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Edited Transcript of ALM.MC earnings conference call or presentation 22-Feb-21 9:00am GMT

·53 min read

Full Year 2020 Almirall SA Earnings Call Barcelona Feb 22, 2021 (Thomson StreetEvents) -- Edited Transcript of Almirall SA earnings conference call or presentation Monday, February 22, 2021 at 9:00:00am GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Carlos Gallardo * Michael McClellan Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board * Pablo Divasson del Fraile Almirall, S.A. - Head of IR & Corporate External Communication * Volker Koscielny Almirall, S.A. - Chief Medical Officer & Member of Management Board ================================================================================ Conference Call Participants ================================================================================ * Alvaro Lenze Julia Alantra Equities Sociedad de Valores, S.A., Research Division - Research Analyst * Francisco Ruiz Exane BNP Paribas, Research Division - Research Analyst * Guilherme Macedo Sampaio Banco BPI, S.A., Research Division - Analyst * Jaime Escribano Grupo Santander, Research Division - Equity Analyst * Krishna Chaitanya Arikatla Goldman Sachs Group, Inc., Research Division - Research Analyst * Peter James Welford Jefferies LLC, Research Division - Senior Equity Analyst & European Pharmaceuticals Analyst * Trung Chuong Huynh Crédit Suisse AG, Research Division - Research Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, and welcome to the Almirall Financial Results and Business Update Full Year 2020 presentation. Today's conference is being recorded. At this time, I would like to turn the conference over to Pablo Divasson. Please go ahead, sir. -------------------------------------------------------------------------------- Pablo Divasson del Fraile, Almirall, S.A. - Head of IR & Corporate External Communication [2] -------------------------------------------------------------------------------- Thank you, Joana. Good morning to everyone on the call. Thank you for joining us to review Almirall's 2020 full year results. I hope that everyone is safe and remaining healthy. As usual, you can find the slides to this call on the Investor page of our website at almirall.com. Moving to Slide 2, I would like to remind you that information presented in this call contain forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. With that, please advance to Slide 3. Presenting today, we have Michael McClellan, Chief Financial Officer and Interim Chief Executive Officer; and Volker Koscielny, Chief Medical Officer. Mike will review the year's business performance and provide you with details on the pipeline as well as the financials and the 2021 outlook. Mr. Volker will provide you with an update on Ilumetri and lebrikizumab. After that, we will open it up for a Q&A session. First, I would like to pass you over to Carlos Gallardo Pique, Almirall's second Vice Chairman and Proprietary Director. -------------------------------------------------------------------------------- Carlos Gallardo, [3] -------------------------------------------------------------------------------- Thank you, Pablo. Good morning, ladies and gentlemen. I am Carlos Gallardo, one of the founding Gallardo family. Last November, I was proposed as Vice Chairman of the Board, and my nomination will come up for confirmation at our next general -- Annual General Meeting in May. So I wanted to introduce myself to shareholders and analysts. On behalf of the Board, I would also like to make 1 or 2 comments on recent changes to the Almirall's Executive team. A bit of background about myself. I graduated in Industrial Engineering here in Spain, and followed this with an MBA from Stanford University in California. I have 18 years experience in the pharmaceutical industry and have held executive positions in Almirall and Pfizer, mainly in licensing, business development and territory of general management, including as General Manager of Almirall's subsidiaries in the U.K. and Ireland. In 2014, I was appointed as one of the family representatives on the Board of Almirall. And I also set up CG Health Ventures, building and investing in companies in digital health and other novel health technology. You will be aware that we announced last autumn that our CEO, Peter Guenter, will be leaving Almirall at the end of the year. The Board immediately set in motion a thorough search for Peter's replacements and also appointed our CFO, Mike McClellan, as interim CEO. Mike is doing an excellent job, and the Board thanks him very much for all his leadership. On 3rd February, we were very pleased to announce the appointment of Gianfranco Nazzi as CEO from 1st May, after considering quite a number of excellent candidates. As it happens, Mike and Gianfranco know each other well, having worked today at Teva. And the Board is confident that they will form an outstanding leadership team to take Almirall to the next stage in its development. And now I will hand over to Mike. