Endo International plc

Thank you for standing by and welcome to the second quarter 2021 Indoor International PLC earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then 1 on your telephone. Please be advised that today's call is being recorded. If you require additional assistance, press star then 0 to reach an operator. I would now like to hand the call over to Lori Park, Senior Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Thank you, Michelle. Good morning, and thank you for joining us to discuss our second quarter 2021 financial results. Joining me on today's call are Blaise Coleman, President and CEO of Endo, Mark Bradley, Executive Vice President and CFO, and Patrick Berry, President, Global Commercial Operations. We have prepared a slide presentation to accompany today's webcast, and that presentation will as well as other materials are posted online in the investor section at endo.com. I would like to remind you that any forward-looking statements made by management are covered under the U.S. Private Securities Litigation Reform Act of 1995 and the applicable Canadian securities laws and are subject to the changes, risks and uncertainties described in the press release and in our U.S. and Canadian securities filings. In addition, During the course of the call, we may refer to non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States and that may be different from non-GAAP financial measures used by other companies. Investors are encouraged to review ENDO's current report on Form 8K furnished with the SEC for ENDO's reasons for including those non-GAAP financial measures in its earnings release and presentation. The reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures are contained in our earnings press release issued yesterday, unless otherwise noted therein. I'd now like to turn the call over to Blaze. Blaze?

Thank you, Lori. Good morning, everyone, and thank you for joining us. We are pleased to report solid financial performance and continued progress against our strategic priorities during the second quarter. We saw a better-than-expected performance across each of our segments, including double-digit percentage sequential revenue growth in our brand pharmaceutical segment, driven by continued strong volume growth in Zyaflex. Based on the strength of our second quarter performance, we are raising the low end of our 2021 full-year financial guidance. Turning to slide three, last year at this time, we introduced our strategic priorities, which guide all that we do as we work to transform our company. During the second quarter, we made progress across all three of our strategic priorities. In expand and enhance our portfolio, we continue to successfully deliver on our core launch plan, drive continued strong Ziaflex volume growth through effective commercial execution and focused investments, progress and grow our internal product pipeline, and actively pursue external business development opportunities in our core areas of growth. In reinvent how we work, We continue to advance our business transformation initiatives, including the recently announced sale of our manufacturing facility in Chestnut Ridge, New York. In view of force for good, we published our second annual ESG report in May, reporting our continued progress across many of our initiatives in support of our ambition to adopt more sustainable practices that benefit all of our stakeholders. Moving to slide four. This is a snapshot of our segment and consolidated revenues and our adjusted EBITDA for the quarter. Second quarter revenues of $714 million increased by 4% compared to the prior year. This increase was mainly due to an increase in revenues from the specialty products portfolio of our branded pharmaceutical segment, partially offset by anticipated decreases in revenues from our generic pharmaceuticals and sterile injectable segments. reported second quarter adjusted EBITDA of $343 million, increased by 2% compared to prior year. This increase was primarily due to higher consolidated revenues and favorable changes in product mix and was partially offset by increased adjusted operating expenses. Second quarter 2021 consolidated revenues and adjusted EBITDA exceeded our previously communicated expectations due to better than expected performance across all of our segments and lower adjusted operating expenses, mainly due to the re-phasing of expenses to the second half of the year. Turning to slide five, second quarter revenues from our branded pharmaceutical segment increased 76 percent compared to prior year, driven by the performance of our specialty products portfolio. Xiflex revenues increased by over 200 percent in the second quarter compared to the prior year. On a sequential basis, Zyflex neck sales grew 17%, driven by an 11% increase in volume compared to the first quarter of 2021. These increases are the result of an increase in physician office activity and patient office visits, coupled with continued strong commercial execution. Compared to the same period in 2019, Zyflex revenues have grown at an impressive compound annual growth rate of approximately 22 percent. As we discussed earlier this year, we are continuing to invest in a Xiflex commercial strategy that includes increasing patient awareness through expanded promotion to empower patients to seek non-surgical options, coupled with physician education and training. Based on strong demand growth and the ongoing opportunity to improve condition awareness and enhance overall treatment and diagnosis rates, We are planning additional investments in direct-to-consumer marketing campaigns in the second half of the year as part of our overall commercial strategy. Specifically, we are planning to introduce a branded consumer activation strategy for the Peyronie's indication. We believe a branded DTC approach will further enable diagnosis, treatment, and unlock further demand for Xiflex. Our experience so far demonstrates the majority of consumers who request Zyaflex by name receive treatment. These additional investments are reflected in our full-year financial guidance that Mark will discuss later in the presentation. Soprel and LA revenues grew by 79 percent in the second quarter compared to prior year, primarily driven by the product's continued recovery from the pandemic, as well as stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage. We are pleased by the volume growth in the quarter in the first half of 2021, and are proud to provide central precocious puberty patients and their healthcare providers with a solution that delivers 12 months of duration. Revenues from our sterile injectable segment declined by 8% compared to the second quarter of 2020. However, revenues did exceed our expectations for the quarter. Vasostrict revenues declined by 8% in the quarter compared to prior year, driven by the anticipated decrease in volumes as COVID-19-related hospitalizations declined. On a full year, Bayes' strict revenue assumptions anticipate a continued decline toward pre-COVID-19 volume levels in the second half of 2021. Moving to slide six, revenues from our generic pharmaceutical segment decreased by 23 percent in the second quarter compared to the prior year. The anticipated decrease was primarily due to the impact of prior competitive events. This decline was partially offset by the successful launch of Lubiprostone capsules, the authorized generic of Ametiza, in January of this year. Second quarter generic pharmaceutical segment revenues exceeded our expectations mainly due to delay in certain anticipated competitive events coupled with better than expected Lubiprostone brand to generic conversion. Finally, international pharmaceutical segment revenues for the second quarter were comparable to the second quarter 2020 revenues. Turning to slide seven, while still early in our launch of Quo, we are pleased with our progress to date and the positive feedback we are receiving from both the medical aesthetics community and women who have been treated with Quo. We recently completed a market survey of early experience healthcare professionals and patients being treated with Quo, which showed that a strong majority of the patients and clinicians are satisfied with the treatment results. Approximately 80% of treating physicians rate the overall experience positively and would recommend quo to a fellow colleague. After completing the full quo treatment, approximately 75% of the patients reported being satisfied with the treatment and would recommend treatment to others. Survey results also suggested a boost in patient feeling largely involving increasing confidence among the other factors. Our PR and media planning continues to generate brand awareness and consumer enthusiasm in the marketplace. Year to date, Quo has had 134 unique media placements, generated over 5.3 billion media impressions, 88 feature stories, and had 36 broadcast placements. Additionally, Quo continues to be recognized with Consumer Beauty Awards. So far, Quo has been awarded the 2021 New Beauty Award, the Shaped Skin Award, and recently brought home the 2021 Cosmopolitan Beauty Breakthrough Award, increasing the number of beauty awards received to five. To complement growing consumer awareness, we recently launched a Find a Specialist feature on our Quo website to match interested consumers with treating medical aesthetics practices. In terms of our launch execution, we are on target with our planned account onboarding, purchase and utilization rates, our focus, continues to be a deliberate and progressive approach aimed at supporting practices to successfully launch and integrate Qo into their practices in an effort to support positive patient outcomes and overall consumer satisfaction. Moving to slide eight and discussing our ongoing branded clinical studies and pipeline, starting with Qo, our data generation plans remain focused on dosing, injection technique, and responses in target patient populations as well as rollover studies on durability. Results and analysis from these studies are key to our publication and presentation strategies. We continue to make progress on our Xiflex development programs. Last week at the American Podiatric Medical Association annual meeting held in Denver, we presented an e-poster on the phase one safety and tolerability results of Xiflex as a non-surgical treatment for plantar fibromatosis. We're encouraged by these initial findings and are excited to progress our plantar fibromytosis program with the initiation of a Phase II study in the second half of this year. In terms of adhesive capsulitis, our Phase IIb study interim analysis is anticipated towards the end of the year. We believe both plantar fibromytosis and adhesive capsulitis represent opportunities to bring innovative treatment options to address potential large unmet needs for patients who are seeking non-surgical approaches to treatment. Turning to slide nine, we continue to evolve our R&D pipeline and manufacturing capabilities to support the introduction of more sterile products that focus on the evolving needs of our customers. The number of R&D projects in our pipeline has increased to approximately 35 with the addition of new sterile injectable projects. Overall, greater than 80 percent of our R&D pipeline consists of projects across the sterile injectable product continuum. with approximately two-thirds in ready-to-use and more differentiated products. Across our sterile injectables and generic segments, we plan to launch approximately 10 products in 2021, which includes our launch of Luby ProStone capsules earlier this year. In addition to organic efforts to expand and enhance our portfolio, we continue to remain active on the business development front. We're focused on opportunities in our core areas of growth, including medical therapeutics, medical aesthetics, and sterile injectables to enable us to further leverage our existing capabilities. We've taken and we'll continue to take a disciplined approach to deploying capital on business development opportunities. Now, let me turn the call over to Mark to further discuss the company's financial results and our financial guidance. Mark.

