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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 safe harbor provisions of the Private Securities Litigation Reform Act. We caution... | neutral |
This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 18, 2024. 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 ... | neutral |
With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer. Michael, the floor is yours. | neutral |
Thanks, Eric. And welcome, everyone, to our fourth quarter and full year 2020 financial Results Conference Call. Last quarter, I talked about how [indiscernible] to pull on as we continue our growth into a development and commercial organization. Those levers were revenues, agreements and sources of capital. Today, I w... | neutral |
So let's dive right into it with our 2 FDA-approved products sobetosole propionate ophthalmic suspension 0.05% and MydCombi. As you may recall, the U.S. commercial rights for Clobetasol were acquired from Taiwan based for most of pharmaceuticals last August. Just last week, we transferred the NDA for clobetasol from Fo... | neutral |
Clobetasol is a potent steroid indicated for pain and inflammation following ocular surgery. This is the first time that this molecule is available in ophthalmology. Its efficacy and safety profile is highly desirable with nearly 9 out of 10 patients achieving complete absence of postsurgical pain and 6 out of 10 achie... | positive |
It is estimated there are more than 7 million ocular surgeries in the U.S. each year. most of which are treated with topical ocular steroids and steroid combinations currently totaling $1.3 billion in sales. This is a very significant market opportunity and 1 that we think we can capture a mid-single-digit market share... | positive |
Longer term, we see a potential opportunity to develop a formulation of clobetasol for our Optojet dispenser as a potential treatment for dry eye, a market estimated to be worth over $3.6 billion. To that end, we plan to engage with the FDA in the coming months to discuss a path forward in that indication. While mobeta... | positive |
In terms of manufacturing, in November, we were very pleased to announce that our contract manufacturer, Coastline International was approved by the FDA for MydCombi commercial manufacturing. We also recently announced FDA approval of our Redwood City facility as a commercial manufacturing facility. With Redwood City, ... | positive |
Customer feedback on MydCombi has been excellent. And to further illustrate that point, we are very pleased to announce that Vision Source, a leading network of approximately 3,000 locally owned optometry offices has added MydCombi as an approved product for its membership. We have great expectations for the sales chan... | positive |
Staying on the topic of MydCombi for a moment, we recently completed the study to determine if there was a lower dose that could be effective to achieve pupil dilation for drug-sensitive patients. The study was conducted by [ Dr. Denis Pencil ]of the State University of New York School of Optometry. 29 subjects were t... | positive |
Given that a standard of care mydriasis agent, senolefrin, may present safety risks in a few older patients the greater dosing flexibility enabled by MydCombi and the Optejet could address an unmet need among the approximately 100 million comprehensive and diabetic eye exams and over 4 million cataract surgeries perfor... | positive |
In summary, we are actively promoting MydCombi and we'll be leveraging our new agreement with Vision Source. We are preparing to commercialize Clobetasol and will [indiscernible] our new agreement with NovaBay, and we are reloading our pipeline by bringing MicroPine back through reacquiring the commercial and developme... | positive |
In terms of next steps, we are continuing to advance Phase III CHAPERONE study, and we plan to meet with the FDA to explore options to expedite development and registration of MicroPine in a capital-efficient manner. [ One action ] we are working on is a planned interim look at the CHAPERONE data later this year. If th... | neutral |
At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update. Bren? | neutral |
Thank you, Michael. During the fourth quarter and through early this year, we continue to execute on our strategy to maintain control of our manufacturing processes, ensuring our products meet high levels of reliability and stability. As a reminder, we use contract manufacturers to supplies with drug substance, which w... | positive |
As previously announced, Coast Lining International also received FDA approval and is now producing MydCombi commercial supply. Redwood City will also be the manufacturing site of our Gen 2 device which has significantly fewer parts than our existing device, making its manufacturing easier and more reliable. We are tar... | positive |
As noted earlier this year, Eyenovia has reacquired the rights to MicroPine. MicroPine is an investigational 8-microliter ophthalmic spray of atropine delivered by Eyenovia's proprietary Optejet device being evaluated as a potential treatment for pediatric progressive myopia characterized by elongation of the retina. W... | positive |
