PetVivo Holdings, Inc. (PETV) Earnings Call Transcript & Summary

Good afternoon, everyone. Thank you for joining us today for an update to our shareholders and a 2025 company overview. Hosting the call today is our Chief Executive Officer, John Lai; and myself, John Dolan, PetVivo's Chief Business Development Officer and General Counsel. Following our presentation, we'll open the call to your questions. I'd like to remind everyone that today's call is being recorded, and it will be made available for telecom replay per the instructions provided in the press release related to the shareholders' update meeting issued on December 30, 2024, which is available in the Investor Relations section of our website. I would like to start the meeting with a simple notice to the shareholders regarding the recent submission of a definitive 14C information statement on December 23, 2024. The information statement provided notice to the shareholders that the holders of record representing the majority of the outstanding voting power of the company have, by written consent, in lieu of an annual or special meeting of the stockholders of the company, approved the following matters. The first, the election of 7 directors to the company's Board of Directors to hold office until the next Annual Meeting of the Stockholders of the company or until their respective successors have been elected or qualified or until such director resigns or is removed. The elected directors are Robert Rudelius, Joseph Jasper, Robert Costantino, Diane Levitan, Spencer Breithaupt, Michael Eldred and John Lai. Second, the 14C also ended up showing the ratification of the appointment of Assurance Dimensions, Inc. as the independent registered public accounting firm of the company for the fiscal year ended March 31, 2025. If you'd like to review the entire definitive 14C information statement in its entirety, it can be found in the company's SEC filings. Before I introduce John Lai to provide us a company update for the 2025 fiscal year and a glimpse towards the upcoming year, I would like to first provide some important cautions regarding the company's safe harbor statement that includes cautions related -- regarding forward-looking statements made during today's call. The information that we provide in this conference call includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the company's future revenue, future plans, objectives, expectations and events, assumptions and estimates. Forward-looking statements can be identified by the use of words or phrases usually containing the words believe, estimate, project, intend, expect, should, will or similar expressions. Statements that are not historical facts are based on the company's current expectations, beliefs, assumptions, estimates, forecasts and projections for its business and the industry and markets related to its business. Any forward-looking statements made during this conference call are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, various risks as detailed in the company's periodic report filings with the Securities and Exchange Commission. For more information about risks and uncertainties associated with the company's business, please refer to the Management's Discussion and Analysis of Financial Conditions or Results of Operations and Risk Factors sections of the company's SEC filings, including, but not limited to, its annual report on the Form 10-K and quarterly reports for Form 10-Q. Any forward-looking statements made during the conference call speaks as of today's date. The company expressly disclaims any obligations or undertakings to update or revise any forward-looking statements made during the conference call to reflect any changes in its expectations with regard thereto or any changes in its events, conditions or circumstances of which the forward-looking statements are based, except as required by law. I would like to remind everyone again that this call will be available for replay starting later this evening or early tomorrow. Please refer to today's shareholders' update meeting for replay instructions available via the company's website at www.petvivo.com. Thank you for attending today's presentation. Now I would like to turn the call over to our CEO, John Lai, to provide us with the company update.

