Earnings Labs

EyePoint Pharmaceuticals, Inc. (EYPT)

Q4 2022 Earnings Call· Thu, Mar 2, 2023

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Transcript

Operator

Operator

Good day and welcome to the EyePoint Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your speaker, Mr. George Elston, Chief Financial Officer. Please go ahead, sir.

George O. Elston

Analyst

Thank you and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals fourth quarter and full year 2022 financial results and recent corporate developments. With me today are Nancy Lurker, Chief Executive Officer; Dr. Jay Duker, President and Chief Operating Officer; and Scott Jones, Chief Commercial Officer. Nancy will begin with a review of recent corporate updates. Dr. Duker will then discuss pipeline developments and Scott will comment on our commercial activities. I will close with commentary on the fourth quarter and full year 2022 financial results. We will then open up the call for your questions. Earlier this morning, we issued a press release detailing our financial results and recent corporate developments. A copy of the release can be found on the Investor Relations tab on the company website www.eyepointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. These include statements about our future expectations, clinical developments, and regulatory matters and timelines, the potential success of our products and product candidates, financial projections, and other plans and prospects. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the Risk Factors section of our most recent Annual Report on Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals.

Nancy Lurker

Analyst

Thank you, George. Good morning, everyone and thank you for joining us as 2022 was really an exceptional year for EyePoint Pharmaceuticals. We continue to execute on our goal of being the leader in innovative sustained ocular drug delivery using our best in class Durasert technology to achieve improved outcomes with more convenient dosing regimens. I'll begin by reviewing our lead development program EYP-1901 and why we believe this therapy’s six to nine months treatment interval, zero order kinetics, and new ocular mechanisms of action could be a game changer in retinal diseases like wet AMD that require lifelong treatment. EYP-1901 is a bioerodible Durasert insert that delivers Vorolanib, a selective and patented tyrosine kinase inhibitor delivered through a single intravitreal injection in the physician's office. We have advanced EYP-1901 into two Phase 2 clinical trials in wet AMD and non-proliferative diabetic retinopathy otherwise known as NPDR based on the positive DAVIO Phase 1 clinical trial results that we reported last year. EYP-1901 has emerged as a promising potential therapeutic for serious eye diseases, bringing key attributes to patients including delivery of the active drug Vorolanib consistently over six to nine months, with the majority of patients not requiring any supplemental therapy up to six months after a single treatment in wet AMD. A new mechanism of action to treating retinal eye diseases beyond the current anti-VEGF ligand blockers on the market today through potential for neuroprotective and anti-fibrotic benefits to the retina, a proven drug delivery technology with a very positive safety profile, and upon completion of our Phase 2 trials and importantly, the EYP-1901 will have the most robust clinical data for any ocular TKI program with over 180 patients having been dosed by the end of our Phase 2 programs in both wet AMD and NPDR. This…

Jay Duker

Analyst

Thank you, Nancy and good morning, everyone. Before I begin, I'd like to reiterate what important point this is in EyePoint’s journey. Our team is positioned to execute on multiple catalysts this year as we advance our Phase 2 clinical programs and growing pipeline opportunities. I'm also incredibly grateful to Nancy and the Board of Directors to allow me to take on a new leadership role at EyePoint as President in addition to Chief Operating Officer. I will begin with reviewing why as a practicing retinal physician, I'm incredibly excited about the potential of treating patients with EYP-1901 and why it represents a potential huge leap forward in this space before reviewing our clinical data and our Phase 2 programs in progress. Turning to our lead product candidate, EYP-1901 is an investigational sustained release therapy that uses a bioerodible formulation of our Durasert technology, which we are now referring to as Durasert E for erodible with Vorolanib, a tyrosine kinase inhibitor that acts through intracellular binding of all vascular endothelial growth factor or VEGF receptors, thereby blocking all VEGF isoforms. The role in its differentiated MOA versus the standard of care ligand blockers may provide additional treatment benefits beyond anti-VEGF activity with extended longevity between treatments such as neuroprotection. And we planned to share preclinical data from a mouse model of retinal detachment that suggests this differentiated advantage at the 2023 ARVO Annual Meeting next month. Additionally, compared to other TKI’s Vorolanib features reduced off target binding, specifically minimal activity against Type 2 leading to a potentially improved safety and efficacy profile. Bioerodible Durasert E, a miniaturized injectable insert is the same technology used in the non-erodible products like YUTIQ. However, the non-erodible shell is removed. Durasert products have been delivered to over 80,000 eyes with a consistently strong safety…

