Earnings Call Transcript
PetVivo Holdings, Inc. (PETV)
Earnings Call Transcript - PETV Q3 2023
John Dolan, Chief Business Development Officer and General Counsel
Greetings, and welcome to the PetVivo Holdings Third Quarter of Fiscal Year 2023 Financial Results Conference Call. My name is John Dolan, the Chief Business Development Officer and General Counsel at PetVivo. Today's call is being webcast and will be posted on the company's website for playback. Before we begin, I would like to remind everyone that comments made during this conference call by PetVivo's executives may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and are subject to risks and uncertainties. Any statement that refers to expectations, projections or other characterizations of future events, including financial projections or future market conditions, is a forward-looking statement. PetVivo's actual future results could differ materially from those expressed in such forward-looking statements for any reason, including those listed in its SEC filings. PetVivo assumes no obligation to update any such forward-looking statements. PetVivo filed its earnings release and Form 10-Q with the SEC today, which provide a detailed discussion of our financial results. These documents can be found in the SEC website and the Investor Relations section of our website. I would like to now turn the call over to John Lai, the CEO and President of PetVivo. Please go ahead, John.
John Lai, CEO and President
Thank you, John, and welcome. Also joining me today will be Bob Folkes, our Chief Financial Officer. I would like to begin by discussing some highlights from last quarter then Bob will discuss our financial results in greater detail. I will conclude by sharing some additional thoughts on our business strategy and key focus areas for fiscal 2023 before we open the line up for questions. Our key highlights for the third quarter of fiscal 2023 were we reported revenues of $510,000 as compared to $51,000 in the third quarter of fiscal 2022. Revenues for the third quarter included net revenues of $457,000 from shipments of Spryng to MWI Animal Health, a subsidiary of AmerisourceBergen. They are our exclusive distribution partner which we signed in June 2022. We continue to expand our national presence highlighted by our attendance at the American Association of Equine Practitioners' annual conference in November 2022, which Dr. Manning, our senior technical veterinarian, delivered two theater presentations, where we received very good responses, and we opened accounts in over 47 states. We are starting to see the results of the investments we have made in expanding the awareness and efficacy benefits of Spryng with Companion Animals. I would like to now turn the call over to Bob Folkes, our Chief Financial Officer, who will discuss our financial results.
Bob Folkes, Chief Financial Officer
Thank you, John, and good afternoon, everyone. For the three months ended December 31, 2022, we reported revenues of $510,000 as compared to $51,000 in the prior year. And as John noted, this increase was driven by revenues of $457,000 related to shipments of Spryng to MWI. For the nine months ended December 31, 2022, we reported revenues of $792,000 as compared to $60,000 in the prior year period. This increase was driven by revenues of $575,000 related to shipments of Spryng to MWI. At December 31, 2022, the company had $375,000 in cash and working capital of $171,000. In January 2023, we raised approximately $1.4 million after deducting transaction expenses from the sale of just over 610,000 shares of our common stock in a registered direct offering at a price of $2.32 per share. We also entered into a lease agreement for approximately 14,000 square feet of production and warehouse space. This new facility will include multiple clean rooms for large-scale production of Spryng as well as other medical devices and therapeutics in our product pipeline. We plan to move all of our production to this facility beginning in August 2023. And just to conclude here, we continue to invest our resources to expand our sales and marketing efforts, clinical studies, and manufacturing capacity to gain veterinary acceptance and support increased revenues from the sale of Spryng. So now I will turn the call back over to John.
