KALA BIO, Inc. (KALA) Earnings Call Transcript & Summary

Morning. I'm Chris Neyor from the U.S. pharma team at JPMorgan. I'm glad to introduce Kala Pharmaceuticals and CEO, Mark Iwicki. On today's format, we have a presentation followed by a Q&A session with Kala's management team. If you have any questions, you can use the ask your question feature online, and I'll integrate those questions in the Q&A session. With that, I'll hand it over to Mark.

Thank you so much, Chris, and good morning, everyone. Thank you for being with us, and we're really pleased to give you an update on Kala Pharmaceuticals. Just moving to Slide 2, we will be making forward-looking statements today, so please refer to our disclaimers and notices. I'm moving to Slide 3 now. Kala has been on a mission to become a leader in ophthalmic diseases. We have a portfolio of innovative therapies, 2 marketed products, that utilize our proprietary amplified mucus-penetrating particle delivery system. And we'll show you in a minute why that really makes a difference for our products and has enabled us to get 2 products to the market in the last 2 years. We also have an early-stage pipeline with multiple proprietary NCE development programs that are targeted to address front and back of the eye diseases. We have worldwide rights on the IP to all of our marketed products and pipeline assets. Not only that, but we've become a fully integrated company over the last 10 years. We have R&D capabilities. And of course, our new commercial capability, starting with the launch of INVELTYS. We have approximately 190 employees, and we recently expanded our ophthalmic sales and marketing teams for the launch of EYSUVIS. We have deep expertise in discovery, clinical operations, regulatory affairs, and that's for both front and back of the eye diseases. We also have a strong cash position. We expect to report cash, cash equivalents and short-term investments of $153.5 million as of December 31, 2020. And that existing cash position gives us a runway into, at least, the fourth quarter of 2022. And revenue generated from the sales of EYSUVIS will provide additional cash runway. On Slide 4 is an overview of our marketed products and our internal pipeline, we're really excited to now have 2 products in the marketplace. We launched EYSUVIS in early 2019, and are now focusing on the launch of EYSUVIS, just getting started over the past 2 weeks. And then as I mentioned, we have an internal pipeline with a kinase inhibitor, surface targeted steroid and a SEGRM as well, and we'll talk more about those in a few minutes. So on Slide 5, you can see a graphic representation of what our AMPPLIFY technology helps us do. And this is a description of what we've been able to do with our first 2 products that have loteprednol etabonate in them. And essentially, our technology enables us to deliver the drug through the mucus layers and mucin tissues and get 3.0 to 4.0x as much drug to the targeted tissues. And that is both corneal tissues as well as aqueous humor and all of the relevant targets for both INVELTYS and for EYSUVIS. And that technology on Slide 6 is what enabled INVELTYS, our first product to be the only BID twice a day steroid for post-surgical use. The product has an excellent safety and tolerability profile. We've been in the market for 2 years with it. In addition to the efficacy and tolerability profile, we also showed that we had an intraocular pressure profile that was comparable to placebo or vehicle. It does use, as I mentioned, our AMPPLIFY nanoparticle technology, and we've been really pleased with the reaction to the product in the market. On Slide 7, you can see that we were certainly on a strong growth trajectory after we launched the product, there is no doubt that the COVID pandemic hurt the number of surgeries or reduce the number of surgeries that were happening in the second quarter of last year, late first quarter, second quarter, and that continued into the third quarter as well. We see a resurgence in both the number of surgeries as well as our INVELTYS prescriptions. As you start to get into June, July, August. And we're almost back to those pre-covid levels and pleased with the growth and market share progress that we've shown on INVELTYS. We certainly expect when the pandemic subsides, more, may be correlated with the vaccine that surgeries will be fully back up and running with ophthalmologists and that will give us an opportunity to further grow the INVELTYS product. On Slide 8, again, we just couldn't be more pleased than the progress we've made with EYSUVIS. The product was approved in October of 2020, and we very quickly increased the size of our sales force and got ready to launch it. It's the first and only prescription therapy, specifically designed for the short-term treatment of the signs and symptoms of dry eye disease. And about 80% of dry eye patients routinely experience dry eye flares. That gives us a really big opportunity to capture that large, significant unmet need in dry eye, and we have really deep experience across the organization in dry eye disease. We have a strong IP position, as I mentioned, but in addition to that, a proprietary manufacturing process. So we expect quite a long runway with EYSUVIS. On Slide 9 is an overview of the dry eye market. And I'm sure that some of you are familiar with products that were launched for the maintenance therapy in dry eye disease. And those are often used for the most severe patients. There are about 38 million patients estimated to have dry eye disease. And importantly, roughly half of those patients, 17.2 million have been diagnosed and are under the care of an eye care professional. About 75% of patients, though, have never tried a prescription therapy. They just use OTCs and other home remedies. And if you think about even the group that's tried prescriptions, only 10% are currently on a chronic Rx therapy. And further breaking that down, if you look at products like steroids or off-label steroids, that's an even smaller number, only about 2.9% of patients ever receive an off-label prescription for a steroid that does, though, lead to about 6.1 million chronic TRxs per year, and that market is valued at about $1.5 billion with Restasis, Cequa and Xiidra, currently. About 80%, though, of those patients are discontinuing their chronic medication by about 4 months. There are issues with onset of action and tolerability as well as the fact that some patients find that, that's just