Good day, everyone, and welcome to today's ANI Pharmaceuticals New Day study results call. Please note this call is being recorded. After the speaker's opening remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, then the number one on your telephone keypad. If you would like to withdraw your question, please press the star key, then the number two on your telephone keypad. It is now my pleasure to turn the conference over to Ms. Lisa Wilson. Ms. Wilson, please go ahead, ma'am.
Thank you, operator. Welcome to ANI Pharmaceuticals' call today for the results from the New Day clinical trial for Iluvien. This is Lisa Wilson, Investor Relations for ANI. With me on today's call are Nikhil Lalwani, President and Chief Executive Officer; Chris Mutz, Senior Vice President, Head of Rare Disease at ANI Pharmaceuticals; and Mary Pau, Chief Medical Officer of ANI. Also joining the call today is Dr. Michael Singer, Clinical Professor of Ophthalmology at University of Texas Health Science Center and Director of Clinical Research at Medical Center Ophthalmology Associates in Texas. You can also access the webcast of this call through the investor section of the ANI website at ani-pharmaceuticals.com.
Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events in the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to ANI Pharmaceuticals management as of today and involve risks and uncertainties, including those noted in our press release issued this morning and our filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ANI specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. The archived webcast will be available for 30 days on our website at ani-pharmaceuticals.com.
For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on July 23, 2025. Since then, ANI may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings. With that, I'll turn the call over to Nikhil Lalwani.
Thank you, Lisa. Good morning, everyone, and thank you for joining us. Before we get started, I would like to remind everyone of our disclaimers. Next slide, please. I will kick off today's call with an overview of the agenda and opening remarks, followed by Dr. Mary Pau, our Chief Medical Officer, who will provide a brief background on Iluvien and its relevance for the treatment for DME. Next, Dr. Singer will walk through the New Day study design and results. I really want to thank Dr. Singer for his participation in today's conference call and for presenting the data at the annual meeting of the American Society of Retina Specialists, or ASRS. After Dr. Singer, I will return to provide closing remarks, and then Chris Mutz, our Head of Rare Disease, Dr. Mary Pau, our Chief Medical Officer, Dr. Singer, and myself will take your questions.
To start, we are pleased to be here today to discuss the results from the New Day clinical trial, which explored the use of Iluvien as baseline therapy in patients with early diabetic macular edema, or DME. We acquired Iluvien in our 2024 acquisition of Alimera Sciences, and the New Day trial was already well underway at that time. For context, New Day is one of the largest studies comparing a corticosteroid therapy versus an anti-VEGF therapy arm in the treatment of DME. As we will discuss today, we believe the New Day results further highlight its potential as an important option for DME patients and have the potential to support earlier usage of Iluvien as part of treatment and its role in reducing treatment burden in DME.
More broadly, the New Day trial and our other ongoing clinical and scientific studies for our rare disease business and our retina business are in line with our commitment to generating data to help physicians inform their clinical decision-making. To that end, we will continue to analyze the New Day results and present the full trial data and potentially other analysis in the future to continue to support our customers and the patients they serve. Before I hand it over to Dr. Pau, we wanted to share a quick performance update on our retina products. These have been ADK this morning. Our preliminary unaudited financial results for the second quarter ended June 30, 2025. For our retina products, which are Iluvien and Yutiq, the company expects combined Iluvien and Yutiq net revenues of $22.3 million for the three months ending June 30, 2025.
Our retina product performance was in line with our expectations. The second quarter was an exceptionally busy one for our team as we executed on the Iluvien launch under the combined label for chronic non-infectious uveitis for the posterior segment of the eye and diabetic macular edema, DME. The transition from Yutiq to Iluvien, which is now done, This included helping retina practices navigate recent market access challenges for Medicare patients , all while expanding and strengthening our ophthalmology sales team with experienced reps. With that, I will turn it over to Mary to share the New Day results. Mary.
Good morning, everyone. Thank you, Dr. Mary Pau, the Chief Medical Officer , and thank you especially to the West Coast colleagues people who are joining us so early. Let’s take a look at the current slide. This is a slide with an overview of Iluvien, which is the product we're discussing. On the left, if you take a look, there are the approved indications, and on the right, you can orient yourself to a high-level description of its mechanism of action, which I'll discuss in a second. As many of you already know, Iluvien is a novel, long-acting intravitreal corticosteroid implant, and it releases the corticosteroid fluocinolone acetonide in a constant and controlled manner for up to 36 months. It's indicated for the treatment of appropriate patients with diabetic macular edema, or DME, which is a chronic disease that causes swelling in the macula of the eye.
