KALA BIO, Inc.

in the most recent four weeks versus the four weeks prior compared to the branded market that was up only 4% and the overall market which was up only 3.3% during this time. While we are very encouraged by these trends and believe they bode well for Indultus over the long term, we recognize that the ongoing surge or future surges in COVID cases may result in some states reinstating restrictions on elective procedures. which could again impact indulgent sales. I will now turn the call over to Mary to discuss our third quarter financial results.

Mary Gambaugh- Thanks, Todd. During this discussion of our financial results, I will reference certain non-GAAP financial measures. These non-GAAP financial measures exclude stock-based compensation, depreciation, and non-cash interest expense. 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. As of September 30th, we reported total cash, cash equivalents, and short-term investments of $159.1 million compared to $85.4 million as of December 31st, 2019. This increase reflects proceeds from our underwritten public offering of common stock in March, as well as proceeds from sales of common stock under our ATM program during the first part of this year, partially offset by cash used to fund our operations during the first nine months of 2020. We anticipate that our existing cash, cash equivalents, short-term investments, and anticipated revenue from Inveltis will enable us to fund our operations into at least the third quarter of 2022. We also expect that revenue anticipated to be generated from the sales of ISUVIS will provide additional cash runway. For the third quarter of 2020, we reported In Beltis net revenue of $2.2 million compared to $1.5 million in the third quarter of 2019, or an increase of $0.7 million from the same period last year. Cost of product revenues for the third quarter of 2020 were $0.7 million, which is consistent with the same period in 2019. Non-GAAP cost of product revenues were $0.7 million for the third quarter of 2020, compared to $0.6 million for the same period in 2019. SG&A expenses for the third quarter of 2020 were $23.9 million, compared to $15.3 million for the same period in 2019. The increase was primarily due to an increase in external sales and marketing costs related to preparation for the launch of ISUVIS and increased stock-based compensation costs. Non-GAAP SG&A expenses were $20.5 million for the third quarter of 2020, compared to $13.5 million for the same period in 2019. R&D expenses for the third quarter of 2020 were $3.5 million, compared to $7.1 million for the same period in 2019. The decrease was primarily due to a decrease in external spending on our Stride 3, our Phase 3 clinical trial of ISUVIS. Non-GAAP R&D expenses were $2.4 million for the third quarter of 2020 compared to $6.1 million for the same period in 2019. Loss from operations for the third quarter of 2020 was $25.8 million compared to $21.6 million for the same period in 2019. Non-GAAP operating loss was $21.4 million for the third quarter of 2020 compared to $18.8 million for the same period in 2019. Net loss for the third quarter of 2020 was $27.9 million or 50 cents per share compared to a net loss of $23.2 million or 68 cents per share for the same period in 2019. Non-GAAP net loss was $23.2 million for the third quarter of 2020 compared to $20.1 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 periods discussed. While we've been encouraged with the Invelta's prescription recovery that we've experienced since the end of last quarter, we have continued to see some impact related to COVID during the third quarter as cases surged in different regions throughout the country. As a result, we are still unable to project the specific timing or quantify the specific potential impact on future revenues, given the continued uncertainty around the impact and duration of the restrictions related to COVID-19. However, we expect that net revenues will be negatively impacted for the full year 2020 and could continue to be negatively impacted into 2021. That concludes our prepared remarks for today. I will now pass the call over to the operator for questions.

Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, ladies and gentlemen, that's star then 1 to ask a question. Please stand by while we compile the Q&A roster. Our first question will come from Liana Musatos with Wedbush Securities.

Hi, this is Shweta for Liana. Thank you for taking my question and congrats on all the progress. When can we anticipate updates on ISUVIS commercial peer coverage rebate status?

Hi, Shveta. It's Mark. Good morning, and thanks for the question. I'll let Todd answer that.

Yes, good morning. We'll provide updates on each of our quarterly calls next year with regards to the coverage update status or the coverage status for ISUVIS. So each quarter, When we announce earnings, we'll let you know what the coverage is with both commercial and Medicare plans.