John Lai, CEO and President
Thank you, Bob. I would like to talk about our business strategy and key focus areas for fiscal 2023. The first one is to generate clinical evidence to support the equine and small animal markets. So we have a whole series of studies that we commissioned last year or the year before that many of them are coming to conclusion. And for fiscal 2023, we expect quite a few of these to become public through publications as well as presentations. We're also focused on hiring at least two additional territorial sales managers and business development managers to strengthen our relationship with MWI and expand that relationship. Another focus is promoting awareness of Spryng at major conferences. We kicked off the conference season at the Veterinary Medical Expo in Orlando. What we're seeing, because we had talked about focusing on getting more podium presentations, even though we didn't officially do a podium presentation at this event, a couple of veterinary doctors that were doing presentations brought up our product and discussed the success we are having. Our booth received a substantial amount of visitors, including many veterinary doctors and vet techs. Both days at the AAEP, when Dr. Manning conducted his theater presentations, the theater was at full capacity, which is probably about 100 vets, and we had standing room only. We continue to invest in those presentations at various trade shows, and coming up in mid-March is our first small animal presentation by Ethos to one of the major organizations, the Veterinary Orthopedic Surgical Association. I believe that presentation will provide even more evidence and podium presentations that will draw awareness in the marketplace. I would like to now turn the call over to John Dolan, who will provide an update on our clinical studies and clinical data derived from these studies about the efficacy of Spryng and how it will be helpful to gain more acceptance from the veterinary doctors. John, go ahead.
John Dolan, Chief Business Development Officer and General Counsel
Thank you, John. We have a robust upcoming year concerning clinical trials. PetVivo has a total of seven clinical trials in progress at this time: five small animal clinical trials, i.e., canine and feline, and two equine clinical studies. We are fortunate to be collaborating with a number of world-renowned research organizations such as Colorado State University, Ethos Veterinary Health, and Inotiv Inc. We anticipate that public disclosure of these clinical study results will begin in March 2023 and continue intermittently throughout the remainder of our next fiscal year. The company plans to organize and conduct more clinical studies in addition to those currently in progress in order to support our relationship with MWI and gain veterinary acceptance of Spryng. I'd like to turn it back now to John Lai.
John Lai, CEO and President
Thank you, John. I would like to now open it up to a Q&A session. Operator, will you please explain to the callers or people that are online what they need to do to ask a question?
Operator, Operator
Absolutely.
Unidentified Analyst, Analyst
Hello, I'm on.
John Lai, CEO and President
Yes, you are.
Unidentified Analyst, Analyst
Hi John, that was a great start in the relationship with MWI. Congratulations on the takeoff. I was fortunate enough to visit you at the World Equestrian Village and had a chance to talk to some of the MWI team, and they tell me things are going great. Congratulations.
John Lai, CEO and President
Thank you.
Unidentified Analyst, Analyst
Hopefully you’ll see a very big ramp-up as they go throughout the distribution. Could you basically just talk about the size of the markets in terms of the number of animals in each of the markets, I guess, between the two small animals and also the horses, and the differentiation between the size of the show horse market versus the pet market? So that way, people can get a better idea of the number of animals that MWI is going to be helping to gain access to and how many vets service all these people?
John Lai, CEO and President
So the MWI relationship is working out extremely well for both parties, and we're both very happy. Before each of these shows, MWI does business with about 90% of the veterinary doctors in the United States where they have accounts. They would send a promotional email for us to the vets that they know or the vet techs that are coming to the show to highlight Spryng and encourage them to drop by our booth. So that’s a very good introductory approach for us. The size of the market in terms of dogs in the United States is about 64 million dogs, 53 million cats, and the numbers for horses range anywhere from 8 million to 14 million depending on the source, as there are quite a few wild horses out there too. Currently, I would say that the product mix or the revenue or the bulk of it is coming from the equine space, because the vets tend to see the horses much more often than a small animal vet. They don’t see them for a while, and also the small animal side will probably pick up in the second half of 2023 on a calendar basis because once those studies start coming out, the MWI reps will have data to present to the smaller animal vets. The market is quite large concerning OA lameness and potential rehab markets; it is north of $4.8 billion a year in the United States. So I hope that answers the question.
Unidentified Analyst, Analyst
Yes, it does. Are there any other organic and basically organically derived products that are in the marketplace that are essentially veterinarian medical devices right now, or is this pretty much an open market for you guys?
