Endo International plc

this is the operator today's conference is scheduled to begin shortly please continue to stand by thank you for your patience again this is the operator today's conference is scheduled to begin shortly please continue to stand by thank you for your patience Thank you. Thank you. Good day and thank you for standing by. Welcome to the ENDO International PLC 3rd Quarter 2021 Earnings Conference Call. At this time, all participants are in a 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 1 on your telephone. Please be advised that this conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Laurie Park, Senior Vice President of Investor Relations and Corporate Affairs.

Please go ahead. Thank you, and good morning. Thank you for joining us to discuss our third quarter 2021 financial results. Joining me on today's call are Blaise Coleman, Endo's President and CEO, 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, as well as other materials, are posted online in the Investors 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 security filings. In addition, during the course of this 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 8-K, 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 the earnings press release issued yesterday, unless otherwise noted therein. I would now like to turn the call over to Blaze. Blaze?

Thank you, Laurie. Good morning, everyone, and thank you for joining us. We're pleased to report strong financial performance during the third quarter, which exceeded our expectations and was driven by outstanding execution across all of our businesses, as well as continued progress against our strategic priorities. Based on the strength of our year-to-date performance and expectations for the remainder of the year, we are raising our 2021 full-year financial guidance. Turning to slide three, our strategic priorities continue to guide all that we do as we work to transform our company. During the third quarter, we made progress against all three of those priorities. In expand and enhance our portfolio, we continue to successfully deliver on our quo launch plan, drive Zyaflex volume growth through focused commercial execution and investments, progress our internal product pipeline, and successfully execute new launches. And to reinvent how we work, we continue to advance our business transformation initiatives. including the sale of our manufacturing facility in Chestnut Ridge, New York, and pending sale of our Irvine, California facility. And be a force for good, we continue to make progress across our many initiatives in support of our ambition to adopt the more sustainable practices that benefit all of our stakeholders. Endo team members are proud of the positive impact our products have on the lives of patients we serve. and on the positive impact we have in the communities where we live and work. Moving to slide four, this is a snapshot of our segment and consolidated revenues and our adjusted EBITDA for the quarter. Third quarter enterprise revenues of $772 million increased by 22 percent compared to the prior year, driven by growth in our sterile injectables, generic pharmaceuticals, and branded pharmaceutical segments. Reported third quarter adjusted EBITDA of $387 million increased by 35 percent compared to the prior year. This increase was mainly due to higher consolidated revenues and favorable changes in product mix and was partially offset by higher adjusted operating expenses due to our increase in ZioFlex and Quo commercial investments. Third quarter 2021 consolidated revenues and adjusted EBITDA exceeded our previously communicated expectations due to better-than-expected performance across our sterile injectable segment, primarily driven by vasostrict, and our generic pharmaceuticals segment. Turning to slide five, third-quarter revenues from our branded pharmaceutical segment increased by 3 percent compared to the prior year. This increase was driven by a 16 percent increase in our specialty products portfolio compared to the same quarter last year. Xiflex revenues increased approximately 20% in the third quarter compared to the prior year, driven by strong underlying demand. Third quarter 2021 Xiflex revenue growth was partially impacted by a slowdown in elective procedures, patient flow, and workforce disruptions in physician offices, mainly as a result of the COVID-19 Delta variant. We anticipate improving conditions throughout the fourth quarter, and we remain very encouraged by the continued strong interest of patients willing to seek treatment. Revenues for our sterile injectable segment increased by 37 percent compared to the third quarter of 2020 and exceeded our expectations. This was driven by a 65 percent increase in vasostrict revenues compared to the prior year, mainly due to higher utilization driven by the COVID-19 Delta variant, combined with a return to normal pre-COVID-19 population mobility and activity trends. We anticipate that demand for vasostrict will return to more normalized levels in the fourth quarter of 2021 as COVID-19 related hospitalizations decline. On the vasostrict litigation front, our appeal of the district courts non-infringement finding was filed in September and remains pending. Our full-year financial guidance assumes continued VASA strict market exclusivity for the rest of the year. However, we continue to take the necessary steps to prepare for a potential near-term launch at