Got it. And just one question on the financial results. There was a significant increase in SG&A for Q3. Should we anticipate a similar increase for Q4, given that you're increasing the sales force?

Mary.

Hi, Shavata. Yes, there was a significant increase in SG&A in Q3. That's primarily due to the launch-related expenses for ISUVIS. So we should see Q4 about consistent with Q3.

Got it. Thank you. Thank you. Our next question will come from Christopher Neor with J.P. Morgan. Please go ahead.

Great. Thanks for the questions. A couple on envelopes. Could you update us on where we stand on formulary and payer coverage And then also, how those changes may – how those formulary – how formulary access and coverage may change in 2021. And then a second question, as COLA expands its sales force for ahead of the ICVS launch, should we expect any positive impact on envelopes? Thanks so much.

Hey, Chris. It's Todd. Thanks for your questions this morning. The payer status from Deltas is we're currently just a little bit above 80% unrestricted access with commercial payers, you know, and quite happy with that level of access within commercial. We are at 23% unrestricted access with Medicare. So we've got nearly a quarter of the Medicare lives covered. Still some more work to do there. And we are in the process of resubmitting bids to Medicare plans for discussion and considerations throughout 2021. I'm sorry, what was the second part of your question, Chris?

Yeah, so the second part of the question is on the I3 for Salesforce expansion. Are you expecting any kind of positive impact related to Inveltus from just the greater coverage of the Salesforce and then also more exposure for Inveltus as a product?

Yeah, really good question. You know, just as an update on the Salesforce expansion, it's going really well. We've already extended offers for the majority of physicians and the majority of the folks that we've extended offers to have accepted. So we're on track for the full expansion to be completed here. As we stated in November, we believe in November of this year. And we do believe that that additional coverage will provide some additional exposure for Indeltus, right? We're going to be calling on more than double the number of eye care professionals that we call on today. So there'll be a whole group of new eye care professionals that we'll be able to detail Indeltus to for the first time.

That's super helpful. Thanks.

Thank you. Our next question will come from Francois Brisebois with Oppenheimer. Please go ahead.

Hi, good morning. Thanks for taking the questions. Just a couple here. In terms of the label, how many refills in general would you expect physicians to make? There seems to be an absence of language of monitoring the IOP on every potential refill. So I'm just wondering, any color on that number per physician that you guys are seeing out there?

Todd, do you want to take that? Sure, I'm happy to do so. Good question, Francois. So it's really going to depend on the eye care professionals. You can imagine we spend a lot of time talking to eye care professionals to understand What they think based on their patient population, the refills could be, I think Mark presented earlier that dry eye patients suffer a median of five and a half dry eye flares per year. And certainly the eye care professionals have told us they are completely comfortable with treating or having their patients treat each of their flares with Isobis once it becomes commercially available. So the number of refills are going to likely depend on the individual patient and what their history or pattern of flares have been. And and how many of those flares the eye care professional feels what the patient needs to treat. But there are no restrictions with regards to the eye care professional's ability to write refill prescriptions for their patients. Okay, excellent.

Makes a lot of sense. And then on the side, and this is just a follow-up on the previous question, In terms of envelopes on the commercial coverage, well, not on the commercial, actually, on the Medicare side, with 23%, there's just so much of this population that cataract surgery is probably older. I was just wondering, what are the efforts and how can we feel comfortable that there'll be improvements in that 23% going forward? What are the efforts made there?

Yeah, good question. We continue to call on each of these Medicare plans. We feel like we've got some significant opportunity upcoming, particularly as some of the current branded products are approaching loss of exclusivity and could be going generic, and that creates the possibility of freeing up some contracted positions with some of these Medicare plans. So we think that's going to create a significant opportunity for investors going forward.

