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spk02: Greetings, and welcome to INovia's third quarter 2020 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Eric Dribner, Investor Relations. Thank you. You may begin. Thank you.
spk01: Thank you, and good afternoon, and welcome to Inovia's third quarter 2020 earnings call and audio webcast. With me today are Inovia's chief executive officer and chief medical officer, Dr. Sean Ianchulev, Inovia's chief financial officer, John Gandolfo, and Inovia's vice president of commercial, Michael Rowe. Earlier this afternoon, Inovia issued a press release announcing financial results, but the three months ended September 30, 2020. We encourage everyone to read today's press release as well as Inovia's quarterly report from the Form 10-Q for the third quarter of 2020, which will be filed with the SEC. The company's press release and quarterly report will also be available on Inovia's website at inovia.com. In addition, this conference call is being webcast through the company's website and will be archived there for future reference. Please note that on today's call we will be discussing investigational products which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Act. We caution listeners that during this call, Inovia's management will be making forward-looking statements. Actual results could differ materially from those stated or implied by those forward-looking statements due to risk and uncertainties. associated with the company's business. These forward-looking statements are subject to a number of risks, including risks related to fluctuations in our financial results, volatility and uncertainty in the global economy and financial markets in light of the evolving COVID-19 pandemic and uncertainties arising from the U.S. recent U.S. elections. Our estimates regarding the potential market opportunity for our product candidates and potential revenue from licensing transactions, reliance on third parties, the ability of us and our partners to timely develop, implement, and maintain manufacturing, commercialization, and marketing capabilities and strategies for our product candidates. Risks of our clinical trials, including but not limited to the cost, design, and initiation, and enrollment, which could be adversely impacted by COVID-19 and resulting social distancing, timing, progress, and results of such trials, the potential impact of COVID-19 on our supply chain, the timing, and our ability to submit applications for, obtain, and maintain regulatory approvals for our product candidates, the potential advantages of our product candidates, the rate and degree of market acceptance and clinical utility of our product candidates, our ability to raise additional capital, our ability to attract and retain key personnel, intellectual property risks, and others detailed in and qualified by the cautionary statements contained in INOVIA's press release and SEC filings, including the most recent annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 10, 2020. INOVIA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by applicable securities law. With all that said, I'd like to turn the call over to Dr. Sean Ein-Shuliff, from Inovia.
spk06: Thank you, Eric, and welcome everyone to our third quarter 2020 earnings conference call. During the third quarter and more recently, we continue to solidify our business position through both new strategic partnerships and our proprietary clinical programs. We believe that together these activities have positioned us for continued success as we ramp up our manufacturing capabilities and prepare for our first commercial product launch. Starting with strategic partnerships to date, our business development partnerships have provided a total of approximately $14 million of gross non-dilutive capital in 2020, with the potential to increase to approximately $100 million in gross non-dilutive capital once you consider potential non-sales-related milestones as well as clinical cost savings or reimbursements. During the third quarter, we signed an agreement with Arctic Vision for the development and commercialization of Micropin for progressive myopia and MicroLine for presbyopia for Greater China and South Korea. More recently, we signed an agreement with Bausch Health for Micropin in the U.S. and Canada. These agreements build upon our long-standing partnership with Senju Pharmaceuticals, covering Japan and the rest of Asia, and we believe provide further validation as to the value of our robust Phase III pipeline and innovative microdose delivery technology. Our clinical programs, which are directed towards high-value markets with first-in-class treatments, have also made significant positive progress. Our chaperone program for progressive myopia, which is being transitioned to bowel health, addresses a high-risk pediatric market of approximately 3 million children in the U.S. alone, with a potential value exceeding multiple billions of dollars. The market in China may be equally large due to a patient pool that some estimate to be as much as eight times greater than that of the U.S., Our vision program for improvement of near vision targets the approximately 130 million presbyopic adults, translating to a potential market value that we estimate at about $2 billion. And our recently completed MIST program, delivering positive Phase III results as we prepare the new drug application for Microstat or MitCombi, may provide benefits that address a need for touchless, comfortable, effective, and efficient pupil dilation in a world concerned about COVID-19. The common thread among all three programs is our OptiJet microdose array print technology. The OptiJet with its touchless, smart digital health capabilities is designed for safer, gentler, and more precise delivery to give patients the best-in-class therapeutics they deserve. With two strategic partnerships and pending NDA submission, a unique program for presbyopia in late stage development, as well as a platform technology from which we're working to develop new therapeutic indications, we believe INOVA is well positioned to enter 2021 with significant momentum and a line of sight to milestones that could create incremental value for our shareholders. At this point, I'd like to hand the call over to Michael to provide some highlights from our strategic partnerships. Michael?