Thank you, Blaise, and good morning, everyone. First, on slide 10, you will see a snapshot of our second quarter GAAP and non-GAAP financial results. Blaze covered consolidated and segment revenues earlier, so I will not review that again. On a GAAP basis, loss from continuing operations was approximately $10 million or 4 cents per share on a diluted basis in the second quarter of 2021 compared to income from continuing operations of approximately $18 million or 8 cents per share on a diluted basis in the second quarter of 2020. This decrease was primarily attributable to higher litigation related costs, including the recently announced Tennessee settlement and higher interest expense and was partially offset by increased revenues and a favorable change in product mix. On an adjusted basis, income from continuing operations of $152 million or 65 cents per share on a diluted basis in the second quarter of 2021 was comparable to similar amounts in the second quarter of 2020. Second quarter 2021 results reflected an increase in revenues and a favorable change in product mix partially offset by increases in operating expenses and interest expense compared to the second quarter of 2020. Turning to slide 11, based on better than expected performance across all of our segments in the second quarter, we are raising the low end of our 2021 full year financial guidance. We now expect full year 2021 total revenues to be between $2.73 billion and $2.79 billion, adjusted EBITDA to be between $1.23 billion and $1.28 billion, and adjusted diluted net income per share from continuing operations to be between $2.15 and $2.30. Our full year 2021 guidance continues to assume an adjusted gross margin of 70% to 71%, adjusted interest expense of approximately $560 million, and an adjusted effective tax rate of 11% to 12%. However, we now assume adjusted operating expenses as a percentage of revenue will be approximately 28.5%. While our full-year guidance ranges contemplate a number of different uncertainties, our guidance does not assume a broad reinstatement of COVID-19 restrictions or a significant resurgence of COVID-19 related hospitalizations during the remainder of the year. With respect to quarterly phasing, we expect total revenues to decline by approximately $50 million to $90 million in the third quarter of 2021 compared to the second quarter of 2021. This decline is expected to be driven by anticipated lower sterile injectable segment revenues due to lower vasostric volumes as demand continues to return to more normalized levels, as well as lower generic pharmaceutical segment revenues due to continued expectations for competition on certain generic products. Branded pharmaceutical segment revenues are expected to remain relatively flat in the third quarter of 2021 compared to the second quarter of 2021, as continued growth in Zyaflex is expected to be offset by declines in our established products portfolio due to continued competition. We expect adjusted gross margin in the third quarter to be at the low end of the full year 2021 guidance range, reflecting the change in product mix. Additionally, we expect adjusted operating expenses as a percentage of revenue in the third quarter to be in the low to mid 30% range, which reflects increased investments to support the launch of Quo, the progression of our branded and sterile injectable R&D pipeline projects, and the continued growth of our Xiflex on-market indications, which includes the introduction of a branded direct-to-consumer campaign for our Peronis indication. Switching to slide 12, this is a summary of full-year segment and total enterprise revenue assumptions. As you will notice, we have slightly updated the full-year revenue assumptions for our branded pharmaceuticals, sterile injectables, and generic pharmaceutical segments, as well as for Xiflex and Vasostrict. Advancing to slide 13 and wrapping up the financial discussion, unrestricted cash flow prior to debt payments was $372 million for the first six months of 2021 compared to $390 million in the prior year. This decrease was primarily due to a decrease in cash flow from changes in net working capital and was partially offset by a decrease in cash interest payments and an increase in net cash tax refunds. We ended the second quarter of 2021 with approximately $1.5 billion of unrestricted cash and a net debt to adjusted EBITDA leverage ratio of approximately five times. For the full year 2021, we are updating our expectations for unrestricted cash flow prior to debt payments to be between approximately $195 million and $245 million compared to our prior estimate of between $140 million and $240 million. This net change primarily reflects the increase in the low end of the adjusted EBITDA guidance range previously discussed, coupled with an increase in cash flow from changes in working capital, partially offset by increases in opioid-related legal expenses and cash distribution for settlements, which corresponds with the recently announced Tennessee settlement. Let me now turn the call back over to Blaise.