Okay, great. If I could sneak in a last one. Were you surprised at all by the lack of language on the label around monitoring for usage over 10 days since it is a steroid? It seems like a testament to the side effect profile and then the rise in IOP. If you can just comment on that, that would be great.

Yeah, I'm happy to take that. You know, we studied the product across four trials in over 2,800 patients. and very closely monitored intraocular pressure. So, you know, in general, we do have a similar label to other products, and that physician should monitor and check patients' IOP. But as you point out, there's no language to do that for the direct course of therapy, which is a two-week course of therapy in the label. So, you know, we're pleased with that, and We think it's reflective of the great clinical trial database that we put into the FDA.

Great. Thank you very much. Congrats on the progress.

Thank you.

Again, ladies and gentlemen, if you would like to ask a question, please press the stars and one key. Our next question comes from Yi Chen with HC Wainwright.

Thank you for taking my questions. My first question is, is there an improved

Sir, your line is open. If you could please... Please press star then 1.

Yeah, maybe we can move to the next one, and then when Yi comes back on, we'll take his question.

I'm showing... No further questions?

Okay.

Yichen, your line is now open, if you would like to go ahead.

Can you hear me now?

Yes. Oh, sorry. My first question is, is there an improvement in the net average selling price of envelopes, and if not, do you expect to see an improvement in 2021? Todd?

Yeah, I'm sorry, Yi. I missed the first part of your question. It cut out on me a little bit.

Has there been any improvement in the net average selling price up in Valdez?

Yeah, well, as you know, as we've stated in the past, we don't provide guidance on expectations for, you know, specifics on the growth to net or expectations on net ASP. But they still hold consistent with what we always said, Yi, which is Once we get greater Medicare coverage and become less dependent on the opt-out copay card, which is how we're currently making sure that Medicare patients, post-ocular surgery Medicare patients, have access to Invelta's, that that will result in improvements in gross to Mets. So, you know, we have the card right now. It allows patients to be able to fill the Invelta's prescriptions for a cash acquisition of $60.00. As you can imagine, that puts pressure on gross-to-net, but we feel it's important to do so that Enveltis can be prescribed in the post-ocular surgical setting, particularly for the cataract patients. And as our Medicare coverage increases and improves over time, we will be less dependent on the cards, and as a result, the gross-to-nets we expect to improve. I think important also when you're asking about that is to know that the market dynamic is very different for ISUVIS. because it's not an ocular surgery situation in which the patients are getting the products that are in the post-surgical protocol, and essentially all patients get everything, which means you have to provide these copay cards for Medicare. The GI market is much more a traditional retail market, where clinicians often make a prescribing decision for the individual patient, taking into consideration their insurance coverage and where products are covered within formulary, So we do not need to offer a Medicare opt-out card for the launch of Isobus like we did on Indeltis. So do not expect that level of pressure on the growth nets for Isobus that we experienced during the launch of Indeltis. Does that make sense?

Got it. Yeah, it does. So my second question is, is your sales team already reaching out to ophthalmologists and optometrists to find Isobus? And based on their feedback, Do you think the doctors could prescribe Azuvis for those patients to treat flares, those patients who are currently on chronic therapies for DED?

Yeah, so we've already begun engaging in disease state discussions. They're going very, very well. Our reps are out there talking about dry eye flares with eye care professionals and receiving really great feedback and getting eye care professionals to start thinking about all the patients within their practice. for which a product like iSuvis would be well suited. Soon after we have the virtual launch meeting in early December, we start shipping wholesalers in December, and we'll be in a position soon thereafter to actually have iSuvis product-specific discussions with eye care professionals at that point. And like we said all along, we think there's an opportunity for broad usage of iSuvis across most GI patients. It's certainly treating flares we think will be maybe the largest percent of patients but we've also received a lot of feedback about more severe dry eye patients that could end up going on ISUVIS. We've certainly heard a lot of talk about the presurgical patients that are going into cataract or refractive surgery that have dry eye disease, and there's a desire to treat the dry eye before surgery to clean up the corneal surface in a short-term treatment course with ISUVIS as well suited for those patients. So we think that there will be broad utilization across a number of patient types with GI disease.