DME is actually the leading cause of vision loss in diabetic patients, and symptoms can include blurry or double vision, difficulty seeing colors, Iluvien is also indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, which we’ll refer to as NIU-PS . NIUPS is a long-lasting inflammatory condition in the eye that leads to pain, visual impairment, and also results in vision loss. Delivering corticosteroids directly to the eye helps suppress the inflammatory response, which is a key driver in both DME and chronic NIU-PS. Specifically, corticosteroids increase the production of a compound called lipocortin-1, which you look at on the right, and that blocks the production of phospholipase A2. Thi s a compound that drives inflammation with the downstream production of prostaglandins and leukotrienes. This mechanism helps regulate and control inflammatory response .
In addition, lipocortins also suppress cytokines, which we know are important in the development of inflammation. Next slide, please. On this slide, we're looking at a high-level view of the treatment journey for DME patients. Guidelines from the American Academy of Ophthalmology, or the AAO, recommend treatment with anti-VEGF compounds as the first-line therapy, in addition to regular monitoring that can lead to switching to a different anti-VEGF to improve or optimize results. For patients with more severe visual impairment or that have a suboptimal response on anti-VEGF therapy, guidelines recommend a switch to a different anti-VEGF therapy, an intravitreal corticosteroid such as Iluvien or laser therapy. In real-world practice, steroids such as Iluvien are used by physicians as the treatment of choice for patients who are not well served by anti-VEGF therapy. Why? Because they provide a different complementary mechanism of action focused on the inflammation associated with DME.
On the next slide, we can dig a little bit deeper into the opportunity for steroids to treat patients not well served by anti-VEGF therapy. On the left, you can see we have a column that outlines the various reasons why a patient may have an incomplete or suboptimal response to anti-VEGF therapy. First, the burden of frequent injections can contribute to inferior real-world vision outcomes compared to clinical trials, as demonstrated by a retrospective analysis that's shown that there are fewer anti-VEGF injections and poor one-year visual acuity gains in the real world versus what's shown in the trial.
Second, DME is a multifactorial disease, and so the underlying pathophysiology likely goes beyond just VEGF-driven angiogenesis and likely includes inflammatory, hypoxic, and hemodynamic processes, which can contribute to the disruption of the blood retinal barrier and the increase in vascular permeability that we see in DME, and those cannot be addressed by anti-VEGF therapies alone. Third, the disease may be heterogeneous. There are variations in genetics and phenotypes, such as polymorphisms or differences in gene expression of VEGF that can affect individual responses to anti-VEGF therapy. An enhanced VEGF expression or pathway redundancy may impact the therapeutic efficacy. Fourth, glucose regulation in diabetic patients plays a crucial role in the effectiveness of anti-VEGF therapy in DME. Patients with higher hemoglobin A1c levels often show a less stable response to treatment, and it often is seen that you need tight glycemic control to achieve the optimal anatomic outcome.
Finally, last on this column, access to anti-VEGF therapy can really vary significantly based on a variety of factors that are socio-economic, which affect treatment frequency and visual outcomes. There are disparities based on race, ethnicity, insurance coverage, access to care, and adherence to clinic visits. On the right, we highlight data that shows the correlation between DME severity and inflammatory cytokines. This study implies that corticosteroid treatment, which suppresses inflammation, is positioned as an important treatment for DME, especially for patients that are not well served by anti-VEGF therapy. I will now happily turn the call over to Dr. Michael Singer to discuss the New Day clinical trial, and thank you, everyone.
Thank you, Mary. We're going to talk about the New Day clinical trial. The New Day clinical trial was really to assess the efficacy of Iluvien as baseline therapy in patients with early DME, as well as assessing the safety and tolerability of Iluvien and aflibercept in combination in patients with DME. You can see on the slide that this is the basic schematic. Patients initially were given a steroid challenge because we wanted to treat them on label, and the steroid challenge was with difluprednate. They were randomized one-to-one to Iluvien and aflibercept. The Iluvien arm got one shot followed by four placebo injections over a five-month period of time, while aflibercept was given on label with essentially five injections every four weeks. What would happen during the maintenance phase was to see if supplemental aflibercept injections were needed.
The key details of the intent-to-treat analysis essentially was everybody in the INSPIRE study population, and we wanted to know for the primary endpoint the number of supplemental aflibercept injections that were needed from baseline to week 72. The secondary endpoints that we'll discuss were the time to supplemental therapy from the last injection, the percentage of people who gained 5, 10, or 15 ETDRS letters from baseline to week 72, the baseline change in central subfield thickness in the ITT population on OCT, and the percentage of patients who did not require any supplemental therapy throughout the trial. Obviously, safety is important, so we tracked the rates of cataract surgery, the incidence of intraocular pressure, and intraocular pressure surgery throughout the trial. Next slide, please. In terms of inclusion criteria, you had to be over age 18 with type 1 or type 2 diabetes.
