Kala Pharmaceuticals, Inc.
Q4 2020 Earnings Call Transcript

Published: 25 Feb 2021

[Operator:]

Good morning, and welcome to the Kala Pharmaceuticals Fourth Quarter and Full Year 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, a Q&A session will be held. As a reminder, this call is being recorded. I would now like to turn the call over to Niranjan Kameswaran, Senior Vice President of Strategy for Kala Pharmaceuticals. Please proceed.

[Niranjan Kameswaran:]

Thank you, operator, and thank you all for participating in today's call. Joining me from the company are Mark Iwicki, Chairman, President and Chief Executive Officer; Todd Bazemore, Chief Operating Officer; Kim Brazzell, Chief Medical Officer; Mary Reumuth, Chief Financial Officer; and Hongming Chen, Chief Scientific Officer.

[Mark Iwicki:]

Thanks, Niranjan, and good morning, everyone. Thank you for joining us today to review Kala's fourth quarter and full year financial results and business highlights. This is a very exciting time for Kala. We build a portfolio of innovative therapies, including two marketed products, and established a commercial organization with deep experience working across the ophthalmology and optometry markets, and bringing new treatment options to eye care professionals and patients. As we look to the future, our goals are clear. We aim to establish EYSUVIS as the market leader for the short-term treatment of dry eye disease and to grow INVELTYS to treat more patients with post-operative ocular inflammation and pain, while strategically investing in the development of our internal pipeline of proprietary new chemical entities for the treatment of a range of front and back of the eye diseases.

[Todd Bazemore:]

Thank you, Mark. I'll begin today with the launch update for EYSUVIS. The early response from eye care professionals and patients has been exceedingly positive, and our team has done a great job quickly executing the launch in just three months post approval. As a reminder, dry eye disease affects approximately 38 million people in the U.S. alone, and more than 17 million of these individuals have been diagnosed and are currently under the care of an ophthalmologist or an optometrist.

[Kim Brazzell:]

Thank you, Todd. I'm excited to update our early stage pipeline, which, as Mark mentioned, includes multiple proprietary preclinical candidates targeting diseases of both front and back of the eye. We're currently evaluating three internal preclinical programs, selective glucocorticoid receptor modulator, or SEGRM, a selective small molecule Tyrosine Kinase inhibiting targeting EGF and an ocular surface targeted steroid.

[Mary Reumuth:]

Thanks, Kim. During this discussion of our financial results, I will reference certain non-GAAP financial measures. These non-GAAP financial measures exclude stock-based compensation, non-cash interest expense and depreciation and amortization. For a full reconciliation of our GAAP to non-GAAP financial measures, please refer to today's press release which is available on our Web site.

[Operator:]

. Our first question comes from Christopher Neyor of JPMorgan.

[Christopher Neyor:]

Good morning and congrats on the Express Scripts contract. First question’s on EYSUVIS payer contracting. Todd talked about the potential for adding formulary coverage in the coming weeks and months. Acknowledging that these are ongoing negotiations, can you speak to what gives you confidence in additional contracts? And what aspects of EYSUVIS’ product profile have peers found attractive in initial discussions? I'll start there and then I have one follow up.

[Todd Bazemore:]

Hi, Chris. Good morning. It's Todd Bazemore. So to your first question, what I would say is that we are deep into those discussions and negotiations with other large commercial payers. We're quite happy where those discussions currently are, and are very optimistic that we'll be successful and get additional adds. And also with the ESI contract, that also gives us access to all of their custom clients. So there are a number of additional lives under the ESI umbrella that have the ability to access the contract that we have in place, which will continue to help us grow coverage in the coming weeks and months ahead. So we just feel really good about where we are in all of those discussions and expect to continue to improve commercial access here in 2021.