Got it. Thank you.

Sure.

And we do have a follow-up question from Francois Brisebois with Oppenheimer. Please go ahead.

Hi, thanks for taking a quick follow-up here. You expect to begin shipping to wholesalers by the end of the year. Can you just remind us of when and how you recognize revenues here?

Sure, I can take that. We recognize revenue when we ship to the wholesalers.

Okay, just double checking. Thank you.

Thank you.

Ladies and gentlemen, thank you for participating in today's question and answer session. I would now like to turn the call back over to Mr. Iowicki for any further remarks.

Thank you very much, Operator, and thanks everyone for joining us this morning. We're really pleased with the growth we've seen in and certainly the prescription trends continue to increase, and we're getting close to being where we were pre-COVID in terms of those trends. So we're encouraged by the efforts of our commercial team and, of course, really excited about the approval of ISUVIS, and we're very quickly moving to increase the size of our sales force and get all of our Launch activities are underway, and we will take the opportunity over the next couple of months to make sure that everybody is updated on our progress. Thank you again. Have a great day.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect. Thank you. Thank you. you Thank you.

Thank you. you you

Good morning, and welcome to the Kala Pharmaceuticals Third Quarter 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 Naranjan Kamiswaran, 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 Iwiki, Chairman, President, and Chief Executive Officer, Todd Bazemore, Chief Operating Officer, Mary Remuth, Chief Financial Officer, Kim Brazel, Chief Medical Officer, and Hongming Chen, Chief Scientific Officer. Today's call is being webcast live. The webcast link can be found in the Investors and Media section of our website at www.calaRx.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 CALA'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 ISUVIS, observations associated with our commercialization of In Beltis, the sufficiency of our cash resources, and anticipated revenue. These 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 the forward-looking statement included in the company's quarterly report on Form 10Q and other filings we make with the SEC. The Form 10-Q 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 Iwick.

Thank you, Neerajan, and good morning, everyone. We are entering the fourth quarter at a transformative time for Kala. Since our founding, we've worked hard to advance a pipeline of medicines to improve the treatment of eye conditions and to foster our vision of becoming a leader in eye care. We successfully introduced Inveltis to the market two years ago, and just last week secured FDA approval for our second product, Isovus, for the short-term treatment of the signs and symptoms of dry eye disease. We believe we are well positioned for growth, as we will soon be promoting two products which share a common backbone, our Amplify technology, and which will be prescribed by many of the same eye care professionals. We are also in a strong position financially and confident in our strategy to successfully launch ISUVIS. We are excited to deliver on the promise of this new medicine for millions of people living with dry eye disease who would benefit from a short-term treatment option. Before turning the call over to Todd to discuss our commercial updates in greater depth, let me take a few minutes to review last week's approval and the opportunity before us. Isuvus was approved by the FDA for the short-term, two-week treatment of the signs and symptoms of dry eye disease. Efficacy and safety data generated from over 2,800 patients across four clinical trials show that Isuvus can provide rapid and effective relief of both the signs and symptoms of dry eye disease while also being very well tolerated. Dry eye disease affects over 38 million people in the United States, of which over 17 million have already been diagnosed and are under the care of an eye care professional. Our research suggests that approximately 80% of these people suffer from episodic flares and have a median of 5.5 multi-day flare episodes per year. Their flares are not adequately addressed by other treatment options, and this creates a very compelling opportunity for our service to become first-line prescription therapy for the majority of patients. With last week's approval, ISUVIS became the first prescription therapy specifically intended to address patients' short-term treatment needs and the first ocular corticosteroid indicated for dry eye disease. We believe these two attributes are highly differentiating and will support broad uptake of ISUVIS. As we heard from Dr. Kelly Nichols and Ed Holland at our KOL Symposium in September, eye care professionals and patients are looking for a first-line, short-term prescription therapy that can effectively address their breakthrough flares, and approximately 99% of eye care professionals are interested in the availability of a steroid with a dry eye indication. Our team continues to work hard preparing to launch iSuvis in the United States with a goal of shipping iSuvis to wholesalers in the U.S. by the end of this year and beginning full promotional activities in January. Importantly, we are moving toward launch with a thoughtful and focused strategy in place, which we believe will enable us to successfully launch ISUVIS while continuing to expand the reach for InvelTIS to more eye care professionals. Kala has never been in a stronger position, and we are deeply grateful to our colleagues, investigators, and patients for all their efforts, which enabled us to develop and bring both ISUVIS and InvelTIS to market. I'll now turn the call over to Todd to go through updates for our two commercial programs.

