Eyenovia Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 7 speakers on the call.

Operator

As a reminder, this conference is being recorded. At this time, I would like to hand the call over to your moderator, Eric Ribner of Investor Relations. Thank you. You may begin.

Speaker 1

Good afternoon, everyone, and welcome to Eyenovia's Q2 2023 earnings conference call and audio webcast. With me today are Eyenovia's Chief Executive Officer, Michael Roe Chief Financial Officer, John Gandolfo and Chief Operating Officer, Brian Kern. This afternoon, we issued a press release announcing financial results for the 3 6 month period ending June 30, 2023. We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10 Q for the quarter ended June 30, 2023, which will be filed with the SEC Tomorrow, August 11, and our most recent filed 10 ks. The company's press release and annual report are also available on our website atwww.inovia.com.

Speaker 1

In addition, this conference call is being webcast to the company's website and It will be archived for future reference. Please note that on today's call, we will be discussing products, Product concepts and candidates, some of which have yet to receive FDA approval. Please also note that certain information discussed on the call today is covered under the Harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during the 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 risks and uncertainties associated with the company's business.

Speaker 1

These forward looking statements are subject to a number of risks, which are described in more detail in our annual report and Form 10 ks and other SEC filings. This conference call contains time sensitive information that is accurate only as of the date of this live broadcast, August 10, 2023. 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 that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer.

Speaker 2

Michael? Thank you, Eric,

Speaker 3

and welcome everyone to our Q2 2023 financial results conference call. We had an extremely productive Q2 and I am excited to share with you our progress this afternoon. During our last conference We spoke of our efforts to begin our targeted launch of Bitcombi and our goal of partnering with other companies to leverage and monetize the OptoGen technology Beyond our own development programs, today we will provide an update for both of these topics, starting with midcombi and our recent first commercial sale. As you'll recall in May, we received FDA approval of Midkawi, the first and only fixed combination of tropicamide and phenylephrine And the only ophthalmic spray for inducing mydriasis for diagnostic procedures and then conditions where short term pupil dilation is desired. We are proud to have delivered the 1st FDA approved product that leverages our OptoJet dispensing device.

Speaker 3

This important advancement was featured at the annual Gene Ophthalmology Tech Forum in June, where we highlighted the innovative nature of Begovy and the future of the OptoGen technology to the ophthalmic community, Including potential industry partners, thought leaders and investors. We're thrilled to have initiated sales of Bikcomi to a targeted group of professional offices, ophthalmologists, optometrists, technicians and patients are now experiencing the benefits of INKOMBI themselves And together, we are learning how the product can streamline practices and help with patient management. As we announced last week upon receipt of our New York pharmacy license, We achieved our first commercial sale of Midkabi to world renowned board certified ophthalmologist, Doctor. Nathan Ratcliffe, who becomes first to incorporate Midkabi Into his daily practice. Last week, we conducted training at OC Retina in Orange County, California.

Speaker 4

And as soon as

Speaker 3

our California pharmacy license is received, We anticipate initiating sales in this state. We're already receiving positive feedback from doctors, technicians and patients, We anticipate this will only increase with additional sales and marketing ramp up. To that end, we are in the process of formally adding additional commercial manufacturing sites To support MidConvey, including our Redwood City facility as well as Coastline Manufacturing as a secondary site. Bren will provide additional details during his manufacturing overview. These additional sites will provide us with increased capacity To meet and anticipate demand not only at midcombi, but potential future ophthalmic therapies utilizing the OptoGen.

Speaker 3

If you would like to find out more about Midkombe, track our launch progress and hear what doctors and patients are saying about the product, You can go to the website at midcombi.com. Now I'd like to talk a bit more about our efforts Leverage and monetize the OptoGen technology through partnerships with other companies. We have engaged in active Discussions in this area with no fewer than 4 companies across a variety of topical ophthalmic markets. Some of these discussions take longer than would be assumed because we need to first determine if the products under discussion are compatible with the OptoJet. This is something that is true for any container closure system and usually those tests include both spray performance as well as material compatibility.