[Christopher Neyor:]

Great, that's helpful. Second question’s on EYSUVIS sales force. What impact are you seeing from COVID-19 on the initial product launch? And specifically, are there any limitations on face to face marketing? It seems like you might be seeing a benefit from the early vaccination of physicians and physician office staffs. Perhaps maybe any color on what impact that may be having?

[Mark Iwicki:]

Yes. We've been really, really pleased with the response to our sales force in the launch of EYSUVIS. As you know, we have set ourselves up to be able to do both in-person face to face promotion as well as a full suite of virtual promotional tactics that are available. That having been said, six weeks into launch, 90% of our sales interactions are face to face with eye care professionals. So we're seeing really, really great receptivity. We're getting in to see most of our customers face to face, which means we're able to deliver a sales presentation and make sure they have EYSUVIS samples. So we're just really happy for how that is going, and we can expect it to only continue to improve to your point as more and more of the population becomes vaccinated.

[Christopher Neyor:]

That's great. Thanks for the questions.

[Mark Iwicki:]

Thank you.

[Operator:]

Our next question comes from Andreas Argyrides with Wedbush Securities.

[Andreas Argyrides:]

Good morning, everyone. Thank you for taking our questions. I'm on for Liana Moussatos. Good question regarding the – the previous question regarding formulary access, so congrats by the way. And could you maybe just talk about what factors went in to that? And how do you now anticipate the ramp of the launch kind of changing as a result? And then I have one more follow up.

[Mark Iwicki:]

Sure. Good morning, Andreas. Good questions. What I would tell you is that in all of our clinical presentations to the payers that we have met with to date, there's been good recognition of the clinical differentiation of EYSUVIS in the marketplace, based one on its indication, right, unique indication rapid acting short-term treatment approved for the signs and symptoms of dry eye disease. And then obviously because of the clinical data that supported approval, and the fact that we show a very rapid onset of action, great resolution of signs and symptoms with it only being used for two weeks. So that's being recognized as unique by payers. We are actually having great success with payers actually carving out a unique place in their formularies for EYSUVIS as the only short-term acute dry eye medication that's available. And those conversations have just gone really well. And it sounds like you may have a follow-up question.

[Andreas Argyrides:]

Yes, sorry. I was on mute. And just looking ahead of the pipeline and the wet AMD program in particular, you mentioned that there may be -- there are two routes that you may go, topical and intravitreal. Topical TKIs have had some setbacks in the past. What is it about what have you seen specifically that gives you confidence that topical is a viable route administration? And how do you see a topical treatment, whether it's a couple of times a day being a sort of an issue via compliance or not? Thank you.

[Kim Brazzell:]

Yes. This is Kim Brazzell. I’ll try my best to answer your question. First of all, we've done a great deal of pharmacokinetic and preclinical efficacy evaluations of our topical TKI. And as a start, the compound was designed specifically for use in the eye by scientists at Kala. We've shown with topical administration, we get concentrations that were well above that that's needed for efficacy by the IC50, but interestingly also a similar or higher concentration that have been shown in animal studies with the current inserts that are delivered intravitreally into the eye. So we think that we have robust preclinical data. We're continuing to generate data and analyze this, and also look at the option of doing an insert as well. But we think both products would have a significant place in the treatment armamentarium. A topical product would allow sort of maintenance therapy for patients that don't want to or can't get the frequent intravitreal injections that are required for maintaining the diseases such as AMD and so forth. The logistical issues and so forth make that difficult for some patients. It also could have applicability in patients that have significant AMD in one eye and are developing AMD in the other eye to slow the progression of that. So we see significant opportunities with this product and still have work to do to get it to the next step of going into full development.

[Andreas Argyrides:]

Great. Thank you for taking my questions and congrats on the quarter and progress in the new year. Thank you.

[Mark Iwicki:]

Thank you.

[Operator:]

Our next question comes from Frank Brisebois with Oppenheimer.