Thank you, Mark. I'd like to begin today with ISUVIS and the opportunity we have to bring a new treatment option to eye care professionals and patients who may benefit from a prescription short-term therapy to treat dry eye disease. We have been closely tracking the dry eye disease market and are pleased with its performance throughout the COVID-19 pandemic. As of October 23rd, the dry eye disease market is at nearly 99 percent of its pre-COVID levels, based on Symphony prescription data. We believe that this indicates the strength of the market and the significant need to treat dry eye patients, even during these challenging times. With ISUVIS approved, we see an opportunity to disrupt the dry eye disease market. As Mark mentioned, dry eye disease affects approximately 38 million people in the U.S. 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% have never tried a prescription therapy, and only approximately 10% of patients are currently on a prescription dry eye medication. Across multiple large quantitative market research studies, approximately 80% of dry eye patients report that they suffer from episodic flares, which translates to approximately 14 million of the patients already diagnosed with dry eye disease. Prior to last week's approval of ISUVIS, there were no prescription treatment options FDA approved with a clinical profile targeted to treat these episodic symptoms of dry eye disease. Our research shows that the lack of a rapid-acting prescription therapy to treat episodic flares has made it challenging for eye care professionals to manage the mild to moderate dry eye disease patients. Since receiving approval last week, we have made significant progress in preparing for our launch. We have begun expanding our sales force, which we plan to ultimately grow to approximately 125 sales representatives, who will report up through 14 regional sales leaders to support both iService and Indultus. We will conduct this expansion in two ways, first growing to approximately 90 representatives by the end of this year, with the second expansion planned for 2021 pending the status of the COVID-19 pandemic. We believe this sales structure will allow us to call on the ophthalmologist and optometrist who treat the majority of dry eye patients and who represent more than 85 percent of all dry eye and steroid prescribing. We've extended offers to the first wave of new sales reps, and we remain on track to have our full team of 90 representatives onboarded and trained in November and to host a virtual launch meeting in early December. We expect to begin shipping iSUVIS to wholesalers in the U.S. by the end of 2020 and begin promotional activities soon after, when our experienced sales force will leverage their deep ophthalmic experience to educate eye care professionals on how iSUVIS, with its proprietary Amplify technology, can meet the short-term treatment needs, including flares, of dry eye disease patients. The majority of our engagements with eye care professionals are currently taking place in person and we anticipate this will continue as ophthalmologists and optometrists have learned how to safely treat patients during the COVID-19 pandemic. However, we will train our sales team for both virtual and in-person engagements, so they'll be able to flex between these options based on the needs of eye care professionals. This will allow us to utilize a range of virtual tactics that include web case-based detailing, virtual speaker programs, and online sample ordering and shipping. As I mentioned last week, we are extremely excited to deliver iSUVIS as the first and only FDA-approved prescription product specifically intended for the short-term treatment of the signs and symptoms of dry eye disease. We believe there's a tremendous opportunity for us to establish iSUVIS as the preferred first-line prescription therapy for dry eye disease, and we look forward to updating you on our progress as we move through the initial launch. I'd like to now move on to Indultus, our twice-daily post-surgical ocular steroid. We are pleased to announce significant quarter-over-quarter growth for Indultus. This was driven primarily as a result of increased sales effort and fewer COVID-19-related restrictions on elective procedures, including ocular surgeries, in Q3 compared to Q2. In the third quarter, there were approximately 38,000 prescriptions of Indultus reported by Symphony Health. which represents an increase of 84% compared to the second quarter of 2020. We are pleased with the recovery that Inveltex has shown. It has steadily increased share in the branded market, and as of October 23rd, has achieved an 11.6% branded NRX share, returning to just about where we were prior to COVID. As of October 23rd, total Inveltex prescriptions were up 12.7% in the most recent four weeks, versus the four weeks prior compared to the branded market that was up only 4 percent and the overall market, which was up only 3.3 percent during this time. While we are very encouraged by these trends and believe they bode well for Indultus over the long term, we recognize that the ongoing surge or future surges in COVID cases may result in some states reinstating restrictions on elective procedures, which could again impact Indultus sales. I will now turn the call over to Mary to discuss our third quarter financial results.

