KALA BIO Inc (KALA) 2020 Q4 法說會逐字稿

Good morning and welcome to the Kala Pharmaceuticals Fourth Quarter and Full Year 2020 Financial Results Conference Call.

(Operator Instructions)

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.

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.

Today's call is being webcast live. The webcast link can be found in the Investors section of our website at www.kalarx.com.

During this call, we will be referring to non-GAAP financial measures, which are not prepared in accordance with generally accepted accounting principles. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measures is available in our press release issued today, which can also be found on our website.

On this call, we will make certain comments about Kala's future expectations, plans and prospects that are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements will include statements regarding the potential market and commercial launch plans for EYSUVIS, observations associated with our commercializations of EYSUVIS and INVELTYS, statements regarding our preclinical development programs and the sufficiency of our cash resources. These and other forward-looking statements are based on the beliefs and expectations of management as of this conference call. Our actual results may differ materially from our expectations.

The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances that occur after this conference call, except as required by law. Investors should carefully read the risks and uncertainties described in today's press release as well as the risk factors, which identify specific factors that may cause actual results or events to differ materially from those described in our forward-looking statements included in the company's annual report on Form 10-K and other filings we make with the SEC. The Form 10-K will be filed with the SEC later today and will be available on our website.

I will now turn the call over to Kala's CEO, 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've built a portfolio of innovative therapies, including 2 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 postoperative 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.

Before turning the call over to Todd and Kim to provide an update on our commercial and R&D efforts, I'd like to spend a few moments to reflect on 2020 and our recent accomplishments. Last year was a pivotal year for Kala. In October, we received FDA approval for EYSUVIS as the first medicine specifically developed to treat the short-term signs and symptoms of dry eye disease. This approval was based on the results from 4 clinical trials that demonstrated the differentiated efficacy, rapid onset, safety and tolerability of EYSUVIS. Immediately following approval, our team turned its full attention to finalizing commercial preparations, and in January, we successfully commenced promoting EYSUVIS in the United States.

We are very encouraged by the early launch and feedback from both doctors and patients. It's clear that our commercial team is making strong progress with eye care professionals so they can quickly gain experience with EYSUVIS and their dry eye patients.

Additionally, despite the challenges of COVID-19 and, more specifically, the pandemic's impact on ocular surgeries, INVELTYS continued to have a meaningful place in the market. As the vaccine rollout progresses and the pandemic begins to subside, we believe we'll continue to see ocular surgeries resuming and INVELTYS prescriptions growing.

Finally, we are advancing our next wave of therapeutic candidates, a suite of proprietary and wholly owned new chemical entities for both front and back of the eye diseases. As Kim will explain shortly, we believe these preclinical development programs have the potential to fuel our long-term growth, providing meaningful impact to millions of people worldwide. As we work towards establishing our commercial leadership in eye care with EYSUVIS and INVELTYS, we are excited to invest in our early-stage pipeline where our novel platform capabilities and scientific know-how enable us to design and develop differentiated therapies for major unmet medical needs.

With our existing cash resources, we believe we have sufficient capital to fund our operations into at least the fourth quarter of 2022 and expect the anticipated revenue from EYSUVIS to provide additional runway. With that, I'd like to turn the call over to Todd to go through the updates for EYSUVIS and INVELTYS.

Thank you, Mark. I'll begin today with a 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 3 months postapproval.

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. Based on our research, an estimated 75% of patients have never tried a prescription therapy and only approximately 10% of patients are currently on a prescription chronic dry eye medication. Across multiple large quantitative market research studies, approximately 80% of dry eye disease patients report that they suffer from episodic flares, which translates to approximately 14 million of the diagnosed dry eye patient population in the U.S.

Prior to the launch of EYSUVIS, there were no FDA-approved prescription treatment options with a clinical profile targeted to treat episodic symptoms of dry eye disease. Our market research indicates that the availability of a rapid-acting short-term prescription therapy to treat episodic flares has the potential to become the preferred first-line prescription therapy to treat mild to moderate dry eye disease, which represents the majority of diagnosed patients.

We designed our launch priorities with a focus on 3 key objectives. First, educate eye care professionals on the episodic nature of dry eye disease; second, establish EYSUVIS as the preferred first-line prescription therapy for the short-term treatment of dry eye flares; and third, ensure optimal access and broad payer coverage. The commercial team has been executing against all of these priorities, and we've already begun to see the early results of their hard work.

Last week, we were pleased to announce that EYSUVIS was added to Express Scripts' National Preferred, Basic and High Performance formularies. We believe our success in securing coverage for EYSUVIS at ESI just 1 month into launch indicates payer anticipation of significant demand for EYSUVIS.

