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spk09: Good morning and welcome to the Bausch Health third quarter 2021 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a comfort specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Arthur Shannon, Senior Vice President, Head of Investor Relations and Global Communications. Please go ahead.
spk03: Thank you, Andrew. Good morning, everyone, and welcome to our third quarter 2021 financial results conference call. Participating on today's call are our Chairman and Chief Executive Officer, Mr. Joe Papa, and Chief Financial Officer, Mr. Sam Maldasuki. Also joining for the Q&A portion of today's call are Tom Appio, who will serve as CEO of Bausch Pharma, and Scott Hirsch, who will serve as CEO of Zolta Medical. In addition to today's live webcast, a copy of today's live presentation and a replay of this conference call will be available on our website under the investor relations section. Before we begin, we'd like to remind you that our presentation today contains forward-looking information. We would ask that you take a moment to read the forward-looking statement legend at the beginning of our presentation as it contains important information. This presentation contains non-GAAP financial measures, For more information about these measures, please refer to slide two of the presentation. Non-GAAP reconciliations can be found in the appendix to the presentation posted on our website. Finally, the financial guidance in this presentation is effective as of today only. It is our policy to generally not update guidance until the following quarter and not to update or affirm guidance other than through broadly disseminated public disclosure. With that, it's my pleasure to turn the call over to Joe.
spk08: Thank you, Art, and thank you for joining us today. I will start with an update on the progress we have made on accelerating strategic alternatives to unlock shareholder value. Then I will briefly cover the third quarter highlights before turning the call over to Sam Eldosuki, our CFO, to review the financial results in detail and discuss our 2021 guidance. I will then review the segment results before opening the line for questions. Before I start, let me quickly thank the 21,000 Bausch Health team members. Third quarter 2021 was another great effort by our team that simultaneously delivered a strong EBITDA performance, advanced our R&D projects, and made significant progress with our strategic alternative process to drive shareholder value. I'm pleased to share our great priorities on the strategic alternatives process on page four. Subject to market conditions, regulatory, and other necessary approvals, we expect to launch the proposed SOLTA IPO in December 2021 or January 2022. And then we expect to launch the Bausch & Lomb IPO approximately 30 days after the SOLTA IPO, subject again to market conditions and other necessary approvals. After that, the Bausch and Lomb spinoff of the remaining shares to existing Bausch Health shareholders can occur following expiry of customary lockups, the achievement of target net leverage ratios we previously disclosed, and subject to the receipt of regulatory approvals. We also are making great progress in reducing debt. We repaid $1.1 billion of debt in the third quarter of 2021. Year to date as of September 30th, we have reduced debt by $1.6 billion this year. Total Bausch Health company net leverage as of September 30th, 2021 was 6.4 times. Moving now to slide five, our third quarter results demonstrate that despite ongoing impact from pandemic in certain regions, overall, our recovery range in progress thanks to the continued efforts of our team. In the third quarter of 21, Total company revenue declined by 1% on a reported basis and was flat on an organic basis due to a strong comparator at the third quarter of 20 with a COVID-19 rebound across many of our international markets. Importantly, our business generated strong cash flows from operations of $564 million on a GAAP basis, and on adjusted for insurance recovery, separation costs, and other items, the adjusted cash generated from operations was $382 million, in the third quarter. We continue to see strong performance and recovery from our leading brands. For example, Lumify reported revenue grew by 40% during the third quarter of 2021 compared to last year. We also delivered a near-term R&D catalyst, including the very exciting news that we now have statistically significant top-line results from the second Phase III trial for NOVO3 in dry eye disease associated with meibomian gland dysfunction. And we received FDA approval of Zypyr, which we expect to launch in the first quarter of 2022, both of which I'll discuss in more detail later. To summarize, we have made significant progress on accelerating our strategic alternatives to unlock shareholder value. Our third quarter results demonstrate that the recovery remains in progress. Key products are growing and gaining market share. And we are delivering on near-term R&D catalysts. With that, I'll turn the call over to Sam to cover the financial results in more detail.