You had to have OCT central subfield thickness of greater than 350 microns, and from a vision standpoint, you had to have between 35 and 80 letters initially. What was excluded was patients with a history of glaucoma or ocular hypertension, other conditions associated with macular edema, patients who had prior laser photocoagulation or grid, patients who had a history of intravitreal or periocular steroids or intravitreal injections of anti-VEGF. Within 12 months, you could have had one within the last 12 months, but you couldn't have one greater than six weeks. Essentially, you had to have it greater than six weeks, but only one in the last year. We talked about the steroid challenge. Let's go into bigger detail that essentially we gave people the medication.
They could not have a pressure rise of greater than IOP or greater than 8 millimeters from screening, or they would not be included in the trial. This was a two-week course of difluprednate topical drops. Next slide, please. Looking at the intent-to-treat population, you initially had well divided 154 Iluvien, 152 aflibercept. You can see the people who discontinued early, about 30 in the Iluvien arm and 34 in the aflibercept arm. You can see the reasons. Overall, you had about 124 people in Iluvien and 118 in the aflibercept arm in the total population. Next slide. Looking at the demographics, pretty well balanced. The most important thing we wanted to balance had to do with vision and had to do with lens status, but essentially pretty well balanced in terms of the age, the genders, the race, the ethnicity. Next slide.
Important for the baseline characteristics, like I said, mean visual acuity is something we wanted to stratify for, and that was well put together. Everything else is pretty well stratified as well. I want to bring your attention to the fact that essentially we did have relatively large numbers of people with high-risk NPDR. The other thing that's important in terms of this study, which is different from other Iluvien studies in the past, had a very high percentage of phakic patients, which essentially you could see down here. There were patients who were previously treated for about 10%, which was equal in both arms. Next slide. We're going to talk about a second population that we'll reference, which is called the post-op population. The story was not everybody followed the rules, for lack of a better word.
We look at the post-op population for people who essentially followed the rules. The reason we differed from this initial population was patients who did not have a major study deviation. They were randomized and rolled on a met criteria. They got the right, you know, they made sure they got the right treatment and made sure they did not receive prohibitive treatment. There were 44 patients who had 73 major deviations that excluded them from the post-op analysis. Half of these deviations were when patients were supposed to receive a supplemental injection, and then a third of these patients, patients got a supplemental injection and weren't supposed to get it based on protocol guidelines. If you look at the treatment population, what you can see is we drop it from 154 patients in the Iluvien to 128 and 152 aflibercept to 134.
Then you look at this population in terms of who discontinued early. Your overall completed study population as post-op was pretty balanced at 103 and 104. Next slide. Looking at the demographics, essentially well balanced, just like the ITT population in terms of patient demographics. Next slide. In terms of baseline characteristics, same thing as well, very well balanced in terms of vision, IOP, ETDRS letters, and DRSS scale. Next slide. The primary endpoint, so the primary endpoint turns out you needed less supplemental injections in the Iluvien arm versus the aflibercept arm. However, it did not reach statistical significance. What did reach statistical significance, which is probably more important, is the mean time to supplemental therapy since the last injection was 185 days in the Iluvien arm and 132 days in the aflibercept arm, and that T-value was highly statistically significant.
About 30% equal groups had no need for rescue therapy throughout the trial. It is important to understand that although there were the numbers of the mean number of supplemental injections of 2.4 and 2.5, remember that the aflibercept group got five injections as a head start being treated on label. If you add them together, essentially you're looking at around three injections in Iluvien and 7.5 in aflibercept. Next slide. Looking at the protocol population, in the groups that actually followed the rules, their mean number of supplemental injections was statistically significant, with 1.8 supplemental injections needed in the Iluvien arm and 2.5 in the aflibercept arm. In terms of time to last injection, just like in the ITT population, it was highly statistically significant with 189 days in Iluvien versus 131 days in aflibercept.
Again, looking at the total number of injections throughout the study, the Iluvien arm needed 2.8, while the aflibercept arm needed 7.5, because remember that the aflibercept had a head start with five extra injections. Next slide. Secondary endpoints. In terms of visual acuity, there was a four-letter non-inferiority margin, which we met. The four-letter non-inferiority margin, if you looked at the people who essentially weren't rescued, this four-letter group actually got even smaller for patients who actually didn't need rescue. One of the things we wanted to figure out was, was there a difference between having lens status or not? Because in other steroid studies, there was a difference, and it turns out whether you were phakic at the start, pseudophakic at the start, or pseudophakic during the course of the trial, meaning you had cataract surgery, none of these trends seemed to have any difference on visual acuity.