risk. It is worth noting that while we cannot comment on the specific terms of any of our executed VASA strict settlement agreements, it is commonplace for settlement agreements to include acceleration clauses that allow launches by other filers once there's been a launch at risk, which may also trigger an authorized generic launch. Moving to slide six, revenues from our generic pharmaceutical segment increased by an impressive 29 percent in the third quarter compared to the prior year. Third quarter generic pharmaceutical segment revenues surpassed our expectations, mainly due to better than expected Luby ProStone branded generic conversion, coupled with delayed competition on certain key generic products. We're very pleased to have received FDA approval for generic Varenicline during the quarter. Our product is currently the only FDA-approved generic Varenicline tablet. While still early days with the launch, we have a progressive supply plan that we expect will enable us, over time, to make this product available to a larger portion of the market. Finally, international pharmaceutical segment revenues for the third quarter were comparable to the third quarter 2020 revenues. On slide seven, a key component of our Xiflex maximization strategy includes increasing patient awareness through expanded promotion to empower patients to seek non-surgical options, combined with HCP promotional activities, physician education, and injection training. On this front, we're excited to have an integrated, branded, direct-to-consumer campaign for Peyronie's indication that was launched in late October. We believe the new multi-channel integrated campaign will help drive patients to find a specialized urologist and to empower men with Peyronie's to request Zyaflex. This launch represents an important milestone as it is the first branded direct-to-consumer television campaign for Zyaflex and the company. The campaign will utilize multiple media channels and will be pulled through with an integrated HCP effort from our capable men's health field sales force. This campaign is representative of the consumer activation capability we've built over the last few years. During the recent Sexual Medicine Society of North America meeting, we were able to share new post-hoc data about Xiflex in treating PD. The data analysis points to the potential benefits of completing the full Xiflex treatment course for PD, and it further demonstrates to the HCP community our ongoing commitment to invest in this important treatment and condition. Lastly, our Xiflex maximization plan continues to be supported with ongoing consumer activation activities centered on creating condition awareness of Dupuytren's contracture. We're in the process of evolving our disease state awareness campaign to its next iteration, featuring multiple real people living with the condition. We look forward to launching a new unbranded campaign early next year. Turning to slide eight, in our medical aesthetics business, we remain focused on the successful launch of Quo, building brand awareness and driving trial and adoption. Our launch efforts are centered on building a new category within medical aesthetics by emphasizing product education and the importance of patient selection that leads to positive patient outcomes while building practice success with our onboarded accounts. We are pleased with our progress and the positive feedback we are receiving from both the medical aesthetics community and the women who have been treated with Quo. In terms of our launch execution, we continue to take a disciplined and progressive approach to establishing a base of Quo injectors, and to date, we have trained and certified greater than 1,300 accounts. To match interested consumers with treating medical aesthetics practices, we've activated a Find a Specialist feature on our Quo website with robust activity. This is a good early indicator of potential future patient demand for Quo, as well as an example of our commitment to building a category and supporting demand generation. Our PR and media planning continues to generate excellent brand awareness and consumer enthusiasm in the marketplace. Quo recently made the cover of a lore magazine under the headline, The Science of Beauty. And later this month, we plan to host a media event along with one of our HCP partners to reach Latina women with our Quo product offering. Additionally, we plan to launch our Quo direct-to-consumer campaign titled But First next year with the initial teaser campaign recently relaunched. Our approach will continue focusing on supporting practices to successfully launch and integrate Quo to achieve positive patient outcomes and increase trial and adoption. We are pleased that based on our ongoing ATU market research survey of aesthetic clinicians, Quo is already leading the cellulite treatment category with the highest level of unaided awareness. Moving to slide nine and discussing our ongoing branded segment clinical studies and pipeline, starting with Quo, our data generation plans remain focused on dosing, injection technique, durability, and responses in target patient populations. For example, as we've previously highlighted, our 305 Phase 3B RILS study looked at QUEL effectiveness in a real-world population, as well as thigh injection technique and overall investigator experience. At day 90, greater than 90 percent of investigators perceived improvement in cellulite appearance, and 