spk01: Thank you, Joe. Just a reminder before I discuss our third quarter performance, when we talk about organic revenue growth, we mean on a constant currency basis and adjusted to remove the impact of disasters and discontinuations. Another reminder, during the third quarter, we completed the sale of Amun, our Egyptian pharma business. Now, turning to our results, third quarter revenue totaled $2.1 billion, down 1% on a reported basis and flat organically. In the prior year quarter, we saw a surge in demand coming out of the Q2 death of COVID, so being flat organically is better than it sounds. Year-to-date, revenue is up 7% on a reported basis and 6% organically. A key point, our third quarter revenue confirms the continuation of our recovery from COVID, but to be clear, we're not yet fully recovered. As our markets around the world stabilize and recover, our teams are well positioned to return our businesses to pre-COVID levels and grow from there. If you turn to slide six, start with the B&L segment. Third quarter revenue of $949 million was up 3% organically, and for the nine months year-to-date, the B&L segment was up 10% organically, but compared to the same period last year. Three of the four businesses within B&L posted organic growth, starting with the global vision care business. Third quarter revenue of $226 million was up 6% organically, led by 8% growth of international vision care, while the U.S. was up 2%. International vision care growth was driven by our key promoter brands, including Buy Through One Day, Ultra, and SoftLens. In the U.S., retail and e-commerce consumption was up 4% from a year ago and 15% versus the pre-COVID third quarter of 2019, with our daily side headlines infused, continuing to gain share and drive growth. We continue to see a steady recovery in our global vision care business, with a year-to-date growth of 21% organically as compared to last year. Moving on to our global surgical business, third quarter revenue of $173 million was up 13% organically versus Q3 2020, with international up 16% and the U.S. up 6%. The growth in our surgical business reflects CARACT and RETINA procedures recovering and now exceeding 2019 levels. Year-to-date, the global surgical business grew 28% organically as compared to 2020. Turning to global consumer business, third-core revenue of $379 million was up 7% organically, with the international consumer business up 15%, while the U.S. consumer business was flat. The growth in the international consumer was mainly driven by gaining market share and strengthening our iVitamin brand, Arcelax, Renew, and buy-through multipurpose solutions. The U.S. consumer business experienced a very strong quarter a year ago due to the impact of an opportunistic one-time sale of Suze. In the current quarter, our I-Vitamins, Occupy and Preservation, and Lumify continue to deliver strong growth in the U.S. Finally, the global OptoRx business third quarter revenue of $171 million was down 15% organically versus third quarter 2020. The decline was driven by the LOEs and the natural erosion of the Genetics-branded products in the U.S. business. Our promoted brands continue to benefit from expanded access and mid-D coverage. In the current quarter, results show 37% TRX growth versus third quarter 2020. Now, turning to Salix. Third quarter revenue of $527 million was up 6% from Q3 2020. Performance was mainly driven by Difaxin, up 12%. Relastor up 14%, and TruLens up 14%. Breaking down the components of the 12% increase in the Zyfaxion revenue, it was 6% due to volume and 6% from the net impact of the price increase which we took for Zyfaxion in the beginning of the year. Zyfaxion TRX trends continue to demonstrate recovery with 6% TRX growth versus third quarter of 2020. As we discussed in prior quarters, COVID-19 negatively impacted the long-term care facilities with less patients in those settings. Long-term care is an important segment for Xifaxin, especially for the HE indication. We continue to see steady recovery for Xifaxin prescriptions within the long-term care channel, and we expect the rebound to continue in Q4 2021 and throughout 2022. The growth in Trulance was up 14%, was driven by Volume 2, our successful efforts to expand managed care coverage for the brand. Relastor was up 14% from a mix of price and volume. We feel good about the recovery and the growth trajectory within our sales business. Year-to-date, the sales business grew 10% as compared to the same period in 2020. Now turning to the international Rx segment. Third quarter revenue of $271 million was down 1% organically. The decline is driven by LOE impact in Canada, combined with a comparison against a very strong quarter last year, driven by ivermectin sales in Mexico due to COVID-related demand. These declines were nearly offset by growth in several markets, including Poland, that was up 30% organically versus Q3 2020. Moving on to orthoderm segment, third quarter revenue of $140 million was down 3% organically. The medical derm business was down 6%, mainly driven by lower net realized pricing. The global solar business was down 1% organically. This was mainly driven by the COVID-19 shutdown in local markets in Southeast Asia and Europe. Also, it's important to point out that in Q3 2020, we saw a large surge in demand for Solta products as markets reopened, coming out of COVID-19 shutdown in Q2 2020. Year-to-date, the global Solta revenues are up 27% organically, a continuation of the impressive growth trends for this business. Finally, our diversified segment, third quarter revenue of $224 million, declined 19% organically, Our narrow business was down 25% due to lower volumes and net realized pricing on Walbutrin. We also sold lower volumes on Pepsin and Ativan, which benefited from the competitor supply issue in the prior year's quarter. Our generics business was down 14% organically, with the biggest factor being the natural erosion of volumes and net pricing as additional competitors enter the market and compete with our generic products. Finally, density was up 32% organically, driven by volume growth in our residents as it rebounded from prior year COVID-19 impacts. Turning now to the quarter P&L on slide seven. We covered revenue, so I'll start with the gross margin, which was flat versus Q3 2020. Mix was a key factor for this quarter. Similar to prior course, we continue to identify and implement operating efficiencies within our global supply chain. designed to enable us to absorb inflation pressure and other mixed impacts. Note that in our guidance for the full year, gross margin is expected to be roughly 71%. Within operating expenses, on an adjusted basis, SG&E costs were unfavorable by $43 million versus Q3 2020. In the current quarter, we have had an elevated level of promotional spending, especially to support our product launches in Global Vision Care. coupled with a return to a more normal level for promotional activities versus Q3 2020. R&D increased by 17% as compared to Q3 2020, as we continue to return to a more normalized run rate in supporting our future pipeline and key projects. Adjusted EBITDA of 885 million for the quarter was down 9% on a constant