not the best solution for them. On Slide 10, what you can see here is that there's a large group of patients that are in the dry eye diagnosis category, but they suffer mostly from episodic flares and not significant continual symptoms. And so if you think about dry eye disease, it is very likely a chronic condition, so that once you're diagnosed, you're likely to have that condition for the rest of your life. But for most people, it's a flaring or episodic disease and not one that carries the burden of everyday symptomatology that warrants treatment. So what you have is about 80% of patients that are really suffering from flares a couple of times a year. So a more mild patient may have 2 or 3 flares a year, a moderate patient, maybe 5 or 6 flares a year. And as you get more severe, you may even have 6, 7, 8 flares per year. You can see in the data at the bottom of the slide that people suffer from flares, whether they are on artificial tears or if they're on prescription medicines. And although some of the chronic medicines that have been approved, certainly provide relief for some patients, those patients also experience a significant burden of flare. So they may be controlled when they're not experiencing a lot of triggers and then hit a trigger and even have a flare or many flares per year, while they're on their chronic maintenance therapy. So on average, and although, there's a wide distribution, what we found is that patients suffer from about 5.5 flares per year. On Slide 11, we want to talk a bit about the patient journey because this highlights the unmet need and why we think that EYSUVIS really fits that unmet need, and we've had a great initial reaction from prescribers and patients. So the way that patients kind of start on the disease is they experience some symptomatology, maybe a foreign body sensation, some dryness or sensitivity to wind or other triggers that they may experience routinely in their home or at work or even outside. And most patients figure out that it might be something that an artificial tear could help them with. And so they use artificial tears for a period of time. And what you often hear from patients is, but then they'll have a flare that really makes them concerned. They can't get rid of this foreign body sensation. Their eyes are really sensitive. They can't even sometimes keep their eyes open for very long. They have to close them. They're using a lot of artificial tears and that will bring them into the doctor's office out of concern. And of course, worry that something is going on that needs to be treated. Unfortunately, because there's been no -- what we think of as appropriate first-line prescription therapy that's been approved by the FDA for dry eye flares, which is what these patients are experiencing, they often get sent home and told to try a different artificial tear. Now at this point, most patients have been through various artificial tears and other home remedies. And because of the internet, they're able to find a lot of this information out very easily. And so this leads to a bit of a spiral and a frustration by patients because they're going back maybe a couple of times a year and maybe for several years and not really advancing their care. And you might ask, well, why is that happening? Well, they're still mostly experiencing 2, 3, 4 flares a year. And then that situation, most doctors are not thinking that they're really appropriate candidates for a maintenance therapy. Typically, the flares do resolve. So the doctor is trying to do the best they can, are asking the patients to use these other OTC remedies to try to get by for a while. And then what you hear from patients and doctors is that, then the flares kind of build up or get more severe, perhaps the patients aren't able to even do some of the things they typically did. You often hear, "I can't be outside when it's really windy, my eyes bother me, I used to wear my contacts all the time. Now I can only wear them for an hour or two. I can't wear them to work. And if I do wear them all day long, my eyes bother me for days after that." And so that is kind of the cycle and as patients get more and more bothered by their flares, they go back to the doctor looking for relief. And as I said, that's about 80% of patients. That's the way they experience the disease. And again, a huge group of patients are in the doctor's offices being treated with OTC remedies, but really not being treated with any kind of prescription to date. And that's where EYSUVIS can come in, and we're very excited about the clinical profile that we're able to give to doctors. On Slide 12, you can see that we have a rapid onset of relief in ocular discomfort, which is really important to the patients. We have a clinically meaningful effect starting as early as day 2 and maintained throughout the course of therapy in our clinical trials. And on the right-hand side, you can see data from our STRIDE 1 Phase III trial, and we've been able to demonstrate this in several trials. As well and physicians are very interested in our data that shows that we have a meaningful effect on inflammation. And so at the 2-week mark, we have statistically significant benefits in conjunctival hyperemia, which is the hallmark symptom of inflammation. And in addition to that, we've been able to show very clinically relevant data on corneal staining at 2 weeks, which is a marker of being able to treat that inflammation and improve the symptomatology, overall symptomatology for the patients. So on Slide 13, you can see that EYSUVIS is a very comfortable drop and the intraocular pressure profile is comparable to vehicle. And we've studied EYSUVIS in over 2,800 patients. So with that profile, on Slide 14, we feel that EYSUVIS is the ideal first-line product when patients really are not feeling they're getting the kind of relief they want and the doctor -- and they go to the doctor, the doctor can now have an FDA-approved on-label product to treat the signs and symptoms of the dry eye disease. And again, that's 80% to 90% of patients that are not on any kind of prescription therapy today. So this gives the doctor a great tool, especially for those kind of first-line patients that might be having mild to moderate disease and experiencing a couple of flares a year. But in addition to that, as I mentioned earlier, patients that are on chronic therapy are also experiencing triggers and exacerbations in their symptomatology. So we believe that EYSUVIS, it could be a