Thank you, John. I will do a presentation at the PowerPoint. Please keep your questions until at the end of the presentation. The operator will instruct on how to ask these questions. So forward-looking statements, John Dolan had gone over that. So basically, we have developed the protein particle matrix that mimics cartilage and tissue. It's a very effective tool in the management of osteoarthritis, lameness and rehab. These particles are declared as a veterinary medical device. So if we look at the company highlights, we're focused on the $11 billion animal veterinary care product sales market. Spryng is classified as a veterinary medical device. And this product is -- Spryng with OsteoCushion Technology is sold to veterinary doctors, where, in turn, they use in the -- as an effective tool for the management of osteoarthritis, lameness and rehab. It's an intra-articular injection. Spryng is comprised of components that are naturally derived, the proteins are collagen and elastin. We have distribution through MWI and Covetrus, wholesalers of Clipper Distribution Company, Vedco. So we're in multiple distribution centers -- or distribution partners, like Patterson, Midwest Veterinary, Penn animal supplies. We have a very strong IP portfolio, 12 U.S. and 9 foreign. We don't require FDA approval because, on the human side, we've already been declared as a human veterinary device. We have a very experienced management team and a very active strong Board of Directors. Our product allows veterinary doctors to drive traffic through their practice as well as have very high-margin business. So osteoarthritis is a very large growing market. It's about $4.8 billion in the United States. It affects about 34 million adult dogs and about 1 million horses. So osteoarthritis is basically caused by degrading of the cartilage, which creates pain and inflammation. The lameness gets worse over time. It doesn't get better. So the current solution or treatment, how we're different, is currently everyone has been focused on mastering the symptoms. And we're focused on addressing the root cause of the problem, which is bone-on-bone contact, plus creating a proper environment for proper joint function or particles, once it's injected, will lead to better articulating function of the synovium. So right now, the gold standard treatment pretty much is NSAIDs. It's focused on, once again, the symptoms of masking the pain and bringing down inflammation. Problem is the long-term effects are liver and kidney issues as well as it doesn't do anything to slow down or the degrading of the cartilage. And I actually would argue, it speeds up the process of the ability for the dog to damage the cartilage. Because if the dog doesn't feel pain, it'll run and jump in situations it would not and, hence, leading to faster degrading and damaging. Steroids, HA, all very short-term oriented. And over time, the efficacy tends to get reduced. Stem cell PRP, a very good treatment, but it requires drawing of the animal's own blood and then going through a centrifuge. It's time consuming and, once again, requires multiple treatments over a year. The Spryng product, basically, is a single injection. It lasts at least a year. So we feel Spryng is the optimal technology for osteoarthritis. It's naturally derived. The proteins are collagen and elastin, with heparin as the carbohydrate that helps bind the materials. It's injected into the synovial space. And once it's injected, initially, it tends to provide a scaffolding effect and provide cushion between the joints. But as the next 2 to 3 weeks, the particles go to the outer synovium and helps create proper joint function. We have seen that with the use of Spryng with OsteoCushion Technology. We have seen many dogs, cats and so on reduce the need for NSAIDs, which helps prevent the -- every pharmaceutical biologic most likely will have a side effect of some type. It's a very effective and economical solution in the management of osteoarthritis. So Spryng is a unique medical device addressing the root cause of the problem, not just the symptoms. It's naturally derived. It's bovine collagen and elastin. The carbohydrate, we use heparin from mice. And also, we have seen it does not cause adverse events. The adverse events is a very low number. I think we published, it's under 1%. We have had a human study of 145 humans as a dermal filler product that allows us to get the designation as a veterinary medical device. And therefore, we have shown quite a bit of good safety data as well for both dogs, horses and cats. Strong IP portfolio. And on the bottom of this slide -- oh, by the way, this deck is available on our website under Investors section, and it gives the clinical trial of the human dermal filler study. The mechanism of action basically osteoarthritis is the damaging and loss of cartilage. Spryng, once it's injected, reinforces synovium membrane. And once again, it's a mechanical function, it's not a pharmaceutical or biologic function. The particles are wet and lubricious, which provides the lubrication of the joint. And as it goes into the synovium's outer lining, it reinforces and strengthens. So it allows the synovium membrane to properly function and also minimize the cytokines that are causing the inflammation. We have, in many cases, studies published out on our website, but we highlight Buggy here, which is a 13-year-old mix breed. After the