Thanks, Mark. Hey, prior to turning the call over to Laurie to manage our question-answer period, we understand there are many questions regarding our ongoing trials in California and New York, our recently announced Tennessee settlement, and the opioid litigation matter as a whole. However, as I'm sure you can appreciate, we're limited on what we can say on this front. With respect to Tennessee, our settlement includes no admission of wrongdoing, fault, or liability of any kind by endo, and our decision to enter into it was based on avoiding litigation risk and the cases associated costs. With respect to California and New York, the liability phase of both trials are pending, so we're not going to comment on those proceedings. With respect to the opioid litigation as a whole, we continue to be open to identifying and executing on a constructive path for resolution. It's important to note that while constructive resolution remains our goal, there can be no assurances that this will be achieved, and we are prepared to continue to litigate if necessary. More importantly, while we continue to address the opioid litigation, our endo team remains highly focused on our day-to-day business execution, advancing our strategic priorities, and delivering on our portfolio of life-enhancing products to our customers and the patients they serve. I want to thank each of our endo team members for all their strong execution during the quarter and continued commitment to helping us transform into the company that we aspire to be in the future. Let me now turn the call over to Lori to manage our question and answer period. Lori?

Thank you, Blaise. In the interest of time, if you could limit your initial questions to one, we can get in as many as possible. We would definitely appreciate it. Operator, can we have the first question, please?

Our first question comes from Chris Schott with JPMorgan. Your line is open.

Great. Thanks so much for the question. I guess my question is on quo and some of those numbers you cited with the early access program. And I guess maybe specifically the 75% satisfaction rate, were there any themes in, I guess, the 25% that weren't satisfied as you look to maybe further refine the target population? I guess was there, you know, just anything that you take away from that initial survey that you use going forward? And just maybe more broadly, I guess I think about 75%, it's clearly, you know, a good number. Just given some of the high satisfaction rates we see in other aesthetic markets, how do you think about positioning that as you think about a broader rollout of the product? Thanks so much.

Yeah, Chris, thank you very much for those questions. And I'll let Patrick address those. Patrick?

Yeah, thanks for the question, Chris. Again, I think the takeaway on the early experience market research is that that's an early directional trend. So we did we did actually engage with those patients relatively early after the completion of their course of therapy. So we really like the fact that 75% is directionally a good watermark for us. It also is somewhat consistent with what we saw in some of our other data generation as well. If you look at our 305 trial, which studied patients in both buttocks and thighs, we saw investigator global aesthetic improvement scores and patient satisfaction scores well into the 80s. So again, directionally, in the early days, we're looking for a focus on good patient outcomes and good patient satisfaction. And so what we're seeing in terms of data generation and also what we're seeing in this small market survey is exactly what we want to see. And that's where our focus is to continue to drive good patient outcomes.

Next question, please.

Our next question comes from David M. Sellem with Piper Sandler. Your line is open.

Thanks. So on VASA strict, if I'm not mistaken, back in 2019, you ran a PK study, I believe, looking at a ready-to-use formulation. So can you talk broadly about any line extensions? on VASA strict and when you could be in a position to bring improved version of it to market. And then with that in mind, to the extent you do lose excessivity, can you just talk broadly about the extent to which that could create any liquidity issues for you? Thanks.

Great, David. Thank you for the questions on VASO. So, David, on VASO, we do have a very active lifecycle management strategy around that. What we have right now approved is a vasostrict premixed bottle. We believe that's going to really bring value to our customers as they look to identify and realize the benefits of what a ready-to-use product like a vasopremixed bottle can bring to the market. And what we've talked about is that we will launch that product strategically. In terms of potential outcomes around launch of exclusivity, David, we're really not going to speculate around that. We have the matter is pending with the court in Delaware, and we'll be ready for whatever that decision is, but we're not going to speculate in terms of that potential outcome. Overall, from a liquidity standpoint, right now we feel very good about our liquidity and our go-forward position on that front, regardless of the outcome on that matter. But that's where we stand in terms of the data-strict matter, so we're not going to comment much more on that until we have the decision in the Delaware trial.

Michelle, can we have the next question, please? Our next question comes from Navan Thai with Citi. Your line is open.

Hi, good morning. First, can I try on opioids? I know you can't comment on New York and California, but are you able to comment generally on the progress towards a potential global settlement? Do you feel that plaintiffs are more willing to settle, and do you have a better idea on timing? And then I have a second question on Quo, if you had any updates on the introductory offer price. Thank you.

Patrick, why don't you comment on the price, and I'll take the opioid question.

Yeah, sure, Blaise. We launched through an early experience program at an introductory price, and that still is in the market. We're not commenting beyond that. So we've got two price points out there. We've got a 4 ml at $200 per vial, and then we have an 8 ml at $350. What I would say is that we've received really very positive receptivity to our price point. I think it allows us to have a price in the marketplace that allows our clinicians to drive good margin, introduce a new vertical. But in doing so, it also creates a product that's very accessible to a wide swath of consumers. And so that's what we wanted to do is really address a wide scale market. need for an effective cellulite treatment, and that's the first and only injectable at those price points, we've received really positive feedback on our price.

On the opioids question, as we said in our prepared remarks, we continue to work towards identifying and executing on a constructive path for resolution. We believe it's in the best interest of all of the various parties and stakeholders to find that type of constructive resolution. However, this is a very complex matter, and as we said, it's not really possible for us to assign a probability of likelihood of that outcome or when the timing of that outcome might be reached.

Thank you, Blaise. Michelle, next question.

Our next question comes from Gary Nachman with BMO Capital Markets. Your line is open.

Hi, good morning. As Zyaflex continues to outperform, has more of the upside been coming from Dupuytren's or Peyronie's? It seems like you're pretty optimistic for upside in Peyronie's going forward with the DTC campaign. Can you comment on that? And are you getting a tailwind from the pandemic with people less inclined to get surgical procedures at this point? And then just a quick one on Quo. How many physicians have you trained thus far? I think you started with 350 for the EEP. And how much will you expand that network over the next year? Just talk about the process for getting certified and how that will play out. Thanks.

