Hyperion DeFi, Inc. (HYPD) Q4 2020 Earnings Report, Transcript and Summary

Greetings, welcome to Eyenovia's Fourth Quarter and Full Year 2020 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, Eric Ribner. You may begin.

Good afternoon, everyone, and welcome to Eyenovia's fourth quarter 2020 earnings conference call and audio webcast. With me today are Eyenovia's Chief Executive Officer and Chief Medical Officer, Dr. Sean Ianchulev; and Eyenovia's Chief Financial Officer, John Gandolfo; and Eyenovia's Chief Operating Officer, Michael Rowe. Earlier this afternoon, Eyenovia issued a press release announcing financial results for the three and 12 months ended December 31, 2020. We encourage everyone to read today's press release, as well as Eyenovia's annual report on Form 10-K for the year ending December 31, 2020, which will be filed with the SEC within the next few days. The company's press release and annual report also will be available on Eyenovia's website at eyenovia.com. In addition, this conference call is being webcast through the company's website, and will be archived 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 provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Eyenovia'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, our need to raise additional money to fund our operations for at least the next 12 months as a going concern, our estimates regarding the potential market opportunity for our product candidates and platform technology 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 and our licenses clinical trials including, but not limited to, the cost, design, 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 licenses ability to submit applications for, obtain and maintain regulatory approvals for our product candidates, the potential advantages of our product candidates and platform technology, the rate and degree of market acceptance and clinical utility of our product candidates, and platform technology our ability to attract and retain key personnel, intellectual property risks, and other risks related in and qualified by the cautionary statements contained in Eyenovia's press release and SEC filings, including its 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, March 25, 2021. Eyenovia 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 Ianchulev.

Thank you, Eric. And welcome everyone to our fourth quarter and full year 2020 earnings conference call. During the fourth quarter and more recently, we made significant progress towards advancing our proprietary clinical programs and becoming a recognized leader in the field of ophthalmology. Most notably, we recently announced that the FDA accepted our new drug application for MydCombi, our proprietary fixed combination mydriatic for potential use in the over 80 million comprehensive eye exams currently conducted each year in the United States. If approved not only would, MydCombi be the first microdosed ocular therapeutic applied with our proprietary high precision smart delivery system, the Optejet, but it would be – it would transition us into a commercial stage company. We have been given and expected PDUFA date of October 28, 2021 for MydCombi and if approved, we believe we can effectively and efficiently market MydCombi with a small and highly targeted field salesforce in combination with a specialty pharmacy network. Michael will elaborate on this shortly. We also announced earlier this year that the first patient had been dosed in our VISION-1 Phase 3 clinical study evaluating our proprietary pilocarpine formulation, MicroLine, which is also delivered via the Optejet, for the improvement of near vision in patients with presbyopia, I'm happy to announce that VISION-1 is now fully enrolled and we're on track to deliver top-line results in the second quarter of 2021. As a reminder, presbyopia is the age-related hardening of the eyes lens causing blurred near vision. Vision impairment typically begins after the age of 40 and is often corrected with eyeglasses, readers, contact lenses or surgery. We believe MicroLine has a significant market opportunity in that it's estimated that presbyopia affects more than 113 million people in the U.S. alone. Recall that our third clinical program MicroPine for the reduction of pediatric myopia progression has been out licensed to Bausch Health in the U.S. and Canada. In addition, we have outlicensed MicroPine, as well as MicroLine to Arctic Vision in greater China and South Korea. To date, these partnerships have generated a total of approximately $16 million of upfront and milestone-based non-dilutive license fees with the potential to increase to approximately $100 million in gross non-dilutive capital once potential non-sales related milestones, as well as clinical cost savings or reimbursement to taken into account. With one NDA accepted, a second Phase 3 program now initiated and fully enrolled as well as several robust development partnerships with ophthalmologic leaders established. I'm very pleased with our progress last year and believe we have entered 2021 with significant momentum and line of sight to multiple potentially value creating milestones. At this point, I would like to hand the call over to Michael to provide some highlights from our MydCombi program. Michael?