John Lai, CEO and President
So I feel our product is quite disruptive and unique in the sense that it deviates from what everyone else has been focused on. Our product targets the root cause of osteoarthritis and other lameness issues, while competitive products are focused on treating the symptoms. While we're focused on the actual disruption of friction between bone-on-bone contact, I feel we're unique in that sense, and that's a key part of the educational process because when a veterinary doctor leaves vet school, they learn that it’s a lifetime management of osteoarthritis. It’s a multimodal approach; you’re using NSAIDs, then you move on to non-organic assets, then you go on to steroids, and then eventually to stem cell joint replacement. We're actually disrupting and changing that equation because we believe once the Spryng particles are injected into the joint, it will lead to a tremendous reduction in the need for NSAIDs or the other materials, or a complete elimination of it, which helps reduce the side effects for the horse. All these other items have long-term negative effects and side effects while ours is purely neutral, and that's how we got the veterinary device designation.
Unidentified Analyst, Analyst
Years ago, there was a company that got involved very early and became significant. They injected hyaluronic acid into cartilage that was already leaking. The issue with that, clearly, is similar to putting air into a leaking balloon; the air escapes. It might be fair to say that this is a cartilage-type material that behaves differently from hyaluronic acid, which is widely known for use in both equines and humans. Isn't that a reasonable perspective? You're not encountering the leakage that you would typically see with the hyaluronic acid escaping from the cartilage?
John Lai, CEO and President
Well, yes - but also duration, duration is key here. So once our particle goes in, the matrix particles start forming a scaffolding, which, in essence, over probably the next month or two, the joint actually improves, while if you're using other products that focus on symptoms, they tend to diminish after the initial injection. Each time you're using an HA product, you may be diminishing the efficacy as well as the surrounding soft tissue.
Unidentified Analyst, Analyst
I think you'll have the same type of luck as Biomatrix had; I believe we could easily suppress that.
John Lai, CEO and President
Thank you.
John Dolan, Chief Business Development Officer and General Counsel
John, would you like me to add a little bit to that?
John Lai, CEO and President
Sure. Go ahead.
John Dolan, Chief Business Development Officer and General Counsel
Actually, you're exactly right. When you were talking about medical devices, there are a few products in the market that have been classified as medical devices, polyglycan, for example, is one, and the HA products, also high-risk products, are in the same category. John has hit it on the head, though. Many of the products in the market are trying to address certain symptoms that happen when you lose or have damaged cartilage. For instance, lubrication of the joint; if you put HA into a joint, you're looking to lubricate that joint. The issue is, you're exactly right also, within probably 48 hours, that HA is out of the joint. You may get some beneficial results for a couple of months, but then you end up losing the effectiveness of that particular medical device. Now John has hit it on the head. With our product, we inject a solid into the joint, a particle that's sponge-like, that fills in all the gaps in the cartilage. So when I say it's a particle, the nice thing about that is that it is large enough to not get by the synovial membrane, so it stays inside that joint, thereby filling in all the gaps. In other words, as John mentioned earlier, you're treating the affliction or addressing the affliction by recreating that cushion between the bones.
Unidentified Analyst, Analyst
Right, thank you.
Operator, Operator
We have another question.
John Lai, CEO and President
Go ahead.
Operator, Operator
Please unmute yourself, perfect.
Unidentified Analyst, Analyst
Hi, congratulations on an excellent quarter. I have a question regarding your manufacturing facility, which has a capacity of about 0.5 million units and is estimated to generate $100 million in revenue. Has there been any change in that capacity, or what has led to the decision to expand into another facility at this time?
John Lai, CEO and President
Well, thanks for the question, David. The expansion, actually, if you look, has multiple clean rooms and potential for what we call current manufacturing practice, current good manufacturing practice certifications. It has the ability to scale at much higher volumes with the addition of automated equipment. Also, it clearly identifies future potential product pipelines to run through there. If you're just using our current facility, you would have to shut down the manufacturing of Spryng for the next product pipeline and then rotate back and forth. So there's tremendous efficiencies and scalability in this new facility. You would see that it's probably 3.5 times the size of what we currently have from a production standpoint. So that's one way to answer it. So we're just positioning for future growth and potential rapid growth.