[François Brisebois:]

Hi. Thanks for taking the questions. I was just wondering -- you guys mentioned the 550 eye care professionals that have prescribed already. Can you discuss -- that's 550 out of how many are you targeting again? And how concentrated -- is there a couple that -- there are a couple that prescribed quite a bit more than others. How much granularity is there in that number? And then I have a follow up.

[Todd Bazemore:]

Hi, Frank. Good morning. It's Todd. So to your first question, we are targeting with our 91 representatives about 12,000 eye care professionals right now. It's pretty evenly mixed between ophthalmologists and optometrists. So there’s 550 subscribers that have come on board already. I would describe that as we've got good broad prescribing across the overall group. So with dry eye I think with this initial group is, is they are seeing patients that are suffering flares. They have begun using -- not only prescribing but also we put a lot of samples into the market. So we're getting a lot of clinical experience in the samples that we put out there as well. And the feedback has been overwhelmingly positive. With our patient starter kits, we had a feedback mechanism that early experience kits were provided to patients, doctors were able to collect clinical feedback from the patient as to how they were doing. And the two most common themes that patients have reported back from those early experience programs is that they experienced a very rapid onset of action, the drug worked very quickly to relieve their symptoms and that it's a very comfortable eye drop that they're not experiencing any tolerability issues with burning or stinging or blurred vision. So just really, really positive feedback that's then reinforcing utilization of EYSUVIS with the eye care professionals.

[François Brisebois:]

Okay, great. And then on the reimbursement side, congrats on Express Scripts obviously. Is that kind of quicker than expectations? It seems pretty quick into launch. And what other big players are there out there? How much does Express Scripts kind of cover in terms of commercial side percentage there? And then if you can just remind us again, you compare it to the generic steroids that aren't necessarily the cheapest either. Can you just talk about the co-pay that's necessary with the coverage here compared to generic steroids? And basically, if you are programmed to maybe help with the co-pay and how much that might penalize you, I guess; so just more on the reimbursement side?

[Todd Bazemore:]

Sure. So to your first question, yes, we feel like this initial EYSUVIS coverage came very quickly, only 30 days after the launch. It is very common for new product launches with the three large PBMs to not be reviewed for the first six months they’re are on the market. Quite often the PBMs will prick sort of this six-month new to market block where they don't even consider adding new formulary. That has not been the case. We are deep into discussions with all three of the major PBMs; ESI, CVS Caremark and OptumRx , and we’re very pleased with the way those discussions are progressing. And we’re optimistic as I said that we're going to continue to grow our access here in the coming weeks and months. So we feel really good about that. You had a second part to your question, Frank. Can you remind me what it was?

[François Brisebois:]

Yes, just in terms of the co-pay, just to help us -- I don’t know, for some it might be higher, but you guys have a program to help with the co-pay. So just remind us when you compare it to the generic steroid market.

[Mark Iwicki:]

We believe with the ESI contract, again, it depends on the patient's specific health plan, the benefit design within that plan, but the range of potential co-pays could be anywhere from $25 to $75. But as you know, we have a co-pay program that we've put out there for commercial patients where they never have to pay more than $40. We can dial the co-pay down to $40. So net that means essentially that most of those patients should end up with a co-pay somewhere in the $25 to $40 range, again, depending on their health plan. And the feedback we've gotten from speaking with eye care professionals is that's very reasonable, particularly considering that EYSUVIS is an acute medication used on a short-term basis and most patients may only need two or three prescriptions per year, unlike chronic medications where they have to refill their prescription every month and incur that co-pay cost or expense every single month.

[François Brisebois:]

Okay, great. That's very helpful. And if I can, I'll sneak in a real quick one here. You guys mentioned the -- we can track the scripts through Symphony. It seems like -- there's obviously some scripts not only Symphony but especially with the patient hub, especially early in the launch. Is it fair to say it seems like most scripts though are reported through Symphony at this point? I'm just trying to gauge the percentage that is still hard for us to track because of the patient hub?

