Aiera/aiera-transcript-sentiment huggingface dataset:
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 full year decrease was driven by a reduction in legal expenses and executive recruitment costs on a year-over-year basis. Total operating expenses for the fourth quarter of 2023 were approximately $7.5 million as compared to $5.4 million for the same period in 2022. This represents an increase of approximately 39%. Total operating expenses for the full year 2023 decreased approximately 5.6%, $25.4 million as compared to $26.9 million for the full year 2022. As of December 31, 2023, company's cash balance was approximately $14.8 million as compared to $22.9 million as of December 31, 2022. We are currently reviewing -- evaluating various structures and alternatives to increase our cash resources in order to fund our corporate strategy going forward.
Sentiment: 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 execution of the ongoing Phase III CHAPERONE trial. Our agreement with Arctic Vision covers MicroPine, MicroLine and MydCombi and provides us sales royalties in addition to development milestones. MicroPine in particular, is a significant opportunity in China for pediatric myopia. If approved, MicroPine could be a potentially meaningful source of nondilutive funding for our company over the long term. To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn additional $25 million in net license and development milestones from Arctic Vision over the next 3 to 4 years. If our products are approved on commercialization, Eyenovia is also eligible to earn significant sales royalties as well. We are continuing to assess potential pipeline expansion opportunities similar to our Formosa agreement and we will continue to leverage the Optejet technology to address unmet needs and additional large ophthalmic indications beginning with dry eye.
Sentiment: 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 potential treatment for progressive pediatric myopia, a potential blockbuster opportunity for the company. We announced FDA approval of Clobetasol for the treatment of pain and inflammation following ocular surgery. We announced 2 important agreements to complement our own sales efforts, one with Vision Source for MydCombi and one with NovaBay for clobetasol and AVANOVA. We finalized the build-out of our manufacturing capabilities to support MydCombi production with cosign manufacturing and our Redwood City facility is now online in addition to our facility in Reno. And finally, our licensing agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties and commercialization.
Sentiment: positive
That concludes our prepared remarks. We would now like to turn the call over for questions. Operator?
Sentiment: neutral
[Operator Instructions]. Our first question comes from the line of Tim Lugo with William Blair.
Sentiment: 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 could do for this acceleration of the development?
Sentiment: 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 we are successful, as a placebo-controlled study, we may be able to make the argument that it's really not ethical to continue as it is with a placebo arm. If we can show that we already have a significant event, and that could shave a number of years off this study and enable us to bring it to an NDA that much faster. So the strategy is to do the interim analysis towards the end of this year. And if that is successful to talk to the FDA about how we can close that study earlier so that we can move to an NDA.
Sentiment: 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?
Sentiment: 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.
Sentiment: 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.
Sentiment: 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 those offices. And every time they're successful, they will get a percentage of that sale. And likewise, we can hand carry their product AVANOVA into cataract surgeons, where we do have salespeople because it is part of many of their practices. And where we are successful, we get a portion of that. So basically, it's a way to extend our promotional reach with no additional cost and the opportunity to pick up some money at the same time.
Sentiment: positive
Our next question comes from the line of Matt Kaplan with Ladenburg Thalmann.
Sentiment: 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?
Sentiment: 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.
Sentiment: 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 market for a while. But overall, I think we're comfortable with the analyst estimates, et cetera, out there.
Sentiment: 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 launch on MydCombi and Clobetasol?
Sentiment: 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. What they do now is they use the model once and they throw it away. And it's costly to them, it's like $15 every time they do this to a patient. So they would replace that with MydCombi. And we are working right now to get some of these agreements signed where we would essentially be on their formulary replacing what they're doing now.
Sentiment: 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.
Sentiment: positive
Bren, would you like to give a high-level discussion about Gen 2?
Sentiment: 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 then we'll be speaking with the FDA on getting the Gen 2 platform into MydCombi, hopefully early next year after we get the registration batches put up.
Sentiment: 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?