Yeah. Thanks, Gary, for those questions. I'll let Patrick comment on both. Maybe just a quick comment on Xiflex is that we've seen really impressive growth on both indications, and we are very excited about our move to a branded strategy on the Peronis indication, and Patrick can comment more about that in a moment. On Quo, Gary, right now we're really focused on driving awareness and trial of that product, and a big part of that is training. We're probably not going to get into specific numbers on exactly how many we've trained at this date. We feel really good about the progress we've made, but I'll again let Patrick provide some additional color on what we're doing on that front as well.

Sure. Thank you for the question. Let me start with Zyaflex. We've seen really very impressive growth, really across both indications. As we discussed in our prepared comments, we saw a revenue growth of over 200%, and that was largely driven from a volume perspective. Both indications are growing versus prior year. The Peronis indication grew at about 80% from an underlying demand perspective, and the Jupitren's indication grew at 138%. And we saw really excellent sequential volume growth across the board. So double digit volume growth in quarter two versus quarter one. So really all good signs that we see really strong health across the molecule. And that's exactly what we want to see. I would attribute that to a couple of things. I would attribute that to the fact that we're seeing an increase in physician activity. We're seeing an approach towards pre-COVID level in terms of consumer and patient activities. And we continue to stay committed to our Xiflex maximization plan to have the right resources in the market. And our teams are executing extremely well. It's based on that confidence that we are moving forward with plans to introduce a branded direct-to-consumer activation strategy behind Peronis. As we've created conditional awareness, we have created a strong call to action in the marketplace. And a key insight and key learning for us is that when that patient does, in fact, ask for Zyaflex, the majority of the time for that Peyronie's indication, they do get Zyaflex. And so for us, that exudes a lot of confidence going into the latter part of the year and an exciting opportunity for us to introduce a branded campaign, which we think will further enable diagnosis treatment and unlock underlying demand, which is really great for patients. As it relates to quo, I think Blaise addressed that question. Again, I think in the early days, it's really about a focus in on patient outcomes and helping physicians integrate it into their practice and to have confidence. And so, again, in our prepared comments, you know, the trends are very, very positive. If you look at the early experience program, the fact that 80% of those market influencers had a positive experience with endoesthetics, positive experience with quo, and that's exactly what we want to see. Those patients are satisfied and they're satisfied with their treatment and they're willing to recommend as well. So that's really our focus in the early days is on patient outcomes integrated deeply into the practices and getting repeat utilization.

Next question, please.

As a reminder, to ask a question, please press star then 1. Our next question comes from Annabel Famini with Stifel. Your line is open.

Hi. Thanks for taking my question. A few questions again on Quo. First, now that you've had a little time with the soft launch in the market, what are physicians seeing as far as patients coming in for the full course of treatment? And how is the potential introduction of soliton for cellulite, which was just acquired by Allergan Aesthetic is going to be changing the competitive landscape for you. Have you heard any buzz there? And then on Zyflex, it's been out there for quite some time now. I imagine that most of the physicians who would adopt this product have already adopted. So what is the focus of your primary investment? DTC clearly to bring patients in, but do you feel that you've fully penetrated the physician population and and you can move your investment dollars more in the development area. Thanks.

Great, great. Thanks for those questions on Quo and Zyaflex. Maybe a quick comment or two on Zyaflex, which is, as Patrick said, we're really excited about now moving into the branded consumer activation strategy on Peyronie's disease, and there is still a significant, significant opportunity there. And one of the ways we're going to drive is what Patrick said, which is by further activation of the consumer. And so, as Patrick says, as we activate that consumer and that consumer recognizes that there's not only a non-surgical treatment to treat that condition, but also knows it by name, that's going to have significant impact and drive additional demand, not only with existing physicians that use Xiflex today, but also additional extension of new injectors going forward. But, Patrick, maybe you can comment further on Quo and anything else on Xiflex.

Sure, happy to do so. Let me start with the quo question. Again, it's certainly early days, but we are generally seeing that physicians are positioning quo for a full course of treatment. Again, the clinical trials were focused on three courses, three cycles, and so we're generally seeing patients willing to go through a full course, and we're seeing physicians successfully position it that way. As it relates to Soliton and the acquisition from Avi Allergan, the way we look at it, we certainly feel like that validates some of our sentiments on the relative size of Cellulite, the enthusiasm for that market opportunity. Anytime you're going to get a player like Allergan coming into the market, that's only going to fuel condition awareness. So that's a good thing for us. There's certainly room for multiple treatments. We see in the medical aesthetic area many times physicians look to a multi-modality type approach. And so we really like the positioning that Quo has as the first and only injectable to treat cellulite. With an injectable, I think that positions us well. Patients are very accepting of injectables. We also know that physicians can very easily operationalized and injectable in their practice. There's no capital outlay. They know how to do that. And so there's an opportunity to create a new vertical for them, an opportunity to grab good margin, and an opportunity to have a price point that is accessible to a wide addressable market. As it relates to Zyaflex, again, You know, we'll all focus in on the Peyronie's indication since we talked about a branded campaign there. You've got about 12,000 high-prescribing urologists out there that are treating erectile dysfunction, treating men's health issues on a daily basis. We know that the diagnosis rates and treatment rates are really, really low. And so there's a huge opportunity to pour more patients into the funnel. There's an opportunity to activate more urologists. And again, we know that based on the growth of the Peyronie's indication that the condition awareness has been effective. And we also know that when they ask for Zyfex by name, it unlocks even more underlying demand. There are men out there suffering in silence with Peyronie's disease, and we feel like this is a great opportunity to not only create further condition awareness, but to get more treatment, get more diagnosis and more treatment, more men treated. And so that's an exciting day for patients with the branded campaign coming in the future.

Next question, please.

There are no further questions. I'd like to turn the call back over to Blaise Coleman for any closing remarks.

Great. Thank you very much, operator. Just want to thank everybody for joining this morning, and we look forward to providing updates as we move forward. Thank you, everybody.