Unidentified Analyst, Analyst
Excellent, so what particular products would you have in mind then to be simultaneously scaling in a facility that can serve both of those end results?
John Lai, CEO and President
So we're not moving into the other facility until probably August. As you see from our studies, everything is in equine, canine, and feline. So those products will be out. In the next year, we could have a couple of other products ready to roll out anytime; we just have to have studies to support it. So we need to prep for that and have that place ready.
Unidentified Analyst, Analyst
Terrific, so it gives you some dual path leverageability in your facility, which is kind of the net-net of that?
John Lai, CEO and President
Yes, absolutely. And also a disaster recovery type potential situation. So we won't get disrupted in the Spryng aspect, no matter what. Well, I shouldn’t say there could be a major disaster where a lot of stuff gets taken out. But otherwise, we’re doing the right thing to make sure we don’t interrupt Spryng with the momentum we have going right now. Because we're seeing a lot of veterinary doctors now actually putting up videos of success stories of dogs and horses, and some veterinary doctors are starting to inject some cats and are seeing really good results. Those videos are very powerful when they come from the vets themselves to let the public and other veterinary doctors know how well the product is working.
Unidentified Analyst, Analyst
That's it, thanks for the overview.
John Lai, CEO and President
Thank you.
Operator, Operator
We are now allowing the number ending in 9170.
John Lai, CEO and President
Go ahead.
Unidentified Analyst, Analyst
My name is Elizabeth Cantordale. I just wanted to call in quickly to congratulate you on a great quarter.
John Lai, CEO and President
Thank you.
Unidentified Analyst, Analyst
So I started using those products back in October on a family friend's racehorse. This horse in the past was a very expensive horse. It ended up with a bad ankle. His ankle became the size of a softball. He just couldn't really run anymore. So one injection and he performed incredibly just a week later and then ended up winning quite a few races within the last four or five months. So we are five months out from injection now, and we were thinking it would be time for another one, as it might start wearing off. The results are just getting better. We feel that maybe that protein matrix has started to rebuild the joints. I was very surprised - I really thought we'd be ready for another injection. But my father, as some of you know, is a very high-level veterinarian in the racing world, and he's just so impressed. He's said he’s never seen anything like this before.
John Lai, CEO and President
So yes, I remember the early onset; he didn’t believe this stuff would work.
Unidentified Analyst, Analyst
No, we did it. It's such an incredible step-up from what we were using before. Cortisone, over time, as most of you know, degrades the joint. From what we understand about this, is simply not going to be the case, which is huge for longevity. You buy a $300,000 horse, you want it to last.
John Lai, CEO and President
Correct. So we say generally it lasts a year; it all varies. We have seen last well beyond a year. We're comfortable saying a year because when we did the human studies on the human side, we tracked the humans for a year and identified the particle still in the body. We have seen situations where in birth defect puppies, when they came of age, where everything is pretty grown in, we did injections of defective hips where the particles lasted eight years, which was really surprising. And I talked about the improvement after the matrix goes into the joint; once that scaffolding starts to formulate, it tends to keep the joint functioning even better. So when you first did the injection in the horse, I kind of said you wanted to wait 10 days, but I guess the trainer and your dad said it was okay to let the horse run after a few days, which kind of surprised me, but the horse did extremely well.
Unidentified Analyst, Analyst
He did, he ran incredibly. May I wanted to wait, but the trainer, that's their livelihood, wanted the horse right back on the track. What was it, gosh, a month or two ago, he went as fast as he ever had in the last two years in five-degree weather, just won the race for fun. I mean, there were 20 lengths between him and the rest of the pack. It is absolutely incredible.