[Mark Iwicki:]

Yes, really good question. We did monitor the patient hub. That's the EYSUVIS I-Save program, which is our internal patient hub. Most of the scripts are getting captured by Symphony. There are some scripts that get billed directly through the hub that do not report out through Symphony. And then I think the other thing to keep in mind is that, that hub is set up so that doctors can send prescriptions to the hub that may not -- that may require rather a prior authorization approval if that patient's particular health plan is not yet covered in EYSUVIS. And so in addition to the 2,200 prescriptions that you've seen reported through Symphony already, there's another 1,200 prescriptions that have been sent to our patient hub that are somewhere in the process of working through prior authorization approval so that we can hopefully secure insurance coverage for those patients, and they can go and get their prescription filled at a local retail pharmacy. So I think -- when you think about the scripts, you're seeing reported through Symphony that have been filled, think of probably another 50% volume on top of that of demand that's been prescribed that's working somewhere through the prior process at our patient hub.

[François Brisebois:]

Okay, that’s extremely helpful. Thank you.

[Mark Iwicki:]

Sure. Thank you, Frank.

[Operator:]

Our next question comes from Biren Amin with Jefferies.

[Biren Amin:]

Hi, guys. Thanks for taking my questions. Could you comment on the prescribers that have written for EYSUVIS and just your outreach there, and I guess their incentive in writing for a service? Are these mainly high prescribers in dry eye disease? Anything you could I guess provide in terms of color, in terms of the prescribing base currently? Thanks.

[Todd Bazemore:]

Yes, Biren, I’m happy to do so. Good morning. So a couple of things. At this point, we're still really early in March so we have still haven't gotten to a little less than half of our targeted dry eye physicians that we've had a chance to get at least one sales call on, and most of them we've had the opportunity to that half that we called on have also received the sample. So we're really happy with the early uptake considering that we still have half of our targeted physicians to get to here in the second half of the first quarter. With those that have started prescribing, the 550 that are prescribing to date, that split is about 55% optometrists and 45% ophthalmologists. So we are seeing those optometrists really sort of stepping forward as early adopters. We're not surprised by that, right, because we've always said in the past that optometrists tend to treat a higher volume of the patients with more mild to moderate dry eye disease that are more likely to present with a more episodic manifestation of their symptoms and are probably ideal candidates for short-term treatment with a drug like EYSUVIS a few times a year. And certainly that's what we're seeing. In terms of sort of the mix of prescribing, we definitely are seeing the higher decile I think of 7 to 10 doctors being the ones that are coming on first and initially trialing EYSUVIS. But as the sales force gets further reach and starts calling on doctors in the low to mid deciles, we expect them to start prescribing as well. It's just a matter of needing more time and territory, so we can reach more of our targeted physicians.

[Biren Amin:]

And then with regards to the hub, you mentioned previously that about 50% -- or of the 2,200 scripts, you have another I think 1,200 scripts that are in the hub waiting for reimbursement to come through with prior auth and such. Typically, how long does it take to navigate through that? And I guess -- and another question is, of the scripts written so far, have these primarily been patients on private insurance? And I guess if you could give us a split between private insurance versus government insurance?

[Mark Iwicki:]

Yes, really good questions. That by our process we're finding can take anywhere from a week to two depending on the patient's health plan, sometimes also it can depend on how quickly the doctor's office gets back if there's additional information that they have to provide to the insurance plan for that patient in order to secure approval. So it’s probably reasonable to assume it can take up to a couple of weeks to work through that process. In terms of the early split, it is skewing predominantly to commercial. I think early on, at least for the prescriptions that are getting filled, upwards of 70% of those prescriptions are to commercial payers.

[Biren Amin:]

Okay. And then maybe just one last question for me. I know the company’s probably not going to provide annual sales guidance. But how should we think about the EYSUVIS launch? Currently, if I look at consensus, total sales are 37 million across both EYSUVIS and INVELTYS. And if we assume 9 million to 10 million for INVELTYS, that kind of suggests that EYSUVIS’ consensus is around 27 million, 28 million. So given where you're at with the first six weeks, do you think we're thinking about the EYSUVIS launch the right way with consensus about 27 million, 28 million?

