PetVivo Holdings, Inc.

Good afternoon, everyone. Thank you for joining us today to discuss Petvivo's results for its fiscal first quarter ended June 30th, 2024. Hosting the call today are the Chief Executive Officer of Petvivo, John Lai, the company's Chief Financial Officer, Gary Lowenthal, and myself, John Dolan, Chief Business Development Officer in General Counsel. Following the remarks of the hosts, we'll open the call to your questions. The operator will explain how to participate in the Q&A following the presentation by the hosts. Before we conclude today's call, I'll provide some important cautions regarding the forward-looking statements made by management during the call. I'd like to remind everyone that today's call is being recorded and it will be made available for telecom replay per the instruction in today's press release, which is available in the investor relations section of the company's website. Before we venture into the details of the first quarter of 2025, let me provide you an introductory overview related to the company and a few highlights. In our fiscal first quarter of 2025, we achieved strong financial and operational progress as we continue to advance the rollout of our flagship product, Spring, with Osseocushy Technology. which promotes the restoration of proper joint mechanics. This injectable intraarticular veterinary device is composed of patented biocompatible microparticles derived from natural sources. The novel technology results from years of R&D and clinical studies. Spring's unique, lubricious, and viscoelastic characteristics address a prevalent unmet medical need to reduce the joint pain and discomfort caused by osteoarthritis and poor joint biomechanics that affect millions of pets and horses. This includes more than 80% of all dogs and cats and more than half of all horses at some time during their lifetime. These porous spongy microparticles are specifically designed to absorb and release synovial fluid in the joint in response to mechanical forces, thereby mimicking the properties of natural cartilage. Most importantly, SPRING has been clinically shown to go beyond the simple masking of symptoms to address the root cause of lameness, which is usually missing or damaged cartilage. As the word continues to spread among veterinary practices and from our presentations at leading veterinary conferences about these breakthrough medical benefits for horses and companion animals, we are seeing increased demand from our distribution network. In fact, our revenue growth for this past quarter was driven largely by distributor sales, which more than doubled over the past year, and they continue to climb. Meanwhile, we've been able to maintain our highly favorable gross margins of 89.5%. During this past quarter, our distribution of spring surpassed more than 800 veterinary clinics across 50 states. This has led to now more than 10,000 dogs, cats, and horses that have experienced the benefits of spring nationwide. With this growing adoption of spring, veterinarians now have a valuable new revenue stream that creates better outcomes for their patients and at a lower cost for pet owners as compared to traditional methods of treatment. Now after accumulating a strong body of independent research that reveals benefits of SPRING for commanding animals, we have established the ideal position for accelerating the market adoption of SPRING. We recently restructured and realigned our sales and marketing teams and strengthened our efforts with the appointment of two key senior sales and marketing professionals with extraordinary records of achievement in executive roles at Fortune 500 companies. This includes appointing formal Hills Pet Nutrition and Novus International Senior Sales and Marketing Executive Brian Moniger to the position of VP of Sales in June, and then appointing former Procter & Gamble and Clorox Sales and Marketing Executive April Boyce as VP of Marketing also in June. As sales continue to ramp, we plan to add additional sales and marketing personnel to support our growing distribution relationships and market leaders that currently include MWI and Covetris. We also plan to hire additional personnel to support direct sales and marketing to leading veterinary clinics nationwide. Now, before we get into some exciting recent developments and our outlook for the rest of the year, including comments from our Chief Executive Officer, John Lye, I would like to turn the call over to our CFO, Gary Lowenthal, who will take us briefly through the financial details for the quarter. Gary.