Scott Jones

Analyst

Thank you, Jay. We're excited to report a strong year for our commercial business with 39.9 million of net product revenue, a 13% increase compared to 2021. Our Q4 net product revenue for YUTIQ was 9 million compared to 5.8 million for the fourth quarter ended December 31, 2021, a 55% increase. YUTIQ customer demand was approximately 980 units compared to approximately 890 units for the third quarter of 2022, a 10% increase. We're pleased with the continued customer demand increase for YUTIQ based on continued utilization by retinal physicians and consistent messaging from a marketing and sales teams. We continue to collect real world data on the benefits of YUTIQ for the treatment of chronic non-infectious posterior segment uveitis in the Phase 4 CALM registry study, which is conducted in collaboration between EyePoint and the Cleveland Clinic. Data from the YUTIQ CALM registry study were presented in poster presentation by Dr. Pouya Dayani at the Retina Society's 55th Annual Scientific Meeting in November 2022. And we look forward to presenting an additional update from the Calm study and three abstracts at the 2023 ARVO Annual Meeting next month. As Nancy previously mentioned, in partnership with Ocumension Therapeutics, YUTIQ commercially launched in China at the end of last year. Since its approval in the U.S. over four years ago, EyePoint has been able to deliver this innovative ocular therapy to patients and provide an improved standard of care for patients with upto three years of continuous control in chronic non-infectious uveitis affecting the posterior segment of the eye. We look forward to continuing to partner with Ocumension and expand YUTIQ’s global reach in China as we work together to improve the lives of patients with serious items of disorders around the world. We're very pleased by the strong 2022 performance and expect a profitable YUTIQ franchise in 2023. I'd like to thank our commercial team for their dedication to bring YUTIQ to physicians and patients in need. We look forward to updating you on revenues and demand in the quarters to come. I would now like to turn the call over to George to review the financials. George.

George O. Elston

Analyst

Thank you Scott. As the financial results for the three months and full year ended December 31, 2022 were included in the press release issued this morning, my comments today will be focused on a high level review for the quarter. For the quarter ended December 31, 2022 total net revenue was 10.5 million compared to 11.5 million for the quarter ended December 31, 2021. Net product revenue for the quarter ended December 31, 2022 was 9.9 million compared to net product revenue for the quarter ended December 31, 2021 of 11.2 million. Despite strong year-over-year performance by YUTIQ, total net product revenues were impacted by the anticipated loss of pass through reimbursement for DEXYCU at the end of 2022. Net Revenue from royalties and collaborations for the quarter ended December 31, 2022, totaled 0.6 million compared 0.3 million in the corresponding period in 2021. Operating expenses for the quarter ended December 31, 2022 totaled 54.3 million compared to 29.6 million in the prior year period. This increase was primarily driven by a one-time $20.7 million non-cash impairment charge of the intangible assets associated with DEXYCU due to the loss of pass through reimbursement by the Centers for Medicare and Medicaid, effective January 1, 2023. Further, there was a $6.6 million increase in R&D expense and $0.4 million increase in the cost of sales. This was offset by a $1.9 million decrease in sales and marketing expense and $0.7 million decrease in G&A expense. Non-operating income net totaled 0.3 million and net loss was 43.5 million or $1.16 per share, compared to a net loss of 19.4 million or $0.59 per share for the prior year period. Turning to the full year ended December 31, 2022, total net revenue was 41.4 million compared to 36.9 million for the full year…