terrific product as adjunctive therapy for those patients that are on a maintenance therapy. We know that patients are going to see their doctor, 2 to 3x per year. And interestingly enough, doctors report to us that patients, when they come to seek care for dry eye, about 42% of the time, it's for dry eye flare. So they're certainly coming into the office, talking about their symptomatology, asking for something to treat it. So that they can feel better and hopefully get back to the normal course of their daily living. On Slide 15, it's a summary to say that we have broad anti-inflammatory effects. We have a rapid onset of relief. It's well tolerated. It's the first and only corticosteroid that's FDA-approved and indicated for dry eye disease. And we know that eye care professionals really prefer an on-label steroid. Not all steroids are the same and many off-label steroids have very varied safety profiles, the risk of intraocular pressure increase is quite different across the different steroids. The dry eye indication provides, for the doctor and for the patient, some comfort and confidence that the FDA has reviewed the product. And in our market research, we've seen that about 99% of eye care professionals are very interested in seeing a product like EYSUVIS have a dry disease indication. So we believe that EYSUVIS has the potential to be the preferred prescription therapy for dry eye flares. And we couldn't be more pleased on Slide 16 than to let all of you know that we have now launched the product. We began the trade stocking late in 2020. And as of the week of January 11, all of the wholesalers and targeted retail pharmacies have been stocked. We have our marketing plans that are kicking off and education programs with doctors, our sales team of 91 highly experienced representatives are out there, explaining EYSUVIS and the nature of dry flares and how they can be appropriately treated with EYSUVIS. We also have patient access programs, as we're working through getting access for commercial and Medicare Part D programs to help make sure that the patients get the product, EYSUVIS. And even a patient hub in place to really assist with the process. So on Slide 17, in summary for EYSUVIS, it is just a huge opportunity for Kala. There are 17 million diagnosed dry eye patients that are experiencing flares, that's 13 million to 15 million patients having about 5.5 flares per year. That translates into 330 million treatable flare days for which we feel EYSUVIS could be a great product for them to be used. Only 15% of diagnosed dry eye patients are currently on an Rx medication. For all the reasons that I already discussed. And again, 75% have never even tried a prescription therapy. So if you put all that together, a massive market and a huge unmet need, you can see why we're very excited about the opportunity to bring EYSUVIS to the market. I'd like to turn now to our development-stage programs. And on Slide 19, I want to spend a few minutes talking about the diseases that we're most interested in targeting with our pipeline programs. AMD and especially wet AMD is a huge burden on the world's population and estimated to be approaching 288 million patients with AMD by 2040 and 22 million in -- by 2050 in the United States alone. And there are some effective products, but patients still -- there are some patients that still remain not adequately controlled, and we feel that, that is a terrific target for some of our pipeline programs. In addition, diabetic retinopathy and DME have about 93 million patients worldwide and as many as 16 million Americans are expected to have these indications by 2050. RVO, another important and can be very severe disorder. For patients there are about 16.4 million patients globally and a little bit over 1 million estimated in the U.S. to have RVO. On Slide 20, you can see our pipeline and I think it's important to say that all of these products were developed by Kala, they are proprietary NCE development programs, and again, targeted to address front and back of the eye diseases. Our kinase inhibitor program, which we previously talked about, we've been able to make significant progress on. We have a topical formulation that could be used for AMD, DME, RVO as well as we are working on a depot formulation for that kinase inhibitor. We have a surface-targeted steroid that could provide meaningful benefit by just targeting those surface tissues and not getting deeper into the ocular tissues, thereby hopefully providing the efficacy that is expected from a steroid without some of the unwanted side effects or safety issues. So that could be a quite meaningful product. In the future for ocular surface disorders. And then we have a selective glucocorticoid receptor modulator. The acronym there is SEGRM and that's a really exciting class of compounds that we'll talk about in a few minutes. On Slide 21, you can see that we have designed a kinase inhibitor after synthesizing over 100 molecules that is really selective and potent. And we've identified our league compound, 285, we get meaningful levels in the appropriate target tissue. And we're very excited about this product because it has both a topical delivery opportunity as well as a depot. On Slide 22 is our SEGRM. And the key here is that you can activate that glucocorticoid receptor with a steroid, but you're activating with a steroid, both the transactivation and transrepression pathways. With SEGRM, it's thought that you can just activate the TR pathway and not the TA pathway, which leads to the significant side effects and safety issues. So this is a very novel class of drugs and anti-inflammatory agents that could provide a really kind of first-in-class meaningfully differentiated anti-inflammatory product for ophthalmology. And then finally, on Slide 23, as our surface targeted steroid, you can see that in our early preclinical studies, we have a meaningful effect on inflammation without raising intraocular pressure. So in summary, on Slide 24, we're very excited now to have 2 products in the market. Our major focus for the next couple of years will be EYSUVIS. We do expect INVELTYS to return to growth when surgeries come back online, as COVID subsides. We are advancing our pipeline programs, and we have a strong financial position, with cash that takes us, at least, into the fourth quarter of '22. And revenue from EYSUVIS will provide additional cash runway to that. So thank you very much, and we look forward to the Q&A discussion.