spk05: Thank you, Sean, and greetings from our R&D and Engineering Center in Reno, Nevada. During the third quarter, and also more recently, we executed on a strategy to out-license our technology and our MicroLine and MicroPine programs to partners who could potentially provide greater commercial reach than we could on our own. The first of these partnerships is with Arctic Vision, a leading ophthalmic company in China who obtained rights to develop and commercialize both microline and micropine in Greater China and South Korea. The second more recent agreement is with Bausch Health, a division of Bausch and Lomb, who licensed the rights to develop and commercialize micropine in the U.S. and Canada. It is important to note that we have retained the rights to both of these programs in Europe and the rest of the world outside Asia, including Australia, South and Central America, among other territories. Myopia is among the most common ocular disorders worldwide and the leading cause of visual impairment in children. In the United States, myopia is estimated to affect approximately 25 million children, with up to 3 million considered to be at high risk for high myopia. In China, the number of children at high risk may be eight times higher. Upon signing a licensing agreement with Bausch Health, we received a 10 million upfront payment and Bausch Health assumed oversight and costs relating to the ongoing Chaperone Phase III clinical trial. Recall that the Chaperone trial is a randomized double-mass clinical trial targeting enrollment of more than 400 children between 3 and 12 years of age. The trial is assessing the safety and efficacy of low-dose atropine delivered in the OptiJet dispenser for the reduction of progressive myopia. The primary efficacy endpoint is the change in refractive error from baseline through 36 months. Enrollment resumed in late June following a brief pause due to COVID-19. Chaperone is a large, long-term trial, and the assumption that trial execution and costs by Bausch Health potentially creates millions of dollars per year in savings for our company that we can channel into our microline Phase III studies, as well as other development activities to evaluate new therapies leveraging our microdosing technology. In addition, we are eligible to receive up to $35 million in payments from Bausch Health, based on product approval and commercial launch-based milestones, as well as tiered sales royalties ranging from mid-single-digit to mid-teen percentages of gross profit on sales of MicroPine in the U.S. and Canada. The Bounce Health transaction came just 60 days after we signed with the Arctic Vision Agreement for the rights to MicroPine, as well as MicroLine in Greater China and South Korea. Together, these two agreements could represent potential upfront payments, non-sales-related milestones, and product and clinical development cost savings or reimbursements of approximately $100 million. We continue to evaluate other strategic partnering opportunities for additional indications and or territories, as we believe partnerships could be an important contributor to our long-term growth going forward. Now, I would like to hand the call back to Sean to provide an update on our ongoing clinical activities. Sean?