currency basis from Q3 2020. The divestment of a moon reduced adjusted EBITDA by roughly 10 million, The adjusted EBITDA in the current quarter reflects a more normalized run rate with an adjusted EBITDA margin of 41.9% compared with 44.3% in Q3 2020. The operating margins we reported in Q3 and Q4 of last year were terrific, but did not reflect our normal run rate. We believe that the investments in promotional programs are essential and a key driver to deliver profitable organic growth in the future. Turning to slide eight, During the quarter, we generated $564 million of cash from operations on a GAAP basis. Adjusted for insurance recoveries, separation-related costs, and other items, the adjusted cash generated from operations in Q3 2021 was $382 million, bringing the total to $1.378 billion year-to-date. We've been making real strides in improving our operations and working capital management to address our leverage. With our cash generated to date, we are in line to deliver roughly $1.6 billion of adjusted cash from operations in 2021. This implies that our cash generation in Q4 will be at a lower run rate than what we have seen to date. This is mainly due to our expectation on timing of payments in Q4 2021. Turning to slide 9, we continue to make progress on our debt paydowns. During the third quarter, we repaid $1.1 billion of debt with $500 million coming from cash on hand and cash from operations, and $600 million of cash proceeds from that moon divestiture. Our focus and commitment to reducing our debt, combined with our strong recovery in 2021, resulted in net leverage of 6.4 times as of the end of the third quarter of 2021. Something to keep in mind, while we're very pleased with our debt paydown progress, Looking ahead to year-end 2021, we expect our net leverage to remain flat or even slightly increased versus our 6.4 times leverage that we have today. On slide 10, we'll continue to make nice progress with our debt maturities, and as of the end of Q3, we don't have any debt maturities or mandatory amortization payments until 2025. Before we discuss full-year guidance, I want to mention one development that we'll be disclosing in our 10Q findings later today. In the last few years, we disclosed the internal tax restructuring that we did in 2017, known as the Granite Trust Transaction. This transaction resulted in a capital loss that the IRS is now challenging. We intend to contest the IRS position, and we feel confident that the law is clear and on our side. We don't believe at this time that this will result in any tax liability, and therefore no income tax provision has been recorded. Now turning to our guidance on slides 12 and 13. On this slide, you can see the progression of our full year guidance. While we expect our businesses will continue to grow and overcome the pandemic challenges, it's important to point out that the rate and duration of recovery is different by business. We're not yet fully recovered, and we expect that the recovery will continue in Q4 and into 2022. Also, at our macro level, we have seen inflation and supply chain pressure, which is consistent with what you have seen across the market. We're taking proactive steps to mitigate and overcome these challenges, but we do expect to see pressure on margin as we move forward. With that being said, we're holding our revenue guidance in the range of $8.4 to $8.6 billion, and our adjusted EBITDA guidance in the range of $3.35 to $3.5 billion. We've also updated several of our guidance assumptions to reflect our expectation for the full year. Now back to you, Joe.
spk08: Thank you, Sam. Let's begin with Bausch & Lomb on slide 15. Global Vision Care saw organic revenue growth of 6% driven by strong worldwide demand. In the U.S., organic revenue growth of 2% was driven by positive consumption trends and the ongoing launch of Infuse. Infused U.S. consumption sales increased sequentially by 42% over the second quarter, as we continue to see strong demand for our SiHi daily lenses, which help minimize symptoms of contact lens dryness. Global consumer organic revenue grew by 7%, driven by Lumify with 40% reported revenue growth, and Occuvite and Preservision, both which gained shares. The 13% organic revenue growth in the global surgical business was primarily driven by a rebound from COVID-19 delayed surgeries in both international and the U.S. in the third quarter of last year. We estimate approximately 650,000 cataract surgeries, or about 16% in the U.S., were delayed in 2020, while outside the U.S., we estimate about 20% of the surgeries were delayed, creating a tailwind for 2021 and beyond. Finally, In global opto-RX, by Zolta TRXs in the U.S. grew by 37% compared to the third quarter of 2020, primarily driven by demand and increased market access coverage. On slide 16, we highlight four of the recent advancements we've achieved in B&L late-stage programs. First, B&L's infused SciHi daily lenses We're launching the fastest-growing contact lens category. The U.S. market for SIHI daily lenses is approximately $1 billion, and we estimate it will be $3 billion by 2030. We also expect to launch our SIHI daily lenses in several additional countries next year. Next, FDA approval of Zypure and the tremendous top-line results for the Novo 3, which I'll cover in more detail in the following slides. And finally, Stata and our partner X-Brain Anticipate filing an abbreviated biologics license application with the FDA in the fourth quarter of 2021 for its Lucentis biosimilar candidate, which we have exclusive rights to the U.S. and Canadian markets. Based on these catalysts and future opportunities, we believe Bausch & Lomb is well positioned for an upcoming IPO. I want to spend a minute on the reported top line results of our second phase three trial for Novo3. an important milestone in bringing NOVA3 to the market as a potential first-in-class treatment for dry eye disease associated with mycomium gland dysfunction. Page 17, we showed the efficacy endpoints for the second phase three trials on the charts. Importantly, all primary and secondary endpoints were achieved, including statistically significant changes from baseline as early as day 15. These findings reinforce the results of the first phase three trial and further support the efficacy and safety profile of Novo3. Furthermore, we are planning a number of clinical and preclinical trials with the objective of differentiating Novo3 from other competitors in the dry ice space. We anticipate filing an NDA for Novo3 in the first half of 2022. Moving now to slide 18. We announced last week that the FDA approved Zypyr based on results from a Phase III clinical trial of 160 patients, which met its primary endpoint. Zypyr is the first and only therapy available in the U.S. that utilizes a suprachoroidal space to treat patients suffering from macular edema associated with uveitis, which if left untreated, may lead to permanent vision loss. We anticipate making Zypyr available in the U.S. in the first quarter of 2022. The charts on slide 19 show the recovery trends in key areas of Bausch & Lomb business, all of which point to a recovery in progress for this segment. Turning now to slide 