Sentiment: 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 compatible. And then we have a third one that we're -- also would be in chronic a different molecule that we're working on. So what we want to do is we have collaboration agreements in place. And what's happening in that collaboration agreement is we're working out all of the CMC issues of how do we get your drug over to our facility in a sterile fashion and how do we make sure it's compatible with our device. All of that takes anywhere between 4 and 6 months. when that's done, that leads to an option for a development agreement, and that's when we'll talk about it publicly.
Sentiment: neutral
Our next question comes from the line of Matthew Caufield with H.C. Wainright.
Sentiment: 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?
Sentiment: 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 pain and inflammation because according to the FDA, the Optejet delivers an opthalmic spray which is a different form than a thalamic solution. So it requires a Phase III study. Why that's a good thing is that it makes it impossible to replace the Optejet with an eye drop. So from a generic point of view, you can't simply take a molecule we put into the Optejet, and replace it with something that's in an eye drop form. So that's a good thing. But on the other hand, it causes us a little bit more time to get something approved. So the strategy was let's get this additional indication for dry eye, which is a much bigger indication for the product. And then we can make the decision to pivot back and redo a pain and inflammation on study to add that on to the Optejet and then ultimately just be on the Optejet platform.
Sentiment: 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?
Sentiment: 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 that to change at all. We will see some decrease in R&D expenses, some increase associated with the MicroPine study. So that's basically where we think the operating [ burn ] will come in for the year. We are expecting close to $2 million from Arctic Vision as well for a product development milestone going forward. So that gives you somewhat of a sense of where we see us from a cash standpoint.
Sentiment: neutral
Our next question comes from the line of Kemp Dolliver with Brookline Capital Markets.
Sentiment: neutral
I have 2 questions. First, with regard to Aperture, what needs to change for you to start advancing that program again?
Sentiment: 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 basically do a relaunch of this. So if I look at it, if we do it, it's $1 million to do the registration batches, it's $4 million to file the NDA. So that's $5 million, and that's without making the investment try to lift the market. And that's pretty pricy in a market right now that's doing less than $15 million. So there is already one approved product that's waiting on the sidelines, an eye drop to come in. There's another one that's in Phase III. I think in the end, there may be multiple eye drop competitors in the market, but we would be the only Optejet. So if 1 or 2 of them come in and they're able to resurrect this market, we are entirely comfortable with letting someone else do that and coming in with what we perceive as the better product, better for patients and better for the doctors as well and coming in after they do the heavy lifting. So we'll be happy to take our money and use it elsewhere and then wait and know that we can pivot to this at any time.
Sentiment: negative
Is this something you would partner out possibly?
Sentiment: 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.
Sentiment: 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.
Sentiment: 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 steroid market. There's one other brand that's in there that I think does about $35 million a year that's been out there maybe 2 years. So we would be coming into that. So we do have the better product, but we're always going to be up against people who will want to go with the generic option. And this is why we are pricing our product basically at the same as a generic co-pay so that the economics do not become an issue when using us. And we're going to see what happens over the next 2 years by doing this strategy of what we call value pricing. And if it takes off the way we suspect after talking with customers, then I would be very happy to come back here a year or 2 from now and say, that number is much higher than I thought.
Sentiment: neutral
And have you started speaking with payers? Do you have any progress to report yet?
Sentiment: 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, they'll be using an e-pharmacy, one, they're very familiar with and the entire thing is cash, again, the same as a branded co-pay. So there's no insurance issues, there's no callbacks. There's none of the things that are both timely and costly for the physicians.
Sentiment: 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.
Sentiment: 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 to talking again with you for our first quarter update in the spring.
Sentiment: positive
This concludes today's telenference. You may disconnect your lines at this time. Thank you for your participation.
Sentiment: neutral
My name is Celine, and I will be your conference operator today.
Sentiment: neutral
(Operator Instructions)Please be advised that today's conference is being recorded.
Sentiment: neutral
I would now like to hand the conference over to your speaker today, Anil Gupta, Vice President, Investor Relations.