This concludes the program. You may now disconnect. Everyone, have a great day. Thank you. Music. Thank you. Thank you. Thank you for standing by, and welcome to the second quarter 2021 Indoor International PLC earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then 1 on your telephone. Please be advised that today's call is being recorded. If you require additional assistance, press star then 0 to reach an operator. I would now like to hand the call over to Lori Park, Senior Vice President, Investor Relations and Corporate Affairs. Please go ahead.

Thank you, Michelle. Good morning, and thank you for joining us to discuss our second quarter 2021 financial results. Joining me on today's call are Blaise Coleman, President and CEO of Endo, Mark Bradley, Executive Vice President and CFO, and Patrick Berry, President, Global Commercial Operations. We have prepared a slide presentation to accompany today's webcast, and that presentation is as well as other materials are posted online in the investor section at endo.com. I would like to remind you that any forward-looking statements made by management are covered under the U.S. Private Securities Litigation Reform Act of 1995 and the applicable Canadian securities laws and are subject to the changes, risks and uncertainties described in the press release and in our U.S. and Canadian securities filings. In addition, During the course of the call, we may refer to non-GAAP financial measures that are not prepared in accordance with accounting principles generally accepted in the United States and that may be different from non-GAAP financial measures used by other companies. Investors are encouraged to review ENDO's current report on Form 8K furnished with the SEC for ENDO's reasons for including those non-GAAP financial measures in its earnings release and presentation. The reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures are contained in our earnings press release issued yesterday, unless otherwise noted therein. I'd now like to turn the call over to Blaze. Blaze?

Thank you, Lori. Good morning, everyone, and thank you for joining us. We are pleased to report solid financial performance and continued progress against our strategic priorities during the second quarter. We saw a better-than-expected performance across each of our segments, including double-digit percentage sequential revenue growth in our brand pharmaceutical segment, driven by continued strong volume growth in Zyaflex. Based on the strength of our second quarter performance, we're raising the low end of our 2021 full-year financial guidance. Turning to slide three, last year at this time, we introduced our strategic priorities, which guide all that we do as we work to transform our company. During the second quarter, we made progress across all three of our strategic priorities. In expand and enhance our portfolio, we continue to successfully deliver on our core launch plan, drive continued strong Zyaflex volume growth through effective commercial execution and focused investments, progress and grow our internal product pipeline, and actively pursue external business development opportunities in our core areas of growth. In reinvent how we work, We continue to advance our business transformation initiatives, including the recently announced sale of our manufacturing facility in Chestnut Ridge, New York. In Be a Force for Good, we published our second annual ESG report in May, reporting our continued progress across many of our initiatives in support of our ambition to adopt more sustainable practices that benefit all of our stakeholders. Moving to slide four. This is a snapshot of our segment and consolidated revenues and our adjusted EBITDA for the quarter. Second quarter revenues of $714 million increased by 4% compared to the prior year. This increase was mainly due to an increase in revenues from the specialty products portfolio of our branded pharmaceutical segment, partially offset by anticipated decreases in revenues from our generic pharmaceuticals and sterile injectable segments. reported second quarter adjusted EBITDA of $343 million, increased by 2% compared to prior year. This increase was primarily due to higher consolidated revenues and favorable changes in product mix and was partially offset by increased adjusted operating expenses. Second quarter 2021 consolidated revenues and adjusted EBITDA exceeded our previously communicated expectations due to better than expected performance across all of our segments and lower adjusted operating expenses, mainly due to the re-phasing of expenses to the second half of the year. Turning to slide five, second quarter revenues from our branded pharmaceutical segment increased 76 percent compared to prior year, driven by the performance of our specialty products portfolio. Xiflex revenues increased by over 200 percent in the second quarter compared to the prior year. On a sequential basis, Zyflex neck sales grew 17%, driven by an 11% increase in volume compared to the first quarter of 2021. These increases are the result of an increase in physician office activity and patient office visits, coupled with continued strong commercial execution. Compared to the same period in 2019, Zyflex revenues have grown at an impressive compound annual growth rate of approximately 22 percent. As we discussed earlier this year, we are continuing to invest in a Xiflex commercial strategy that includes increasing patient awareness through expanded promotion to empower patients to seek non-surgical options, coupled with physician education and training. Based on strong demand growth and the ongoing opportunity to improve condition awareness and enhance overall treatment and diagnosis rates, We are planning additional investments in direct-to-consumer marketing campaigns in the second half of the year as part of our overall commercial strategy. Specifically, we are planning to introduce a branded consumer activation strategy for the Peyronie's indication. We believe a branded DTC approach will further enable diagnosis, treatment, and unlock further demand for Xiflex. Our experience so far demonstrates the majority of consumers who request Zyaflex by name receive treatment. These additional investments are reflected in our full-year financial guidance that Mark will discuss later in the presentation. Soprel and LA revenues grew by 79% in the second quarter compared to prior year, primarily driven by the product's continued recovery from the pandemic, as well as stronger-than-expected demand resulting from expanded patient awareness and a competitor product shortage. We are pleased by the volume growth in the quarter in the first half of 2021, and are proud to provide central precocious puberty patients and their healthcare providers with a solution that delivers 12 months of duration. Revenues from our sterile injectable segment declined by 8% compared to the second quarter of 2020. However, revenues did exceed our expectations for the quarter. Vasostrict revenues declined by 8% in the quarter compared to prior year, driven by the anticipated decrease in volumes as COVID-19-related hospitalizations declined. On a full year, Bayes' strict revenue assumptions anticipate a continued decline toward pre-COVID-19 volume levels in the second half of 2021. Moving to slide six, revenues from our generic pharmaceutical segment decreased by 23 percent in the second quarter compared to the prior year. The anticipated decrease was primarily due to the impact of prior competitive events. This decline was partially offset by the successful launch of LubiproStone capsules, the authorized generic of Ametiza, in January of this year. Second quarter generic pharmaceutical segment revenues exceeded our expectations, mainly due to delay in certain anticipated competitive events, coupled with better than expected LubiproStone brand to generic conversion. Finally, international pharmaceutical segment revenues for the second quarter were comparable to the second quarter 2020 revenues. Turning to slide seven, while still early in our launch of Quo, we are pleased with our progress to date and the positive feedback we are receiving from both the medical aesthetics community and women who have been treated with Quo. We recently completed a market survey of early experience healthcare professionals and patients being treated with Quo, which showed that a strong majority of the patients and clinicians are satisfied with the treatment results. Approximately 80% of treating physicians rate the overall experience positively and would recommend quo to a fellow colleague. After completing the full quo treatment, approximately 75% of the patients reported being satisfied with the treatment and would recommend treatment to others. Survey results also suggested a boost in patient feeling largely involving increasing confidence among the other factors. Our PR and media planning continues to generate brand awareness and consumer enthusiasm in the marketplace. Year to date, Quo has had 134 unique media placements, generated over 5.3 billion media impressions, 88 feature stories, and had 36 broadcast placements. Additionally, Quo continues to be recognized with Consumer Beauty Awards. So far, Quo has been awarded the 2021 New Beauty Award, the Shaped Skin Award, and recently brought home the 2021 Cosmopolitan Beauty Breakthrough Award, increasing the number of beauty awards received to five. To complement growing consumer awareness, we recently launched a Find a Specialist feature on our Quo website to match interested consumers with treating medical aesthetics practices. In terms of our launch execution, we are on target with our planned account onboarding, purchase and utilization rates, our focus, continues to be a deliberate and progressive approach aimed at supporting practices to successfully launch and integrate Qo into their practices in an effort to support positive patient outcomes and overall consumer satisfaction. Moving to slide eight and discussing our ongoing branded clinical studies and pipeline, starting with Qo, our data generation plans remain focused on dosing, injection technique, and responses in target patient populations as well as rollover studies on durability. Results and analysis from these studies are key to our publication and presentation strategies. We continue to make progress on our Xiflex development programs. Last week at the American Podiatric Medical Association annual meeting held in Denver, we presented an e-poster on the phase one safety and tolerability results of Xiflex as a non-surgical treatment for plantar fibromatosis. We're encouraged by these initial findings and are excited to progress our plantar fibromytosis program with the initiation of a Phase II study in the second half of this year. In terms of adhesive capsulitis, our Phase IIb study interim analysis is anticipated towards the end of the year. We believe both plantar fibromytosis and adhesive capsulitis represent opportunities to bring innovative treatment options to address potential large unmet needs for patients who are seeking non-surgical approaches to treatment. Turning to slide nine, we continue to evolve our R&D pipeline and manufacturing capabilities to support the introduction of more sterile products that focus on the evolving needs of our customers. The number of R&D projects in our pipeline has increased to approximately 35 with the addition of new sterile injectable projects. Overall, greater than 80% of our R&D pipeline consists of projects across the sterile injectable product continuum. with approximately two-thirds in ready-to-use and more differentiated products. Across our sterile injectables and generic segments, we plan to launch approximately 10 products in 2021, which includes our launch of Luby ProStone capsules earlier this year. In addition to organic efforts to expand and enhance our portfolio, we continue to remain active on the business development front. We're focused on opportunities in our core areas of growth, including medical therapeutics, medical aesthetics, and sterile injectables to enable us to further leverage our existing capabilities. We've taken and we'll continue to take a disciplined approach to deploying capital on business development opportunities. Now, let me turn the call over to Mark to further discuss the company's financial results and our financial guidance. Mark?

