EyePoint Pharmaceuticals, Inc. (EYPT) Q4 2015 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the pSivida Corporation Fourth Quarter 2015 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference, Vice President of Corporate Affairs and General Counsel, Lori Freedman. Please go ahead, ma'am.

Thank you, Melanie. Good morning, everyone and thank you for joining us. Earlier today, we released our fiscal 2015 full year and fourth quarter financial results. A copy of the release is available in the Investor section of our website at www.psivida.com. On the call with me today is Dr. Ashton, President and Chief Executive Officer; and Len Ross, Vice President of Finance. Before I hand the call over to Paul, I need to remind everyone that some of our prepared remarks are and answers to your questions maybe forward-looking in nature. Forward-looking statements are inherently subject to risks and uncertainties. All statements other than statements of historical facts are forward-looking statements and we cannot guarantee that the results and other expectations expressed, anticipated or implied will be realized. Actual results could differ materially from those anticipated, estimated or projected in the forward-looking statements. For a more detailed discussion of risk factors that could impact our future results and financial condition, I refer you to our filings with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. We undertake no obligation to update any forward-looking statement in order to reflect events or circumstances that may arise after this conference call. With that, I’d like to turn the call over to Paul.

Great, thank you, Lori, and good afternoon everyone as we discuss the results of our fiscal 2015 full year and fourth quarter. This was a great year for us. Our first Phase III clinical trial for Medidur for posterior uveitis, our lead development product, is fully enrolled and enrollment in the second trial is proceeding. We anticipate filing the NDA in the first half of 2017, assuming good results. Our preclinical studies are progressing well. We anticipate an IND will be filed for Durasert product for knee osteoarthritis shortly through our collaboration with Hospital for Special Surgery at the America’s leading orthopedic hospital. We’re very pleased with our recent progress on [pivotal] research for biologic delivery and Durasert for AMD. ILUVIEN, our lead licensed product, has been approved by the FDA; it was launched in the US in February and is now gaining traction. Finally, we ended the year with over $28 million in cash and no debt. That’s the healthiest year in total we've ever had. So, let's get into the details. As you know, Medidur is an injectable micro-insert designed to provide three years of treatment of posterior uveitis from a single injection. It's the same micro-insert as ILUVIEN for DME, given in the same drug at the same release rate. We completed enrolment of our first Phase III trial of Medidur at the end of March and are currently enrolling the second trial. The primary endpoint of the first trial is recurrence of disease within the first 12 months. So we will have top line data in about nine months. Based on our meetings with the FDA, the second trial has a shorter primary endpoint of recurrence of disease at six months. This means that assuming positive results, we anticipate filing the NDA in the first half of 2017. We’re optimistic that our Phase III trial for Medidur will show efficacy, because Medidur delivers the same corticosteroid that’s been shown to be effective in treating posterior uveitis in the FDA-approved RETISERT. However, Medidur delivers a lower and more consistent dose of that drug than RETISERT. Now, because the elevated intraocular pressure is a known side effect of steroids, we expect the lower dose delivered by Medidur will result in a far better side effect profile than assumed by RETISERT and its Phase III trials and a side effect profile at least as good or even better than that shown by ILUVIEN in its DME trial. Recent data provide a promising indication of the safety and efficacy of Medidur. With respect to efficacy, Dr. Glenn Jaffe, a professor at Duke University and the principal investigator in our first Phase III trial, he presented dramatic top line results from his three-year ongoing investigator-sponsored study of high and low dose Medidur for treating uveitis. You'll recall we're studying only the low dose in our Phase III trial and as Dr. Jaffe's study is ongoing, results remain masked as to the high and low doses. Dr. Jaffe reported both a statistically significant reduction in recurrence of uveitis, and that's a primary endpoint in the Phase III studies, and a statistically significant improvement in visual acuity in eyes treated with Medidur relative to [indiscernible] eyes treated with standard of care. In fact, through the last fall of visit reported, none of the eyes treated with Medidur has had any recurrence of uveitis, while celluloids treated with standard of care averaged 2.33 recurrences. In addition, as the last follow-up visit reported, Medidur treated eyes have gained an average of over 20 letters of visual acuity, while eyes treated with standard of care had unfortunately experienced an average decline of 10 letters. Now, our own Phase III trial is giving us an early positive look at safety. The trials are of course, maxed. Still we can look at the difference in elevated IOP between study eyes, two thirds of which received Medidur and non-study eyes none of which received Medidur. We now have data on all 129 patients in our first trial at the three-month follow-up. This showed only a 5% difference in the number of study eyes with elevated IOP compared to non-study eyes. This is very encouraging. Initial elevation of IOP is an indication of the likelihood of subsequent clinically significant IOP increases. The