[Mark Iwicki:]

Hi, Biren. It’s Mark. Thanks for the question. We're really excited by the early uptake and in particular, the feedback. It was great to get the ESI contract as well. So I feel like we're on a good track. It certainly will be great if the pandemic starts to subside or the vaccinations really take hold. And we are hoping that the surgery market will rebound a bit. In INVELTYS, performance has been robust but the market is still significantly down and also has an impact on launching EYSUVIS obviously as procedures within offices are altered versus the normal interactions that sales professionals can have. So we believe that we're seeing all of the right signs and hopefully that we will be able to have a strong year.

[Biren Amin:]

Great. Thank for taking my questions.

[Mark Iwicki:]

Thank you.

[Operator:]

Our next question comes from Yi Chen with H.C. Wainwright.

[Yi Chen:]

Thank you for taking my questions. First question is, when do you plan to increase the sales team for EYSUVIS? Is it in any way related to increasing formulary access?

[Todd Bazemore:]

Hi, Yi. Good morning. It's Todd. So we're conducting those assessments right now. We haven't determined the final timing of expanding the sales force, that second wave expansion to get to approximately 125 reps. I would say there’s two major determinants in the timing of that. One is what you said, right, which is securing additional payer access and we're very pleased with that payer coverage. Looks like it is coming quicker than what we had even initially anticipated. And then secondly would be where we stand with the pandemic and the impact that it's having on patient flows into the office. And as we continue to assess those two things and feel like we're in a good position, we know that we can very quickly pull the trigger to begin the expansion to grow the sales force. But more to come on the specific timing.

[Yi Chen:]

Got it. And could you please comment on the trend of ocular surgeries in the past two months?

[Todd Bazemore:]

Yes. They definitely have been negatively impacted by the increases that we've seen. I think we've sort of seen two additional spikes in COVID cases across the country post the holidays, right. There was sort of that post Thanksgiving holiday break spike and then another one that occurred after the Christmas holidays. Those have definitely created some headwinds for the number of surgical procedures that has continued to be down. As Mark said a little bit earlier, we're really happy with INVELTYS performance within the market. We have around 11.5% branded new prescription market share. So we're near our sort of all-time high in our market share for INVELTYS. But that's a market share in a currently declined market because of the COVID impact on the number of elective procedures that are occurring. But that's also why we're really optimistic because INVELTYS has performed so well that once we get a significant portion of the population vaccinated and surgical volume returns to the pre-COVID levels, we're very optimistic about INVELTYS potential growth in the future.

[Yi Chen:]

Got it. Last question with respect to the TKI candidate in the pipeline for AMD, is it going to be a long-acting treatment?

[Kim Brazzell:]

As we've said, and I said earlier, we're really right now looking at the two options, one being a topical treatment that would be given on a daily basis, and the other would be an intravitreal sustained release delivery, which we would target for six to nine months or even longer. So we're currently evaluating both approaches. We think both have their advantages and would have a unique position in the marketplace.

[Yi Chen:]

Thank you.

[Operator:]

Our next question comes from Tim Chiang with Northland Securities.

[Tim Chiang:]

Hi. Thanks. Mark, could you just comment on the sampling program? Are all the prescriptions that you're seeing so far are all coming from samples, or are you seeing prescriptions being written from some of your high prescribing eye care professionals, even without the samples for EYSUVIS?