Thanks, Sean. As Sean indicated, we recently announced that the FDA has accepted our NDA for MydCombi. Our proprietary mydriatic agents administered via our microdose array print or MAP technology upon which our Optejet dispensers base. The current standard of care for pupil dilation requires multiple eye drops given at least several minutes apart. This can take considerable time and often cause both discomfort and drug overflow. Prior research has found that as many as 90% of eye care providers reported that they encounter situations where patients skip the comprehensive eye exam, because they do not want to undergo an uncomfortable pharmaceutical pupil dilation procedure. So we believe there is significant need for the improved process of pupil dilation to help make sure that everyone who should have a comprehensive exam is more willing to get one. Additionally, in the age of COVID-19, there is greater sensitivity to the usual practice of sharing conventional droppers of pupil dilation medication across a number of patients. MydCombi was developed with the goal of providing a touchless fixed combination microdose formulation, designed to improve the hygiene related to the process of pupil dilation and improve the efficiency of the process. The Optejet is designed with no protruding parts which may help prevent accidental touching of the ocular surface to help reduce the chance of cross-contamination between patients. The MydCombi NDA submission was based on the Phase 3 MIST-1 and MIST-2 studies. In these two studies, a fixed combination of micro-dosed tropicamide 1% and phenylephrine 2.5% ophthalmic solution met the studies’ primary endpoints and was shown to be safe and effective for pharmacologic mydriasis. Approximately 94% of treated eyes achieved 6 mm or greater dilation at 35 minutes post-instillation. Adverse events were infrequent, with fewer than 1% of patients reporting blurred vision, reduced acuity, photophobia or instillation site pain. The study results were recently published in the peer-review journal therapeutic delivery, and are available online in an open access format. We have received an expected PDUFA date of October 28, 2021 for MydCombi and have come measured investments in our U.S. commercial infrastructure. We are designing our commercial launch of MydCombi to be highly efficient, if and when we receive that approval. I would like to take a moment here and explain what we mean by an efficient commercial launch of MydCombi. MydCombi is a diagnostic pharmaceutical used in our exams. The product is not prescribed to individual patients, nor is it dependent on formulary acceptance or reimbursement. It is typically purchased by the practice on behalf of all doctors in that practice. And through our recently announced agreement with EVERSANA would be distributed through a streamlined system making use of e-commerce and real time sales data. If our commercial launch is successful, it will eliminate the need for a large conventional sales force and detailing, which can in some cases require about 100 salespeople and significant related infrastructure. We expect our launch on the other hand to be led by approximately 10 account managers who will focus on the largest practices and the largest population centers in the U.S. and expand further once those practices have incorporated MydCombi into their process. With our planned commercial launch, we estimate that we can get to approximately 50% of the patient volume in the U.S. by the end of 2022. We plan to have our sales force launch day ready so we can work on capturing our addressable market as quickly and efficiently as possible. We also are exploring partnerships with organizations that already have significant reach and presence into these offices to augment the work that our own account managers will be doing. It is worth highlighting that we believe the value proposition of MydCombi to the ophthalmologist or optometrist is very compelling. At a comparable cost to what they are spending today with the use of MydCombi, doctors can prepare a patient for a comprehensive eye exam faster than conventional [indiscernible] drops potentially resulting in reduced patient chair time and greater office throughput. This could in turn improve the practices bottom line. We believe MydCombi's value proposition coupled with our targeted distribution strategy will help drive the success of our commercial rollout. Needless to say, we are excited about the potential of MydCombi to disrupt what we estimate to be approximately $250 million market, and we look forward to meeting with the FDA later this year. If approved, MydCombi would be our first commercially available product and a significant milestone for our company. With that I'd like to turn it back over to Sean.