Nancy Lurker

Analyst

Thank you, George. We trust this review has given you a greater understanding of EyePoint’s progress over the past year and our potential moving forward. Over the past year, we've executed the plan and our achievements form the foundation for future growth. This is a highly experienced management team, one we are keenly focused on delivering results and executing well. Biotech is a rewarding but risky business and it requires well thought out and methodically executed plans. 2023 promises to be another productive and rewarding for EyePoint pharmaceuticals as we continue to execute on multiple clinical catalysts and strengthen our commercial business. Over the coming year, we expect to complete enrollment in the Phase 2 DAVIO 2 trial of EYP-1901 in wet AMD and in the Phase 2 PAVIA trial of EYP -1901 in non-proliferative diabetic retinopathy. We expect to dose the first patient in the Phase 1one clinical trial of EYP-1901 in DME later this year or early next year. We expect to report top line six months data for our Phase 2 DAVIO 2 clinical trials. We expect to publish neuroprotective preclinical data for EYP-1901, using Vorolanib and we continue to grow revenue for YUTIQ. We've had a great year and we have a terrific team and we're confident that EyePoint will continue to execute. We look forward to keeping you all updated as we advance these value creating milestones. Before opening the call to your questions, I do want to note how grateful I am for a fantastic team at EyePoint pharmaceuticals, who continue to drive our progress and are responsible for our company's clinical, operational, and financial success to date. We've made tremendous progress, as I've mentioned in the last year, and we're excited and motivated to advance the future of sustained ocular drug delivery to benefit, most importantly, the millions of patients who are at risk of serious vision loss. Thank you all very much for listening this morning. And I'll now turn it over to the operator for questions. Thank you.

Operator

Operator

Thank you. [Operator Instructions]. And our first question will come from the line of getting Yatin Suneja with Guggenheim. Your line is open.

Unidentified Analyst

Analyst

Yeah, good morning. This is Eddie on for Yatin. Thank you so much for taking my questions and congrats on all the progress. How soon after the Phase 2 data and 4Q do you think you'd be able to initiate a pivotal program and is there any other non-clinical or device work you need to do? And then if you could give us a little bit more color on what we should be looking for in the ARVO neuro protection data and how it might correlate to human patients and what might add -- what added benefit that might have for 1901 in the future? Thank you so much.

Nancy Lurker

Analyst

Yeah, Jay why don't you take that question or those two questions?

Jay Duker

Analyst

Sure. Hi, Eddie, thanks for the questions. First, pending the outcome of the data at the end of this year, we would expect to be able to initiate the pivotal trials in the second half of 2024. The other questions were about injector I believe…

Unidentified Analyst

Analyst

Any other device work or non-clinical work?

Jay Duker

Analyst

Theory is I think, as we've stated many times publicly, we're developing a new patented state of the art injector that we expect to be used in the pivotal trials and commercially. We anticipate using that injector in our DME trial was the first trial that it rolls out. That still has some work to be done. While we're pleased with the current injection system, it's working quite well. We do like to update it with a state of the art injector. And, if need be, we would not delay the pivotals if there's any issue with the development of the new injector. But so far, the development is going smoothly, and we're on target to use it in DME.

Nancy Lurker

Analyst

Yeah, can I just add to that, so let me just reiterate. Number one, we're on track to starting our Phase 3, as Jay said, second half of next year. The injector is a phenomenal, really exceptional, state of the art injector patent protected. And what Jay is trying to also let me just say is that we're on track with the development of that injector but because of the state of the art, we don't want to guarantee that we would actually start right away with that. So we're ready to go with the current injector that we're using on Phase 2 studies and that's working just fine. And we can easily do a bridging study should we need to. So we are well prepared to go forward with our Phase 3 pivotal regardless and we're on track. Also just want to say for listeners a couple of things; number one, getting ready for Phase 3 takes a lot of pre-planning. You have to have clinical supplies ready to go and well developed. not only the injectable but the actual implant itself. You have to have an Interface 2 meeting with the FDA, you have to have made sure that you've got your pivotals well designed, that all takes a lot of pre-planning and ensure that you get it right. You don't start these trials hastily because they are very large, and they do require substantial investment. We're going to go about this methodically, carefully, and ensure we also are as fast to market as possible given the guardrails that I just mentioned. The last thing you want to do is rush into Phase 3 trials hastily and end up with problems on your hands. And we're not going to do that. So we think we're going about the right way. We think it's the prudent, but a prudent, but also ensuring that we ensure fast to market, and we're confident that we're on the right track right now.

Unidentified Analyst

Analyst

Great, thank you so much. And then on the ARVO data?

Nancy Lurker

Analyst

Jay, do you want to take that ARVO data?