Gaining market access coverage with commercial payers is a core part of our launch strategy in 2021. Commercial payers make up the largest proportion of dry eye prescriptions, and patients with mild to moderate dry eye disease are typically younger and are more likely to have commercial health insurance. We believe commercial payer coverage for EYSUVIS will be a key driver of prescription growth and we expect our commercial formulary coverage to continue to expand in the coming weeks and months.

We are also seeing promising week-over-week growth in prescription demand since launch. For the week ending February 12, only 6 weeks into our launch, an aggregate of more than 2,200 EYSUVIS prescriptions have been filled, and we have had over 550 eye care professionals already prescribe EYSUVIS. These figures reflect data from both Symphony Health and the EYSUVIS I Save program, Kala's patient hub.

We are also encouraged by the initial feedback we are receiving from eye care professionals. The feedback speaks to the efficacy of EYSUVIS, further confirming the results from our clinical trials. For example, doctors have shared that patients are experiencing a rapid onset of action. Patients have also given feedback that EYSUVIS is a very comfortable eye drop to administer. We believe that early positive experiences by doctors and patients will help us establish EYSUVIS as the preferred first-line prescription therapy for dry eye disease.

All in all, we are very pleased with the launch to date, and I look forward to updating you on our progress in the months ahead.

I'll now provide an update on INVELTYS, our twice-daily postsurgical ocular steroid. In the fourth quarter, there were approximately 41,000 prescriptions of INVELTYS reported by Symphony Health, which represents an increase of 8% compared to the third quarter of 2020. This was driven primarily as a result of increased sales effort and fewer COVID-19-related restrictions on elective procedures, including ocular surgeries, in Q4, compared to Q3. Despite the challenges that pandemic presented throughout the year, we achieved solid prescription growth for INVELTYS in 2020. For the full year 2020, there were approximately 143,000 prescriptions of INVELTYS reported by Symphony Health. This is an increase of approximately 11% compared to 2019. We continue to have strong commercial coverage for INVELTYS with more than 80% of commercial lives covered.

We believe that INVELTYS prescriptions and revenues will grow over time. However, we remain unable to project the specific timing or quantify the potential impact on future revenues, given the continued uncertainty around the impact and duration of the COVID-19 pandemic on elective procedures. While we believe net revenues for INVELTYS could continue to be negatively impacted in 2021, we remain optimistic about the future growth potential for INVELTYS.

And with that, I'd like to turn the call over to Kim now to go through our pipeline. Kim?

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 3 internal preclinical programs -- a selective glucocorticoid receptor modulator, or SEGRM; a selective small-molecule tyrosine kinase [inhibiting] targeting EGF; and an ocular-surface-targeted steroid. We are particularly excited about the potential of our SEGRM program, as it can provide novel therapies for both front and back of the eye.

As you are aware, traditional corticosteroids work via activation of the glucocorticoid receptor, which stimulates gene expression along two pathways -- the transrepression pathway and the transactivation pathway. There is mounting evidence that the transrepression pathway alone may be sufficient for anti-inflammatory and immunomodulatory activity, with the transactivation pathway being primarily responsible for the untoward effects often seen with ocular and systemic corticosteroids, such as elevated intraocular pressure, hypertension, osteoporosis.

With our SEGRM program, we have designed a novel class of compounds that can selectively activate the transrepression pathway to maximize the anti-inflammatory activity while limiting activation of the transactivation pathway to minimize the untoward effects. We believe that this approach has the potential to deliver anti-inflammatory activity comparable to that of current corticosteroids without the associated side effects. We further believe that a safe and effective SEGRM compound would have significant utility in the treatment of diseases of the front of the eye, such as dry eye disease and other ocular surface inflammatory diseases, as well as a variety of retinal diseases where inflammation is a critical component. We are targeting identification of a development candidate for our SEGRM program by the end of this year.

In our tyrosine kinase inhibitor program, we have developed a proprietary, highly selective and potent lead compound, which has demonstrated subnanomolar in vitro potency against the VEGF receptor 2 kinase and good selectivity against many of the off-target receptor effects. We have demonstrated compelling preclinical pharmacokinetic and efficacy data in relevant animal models and are exploring both topical and sustained intravitreal delivery approaches. We believe that our tyrosine kinase inhibitor program can provide new and exciting therapies for retinal diseases such as AMD and diabetic eye disease.

Our team is excited by the possibility that these programs provide for new and exciting therapies. We're continuing to progress and evaluate each program as part of our portfolio assessment and anticipate providing an update on these programs in the coming months.

I'd like to now pass the call to Mary to go over the financial results.

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, noncash 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 website.

Our cash position as of December 31, 2020, was $153.5 million, compared to $85.4 million as of December 31, 2019. This increase reflects net proceeds of approximately $158.6 million received from our underwritten public offering of common stock in March 2020 as well as sales of common stock under our ATM offering program in 2020, partially offset by cash used in operations.