Speaker 3

We anticipate being able to announce the first of these arrangements very shortly. Our goal with all of these discussions is to marry our leading Delivery technology with a new or unique drug asset to bring the best of both worlds to patients and prescribers, While providing near term revenue and or capital opportunities for the company, I'll now provide an update on Aperture, Our intended brand name for the MicroLine project. Aprosure is our proprietary topical on demand pilocarpine based therapeutic candidate We are developing for the temporary improvement in near vision associated with presbyopia. As you may know, presbyopia is the age related hardening of the eye's lens Causing blurred near vision. This addressable market represents over 18,000,000 people in the United States alone Between the ages of 4055 who otherwise never wore glasses and have the resources for a cash pay product, Our proprietary market research suggests this could be nearly $1,000,000,000 annual market in the U.

Speaker 3

S. Alone. As we discussed last quarter, we received feedback from the FDA outlining a clear path forward for this program towards a new drug application For NDA, and we continue to make progress on this front. Aperture is being designed for use with our more advanced Gen 2 OptoJet device, Which has been optimized for in home use. These will be manufactured in our Redwood City facility and we anticipate that manufacturing of registration batches will commence in the Q4 of this year.

Speaker 3

Based on the FDA requirements of 12 months of real time stability data on the final packaged product before filing an NDA, We plan to file the NDA approximately 12 months after we run those batches till late 2024. ApoSure differs from the current topical drug treatment option for presbyopia on the market and those in development and that is a drug device combination. As such, many optometrists would be able to include AproSure as an offering to patients along with eyeglasses. Aperture has been described by some in market research as a second pair of invisible glasses or the way to gain physical vision For those times when wearing glasses is not desirable. We tested this concept with 100 optometrists who found that Aperture We meet the needs of both themselves and their patients better than any other pharmaceutical option that they have or believe will have available.

Speaker 3

These doctors estimated that apoShark ophthalmic spray could capture as much as 1 third of the presbyopia pharmaceutical market With the other 5 products, all eye drops competing for the remaining 2 thirds of that market. If approved, we believe that Aperture Administered using the OptoJet will stand out as the one and only spray distinguished by its ergonomic design, ease of use And potentially advantageous side effect profile. At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kearns, For our manufacturing update, Bren?

Speaker 4

Thank you, Michael. As Michael mentioned, we continue to expeditiously We build out our manufacturing capabilities in support of Mecomni and registration batches for Aperger. To expand upon the Mecomni targeted launch, We have filed with the FDA a request for approved the use of additional manufacturing site, Coastline International. The FDA has given us a PDUFA date of mid November 2023 for this site to be approved for use. Coastline has already been manufacturing clinical supply for us For over a year and has extensive experience with the OptiGen.

Speaker 4

Following the PDUFA, we anticipate this to be a smooth ramp up And the team at Coastline is eager to support our commercial manufacturing needs. We also submitted our Redwood City facility to the FDA as an additional manufacturing sites And anticipate hearing from the FDA soon without PDUFA date. Our Redwood City facility has made significant progress in qualifying our Gen 2 fill and finish line. The team is scheduled to begin media sales this month, a monumental step in qualifying this production equipment to support Aperger And the remainder of the Eyenovia drug product lines. As Michael mentioned, we are targeting the initiation of Aprosure registration batches in the Q4 of 2023.

Speaker 4

Additionally, our Reno facility continues to make significant progress in establishing base image after manufacturing. On our last earnings call, we noted that the facility construction has been completed and the staff has taken occupancy. Since then, production equipment has been received, Installation of the equipment is currently underway and qualification activities are in the final planning stages. I continue to be excited about We've made to enhance our manufacturing. With an increased manufacturing capacity, we'll be better positioned to meet the anticipated growth demand of OptuJet, Particularly with the approval and commercial availability of MidCombi.

Speaker 4

I would now like to turn the call over to our Chief Financial John Gandolfo to provide a financial update. John?