20 for an update on Salix. Organic revenue recovered to near pre-COVID-19 levels in the third quarter of 2021 compared to last year, with organic revenue growth of 6%. Bifaxin revenue grew by 12% in the quarter, primarily driven by demand in IBSD, And, in fact, since new Rx market share was 87% in the third quarter of 2021 compared to 84.9% last year. We also see a potential future growth opportunity as occupancy levels in the long-term care market have not yet returned to pre-pandemic levels. Trulia's TRX volume grew by 24% versus the third quarter last year and significantly outpaced the market growth rate of 4%. Relastar revenue grew by 14%, driven by Relastar RLTRX volume growth of 11% compared to the third quarter of last year. Salix recovery is very clearly in progress, as shown by the favorable trends in the charts on slide number 21. Moving to slide 22, organic revenue declined by 1% in the international RX segment. However, year-to-date organic revenue for the international RX segment is up 6%, reflecting the strength of our broad and diverse portfolio of our prescription products. Moving on to Salta Medical in slide 23, this business continues to deliver strong performance. Year-to-date organic revenue is up 27%. On an organic basis, Salta revenue grew by 23% in the U.S. and 25% in China. The third quarter organic revenue decline of 1% compared to the prior year quarter reflects headwinds related to COVID-19 impact on parts of Asia, Pacific, and Europe. Additionally, the third quarter of 2020 was a strong compare driven by demand as markets reopened after COVID-19 closures. Moving to slide number 25 for an update on strategic alternative process, we identified the key members of the teams that will lead the three attractive companies we are building. Bausch Pharma will be led by Tom Appio as CEO, Tom Vadekeff as CFO, Shona Carson as General Counsel, and Bob Sperr as President of the U.S. Business. I will lead Bausch & Lime as CEO, along with Samuel DeSouki as CFO. In addition to serving as General Counsel, Christina Ackerman will be running a key business for us upon separation as well, expanding beyond legal to join the business as global leader of the ophthalmology prescription business. Joe Gordon will lead the global consumer, vision care, and surgical businesses. And Solta Medical will be led by Scott Hirsch as CEO, Tom Hart as the COO, and Judah Borelli as General Counsel. We expect to announce a CFO for Solta in the near term. Turning now to slide 26, as I mentioned earlier, we expect to launch a proposed Solta IPO in the December 2021-January 2022 timeframe, subject to market conditions, regulatory, and other necessary approvals. The Solta team has made great progress over the past three months. An S-1 has been confidentially submitted to the SEC. Key leadership appointments have been made. We've also prepared carve-out financial statements and have engaged with a full banking syndicate in preparation for the IPO. Turning to slide 27 for an update on the planned spinoff of Bausch & Lomb, we have now completed the internal objectives necessary for the spin of B&L to be achieved. We intend to use the proceeds of the proposed SILTA IPO to pay down debt And we expect to launch a Bausch & Lomb IPO approximately 30 days after the launch of the Solta IPO. Again, subject to market conditions, regulatory, and other necessary approvals. Bausch Pharma's remaining stake in Solta post the Solta IPO will not be spun off to shareholders. It will be utilized as a corporate asset for Bausch Pharma to de-lever. After that, the full distribution of the remaining B&L shares or the spinoff can occur following the expiry of customer lockups customer lockups, achievement of target net leverage ratios, and receipt of the necessary approvals. In light of securities law's limitations, we will not comment on the pending transactions beyond what we have just disclosed. To summarize, recovery from COVID-19 is ongoing across our businesses. We have been advancing near-term R&D catalysts that will position our business for future growth, and our team has been working diligently to accelerate the strategic alternative process. And finally, we remain committed to unlocking shareholder value across our three attractive businesses as soon as possible. With that, operator, let me open up the line for questions.
spk09: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster? The first question comes from Chris Schott with JPMorgan. Please go ahead.
spk05: Great. Thanks so much for the questions. Just two for me. I guess first on the business, can you just help me a bit on the Solta 3Q results? I think you just mentioned it sounds like there was some impacts in Southeast Asia and Europe from COVID. I guess, have those businesses recovered at this point? So is that just kind of a short-term impact that's recovering, or are those still under some pressure? I'm just trying to get our hands around how we should be thinking about kind of growth and 4Q and going forward given those dynamics. My second question, I don't know how much of this you can answer just given the IPO dynamics, but how quickly should we think about the company's ability to fully separate B&L post its IPO? Is that a relatively short timeframe and should we rethink of the different factors as leverage as the key gating factor? And maybe just kind of tied to that, Do you anticipate that your remaining stake in Solta post the IPO will be netted against your debt as we're thinking about leverage targets, or is that going to be kind of treated as a separate kind of asset on the balance sheet? So I'm trying to get a sense of, as we're calculating leverage, if you have a couple billion dollar stake in Solta, is that helpful in terms of the timelines on the BNL separation? Thanks so much.
spk08: Chris, thank you for the questions. I'm going to let Scott address talk to the third quarter results. I'll talk quickly about the full separation of B and L, and then Sam and you can perhaps talk about how we plan to utilize that value of SOLTA that would be bringing it back to pharma. So Scott, why don't you take that first question?
spk07: Sure. Thanks, Joe. Good morning, Chris. SOLTA had a very strong third quarter, especially given what is a seasonally slow quarter for aesthetics and third quarter given patients and practitioners outside or on holiday. With that said, Solta had a denormalized year-over-year comp this period owing to the timing of shutdowns in the market, particularly in 2020 with COVID and COVID-19 shutdowns last year. So the more normalized trend or growth metric is the year-to-date growth rate, which is 32% reported or 27% organic growth. Those are exactly the kind of numbers that we are targeting and executing on. I'll say where we stand today, you're seeing vaccine access rates around the world vary So who has access to vaccines and the rates of market shutdowns vary. Overall, we're managing quite well globally across Bausch and across the businesses, Solta included within that, through those shutdowns in market. And really what we're seeing is the year-to-date rates are what we're targeting, and that's what we're going to keep pushing forward on.