spk06: Thank you, Michael. At this point, I would like to provide a brief update on our clinical programs before turning the call over to John to review the financials. Taking a step back, for those of you who may be new to our story, OptiJet is a novice proprietary microdosing technology designed for optimal drug delivery to the eye. It utilizes microdose array print technology, similar to an inkjet printer and horizontal delivery to administer a physiologically compatible dose to the cornea of the eye. Studies show that conventional eye drops can overdose the eye by as much as fourfold, leading to unwanted side effects and unnecessary exposure to excess drug and preservatives that can be harmful. The OptiJet has been shown to achieve comparable efficacy to standard eye drops and doses that are approximately 75% less medication. We believe both patients and clinicians are comfortable using the OptiJet. Prior studies found that 95% of clinicians and 88% of patients were able to successfully administer medication using OptiJet on very first attempt. This compares very favorably to eyedroppers, where multiple published studies have shown that fewer than half of users are able to administer medication successfully on first attempt. Importantly, the OptiJet was designed with no protruding parts and cannot touch the ocular surface. These are among the OptiJet's important differentiators, particularly in the age of COVID-19, given the ease with which the infection has spread. Last quarter, I summarized just a few of the publications highlighting the risk of COVID spread in an ophthalmology or optometry examination room. The standard of care eyedropper was found to touch the ocular surface more than 50% of the time. And in the typical clinician's office, for example, a standard eye dropper for dilating drops may be used on literally dozens of different patients. This presents risk for cross-contamination and an important issue that must be addressed by clinicians against the backdrop of the COVID-19 pandemic. The OptiJet has a recessed delivery aperture as well as non-gravity-driven horizontal spray dispensation, which is designed for a more distant misdelivery. In addition, we reported last quarter that the OptiJet appears to be qualified for preservative-free multidosing. So we believe the OptiJet could address the cross-contamination risk associated with shared droppers while also replacing therapeutics that are delivered in single-dose packaging, thereby cutting down on costs and waste. Let's turn to our two clinical programs, Microstat for pharmacologic medriasis and Microlane for presbyopia. Beginning with Microstat, or so-called mid combi going forward, based on our two positive phase three clinical trials, MIST-1 and MIST-2, we continue to work towards submission of an NDA by the end of this year. Pharmacologic medriasis refers to the dilation of the pupil that is part of any comprehensive eye exam. It is estimated that there are 80 million office-based comprehensive and diabetic eye exams and 4 million ophthalmic surgical dilations performed annually in the United States. And pharmacologic mid-dry assist is essential for diabetic retinopathy, glaucoma, and retinal disease screening. Mid-combio was found to achieve mid-dry assist of greater than 6 millimeters in 93% of patients at 35 minutes post-dose. This is clinically meaningful for both office retinal exams as well as surgical dilation. If approved, Mitcombi would be our first commercial product, a critical milestone for Inovia. Mitcombi will introduce physicians and patients to the OptiJet dispenser and potentially generate incremental interest in the OptiJet for additional therapeutics. We believe this is an approximately $250 million market in the U.S. alone, based on in-office and cataract surgery statistics. Finally, we could not be more excited about our Phase 3 MicroLine program for the improvement in near vision in people with presbyopia. Presbyopia, which is the non-preventable age-related hardening of the ocular lens, causing the gradual loss of the eye's ability to focus on nearby objects, affects an estimated 130 million people in the U.S., and hundreds of millions more in China, where we've already licensed the product to Arctic Vision. We believe that there are 31 million people in the U.S. who formed the sweet spot in the market for pharmacologic treatment of presbyopia, mainly those adults between the ages of 40 and 60 who otherwise never had to wear glasses before. We anticipate initiating the Vision 1 studies this year with the first read of the Phase 3 data sometime around in the end of Q1 of 2021, subject to any impact of COVID. There is a growing interest in drug treatment for presbyopia. Currently, the only option for dealing with presbyopia are eyeglasses, contact lenses, or surgery. Our own market research showed high interest among our targeted market for a drug treatment that could provide on-demand improvement in near vision. Microline would be a companion product to eyeglasses for those times when patients would prefer not to wear eyeglasses. The market potential for an on-demand improvement in near vision may be significant. In the U.S. alone, we estimate this opportunity to be in excess of $2 billion. Our vision program will test two different doses of phylocarpine, a compound whose efficacy in improving near vision was validated once again when Allergan announced positive data from its clinical trials in Presbyopia a few weeks ago. What sets us apart, in my opinion, is the OptiJet. If MicroLine is approved, we believe our technology will facilitate accurate and targeted dispensing of pilocarpin without overdosing the eye, as is common with conventional eyedroppers, a century-old technology used to administer other companies' therapists. We believe the increased portability, comfort, and safety offered by the OptiJet will be among key differentiators as our development program advances. And now I'd like to turn the call over to John to review our financials. John?