We anticipate that our cash resources as of December 31, 2020, together with anticipated INVELTYS revenue and the $18.2 million in net proceeds we raised in January of 2021 under our ATM offering program, will enable us to fund our operations into at least the fourth quarter of 2022. We also expect that anticipated revenue generated from sales of EYSUVIS will provide additional cash runway.

For the fourth quarter of 2020, we reported net product revenues of $2.2 million, which is comprised of $1.9 million of net revenues from INVELTYS sales and $300,000 of net revenue from EYSUVIS sales. As a reminder, we recognize revenue when product is shipped to wholesalers. Our fourth quarter 2020 net revenues of $2.2 million is compared to $1.2 million from INVELTYS in the fourth quarter of 2019, or an increase of $1 million from the same period last year.

Cost of product revenues for the fourth quarter of 2020 was $1.4 million, compared to $700,000 for the same period in 2019. Included in cost of product revenues, and due to COVID-19, was a reserve of $500,000 for excess INVELTYS inventory. Non-GAAP cost of product revenues was $1.3 million for the fourth quarter of 2020, compared to $600,000 for the same period in 2019.

SG&A expenses for the fourth quarter of 2020 were $26.5 million, compared to $14.5 million for the same period in 2019. The increase was primarily due to an increase in costs related to preparing for the launch of EYSUVIS, including the expansion of the sales force and increased stock-based compensation costs. Non-GAAP SG&A expenses were $23.1 million for the fourth quarter of 2020, compared to $12.7 million for the same period in 2019.

R&D expenses for the fourth quarter of 2020 were $3.4 million, compared to $6.1 million for the same period in 2019. This decrease was primarily due to a decrease in external spend on our Phase III clinical trial of EYSUVIS. Non-GAAP R&D expenses were $2.5 million for the fourth quarter of 2020, compared to $5.5 million for the same period in 2019.

Loss from operations for the fourth quarter of 2020 was $29 million, compared to $20.2 million for the same period in 2019. Non-GAAP operating loss was $24.7 million for the fourth quarter of 2020, compared to $17.6 million for the same period in 2019. Net loss for the fourth quarter of 2020 was $31.1 million, or $0.55 per share, compared to a net loss of $22 million, or $0.63 per share, for the same period in 2019. Non-GAAP net loss was $26.5 million for the fourth quarter of 2020, compared to $19.2 million for the same period in 2019.

Please refer to today's press release for the weighted-average number of shares used in the calculation of our net loss per share for each of the quarterly and yearly periods discussed.

That concludes our prepared remarks for today. I will now pass the call over to the operator for questions.

(Operator Instructions)

Our first question comes from Christopher Neyor with JPMorgan.

Congrats on the Express Scripts contract. First question is on EYSUVIS payer contracting. Kala has 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 payers found attractive in initial discussions? I'll start there, and then I'll have one follow-up.

Hey, 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 with 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.

Great. That's helpful. Second question is on the 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.

Yes. Look, 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, 6 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 with the way that is going, and we can expect it to only to continue to improve, to your point, as more and more of the U.S. population becomes vaccinated.

Our next question comes from Andreas Argyrides with Wedbush Securities.

I'm on for Liana Moussatos. Good question regarding the previous question regarding formulary access. Congrats, by the way. And could you maybe just talk about what factors went into 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.

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 as the only 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 2 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 just looking ahead at the pipeline and the wet AMD program, in particular, to -- you mentioned that there may be -- there are 2 routes that you may go, topical and intravitreal. Topical TKIs have had some setbacks in the past. What is it about -- and it can be one of the amplified technologies, but what have you seen specifically that gives you confidence that topical is the viable route of 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.

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 our 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 at similar or higher concentrations 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 A&D in one eye and are developing wet 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.

Our next question comes from Frank Brisebois with Oppenheimer.

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 -- are there a couple that prescribed quite a bit more than others? Or how much granularity is there in that number? And then I'll have a follow-up.

Hey, 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, pretty evenly mixed between ophthalmologists and optometrists. So the 550 prescribers 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, is -- with this initial group, is they are seeing patients that are suffering flares. They have begun using not only prescribing but also we've put a lot of samples into the market, so we're getting a lot of clinical experience in the samples that we've put out there as well. And the feedback has been overwhelmingly positive.

With our patient starter kits, we have a feedback mechanism, that when those patient -- 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 2 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 and blurred vision. So it's just really, really positive feedback that's been reinforcing utilization of EYSUVIS with the eye care professionals.

Okay. Okay. Great. And then on the reimbursement side, congrats on Express Scripts, obviously. That seems -- 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, the percentage there?

And then if you can just remind us again, if 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 your program can maybe help with the co-pay and how much that might penalize you, I guess. So just more on the reimbursement side.