Thank you, Michael. As I did last quarter, I would like to take a step back for those who may be new to our story. Optejet is our 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 access drug and preservatives that can be harmful. The Optejet has been shown to achieve comparable efficacy to start on eye drops with approximately 75% less medication. We believe both patients and clinicians are comfortable using the Optejet. Prior studies found that approximately 95% of clinicians and 88% of patients were able to successfully administer medication using Optejet on the 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 the first attempt. Before turning the call to John to review the financials, I would like to conclude with a review of 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 gradual loss of the eyes ability to focus on nearby objects affects an estimated 113 million people in the U.S. and hundreds of millions more in China, where we have already licensed the product Arctic Vision. We recently announced the initiation of the VISION-1 study and anticipate data sometime in Q2 of 2021. We plan to follow this up with the initiation of VISION-2 potentially by the end of the year subject to COVID-19 and other factors in which we intend to test the higher dose of pilocarpine to further assess the tolerability and determine if there is adult depending response. There is 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 shows high interest among our target 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 an excess of $7 billion. Pilocarpine is a compound whose efficacy in improving near vision has been well-documented, what sets us apart from the competition in my opinion is the Optejet. If MicroLine is approved, we believe our technology will facilitate accurate and targeted dispensing of pilocarpine without overdosing BI as is common with conventional eyedroppers; a century-old technology used to administer other company's therapists. We believe the increased portability, comfort, and safety offered by the Optejet are among our important differentiators as we advance our development program. This is a very exciting program for us, and we're pleased to have initiated enrollment in VISiON-1. I'd now like to turn the call over to John to review our financials. John?

Thank you, Sean. Now I would like to review our financial results for the three and 12 months ended December 31, 2020. For the fourth quarter of 2020, we reported a net loss of approximately $4.2 million or $0.17 per share and this compares to a net loss of approximately $5.2 million or $0.31 per share for the fourth quarter of 2019. For the full year 2020 net loss was approximately $19.8 million or a loss of $0.94 per share and this compares to a net loss of approximately $21.2 million or $1.47 per share for the full year 2019. Revenue for the fourth quarter and full year of 2020 was $2 million. This revenue represents a milestone payment related to our exclusive collaboration and license agreement with Arctic Vision, which was announced in August 2020. We did not recognize any revenue in either the fourth quarter or full year of 2019. Research and development expenses totaled approximately $3.4 million for the fourth quarter of 2020; roughly flat with to approximately $3.3 million for the same period in 2019. For the full year 2020 R&D expenses decreased 6% or approximately $13.3 million, and this compares to $14.1 million for the full year 2019. For the fourth quarter of 2020 G&A expenses were approximately $2.1 million compared with approximately $2 million for the fourth quarter of 2019, an increase of approximately 5%. For the full year 2020, general and administrative expenses increased 7% to $7.7 million versus approximately $7.2 million for the full year 2019. Total operating expenses for the fourth quarter of 2020 were approximately $5.4 million, and this compares to total operating expenses of $5.3 million for the same period of 2019. This represents an increase of 2%. Fourth quarter 2020 operating expenses included approximately $656,000 of non-cash stock compensation expense. For the full year of 2020, total operating expenses decreased 1% approximately $21 million compared to $21.3 million for the full year 2019. 2020 operating expenses included approximately $2.5 million of non-cash stock compensation expense. As of December 31, 2020, the company's cash balance was approximately $28.4 million. We believe this cash balance and cash received in the first quarter of 2021 from the milestone payment, as well as Warren exercises is sufficient to last us into the middle of the first quarter of 2022, and will enable us to bring out our MydCombi, Mydriasis' product through the NDA process and commercial launch. In addition to completing the presbyopia clinical program for MicroLine and preparing our pilot manufacturing capabilities for advanced dispenser technology. This concludes our financial statement remarks. So, I'd like to turn the call back over to Sean. Sean?