spk04: Thank you, Sean. Now I would like to review our financial results for the three months ended September 30th, 2020. For the third quarter of 2020, we reported a net loss of approximately $5.1 million, or 23 cents per share. And this compares to a net loss of approximately $4.6 million, or 29 cents per share for the third quarter of 2019. Research and development expenses totaled approximately $3.4 million for the third quarter of 2020. This compares to approximately $3.2 million for the same period in 2019, an increase of approximately 5.1%. For the third quarter of 2020, general and administrative expenses were approximately $1.7 million compared with approximately $1.5 million for the third quarter of 2019. an increase of approximately 16%. Total operating expenses for the third quarter of 2020 were approximately $5.1 million compared to total operating expenses of approximately $4.7 million for the same period in 2019. This represents an increase of 8.6%. It's important to note that the operating expenses included approximately $610,000 of non-cash stock compensation expense in the third quarter of 2020. As of September 30, 2020, the company's cash balance was approximately $22.9 million. This includes net proceeds of approximately $12.5 million from a public offering of common stock that we completed in August, which included the exercise of the underwriters over allotment option. Factoring in the $10 million upfront payment that we received from Bausch Health, Our pro forma cash balance as of today is approximately $31 million. We believe that this is sufficient to bring our Mitcombi, Mitriasis product through the NDA process and commercial launch, complete our Presbyopia clinical program for MicroLine, and also prepare our pilot manufacturing capabilities for advanced dispenser technology. This concludes our financial statement remarks. Now I'd like to turn the call back over to Shawn. John?
spk06: Thank you, John. In closing, we're very pleased with our performance during the third quarter of 2020 and subsequent period. We remain on track to file an NDA by the end of this year and, if approved, plan to introduce our first commercial product in 2021. We also have a second therapeutic that should be enrolling for its phase three studies shortly in a potential multi-billion dollar indication subject to any impact of COVID-19. And we expect our two licensing agreements with Arctic Vision and Bausch Health to provide us with non-diluted funding that we can use to advance these programs while potentially leveraging our dispensing technology into additional high value indications. We believe we're well positioned to achieve multiple commercial, regulatory and development catalysts in 2021, aimed at advancing long-term value for our shareholders. That concludes our prepared remarks. We would now like to open the call to questions. Operator?
spk02: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Yi Shen with HCW. Please proceed with your question.
spk03: Hi, this is Bubal and dialing in for each end. Can you hear me okay?
spk00: Yeah.
spk03: Hi, I would like to ask three questions. So beginning with vision trial, is the company still on track to initiate the vision trial even though the COVID cases are rising?
spk06: Yeah, this is a good question. We, as of the latest, that our clinical operations group has informed us based on feedback from the sites. We have the sites already in the pipe and being prepared. We've gotten feedback that as of now we don't see any disruption to our timelines and hopefully that would continue. I know the sites and the clinical, the clinics of optometry and ophthalmology practices have really ramped up their precautions and they've really adapted over the last few months. Of course, we don't know how this new wave will unfold. So we remain cautiously optimistic and we're monitoring the situation in direct communication with the sites. So we'll probably know a lot more in the coming weeks.
spk03: Understood. Next question. Do you plan to in-license or out-license additional candidates the next 12 months?
spk06: Yeah, so this is something that it's hard to, again, business development and partnerships is a fickle business. It takes time to evolve. And, again, it took us a long time to really develop the relationships that we have with Arctic Vision and Bausch Health. There has been a lot of interest in our technology for even several years, but we've been very cautious in selecting the proper partners for that. Again, I would probably not comment on which way this will go. What we're focused on right now, and the best way we can deliver value, is really to execute on the PressBiopia program and also on the NDA for MidCombi, presbyopia is such a phenomenal opportunity. It's really a big, big market and particularly so disruptive when we, for the first time, are able to do pharmacologic treatment. So we're really focused on working in the trenches with our sites, being able to enroll our studies so that in Q1 of 2021, which is not far from today, to generate phase three data. And I think from what I know, I'm sure there's going to be a lot of interest in our programs. And of course, our management team and our board will evaluate all the options, as well as the option which exists on the table with such a big program is for also Inovia to expand its commercial effort from MidCombi. So, again, we're evaluating that, but the first thing is first, let's execute our program and let's deliver great Phase III data, and then, of course, all the options will be evaluated.