I would now like to turn the call over to our Chief Financial Officer, John Gandolfo, to provide a financial update. John? | neutral |
Thank you, Bren. For the fourth quarter of 2023, we reported net loss of approximately $8 million or $0.18 per share and approximately 45.4 million weighted average shares outstanding. This includes a $0.02 loss related to the onetime repatriation costs for bringing MicroPine back to Eyenovia from Bash. This compares t... | negative |
For the full year 2023, we reported a net loss of approximately $27.3 million or $0.66 per share and approximately 41 million weighted average shares outstanding. This compares to a $28 million or $0.83 per share and approximately 33.6 million weighted average shares outstanding for the full year 2022. Research and dev... | negative |
For the fourth quarter of 2023, general and administrative expenses were approximately $3.4 million as compared to $3.2 million for the fourth quarter of 2022, an increase of 7.3%. For the full year 2023, G&A expenses decreased approximately 8.1% to $12.4 million as compared to $13.5 million for the full year 2022. The... | negative |
I'll now provide an update on our existing licensing agreement with Arctic Vision for all 3 of our products in China and South Korea. Regarding our prior partnership with Bausch and Lomb, as Michael mentioned earlier, we reacquired the development and commercial rights to MicroPine and have taken over continued executi... | neutral |
In conclusion, we are very pleased with our performance in the fourth quarter of 2023 and as well as the subsequent period. To summarize our key highlights today, we reacquired the development and commercialization rights to MicroPine in the U.S. and Canada from Bausch and Lomb. MicroPine is in Phase III and a potentia... | positive |
That concludes our prepared remarks. We would now like to turn the call over for questions. Operator? | neutral |
[Operator Instructions]. Our first question comes from the line of Tim Lugo with William Blair. | neutral |
Now that the MicroPine has been brought back into the company and you have the rights, can you talk about this accelerating the development of the program? I know in the prepared remarks, you mentioned you'll engage with the agency about this [indiscernible] maybe I'd love to hear some initial thoughts around what you ... | neutral |
Yes. Tim, thank you for the question. Our intent is to do a protocol amendment and put in an interim analysis later this year when we believe we would have sufficient power to detect a significant results from one of the arms of this study. And we'll be talking to the FDA about that as well because if we do that and if... | positive |
That's very helpful. And regarding the half dose study, is that something that Optejet can adjust to? Or do you need to submit an sNDA to get this onto the label? | neutral |
Well, to get that on to the label, we would have to submit to the FDA. That study was done to answer a very specific medical question for a specific population. So we are able to adjust to that with the Optejet because we did want to get that answer to see if you could go lower for this particular need. | neutral |
Okay. Fair enough. And for the NovaBay co-promotion, could you -- again -- and maybe you have this in the comments and I missed it, but can you just kind of scope out what capabilities they're bringing to the margin in clobetasol. | neutral |
They are bringing an in-house sales force that's very experienced doing telephone sales into cataract surgeons. They do it now for their product, AVANOVA. So they would take that experience and do the same for fobebazole in those areas where we do not have salespeople. So essentially, they will extend our reach into th... | positive |
Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann. | neutral |
Just wanted to first focus on your commercial programs. Can you help us understand the kind of potential launch trajectories for both Clobetasol and MydCombi and what we should expect, I guess, this year and going into next, specifically? | neutral |
Matt, it's good to have your call. John, I believe that there have been analysts out there that have spoken to this. I know we haven't given guidance, but maybe you can talk to what our reaction has been to the analysts. | neutral |
Yes. So we're -- the analysts do have numbers in their model out there, and we're very comfortable with the analyst estimates that are out there for the balance of 2024. At this point, we're not going to give revenue guidance ourselves. We'll reevaluate that at the end of the year after these products have been in the ... | neutral |
Okay. That's helpful. And maybe just to focus in on a little bit with your new lease signed agreement with Vision Source. You mentioned that there are out 3,000 offices that are associated with that. Should we expect more or additional deals or collaborations such as these kind of going forward as you continue to launc... | neutral |