90 percent of investigators agreed or strongly agreed to incorporate QUEL into their practice. Results and analysis from these studies are key to our publication and presentation strategies. We continue to make progress in our Xiflex clinical development programs. With respect to plantar fibromytosis, based on our interim analysis of the proof-of-concept study, we plan to progress this program with the initiation of a Phase II study later 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. And both development programs are important components of our Xiflex maximization plan. Turning to slide 10, we continue to evolve our R&D pipeline and manufacturing capabilities to support the introduction of an increasing number of sterile products that focus on the evolving needs of our customers. As of the end of the third quarter, we have approximately 40 R&D projects in our pipeline, an increase of more than 30 percent since the beginning of the year, which is mainly driven by an increase in sterile injectable projects. Overall, greater than 85 percent of our R&D pipeline consists of projects across the sterile injectable product continuum. with approximately two thirds and ready to use in other more differentiated products. Year to date, we've launched five products and expect to launch approximately 10 products in 2021 across our sterile injectables and generic pharmaceuticals segments. In addition to our organic efforts to enhance and expand our portfolio, we continue to remain active on the business development front, remain focused on opportunities in our core areas of growth aimed at enabling us to further leverage our existing capabilities. We have taken and will continue to take a disciplined approach to deploying capital and business development opportunities that align with our strategy. 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 11, you will see a snapshot of our third 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 $49 million or 21 cents per share on a diluted basis in the third quarter of 2021 compared to loss from continuing operations of approximately $69 million or 30 cents per share on a diluted basis in the third quarter of 2020. This result was primarily attributable to increased revenue and favorable changes in product mix, which were partially offset by higher opioid litigation-related costs and settlements, asset impairment charges, and higher operating expenses due to increased ZyFlex and Quo commercial investments. On an adjusted basis, income from continuing operations was $189 million, or 80 cents per share on a diluted basis, in the third quarter of 2021, compared to income from continuing operations of $122 million or 52 cents per share on a diluted basis in the third quarter of 2020. This increase was primarily due to higher revenues and favorable changes in product mix in the third quarter of 2021 compared to the prior year and was partially offset by an increase in operating expenses due to increased ZyFlex and Quo commercial investments. Turning to slide 12, based on better than expected performance across all of our businesses in the third quarter and our expectations for the remainder of the year, we are raising our 2021 full-year financial guidance. We now expect full-year 2021 total revenues to be between $2.9 billion and $2.94 billion, adjusted EBITDA to be between $1.4 billion and $1.42 billion, and adjusted diluted net income per share from continuing operations to be between $2.80 and $2.85. Our four-year 2021 guidance now assumes an adjusted gross margin of approximately 71.5 percent, adjusted operating expenses as a percentage of revenue of approximately 26.5 percent, and an adjusted effective tax rate of approximately 13 percent. Our four-year 2021 guidance continues to assume adjusted interest expense of approximately $560 million. While our full-year guidance ranges contemplate a number of different uncertainties, our guidance does not assume a significant resurgence of COVID-19-related hospitalizations or restrictions during the remainder of the year. Switching to slide 13, this is a summary of full-year segment revenue and adjusted gross margin assumptions. We have updated the full-year assumptions for all of our segments, as well as for Zyaflex and VisaStrict. Advancing to slide 14 and wrapping up the financial discussion, unrestricted cash flow prior to debt payments was $401 million for the first nine months of 2021 compared to $308 million in the prior year. This increase was primarily due to higher adjusted EBITDA and increased cash flow from changes in net working capital and was partially offset by an increase in opioid-related legal expenses and settlements. We ended the third quarter of 2021 with approximately $1.6 billion of unrestricted cash and a net debt to adjusted EBITDA leverage ratio of approximately 4.6 times. For the full year 2021, we are updating our expectations for unrestricted cash flow prior to debt payments to be between approximately $265 million and $285 million compared to our prior estimate of between $195 million and $245 million. This change primarily reflects the increase in adjusted EBITDA previously discussed as well as a shift in the estimated timing of cash distributions to settle MESH claims from 2021 to 2022 and is expected to be partially offset by increases in certain prepaid expenses and opioid-related legal expenses and settlements. Let me now turn the call back over to Blaise.