Jay Duker

Analyst

Yes. So the model that was used was a retinal detachment model in animals. After retinal detachment is created, the photoreceptors will degenerate because they're no longer in contact with the retinal pigment epithelium. And what you'll see from our data is that eyes that were treated with Vorolanib had much less damage to their photoreceptors and their subsequent visual acuity than the control eyes that were not treated. This is a model for neuro protection. Retinal detachment technically is subretinal fluid and you may be aware that subretinal fluid is also a feature of wet macular degeneration, and diabetic macular edema. So, while this is a general model for neuro protection, we think they will possibly and likely be read through to the diseases that we're currently treating with EYP-1901.

Unidentified Analyst

Analyst

Great, thank you so much.

Operator

Operator

Thank you. One moment for our next question. And that will come from the line of Georgi Yordanov with Cowen. Your line is open.

Georgi Yordanov

Analyst

Hi, everyone and congratulations on all the progress. Thank you for taking our questions. So maybe starting with the Rallybio partnership, we didn't notice they have two C5 assets based on the antibody platform. Maybe can you talk about the requirements of putting a large protein into the Durasert, maybe talk about why some previous attempts to develop long acting [indiscernible] Eylea have not been successful and in general what gives you confidence that you'll be able to formulate it with one of Rallybio assets? And then we do have a follow-up on the DAVIO trial.

Nancy Lurker

Analyst

Yeah, let me just -- let me make one quick comment and I will let Jay take it from there. First of all, let me make a statement on this, the Rallybio C5 is alpha body, it's a smaller -- it's smaller than the large ligand blockers, like Eylea that are on the market today. So I want to make that clear, it is not as big as an antibody. So that's a key point. Second of all, I'm not going to claim this is going to be easy, it's not, but we do have a stellar scientific team. And they're already going to quickly begin working on this. So we're -- we'll see what happens. But I think this team is very, very well versed in how to deal with this and hopefully, we can be successful. Jay, you want to go ahead.

Jay Duker

Analyst

Yeah, so in order to get a drug to work in Durasert, there's a lot of different factors. The size of the molecule is really what helps to determine the payload. Obviously, bigger molecules, you're not going to be able to get as many into an insert. So that's one factor. Proteins in general tend to degrade at body temperature and that's why small molecules have been preferable. Our team is optimistic about our ability to deliver this alpha body in a sustained release fashion. But until we really have some data to share, I would say that, again, we are optimistic but as Nancy said, this is -- it has a difficult path, others have tried and with large molecules and they have not been able to achieve it. But we're optimistic.

Georgi Yordanov

Analyst

And do we have any idea of -- have you disclosed when you could potentially hear an update on the progress of this program?

Nancy Lurker

Analyst

No, we're not going to get that right now. It's way too early for that.

Georgi Yordanov

Analyst

Thank you. Thank you. Yeah, we're very excited about the asset. And then just finally, can you remind us of the powering assumptions for DAVIO 2 and specifically, if the trial is positive, and you hit [indiscernible] in terms of non-inferiority, could it potentially serve as one of the two pivotal studies?

Nancy Lurker

Analyst

Yeah, let me -- we've stated this before but I'm going to say it again, this is not powered for a P value of 0.5, I want to be very clear about that. And I've said that multiple times. We did not believe, first of all you also have to go out longer in time, as you saw the FDA just issued guidance on these Phase 3 pivotal trials, and wet AMD, and they were very clear. You have to go out nine months, you have to have two dose arms, and a number of other things. The good news is, because we've had our type teaming with the FDA, our planned Phase 3 pivotals, which takes time, I want again reiterate to plan for and develop the right doses and begin to produce the clinical supplies, so that you're ready to go. We followed what the FDA said and based on the guidance that was just issued, we feel we're in a great spot in terms of our pre-planning that’s occurred and we don't have to deviate at all. So that's the great news. But we do not expect that this will count as a pivotal and again, why did we do that? Because these are expensive, large global trials. I can point to any number of companies in this space, I shouldn't say any number, but a few that went from Phase 1 straight to pivotal and failed. You have to have a robust database, you've got to be confident in the data that you've got, and we look forward to the readout of our Phase 2. As I mentioned, we expect that to be 144 patients, coupled with our Phase 1, and what was done in the oral database, we think we'll have a robust database to make wise decisions going into pivotal studies. By the way, we do plan to run those both in parallel and as a result, we still believe that we are in a great spot competitively to get to market in a fast way.