spk03: Understood. One final from me. Has BowShield provided any update on the progress of the chaperone trial? Thank you.
spk05: I can answer that, Sean. Yeah, sure. Go ahead, Matt. So Bausch is nowhere in the process of transitioning Chaperone to Bausch. In the meantime, they're covering us financially, reimbursing us for the work being done. As of right now, we are still managing the Chaperone study. That study is progressing as expected. So there's no update or change there from what we said previously. We expect that study to be fully enrolled by the middle of next year.
spk03: All right, that's it. Thank you.
spk05: You're welcome.
spk02: Our next question is with Matt Kaplan with Leidenberg.
spk09: Please proceed with your questions. Hey, guys. Can you hear me? Yes, Matt. Hi. Yes, Matt. Great to hear. Great. Well, congrats on the progress during the third quarter. It looks very good. I wanted to dig into the microline program a little bit. I guess, you know, We view the program really as clinically de-risked, you know, given the, you know, positive results, recent positive results for pilocarpine from Allergan in Presbyopia. Can you give us a sense in terms of or describe the competitive landscape in Presbyopia with products on the market or either in development? And then what does Mike align really bring as a differentiating point from a treatment point of view?
spk06: Yes, this is actually a very interesting question. It is so interesting because just a few weeks ago, and it seems like other people are following that closely, but a few weeks ago we also were informed that Allergan, which is developing a pilocarpine formulation for presbyopia, had two positive phase three trials. So again, as an ophthalmologist and what I know about pilocarpine and what we've seen with that drug through the years and underappreciated but very well known is that it has a very tremendous ability to create a pinhole pupil, a small aperture, and extended depth of focus with extraction of residual accommodation to really enable near vision. And we've never used that before. And, again, we weren't the first ones to be really astute about that. I think Allergan seems to also have appreciated that, and they're leading the way with their Phase II programs. We're talking about an enormous space here, 113 million potential users in the U.S. and a sweet spot of about 30 to 40 users in the 40 to 60 age group. So we see that this would be a really great solution and treatment. We are really tracking very closely what's happening in the space. Allergan is a first-comer. It's something that we actually appreciate to some degree because they will open a brand-new market, and they're very good at that, as we know, with Botox and other cosmeceuticals. So I think it really validates the mechanism. It validates the compound, and the part that we appreciate is the differentiated approach that we have.
spk05: Yeah, sorry. Go ahead, Michael. To that point on the competitive environment, I think it can sum it up for us in two ways. You know, if you're going to come into the market with something that is essentially a lifestyle drug, which this will be, you need to fit within the lifestyle of the people who are actually using it, and you need to be well-tolerated. Those are the two things you really have to hit out of the park. And I think what Sean was going to say, talk about is with micro dosing and with the opti-jet dispenser that is what differentiates us the micro dosing we believe and we'll see you know what happens in our phase three study uh should result in a better tolerated product both um both you know from how the eyes look as well as with the brow ache which is known to occur at higher doses of pylocarpine so that would be in terms of tolerability in terms of acceptance we know that the opti-jet dispenser makes it much simpler for people to take the medication. And in case in point, when we did market research on this product, we had many people who wear eye makeup who said, well, how is this supposed to work? I can't put drops in my eyes. You know, if I'm already made up for the day and I'm going out to dinner or something like that and want to use the product, I don't want to have to do that and reapply my medication. And it's things like that, which the OptiJet dispenser can make easier for people. and match their lifestyle better. Sean, did I cover the two things you were going to? Yeah, yeah, absolutely.
spk06: And again, another footnote is, if you remember, we prioritized that program over glaucoma, and now we actually feel justified in that because of the opportunity and the timeliness. And it's always come off the charts when Michael does his commercial marketing research. So we see high interest by consumers and patients. Thank you.
spk09: Thanks for that in detail. And I guess maybe a question for Michael. Can you talk about your commercial preparations, where you are for the, I guess it's now called Mid-Combie, potential launch next year if you file the NDA this year?