injection, the dog is still doing extremely well. I believe he's had the injection for close to 2 years. Equine, Fergie, very good case, 16-year-old Saddlebred that exhibit. And you can see -- when you go to a website, there's a link for the video, you can see how the before and after. And we have a whole series of cases that have shown the improvement of using Spryng. And keep in mind, a lot of vets use it as a multimodal approach. And what that means is they use other products with it. Spryng's competitive distinction is, once again, it's addressing the root cause of the problem, not the symptoms. The current treatment is focused on the structural component and not the symptoms. There's a definite price/cost advantage. The materials are all naturally derived. Ease of application. You can inject multiple joints at once without any side effects. It's sold exclusively to veterinary clinics, which allows them to enhance margins because their business model has changed quite a bit. In the old days, they would fill the prescriptions. Today, they're being cut into by Chewy and Costco and so on. We have injected over 10,000 dogs and horses. With very good results. Spryng product category comparison. You can see across the board, we have an advantage in safety and efficacy. Librela and Solensia and us, basically, in the last decade, has been the new innovative products into the marketplace. Everyone else is still focused on using pharmaceutical symptoms to trying to create a better NSAID with less side effects. So you can see, ours is a single injection. Librela and Solensia is 12 injections a year, 1 every month. Adequan, which is intramuscular injection, is 16 to 18 injections. The gold standard treatment, NSAIDs, Rimadyl. You see the slide in differences and then over Synovetin, which is a radioactive isotope. That can be argued as one of the advancements of the last 10 years that are new. Marketing highlights. We've made changes over the years. We feel we've really enhanced the marketing and sales team. We added 8 extra regional sales managers and in-house salespeople. So we -- our budget or results is one of the metrics that we should look at. We're spending less than 35% we did the previous year, yet our interactions and marketing has improved greatly. The percentages are quite high. You can see on here. Our clinicians, 943 registrants and 620 attendees, and this is for continued education credits. So with all the data of our studies, we're able to start getting recognized by the industry as a product that would qualify for continued education and recognized certain manuals and so on as an injection protocol, the Spryng product. We're in the canine injection reference manual now. Before, we were not. So all this is leading to credibility and recognition of the Spryng product. We're seeing the expansion of clinical use. We're seeing major universities start using our product and getting really good results. We're amplifying our awareness, a lot of it through social media. Google's website traffic has increased by 277%, 40,000 new users since we started marketing. So we're spending significantly less but getting a much better return, and we're recognizing how to commercially amplify. And then with the issues at Zoetis, it's actually really helping us gain traction among the canine veterinary doctors and canine marketing. They do a great job at Zoetis of educating the pet owners on how to identify osteoarthritis. So they're really growing that market. Previously, there was estimated 20 million dogs, according to the American Pet Association. And then recently, Piper Sandler did a report showing 34 million dogs are recognized to have osteoarthritis. So that helps grow the whole market as well as how individuals identify osteoarthritis as a problem within their dog and cat. And that, in turn, helps us. So we have recently increased our packaging or improved what we feel is our new packaging improvement. That just got launched into the marketplace at the beginning of the year or near the end of December. And the packaging now is sterile packed. So the surgeon can just rip the syringe packaging right onto the sterile tray and use that. And that's a major advantage we feel that all the vets will really like. Sales organization accomplishments. So we expanded beyond equine in the first 2 years. We were focused on the equine market, which is about 7.3 million horses in the United States. The canine is around 83 million dogs in the United States and cats is about 55 million cats. So we're going into a much larger market. The last 8 hires in the sales team side are small animal focused, canine and feline, and we still have our, of course, equine salespeople. So we put in a brand-new performance-based sales compensation program. So we really incentivize the salespeople to make sales, to make more than they did before based on a higher base salary. We lowered the salary base. We implemented territories that are priority targets, and we're utilizing a very good CRM system package to really give us indicators of what is working out in the field and what are the veterinary doctors wanting to hear from us. And we're also able to supply a lot of resources from the standpoint of the various studies that are being completed. We established new distribution relationships with Clipper and Vedco, and successfully executed the packaging upgrade. Fiscal 2026 sales organization key