[Todd Bazemore:]

Hi, Tim. This is Todd. I'm happy to comment on that. One, just to be clear, the prescriptions you are seeing reported by Symphony are actual prescriptions. So that's not free product that's been given away. But you bring up a really good point. There have been prior launches within the dry eye category where the prescriptions that were generated certainly in the first couple of quarters of launch was a lot of free product that was being given away at the pharmacy. And that is not what we're doing here. So these are actual prescriptions that are being written and filled at the pharmacy for these patients. As to whether or not prescriptions are being written with or without a sample being handed out, we think there's a lot of sampling going on right now. We've made sure we've put a lot of samples into the marketplace, because we think in the early days of launch, while we're securing broad market access coverage, we want to make sure that doctors have samples that they can give to patients to start developing that clinical experience. And that does include that sometimes the patients are being given a sample and a prescription is being written so that they can use the sample for the first few days, because our sample size – our sample bottle size is smaller than the chain bottle size, and then go fill that prescription so they can continue to treat for the rest of the duration of that flare.

[Tim Chiang:]

Interesting. Todd, maybe just one follow up then. How many of the face to face meetings that your sales force is having with eye care professionals are leading to an immediate impact, i.e., prescriptions being filled literally that day or that week? Are you guys tracking that? And I'm just wondering how many of your prescriptions are you actually seen through virtual marketing efforts?

[Todd Bazemore:]

Yes, certainly. Tim, we haven't commented specifically on -- I think we're just trying to get that as how quickly after sales presentations are delivered and just prescriptions start being generated? And I think the easy answer to that would be it sort of depends, right? If you've got good coverage within that practice, particularly now with the ESI formulary, then there's an opportunity to prescribe more quickly. If it's an area where maybe the coverage still isn't where we expect it to be here in the coming months, then what may be happening is the doctor may be giving out samples so that they can start using the product right away in their patients. I think all-in-all, what we're really happy with is the early response in the feedback from both eye care professionals and patients, whether it was a prescription that was written or samples that were given out, the clinical response has been overwhelmingly positive, which we think in highly symptomatic conditions like dry eye is going to be really important for generating additional use and prescribing in the future.

[Tim Chiang:]

Just one last question, Todd. Price isn't coming back -- you're not coming back with feedback from physicians saying that price is an issue here then. Is that right?

[Todd Bazemore:]

Look, we have -- as I said earlier, with our contracted position with ESI and use of our co-pay card, the vast majority of patient's co-pay should be somewhere between $25 and $40. And that’s been received as being -- people find that to be really acceptable. And as I said earlier, particularly when you consider this as an acute medication that patients only have to fill probably two or three prescriptions per year, that's considered a very reasonable co-pay amount.

[Tim Chiang:]

Very good. Thanks, Todd.

[Todd Bazemore:]

Sure.

[Operator:]

. Our next question is a follow-up question from Frank Brisebois with Oppenheimer.

[François Brisebois:]

Hi. Just a quick follow up here. Can you compare and contrast the gross to net expectations between EYSUVIS and INVELTYS? Thanks.

[Todd Bazemore:]

Yes, Frank, I'm happy to jump in. We're not giving specific gross to net numbers. But as we have guided in the past, we do not expect EYSUVIS to face some of the same gross to net pressures that INVELTYS did during launch, because the market dynamics are just very different in the post-surgical market versus the dry eye market which is much more of a traditional retail market, largely driven by commercial insurance whereas in this surgical market it’s much more impacted by Medicare. And in the post-surgical market, that type of programs you roll out for patient access, particularly for the Medicare patients that are having cataract surgery, put a lot more pressure on the gross to net. So we do expect that the gross to net for EYSUVIS will be more favorable than what we saw during the INVELTYS launch.

[François Brisebois:]

Great. Thanks.

[Todd Bazemore:]

Sure.

[Operator:]

And I'm not showing any further questions at this time. I would like to turn the call back over to Mark.

[Mark Iwicki:]

Thank you very much, operator. We appreciate everyone joining this morning. The past 12 months has marked many milestones for Kala, and we're really looking forward to a strong 2021. We're focused on driving the uptake of EYSUVIS and are pleased with our early launch trends. So thank you very much and we look forward to updating everyone soon.

[Operator:]

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.