Thank you, Mark. Prior to turning the call over to Lori to manage our question and answer period, we understand that there are many questions regarding our opioid litigation matter as a whole. However, as I'm sure you can appreciate, we're limited in what we can say on this front. With respect to the California case, the court issued a tentative ruling on November 1st in favor of Endo and the other defendants, finding no liability on all counts, and directed the defendants to prepare and file a proposed settlement of decision and a proposed judgment consistent with the tentative ruling within 30 days. With respect to the opioid litigation as a whole, we're focused on our primary goal of achieving a global settlement of all remaining opioid claims. At the same time, we will continue to actively defend the company in court when necessary, and we will pursue individual settlements when we believe they are in the best interest of the company. Additionally, we are actively exploring other strategic alternatives, both in support of achieving a global settlement and in the event we're unable to achieve such settlement. As with any thorough analysis of a complex situation, the path to a resolution will continue to take time, and we cannot speculate on the likelihood, nature, or timing of any outcome. 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 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 their strong execution during the quarter and continued commitment to helping us transform into the company we aspire to be in the future. Let's now move to the question and answer period. Lori?

Thank you, Blaise. In the interest of time, if you could limit your initial questions to allow us to get in as many as possible, we'd appreciate it. Operator, our first question, please.

Our first question comes from the line of David Anselm from Piper Sandler. Your line is open.

Thanks. So on Quo, I know you didn't break it out, but can you discuss what sales levels were and what portion of your target injector audience have you already trained? And then secondly... Just a little more color on the Chantix generic. How long do you think that's going to be a limited or no competition product? And I guess with that launch, what's the extent to which that could be a contributor such that it might offset some pressure on VASA strict if you did loss exclusivity? Just wanted to get your general thoughts there. Thanks.

Okay, David, thank you very much for those questions. I'll take the second one first, and then Patrick will help on the quo side. So with the launch of our generic Vareniclean, obviously very excited to be the first approved by the FDA for that. And right now, our expectations are that we will see near-term competition. That's how we've planned out our guidance. So that's how we are factoring that in. That said, we have a progressive supply plan in place to really increase our capacity for this product over time. And we're going to obviously seize that opportunity particularly if there is less competition there than we're currently anticipating. On the quo question on the first part with regards to sales, David, we're not disclosing that right now. It doesn't meet our requirements for disclosure from a revenue standpoint. And obviously our focus right now is really driving awareness, trial, and adoption. But I'll let Patrick talk to you about how we're progressing and some of the places that we've really focused in on and penetrated to date.

Thanks for the question, David. As we mentioned in the call, we're taking a progressive and disciplined approach to onboarding. We're really very pleased that at this point with that approach, we've onboarded about 1,300 accounts. Our focus continues to be on patient selection, product education, and integrating Quo deeply into their accounts. We're beginning to see reorders, which is exactly what we would want to be doing. And we're going to continue with that progressive distal approach for the remainder of the year. So you can begin to envision a very similar run rate between now and the end of the year. And that's really job one in terms of sizing the market opportunity. What we're trying to do is establish a base of accounts over time, over the next, say, 12 to 18 months. And you've got a really rich facial filler market which would allow us to establish a good base of accounts along with a really robust and growing body contouring market. And so that's really job one to establish over the next several months a base of injectors that are driving reorder rates and trial and adoption. So that's essentially where we're at in terms of sizing the overall market. Again, we're not going to comment on the relative size of the market, but you can look at the facial filler market in terms of the injector base that we're drawing from and the body contouring market that we're drawing on. That's how we're going to go about establishing a quality base of injectors over time.

Next question, please.

Our next question comes from the line of Nevanti from CD. The line is open.

Hi, good morning. Thanks for taking my question, and thanks for your comments on opioids. On the California trial decision, given that most trials are based on public nuisance claims, does it make you more confident for upcoming trials and for global settlement? And then my second question is on vasostrict. If you have any comments that would help us in 2002, given eagles possible entry in Q1 next year and acceleration closes? Do you expect some mitigation from the injectable nature of vaso or endos defense strategy? Thank you.