minimal distance we saw in the elevated IOP suggests favorable results in this key safety measure of the trial, i.e., the number of eyes treated with Medidur relative to control lines that develop clinically significant increase in IOP. Now, turning to our preclinical research program, I know the slow and unpredictable timing of scientific development can be frustrating to our investors. It certainly is to us. But there really is no alternative to basic scientific discovery methods, hypothesizing, testing, adjusting, and testing again until we get it just right. This is true even when you are treating a known technology such as Durasert for different uses or drugs, or optimizing a new technology like Tethadur. However, I’m pleased to recall we have made very good progress on both Durasert for osteoarthritis and some chronic eye diseases, and for Tethadur to deliver biologics. So moving to osteoarthritis, we've been working with Hospital for Special Surgery at the America’s leading specialty hospitals devoted to orthopedics and rheumatology. We've been working on an implant utilizing our patented Durasert sustained-release technology to treat osteoarthritis of the knee. The implant, which is a screw the delivers drug, will be surgically implanted into the knee and is designed to provide sustained delivery of a corticosteroid directly to the joint for approximately six months to provide long-term pain relief. By sustained delivery of the drug directly to where it's needed, our goal is to delay or eliminate the need for total knee replacement surgery. Osteoarthritis is an extremely common and sometimes debilitating degenerative joint disease caused by breakdown of cartilage and bone in the joints. More than 10 million people suffer from osteoarthritis of the knee. Nearly half of all people over 85 and two-thirds of obese people develop it. Aging and the increasingly overweight population is expected to continue to drive increases in knee osteoarthritis. Now, although there is no cure, pain and stiffness in the joint are currently treated with oral analgesics and nonsteroidal anti-inflammatory drugs, corticosteroids taken orally or injected into the knee, or hyaluronic acid injected into the knee also. These injections are for only temporary relief, and many patients progress to total knee replacement surgery. Last year, in fact, there were over 700,000 knee replacement surgeries performed in the US alone, and damage from knee osteoarthritis is the leading cause. This is why we believe our Durasert product can fill the void by providing long-term pain relief for severe knee osteoarthritis. After several years of work, we’re now ready for clinical studies and we expect an investigator-sponsored IND by a leading physician at HSF that will be submitted shortly. We’re excited to be using our patented Durasert technology in a therapeutic area outside of ophthalmology. We’ve continued our preclinical work using our Durasert and Tethadur technologies to treat some chronic ophthalmic diseases and to deliver antibodies, proteins, and large molecules. This quarter, we've made real strides defining our Tethadur technology to develop proteins. We've been able to optimize the formulation of Tethadur to increase its molecular loading capacity and enhance antibody stability to extend the release and duration. We can now load Tethadur so that it's comprised of over 20% antibodies. This is important because only a limited volume of material can be injected into a small cavity like the eye. We also have optimized the release to deliver antibodies now for up to six months. All of this is in vitro work. The next steps are to confirm these results, as well as safety in preclinical models. While this progress took longer than we originally anticipated, scientific discovery is of course uncertain and we’re very pleased with where we are now with Tethadur. We've also initiated a new preclinical program using our Durasert technology to deliver drugs that treat age-related macular degeneration. We’re looking to apply our proven technology to deliver existing anti-cancer small molecules to the eye to treat AMD. We’ve also made excellent progress in drug delivery for glaucoma. Finally, let’s talk about ILUVIEN. We believe ILUVIEN is an important treatment alternative for patients with DME who are typically managed with laser therapy or intraocular injections of anti-VEGF drugs, including Eylea, Lucentis, and the off-label Avastin. Laser therapy typically only staves-off progression of the disease for a short period. Anti-VEGF drugs must be injected as frequently as every month and don't optimally manage the disease for many patients. By contrast, ILUVIEN provides three years of effective sustained treatments with a single injection. We're optimistic that ILUVIEN will be a significant alternative for patients with DME. Our licensee Alimera Sciences launched ILUVIEN in the US in February and has completed its first quarter of US commercialization. ILUVIEN is approved in the US for patients with DME who have previously undergone a course of corticosteroid treatment without experiencing a clinically significant rise in intraocular pressure. This is a broader label than as approved in Europe, where ILUVIEN now has a monitoring authorization in 17 countries for the treatment of vision impairment associated with chronic DME considered insufficiently response to exiting therapies. In the EU, ILUVIEN was launched in Portugal and re-launched in Germany in the first quarter 2015 and is already sold in the UK. We're entitled to 20% of the net profits of Alimera's sales of ILUVIEN on a quarter by quarter, country by country basis. Alimera reported sales increasing nicely last quarter and we’re optimistic our net profit participation payments will increase. I will now turn the call over to Len who will take us through the financials. Len?