Thank you, John. Thank you. In closing, we were very pleased with our performance during the fourth quarter and full year 2020, and subsequent period. To summarize, our key highlights today we anticipate on October 28, 2021 PDUFA date for our MydCombi NDA, which if approved gives us our first commercial product. We are rapidly advancing our Phase 3 presbyopia program in an estimated multi-billion dollar indication and anticipate data from our first of two Phase 3 studies in the very near term. And our licensing agreements with Arctic Vision and Bausch Health are progressing well and continue to offer the potential for meaningful development and regulatory milestones. Non-diluted funding that if realized we plan to use to among other things expand and advance our pipeline of Novel Therapeutics leveraging our MAP technology. We believe we are well positioned to achieve multiple commercial, regulatory and development catalysts in 2021, aimed at creating long-term value to our shareholders. That concludes our prepared remarks. We would now like to open the call for any questions. Operator?

[Operator Instructions] Our first question is from [indiscernible]. Please proceed with your question.

Hi, thanks. John, with VISION-1 study in addition to the primary endpoint, are there any secondary outcome measures that you're measuring here in this study and will you be able to present any of that data in the second quarter as well when this study is complete?

Yes. So I think it was a little faint to hear, I guess your question just to repeat it for everybody. I hope everybody can hear it is, whether we have any additional end points in addition to the primary end points or whether we're collecting other data? And yes, the answer is we are collecting a lot of data. We have secondary end points and exploratory end points as well. This trial will provide a wealth of data for us. Again, as you know, this is a Phase 3, Phase 2/3 study with two doses and we are really anticipating the data to see how that does with the Optejet. We will be able to be quite informed from this VISION-1 study before we proceed with the VISION-2 study later in the year. So yes, the answer is yes. And now to your question about; when we'll present the data? We will just have to see how that prices with our publication strategy. Of course this probably will be done in synchronization with our registration efforts and probably not ahead of them.

I see. And maybe just one follow-up on MydCombi PDUFA data, I think you guys announced that today, October 28th. At what point do you think you will need to bring in the sales – the specialized salespeople will probably be most likely in the third quarter or will it be before that?

Yes, so I will let Michael – yes, I'll let Michael articulated, but I think one of the parts of his presentation today was really to educate folks on really how we plan to launch this. This is not a launch where we're going to go all out blasting with 80 reps, partially because this is not your traditional commercial therapeutic, where it's prescribed one-by-one from one doctor to one patient. But we have some really mass purchasing distribution advantages here. And this would allow us to do it not only the confessional sales force, and really do it in a very cost effective way. Most people probably think about a commercialization in ophthalmology, typical to other companies where you would have to really bring in a big cost overhead. We are not looking at that as this may happen down when we go down towards MicroLine two years later where this would be justified, but MydCombi is a really perfect way to introduce the technology, prime the market and at the same time do it in a very cost efficient way. So maybe Michael, you can answer that in more detail.

Well, the only thing I would add for Tim is that we don't anticipate bringing anybody onboard before August and they would be here August, September start to be here. August, September in preparation for the approval at the end of October. And we would be using that time to work with them and our medical affairs people to educate potential customers on the technology so that when we do get the approval it becomes that much faster for us to get the uptake.

Okay, great. Well, look forward to seeing the data in the second quarter on MicroLine and thanks very much.

Certainly. Thank you.

And our next question is from Matt Kaplan with Ladenburg. Please proceed with your question.

Hey guys, thanks for taking the questions, and congrats on the recent progress. I guess, starting off, maybe a question for Michael. As you're kind of nearing the PDUFA date at the end of October, can you give us a little bit more sense in terms of your recent agreement with EVERSANA and how that fits into your marketing plans and commercial plan strategy for MydCombi as you prepare to launch?

Yes. And thank you very much for the question. What we're doing is all under the philosophy is we want to be as efficient as possible, and not build up an infrastructure that we're not going to have to feed. So the idea with EVERSANA is that they can take over things like invoicing and billing and customer service and shipping, and basically save us from having to have those things in house. So basically what we will keep in-house are the key account people, because we believe they need to have specialized knowledge about the technology, which a general sales force would not have, and they can do a better job of that. But everything else once that product is ordered, then it will be all online, use credit cards, again to keep it as simple as possible that will go through EVERSANA. So basically outsourcing that entire section of what we would normally, or what a company normally would have in-house, we won't have to build that ourselves.