Thank you, Blaise, and good morning, everyone. First, on slide 10, you will see a snapshot of our second quarter GAAP and non-GAAP financial results. Blaze covered consolidated and segment revenues earlier, so I will not review that again. On a GAAP basis, loss from continuing operations was approximately $10 million or 4 cents per share on a diluted basis in the second quarter of 2021 compared to income from continuing operations of approximately $18 million or 8 cents per share on a diluted basis in the second quarter of 2020. This decrease was primarily attributable to higher litigation related costs, including the recently announced Tennessee settlement and higher interest expense and was partially offset by increased revenues and a favorable change in product mix. On an adjusted basis, income from continuing operations of $152 million or 65 cents per share on a diluted basis in the second quarter of 2021 was comparable to similar amounts in the second quarter of 2020. Second quarter 2021 results reflected an increase in revenues and a favorable change in product mix partially offset by increases in operating expenses and interest expense compared to the second quarter of 2020. Turning to slide 11, based on better than expected performance across all of our segments in the second quarter, we are raising the low end of our 2021 full-year financial guidance. We now expect full-year 2021 total revenues to be between $2.73 billion and $2.79 billion, adjusted EBITDA to be between $1.23 billion and $1.28 billion, and adjusted diluted net income per share from continuing operations to be between $2.15 and $2.30. Our full year 2021 guidance continues to assume an adjusted gross margin of 70% to 71%, adjusted interest expense of approximately $560 million, and an adjusted effective tax rate of 11% to 12%. However, we now assume adjusted operating expenses as a percentage of revenue will be approximately 28.5%. While our full-year guidance ranges contemplate a number of different uncertainties, our guidance does not assume a broad reinstatement of COVID-19 restrictions or a significant resurgence of COVID-19 related hospitalizations during the remainder of the year. With respect to quarterly phasing, we expect total revenues to decline by approximately $50 million to $90 million in the third quarter of 2021 compared to the second quarter of 2021. This decline is expected to be driven by anticipated lower sterile injectable segment revenues due to lower vasostric volumes as demand continues to return to more normalized levels, as well as lower generic pharmaceutical segment revenues due to continued expectations for competition on certain generic products. Branded pharmaceutical segment revenues are expected to remain relatively flat in the third quarter of 2021 compared to the second quarter of 2021, as continued growth in Zyaflex is expected to be offset by declines in our established products portfolio due to continued competition. We expect adjusted gross margin in the third quarter to be at the low end of the full year 2021 guidance range, reflecting the change in product mix. Additionally, we expect adjusted operating expenses as a percentage of revenue in the third quarter to be in the low to mid 30% range, which reflects increased investments to support the launch of Quo, the progression of our branded and sterile injectable R&D pipeline projects, and the continued growth of our Xiflex on-market indications, which includes the introduction of a branded direct-to-consumer campaign for our Peronis indication. Switching to slide 12, this is a summary of full-year segment and total enterprise revenue assumptions. As you will notice, we have slightly updated the full-year revenue assumptions for our branded pharmaceuticals, sterile injectables, and generic pharmaceutical segments, as well as for Xiflex and Vasostrict. Advancing to slide 13 and wrapping up the financial discussion, unrestricted cash flow prior to debt payments was $372 million for the first six months of 2021 compared to $390 million in the prior year. This decrease was primarily due to a decrease in cash flow from changes in net working capital and was partially offset by a decrease in cash interest payments and an increase in net cash tax refunds. We ended the second quarter of 2021 with approximately $1.5 billion of unrestricted cash and a net debt to adjusted EBITDA leverage ratio of approximately five times. For the full year 2021, we are updating our expectations for unrestricted cash flow prior to debt payments to be between approximately $195 million and $245 million. compared to our prior estimate of between $140 million and $240 million. This net change primarily reflects the increase in the low end of the adjusted EBITDA guidance range previously discussed, coupled with an increase in cash flow from changes in working capital, partially offset by increases in opioid-related legal expenses and cash distribution for settlements, which corresponds with the recently announced Tennessee settlement. Let me now turn the call back over to Blaise.