Next slide. Looking at 5, 10, and 15 letter gainers, you can see there's an equivalent number of each group that were able to hit those marks with essentially 11.5% in Iluvien versus 10.3% in aflibercept, 23% versus 29% in 10 letter gainers or two lines, and 41% versus 49% in five letter gainers. It is important to understand that both of these medicines were very good at improving vision, regardless of how you measure it in terms of 5 or 10 or 15 letter gainers on the ETDRS chart, and this is the entire ITT population. Next slide. Looking at central subfield thickness, the overall graph on the left shows that the mean central subfield thickness over time shows an interesting trend.
The trend is if you give aflibercept on label, where you give five shots, aflibercept initially drives the retina better than Iluvien, but over time, the Iluvien group catches up. I look at this kind of like the hare and the tortoise. If you look at the change in BVA over time, you see the same thing. When you look from month nine on in any of the three graphs you see, what happens is Iluvien actually catches up and drives the retina numerically better than aflibercept. Whether you look at the overall mean change, whether you look at mean CSC, or you look at essentially the people who were non-rescued, all the trends are the same. This makes sense with the mechanism of action that Mary explained before, because the fact that steroids take care of inflammation, and inflammation is usually later than the VEGF effect.
This is where steroids really hit their stride is over time, which really works well with the fact that this is an extended-release medication. Next slide. In terms of safety summary, safety essentially had a little more safety issues with the Iluvien group, but nothing that really draws you out. Next slide. This is the overall systemic safety effect. No major things that you see that favor one or the other. Next slide. Looking at ocular systemic treatment, emergent adverse events, cataract was the big one that jumps out. The reality was that there were more patients with cataracts, which should be expected, given the fact that this is a steroid. This cataract surgery essentially happened later in the process, but overall, cataract essentially is a curable thing and is something we would expect typically when we give patients steroids. Next slide.
The other thing people worry about with steroids is increase in intraocular pressure. You can see any patient that had any IOP event was 15% in Iluvien versus 3.3% in aflibercept. Breaking into buckets, which I like to do, you have about 2.6% of an IOP greater than 10, 11% greater than 25, and 1.9% greater than 35. Next slide. It is important to understand what happened to these people. In terms of any surgical procedures, there was a 4.5% incidence of any surgical procedures. When we talk about surgical procedures, we have laser and incisional surgery. Lasers were both SLT and PIs, and that was 2.6% in the Iluvien group, and incisional surgery was 1.9% in the Iluvien group, which essentially is consistent with other trials or maybe even a little bit better. Next slide.
In summary, the mean number of supplemental injections favored the Iluvien arm but did not hit statistical significance. In terms of secondary endpoint, there was a statistically significant increase in the mean time from last injection in the patients with Iluvien of 185 versus 132 days, highly statistically significant. The visual acuity and anatomic changes were right within the non-inferiority arms, and essentially one-third of the patients were able to remain supplement-free, actually in both arms. It showed similar safety in terms of cataract and IOP in previous fluocinolone trials with no retinal detachment or endophthalmitis in the Iluvien arm.
Looking at the protocol population, it showed a statistically significant in the mean number of supplemental injections favoring Iluvien versus aflibercept, and a lower number of total injections needed, which is 2.8 versus 7.5, and a lower number of injections actually, regardless of whether you look at ITT or per protocol population. Next slide. I want to turn this over. I want to thank all the investigators, sites, and patients who really made this possible, and I want to turn it back over to Nikhil.
Thank you, Dr. Singer. The New Day results position Iluvien as an important option for DME patients. We look forward to sharing the results with retina specialists at the ASRS meeting and beyond as part of our broader strategy to position Iluvien for long-term growth. In the near term, the New Day results provide an important opportunity to engage and educate customers on the key learnings from the trial, including the potential to support earlier usage of Iluvien and its role in reducing treatment burden in DME. Longer term, we also plan to share additional analysis from New Day over time. We announced our preliminary unaudited financial results for the second quarter ended June 30, 2025. The company expects combined Iluvien and Yutiq net revenues of $22.3 million for the three months ended June 30, 2025, which is a 38.5% growth over the first quarter, 2025, of $16.1 million.
Our retina product performance was in line with our expectation. In closing, I again want to thank the New Day study sites, patients, and investigators for making this trial possible. With that, operator, I turn it over to you for questions.
Thank you very much, Mr. Lalwani. Ladies and gentlemen, at this time, if you do have any questions or comments, please press star one on your telephone at this time. Again, if you would like to remove yourself from the queue, you can do so by pressing star two. Once again, that's star one for questions. We'll go first this morning to Gary Nockman of Raymond James.
Hi guys. Thanks for the data and the presentation. That was really helpful. First, I guess for Dr. Singer, just how do you think of the relative benefit of having fewer injections with Iluvien versus the increased incidence of cataracts and IOP that you see? Maybe explain more what the issue is with the large number of injections and why you would want to reduce that as much. What portion of your early DME patients do you think you would want to transition them to this new type of approach?