John Lai, CEO and President
Well, that's great to hear. Thank you.
Unidentified Analyst, Analyst
Yes.
Operator, Operator
John Salek, you can unmute yourself.
Unidentified Analyst, Analyst
Yes, sorry. Thanks for the call. My question relates to your burn rate. Can you go over that again? And then also your milestones, what are the milestones that are in progress or that you see developing over the next 12 months?
John Lai, CEO and President
So we stated probably back in August of 2020, when we went on NASDAQ, if you look at the PowerPoint from back then, the milestones would involve getting these studies out. Studies allow our regional sales reps to work with the MWI sales reps to point to specific data for the vets. We believe there will be very good adoption for the canine side once that gets published. So John Dolan talked of seven studies that are in process. We feel there are multiple milestones from that standpoint. Those papers will get published, which will also facilitate adoption. The burn rate, I believe it's probably around $2 million per quarter. Bob, you can comment on that if I'm not too far off, but I recall that being the type of number.
Bob Folkes, Chief Financial Officer
Yes, you're hitting the ballpark.
John Lai, CEO and President
Yes.
Unidentified Analyst, Analyst
Okay. And then - so timing on those clinical trials and studies, can you provide any kind of timeframe or timetable on when they will be released?
John Lai, CEO and President
No, we completed the Ethos one, which was on to cruise ships and dogs because we focus each study on a different joint. That one was completed at the end of October, the first cohort, and the clinician requested to have it presented at the Veterinary Orthopedic Surgical Annual Conference, which is mid-March, so that's coming right up. I think it bodes well because we don’t get to feed results from studies to the audience directly, but they’re getting to present there because that’s all board-certified surgeons, and it’s a prestigious organization. Once that gets presented, we will have an abstract for the salespeople to utilize. Ethos is a very well-respected private research organization. They do work for Merck Animal Health, Watson and so on. They’re owned by NVA, National Veterinary Association. The parent owns 2,000 small animal vet clinics. I feel it will also emphasize that for the MWI sales reps to go into those clinics and start converting. We're seeing MWI make good inroads in getting to the veterinary doctors because recent rounds of ordering have been quite small unit volumes. Usually, a vet orders one to three syringes on their first turn; then 45 days later, or a little longer, they get reports back from the owners of dogs and horses much quicker, and then the next turn, we see larger orders, eventually reaching 40-50 units a month. So we're witnessing that kind of progression. We're also seeing a very good adoption rate. And by that, I mean once the vet tries it, they tend to stick with the product because they see the benefits. Does that answer your question?
Unidentified Analyst, Analyst
Yes, that's great. Thank you.
John Lai, CEO and President
Thank you.
Operator, Operator
We have a question from 9170.
John Lai, CEO and President
Go ahead. Hello.
Unidentified Analyst, Analyst
Oh, I already spoke; I'm not sure why it put me back in the queue.
John Lai, CEO and President
Okay, thank you.
Operator, Operator
Would you like to say anything else? Now we have a new question from Fritz Gerald.
John Lai, CEO and President
Go ahead. Hello.
Operator, Operator
Fritz, you are unmuted if you’d like to ask your question.
John Lai, CEO and President
Well, if there are no more questions, we should - oh, hold on, I got one coming in being typed in. Hang on. No, we can't hear you. I received a message asking if they could hear me; I said no.
Operator, Operator
I see some here in the chat box, if you'd like to address them. What was the dollar amount of the sell-through in Q3 at MWI?
John Lai, CEO and President
I already answered that one.
Operator, Operator
Okay. Are you saying that the Q3 MWI sold Spryng then? Yes - that's the other one.
John Lai, CEO and President
Yes. So we're good. They're having problems. They're going to call me directly and ask whatever question they have.
Operator, Operator
Okay, thank you.
John Lai, CEO and President
If there are no more questions, we can conclude this call. Thank you all for attending. And operator, please officially end the call.
Operator, Operator
Goodbye.