Thanks, John. And good afternoon, everyone. Thank you for joining us today. Our revenues in the fiscal first quarter of 2025 increased 6% to $124,000, largely due to distribution channel expansion and broader adoption of our spring product. This included sales to our distributors, increasing 102% year-over-year to $68,000. Sales to veterinary clinics totaled $55,000, which declined 33% compared to the year-ago period due to veterinary clinics buying direct from our distributors. Furthermore, the marketing transition from solely equine horses sales to include companion animals such as dogs and cats, which represents a far greater market opportunity. As John Dolan mentioned, This transition has been enabled by the numerous positive clinical studies published over the last two years with a number of new studies underway. Gross profit totaled $111,000, 89.5% of revenues as compared to 105,000 or 89.5% of revenues in the first quarter of 2024. Our operating expenses decreased 28% to 2.2 million compared to the first quarter of 2024. This large expense reduction was due to a strategic company-wide cost reduction in corporate restructuring program that decreased general administrative expenses by $530,000 and decreased sales and marketing expenses by $407,000 versus the same year ago quarter. These decreases were partially offset by a nominal increase in research and development of $94,000, mostly clinical studies. Net loss improved to $2 million or 11 cents loss of share per basic and diluted share from a net loss at 2.9 million or 25 cents per basic and diluted share in the same year or quarter. I'll turn you to the balance sheet and cash flow statement. Cash and cash equivalents total 12,000 at June 30th. However, subsequent to the end of the quarter, we raised net proceeds of $2 million which keeps us in a good position to execute our growth plan over the next several months. Net cash use and operating activities decreased 29% or $633,000 compared to fiscal first quarter 2024. Now this completes our financial summary for the quarter. I'd like to now turn the call back over to our Chief Business Development Officer, John Dolan.

Thank you, Gary. As a key part of our strategy to accelerate the adoption of Spring and expand our market reach, we attended two major veterinary conferences in this past quarter. In April, we exhibited Spring at the American College of Veterinary Sports Medicine and Rehabilitation Symposium in Naples, Florida. The symposium provided the perfect venue to present the research-backed benefits of Spring for the management of osteoarthritis to an audience of leading sports medicine rehabilitation experts in the veterinary space. This group of veterinarians are primary users of SPRING, therefore being a key target market for Pet Vivo. We also presented SPRING to leading veterinary pain management experts at the International Veterinary Academy of Pain Management Forum. Our veterinary medical advisor, Dr. Marie Bartling, spoke on the topic how do we elevate our strategy for managing osteoarthritis in pets, which was very well received. This coming fall and early winter provides us the opportunity to exhibit at a number of prominent trade shows in the industry, including the American College of Veterinary Surgeons Summit in October in Phoenix, Arizona, and the American Association of Equine Practitioners Convention in December in Orlando, Florida. Our sales and marketing teams have a number of other shows scheduled during the fall and winter, which we anticipate will enhance veterinarian awareness and educate the veterinary field about the benefits of spring. Also to drive the greater adoption of spring, we are working with a number of prominent organizations to complete existing studies and to prepare protocols for a few more clinical studies that are planned for enrollment in the third and fourth quarter of this year. As mentioned, There are a few studies currently in progress. One is being conducted at Colorado State University where researchers are evaluating the effectiveness of intraarticular spring injections for managing pain associated with naturally occurring elbow osteoarthritis in dogs. The accumulation of data is complete and the scientists and statisticians are currently assessing the numbers and preparing the data and results for publication. We hope to see a presentation of the study sometime in Q1 or Q2 of 2025. The second is a double-blinded placebo-controlled field study supported by Ethos that involves approximately 40 dogs. It is assessing the efficacy of intraarticular spring injections for managing unilateral or bilateral coccyfemoral joint osteoarthritis. This study is expected to conclude by Q3 or Q4 of next year. Finally, the PetVivo R&D team is currently working through the protocol details of the first of a series of studies with Sherman and Deborah Knapp of Orthobiologics Innovation, LLC. We will provide further details of the progress in upcoming earnings calls. All of these studies will add to the body of published clinical research that now totals more than five studies to date. These studies are critical to our distribution strategy as large national and international distributors typically require a university or independently conducted studies before considering a new product for inclusion in their catalogs. Such studies also support our go-to-market strategy by attracting endorsements from key opinion leaders and increasing our chances of being invited to present at animal health conferences and trade shows. Now with that, I'd like to turn the call over to John Lai.