Blaise? Thanks, Mark. Hey, prior to turning the call over to Laurie to manage our question-answer period, we understand there are many questions regarding our ongoing trials in California and New York, our recently announced Tennessee settlement, and the opioid litigation matter as a whole. However, as I'm sure you can appreciate, we're limited on what we can say on this front. With respect to Tennessee, our settlement includes no admission of wrongdoing, fault, or liability of any kind by Ando, and our decision to enter into it was based on avoiding litigation risk and the cases associated costs. With respect to California and New York, the liability phase of both trials are pending, so we're not going to comment on those proceedings. With respect to the opioid litigation as a whole, we continue to be open to identifying and executing on a constructive path for resolution. It's important to note that while constructive resolution remains our goal, there can be no assurances that this will be achieved and we are prepared to continue to litigate if necessary. More importantly, while we continue to address the opioid litigation, our endo team remains highly focused on our day-to-day business execution, advancing our strategic priorities, and delivering on our portfolio of life-enhancing products to our customers and the patients they serve. I want to thank each of our endo team members for all their strong execution during the quarter and continued commitment to helping us transform into the company that we aspire to be in the future. Let me now turn the call over to Lori to manage our question and answer period. Lori?

Thank you, Blaise. In the interest of time, if you could limit your initial questions to one, we can get in as many as possible. We would definitely appreciate it. Operator, can we have the first question, please?

Our first question comes from Chris Schott with JPMorgan. Your line is open.

Great. Thanks so much for the question. I guess my question was on quo and some of those numbers you cited with the early access program. And I guess maybe specifically the 75% satisfaction rate. Were there any themes in, I guess, the 25% that weren't satisfied as you look to maybe further refine the target population? I guess was there, you know, just anything that you take away from that initial survey that you use going forward? And just maybe more broadly, I guess I think about 75%, it's clearly, you know, a good number. Just given some of the high satisfaction rates we see in other aesthetic markets, how do you think about positioning that as you think about a broader rollout of the product? Thanks so much.

Yeah, Chris, thank you very much for those questions, and I'll let Patrick address those. Patrick?

Yeah, thanks for the question, Chris. Again, I think the takeaway on the early experience market research is that that's an early directional trend, so we did We did actually engage with those patients relatively early after the completion of their course of therapy. So we really like the fact that 75% is directionally a good watermark for us. It also is somewhat consistent with what we saw in some of our other data generation as well. If you look at our 305 trial, which studied patients in both buttocks and thighs and we saw investigator global aesthetic improvement scores and patient satisfaction scores well into the 80s. So again, directionally, in the early days, we're looking for a focus on good patient outcomes and good patient satisfaction. And so what we're seeing in terms of data generation and also what we're seeing in this small market survey is exactly what we want to see. And that's where our focus is to continue to drive good patient outcomes.

Next question, please.

Our next question comes from David M. Sellem with Piper Sandler. Your line is open.

Thanks. So on VASA strict, if I'm not mistaken, back in 2019, you ran a PK study, I believe, looking at a ready-to-use formulation. So can you talk broadly about any line extensions? on VASA strict and when you could be in a position to bring improved version of it to market. And then with that in mind, to the extent you do lose excessivity, can you just talk broadly about the extent to which that could create any liquidity issues for you? Thanks.

Great, David. Thank you for the questions on VASO. So, David, on VASO, we do have a very active lifecycle management strategy around that. What we have right now approved is a vasostrict premix bottle. We believe that's going to really bring value to our customers as they look to identify and realize the benefits of what a ready-to-use product like a vasopremix bottle can bring to the market. And what we've talked about is that we will launch that product strategically. In terms of potential outcomes around launch of exclusivity, David, we're really not going to speculate around that. We have the matter is pending with the court in Delaware, and we'll be ready for whatever that decision is, but we're not going to speculate in terms of that potential outcome. Overall, from a liquidity standpoint, right now we feel very good about our liquidity and our go-forward position on that front, regardless of the outcome on that matter. But that's where we stand in terms of the data-strict matter, so we're not going to comment much more on that until we have the decision in the Delaware trial.

Michelle, can we have the next question, please? Our next question comes from Navan Thai with Citi. Your line is open. Hi, good morning.

First, can I try on opioids? I know you can't comment on New York and California, but are you able to comment generally on the progress towards a potential global settlement? Do you feel that plaintiffs are more willing to settle, and do you have a better idea on timing? And then I have a second question on Quo, if you had any updates on the introductory offer price. Thank you.

Patrick, why don't you comment on the price, and I'll take the opioid question.

Yeah, sure, Blaise. We launched through an early experience program at an introductory price, and that still is in the market. We're not commenting beyond that. So we've got two price points out there. We've got a 4 ml at $200 per vial, and then we have an 8 ml at $350. What I would say is that we've received really very positive receptivity to our price point. I think it allows us to have a price in the marketplace that allows our clinicians to drive good margin, introduce a new vertical. But in doing so, it also creates a product that's very accessible to a wide swath of consumers. And so that's what we wanted to do is really address a wide scale market. need for an effective cellulite treatment, and that's the first and only injectable at those price points, we've received really positive feedback on our price.

On the opioids question, as we said in our prepared remarks, we continue to work towards identifying and executing on a constructive path for resolution. We believe it's in the best interest of all of the various parties and stakeholders to find that type of constructive resolution. However, this is a very complex matter, and as we said, it's not really possible for us to assign a probability of likelihood of that outcome or when the timing of that outcome might be reached.

Thank you, Blaise. Michelle, next question.

Our next question comes from Gary Nachman with BMO Capital Markets. Your line is open.