Yes, absolutely. So this is the first one that's signed. We do have others that are in the signature phase and they are a mix. Some of them are like Vision Source, whereas for the retail optometrists, others are with large institutions where they are looking to replace their disposable use of [indiscernible] agents. Wh... | neutral |
Great. And then just shifting to your pipeline, your second-generation device. Can you tell us a little bit more about that and how it differs from the first gen and when we should expect it potentially to be used with MydCombi in the marketplace. | positive |
Bren, would you like to give a high-level discussion about Gen 2? | neutral |
Absolutely. So our Gen 2 product offers simplification from a manufacturing capability, enabling us to produce these more easily with a high reliability. With MydCombi being the first platform that we're going to take that into. We're actually actively working on our registration batches to be completed this year. And ... | positive |
Okay. Great. And then -- with respect to your dry eye program, can you tell us a little bit more about that and when we -- do you expect to move that into the clinic this year? | positive |
Yes. We actually have 3 things that we're working on. We have acute dry eye that we're in discussions with Formosa for Clobetasol. We have chronic dry eye that we're actually actively collaborating with a company where we're working on taking their drug and putting them into the option and making sure it's entirely com... | neutral |
Our next question comes from the line of Matthew Caufield with H.C. Wainright. | neutral |
So with Clobetasol plans for Optejet development in dry eye, are there any comparable advantages to ultimately utilizing Optejet within the approved indication for postoperative pain? | neutral |
Thank you, Matthew, for that question. The answer is yes. It would be a lot easier for cataract and other postsurgical patients to use the Optejet in my opinion than an eye dropper, and we could certainly go back and look at that again. What we would have to do basically is run a pain study, although only one of them p... | neutral |
Understood. Very helpful. And then with the $14.8 million in cash and equivalents through year-end '23, I don't know if I missed this, but did you give any sense of the current cash runway just for the near term? | neutral |
Yes, I'll take that. So as I mentioned in the prepared remarks, we're actually evaluating all different opportunities that we have, and we'll raise cash in order to fund the company's strategy going forward. The historical burn has been about $4.5 million to $5 million per quarter on an operating basis. We don't expect... | neutral |
Our next question comes from the line of Kemp Dolliver with Brookline Capital Markets. | neutral |
I have 2 questions. First, with regard to Aperture, what needs to change for you to start advancing that program again? | negative |
Thank you. It's good to have you on the call and a good question. So right now, that market is pretty stable and [indiscernible] is selling about $14 million or $15 million, maybe not even that high. per year. So to be successful in this market is going to require, in my opinion, a strong promotional effort to basicall... | negative |
Is this something you would partner out possibly? | negative |
We would, and we certainly could be talking with people, but I don't think at the moment, there's a tremendous amount of interest in the market. So again, I think there's a lot of -- the big players are waiting by the side to see what happens as well. | negative |
Great. And second question is with -- on Clobetasol and with your market share guidance, just to take the other side of the thought process. So you have a product with superior dosing. What's the gating factor with the update given that -- or the uptake given that advantage. | positive |
So if you look at the glaucoma market as a surrogate, because it's very similar, you basically have 80% or 85% of the units are actually sold our generics. And then you have a small group of branded products that make up 15% of the units, but they make up about 50% of the value. So it would be very similar in the stero... | neutral |
And have you started speaking with payers? Do you have any progress to report yet? | negative |
We're doing the entire thing, cash. We're working with an e-pharmacy as well as getting the wholesale licenses because about 85% of ophthalmic surgeons sell the steroid right out of their office. And so the way we're doing this is as a wholesaler, we'll be supplying the physician offices. And for individual patients, t... | positive |
We have reached the end of our question-and-answer session. And with that, I would like to turn the floor back over to Michael Rowe for closing comments. | neutral |
Thank you, and thank all of you for joining us today. and that concludes today's call. We are very pleased with our progress to date, and we are very well positioned to continue our current momentum as our long-term commercial plan and strategy continues to emerge. So thank you again for joining us, and we look forward... | positive |