spk08: Thank you, Scott. I'll take the second part of the question. Chris, I am somewhat limited on what I can say about this, of course, but we're looking at the full separation of B and L. It will be subject to customary lockups of an IPO. Also, I made mention of the regulatory approvals. I remind you that we are seeking to do this in a very tax-efficient way, so we need to make sure we get the appropriate regulatory approvals for that. But our expectation is that we will be able to proceed with that after the IPO, somewhere in that three, six, seven-month type timeframe, depending on how things occur. But we are looking forward to doing that full separation as quickly as we can. And obviously, we want to make sure we take a look at customary lockups and those regulatory approvals. Sam, do you want to take that remaining stake in Solta's valuation?
spk01: Sure. And, Chris, thanks for raising the leverage point. Let me try and give a little bit more color here in terms of how I think about the leverage and the path forward to the leverage. So when you think about the Solta business, first, Solta will help us in two ways. The IPO proceeds from Solta will be used to repay some of the debt back at the fast farmer level. The remaining SALTA ownership, which we're requesting, will be really a corporate asset for the Pash Pharma to use and help it deliver, either through future equity sell-downs or EBITDA growth or a combination of the two. Just to go forward with that, when you think also about the 6.5% and 6.7%, You have the BNL IPO, which will raise proceeds from the IPO from the BNL side, as well as the debt that we'll be putting in on the BNL, which is roughly about 2.5 net lever ratio. So when you combine all those items, combining with what we've done with the divestiture this quarter with Amun and the national delevering that we expect from cash generation, that's how we're thinking about in terms of moving forward with achieving the target of 6.5 to 6.7.
spk08: Thank you, operator. Next question, please.
spk09: The next question comes from Doug Mean with RBC. Please go ahead.
spk11: Yeah, thank you. I just want to get to Xifaxin and review that a little bit more with respect to the long-term care facilities. Can you maybe give us a bit more detail on how you see that rolling out in terms of it being a gating factor with respect to further growth or an acceleration in growth in Zyfaxan. And then the second thing is, Sam, you went through the tax situation very quickly. Could you review that just in a little bit more detail? Thank you.
spk08: Sure. I'll start with the Zyfaxan long-term care. Clearly, COVID had an impact on the population of patients in long-term care. We did see a decline in that overall census or population of long-term care. It didn't have anything specifically to do with Xifaxin. It was just the general population in long-term care. And we do see that starting to regain population census occurring, but that is something that is slightly below, certainly below where it was pre-COVID. However, in the last 10 weeks, we have been tracking it, the Xifaxin long-term care growth year-over-year is now up about 3%. So a little below what we're seeing for total Syphaxin, last 10 weeks of total Syphaxin was up 5%. So we're clearly seeing it started to grow, but it is a little bit behind where it was pre-COVID. And we do expect that that will come back, that census population in the long-term care will come back. But it is certainly something that we're looking at as a potential tailwind as we think about the rest of 2021 and into 2022. But that's something we're continuing to monitor very closely. The population of the long-term care, as a general commentary, is about 22% of SyFax. And so it gives you some sense of it's a market we're tracking very closely. We are starting to see some growth, but it is slightly behind the overall growth of the SyFax in total. Once again, as Sam mentioned, I'll make a quick comment on Sifax and IBSD. That was up about 12% versus a year ago timeframe. So you're seeing a lot of growth there, to be clear. We're waiting for the long-term care to continue to rebound. And once again, it's mostly on a census of the population that's in long-term care. Sam, do you want to take that second part of the question on the tax, please?
spk01: Sure, Doug. Thank you for... Thank you for the question. So let me start by underscoring just our level of confidence in our position based on the facts and the law. The Granite Trust Transaction, it's a commonly used structure where you'll recognize economic loss and monetize that loss. So based on what we believe, our facts and the law, we feel very comfortable with our position. We have steep evaluations, both internal and external, that supports our position. And as we look at how the transactions being applied and how much the IRS, in terms of their position, will believe that they have no legal basis for the IRS and have no merit. So our view here is the IRS argument contradicts the current law, and our position is pretty clear in both the law as well as in our facts. Thank you, operator. We'll take the next question.
spk09: The next question comes from Jason Gerbery with Bank of America. Please go ahead.
spk02: Hey, guys. Good morning. Thanks for taking my questions. Can you talk a little bit about how you're thinking about guiding to your business or businesses for 2022, given all the moving parts here? I imagine Solta, you might be looking to guide sooner than some of the other component parts of the business, but curious if you can talk about that. And then also, do you have any sense of when we'll get detailed data for NOV03? It will be published. I was looking at AAO for 2021. It doesn't look like The data will be presented in the next couple of weeks at the AAO medical meeting, but do you have a sense of when we can get the data for NOB03? Thanks.