focuses. We're targeting dramatic growth, doubling overall Spryng sales, establishing new sales territories in Pennsylvania, Texas, Southwest United States as well as Pacific Northwest. We're driving awareness, trialing uses within the veterinary profession. We're achieving osteoarthritis protocol changes to include Spryng, and that was part of the clinicians manual and all that. We're getting recognized in a lot of good resource channels for veterinary doctors. We're going to continue to develop further territories. We're integrating more and more distribution partners, and we're upgrading our CRM systems. So we're really understanding how the system works and getting the salespeople to input the proper data so we can really focus on using objective based analysis of what are the tools that are helping the veterinary doctors. So we have distribution with basically the top players in the business: MWI Animal Health, Covetrus, Vedco, Clipper, so also Patterson as well as Penn Animal Supplies and Midwest Veterinary. Midwest is obviously right out of Minneapolis here, St. Paul, I should say. So there was an obvious partnership or sales agreement in place. We talked about the tolerance study. So we have a canine and a feline tolerance study. All of these are on our website. We've had very good results with all the studies from a tolerability studies. We had 2 really good pilot studies done by Ethos, which is one of the largest research organizations for the animal health space. One was on canine hip dysplasia. We basically took dogs on a scale of 1 to 5, 5 being the worst. After 84 days of injection of Spryng, close to 78% were under a Level 3, which is a moderate case of hip dysplasia. And 100% of them actually dropped under Level 2, which would be a mild case of hip dysplasia. So that was a very powerful pilot study. Also, we had canine stifle OA or CCL disease. And about 55% of those dogs that had a CCL issue, after the injection at day 84, basically really did not require surgery, they were able to rehab. So once again, very good pilot study. This leads into full-blown double-blind studies, which we are in the process of doing. I think we have about 7 studies that are in process, and quite a few of them will be presented this in 2025 -- calendar 2025. The Colorado State University study should be completed first quarter of 2025, that's calendar. And canine study on the hip dysplasia should be done by the fourth quarter of 2025. And then Dr. Sherman Canapp's elbow study should be completed third quarter of 2025. If it follows what we're seeing in the pilot studies, these double-blind studies will show a dramatic improvement over the current therapies used for these conditions. Our facility is designed to meet the highest human medical device standards, which is not required in the animal health space. We have ISO 5, 7 and 8 certifications. We started off the initial batch with 500, and then we'll be moving up to 5,000 syringes per month on production. We can easily produce over 100,000 syringes a year. And the facility can be easily duplicated. So we have the ability to scale without major capital investments. And as you look at our last 10-Q, our gross profit margin was 89.5%. We have a very deep comprehensive patent portfolio, 12 U.S., 9 foreign. The language on our claims are very broad. And how we know that is based on the citations by patent examiners and patent applicants were well over 500, and some citations when people are trying to file their patents. Product pipeline. So we have canine commercialized, we have equine commercialized and feline Spryng commercialized. So we have digital cushion lameness technology. Currently, there is no treatment or therapy that's used, and it's basically the leg and the hoof. There's a padding that exists for horses. Once it collapses, the horse is basically needing to be put down. We have injected the particles and rebuilt that cushion where the horse was running fine without any additional working requirement. And we have had prolonged usage of real-world case studies. So we'll be probably putting together a study on that to establish the data, but that's our -- some of the vets are using that already in the Equine space. And then urinary incontinence for dogs. As part of our studies when at the -- we did urinary incontinence studies on pigs, where we injected the sphincter muscle, and we were able to establish improvement. And actually, we stopped urinary incontinence in the pigs for a long period of time after the particles were injected into the sphincter muscle. So we feel that can be duplicated within the canine market. But right now, our focus is to sell the Spryng with OsteoCushion Technology market into the canine, equine and feline space. And then mucoadhesive device is a wafer that we're able to deliver any agent into the bloodstream at probably 6 to 10x bioavailability. So an example, if we were launching 500 milligrams of vitamin C, you take that orally, we can duplicate the same amount of that vitamin C in your bloodstream by using 50 milligrams. So we believe there's multiple applications for the pharmaceutical industry using this -- using our technology. Market overview: companion animal/veterinary. So pet spend has been increasing at least at 5% a year. $123.6 billion in 2021. In 2022, $138 billion. Veterinary care and products is a leading growth driver. In 2021, it's about $11 billion. That's expected to grow right around 7%. 