Okay, I'll start with the beginning of the questions. Happy to answer. Essentially, why do we want something that's an extended duration medicine? If we look at diabetic patients, they're notoriously non-compliant. Understanding your diabetic patients, it's a general rule a lot of them are working age. If we look at the data, the data that came out looking at the number of doctor visits that these patients go to who have diabetic macular edema, over the course of the year, they have 25 visits to lots of specialists. By the time they get to you as a retina specialist, it's actually not very many visits, and eye doctors in general have four visits. The fact is you're not going to get as many intravitreal anti-VEGF injections in as you particularly want. Having a drug that essentially works over time is very valuable in this patient population.
I've written a number of articles about how non-compliant diabetic patients are. That being said, we can use this. Now, IOP and cataracts are well known. Especially, you know, my feeling about cataract is interesting. If you're an older patient, cataract is the inevitability, and it's sooner in diabetic patients. We talk about cataracts. One of the things to understand is that the vast majority of patients who get intraocular pressure elevations are well controlled with topical medicines. It isn't a first-line therapy. Anti-VEGF will continue, but the thought is there is, if you look at a number of studies, including an analysis of Protocol T, which was the DRCR network, they showed about 25% of people were essentially non-responsive to aflibercept, which is at the time the strongest DME medicine that was tested in this one-to-one comparison with aflibercept, ranibizumab, and bevacizumab.
You've got 25% of your population that are essentially inflammatory-driven more than VEGF-driven. Having something that fixes that really has some great value. As something that's long duration, as you look at all the other plays, everybody's trying to play in the long duration race. Look at the TKIs and everything. Proven track record that you can see, even in this trial, 30% of people were one and done.
To build on Dr. Singer's response, Gary, good morning, and thank you for joining us. We reported the safety data from the New Day in our presentation this morning. In general, Iluvien was very well tolerated in this trial with a safety profile that is consistent with data from prior Iluvien clinical trials and real-world use. We also believe New Day generated clinically meaningful safety data, including additional data around the IOP increase events in patients who passed a steroid challenge. Notably, this is the first prospective steroid trial to use a standardized topical steroid challenge in the protocol, the difluprednate that was given four times daily for two weeks prior to visit two.
Okay, that's helpful. Dr. Singer, what portion of your early DME patients would you want to transition over potentially? Is it a significant portion of that patient pool?
I think the people that are non-responsive will be the people that I would do. What I typically do is I try people with anti-VEGF medicines first. If I look like I'm not making any headway, I'm going to start looking at steroids. I have an algorithm that I look at people that essentially, if I give you three anti-VEGFs and we're not making that much progress, I'll give you, after the fourth injection, I'll see you back in two weeks. If I don't see a 50% drying, then I know it's basically inflammatory-driven, and that's where I'll start using steroids. The good news is that by starting them earlier, I'm going to have a higher potential to maintain or increase the vision they have and a much higher chance of making sure they stay compliant.
As you can see from the OCT data, over time, they're going to get even drier than they would have with their anti-VEGF because this population is really inflammatory-driven as opposed to VEGF-driven, as Mary talked about today.
Gary, if I was just to build on what Dr. Singer said, you know, as previously communicated, we had identified a target addressable market of over 50,000 DME patients, specifically those with a suboptimal response, as Dr. Singer was talking about, following treatment with two or more anti-VEGF agents and who've been previously treated with corticosteroids. This estimate is obviously based on the estimate was based on a combination of epidemiological data and quantitative market research. We believe the findings from the New Day study further confirm and validate this TAM, reinforcing the clinical relevance and unmet need within this specific patient population. What it does is that we believe that this data reinforces our confidence in our ability to capture more of the TAM of 50,000 DME patients. Remember, Iluvien is being given to less than 5,000 patients today on a yearly basis.
At this point, we are speaking about the broadening of the TAM because we're at less than 5,000, we're out of 50,000. Great. Thanks, Gary.
Okay. Just another follow-up. There were a bunch of these protocol deviations. I'm just curious, what was the biggest issue overall with those patients leading to the deviations? Do you think you need to show the per protocol results for it to be compelling enough, or is the ITT enough? Nikhil, maybe just talk about how you're going to promote the data to physicians and how long you think it'll take for some of the retina specialists to adopt this. Thanks.
Why don't I take these and then I can get help from my colleagues as needed. On the per protocol population, upon when we identified a total of 44 out of 306 patients who had major protocol deviations, which potentially confounded the analysis of the data, which is why we shared it. Those 44 patients experienced 73 major deviations that were excluded from the post-op patient population analysis. Half of those deviations were cases in which a patient did not receive supplemental injections when they should have, and one-third of those deviations were cases in which a patient received a supplemental injection, but they should not have. The post-op analysis was conducted on the remaining subset of patients, so 128 and 134, the per protocol population. That's the answer to that question. The New Day study results are being shared, going to your, I think, your first question.