Thank you, Paul, and good afternoon everyone. I will briefly review our fourth quarter and fiscal year 2015 results reported earlier today, starting with our financial position. As Paul noted, at June 30, 2015, we had cash, cash equivalents and marketable securities of $28.5 million, an increase of $10.2 million compared to $18.3 million at June 2014. This reflected a $25 million ILUVIEN FDA milestone that we received in fiscal 2015 second quarter. For the fourth quarter of fiscal 2015, net cash usage was $3.1 million. We anticipate that our existing capital resources and expected cash inflows under our existing collaboration agreements will enable us to fund our current and planned operations into early calendar year 2017. This estimate includes expected costs of the ongoing Phase III clinical trials of Medidur, but excludes any potential net profit participation receipts from sales of ILUVIEN. To date, we have received $43,000 of net profit participation from Alimera’s sales of ILUVIEN in the UK and Germany. We do not know when or if we will receive additional net profits from ILUVIEN sales in the EU, or commence receipt of net profits from sales of ILUVIEN in the US or Portugal where Alimera launched the product during our fiscal 2015 third quarter. Turning now to our full-year fiscal 2015 results, revenues increased by $23.1 million to $26.6 million for the year ended June 2015, compared to $3.5 million for the same period last year. This increase primarily reflected revenue recognition from of $25 million ILUVIEN FDA milestone, partially offset by a $1.8 million reduction of revenues from feasibility study arrangements. [indiscernible] royalty income of approximately $1.2 million represented a decrease of $164,000 or 12% from the previous year. Research and development totaled $12.1 million for fiscal 2015, an increase of $2.5 million or 26% compared to $9.6 million in the prior fiscal year. This change was primarily attributable to a $2 million increase in contract research organization or CRO costs for our ongoing Medidur Phase III clinical trials and a $240,000 increase in personnel-related costs including stock based compensation. We currently expect cost of our ongoing Medidur clinical development program in fiscal 2016 to increase by approximately $600,000 or 10% compared to the current year. General and administrative expense increased by $588,000 or 8% to $8.1 million for fiscal 2015 from $7.5 million in the prior year, primarily attributable to a $530,000 increase in professional fees and a $390,000 increase in stock based compensation. Income tax expense totaled $96,000 in fiscal 2015 compared to an income tax benefit of 130,000 in fiscal 2014. Fiscal 2015 tax expense reflected $263,000 of US federal alternative minimum taxes. For our calendar year 2014, primarily the result of the ILUVIEN FDA approval milestone, refundable foreign research and development tax credits totaled $167,000 in fiscal 2015 compared to $130,000 in fiscal 2014. Net income for the year ended June 2015 was $6.3 million or $0.21 per diluted share compared to a net loss of $13.4 million or $0.49 per share for the year ended June 2014. Turning briefly to our fourth quarter results, we reported revenues of $409,000 compared to $292,000 for the same period last year, and this increase was primarily due to higher Durasert royalty income. Research and development totaled $3.2 million in our fiscal fourth quarter, an increase of $890,000 or 39% compared to $2.3 million in the fourth quarter last year, again primarily due to higher CRO cost of the Medidur Phase III trials. General and administrative expense totaled $2.4 million in the current year fourth quarter, an increase of $411,000 or 21% compared to $2 million for the three months ended June 2014 and this was primarily attributable to increased professional fees. Our net loss for the fourth quarter of fiscal 2015 was $5.1 million or $0.17 per share compared to a net loss of $4 million or $0.14 per share for the prior year period. I will now turn the call back over to Paul.