spk05: Yes. So our plan is, you know, we said we intend to file that NDA the end of this year. We would start our commercial preparations towards April, May of next year. The idea behind that, behind MidCombi, is that we don't need to have a huge sales force to make this successful. This is not a traditional type of pharmaceutical sale where you need to do samples and you need to be in the office often and you need to get formulary acceptance. This is essentially a diagnostic supply, which means you go in, you sell into the office, and once you demonstrate for them what the really tremendous value proposition is for the product in addition to it being faster for them, potentially safer, more comfortable, not going to cost a whole heck of a lot more. Once you've made that sale, you're done, and you move on to the next big office. So that preparation could be done, we believe, by putting 12 very good people in the largest population centers and working from there. And those are people we would start to bring on board probably – towards the latter half of the year in preparation for a launch in the fourth quarter. Great. Well, thanks for taking the questions. Thanks, Matt.
spk02: Our next question is with Lenya from StockDocPartners. Please proceed with your question.
spk05: Lenya may be on mute. Oh, okay. Maria, let's go to the next person.
spk02: Our next question is with Jonathan Askoff with Roth Capital Partners. Please proceed with your question.
spk07: Thank you. Hi, guys. I was wondering, so Allergan said that we will not get any more detailed Phase 3 presbyopia data until, you know, at least ARVO next year. So I guess you kind of won't know you know, what kind of pilocarpine efficacy to kind of beat. And so I guess I was curious, if you were going to have the same primary endpoints as Allergan did, essentially near-term vision improving and then near-term vision improving without distance vision worsening, and on what day after the start of therapy would you be assessing that primary endpoint?
spk06: Yes, Jonathan. So for our program, we have a distance-corrected near visual acuity, which is pretty standard. I believe this is what they have as well in theirs. And the distance-corrected near visual acuity post-dosing. For us, we are assessing that through a three-hour period after administration. And so our study is really designed in such a way that we will be able to enroll and very expeditiously assess the efficacy of our treatment because we're using that and we're looking at the efficacy literally within several hours post-administration, which is where our endpoint is. So, yes, I'm looking forward to actually seeing their data as well and seeing how the pilocarpin performed in an eyedropper. By that time, I would assume if we're talking our role of next year, that by that time we would have some of our Phase III data as well. And hopefully we will see what we've seen before in terms of the differentiation and the benefits of our microarray print technology. Michael, do you want to add anything?
spk05: Yes, I would also add, Jonathan, that the way they're looking at dosing is very different from ours. I believe in their protocol they were dosing every day. They're looking at it almost as like a chronic medication. We're approaching this as something that you would use on demand. So you would literally only take the spray from the OptiJet 15 minutes before you intended to make use of the product. So it's a different way of saying where we think this drug will fit. And we just personally from our market research think the on-demand model is much more likely to to fit with these particular types of patients.
spk07: You actually bring up another question. Do you think that you guys would have a different onset of activity compared to Allergan?
spk05: Well, I'm not familiar with their formulation. We know we have a pretty good idea of our onset of activity, which is, like I said, we think it's going to be working within 15 minutes to fit that on-demand profile.
spk07: Okay, and I didn't quite remember what you said in answer to my first question. Will you have that composite endpoint of near vision improving without distance visioning worsening?
spk06: Yeah, so we will have the data on both. We're not going to have a composite endpoint because that's not pre-specified, but we will have, obviously we're taking data on both the near and the distance visioning. We don't have a composite endpoint in our clinical study.
spk07: Okay, and then lastly, I was just curious, you know, since they'll be out first in all likelihood, do you think you'll let their pricing weigh heavily upon your pricing decision, or do you think the differential in, you know, the technology and the benefits therein don't force you to really pay attention or pay much attention to that despite it being a cash market?
spk05: Jonathan, if they have a high price, I'll be happy to take it. Is that what you mean?
spk07: No, I think that would be one way of looking at it.
spk05: One way to look at it. But if they come out with a price that I think doesn't reflect the value that we're bringing, I wouldn't let that impact us too much. We think you have a price that I think is very fair and within reach for, we think, about 31 million patients who we're targeting. These are people who have the means and who have never needed to wear glasses before in their lives. So there's plenty of them, and at the right price, we believe they'd be very happy to use the products.