This concludes today's telenference. You may disconnect your lines at this time. Thank you for your participation. | neutral |
My name is Celine, and I will be your conference operator today. | neutral |
(Operator Instructions)Please be advised that today's conference is being recorded. | neutral |
I would now like to hand the conference over to your speaker today, Anil Gupta, Vice President, Investor Relations. | neutral |
Good afternoon, and welcome to the Coinbase Third Quarter 2021 Earnings Call. | neutral |
Joining me on today's call are Brian Armstrong, Co-Founder and CEO; and Emilie Choi, President and COO; and Alesia Haas, CFO. | neutral |
I hope you have all had the opportunity to read our shareholder letter, which was published on our Investor Relations website earlier today. | neutral |
Before we get started, I'd like to remind you that during today's call, we may make forward-looking statements. | neutral |
Actual results may vary materially from today's statements. | neutral |
Information concerning risks, uncertainties and other factors that could cause results to differ from these forward-looking statements is included in our SEC filings and shareholder letter available on our IR website at investor.coinbase.com. | neutral |
Our discussion today will include references to adjusted EBITDA, a non-GAAP financial measure. | neutral |
We believe that certain non-GAAP measures of financial results provide useful information to management and investors regarding trends relating to our financial condition and results of operations. | neutral |
Non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, GAAP measures. | neutral |
You can find additional disclosures regarding adjusted EBITDA, including a reconciliation to net income as a comparable GAAP measure, in our shareholder letter and current report on Form 8-K, which are posted on our IR website. | neutral |
I want to note that we are once again using the Say Technologies platform to enable our shareholders to post questions to our management team. | neutral |
In addition, we will take some live questions from our research analysts. | neutral |
And with that, I'll turn it over to Brian and Alesia for some introductory comments. | neutral |
Thanks, everybody, for joining us as well. | neutral |
So we've had another solid quarter, and this is amidst the volatility happening out there in the crypto market. | positive |
So we never know exactly what's going to be happening this quarter in crypto, but we are seeing really strong and accelerating pace of crypto adoption globally. | positive |
So in the letter, we actually shared some insights on the pace of this adoption and how it mirrors that of the Internet 25 to 30 years ago and looked at some third-party research, which indicates that crypto users have doubled in the first half of this year, now over 200 million people, and that growth is accelerating. | positive |
So what are we going to focus on at Coinbase? | neutral |
We're a product-led company, and we focus a lot on how we can improve the customer experience to get 1 billion people accessing the cryptoeconomy through our products every day. | neutral |
Well, we're investing in our core apps, the main retail app. | neutral |
We're also investing in our Prime brokerage app for institutions. | neutral |
We're building Coinbase Cloud, which is our AWS-like developer platform, for any business out there that wants to build into the cryptoeconomy. | neutral |
And we're even investing in new initiatives like our NFT marketplace and our direct deposit offering. | neutral |
The second area is around customer service. | neutral |
So you saw that we announced 24/7 phone customer support, which we're going to be rolling out next quarter. | positive |
We're also investing in site reliability. | neutral |
Amidst of all this growth, we're very focused on maintaining adequate uptime for our apps and websites in this unprecedented growth period. | neutral |
And then lastly, we're focused on our policy and government relations efforts and in regulation. | neutral |
And so this is continuing the tradition that Coinbase has had since the beginning of seeking out regulators, being the most trusted; getting licenses; and actually being an educational resource to help educate folks around the world about how this industry can be something very positive for the world. | positive |
So I know there's lots of questions to get to. | neutral |
But let me stop there, and I'm going to turn it over to Alesia next to share a summary of our financial performance. | neutral |
As Brian shared, Q3 was a strong quarter for Coinbase. | positive |
We provided a lot of disclosure in our letter, but I thought I would share a few perspectives. | neutral |
The story of our third quarter really centers on lower volatility that we saw early in the quarter. | neutral |
Our monthly transacting users and trading volumes, and therefore, transaction fee revenue, all correlate with volatility. | neutral |
So it's a very important driver of financials. | neutral |
Trading volume across the entire crypto spot market declined quarter-over-quarter in Q3. | negative |
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