Great. Thanks, Len. So to sum, it was a really good quarter and year. Key points are number one, our phase II trials for posterior uveitis continue to advance. We expect to have top line data from the first Phase III in mid-calendar 2016 and to file the NDA as early as first half of 2017. Two, we expect an investigator-sponsored IND to be filed shortly by our collaborative partner Hospital for Special Surgery for Durasert to treat osteoarthritis of the knee. Three, we've made significant progress in optimizing [indiscernible] to deliver proteins and antibodies. Four, we've commenced a new pre-clinical program for Durasert system for AMD. Five, Alimera has launched ILUVIEN in the US and sales last quarter picked up nicely. Six, we believe we have enough cash to fund our planned operations into 2017, including major trials without assuming any cash from ILUVIEN net profit. So at this point, we would be happy to take your questions. Operator, would you please initiate the Q&A portion of the call?

[Operator Instructions] Our first question comes from the line of Matt Kaplan with Ladenburg Thalmann.

A couple follow-up questions just in terms of the second Phase III. Could you give us a bit of a sense in terms of the timeline there for enrollment? Obviously, it's a shorter time. The endpoint was six months, but when do think you'll be able to see data from that study?

We anticipate the trial will be with complete enrollment more less than middle of next calendar year. Six months after that is the end of 2016.

And then just with respect to the osteoarthritis of the knee program, give us a little more color in terms of the plan for the investigator study design for that.

I guess it’s described as a Phase IIa investigator-sponsored study. We’re going to take patients with severe osteoarthritis who are anticipating a total joint replacement and give them an implant which is essentially a screw that is placed into a non-load-bearing parts of the knee and see how they do.

So you're going to look at outcomes such as impact on pain and progression to full knee replacement?

Yes, it's going to be the – pain is the main outcome that we are looking for. And it's one of those things that steroid injections into the knee are very, very common, as I'm sure you know. It's just that they really don't last very long, and you get this weird trampling effect while the first injection is very effective, the second one isn't as effective and doesn't last as long, et cetera, et cetera. And it's very analogous to what you see in ophthalmology with uveitis. It seems a very straightforward thing theoretically to contemplate.

And then uveitis has a licensing opportunity after the data?

Let's see how the data looks, but yes, as we move out of ophthalmology into a lot of different areas, then we'd be anticipating out-licensing to some of the companies that are already in this space. Same would be said for some of the Tethadur applications. With some obvious applications of a sustained-release antibody that's injectable, the obvious one would be a sustained Humira, which is coming off patent very shortly. That does $1 billion a month, I believe. Now, we are not going to be setting up shop to challenge AbbVie on that, but it's someone that we could potentially partner.

And then with respect to the progress you've made with both Tethadur and the Durasert AMD programs, when do think you could be in a position to file an IND for either of the programs of the two drugs?

I'd like to see the Tethadur filed within our fiscal 2016, so i.e., within nine months, and probably a similar timeline for the AMD program. With the AMD program, we're just taking some existing anti-cancer drugs, small molecules, there's a bunch of then now which are about to come off patent or will be off patent shortly, which their mode of action is to inhibit VEGF and PDGF. Those are some very attractive targets. It's a case of the drugs are targeting the right elements that are triggering AMD, and you know that the implants can achieve long-term sustained delivery. Again, it seems a very logical thing to combine these.

And then should we expect to see any pre-clinical data from Tethadur or the Medidur AMD programs between now and the IND?

Between now and the...

IND filings?

Yes, we'd be looking to publish some of the – or at least present some of the pre-clinical data as it becomes available as we publish it over the next six to nine months.

Our next question comes from the line of Suraj Kalia from Northland Securities.