Okay. And do you see your sales force is going to initially having kind of a very hands-on approach in terms of teaching the doctors and officers to use the device and then approach it that way or what's your strategy there?

So the strategy is it would be hands-on, it doesn't take a lot to educate them on how to use the product. It takes about 15 minutes, but we do believe you need to be able to touch and feel it to really get the best experience with the product. So the idea would be that our key account people would go into the practices and work with the technicians who most often they are the ones who actually do the pupil dilation and the office managers, they are the ones that do the ordering and the doctors in the end who have the final say, but they would go in there, they'd spend a lunchtime showing them how the dispenser works and what the advantages are and how to use it. And then they'd likely leave one for evaluation for three or four days. So they can actually use it on 75 patients and then come back and hopefully, because we'll be delighted by then complete the sale.

Great. Thanks. And then maybe a question for Sean, anticipating the potential success for MicroLine and VISION-1 given pilot [indiscernible] success in this indication already, what are your plans for VISION-2 – the VISION-2 study? And how that should take shape in terms of maybe timing and then any differences you're foreseeing versus VISION-1?

Yes, Matt, this is a very good question and maybe it's in terms of background, if you remember initially even before COVID we were planning to do VISION-1 and VISION-2 at the same time. I think COVID this intermediates that plan a little bit, and also when we looked at it, it actually made sense to learn from VISION-1 maximum we can and then apply it to VISION-2 because again, this is a really new indication, there's a whole lot of companies rushing into that. We know there were two positive Phase 3 studies from Allergan, AbbVie with the same compound, but we haven't even seen data yet. So I think we wanted to take a more measured approach where we really learn stepwise. The plan here is really to get quickly comfortable with the VISION-1 data in Q2 of next year, Q3 and very quickly by the end of the year, enroll starting to initiating enrollment of the VISION-2 study. And again, VISION-2 will not be materially different from VISION-1. We're still looking for the indications for on demand, improvement of near visual acuity. So a lot of the endpoints will be the same. We may down-select the dose from VISION-1 depending on the results. So I think it will be hard to say exactly what we will do, except that it's going to be very, very similar. We hope that this will be a positive study and would allow us to launch a VISION-2 promptly by the end of the year. And if that happens, Matt, I think we will be able to execute very similar to VISION-1. I mean, Ginger and her team did a phenomenal job in the midst of a COVID pandemic site closure and everything else. We were able to launch a study, operationalize it, execute and fully enroll it as we disclosed today. So I think that we're going be looking hopefully for a very similar cadence, a very prompt enrollment. We have so many patients. I mean, that's the beauty about this indication. There's just so many patients available. It's such a big opportunity in patient population. And patients and science are ecstatic about not just being able to be free of hardware and change the treatment paradigm for presbyopia. They're really ecstatic about the new technology where you don't have to have overdosing to the eye, redness and really use a very antiquated paradigm with the eye dropper to use something very modern and smart. So I think for us, we don't foresee any issues when we decide and push the button to launch VISION-2 hopefully by the end of this year to really get very quick results for VISION-2 as well.

Great. Thank you. And definitely impressive execution by your clinical team, given the backdrop of the pandemic. So congrats on that.

Thank you, Matt.

Our next question is from Jonathan Aschoff with ROTH Capital Partners. Please proceed with your question.

Thank you. I was wondering, even though you were talking about Mydcombi, not being sold to individual patients, is there any way that it could somehow still be used off label in amblyopia? Do you expect any news from that setting?