Great. For the Q&A session, we're going to have CEO, Mark Iwicki as well as Todd Bazemore, COO; Kim Brazzell, CMO; and Mary Reumuth, CFO. Maybe I kick it off with the first question. Acknowledging it's still early days on the EYSUVIS product launch. What's your initial feedback from physicians and other key stakeholders on the product thus far?

Well, thanks for the question, Chris. We did a bunch of market research and outreach to key opinion leaders just after the product was approved. And we're really excited about what we heard. And I'll give an anecdote and then turn it over to Todd. We had some of the top thought leaders in the U.S., saying to us that, for years, they just didn't have the right tools to be able to practice the best medicine or give the best care to these patients that have flares. They had 1 or 2 options for the more severe patients, but they didn't really have that first-line prescription therapy that work quickly, was well tolerated and had a good safety profile like EYSUVIS. So to hear them talk about almost in relief. We realized we weren't providing the best care we could. Now we have EYSUVIS, and that gives us a great option to be able to treat so many of these patients that -- in their own words, we used to send them home telling them to essentially do the same thing they had been doing for years. So that was just terrific feedback that we heard from the absolute top thought leaders in the United States. But maybe, Todd, I could turn it over to you to give a little bit more color on how the launch is going.

Sure. I'm happy to do so. Chris, as part of the launch in December before the holiday shutdown, we rolled out patient starter kits to a number of the largest dry eye products across the U.S. and those patient starter kits included a clinical experience program, by which the eye care professional could gather feedback from the initial patients that we're placing on the samples of EYSUVIS. And that feedback is starting to come in now, albeit early overloading with positives. And as we've been going through in -- or gather that feedback to the eye care professionals, 2 consistent themes have come through. One is a very rapid onset of activity. Our clinical trials, where we -- demonstrates the typical significance for improving incentives by day 2, their clinical experience program, physicians are telling us patients are getting effect immediately on day 1, they're reporting that their eyes begin to feel better, and they're seeing improvement in their symptoms. So we're just really, really happy with that feedback on that onset. And then the other -- second theme that we're consistently hearing is that it's a very comfortable eye drop, that's not causing any of the burning or skinning or blurred vision that has been associated with some of the previous dry eye therapies that are out in the market for a few years. So we're really happy for the early feedback. We continue to monitor a number of those patients who are part of the early experience program. We're already calling back and asking the identification or later prescription for them.