spk07: Okay. Thank you very much, guys. You're welcome.
spk02: As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. Our next question is with Stuart Grant. Please proceed with your question.
spk05: Hi, Sean. Congratulations on the – Congratulations on the Bausch Health and Arctic Vision deals. Those are awesome, and it appears that the business is executing very well. But unfortunately, the stock price has been pretty stagnant. Why do you think the market is not recognizing the value in the Bausch Health and Arctic Vision deals, and is the board concerned about the lack of performance of the stock price?
spk06: Yes, that, Stuart, is a very good and loaded question. I think that maybe the best way to address it is just giving my perspective, which really doesn't oblige anybody. We obviously expected this to be appreciated a lot more from a stock perspective, an appreciation of the value of the stock, given how significant the Bausch transaction and the Arctic Vision transactions are. I mean, they're not only providing non-dilutive capital today and up to 100 million of non-sales milestones over the coming years, but then potentially huge revenue of fairly de-risked late-stage programs that weren't there before. And so it's a good question why we really haven't seen that. I think our team made a very concerted effort to hold a press conference and really share with people the details of our transaction. And we actually felt very happy about the partnership. But again, going back in the context I wanted to share, if you remember several years ago we reported the results of our Phase II trial in IOP lowering, PG21, and that was a very significant trial because it validated our microdose technology beyond pupil dilation. And that didn't really lift the stock very much. We had subsequent great events from the MIST-1 and MIST-2 study, as well as some of the additional milestones that we've reached. including now preparing. We are on the verge of launching a phase three program in one of the biggest indications in ophthalmology. So it's really hard to explain. I think we do have a shareholder base that we may want to reach out more. I think everybody is distracted with the big biotech and new molecular entities, and sometimes maybe people miss the small players. And let's not forget that we're really a micro-cap And as such, maybe writing on much bigger programs that actually correspond to what people would expect from a micro-cap. So this is not the first time I've seen a value unappreciation, so to speak, and most of my private ventures and exits, that's always been the case until you have the major result or breakthrough or exit. So we hope people will follow and see the programs and the milestones that are coming forth, which are great. And we hope those really end up in the spotlight of what biotech and life-size success is, because we're very excited and our board is very excited about where the company is heading. And the fact that we do have now a balance sheet that has been augmented by those business development partnerships significantly and provides us probably one of the best cash positions we've had before.
spk05: And if I might just follow up, is it fair to assume that given the upfront payments that were made that this fourth quarter, at least for the quarter, that Inovio will actually be profitable?
spk04: Not on a P&L basis, because for GAAP purposes, you need to defer the upfront cash payment. So when you look at our profit and loss statement, you'll see that we included the upfront cash payment received from Arctic Vision in deferred revenue on our balance sheet. And so we will not be able to recognize that. until we provide clinical trial data to Arctic Vision, which will be, you know, 12 to 18 months from now, even though we received the cash. So it's just a nuance associated with that.
spk05: So from a cash flow basis, you'll be positive cash flow for the quarter, but not on a P&L gap basis?
spk04: Yeah, correct. Exactly right.
spk05: Okay. Thank you. Thank you, Stuart.
spk02: Our next question is with Len Yath with Stock Dock Partners. Please proceed with your question.
spk08: Thank you very much. I had to hop off for a bit, so I apologize if these questions were already asked. I was wondering if you could compare and contrast, you did a little bit in your opening comments, pilocarpine that Allergan is using in the Gemini 1 and 2 study in terms of the dose they're using. I think it was one dose, and if you're using more than one, Obviously, the issue in the coronavirus pandemic time that we're in with the cleanliness, I think, is a major advantage. And if there are any other issues in that regard, if you want to comment on. And then secondly, when Bausch had their recent reporting of their Q3 results, they talked about the fact they felt they were really incredibly positioned in pediatric progressive myopia with a contact lens company agreement. and then with you guys on the pharmacologic side. And I was just wondering if Bausch's devotion to this indication is something that you think could lead your product to be one of the leaders in this of the various companies working on, given their presence in ophthalmology and the fact that given that they're looking at both ways of approaching it, they seem to be very dedicated. Thank you very much.