Sentiment: neutral
Good afternoon, and welcome to the Coinbase Third Quarter 2021 Earnings Call.
Sentiment: neutral
Joining me on today's call are Brian Armstrong, Co-Founder and CEO; and Emilie Choi, President and COO; and Alesia Haas, CFO.
Sentiment: neutral
I hope you have all had the opportunity to read our shareholder letter, which was published on our Investor Relations website earlier today.
Sentiment: neutral
Before we get started, I'd like to remind you that during today's call, we may make forward-looking statements.
Sentiment: neutral
Actual results may vary materially from today's statements.
Sentiment: 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.
Sentiment: neutral
Our discussion today will include references to adjusted EBITDA, a non-GAAP financial measure.
Sentiment: 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.
Sentiment: neutral
Non-GAAP financial measures should be considered in addition to, not as a substitute for or in isolation from, GAAP measures.
Sentiment: 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.
Sentiment: 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.
Sentiment: neutral
In addition, we will take some live questions from our research analysts.
Sentiment: neutral
And with that, I'll turn it over to Brian and Alesia for some introductory comments.
Sentiment: neutral
Thanks, everybody, for joining us as well.
Sentiment: neutral
So we've had another solid quarter, and this is amidst the volatility happening out there in the crypto market.
Sentiment: 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.
Sentiment: 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.
Sentiment: positive
So what are we going to focus on at Coinbase?
Sentiment: 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.
Sentiment: neutral
Well, we're investing in our core apps, the main retail app.
Sentiment: neutral
We're also investing in our Prime brokerage app for institutions.
Sentiment: 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.
Sentiment: neutral
And we're even investing in new initiatives like our NFT marketplace and our direct deposit offering.
Sentiment: neutral
The second area is around customer service.
Sentiment: neutral
So you saw that we announced 24/7 phone customer support, which we're going to be rolling out next quarter.
Sentiment: positive
We're also investing in site reliability.
Sentiment: neutral
Amidst of all this growth, we're very focused on maintaining adequate uptime for our apps and websites in this unprecedented growth period.
Sentiment: neutral
And then lastly, we're focused on our policy and government relations efforts and in regulation.
Sentiment: 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.
Sentiment: positive
So I know there's lots of questions to get to.
Sentiment: 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.
Sentiment: neutral
As Brian shared, Q3 was a strong quarter for Coinbase.
Sentiment: positive
We provided a lot of disclosure in our letter, but I thought I would share a few perspectives.
Sentiment: neutral
The story of our third quarter really centers on lower volatility that we saw early in the quarter.
Sentiment: neutral
Our monthly transacting users and trading volumes, and therefore, transaction fee revenue, all correlate with volatility.
Sentiment: neutral
So it's a very important driver of financials.
Sentiment: neutral
Trading volume across the entire crypto spot market declined quarter-over-quarter in Q3.
Sentiment: negative
For Coinbase, our institutional volumes outperformed this broader market, and our retail volumes performed in line with the industry.
Sentiment: positive
Next, I want to share a bit of color on our retail transaction piece because I know you all watch this closely.
Sentiment: neutral
As you'll see through our disclosures, the blended average fee rates were lower in Q3 versus Q2 for our retail business.
Sentiment: negative
We want to be clear, there was no change to our retail transaction fee rate in the quarter.
Sentiment: neutral
The decline that you see is the result of math.
Sentiment: neutral
It is a result of the fact that in lower volatility periods, we see our low dollar volume traders become less active.
Sentiment: negative
We've seen this transaction reverse in October as customers have been very active on Coinbase given the change in crypto prices and volatility that we've seen in October.
Sentiment: positive
And our blended average retail fees were higher in October.
Sentiment: positive
So I want to share with you again, this is just an outcome of activity on our platform and that there's no underlying change to the fee rates.
Sentiment: neutral
Three other important trends I want to call out.
Sentiment: neutral
First, our focus on asset addition is paying off.
Sentiment: positive