Thanks, Todd. During this discussion of our financial results, I will reference certain non-GAAP financial measures. These non-GAAP financial measures exclude stock-based compensation, depreciation, and non-cash interest expense. 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. As of September 30th, we reported total cash, cash equivalents, and short-term investments of $159.1 million compared to $85.4 million as of December 31st, 2019. This increase reflects proceeds from our underwritten public offering of common stock in March, as well as proceeds from sales of common stock under our ATM program during the first part of this year, partially offset by cash used to fund our operations. during the first nine months of 2020. We anticipate that our existing cash, cash equivalents, short-term investments, and anticipated revenue from Inveltis will enable us to fund our operations into at least the third quarter of 2022. We also expect that revenue anticipated to be generated from the sales of ISUVIS will provide additional cash runway. For the third quarter of 2020, we reported In Beltis net revenue of $2.2 million compared to $1.5 million in the third quarter of 2019, or an increase of $.7 million from the same period last year. Cost of product revenues for the third quarter of 2020 were $.7 million, which is consistent with the same period in 2019. Non-GAAP cost of product revenues were $.7 million for the third quarter of 2020, compared to $0.6 million for the same period in 2019. SG&A expenses for the third quarter of 2020 were $23.9 million, compared to $15.3 million for the same period in 2019. The increase was primarily due to an increase in external sales and marketing costs related to preparation for the launch of ISUVIS and increased stock-based compensation costs. Non-GAAP SG&A expenses were $20.5 million for the third quarter of 2020, compared to $13.5 million for the same period in 2019. R&D expenses for the third quarter of 2020 were $3.5 million, compared to $7.1 million for the same period in 2019. The decrease was primarily due to a decrease in external spending on our Stride 3, our Phase 3 clinical trial of ISUVIS. Non-GAAP R&D expenses were $2.4 million for the third quarter of 2020 compared to $6.1 million for the same period in 2019. Loss from operations for the third quarter of 2020 was $25.8 million compared to $21.6 million for the same period in 2019. Non-GAAP operating loss was $21.4 million for the third quarter of 2020 compared to $18.8 million for the same period in 2019. Net loss for the third quarter of 2020 was $27.9 million or 50 cents per share compared to a net loss of $23.2 million or 68 cents per share for the same period in 2019. Non-GAAP net loss was $23.2 million for the third quarter of 2020 compared to $20.1 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 periods discussed. While we've been encouraged with the Invelta's prescription recovery that we've experienced since the end of last quarter, we have continued to see some impact related to COVID during the third quarter as cases surged in different regions throughout the country. As a result, we are still unable to project the specific timing or quantify the specific potential impact on future revenues, given the continued uncertainty around the impact and duration of the restrictions related to COVID-19. However, we expect that net revenues will be negatively impacted for the full year 2020 and could continue to be negatively impacted into 2021. That concludes our prepared remarks for today. I will now pass the call over to the operator for questions.