spk06: Okay. Well, Len, these are great questions, as always. So let me start with the second one, and then Michael can chime in. But again, progressive myopia right now is kind of like the anti-VEGF and wet AMD before we developed Lucentis, which then became a $10 billion market. We're talking one of the biggest opportunities in ophthalmology. And so it's going to be a place where different technologies and approaches will work and be synergistic. In terms of the contact lenses, that is a very hardware approach to the disease that requires the ability to put a contact lens and wear it. And again, it's not for everybody. And a pharmaceutical treatment once at night with an eye drop, particularly if it comes in a very elegant dispenser with a microdose, would probably be something that at least we believe is much more germane to the general market. Now, the good part is also that because they have very different mechanisms of how they address progressive myopia, I think clinically one would be completely open to the idea of using them together to even further influence the progression of myopia and improve the outcomes. Maybe I'll let here Michael to chime in if he has any other commercial perspective.
spk05: No, Sean, I think that's exactly it, that the people who are treating pediatric myopia want to have both options available to them. There will be patients where they'll use both And I think actually that's their preferred because they'd like to hit the myopia as hard as they possibly can and as much as the child can do. So from Daush's perspective, they are looking to be the one-stop shop with what they perceive as having the best hardware solution and with us, the best pharmaceutical solution. And I think even in the comments from Joe Papa, he mentioned that he did think that it was our dispenser technology that really makes the difference, making it possible for these kids who will be medicating themselves for years to be able to take control of their own treatment and not even talking about the ability to monitor usage and with reminders and everything else that the dispenser can do. So thank you. Yeah.
spk06: Great. So absolutely. And to your first question, and by the way, just to finish, I think personally I'm impressed and I think Bausch has a very mature way of blueprinting the entire progressive myopia future and space. And that's great that they have multiple ways because it's a big opportunity. And if I were a big company, I would definitely pursue multiple venues. That aside, your other question on pylocarpine, again, we're very encouraged about pylocarpine. We actually know pylocarpine very well. It's been around for 50 years. So it's not a surprise to us that we're seeing positive Phase III results from another company like Allergan, and we're not surprised that Allergan is the one moving into that space. In terms of our dosing, we are using the 1% and 2% dose. Initially, we were thinking to just do a 1%, but because microdosing and microarray print technology offers some very interesting advantages, whereby a higher dose with the lower total exposure of the cornea and the ocular surface with the targeted delivery can really enhance certain parts of the equation and really inflict the therapeutic index. We decided to put also the 2% as well, and that will be part of our Vision 1 study. So we're very excited to see the data, hopefully in a few months, and share that with you and the Winder clinical community in ophthalmology and optometry.
spk08: And then lastly, on Mitkambi, how long do you think the FDA review process would be? Is it going to be a standard 10- or 12-month review, do you expect, from when you file?
spk06: Yeah, I think we're assuming that. It's really hard to believe today. We're looking at extraordinary times. But we have seen in all of our communications with the FDA a very proactive response approach and timeliness, which has been really appreciated by our team. We think we're going to submit very clean data. Our MIST one and MIST two studies were extremely clean and very, very informative with clear efficacy and safety. So from my experience of a decade plus, the cleaner the data, the more articulate you are for the FDA, the easier you make their job and the faster they can perform. So we hope that will be the case, and we hope also that they appreciate the advantages of this technology. We spent quite a bit of time really exposing you today to the fact that we have a touch less delivery with our recessed nozzle that doesn't cross-contaminate as much, we hope. just by virtue of inherent intrinsic design. At least that's what our KOLs really appreciate. So hopefully these would be all things that can really rationalize an expedient process, but we're going to be supporting them as needed to make that decision and get through that diligence. Great.
spk02: Thanks so much.
spk06: Sure. Thank you.
spk02: There are no further questions at this time. I would like to turn the floor back over to Sean Ianculev for closing comments.
spk06: Well, again, that was a great, very informative call today, I hope, and this concludes our call. Thank you again for joining us, and we look forward to our next financial update in 2021. Have a good afternoon.
spk02: This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.
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