That is geat to hear. And then 1 question we have incoming. So on the EYSUVIS sales force expansion, could you update us on where we stand there? And also, what impact the winter COVID wave could potentially have on your expansion plans?

Sure. So as you know, we decided to break up that expansion to 2 waves. We executed the first wave after approval in the fourth quarter of 2020 where we grew our sales force from approximately 55 reps to 91 representatives. They are all hired, trained in the field as of last week calling on customers. It's a really experienced group. They have, on average, more than 7 years of ophthalmic experience, and more than half of them have experience having previously sold dry eye therapies. We will grow that sales force from 91 to 125 at some point in 2021, COVID permitting. And what I can tell you is that, while there is a resurgence in COVID, is not significantly impacting our ability to get into the eye care professional's office for face-to-face details. More than 80% of our sales calls are currently face-to-face and a little less than 20% of virtual. We have a full suite of virtual promotional tactics available. So reps can interact with those eye care professionals which are unable to see in person.

And then maybe you could touch on the dry eye market performance more holistically. So you look at the dry eye market, the relative performance in 2020. We've seen less impact from COVID disruptions relative to some other areas of ophthalmology. Maybe you could talk about the backdrop for the chronic dry eye therapies. And maybe how that informs your view of the launch expectations for EYSUVIS?

Sure. I'm happy to. And to your point, Chris, the dry eye market was not impacted as heavily by the pandemic this past spring, as were other ophthalmic markets. I think even at its lowest point, it was still at 85%, 86% of the pre-COVID levels. At this point, the dry eye market has fully recovered. In fact, some recent weekly data, I was looking, the market is up more than 100% of where it was pre-COVID. So the market is showing really, really strong growth. And we're optimistic that even as we're seeing a resurgence in the pandemic this winter that the dry eye market will continue to be strong and grow.

And for the launch, as we go through the initial quarters in 2021, can you talk about any key performance indicators you're watching in the first few quarters? And how do you evaluate the uptake for the product?

Yes. We'll be watching all the normal KPIs, such as prescription growth, market share penetration, number of prescribers and new prescribers that we are able to add every week. And then as we've discussed previously, our ability to achieve [indiscernible] with both commercial and Medicare payers. And we plan to report out of all of those metrics, Chris, on our quarterly earnings calls.

That's great. And then maybe I have to pivot a bit. Could you touch on the impact you're seeing potentially for INVELTYS? I think that's a market that's a bit more impacted by COVID. What's your -- how do you think about the impact relative to what we saw maybe in calendar Q2 2020? It seems like there's less disruptions to the surgical market than we saw last year. And maybe just an outlook for the products as we move into the first half?

Sure. Look, we continue to be really excited about the future prospect for INVELTYS and I think it's going to be a really important contributor to Kala. As to your point, there was big impact seen in the spring from all post ocular surgery products. Those impacts appear to be less, as we're experiencing the resurgence that's ongoing right now. I think eye care professionals, ophthalmologists specifically become very adapted, dealing with the pandemic and are able to see and treat patients. There certainly are some disruptions, that are not so much -- situation where the surgical centers are closing down as they did in the spring, but rather, there are patients that are choosing to wait until after they've been vaccinated to come in for their ocular surgery, cataract surgery in particular. So we do expect the market to be less impacted in early 2021 than it was in early 2020. And really, once we get a significant portion of the population that's been vaccinated, expect that market to fully return to where it was in the pre-COVID period.

Great. And I definitely want to touch on the pipeline, you guys had some exciting announcements there as well. Maybe you could talk us more about the preclinical programs and maybe what next important updates we should be watching for?