Thank you. Ladies and gentlemen, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, ladies and gentlemen, that's star then 1 to ask a question. Please stand by while we compile the Q&A roster. Our first question will come from Liana Musatos with Wedbush Securities.

Hi, this is Shweta for Liana. Thank you for taking my question and congrats on all the progress. When can we anticipate updates on ISUVIS commercial peer coverage rebate status?

Hi, Shveta. It's Mark. Good morning, and thanks for the question. I'll let Todd answer that.

Yes, good morning. We'll provide updates on each of our quarterly calls next year with regards to the coverage update status or the coverage status for ISUVIS. So, each quarter, When we announce earnings, we'll let you know what the coverage is with both commercial and Medicare plans.

Got it. And just one question on the financial results. There was a significant increase in SG&A for Q3. Should we anticipate a similar increase for Q4, given that you're increasing the sales force?

Mary.

Hi, Shavata. Yes, there was a significant increase in SG&A in Q3. That's primarily due to the launch-related expenses for ISUVIS. So we should see Q4 about consistent with Q3.

Got it. Thank you. Thank you. Our next question will come from Christopher Neor with J.P. Morgan. Please go ahead.

Great. Thanks for the questions. A couple on envelopes. Could you update us on where we stand on formulary and payer coverage And then also how those changes may – how those formulary – how formulary access and coverage may change in 2021. And then a second question, as COLA expands its sales force for ahead of the ISUVIS launch, should we expect any positive impact on in VELTUS? Thanks so much.

Hey, Chris. It's Todd. Thanks for your questions this morning. The payer status from Deltas is we're currently just a little bit above 80% unrestricted access with commercial payers, you know, and quite happy with that level of access within commercial. We are at 23% unrestricted access with Medicare. So we've got nearly a quarter of the Medicare lives covered. Still some more work to do there. And we are in the process of resubmitting bids to Medicare plans for discussion and considerations throughout 2021. I'm sorry, what was the second part of your question, Chris?

Yeah, so the second part of the question is on the I3 for Salesforce expansion. Are you expecting any kind of positive impact related to Inveltus from just the greater coverage of the Salesforce and then also more exposure for Inveltus as a product?

Yeah, really good question. You know, just as an update on the Salesforce expansion, it's going really well. We've already extended offers to the majority of physicians and the majority of the folks that we've extended offers to have accepted. So we're on track for the full expansion to be completed here, as we stated in November. We believe in November of this year. And we do believe that that additional coverage will provide some additional exposure for Indeltus, right? We're going to be calling on more than double the number of eye care professionals that we call on today. So there'll be a whole group of new eye care professionals that we'll be able to detail Indeltus to for the first time.

That's super helpful. Thanks.

Thank you. Our next question will come from Francois Brisebois with Oppenheimer. Please go ahead.

Hi, good morning. Thanks for taking the questions. Just a couple here. In terms of the label, how many refills in general would you expect physicians to make? There seems to be an absence of language of you know, monitoring the IOP on every potential refill. So I'm just wondering any color on that number per physician that you guys are seeing out there.

Todd, do you want to take that? Sure. I'm happy to do so. Good question, Francois. So, you know, it's really going to depend on the eye care professionals. You can imagine we spend a lot of time talking to eye care professionals to understand the What they think based on their patient population, the refills could be, I think Mark presented earlier that dry eye patients suffer a median of five and a half dry eye flares per year. And certainly the eye care professionals have told us they are completely comfortable with treating or having their patients treat each of their flares with Isobis once it becomes commercially available. So the number of refills are going to likely depend on the individual patient and what their history or pattern of flares have been. And and how many of those flares the eye care professional feels what the patient needs to treat. But there are no restrictions with regards to the eye care professional's ability to write refill prescriptions for their patients.