Jay Duker

Analyst

Can I just add one more comment to that? It really -- it won't be a pivotal for reasons that Nancy stated. But I think if you look at our Phase 2 design and say how will the pivotal differ, basically, in just two ways. The major way that it's going to differ is we're going to do reinjection and the second is the time. The FDA asks for nine months after your study drug is injected at a minimum for efficacy and they want to your safety. So this we're having a readout in DAVIO 2 of six months after 1901 goes in. So that's the -- will be the at least in the planning stage right now, the major differences between the Phase 2 in the pivotals.

Georgi Yordanov

Analyst

This is great. Thank you so much. It's super helpful. And congratulations again on the progress.

Nancy Lurker

Analyst

Thank you.

Operator

Operator

Thank you. One moment for our next question. And that will come from the line of Jennifer Kim with Cantor Fitzgerald. Your line is open.

Jennifer Kim

Analyst

Hey, everyone, thanks for taking my questions. I have a few here. Maybe to start off with timelines for 1901. I think you said that the data is coming by year-end of this year and I'm wondering, does that language reflect anything in terms of, I guess, like what you're seeing in terms of enrollment? And then same with PAVIA, that seems all on track, so how does enrollment look for that trial? And then DME, I think that timeline, you said later this year or early next year, is there anything that sort of like pushed that timing? Thanks.

Nancy Lurker

Analyst

So let me answer first, I'm going to let Jay take the DME. So first of all, we are happy with our current enrollment rate, we're on track, we still expect barring any unforeseen circumstances that we will have a readout later this year. Now, again, I just want to -- stuff happens so I'm always cautious in making any definitive statements. But right now, we're happy with where we sit. And Jay, why don't you take DME?

Jay Duker

Analyst

So, with respect to DME, we are looking at that trial in kind of a multi-pronged way. I mentioned already that we expect that to be the first trial that uses our state of the art injector. And so we would like to, from a timing perspective, have that injector ready to go with DME. That, again, may or may not be the rate limiting step here there are other factors that certainly go into decisions strategically about when to start a trial and how large, etc. So we're still kind of working through that. I think we'll be able to nail down the start time a little bit more later in this year. But right now, it looks like Q4 start and as I said, one of the things we'd like to do along with testing 1901 in DME is literally give it a shot with the new injector.

Jennifer Kim

Analyst

Okay, and then with PAVIA that -- like the timeline has been pretty consistent. Does that reflect anything in terms of what a sustained delivery treatment option could mean for this kind of patient population or I guess the unmet need, it is pretty clear that you need sustained delivery?

Jay Duker

Analyst

Yeah, I think the time of the reflection and time of getting patients in has much more to do with the type of patient that would enroll in an NPDR trial versus a wet AMD trial number one. And number two is, interestingly, if you've got a patient with wet AMD is getting injections, you ask them, do you have wet AMD that you're getting injections, the answer they're going to give is yes. If you ask a diabetic, what level of retinopathy do you have, they have no clue. And therefore, it's a little bit harder for the patients to get interested in the trial and even in some ways for the doctors to identify those patients, because in general even retinal physicians in their office aren't documenting the diabetic retinopathy scale of their patients. So it means casting a wider net of the patients to get the appropriate ones. And so, this isn't new. We said before, it's probably going to take about a year to enroll the PAVIA trial. And as Nancy said, so far, so good, our moment is going great in the times that we have been talking about for full enrollment and beta read out are still consistent.

Jennifer Kim

Analyst

Okay, and then my second question is, I think during your opening remarks, Nancy, you mentioned having like, significant optionality in terms of the global pivotal program. Can you go more into that in terms of how you're thinking about all that?

Nancy Lurker

Analyst

Yeah, so our goal is to potentially get a partnership with a strategic partner and we are in discussions with a number of them as we speak. So it obviously depends on the data, but really that's our goal. We want to minimize dilutive financing. And our goal is to be able to go into those pivotals with a partner. These again are large studies, and we can do it ourselves if we need to. But our preference is to partner this with a large pharma or mid to large pharma companies. So the main one, most of you know who those are. And again, it's going to be somewhat dependent. Obviously, it's going to be dependent on the readout of our Phase 2 data. So we do expect that anything announced, should we be able to strike a deal will happen in the first half of 2024, a data readout as we said is towards the end of 2023.