Thank you, John. I like to talk more about the strategy for further expanding the market's adoption of spring. You know, the industry basically says that osteoarthritis affects 80% of dogs that are over age eight. There's currently about 80 million dogs in the United States and 61% of cats over the age of six. There's about 55 million cats in the United States currently. And over 50% of the horses, when they're over age 15, currently about 7.2 million horses. This is a very large population. And there is a definite need in the marketplace for a better approach to treating osteoarthritis within the animals. What makes our product unique is that we're focused on the symptom, which is, I mean, on the actual symptoms. issue of bone-on-bone contact and wearing away of cartilage, while many of the current products on the market are focused on the symptoms. So the current market size is approximately 3.7 billion this year, and it's expected to grow to more than, well, it's expected to grow at 10% a year in anticipation of hitting probably 11 billion by 2030. What's really happening also from a macro standpoint is Zoetis is doing a great job of educating pet owners with they're providing pet owners with many tools to identify osteoarthritis. And this confirmed itself with recent reports and study. They show that last year, it was anticipated that 20 million dogs had osteoarthritis, and the latest survey show about 35 million dogs this year having osteoarthritis. And if you look at pet owners, millennials and Gen Zs own 55% of pets today, and they're the ones that are actually doing a great deal of research online. They're looking at their pets as part of the family, and they're willing to spend whatever it takes to improve the quality of life for these dogs. So we love all the macro drivers that are helping the pet owners to educate and look at newer products and newer approaches and more natural approaches towards therapy. We recently announced two appointments that we feel will greatly strengthen the team and align the team in sales and marketing. Brian Morlinger, which is our new VP of sales, and April Boyce, our VP of marketing. They both joined Pet Vivo around June, and they have been working extremely well as a team to coordinate the marketing and sales to be working together as well as the rest of the company to be properly aligned to target the small animal market. market, the companion animal market, because we are making that shift from equine to hiring the people that can help us in the small animal space. Each having 20 plus 20 years of experience with major fortune 500 companies. So under this new leadership of Brian and April, We got the alignment of marketing and sales and education TSV. We plan to add 10 additional sales reps within the next 12 months in the small animal space. We're also increasing the educational side of it by providing to the veterinary doctors and vet techs, continued CE educational credits. We're going to be expanding all that. We've had multiple events that have had great turnouts and also been able to follow up with many of the veterinary doctors and vet techs. In June, we did a presentation at the Long Island Veterinary Medical Association, which Dr. Bartning, Dr. Tomas Influenzo, and Dr. Dexter Archer, which is or out in the Long Island area that have been using the product spring for at least a year, year and a half, talked about the effects of working spring into their practice and how to provide much better outcomes for the pets as well as the pet owners. So there was a, pain management doctor, a surgeon, and a rehab doctor, and they walk through the process and connect the dot how spring should be part of the rehab of osteoarthritis and surgery. In July, we had a very good webinar that was presented by a organization that had over 55,000 members. in the veterinary space in terms of veterinary doctors and vet techs. And out of that seminar, we had a very high participation and a very high rate that stayed an hour after the formal presentation was given to ask questions. We had over 90 questions asked. So that's a very, very good ratio. And the numbers were very, Very strong. Also, we have been able to approach different channels of how to get the consumer to learn about spring, as well as helping with the veterinary clinics, the receptionists, the vet techs, providing them with proper literature to give to the pet owner to learn about how spring can help their dog or cat. And that's been very successful. So we have created multiple innovative channels that have worked well, like dog groomers. And the number of dogs that we have treated and horses, it's starting to really gel on its own to where they're sharing the stories of very good success. Thanks to our existing US distributors, recent key hires in marketing and sales, revenues are on the rise. And to give an example of what's just happened in the last 30 days, we have picked up 110 new clinic users of Sprint. And that's because we're using a lot of new marketing channels as well as sales approaches, as well as the education of our tech services vets to the vet clinics. So we feel there's going to be very strong drivers to continue the growth. Earlier, I talked about the current markets, about $5 billion, and we're looking at it to go to about the $11 billion by 2030. Major tailwinds also is insurance, pet insurance in general, and companies like True Panyon and Lemonade are doing a great job of private labeling and providing pet owners new channels of access to pick up pet insurance. Our product is deemed as a veterinary medical device, so it's covered under most insurance. And the insurance industry is basically the last five years been growing at about 25% a year. Uh, the estimates anywhere from five to 10% of pet owners currently have pet insurance. I believe that to be real, it's going to really grow much faster as companies like true pannion that partnered up with chewy. When you buy your pet insurance through chewy, you're really buying a private label insurance, or if you're buying through state farm, it's really, uh, Trupanion's insurance. Going forward, we will continue to drive different methods of increasing veterinary doctors for the adoption of SPRINT. Presentations at trade shows, continue education programs, veterinary clinic titians that are key opinion leaders speaking about our product. We continue and continue to see much more of the spring name showing up in multiple social media sites. We're having dogs that have instant grams that got the spring injection showing the owner, showing how well the dog is doing. And it's just excited to share their experiences. So, so these are the passion drivers that we're very excited about and seeing these trends to really pick up an increase. So if we look at some of the positive outlooks and highlights in the financials, I mean, our gross profit margin is 89.5. We reduce operating expenses by 28%. And that was in a quarter where we got a new CFO. I feel that trend will continue in terms of lowering costs. And it's hard to increase the operating costs. gross profit margin, but I think you'll see a nice uptick into that point. So today we are actually in all 50 states, the spring product has been used and it's over 800 clinics and we've injected over 10,000 animals, which, you know, that all adds to increasing the helping the consumers or the pet owners to use their social media to to help us spread the word. Now with that, I would like to open the call to your questions. Operator, would you please explain to the listeners how they can ask questions?