Speaker 5

Thanks, Brent. For the Q2 of 2023, net loss was approximately $6,200,000 or $0.16 per share Compared to a net loss of approximately $7,200,000 or $0.22 per share for the Q2 of 2022. Research and development expenses totaled approximately $2,800,000 for the Q2 of 2023 as compared to $3,600,000 for the Q2 of 2022. For the Q2 of 2023, G and A expenses were approximately $3,100,000 Compared to $3,500,000 for the Q2 of 2022. Total operating expenses For the Q2 of 2023 were approximately $6,000,000 compared to $7,100,000 for the Q2 of 2022.

Speaker 5

As of June 30, 2023, company's cash and cash equivalents were approximately $17,500,000 Compared to $22,900,000 as of December 31, 2022. This includes an additional $5,000,000 drawdown on our credit Line with Avenue Capital that was triggered by the FDA approval of Midcombi. For a brief update on our licensing revenues, In addition to the cash balance noted above, we have receivable from our licensed partners of approximately $430,000 as of June 30, 2023, And expect a reimbursement payment of approximately $2,000,000 from Arctic Vision for product development expenses in the second half of twenty twenty three. I'll now provide an update on our existing licensing programs with Bausch Health for MicroPine in the U. S.

Speaker 5

And Canada Endartic Vision for all three of our products in China and South Korea. Fashion Long is continuing to enroll in the ongoing Phase 3 chaperone trial of atropine, a proprietary atropine formulation for the reduction of pediatric myopia progression. It has been shown in clinical studies to slow myopia progression by 60% or more. There are currently no FDA approved drug therapies for this indication And if left untreated, this can result in retinal detachment, myopic retinopathy as well as vision loss. Our agreement with Arc Division covers Greater China and South Korea and covers MicroPine, MicroLine and Midcombi And provides us sales royalties in addition to development milestones.

Speaker 5

MicroPine in particular is a significant opportunity in China for pediatric myopia. If approved, MicroPine could be a significant source of non dilutive funding for our company over the long term. To date, our license agreements have generated approximately $16,000,000 in license fees with the potential to earn an additional $60,000,000 In net license and development milestones as well as reimbursable expenses over the next 4 years. Upon commercialization, if our products are approved, Eyenovia is also eligible to earn significant sales royalties. We are also continuing to assess potential pipeline expansion opportunities Similar to our Formosa agreement, and we will continue to leverage the OptoJet technology to address unmet needs And additional large ophthalmic indications.

Speaker 5

Finally, Eyenovia was added to the small cap Russell 2000 and broad market Russell 3,000 indices effective in June as part of the annual Russell Indexes reconstitution. The reconstitution captures the 4,000 largest U. S. Stocks as of April 28, 2023 ranked by total market capitalization. So in conclusion, we are very pleased with our performance through the first half of twenty twenty three.

Speaker 5

To summarize some of the key highlights, We received FDA approval of Midcombi and initiated sales to select professional offices. Registration batches for our Aperture press The opioid programs are expected to initiate in the Q4 of 2023. We continue to advance discussions with multiple potential partners We'll leverage the OptoJet in additional ophthalmic indications. We're continuing to build out our manufacturing capabilities With Coastline Manufacturing and our Redwood City facilities anticipated to come to support Midcombi production in late 2023 In early 2024 respectively. And our licensing agreements with Arctic Vision and Bastian Loan are progressing well And remain a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties.

Speaker 5

That concludes our prepared remarks today. We would now like to open the call to questions. Operator?

Operator

Thank you. We will now be conducting a question and answer Our first question has come from the line of Matthew Caufield with H. C. Wainwright. Please proceed with your question.

Speaker 6

Yes. Hey, guys. Can you hear me okay?

Speaker 3

Yes, Matt.

Speaker 6

Great. Michael and team, thanks for taking our questions and congrats obviously on the ongoing OpRegen progress this quarter. So first of two questions. Regarding development of the Gen 2 device, particularly for on demand presbyopia, is there a point in the future where all devices will be Gen 2, Both prospectively for MicroLine or Aperture as well as for a midcombi. Just kind of wondering if there's any sort of manufacturing streamlining If all optogets are based on the Gen 2 design.