Paul, a bunch of questions from my side and let me start off with the first, my apologies if I got this wrong. If I remember correctly, for ILUVIEN, elevated IOP was defined as greater than equal to 30 millimeter of mercury, and for Medidur uveitis it's greater than 21 millimeter of mercury. First, am I wrong in this? That's what my memory was about 30 millimeter of mercury, and I see 21 millimeter of mercury here. And the second part of this is why the more stringent criteria in uveitis?

So elevation of IOP is – normal IOP is below 20 millimeter of mercury; average is about 15 millimeter of mercury. And the higher it gets, the more problematic it potentially can be. So when people were talking about IOP for ILUVIEN in DME, they were talking about the percentage of patients whose IOP was above 30 millimeter of mercury at some point in the studies. A more full description would've also included the percentage of patients whose IOP was above 25 millimeter of mercury. If you really want to go whole hog, you'd also talk about the percentage of patients who have no IOP above 20 millimeter of mercury. Now, to be clear, there's quite a lot of people walking around with an IOP of 20 odd and it's not a big deal. It's borderline if you'd even bother to give people eye drops for that; 25 millimeter of mercury you would give them eye drops, and at 30 millimeter of mercury after, no one's going to want to walk around with an IOP of 30 millimeter of mercury. So it turns out that when people are on steroids, if they have an initial increase in IOP of – I will rephrase this again, it seems that there's about 30%-odd of the patients of the population whose IOP is sensitive to steroids. And you will typically find that they will have an early initial increase in pressure. Over the long term, those patients have a much higher likelihood of developing much more significant increases in eye pressure. Those, where there is no difference, where there is no real increase in pressure, they have a much lower likelihood of developing elevated IOP in the long-term. What we've found in our observation of the first three months is that there seems to be very little difference in the percentage of patients who have a small increase in pressure between the study eyes and the fellow eyes. So that suggests that in the long term, we won't see much of a difference in the percentage of patients who have a big increase in pressure. Is that clear? We're using the small increase in pressure to try to be an early warning sign to differentiate people who may subsequently be at risk of developing worse pressure.

Paul, the 5% in the treatment arm versus the control arm, can you give some more color about it? The press release says 5% more. What are the actual numbers? Are you all at a position to reveal that?

I don't have that in front of me, but the issue for the FDA or indeed anyone using this product, is how much of an increase in a side effect like pressure does the implant cause? In some patients, in uveitis patients in particular, it's quite a complicated question because in uveitis, a lot of patients will develop increased eye pressure anyway as part of the natural course of their disease, because you get a lot of proteins and particulate matter that build up in the eye that physically block the outflow of aqueous humor, so it causes the eye pressure to increase. Conversely, by the same token, sometimes the eye gets so inflamed they become incapable of making the aqueous humor, and those patients get hypotony, so the pressure gets too low, and that's actually a bigger problem. So ultimately we're looking for the difference between IOP in patients who get the implant versus IOP in patients who on standard of care, so that's where the 5% number comes from. Now, from memory, and I apologize to people who are listening, it's only from memory here, I believe that for ILUVIEN in DME, there was something like a 30% difference in IOP between treatments and control at 25 millimeters of pressure at three years. We're obviously optimistic that Medidur will, in uveitis, will show a smaller elevation than that.

Paul, One last question and I will hop back in queue. One of your programs that I find fascinating is this osteoarthritis program, and partly the reason is because you look at Anika, you look at Flexion, and you look at Carbylan. Combined, all these companies are trying to do the same thing that you guys are doing, albeit using hyaluronic acid. I'm sure you'll notice that Flexion had some issues with their Phase II results yesterday that they announced. At least from all the commentary, Paul, what they are talking about is pain is a subjective score. We saw it at 11 weeks, everything was statistically superior, and in week 12, there was an anomaly, and part of it is being blamed on the subjective assessment of pain. A two-fold question for you Paul, in this. One is how do you see your program for OA, vis-a-vis, some of the other hyaluronic acid based modalities out there? And the second thing is just from your view on pain as a primary endpoint or a marker for efficacy.