Jennifer Kim

Analyst

Okay, that's helpful. And then my last question, a smaller question, is there anything that drove the higher cost of sales for the quarter?

Nancy Lurker

Analyst

Yeah, we have a great team, we will see two. And I'm just going to say, and I've told our team this. First off we have a great product, YUTIQ is really a terrific product for patients with posterior segment uveitis, the team has done a fantastic job. And they've done a fantastic job as well reaching out to retinal specialists over and above just uveitis specialists because they treat posterior segment inflammation as well and uveitis. So they've done a fantastic job. I just want to say it's a tribute to having a high quality team, a sound marketing plan, and how you go about talking about the product that physicians start to realize where the opportunity is. And the product continues to deliver in terms of efficacy and safety. It just continued to do very well. Now again, I always put caveats because drugs are funny things. Generally, we've got a great track record, we continue to have a great track record, never can promise that something couldn't happen down the road. But right now, it just continues to look great. Scott, I'm going to ask if you want to add anything to that.

Scott Jones

Analyst

Thank you, Nancy. I would reiterate a lot of the comments that you had. I think, Jennifer, if I heard your question correctly you're asking about the change in the cost of sales. I think a lot of that is related to just investment, timing of investments that were made for various meetings and some of the ongoing trials that are going on, such as the CALM study, etc. So it was really that was more of a timing issue.

Jennifer Kim

Analyst

Okay. Alright. Thanks for taking my questions, guys.

Operator

Operator

Thank you. One moment for our next question.

George O. Elston

Analyst

This is George, just to clarify on cost of sales to Jennifer's question. The big driver, YUTIQ is a bigger mix because of the drop off in DEXYCU. And cost of sales in Q4 in particular, was impacted by a slight provision for remaining DEXYCU inventory because of that drop off. We don't expect that to continue 2023 forward. And the items that Scott talked about are below the cost of goods line, just to clarify for the callers.

Operator

Operator

Thank you. And our next question will come from the line of Yale Jen with Laidlaw. Your line is open.

Yale Jen

Analyst

Good morning and thanks for taking the questions. So my first question is in terms of the new injector you're developing. Could you provide a little more color in terms of the specifics so the benefit attributes could provide by this new device?

Nancy Lurker

Analyst

Oh, sure, Jay go ahead on that, but let me just say that it really is best in class. Well, it's a -- we believe a state, it's a state of the art for sure. And I would also say could be best in class. It's just a really, really nice injector. And we've obviously tested that with physicians who are using it. So Jay, you can take it from here.

Jay Duker

Analyst

Yeah, so the current injection system is based on the YUTIQ injector, which was developed well over a decade ago. It's essentially like a syringe with a plunger and the doctor presses the plunger to get the inserts into the eye. With a state of the art injector you have a trigger or button that you press and the mechanism within the injector delivers in a very controlled manner, the inserts. Now remember, we can inject up to three inserts with a single injection. And we want to do that in a safe and controlled manner. This new injector system allows that. What it also will feature is a visual guide to the doctor that lets him or her know that all the inserts have been delivered. So it's in a very ergonomic package. We're trying to minimize things like disposable items, minimize the size of the packaging, things that really physicians care about for stocking and the environment and things like that. So we're really looking at it kind of from a 360 perspective to provide retinal specialists and ophthalmologists something that they find to be easy, ergonomic, and very reliable, even when delivering up to three inserts.

Yale Jen

Analyst

Okay, great. That's very helpful. Maybe two quick ones. The first one is in terms of the -- you announced yesterday. My question is why choose C5 versus other sort of complements which are also in development, is there any specific sort of reason for that?

Nancy Lurker

Analyst

Let me take that. Look, Rallybio is a great company, and they've got a C5 that is validated in some of their other clinical trials. We like a lot of it also depends on making sure that you get the right terms and you've got a good partnership. C5 and C6 both are validated targets. Right now, I would say we're probably neutral between the two. So our goal was to work with a partner that we had a good collaboration with, has a validated target, and we are in sync. So I think it is just as simple as that. And look, it's certainly a well validated target. I think there's a lot yet to play out between the nuances between C3 and C5, but I want to state both of them are highly validated targets now.