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 3 large PBMs to not be reviewed for the first 6 months that are on the market. Quite often, the PBMs will pick sort of this 6-month new-to-market block where they don't even consider adding them into formulary. That has not been the case. We are deep into discussions with all 3 of the major PBMS -- ESI, CVS Caremark and Optum/United -- and are very pleased with the way those discussions are progressing, and are 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?

Yes. Just in terms of that co-pay, just to help us -- I 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.

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 buy the co-pay down to $40. So net effect of -- 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 2 or 3 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.

Okay. 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, that -- especially with the patient hub, especially early in the launch -- is it fair to say, it seems like most scripts, though, are through -- are reported through Symphony at this point? Or I'm just trying to gauge the percentage that it's still hard for us to track because of the patient hub.

Yes. Really good question, and we did launch with a 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 filled directly through the hub that do not report out to 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 covering 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% of volume on top of that of demand that's been prescribed that's working somewhere through the prior auth process at our patient hub.

Our next question comes from Biren Amin with Jefferies.

Maybe could you comment on the prescribers that have written for EYSUVIS and just your outreach there? And I guess, their incentive in writing for EYSUVIS. 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.

Yes, Biren, happy to do so, and good morning. So a couple of things. At this point, we're still really early in launch. So we have still only 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 drop some samples -- well, that half, that is, that we've called on, have also received a 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 have prescribed to date, that split is about 55% optometrist and 45% ophthalmologist. 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 deciles -- think of that as deciles 7 through 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 lower 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.

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 then 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.

Yes. Really good questions. That prior auth process we're finding can take anywhere from a week to 2, 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 could -- probably reasonable to assume it can take up to a couple of weeks to work through that process.

And 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 through commercial payers.

Okay. And then maybe just one last question from me. I know the company is 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 6 weeks, do you think we're thinking about the EYSUVIS launch the right way with consensus of about $27 million, $28 million?

Hey, Biren, it's Mark. Thanks for the question. No, 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. 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 hopeful that we'll be able to have a strong year.

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

My first question is, when do you plan to increase the sales team for EYSUVIS? Is it in any way related to increasing formulary access?

Hey, 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 2 major determinants in the timing of that. One is what you said, right, which is securing additional payer access, and we're very pleased that that payer coverage looks like it's coming quicker than what we had even initially anticipated. And then secondly would be where we stand with the pandemic and the impacts that it's having on patient flows into the office. And as we continue to assess those 2 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. So -- but more to come on the specific timing.

Got it. And could you please comment on the trend of ocular surgeries in the past 2 months?

Yes, they definitely have been negatively impacted by the increases that we've seen. I think we've sort of seen 2 additional spikes in COVID cases across the country post the holidays, right? They were 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; those continued to be down.

As Mark said a little bit earlier, we're really happy with INVELTYS' performance within the market. We are at around an 11.5% branded new prescription market share, so we're near our sort of all-time high NRx 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.

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

As we've said, and I said earlier, we're really right now looking at the 2 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 6 to 9 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.

Our next question comes from Tim Chiang with Northland Securities.

Mark, could you just comment on the sampling program? Are all the prescriptions that you're seeing so far 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?

Hey, 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. I think 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. 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 handled 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 the patients to start developing that clinical experience, and that does include that sometimes the patients are being given a sample and a prescription's being written so that they can use the sample for the first few days, because our sample size of -- sample bottle size is smaller than the trade bottle size, and then go fill that prescription so they can continue to treat for the rest of the duration of that flare.

Interesting. Todd, maybe just one follow-up then. And 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? I mean, are you guys tracking that? And I'm just wondering, how many of your prescriptions are you actually seeing through virtual marketing efforts?

Yes. Certainly -- so Tim, we haven't commented specifically on -- I think what you're trying to get at is how quickly after sales presentations are delivered does prescription 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 win, 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 in all -- all in all, what we're really happy with is the early response and 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.

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

Look, we have, as I said earlier, when -- with our contracted position at ESI and use of our co-pay card, the vast majority of patients' co-pays should be somewhere between $25 and $40. And that's been received as being -- people find that to be very acceptable. And as I said earlier, particularly when you consider this is an acute medication that patients only have to fill probably 2 or 3 prescriptions per year, that's considered a very reasonable co-pay amount.

(Operator Instructions)

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

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

Yes, Frank, I'm happy to jump in, yes. No, 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 postsurgical market versus the dry eye market, which is much more of a traditional retail market, largely driven by commercial insurance, whereas in the surgical market, it's much more impacted by Medicare. And in the -- for the surgical market, the 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 nets, so we do expect that the gross to nets for EYSUVIS will be more favorable than what we saw during the INVELTYS launch.

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

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 the early launch trends. So thank you very much, and we look forward to updating everyone soon.

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