Okay, excellent. Makes a lot of sense. And then on the side, and this is just a follow-up on the previous question, In terms of envelopes on the commercial coverage, well, not on the commercial, actually, on the Medicare side, with 23%, there's just so much of this population that cataract surgery is probably older. I was just wondering, what are the efforts and how can we feel comfortable that there'll be improvements in that 23% going forward? What are the efforts made there?

Yeah, good question. We continue to call on each of these Medicare plans. We feel like we've got some significant opportunity upcoming, particularly as some of the current branded products are approaching loss of exclusivity and could be going generic. And that creates the possibility of freeing up some contracted positions with some of these Medicare plans. So we think that's going to create a significant opportunity for investors going forward.

Okay, great. If I could sneak in a last one. Were you surprised at all by the lack of language on the label around monitoring for usage over 10 days since it is a steroid? It seems like a testament to the side effect profile and then the rise in IOP. If you can just comment on that, that would be great.

Yeah, I'm happy to take that. You know, we studied the product across four trials in over 2,800 patients. and very closely monitored intraocular pressure. So, you know, in general, we do have a similar label to other products, and that physician should monitor and check patients' IOP. But as you point out, there's no language to do that for the direct course of therapy, which is a two-week course of therapy in the label. So, you know, we're pleased with that, and We think it's reflective of the great clinical trial database that we put into the FDA.

Great. Thank you very much. Congrats on the progress.

Thank you.

Again, ladies and gentlemen, if you would like to ask a question, please press the stars and one key. Our next question comes from Yi Chen with HC Wainwright. Yi Chen, your line is now open if you would like to go ahead.

Amy, now?

Yes.

Oh, sorry. My first question is, is there an improvement in the net average selling price of Invelta's? And if not, do you expect to see an improvement in 2021? Todd? Yeah, I'm sorry, Yi.

I missed the first part of your question. It cut out on me a little bit.

Has there been any improvement in the net average selling price of Invelta's?

Yeah, well, as you know, as we've stated in the past, we don't provide guidance on expectations for, you know, specifics on the growth to net or expectations on net ASP. But they still hold consistent with what we always said, which is once we get greater Medicare coverage and become less dependent on the opt-out copay card, which is how we're currently making sure that Medicare patients, post-ocular surgery Medicare patients have access to Invelta's, that that will result in improvements in gross to nets. So, you know, we have the card right now. It allows patients to be able to fill the Invultus prescriptions for a cash acquisition of $60. As you can imagine, that puts pressure on gross to net, but we feel it's important to do so that Invultus can be prescribed in the post-ocular surgical setting, particularly for the cataract patients. And as our Medicare coverage increases and improves over time, we will be less dependent on the cards. And as a result, the gross to net we expect to improve. I think important also when you're asking about that is to know that the market dynamic is very different for ISUVIS because it's not an ocular surgery situation in which the patients are getting the products that are in the post-surgical protocol. And essentially all patients get everything, which means you have to provide these copay cards for Medicare The dry eye market is much more a traditional retail market where clinicians often make a prescribing decision for the individual patient taking into consideration their insurance coverage and where products are covered within formulary. So we do not need to offer a Medicare opt-out card for the launch of Isobus like we did on Invelta's. So do not expect that level of pressure on the growth nets for Isobus that we experienced during the launch of Invelta's.

Does that make sense? Yeah, it does. So my second question is, is your sales team already reaching out to ophthalmologists and optometrists to find SUVIS? And based on their feedback, do you think the doctors could prescribe SUVIS for those patients to treat flares, those patients who are currently on chronic therapies for DEDs?

Yeah, so we've already begun engaging in disease state discussions. They're going very, very well. Our reps are out there talking about dry eye flares with eye care professionals and receiving really great feedback and getting eye care professionals to start thinking about all the patients within their practice for which a product like EyeService would be well suited. Soon after we have the virtual launch meeting in early December, we start shipping wholesalers in December and we'll be in a position soon thereafter to actually have I assume it's product-specific discussions with IKEA professionals at that point. And like we said all along, we think there's an opportunity for