spk08: Great. Great question. Thank you, Jason, for your questions. Let me start with how we think about the 2022 guidance for each of our business. As is normally our case, we will be guiding on the businesses in the February timeframe. Having said that, though, as you think about our plans for SOLTA and followed by 30 days later by an IPO for the B&L business, you can expect us to make comments in that December 2021, February 2022 for the SOLTA business, obviously, as we think about the future of it. I can't make any more comments right now, as you understand, because we're going through the IPO process. But then following that, As I said, within the 30 days after the SOLTA IPO, we will follow it up with a Bausch & Lomb IPO. And our expectation is we'll have additional comments on that as we go to that IPO. So that would be the planning timing frame for how we'll address the 2022 guidance. Obviously, the remaining Bausch Pharma business, which we will rebrand, We'll have additional comments on that business as well in that February of 2022 timing. So that's the plan how we're going to take a look at that. On the NOVO3 data, as you can tell from my comments, we are really very excited about having this type of data for patients that have dry eye disease associated with myeloma and gland dysfunction. We think that we will have an opportunity to present that data in the very near future. I don't have, obviously, the date. specific date yet. As you can understand, this second phase two trial is obviously late-breaking information. We will get it out published. But the important point I would make is that what we see is a product that, if approved by the FDA, will have very strong efficacy data. And within the 15-day timeframe, we start to see the efficacy. And that is statistically significant efficacy. in both signs and symptoms of dry eye disease associated with myeloma and gland dysfunction. So, if approved, we are very excited about what that means. We don't have a specific publication date, to my knowledge, but we will get it out in the very near future. As I said, it was late-breaking information.
spk02: Joe, do you think pricing being worthy of being on par with, like, the branded eye drops, like Restasis and Zdra? Did you think about the pricing for that versus, say, artificial tears?
spk08: Yeah, so we have not specifically disclosed a price for it yet, but we think based on the efficacy of this product, based on the fact that it has a, what we think is a very rapid onset of action relative to other products in the space, we do think that pricing for it will be competitive with the other major products out in the category. As you know, this category is about a $1.5 billion product. U.S. market. So we're very excited. Once again, I'm not going to go into specifics, as you can guess, but very excited about what it means and the fact that we have good efficacy and relatively very rapid onset of activity. We saw it as early as 15 days. So if approved, we're really excited what it means for our company. Next question, please.
spk09: Next question comes from Gary Nachman with BMO Capital Markets. Please go ahead.
spk12: Hi, guys. Good morning. First, for the SOLTA IPO, does that have to happen first in order to facilitate the B&L IPO? So if SOLTA gets delayed for some reason, B&L automatically gets delayed, is there a valuation range you need to hit with SOLTA in order for B&L to happen? I just want to get a sense for how dependent or independent those events are. And then for Scott, just on SOLTA, Where is most of the growth going to come from to maintain that 27% year-to-date level that you talked about, both from a product and geographic standpoint? Just talk about the business a little bit more and how you're confident in achieving that type of growth trajectory. Thanks.
spk08: All right. I'll start. Good question, Gary. Right now, for planning purposes, we are planning the SOLTA IPO, as I said, in that December 2021, January 2022 timeframe. The specific question you're asking, does it have to happen first? How dependent are these events? The answer is it does not have to happen. We could do the BNL IPO prior to SOLTA, but for right now, we think the planning horizon, we think SOLTA IPO can happen in that December, January timeframe, and then followed by the B&L IPO. They're not absolutely linked, though. If something was to happen with Solta, we could absolutely go forward with the B&L IPO, but our current planning horizon, we think it's the right one that we do the Solta first. Scott, do you want to take that second question?
spk07: Yeah, Gary, what I'll talk about probably is more the long-term drivers of the business, given a number of the shifting dynamics related to COVID shutdowns and the rest, which are really not kind of the focus point for me right now. I think there are four main drivers of Solta. First is just to maximize our growth over the current geographic footprint, which is predominantly Asia-Pac and U.S. today. Second is to expand the portfolio over our current footprint. So right now we do not have our full product portfolio distributed through our current geographic footprint, so we have an expansion opportunity of taking the products that we currently have in some markets and expanding them to all markets. Third, we have geographic expansion, and we have just started to expand into the EU5. So, again, we started U.S., went to Asia-Pac, and now we're branching out into EU5. And then we have yet to tap Latin America. Both Europe and Latin America are impressive opportunities for us. And then lastly, we have both pipelines as well as organic and inorganic growth drivers, we will have a very attractive structure with respect to being Canadian and Irish, and so our ability to become a structure that absorbs products and new products very easily and with cash generation is very attractive for us. So those are the four main growth drivers that I'll articulate for the long term of Solta.
spk08: Operator, let's take another question, please. Thank you.
spk09: The next question comes from David Amsalem with Piper Sandler. Please go ahead.
spk10: Thanks. So just a couple of questions on the Bausch Pharma piece of the business. First, on the medical dermatology segment, Ortho, can you just talk about the role of that business in the pharma organization, particularly given the the difficult dynamics associated with that business and the reimbursement landscape that you're seeing with key new brands that you had once had high hopes for. Just talk about how you're thinking about further investment in that business as you effectuate the spin. So that's number one. And then secondly, I know you've talked about this before, Joe, but maybe just some updated thoughts on how you're thinking about R&D spend for Dow Pharma In other words, do you manage that business largely for cash or can you focus a significant amount of resources on R&D spend? Just latest thoughts there. Thanks.