Great. Thank you for those questions. First on the question around California, I mean, here's what I would say is that First, we believe the California tentative ruling really reflects the evidence that ENDO did not make any false or misleading statements, and the ENDO lawful conduct did not cause a widespread public nuisance alleged by the plaintiffs. So that's clearly what came through in the California trial. Now, with that tentative ruling, our strategy and approach to this overall matter stays the same, which is our approach is to design really to help us achieve our primary objective, which is to achieve a global settlement, Under that approach, as I said in pre-prepared remarks, we're going to continue to defend the company. When necessary, we're going to execute individual settlements where we think that's in the best interest of the company, and we're going to have to continue to explore other strategic alternatives in support of us achieving our objective, which is a global settlement, but also in the instance where we're unable to do that. So that's going to be our go-forward approach. Obviously very satisfied with with the finding in California and completely aligned with what we believe is a company. Now, in terms of Vasostrict and sort of the question around durability, we're not really going to make predictions here in terms of the potential outcome of when we might see competition and what that impact is going to be. We feel very good about the preparation we have in place. that if competition does show up, what we're going to be doing commercially. And so feel very well prepared if we find ourselves in that situation sooner rather than later.

Next question, please.

Our next question comes from the line of Balaji Prasad from Barclays. Your line is open.

Hi. Good morning. Just two-part questions from me. Firstly, on the campaigns, both for Quo and And Zaflex, do you see scope to continue these campaigns well into 2022 and on any kind of potential impact or results that you're anticipating from these campaigns that you can quantify? And secondly, on sterile injectables, you launched five of the 10 that you anticipated to launch. I'm just curious to understand if there's any particular reason why five of these have been bunched up now in the last two months of the year? And if you can give some color on the nature of these products and impact to revenues or your goal that you anticipate, that would be great. Thank you.

Great. Thank you for those questions. On the second question first, listen, product launches come when they come. And so we'll take them when we can get them. There's nothing specific to why they're coming to the end of the year. But obviously the impact from those launches are really going to be felt in 2022. Not going to dimensionalize the size of those, but we feel good about getting those launches out at the end of the year and then really seeing the impact of those in 2022. In terms of your question on our campaigns for Quorum and Zyflex, I'll certainly turn it over to Patrick to talk about our focus there in terms of consumer activation, and this is definitely something that we're committed to over time. And maybe the only point I would make on Zyflex is this idea around what we've been able to do to drive Zyaflex growth to date, as particularly PD has been around disease awareness. And we think it's a very natural progression for us now to move to a branded discussion and really a solution for that condition. But I'll turn it over to Patrick to really talk more about it.

Yeah, thanks, Blaise. First of all, I'll start with Zyaflex. First of all, as Blaise said, we know consumer activation is effective and it's working. It's driven growth over the last few years. With our condition awareness campaign, we've really normalized the conversation, and we feel like we have an opportunity to further medicalize discussion. Our condition awareness, with the effectiveness, demonstrated that about 25% of the time that would result in a Zyaflex treatment request, and we believe that to be honored anywhere between 65% and 70% of the time. So we believe a branded Zyaflex campaign that takes this normalized discussion and and further medicalizes it, and also results in a Xiflex request, will further enhance our growth. So we're really excited about the campaign. We think the Bent Carrot Campaign is a friendly, tasteful, and visual approach to a condition that can be embarrassing for men, and they may feel that it's too intimate to discuss. But we believe the campaign is going to be memorable, easy to recall, and it's really going to build upon the disease state condition awareness that we've been doing over the last three years. So we're very excited about it. Early feedback from our key urologists has been very positive in terms of taste and tone and effectiveness, and so we're excited about what a branded campaign can mean to Xiflex for our Peyronie's indication. On Quo, again, we continued to say what we were going to do and continue to do what we said we were going to do. So We began with condition awareness to begin to create an understanding of the underlying causes of cellulite, informing women as to the causes of the condition of cellulite so they can be informed consumers. We've worked really hard to begin to establish a base of injectors. And we're moving into an era where, with a base of injectors, it would be only natural that we would flip to more of a branded campaign. We're very excited about our But First campaign, again, striking the right taste and tone in the marketplace. We are launching with some teasers, mainly on digital channels. And over time, we would look to broaden our efforts around the branded campaign for Quo as well.

Next question, please.

Our next question comes from the line of Gary McMillan from BMO Capital Markets. Your line is open.