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Okay, operator. I'm going to assume there's no questions. I do want to just make one closing comment. We're pretty excited over the next 60 days. I think we're going to see a lot of good things happen from the social media. or marketing standpoint that will help us drive and adopt the veterinary and consumer use of the product here at a very good rate. So I expect, you know, from September on that quarter, calendar quarter, I think we're going to see very good clinic adoption and we're very comfortable on reiterating what our forecast was of a million and a half which would be a 50% growth year to year, to possibly 2 million, which is 100% growth in revenues. I would like to once again, thank everybody. Oh, sorry.

We have someone that just raised his hands. So the number that did it ends with 741. I will go ahead and... you should be prompted to talk. So in order to unmute yourself, dial star six, number ending with 741.

Good afternoon, gentlemen. This is Greg Pearl. Good afternoon, John. I'd like to ask fellows if you have had any future or further consideration for human studies with SPRING.

Yes. I mean, that's something we're going to focus on as we move forward, because right now everybody's concentration is going to be focused on launching spring and getting spring adapted into the small animal side. As you look at how big the market is, just a small percentage of market share will give you a likelihood of very good increased valuation within the company. But yes, we are We do see how this product works in animals, and there is a very good, I believe, a likelihood that the same type of results can be brought into the human side of the market for osteoarthritis.

Okay. And one further question, if I may. What is the possibility of, well, first of all, let me precede that. What or who are the major competitors right now to Sprint?