spk08: Sure. So on the – good questions. On the Med Derm, what we've taken an approach over the last, I'd say, 12 months now is to really focus on what I would refer to as profitable growth, making sure that where we invest in that business, we can find profitable growth. There were some challenges, as everyone knows, in terms of the Med Derm, in terms of the reimbursement environment, and so we've migrated our approach there to make sure that we are focused on profitable growth in terms of looking at the difficult dynamics in the marketplace. Beyond the profitable growth, we still believe that the opportunity exists for the dermatology.com. We do think that that has a place, especially as we think about some of the changes, certainly in places like the acne market, where we have very efficacious products that we do believe are wanted by the consumers. And we're looking at dermatology.com as a way to make sure that we can make that access available. Final comment on MedDerm is we do have some very good data on a triple therapy for the, we call it IDP-126, that we believe has an opportunity to really differentiate itself with what we think is going to be unsurpassed efficacy for the treatment of derm. So it's going to be profitable growth. Dermatology.com, and we still have some pipeline products that we plan to roll out. On the question of R&D spend and what we're thinking about for Bausch Pharma, will we manage the business for cash or can we spend in R&D? We absolutely are looking at the spend in the R&D place for our biopharma relative to certainly what we've talked about previously. We have some novel formulations of rifaximin that also are going after new indications. I mean, we've talked about it before. We think there's an opportunity there for the sickle cell disease as certainly one example based on what we're seeing in terms of rifaximin reducing circulating activated neutrophils. We do think that's an interesting opportunity, one that we will continue to move forward with. I also mentioned in past calls some of the things that we are seeing with the reduction in cirrhosis. We look at that as taking us to a space where not only are we able to treat patients that have hepatic encephalopathy, but potentially we can prevent patients from going into hepatic encephalopathy by treating those patients that have cirrhosis and avoiding the need for hospitalization If we could prove that out with our clinical trial that we're referring to as Red C, we do think that that would be a very important application of our Rifaximin formulation. So there's a number of things we're doing there. The other thing we're tracking very closely is what's happening in the treatment of inflammatory bowel disease. We clearly know that some of the challenges that some of the products have run into, the JAK inhibitors, the TIK2 products that we are tracking, and therefore, we believe a novel product in the area, like our MSL mod, could have application. We've started that clinical trial. We have patients enrolled. Obviously, we've got to get to the data point to understand that. But if we get some data there, we think that also could have value. So that we do think there's an opportunity to spend money in the R&D side to build the pipeline out for the Bausch Pharma. We'll obviously have to wait to see what the data looks like. And I'm sure Tom, Appio, and others will continue to move those projects forward. Operator, next question, please.
spk09: Yes. The next question comes from Umar Rafat with Evercore. Please go ahead.
spk04: Hi, guys. Thanks for taking my questions. Maybe three quick ones, if I may. First, super helpful disclosures on Solta and the slides today, but I just thought it would be helpful to understand the growth better. So perhaps, Scott, if I look at the prior three or so years of revenue growth for Thermage, how much of that is from consumable versus machine? And I ask in light of the Thermage Gen 3 device launch in 2018. Secondly, perhaps, Joe, on Novo 3, I realize this will be one of the highest profile launches for the B&L business going forward, and we're entering the zone where Street will be tweaking the estimates very closely in 2022. I guess my question is, are you characterizing the commercial opportunity and, as a result, launch expectations as more of a dry eye drug like a Restasis or more of an RX version of an artificial tear? Because I feel like that could help set expectations appropriately heading into that launch. And then finally, Sam, perhaps anything to make of the DERM inventory level changes seen in this quarter? Thank you.
spk08: Okay, Scott, why don't you take that first question on the SOLTA. I'll take the NOAA three questions, and then Sam, you can take the final question.
spk07: Sure. Good morning, Robert. Thanks for the question. I actually think it highlights one of the most significant differentiating characteristics of Solta, which is the fact that the business has approximately 72%, 73% consumable revenues or reusable, returnable revenues. And so it's a great asset for the business. It's a great dynamic and a business model of Solta. We're not looking to just put a piece of equipment on every street corner. What we're really looking to do is make sure that we maximize and extract the opportunity out of every machine that's out there, and that means growing the reusable base of our business, and Solta has been able to do that fantastically well. Like I said, we have about a 72%, 73% consumable ratio in our revenue stream today.
spk08: On your second question on the NOVO3, we do think this is a significant commercial opportunity. We do believe that based on the phase two data that we have, now having two completed phase three clinical trials, we look forward to submitting that information to the FDA in the very near future. Our view on this is that it has very good efficacy. certainly compared with the commercial opportunity for dry eye disease. I want to be clear, we are seeking a mevolin gland dysfunction associated with dry eye disease, so that is specifically what we're targeting. But we look at that time to onset of symptom release and being able to show data within 15 days. We believe that that will be a very important differentiator versus the marketplace. In my comments, I made a brief comment, but I will say that we are going to look at preclinical and clinical data to help us differentiate from the existing therapies. So, we clearly look at it as a product that compared to a Restasis or a Zydra. we'll have a very significant opportunity. Now, it's going to be a little bit different patient segment. We get it. But nonetheless, we do think that there is a real Rx opportunity here for our Novo 3 product. Sam, do you want to take that last comment?
spk01: Yeah, and let me touch on the inventory. When you look at the DERM, it's really just a natural fluctuation in the timing of orders. Overall, when we look at the inventory, we try to stay around the one month. It fluctuates a little bit between various scores, but that's really where we target to stay around the one month, Omar.
spk04: Thank you, guys.
spk08: Operator, next question, please.
spk09: Thank you. The next question comes from Balaji Prasad with Barclays. Please go ahead.