Speaker 3

Thank you, Matt, for that question. The answer is Yes. And the reason we're going from Gen 1 to Gen 2 is, not just because Gen 2 ergonomically and aesthetically we believe is a nicer product, But it has far fewer parts than the Gen 1 does. So while the system that you use to spray is identical, The parts within the Gen 2 make it a lot easier and simpler and less costly to actually build. So in the long term, we do want to get everything on

Speaker 6

Got it. Very helpful. And then just one kind of follow-up on the presbyopia progress. So have the Generation 2 studies for microbial challenge, human factor, electronic safety And any drug stability data? Have those all been completed?

Speaker 6

Or are any of those efforts kind of still ongoing presently?

Speaker 3

Some of those are completed, some are ongoing, but they will all be done probably by the end of this year. So they're not a rate limiting step and there's nothing in there that causes us any pause because a lot of this is very similar to what we did with the Gen 1. So really the rate limiting That is the 12 month stability.

Speaker 6

Got it. Very helpful. All right. Thank you very much guys and congrats again on the progress this Thank

Speaker 3

you, Matt.

Operator

Thank you. Our next questions come from the line of Matt Kaplan with Ladenburg Thalmann. Please proceed with your question.

Speaker 2

Hi. This is Raymond in for Matt. Thanks for taking our question and congrats on all the progress. I'm glad to see the economy being used. I guess Relating to that, I was wondering, how should we think about kind of the stages of the launches as it progresses in terms of licenses, uptake And so forth.

Speaker 2

Thanks.

Speaker 1

And

Speaker 2

a follow-up. Thanks.

Speaker 3

John, do you want to take this or I can? It's up to you.

Speaker 5

No, it's okay. So I think that the with respect to Midkombe, we're focusing initially, as Michael mentioned, on a targeted launch program. We feel that with the Coastline manufacturing coming up towards the end of this year, We'll be able to give better visibility to the investor community as to guidance of MidCombi once we have that in place. So we expect probably with that Q3 earnings call, which will be in November, we'll be able to give guidance for Obviously, 2024, probably beyond as well. With respect to licenses or partnership opportunities, They remain a key focus of ours.

Speaker 5

Michael highlighted that we're speaking to no less than 4 parties at this time. So that continues to be a major focus for the company.

Speaker 2

Okay. Yes. No, definitely appreciate that color. I guess I was wondering, Are there any early feedback you're getting? And are you kind of do you see how you would like to incorporate that as you are Getting ready for a national launch next year?

Speaker 3

Yes. It's funny that you asked this question because we just were speaking With some of the technicians at one of the offices in New York, they've now used the product for a week. And What they're finding out is they started by using it on a few patients. They told us today they used it on every patient, 40 patients they dilated today. And the more they use it, the more they like it.

Speaker 3

What they're also finding is that the duration of dilation is less Then, it is with eye drops, which is actually a positive because one of the reasons people don't like to get dilated is they end up being dilated for hours and hours and hours Through the rest of the day and it's looking like with Midkombe you get the efficacy that you need and then It may very well not last as long, which is a positive you get back to normal. So we're definitely looking into that some more.

Speaker 2

I appreciate that detail. Very helpful. I'll jump back in the queue. Thanks.

Speaker 1

Thank

Operator

you. Thank you. I'm showing no further questions at this time. I'd like to hand the floor back to management for any closing

Speaker 3

Thank you. And thanks everybody for joining us today and that concludes today's call. We are very pleased with the year we have had so far. We've had our first FDA approval and commercial sale of MYCOMBI. Our Aperture presbyopia program is progressing And our manufacturing capabilities are continuing to grow.

Speaker 3

We look forward to continued momentum through the rest of 2023 and beyond. You again for joining us. We look forward to the Q3 update in

Operator

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your

Remove Ads
Powered by Quartr
Earnings Conference Call
Eyenovia Q2 2023
00:00 / 00:00
Remove Ads