Hi, good morning, guys. First on Zyaflex, just a little more on why it was down sequentially in the third quarter. You know, in addition to the COVID headwinds, was there a seasonal effect in the summer months? And how quickly do you think that can bounce back in the fourth quarter and have momentum into next year, just in terms of dynamics in the physicians' offices? I'm just curious what you're seeing there. And then, you know, with the additional cash flow that you generate from vasostricts, Can you pay down debt more aggressively, or do you need to keep that on the balance sheet with the opioid litigation outstanding? And just how much flexibility do you have on business development at this point, just given the opioid overhang? You mentioned that, you know, that's still a focus for you guys, so I'm curious how much you could do on that front potentially. Thank you.

Great. Thanks, Gary. What I'll do is I'll let Patrick take the bounce-back question going forward. I'll have Mark take the BD question. On your question on Xiflex sequentially, demand for Xiflex sequentially was actually flat. And what you're seeing from a revenue standpoint is that we actually had destocking between Q2 and Q3 during the year. So the reason it was down was really a function of destocking. Demand was relatively flat. and that was really related to the COVID-19 Delta variant impact. But I'll let Patrick talk about the bounce back.

Yeah, good comment on the sequential impact of the inventory burn. As we look at revenue growth overall, as we noted on the call, 20% year-over-year revenue growth, the underpinning of that revenue growth was really driven by a 19% demand growth. And so despite some headwinds that we saw in the quarter that really came in at the beginning of August into September, again, due to COVID-19 Delta variant, we did see a slowing of that growth, mainly dampening of elective procedures in the orthopedic segment, some consumer traffic slowdown in both urology as well as orthopedics. And frankly, we saw our physician customers be a bit challenged with workforce disruptions associated with COVID. All that being said, we're very encouraged by the fact that despite that transitory effect of COVID-19, we were still producing very strong demand growth of 19%. In fact, both indications did demonstrate positive growth. And so, as we look into the remainder of the year, we would anticipate a recovery to travel along with, you know, as COVID-19 dissipates. Our goal would be to continue to drive underlying demand growth and, you have Zyaflex overall in the mid-term, long-term, have a growth trajectory very similar to what we saw in 2019.

Male Speaker 1 Yeah, and now I'll let Mark can take the capital allocation question around debt and our ability to invest from a BD standpoint. Mark?

Mark Lundstrom Yeah, sure. So, thanks for the question. Yeah, you know, I think we've been pretty clear that, you know, our capital allocation priorities are really focused on investing in our internal assets first and getting everything we can out of those assets. Then we would look to complementary business development, and then we would look to debt paydowns. You know, I think our core areas of growth, you know, really remain unchanged. We look to invest behind Zyaflex, as we're doing with the DTC program that Patrick and others have mentioned. You know, we're fully investing behind Quo and our medical aesthetics capabilities. We're investing behind Zyaflex pipeline opportunities, and we're also investing behind our sterile injectables pipelining capabilities. We believe that, you know, deleveraging really will come through an expansion of EBITDA first, and that's why we're really focused on the portfolio and investing behind the portfolio. We would then look to complementary business development opportunities along those same core areas of growth. And then after that, like I mentioned, we would consider debt paydowns. Next question, please.

Our next question comes from the line of Annabelle Samini from CFO. Your line is open.

Hi, thanks for taking my questions. I had two. First on quo, I guess now that you're in a number of practices moving from 350 to about 1300, I'm curious about the feedback that you're getting from the practices on the results that they're seeing and the level of satisfaction of the patients relative to the time commitment they need to make for the administration over the three courses, and how do you think they're managing this within their practice? Is it moving more towards the technician, or is it something that they have to figure out how to balance? And then second, I guess, you mentioned a couple times that in light of a global opioid settlement, you're possibly pursuing different strategic decisions. Maybe you can tell us what you mean by some of the strategic initiatives you're taking in light of a global settlement and then putting aside anything related to the opioid settlement. Is there any more thought to divestiture as part of a strategic focus, such as, you know, do you need to be an international? What is that giving you other than flat growth or declining growth? So I was just wanting to know how you're thinking about those strategic decisions. Thanks.