spk00: All right, good morning, and thanks for the questions. A couple from me. Firstly, on Zypair, can you help us set the expectations around the drug and the form of the launch or the commercial launch and the investments that's needed for it next year? And as I think about the spend going into next year, it kind of also takes me to the next question. So currently Street EBITDA is at around $3.6 billion for next year. I know you said, Joe, that you'll be commenting the guidance later on. But as we think about the forward EBITDA, can you call out the major levers towards this variation for the $3.6 billion that consensus is forecasting for 2022? Thank you.
spk08: Okay, I'll take that first one on Zypure, and Sam and I will do the combination of the second one in terms of guidance commentary. First of all, in terms of Zypure commercial launch, I made a comment during my comments in the call that we're very excited about it because it will be the first and only product that treats patients by going into the suprachoroidal space. which we think is an important way to deliver products to the eye. Second comment, though, in terms of thinking about what does that mean for us, we're going to be able to launch it starting in that first quarter of 2022. So that is when we think we can be out there with the product. Probably the commentary on the commercial side, we do believe that we have and are in the process of making all the investment needed for it. I'm here in headquarters today, and we have some of the really ongoing activities with our Salesforce as I sit here today as we get ready for this launch. So we believe we've got the activities that are going to be required to launch it and be successful. That activity has already happened. It's part of our ongoing expense. I'm not going to make any specific comments on the exact sales expectations, but we believe having a physician as the first and only product that can be treated, treat patients through the suprachloroidal space, we think is an important initiative. And the consequences of not being able to treat this is that patients can lose their vision, we think is an important consequence of not treating. So we do think there's a real opportunity here. Sam, the question on the guidance for the 2022, as we've made the comment, we're really not going to make any specific comments on 2022. We will talk about SOLTA as we go out with the IPO. We will talk about Bausch & Lomb as we go out with that IPO. I'm somewhat prohibited from making anything further on that comment now. And then in total, Sharma will also be in that February 2022 timeframe. Anything else we can say on this question, really?
spk01: No, not at this point, but I think it's one of those areas where – As Joe mentioned, as we start moving forward with the IPO, we'll probably hear more from us as we launch the IPO.
spk08: Okay. Thank you for the question. Operator, I have time maybe for one more question, please.
spk09: Thank you, sir. And that question comes from Greg Fraser with Truist. Please go ahead.
spk06: Good morning, folks. Thanks for taking the questions. Can you walk through what you'll need to address on the debt structure for Balanced Pharma ahead of the P&L spin separate from reaching your leverage target, such as any necessary refinancings? And my second question is on Loomify. How big do you think that product could get with the current label, and how are you thinking about label expansion opportunities? Thank you. Okay. I'll take the first one. I'll take the Loomify.
spk01: So, Craig, thanks for your question. So, when you think about our debt and the landscape of our debt, one of the of things that we've done over the last couple of years did a very nice job in terms of making sure that we manage the maturities. And we don't have any maturities until 2025. And when you think about the debt maturity of 2025, it's roughly about $9.7 billion, of which about $4 billion is unsecured and about $5.5 billion, which consists of the secured and the term loan. So as we think about where we are today, we don't feel like we need to take any specific action at this point in terms of dealing with anything from a maturity. But as we start thinking about the path to de-levering, as I said, you think about the IPO for Solta is one path where we will raise money that we'll be able to use to be able to bring down the debt. as well as the remaining value of SOLTA, which will be either, again, monetized and sold or leveraged through EBITDA. You combine that with the impact of potential proceeds from the IPO of the BNL as well as the debt raise on BNL, and I think that will give you pretty much the sufficient proceeds and funds that will be able for us to deal with the majority of what we would see outstanding for 2025 and dealing with that level in 2025. That's really how we're thinking about it and our approach for it at this point.
spk08: A final question you had was on Lumify, how we think about label expansion opportunities. Let me start a little bit in terms of where we start. First of all, we think that Lumify is a great example of having an integrated platform where we are seeing doctors, the optometrists and ophthalmologists, both for our consumer business, but we're also seeing for the Rx business, also for the surgical business. We believe that an integrated platform we have allows us to be very successful with the launch of any new product because we're seeing the doctors that treat eye health in many different situations. We think having that was part of the reason we got the number one recommended product by ophthalmologists and optometrists in a very rapid timeframe. I think it was within the first 12 months with Lumify. Number two, we clearly see that Lumify will continue to expand the category of the treatment of red eyes simply because of The mechanism of action, we think it's a better mechanism of action. So we think that that's, you know, because we don't constrict the arterial blood flow to the eye, which some of the other products do. We have a different mechanism of action we think is part of the reason why it continues to be the number one product. And it is also growing the category, expanding the category, because we believe of that mechanism of action rather than just simply We're taking share, but we're also expanding the category, and I believe that's the reason why you're seeing the growth. Final comment is in terms of long-term opportunity, we also view that there are line extension opportunities for Lumify. Clearly, we're going to continue to look at trying to bring forth products that certainly help with the redness in the eye, but one can also quickly think about it's more than just redness in the eye relief. If you also have patients who have allergic eyes, for example, as we can combine the Lumify active ingredients with other products to have combination products, we think there are clear line extension opportunities with new label indications as well. So a lot of different ways that we can address Lumify, and we're very optimistic about it for the future. That concludes my comments today. First of all, I want to tell everyone that we have many plans for a busy and active next few months. We expect to have frequent communication with all of our stakeholders over that time period. And I want to thank everyone for joining us today. Have a great day, everyone.
spk09: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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