Jay Duker

Analyst

And if I could add, check it out to that. We're still watching very carefully this space and looking at potentially other partnerships and other targets. Other companies are looking at membrane attack complex as a target, as well as Complement Vector B. And I think both of those are promising. They're clearly not as validated as either C3 or C5. But I don't think from a scientific perspective, you should view this partnership as we believe C5 is validated while C3 or the other ones are not, not at all. We think that there may be multiple ways to block Complement successfully here in what we can provide is that zero order kinetics sustained release fewer injections, and perhaps because of your order kinetics better results.

Yale Jen

Analyst

Okay, great. And then last question here is that the given YUTIQ has a pretty robust quarter sales and should we anticipate at least for a modeling perspective, that 2023 quarterly that will be -- the fourth quarter number will be a baseline moving forward for 2023?

Nancy Lurker

Analyst

Yeah, first of all, let me reiterate, yeah, we don't give guidance, we never have, and we're not going to start. Second of all, and by the way, just take the pandemic as a case in point so in terms of being able to project guidance. The other issue is that remember, in Medicare Part B drugs, and frankly probably a lot of Medicare Part D as well, you end up with quarterly to quarterly fluctuations. So first quarter, oftentimes is lower in all -- in most categories of drugs, it is lower than fourth quarter the prior year. And the reason is, because insurance resets, co-pays kick back in again, and so patients tend to -- and also you get holiday bills coming in. So what we find is first quarter patients tend to skimp on their drug utilization. That being said, we are looking great in first quarter and we do expect 2023 overall, will be higher than 2022. But I'm not going to sit here and project quarter by quarter by quarter because again, this is a category in Medicare Part B, where co pays kick in and first quarter can oftentimes be a little weaker than fourth quarter. But again, we want to look year-over-year, quarter-over-yearly quarter. And we expect to continue to have slightly higher highs each quarter over prior year’s quarter.

Yale Jen

Analyst

Okay, great. That's very, very helpful and congrats on all the progress.

Nancy Lurker

Analyst

Yeah, thank you.

Operator

Operator

Thank you. One moment for our next question. And that will come from the line of Yi Chen with H.C.W. Your line is open.

Yi Chen

Analyst

Thank you for taking my questions. Just to clarify, was there any sales product revenue from DEXYCU in the first quarter?

Nancy Lurker

Analyst

George, do you want to comment on that?

George O. Elston

Analyst

Yeah. There was Yi. We still had DEXYCU revenues in Q4, but it dropped off meaningfully from the -- and then we will file again next week.

Yi Chen

Analyst

Do you expect any further impairment charge?

George O. Elston

Analyst

No, so if you look at the results this morning, and you'll see that we've recorded a full impairment of the DEXYCU intangible. And there was -- and to the earlier question, there was a little bit of incremental inventory that was reserved for us as well. So from a financial perspective, we start 2023 with a clean slate as it relates to DEXYCU.

Yi Chen

Analyst

Okay, was there an increase in the price for YUTIQ?

Nancy Lurker

Analyst

Yeah, we always have very, very modest price increases. But again, we always take very modest ones. And George if you want to just comment what we took in 2022 but again, we typically stay way below inflation. They're very, very modest.

George O. Elston

Analyst

Yeah, I think you've just -- most are the vast majority of the revenue increase for YUTIQ is demand and you could see that in the details quarter-over-quarter. The team continues to do incredibly well with that product. And price is a very small piece of that.

Yi Chen

Analyst

Got it. And lastly, so shall we expect the gross margin for 2023 to return to the levels observed in the third quarter, second quarter of 2022?

Jay Duker

Analyst

So I would say that YUTIQ that carried a much higher margin than DEXYCU so I would expect margins to improve as it relates to just that. Because it will largely be just that product in 2023. Again, we're not giving full guidance on that but it is safe to say that we expect markets to improve because of the weighting higher to YUTIQ.

Yi Chen

Analyst

Okay, thank you.

Operator

Operator

Thank you. I'm showing no further questions in the queue at this time. I would like to turn the call back over to management for any further remarks.

Nancy Lurker

Analyst

Yeah, I want to thank everybody for your time. I again, want to reiterate I'm very proud of our progress. We are very keenly focused on executing methodically and we expect to have hopefully, a good year in 2023. So thank you very much. Look forward to keeping you all updated as we continue to make progress, especially on our Phase 2 clinical program. Thank you.

Operator

Operator

Thank you all for participating. This concludes today's program. You may now disconnect.