The New Day study results are being shared with ASRS attendees through a presentation today, a paper-on-demand presentation today. We've had discussions, as you would expect, with some of the investigators, including Dr. Michael Singer. Their feedback has been that the New Day study may support, provides additional data that may support treating early with steroid implants, and has the potential to benefit patients with DME. I think your other question was around what are we doing with this data. Following the release of this data, several next steps are underway. We're preparing additional data presentations at upcoming national and international conferences to further share and contextualize these findings. In parallel, we're actively exploring the potential of including New Day data in promotion, aimed at increasing awareness and understanding of the study.
Okay. Are you still comfortable with the full-year guidance for this year? You gave the Q2 sales. Are you reaffirming that today for Iluvien and Yutiq?
We look forward to providing an update on the guidance for the total company and the specific cuts that we provide, including rare disease, generics, etc., at the earnings, which is in a couple of weeks.
Okay, got it. All right. Thank you very much. Appreciate it.
Thank you. We go next now to David M. Amsellem of Piper Sandler.
Hey, thanks. Just a quick one from me. Dr. Singer, as you think about the anti-VEGF competitive landscape, it's certainly a more varied landscape. You have a number of anti-VEGF options. There is a ranibizumab implantable. To your point about duration, I guess my question here is, there's the data that you've presented, but how do you square the dominance of anti-VEGF and the fact that it is a more varied anti-VEGF treatment landscape, so there's more product offerings and more options compared to, say, five years ago? How do you square that with trying to win over hearts and minds regarding earlier usage of the long-duration corticosteroid? That's my first question. Secondly, I guess I'm struggling with how you can leverage post-hoc analyses here to drive more usage or earlier usage of Iluvien.
I'm just kind of wondering out loud how that kind of data is going to be received by your peers in the community. Thanks.
Let me start with the first question. Thank you for asking. Basically, yes, there are a number of anti-VEGF medicines out there, but just understand that I've been involved in all these trials. The reality is that they all essentially, with the exception of one of them, really target VEGF. It's the same pathway. We may have stronger medicines. We may have longer medicines. Again, we're still looking at that proportion of patients that are VEGF receptive. It's about 75% of people based on that Protocol T analysis I told you. Everyone's jockeying for that process. Even the furosemide product, which essentially is AMS-2, does not affect a lot of these inflammatory factors that Mary showed you in the slide before. The story is that people know inflammation is an issue. What we wanted to know is how well does it stack up?
What's interesting to understand is that New Day is everybody wanted to see New Day because New Day gave everyone a fair shot from scratch. A lot of the steroid trials, and I've written on most of those articles, were people who were previously treated. Looking at patients square, understanding in the background that most of DME, three-quarters, is VEGF-driven, New Day held its own. It held its own relatively well because of the fact that it had one shot versus five shots of aflibercept. In a race that was really stacked against the Iluvien, it still pretty much held its own. We're going to talk to doctors about that. Doctors do believe that there's more than VEGF in the process.
To your point, as more medicines come out and they talk about new things that are on the horizon, people are realizing that DME has inflammatory factors and that steroids still do a really good job of controlling them. They have a relatively good safety profile. I mean, as the steroid challenge really decreased the number of people who needed incisional surgery, and the laser surgery, which I didn't spend a lot of time on, half of those weren't really due to increased steroid-induced intraocular pressure. TIs are not used for that. The data is probably really better than before. I think there's a value in that. In terms of your per protocol population, obviously, doctors always kind of go, well, the post-hoc analysis, they'll have a little bit of skepticism.
What I think was really interesting is regardless if it was at the ITT population or the per protocol population, the time from last injection was highly statistically significant. The duration play really plays strong. If you look at all the TKIs that are being anti-gene therapies that are being introduced to our landscape, they all play to the fact that they last longer. Nobody really says they're stronger, they last longer. This medicine is approved. It's been out for a while. I know this is VMO medicine. I've been involved in those trials. That's a surgical procedure. This is a simple intraocular injection that people have been doing for the last 10 years. Now we're getting it validated that it really can hold its own against anti-VEGF.
In a good set of population where VEGF isn't working, we should start this earlier because we'll be able to keep the vision better and maintain the anatomy sooner.
Thank you. Good morning, David, and thank you for your question. I think just two things to build on what Dr. Singer said. One, that steroids are the treatment of choice for DME patients that are not well served by anti-VEGF therapy. Dr. Singer brought some numbers about total DME population and what % are served by the menu of anti-VEGF therapy that's available. That's one. The second is what this study was evaluating, looking at assessing the efficacy of Iluvien as a baseline therapy in patients with early DME, and assessing the safety and tolerability of Iluvien and aflibercept in combination in patients with DME. There's a clear understanding that anti-VEGF is the first-line therapy.