So for me, if you look at the peer approach of osteoarthritis and how our product is categorized, you know, so we are a hydrogel. They would categorize as a hydrogel, but we're really an extracellular matrix. So all the competitive products are more focused on symptoms. Now, the one that's gotten a lot of attraction, and I keep thanking them, is Zoetta's. labrella and cilinthia. So their product works, their mechanism of action is basically injected and it blocks the nerve growth factor. So the nerve growth factor is what tells the brain there's pain. So they're blocking the pain. But what it doesn't do is to provide proper joint function and gives protection to the area. So I have always argued and Zoetis' own data shows that you really don't know if the product works until three injections, which injection is once every 30 days and the cost and its user pay is about $160 per injection for the life of the animal. So in the case of a dog, I would argue, it would be a very good multimodal approach to use that. And then the vet can follow along with the use of spring, which spring would in essence help protect the synovium as well as help correct the synovium into the point where we reduce the likelihood of certain inflammatory cytokines and pain cytokines and give the proper function. So you have proper joint function protection. And with a labrella, labrella will provide the blocking of the pain. So in essence, SPRING really should be looked at as a combination or multimodal approach to total joint health. That's the way I would talk about it and position it.

And do we know of any contraindications of using SPRING with any other type of pain blocking medications?

So, you know, our studies in the human side show that it was innate. So that means our product doesn't create any type of reaction. Or if there is, it's very minimal. Otherwise, we would have never gotten the human medical device designation. So we haven't done the studies, but vets all the time use different combinations of stuff. We never tell a vet what they can use and can't use.

Okay. And indicated from your studies are that the animals react much quicker to the first injection of spring than they do to anything else. And can we assume from that or presume from that that their pain has actually decreased or gone away with those injections of spring?

So if you look at what the predecessor that creates pain is probably inflammation. or actually joint on joint contact that causes the inflammation. So, um, spring in itself is trying to create proper joint function. So you should minimize those functional points and keep in mind spring is a single injection where it should last a year. Many of the other products are, you know, once every 30 days, once every 45 days, once every 60 days.

It seems to be a significant marketing point, I would assume.

Yeah, if you want to get down to the annual terms of economics, it makes a lot of sense because if you look at, you know, NSAIDs and so on, you know, Rumadel is probably around $600 for the year. If you look at what they call a higher end type of like adequate, not adequate, I'm sorry, I'm sorry. Gallopant, that's about $1,200 to $1,500 a year. And it's supposed to have less side effects and so on because any pharmaceutical you take are going to have side effects. So that's one of the major advantages of spring is the likelihood of side effects are greatly reduced based on the designation of a veterinary medical device or a human medical device.

Do we know given the number of vets and the vet clinics that have been signed on with you, about what the median price of application would be for visits?

Well, the median treatment, no, because every region is totally different. You can be in a small southern country town and the vet may charge $500, $600. You can be in a major city for that same injection, a vet may charge $1,200 or more. Mm-hmm.

But we haven't gathered the data yet to know what the median price would be, in other words.

Well, we typically say about $600 to $800. Okay.

Yeah, that's okay. That gets me close to what I was asking. Okay. Thank you, John. Appreciate it.

Thank you. Is there any more questions?

If you have any more questions, over the phone, dial star 9 or 8. over the Zoom app, go to the reactions button and click on raise hand.

Okay, once again, if there's no more questions, I would like to once again thank everybody for dialing in today. We look forward to talking with you again very soon and presenting our second quarter of 2025 results when we report again in November. As always, take care and thank everyone for dialing in today. John Dolan. Please go ahead and wrap up the call.

Thank you, John. Before we conclude today's call, I would like to provide the company's safe harbor statement that includes cautions regarding forward-looking statements made during today's call. The information that we have provided 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 performances and involve certain risks, uncertainties, and assumptions, which are difficult to predict. Actual outcome 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 not limited to, various risks as detailed in the company's periodic report filings with the Securities and Exchange Commission. For more information about risk 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 undertaking to update or revise any forward-looking statements made during the conference call to reflect any changes in its expectations with regard thereto to any changes in its events, conditions, or circumstances of which any forward-looking statement is based, except as required by law. I would like to remind everyone that this call will be available for replay starting later this evening or likely tomorrow. Please refer to today's earnings release for dial-in replay instructions available via the company's website at www.petvivo.com. Thank you for attending today's presentation. This concludes our conference call. We may now disconnect.