Hi, good morning. As Zyaflex continues to outperform, has more of the upside been coming from Dupuytren's or Peyronie's? It seems like you're pretty optimistic for upside in Peyronie's going forward with the DTC campaign. Can you comment on that? And are you getting a tailwind from the pandemic with people less inclined to get surgical procedures at this point? And then just a quick one on Quo. How many physicians have you trained thus far? I think you started with 350 for the EEP. And how much will you expand that network over the next year? Just talk about the process for getting certified and how that will play out. Thanks.

Yeah. Thanks, Gary, for those questions. I'll let Patrick comment on both. Maybe just a quick comment on Xiflex is that we've seen really impressive growth on both indications, and we are very excited about our move to a branded Xiflex. strategy on the Peronis indication, and Patrick can comment more about that in a moment. On Quo, Gary, right now we're really focused on driving awareness and trial of that product, and a big part of that is training. We're probably not going to get into specific numbers on exactly how many we've trained at this date. We feel really good about the progress we've made, but I'll again let Patrick provide some additional color on what we're doing on that front as well.

Sure. Thank you for the question. Let me start with Zyaflex. We've seen really very impressive growth, really across both indications. As we discussed in our prepared comments, we saw a revenue growth of over 200%, and that was largely driven from a volume perspective. Both indications are growing versus prior year. The Peronis indication grew at about 80% from an underlying demand perspective, and the Jupitren's indication grew at 138%. And we saw really excellent sequential volume growth across the board. So double-digit volume growth in quarter two versus quarter one. So really all good signs that we see really strong health across the molecule, and that's exactly what we want to see. I would attribute that to a couple things. I would attribute that to the fact that we're seeing an increase in physician activity. We're seeing an approach towards pre-COVID level in terms of consumer activity. and patient activities. And we continue to stay committed to our Xiflex maximization plan to have the right resources in the market. And our teams are executing extremely well. It's based on that confidence that we are moving forward with plans to introduce a branded direct-to-consumer activation strategy behind Peronis. As we've created condition awareness, we have created a strong call to action in the marketplace. And a key insight and key learning for us is that when that patient does, in fact, ask for Zyaflex, the majority of the time for that Peyronie's indication, they do get Zyaflex. And so for us, that exudes a lot of confidence going into the latter part of the year and an exciting opportunity for us to introduce a branded campaign, which we think will further enable diagnosis treatment and unlock underlying demand, which is really great for patients. As it relates to quo, I think Blaise addressed that question. Again, I think in the early days, it's really about a focus in on patient outcomes and helping physicians integrate it into their practice and to have confidence. And so, again, in our prepared comments, you know, the trends are very, very positive. If you look at the early experience program, the fact that 80% of those market influencers had a positive experience with endoesthetics, positive experience with quo, and that's exactly what we want to see. Those patients are satisfied, and they're satisfied with their treatment, and they're willing to recommend as well. So that's really our focus in the early days is on patient outcomes integrated deeply into the practices and getting repeat utilization.

Next question, please.

As a reminder, to ask a question, please press star then 1. Our next question comes from Annabelle Samimi with Stifel. Your line is open.

Hi. Thanks for taking my question. A few questions again on Quo. First, now that you've had a little time with the soft launch in the market, what are physicians seeing as far as patients coming in for the full course of treatment? And how is the potential introduction of soliton for cellulite, which was just acquired by Allergan Aesthetic is going to be changing the competitive landscape for you. Have you heard any buzz there? And then on Zyflex, it's been out there for quite some time now. I imagine that most of the physicians who would adopt this product have already adopted. So what is the focus of your primary investment? DTC clearly to bring patients in, but do you feel that you've fully penetrated the physician population and and you can move your investment dollars more in the development area. Thanks.

Great, great. Thanks for those questions on Quo and Zyaflex. Maybe a quick comment or two on Zyaflex, which is, as Patrick said, we're really excited about now moving into the branded consumer activation strategy on Peyronie's disease, and there is still a significant, significant opportunity there. And one of the ways we're going to drive it is what Patrick said, which is by further activation of the consumer. And so, as Patrick says, as we activate that consumer, and that consumer recognizes that there's not only a non-surgical treatment to treat that condition, but also knows it by name, that's going to have significant impact and drive additional demand, not only with existing physicians that use Xiflex today, but also additional extension of new injectors going forward. But, Patrick, maybe you can comment further on Quo and anything else on Xiflex.

Sure, happy to do so. Let me start with the quo question. Again, it's certainly early days, but we are generally seeing that physicians are positioning quo for a full course of treatment. Again, the clinical trials were focused on three courses, three cycles, and so we're generally seeing patients willing to go through a full course, and we're seeing physicians successfully position it that way. As it relates to Soliton and the acquisition from Avi Allergan, The way we look at it, we certainly feel like that validates some of our sentiments on the relative size of cellulite, the enthusiasm for that market opportunity. Anytime you're going to get a player like Allergan coming into the market, that's only going to fuel condition awareness, so that's a good thing for us. There's certainly room for multiple treatments. We see in the medical aesthetic area many times physicians say, look to a multi-modality type approach. And so we really like the positioning that Quo has as the first and only injectable to treat cellulite. With an injectable, I think that positions us well. Patients are very accepting of injectables. We also know that physicians can very easily operationalize an injectable in their practice. There's no capital outlay. They know how to do that. And so there's an opportunity to create a new vertical for them, an opportunity to grab good margin, and an opportunity to have a price point that is accessible to a wide addressable market. As it relates to Zyaflex, again, you know, we'll all focus in on the Peronis indication since we talked about a branded campaign there. You've got about 12,000 high prescribing urologists out there that are treating erectile dysfunction, treating men's health issues on a daily basis. We know that the diagnosis rates and treatment rates are really, really low. And so there's a huge opportunity to pour more patients into the funnel. There's an opportunity to activate more urologists. And again, we know that based on the growth of the Peyronie's indication that the condition awareness has been effective. And we also know that when they ask for Zyfex by name, it unlocks even more underlying demand. There are men out there suffering in silence with Peyronie's disease, and we feel like this is a great opportunity to not only create further condition awareness, but to get more diagnosis and more treatment, more men treated. And so that's an exciting day for patients with a branded campaign coming in the future.

Next question, please.

There are no further questions. I'd like to turn the call back over to Blaise Coleman for any closing remarks.

Great. Thank you very much, Operator. Just want to thank everybody for joining this morning, and we look forward to providing updates as we move forward. Thank you, everybody.

This concludes the program. You may now disconnect. Everyone, have a great day.