program to ensure that the retain their patients on Vazalore, provide them a sample, a high value coupon to drive them to the retailers, but also provide patient education materials that really describe the difference between Vazalore and the other aspirin formulations on the market and why it is so different and why this is relevant to managing their own disease.
We do see and track data as it relates to these different HCPs, and we will continue to watch that. We do think it’s a worthwhile investment because they are our base business, and what our primary goal is, is to maintain the value behind the asset and the company as we engage and continue to engage in our strategic alternatives process.
Jason Butler
Great, and then just a follow-up there, can you maybe speak to any data you have about the physicians that are using Vazalore or directing patients to use Vazalore for pain, how much traction you’re gaining there with your promotional efforts over the last quarter? Thanks.
Natasha Giordano
Sure. You know, it is difficult given that it’s an over-the-counter product to discern what each dose is being used for, so what we look at is the percentage split between the two doses. I can tell you that in the Pain Awareness Month in September, that’s when we launched our campaign with John Smoltz, who is an avid believer in Vazalore and has made a significant difference in his daily life as he transitions from baseball to a lot of golf. We have a lot of, Jason, anecdotal reviews, anecdotes from physicians and from consumers that tell us that Vazalore is quite different in the management of pain, and that is factored into our ongoing commercial strategy on how to position Vazalore not only for cardiovascular disease, but also for pain.
Jason Butler
Great, thanks for taking the questions.
Natasha Giordano
Thank you Jason.
Operator
We’re showing no further questions in queue at this time. I’d like to turn the call back to Janet Barth for closing remarks.
Janet Barth
Thank you Liz, and thank you all for participating in our call today. Please feel free to contact me with any additional follow-up questions. Have a great day.
Operator
This concludes today’s conference call. Thank you for participating. You may now disconnect.
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