What we were exploring with the New Day study is the efficacy of Iluvien as a baseline therapy in patients with early DME and using a multimodal approach to treatment, as is done in several therapeutic areas. Thank you, David.
Thanks.
Thank you. We'll go next now to Faisal Khurshid of Leerink Partners.
Thank you for the question. Nikhil, can I ask you just to clarify, do you believe this data is viable and could support a label expansion for Iluvien? A follow-up question to that is, you know, where is Iluvien used mostly today, and do you expect that to change based on this data either from just like scientific dissemination or from potential label expansion? Thank you.
Thank you, Faisal. Following the release of this data, which happened today, several next steps are underway. We're preparing additional data presentations at upcoming national and international conferences to further share and contextualize these findings. In parallel, we're actively exploring the potential of including New Day data in promotion that's aimed at increasing the awareness and understanding of the study results. Going to your second question, we've always talked about there are 50,000, 53,000-ish, or 50,000 plus DME patients who show suboptimal response following the treatment with two or more anti-VEGF agents and show positive response to steroid trial. We're treating less than 5,000 patients with Iluvien today. This data, the largest prospective trial, we believe that these findings further can reinforce the clinical relevance and unmet need within this specific patient population and in our ability to capture more of the 50,000 DME patients and even earlier.
We're at less than 5,000 out of 50,000 to start with.
Got it. Thank you.
Thanks, Faisal.
Yeah.
Thank you. Just a quick reminder, star one for any further questions today. We go next now to Les Swiatkowski of Turis Securities.
Good morning. Thank you for taking my questions. Dr. Singer, just for you, what would you say the real-world data is more resembling of the ITT or the DME patient population? Does coverage or copay assistance influence your treatment with Iluvien? Lastly, for Nikhil, perhaps on the $22.3 million guide for Q2, what portion of that or any sort of allocation can you attribute to the new salesforce transition? Thank you.
Why don't I take your third question, which is the $22.3 million revenues in Q2, the preliminary results we shared, you know, how much of that was due to the strengthening of our salesforce? We're not disaggregating the impact. Look, between different elements, the second quarter, we executed on the Iluvien launch under combined label, right, chronic NIUPS and DME. We transitioned our Yutiq to Iluvien and helped retina practices navigate some of these market access challenges that you just spoke about, all while expanding and strengthening our ophthalmology sales team. We had most of our, let's call it, open positions filled, obviously, and have strengthened our sales team. It's a combination of different elements that played into the performance. I think you also asked about the, you know, I guess your question was coverage and copay impact to Dr. Singer. Dr. Singer, I'll turn it over to you.
Yes, I mean, I can, we can talk about that. I think the chronic disease fund obviously is affecting everybody. We're all worried about the process. I will tell you, given a medicine that lasts that long, the hope is that you don't have to keep going back to the chronic disease well as you would for anti-VEGF all the time. As certain people get, they get funded and then defunded, you only have to do this once. If you get it at the right time, that works, which would be nice. Your other question with ITT versus postdoc, people want to know how the, want to know the rules. I referenced this earlier, both populations had a statistically significant increase in time from last injection versus aflibercept, which really fights the fact that either way you do it, it is a good duration medicine.
It plays to the duration play. I think that's really important. Obviously, people will look at it and say, people don't follow the rules. If you do it right and you follow the rules, you should have very few rescues, and you should be able to essentially have good vision, because essentially we talked about people who weren't rescued. That was in your essentially a version of your per protocol population and the CST, that these people hold their own in a disease where they don't have a pre-VEGF starting point. What's interesting about New Day, and I don't think I really said, this is the first Iluvien trial that essentially went against an anti-VEGF competitor. If you look at the previous trials for approval, they didn't do this.
That's always been one of the criticisms that people had was, whether it was Ozurdex or Iluvien, basically the meat and thing trials went against placebo. To be honest, so did a good number of the original anti-VEGFs. This is a really good head-to-head trial, which essentially showed that it held its own against anti-VEGF. Even though it won't be used initially as a first-line therapy, you can feel pretty confident that it's going to do a good job in thinking about treating it earlier. We'll actually make it earlier in people's thought process. Hey, look, if I'm not getting anywhere, why don't I change course sooner rather than later?
I appreciate the color, Dr. Singer. Maybe you can just kind of build up on that as a follow-up. In the real-world scenario, would you say most physicians are representative of the ITT or the PT patient group? How would you kind of go about in future learnings around that physician group? Thank you.
Yeah, I think most people are in the ITT. I'm sorry.
Yeah, sorry. Go ahead, Dr. Singer.