63% of households own a pet. We talked about 53 -- or 83 million dogs and a little over 50 million cats and 7.2 million horses. So one of the metrics that we see, how the humanization of the pet to the family is really strong. We're seeing less and less people get married. So people look at their pets as like their children, and you can see the level of spend. Here's an example of dogs, at what dollar level before they would stop treatment. In 2012, it was $1,700. In 2020, it was $10,700 before they would stop treatment on their dog. Pet insurance is growing rapidly. So we have a very good tailwind for us there. Our product is declared as a veterinarian medical device. So generally, it's covered under pet insurance. So right now, there's probably 4 million pets that are insured, but it's growing at 27% a year. That could be a very good tailwind for us. The market is really position and ripe for innovation. There hasn't, like I said, been really much innovation in the last 10, 15 years. The only innovative products that's really come out that's different than a me-too approach of minimizing side effects, it's Zoetis' monoclonal antibody, Librela and Solensia; and then PetVivo with Spryng and OsteoCushion Technology; and then another product is Synovetin, which is focused on radioactive isotopes being injected into the dog elbows to neutralize pain. So that's a very expensive procedure. It's probably $2,500 per elbow. We have a very strong management team. The resumes are on our website. I'd rather open the time up for the questions. I believe we have about 30 employees within the company. Our excellent Board of Directors. Our most recent one was Mike Eldred. He was the former CEO of Dechra Pharmaceuticals, North America. So he has a very strong background in veterinary product sales. Spencer Breithaupt, VP of Sales at MWI Distribution, the largest distributor in the United States. They did about $5 billion a year. So the management or the Board of Directors is very good at giving us guidance. We have very good technical advisers in Dr. Tracy Turner, Dr. Sherman Canapp and Dr. Debra Canapp. Growth drivers. We're expanding regional sales managers. We're expanding distributors, wholesalers. As you can see, we -- in December, we added Vedco and Clipper distribution. Also, MWI -- well, I should say, we have MWI and Covetrus. We added Midwest Veterinary, and Patterson is part of the distribution channel. So we really expanded that. The product has been used by approximately 800 clinics -- well, more than 800 clinics. And we're expecting that to grow as more and more clinical data and more and more trade shows occur. So the 2 largest trade shows, one is VMX, Veterinary Medical Expo in Orlando. It's the last week in January. It's the largest show in the United States. And then about 30 days after that is the Western Veterinary Conference, which is the second largest show and that one's out in Vegas. So we got both regions covered. And it's very similar to the golf show. All the new products, everything gets featured at that show. Because the golf show, I believe, it's second week or third week of January. And so just to give you an idea how powerful and important these shows are for us. We have regulatory tailwind in our favor. This is on the equine side. So HISA, which is the Horse Integrity Safety Authority, they govern horse racing in the United States. And they basically said that anyone using a hydrogel that's polyacrylamide base. If a vet's injecting it on the racetrack, which is a lubricant, it's synthetic lubricant, they're going to get fined. And they're also could be subject to suspension. But also the horse that gets injected, it's 6 months from -- prohibited from racing. Now what was good in their rule, they stated that Spryng with OsteoCushion Technology could be used, and it would be the standard 2-week prohibition. So in horse racing, anything you put in basically has a 2-week from racing. The industry and veterinary adapters, just like on the human side, are looking at options that are naturally based because it's less likely to have side effects. So we feel we're having the right drivers and tailwinds to hit us. Clinical studies. We got the Ethos CCL study coming up. We got the Ethos hip dysplasia, the orthobiologics elbow study, Colorado State elbow study, Inotiv -- while we completed the Inotiv canine tolerance study and feline tolerance study, additional studies in canine, feline and equine are occurring as we speak. I think there's about 7 of them. And we're looking at expanding Spryng to other indications and other potential combinations. And we're looking at also expanding within the North American space to Canada and Mexico and then eventually into Europe. So as our purpose, we're enriching the lives of our companion animals and their family. Pursuit is the lead innovation in naturally derived veterinary medical solutions. Our revenue goals is to basically more than double over the next year of $2.5 million. I'm going to just keep moving and going on to more the Q&A. Operator, can you please open up to Q&A and instruct the people how to ask questions? Thank you.

[Operator Instructions]

Also, the replay of this will be available, I think, tomorrow on our website. So just to let everyone know.

[Operator Instructions]

So if we don't have any questions, I think we can close down the session.

We have one.

Okay, good.