Okay, thanks Annabelle. So on your second question, I'll take that first. In terms of divestitures, divestitures are always something we're constantly looking at in terms of are we in the right businesses? Do these businesses make sense for us going forward? I will tell you that over the last 20 months, we feel that having a diversified set of businesses has served us very well in terms of obviously what we just went through COVID-19. That all being said, that's something we continue to look at and we'll continue to look at going forward when we make those decisions as we move forward. On your question around strategic alternatives, in terms of what we referenced, we're not going to comment on any specific alternatives the company may be exploring other than to say the strategic alternatives we're exploring are broad-based in nature, and we're committed to making sure we take all actions possible to really help us achieve our overall goal, which is trying to get to a reasonable settlement on the opioid litigation. For your question on feedback from what we're hearing from the practices, I'll turn it over to Patrick.

Thank you, Blaise. We're very pleased. I mean, it's certainly early in the launch, but we are pleased with our progress and the positive feedback we're receiving, both from practicing physicians, the medical aesthetic community overall, and the women who have been treated with Quo. We referenced some ATU market research during the call, and within a short period of time, we're very excited that now Quo is not only the leading product in the cellulite category, but it's also receiving the highest satisfaction among cellulite treatments. And so certainly market research is – we look at market research for trends and attitudes, trial and usage, and it's certainly informative. But I would continue to look back at the robust real-world data that we have. I'd point to the real-world data as a better determinant on how the product is performing and the satisfaction. And I would point to the 305 phase 3B real study where we looked at quo effectiveness in a real-world population. And at day 90, investigator-perceived improvement scores were higher than 90% in cellulite appearance. And the investigators strongly agreed that they would incorporate it into the practice. And so in the real world, that's what we're seeing. We're seeing that line up pretty well and pretty consistently here. So it's early days and a lot of work to do, a lot of accounts to onboard, but we're very pleased with the progress we're making with this progressive discipline approach.

Next question, please. Again, to ask a question, press star 1 on your telephone. We have a follow-up question from Navanti from CBC. The line is open.

Hi. Thanks for taking my additional question. On call, we heard about post-procedure bruising, which you have also mentioned. Has it impacted close launch at all, and how do you educate physicians and patients about the bruising? Thank you.

Sure. I think we've been very upfront about the bruising, but I'll let Patrick talk about our approach and what we're seeing.

Sure. Thank you for the follow-up question. Yeah, we've been very consistent on this. And again, this is feedback that we heard loud and clear when we were doing our market research, when we were hearing from our advisors that, you know, bruising is the most common side effect. In most cases, it resolves on its own. And I think we've done a good job of setting that expectation in the marketplace with our customers, and we will continue to do so. And when our customers do set that expectation with their patients, they understand what the patient experience is going to be like, and we've seen that that's been a really effective approach. So we're going to continue to lean into that and assist our customers with good information around bruising.

Next question, please.

We have a follow-up question from Gary Neckman from BMO Capital. Marcus, your line is open.

Hi, thanks for the follow-up. I'm just curious, with the sale of the Chestnut and Irvine facility, does that impact your generic portfolio at all, and have you transferred everything out of those or rationalized the portfolio as a result? I'm just curious what the impact to the business is as a result of the sale of those facilities. Thank you.

Yeah, thanks, Gary, for that follow-up question. So you might recall back in November of 20, we announced a set of business transformation initiatives, and really the goal was, from a generic pharmaceutical segment standpoint, was to make us more competitive in that space. And what we were focused in on is really driving down what we would consider our cost per unit sold. And so this is all the sale of Chestnut Ridge and the pending sale of Irvine. Those two sites were identified for closure as part of our plan. And so this is a great outcome for us in terms of being able to sell these facilities. First, it saves a lot of jobs in both those locations. Two, it provides us cash proceeds that we otherwise wouldn't have had. avoid cost of change costs as well. And from a continuity of supply standpoint, it's really helping us as we perform some transfers that we've been ongoing over the last year now to our different facilities and third parties. So, this is actually a really positive development in terms of what we're trying to do. to make our generic pharmaceutical segment more competitive going forward. And there's really no meaningful impact from a portfolio standpoint in terms of some of the ANDAs that we sold as part of this. Really, from a gross margin standpoint, we're not significant contributors for us.

Next question, please.

There are no further questions at this time. Now I turn the call back over to our CEO, Blaise Coleman, for closing remarks.

Thank you, Operator. Okay, thank you, everyone, for joining us this morning. We look forward to providing you updates as we move forward, and we hope everybody has a fantastic weekend.

This concludes today's conference call. Thank you for participating in Manow Disconnect.