Right. So when you say Mydcombi used for amblyopia, first we as a company will never really encourage off label use in anyway. Second, I think therapeutically today, the way amblyopia is treated is by use of actual pain not by use of a fixed combination phenylephrine and tropicamide. So again, we don't really know. I think that the response to Mydcombi and to the technologies is huge. People really don't understand how game-changing that is for the eye exam today, which hasn't changed in almost a 100 years and transitioning from two or three drops to a single pray that really can alleviate a lot of the discomfort and problems with patient experience with that. I'm not – I'm sure doctors and people, clinicians out there who are very creative, may find different applications. And certainly, Eyenovia will support them in that as a – through a registration pathway, such as part of the life cycle section we find but in that as a through a registration pathway, such as part of the life cycle section we find. But for now we're really focused on the market. And when Michael says it's a $250 million market, it's a $250 million market, assuming we're really on parity – price parity with the conventional paradigm. And we're not dramatically moving the price target, which may be very different once we have a very successful product. And we find out that that market can be re-energized in a major way. And after all, you have so many dilations happening every year here. But who knows what the clinicians will suggest, and we'll certainly be listening to the marketplace out there.

Actually how clear have you been with what your pricing – your initial pricing will be to Mydcombi?

Yes. Michael, do you want to address that?

Yes, so and thanks, Jonathan. We know that what doctors are spending or officers are spending now for the two drugs that they currently use is somewhere around a $1, $1.5 for patients. And we've said that, we're going to be very close to that. We're anticipating a price of about $100, a cartridge and a cartridge should treat at least 75 patients. So from an out of pocket expense for the practice, it should not be an issue.

Okay. Thank you very much, guys.

You're welcome.

[Operator Instructions] Our next question is from Leonard Yaffe with Stoc*Doc Partners. Please proceed with your question.

Thank you very much. And I think this is the first conference call that you've had since the promotion of Mr. Rowe to COO. So I just wanted to commend you on that new responsibility for him. My question is when we get the results from VISION-1, we'd be getting results similar to the Allergan endpoint of improvement in their vision and low light conditions without a endpoint of improvement in near vision and low-light conditions without a loss of distance vision, or let's just be a subset of that?

Yes, Leonard, thank you. And again, it's a really timely congratulations and we're very excited about the increased responsibility and role for Michael. And in that spirit, I'll just let him answer that question.

Thank you, doctor and doctor. The results that we're going to have available in the second quarter will be top-line. There'll be very similar to the results that have been presented by Allergan. We're also going to take a special look when at the side effect profile. We have a strong history in clinical studies of demonstrating that by using our technology, you can get similar effectiveness and much better tolerability. And we're hoping and looking forward to being able to see that in the presbyopia trials. One of the things that's held back pylocarpine as an eye drop for presbyopia is that it's known to have a brow ache or headache side effect is about 20% of patients. And we believe in our market research shows us that if we can significantly improve on that it would do a lot to encourage uptake and eventually choosing the microdose product, our product, and the Optejet over a traditional eye dropper.

Yes, I think that your dosing is I think on either side of the Allergan dose, but you deliver less. I was wondering of pilocarpine, the two doses you've chosen, I was wondering if you could comment on that. And secondly, I think that it's an important point given that there is a non-medical need for a presbyopia drug in their alternatives that can be used such that if the patients are experiencing any discomfort of any consequence, they're very likely to revert back to eyeglasses or contact lenses. So I think that bears great understanding. Thank you.

Yes. Certainly on the second part, we would agree that people don’t want to have to feel tied to their reading glasses all of the time, but they're not willing to trade that off for the potential of headache or a brow ache. So we're looking forward to coming in pretty clean on there. And as far as the dose itself, we did 1% and 2% because we wanted to see if we could push up efficacy without reducing the tolerability, and we think we can do that. We didn't choose an intermediate dose because unlike with eye drops, we don't have to worry about being substituted with a generic medication. So if I was an eye drop and I have a 1% pilocarpine for presbyopia, I could easily be substituted with a 1% pilocarpine that's used in glaucoma. So to avoid that, I will go to a 1.25%, for example, pilocarpine, and that's how I get around that from a substitution point of view. But because we cannot be substituted in that way, it's not something we need to worry about.

Great. Thank you.

Thank you.

And we have reached the end of the question-and-answer session, and I will now turn the call over to Sean Ianchulev for closing remarks.

Okay. Well, that concludes the call today. Thank you again for joining us. We look forward to our first quarter 2021 financial update in May, and I hope everybody has a good afternoon. Thank you.

This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.