As you know, hyaluronic acid, elastin gel, for anyone who's not familiar with it, that's injected into joints, was actually approved as a device. And it was initially approved as a means of really replacing the somewhat used-up, burnt out, wasted or ineffective synovial fluid that was thought to be in joints. It turns out that rather than reacting as device, it actually has some efficacy, but it's pretty marginal efficacy. The standard of care for really painful osteoarthritis and, bear in mind, we're going for the severe osteoarthritis, the primary treatment is corticosteroid injections into the knee, which are very effective but they don't last very long. So the concept of providing a long-term steroid is fairly straightforward. With respect to showing efficacy based on pain, you're absolutely correct; it is a subjective model. The secret is to simply plan your studies accordingly; it's as simple as that. There is some additional measures that you can take. You can look at flexibility of the joints and this kind of thing. But it comes down to clinical trial design and powering a study, and you should be able to do that.

And Paul, forgive me I will just sneak in one more. Knowing you guys for so many years, you all are very deliberate in your approach. Is it safe to say that the PK profile of the OA product in the knee would be relatively uniform, because the knee environment is pretty dynamic; it's not like the eye, right or am I thinking – am I not thinking about this right, because I'm just – your environment changes, there's Flexion, there's compression. There is different kinds of loading, the PK profile change, and as a result over time, in different patients, your standard deviation of efficacy could be quite a bit? That would be my last.

The pre-clinical data that we generated indicated pretty constant levels of steroid being maintained in the joint for a prolonged period of time. It could easily be, to your point, there's this hour by hour, there may be significant variations. But the implant is going to release somewhat constant rate and the half-life – the elimination half-life of the drug in the joint is not going to vary enormously. It can change very significantly in cases where the knee becomes inflamed, but we shouldn't see that if we're delivering a steroid. And certainly from earlier work that we did several years ago where we did a study in sheep with a meniscus, meniscectomy. It was very easy to tell which of the animals had a sham procedure or a sham implant and which had the active, because the ones with the sham were universally laying down and the ones with the active were walking around like normal. So that was pretty easy.

[Operator Instructions] Our next question comes from the line of Robert Carlson with Janney, Montgomery, Scott.

Just little bit more on the osteoporosis. I presume this is an outpatient procedure and what happens at the end of six months? Do we go back for another surgery and another implant, and how many of these can you do?

Just to be clear, we're looking at severe osteoarthritis in patients who are otherwise contemplating a total knee replacement surgery. Now this first study, we're looking at six-month implant, but we can certainly extend the duration of the implant once we're sure that we have the right dose. We can make these things last for years if that is appropriate. We also have a system whereby you can essentially recharge the implant in an outpatient procedure. So to answer your question, one, yes six months, by design for this particular study that's coming up that allows us – we have the technology certainly to extend it much longer than that. And in addition, we have the device already designed that allows central drug-bearing to be recharged; it's a refillable device.

[Operator Instructions] And we do have a question from the line of Guy Dietrich with Dietrich Capital.

Could you talk a little bit about what you've been doing with Tethadur in the last quarter to make you so much more enthusiastic about the progress?

With Tethadur, the technical problems that were uncovered or revealed themselves is probably a better way to say was long term stability of the antibody when loaded into the Tethadur molecule itself – when loaded into the Tethadur system. So essentially, we had more than a year's worth of stability data of antibodies loaded into Tethadur at say, 7 degrees, accelerated conditions, all look great. In the wet conditions, however, there seemed to be a – it's likely to be in when you use it, there was surprisingly some degradation of the antibody occurring probably inside Tethadur itself. That's one of those really annoying observations. If you're going to have a stability problem, you want to have it soon rather than after four months. So we've fixed that problem, I believe we fixed that problem, time will tell. And in so doing, fortunately, we've also been able to significantly increase the amount of antibody loading now into the Tethadur itself, so we can get a much higher percentage of antibody into the Tethadur. Both of those things that are looking very promising. That's going into pre-clinical studies now to ensure that we haven't upset any other apples with respect to toxicity and information and those kinds of things, although at the moment, we're not really expecting to see any of that problem, but you've got to check.

I'm not showing any further questions at this time.

I’d like to thank you all for joining us today and I look forward to speaking with you again next quarter. In the meantime, if you have any additional questions, please feel free to contact us. Thank you.