No, please go ahead, Dr. Singer.
I think the per protocol is people follow the rules. People understand when people need to be treated versus when they don't need to be treated. I can't comment to the 43 people what motivated them to do what. Understanding what people do with best-case scenario, the difference, there was a difference. If you follow the rules, you probably need less shots. What's important is any way you slice it, if it's really going to last much longer than aflibercept, it's worth thinking about. Everybody knows DME patients are chronically non-compliant. There are many. The less shots you give, I'm sure there's written a million articles that are referenced today. If you don't give shots, you don't get vision. This is one shot, and you're pretty much good for it.
To build on that, sorry, Dr. Singer, that I interrupted you. I was just trying to share that we do have feedback as we shared these results with some of the other investigators that have been involved with the New Day study. Their feedback has been looking at both sets of data that the New Day study may support treating early with steroid implants that has the potential to benefit patients with DME. Just giving you feedback from some of the other investigators I've seen that have seen the more detailed data. Thank you, Les.
Thank you. We'll go next now to Brandon Folks of H.C. Wainwright.
Hi, thanks for taking questions and thanks for the data. Maybe Nikhil, first up from you. You talked about these sort of 50,000 patients and the 5,000 today. Maybe just twofold on that. What's the patient profile beyond the 50,000 you expect to potentially benefit from Iluvien near-term based on this data? Secondly, does the salesforce detail change at all, or is the focus, you know, remaining on getting that 5K up to the 50K, or do they happen simultaneously?
Thank you for your response. I think that in terms of your second question, which is, your first question in terms of the epidemiology, the 50,000 is patients that have tried more than two anti-VEGF therapies and showed suboptimal response to more than two anti-VEGF therapies and then showed positive response to steroid trial. When you compare that with the patients that were included in this trial, these were largely treatment-naive patients, VEGF-naive patients. As we went through this study, and Mary, you can help me, there are patients that had not taken an anti-VEGF, and I think in the prior 12 months. The patient population is much earlier in the DME patient landscape. That is where you are seeing these results. As I just spoke about, it is looking at assessing the efficacy of Iluvien as a baseline therapy in patients with early DME, so multimodal early DME.
In terms of the salesforce, we just have to be thoughtful about that because following the release, obviously, the salesforce can only speak to what is on the label. Following the release of the data, several next steps are underway. We are preparing additional data presentations at upcoming national and international conferences to further share and contextualize these findings. We are in parallel actively exploring the potential of including new data in promotion aimed at increasing awareness and understanding of the study results. Thank you, Brandon.
Thanks very much. One follow-up, if I may, just for Dr. Singer. As we think about potentially using Iluvien in these earlier DME patients, you talked about the treatment burden and having these patients come back. How do you balance potentially a treatment that could be effective for 185 days? When do you want to see those patients back after giving them Iluvien and how often, given the adverse event profile? How do you monitor that adverse event profile in practice in terms of getting those patients back after?
Essentially, what you would do is, the way typically you follow these people is you're worried, you want to make sure you want to catch the small number of people who have really high IOP rises. I've actually written a number of articles talking about this, including for Yutiq as well. What's nice about this is they fall into buckets. Essentially, what we tell people in general, which is a good idea, is we have them every three months for a safety check, which is understanding. We bring them in, make sure everything's going well. The good news is based on the data that, you know, whether you as a retina specialist or a lower-level provider can do a safety check by checking the pressure, that's when you typically want to see these people every three months. It's just a good rule of thumb.
What's really nice is based on the fact that we showed you from the mean change in terms of time that you, that essentially, they're not going to need a whole lot of supplemental therapy in the first six months, which is really great. That kind of differentiates itself from a lot of the other therapies that are out there that are going to be implants going down the line. I think there's a great value in that. The cataracts are going to happen much later. We didn't fill that in, but it turns out that that's closer to a year and a half. That's really not a problem that people worry about. What keeps people up at night is to know the pressure. If you have an idea of when to follow these people, you'll catch them. You'll put them on therapy if they need them.
If not, they can keep living their life, and they won't have to be coming back every month for shots.
Great. Thank you very much.
Thank you, Brandon.
Thank you. Mr. Lalwani, it appears we have no further questions this morning. Sir, I'd like to turn the conference back to you for any closing comments.
Thank you. Thank you, everybody, for joining our call this morning to share the New Day study results, as well as provide preliminary and audited financials on the Iluvien and Yutiq Q2 revenues. We look forward to updating you further at our Q2 earnings call that should be coming in a couple of weeks. Thanks, everybody, and have a great rest of your day.
Thank you, Mr. Lalwani. Again, ladies and gentlemen, that will conclude the ANI Pharmaceuticals New Day study results call. Again, thanks so much for joining us, everyone, and we wish you all a great day.