Thank you, Chris. This is Kim Brazzell. It's a pleasure to be here today. I can give a little bit color on our programs. As Mark said, we're progressing 3 programs forward. They're all NCEs that were discovered, synthesized by Kala's Discovery Group. So we own all the intellectual property and what have worldwide rights to these. The first one, Mark mentioned is, the tyrosine kinase inhibitor, and that's a program we're very excited about, has a significant application for the treatment of retinal diseases such as AMD, RVO and others. And in that program, we're actually progressing it forward in 2 routes: one with a topical administration. With that, we have demonstrated significant concentrations of drug delivered to the choroid and the retina the target tissues in the back of the eye, following topical administration. We see concentrations there similar to what you see with some of the TKI implants that are currently in development. And we're very pleased to be able to see that we can deliver at least in animals, as much drug is delivered in those intravitreal implant. So that's a very exciting area. We've shown preclinical efficacy data. In 2 models, standard models of a delivered mediated disease, in which we've shown significant efficacy equivalent to that, that you get with intravitreal injections of Avastin or Lucentis. So we're very pleased with the progress there and are moving to that forward to get into IND-enabling in the future. The other pathway we're looking at is the depot formulations that can be injected in the back of the eye. As you know, that's one of the common problems with the current VEGF inhibitors is the frequent need for injections and having a sustained release, and we're looking at least 6 months and perhaps longer having that would improve the compliance with these patients. So we're moving both of those programs forward. We're very excited about it. We think they have applications in age-related macular degeneration, in retinal vein occlusion and perhaps in diabetic macular edema. Again, with those compound, the compound we're using is the novel Kala compound. So it's an NCE, and we have significant IP on that. The SEGRM is another very interesting class. Mark touched on that. Being able to stimulate the pathway of the glucocorticoid receptor that's responsible for the anti-inflammatory effect without stimulating the pathway that leads to many of the untoward effects. And it would be a significant benefit and that it could provide anti-inflammatory activity. Similar to that, that's seeing with current steroids might be devoid or have significantly less side effects. We think that is -- we have significant application and treatment that have chronic ocular surface disease. If they come up with a compound that has the onset and the efficacy of EYSUVIS, but none of these are COVID effects, it could be positioned as an excellent chronic or maintenance therapy for dry eye disease. It also would have application for treatment of retinal diseases. We know that steroids are commonly administered in retinal disease, such as diabetic macular edema, they are very effective, but they have a lot of uninformed effects at the elevation of IOP, which leads to patients being that will need a glaucoma medication ahead in glaucoma surgery and a significant level of cataract formation. So we think, again, this compound would have -- such a compound would have application, both front of the eye and back of the eye. And honestly, could have application in systemic disease because there's a lot of inflammatory diseases for which steroids are currently used, but can't be used chronically. And if they do, they have significant side effects. So with that program, we're in the lead optimization phase that are hoping to have a lead candidate identified by the end of the year. So we can move forward with the development of that. The topical-only steroid would be a unique way to, again, get steroid activity on the front of the eye for ocular surface diseases and be able to not get significant amounts of drugs inside the eye, which is where the problems with current steroids leading to elevated intraocular pressure, the cataract formation. That's mediated by drug levels inside the eye if we can avoid that, not targeting the ocular surface, we could, again, have a potent, effective anti-inflammatory that's deployed or has significantly less formation. So we're very excited about all these with the EYSUVIS and INVELTYS now approved and on the market, our R&D team has the bandwidth and the funding to move forward these programs and provide the next step of Kala's evolution.

That's great background. And then maybe 1 last question before we wrap up here. Maybe you can you update us on where EYSUVIS stands on payer coverage? And what's the strategy there for both the Medicare Part D and also for the commercial market, which obviously, larger segment, we'll be watching that in 2021.

I'm happy to jump in, Chris. So to your point, commercial does represent the largest payer in the market, about 50% of all prescriptions go through commercial payers. We are deep into discussions with those commercial payers now and expect to be able to successfully achieve broad market access with commercial payers in 2021, and we'll report that each quarter how that market access is progressing. But we feel really good about where we're in on those discussions. On the Medicare Part D front, that represents about 40% of our prescriptions. We submitted all of our Medicare Part D bids in the fourth quarter of 2020. Those bids will be under review throughout this calendar year. For the formulary cycle of January of 2022. We do expect we will have some early Medicare wins that will come on board in 2021, but most of the Medicare coverage is likely to come in 2022. And as I said previously, most of our commercial coverage will come this year in 2021.

Perfect. I want to thank Kala team for being here today, and we'll close out the session there.

Thank you, Chris. Thanks for joining. Have a great day.