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [4] -------------------------------------------------------------------------------- Thank you, Carlos, for the kind words and the trust to let me keep things moving forward in the interim period. I'd say good morning to everyone joining the call to discuss our 2020 results in what was a challenging year for everyone. We think the tough realities of doing business during the pandemic, which adversely impacted our medical dermatology business, albeit the impact varied across the geographies. Despite these challenges, we have demonstrated a very resilient business, particularly in Europe and delivered on our latest guidance. To highlight our growth drivers performance. Ilumetri continued to grow strongly, and we're very pleased to have launched in France, which is another building block to continue the excellent momentum of the product. For Skilarence, no surprises here, we're in line with how we guided you earlier in the year. Seysara has seen a rebound in TRx in the second half of 2020, although we're seeing a slow start to 2021 in the overall acne market in the U.S. due to various COVID-related restrictions. I'll provide further details on the growth drivers shortly. We continue to work hard on the late-stage pipeline to leverage the significant potential there. For lebrikizumab, we expect readouts to Phase III in the second half this year as we continue to work with our partner, Eli Lilly, towards the anticipated 2023 EU launch. We're also pleased to announce the recent launch of Klisyri in the U.S., and we're expecting approval in the EU in 2021. Additionally, as you know, we've received the acceptance of our clinical trial application for Seysara in China, which means we are on track to start the Phase III as planned. Another piece of good news related to the pipeline is the acquisition of the EU rights for the product approved as Wynzora in the U.S. It's a topical product for psoriasis, which we plan to launch in the second part of the year, and I'll provide further information later in the presentation. As you can see, there's been important progress in the late-stage pipeline. And this, together with our recent launches, continues to give us confidence in the further growth outlook of our core business. And finally, as recently announced, we've appointed Gianfranco Nazzi as our CEO. So let me start there and summarize his background for you. We're very pleased to have Gianfranco as our new CEO. He will lead the company in continuing to execute on our strategy to become the leader in medical dermatology. He's a great fit for the company and has the right profile to take Almirall to the next level through driving commercial launches and unlocking the significant potential of the pipeline. Gianfranco brings with him a wealth of experience, a broad geographical focus and a strong track record of execution from his current role at Teva as Executive Vice President of the International Markets region, and he previously had commercial roles at AstraZeneca, GSK and Eli Lilly. We are very excited for him to start with us on 1st of May. I know Gianfranco well as we've worked together several years at Teva, and I look forward to working closely with him soon. On to the next slide. As I mentioned before, we are pleased to deliver our latest 2020 guidance. Despite the challenges faced from the impact of COVID-19 during the year, Almirall starts 2021 in good shape operationally. In addition, we have a strong credit rating, reflecting our operational flexibility and healthy balance sheet, which we can use to actively pursue bolt-on acquisitions and late-stage in-licensing opportunities as well as research collaborations that align with our corporate strategy. Now let's move on to Klisyri, which is the brand name of tirbanibulin, which we have launched last week for the small field indication in the U.S. market. Klisyri is a novel first-in-class microtubular inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. Actinic keratosis is a chronic recurrent disease, caused primarily by extensive UV damage to the skin, and is the most common precancerous skin disease. We believe AK is the second most common diagnosis made by dermatologists in the U.S., where the existing topical therapies are associated with significant side effects such as pain, inflammatory reactions, hypopigmentation and scar. Klisyri offers a superior product profile, which represents a significant step forward in the treatment of AK due to its short treatment protocol, it's a once-daily application for 5 days, and proven efficacy and good safety profile. In this context, we believe that Klisyri is well placed within the market. We have now launched in the U.S., and we expect the approval and launch in Europe later this year. Following from the previous slide, we believe that Klisyri has a strong profile. Last week, we were pleased with the publication of the Phase III data in the New England Journal of Medicine, one of the most prestigious and rigorously peer-reviewed medical journals. The clinical trial data demonstrates significant efficacy and importantly, a proven tolerability and safety profile. This, along with the short 5-day application period, provides an important additional medicine for dermatologists in treating AK. To support the launch of the U.S., we are reinforcing the sales force, mainly in the southern states, where there is a greater demand due to the high levels of sun exposure. It's important patients in dermatologists truly understand the product because the real advantage versus other products is the tolerability. So there will be an initial level of education involved. We are confident that this should create an interest from the patients who will benefit from the better tolerability ahead of the typically higher demand seen in the summer months due to sun exposure. Therefore, building a foundation quickly will be critical and our timing, as you can see, is ideal in this respect. So let's now move to the performance of Ilumetri, which continues with excellent momentum. This slide shows that the market dynamics in the Anti-IL-23 class in Germany, where you can see the class capturing 32% market share of new patients within the biologics, keeping head-to-head with the Anti-IL-17. Within the Anti-IL-23 class, Ilumetri has increased market share of new patients to achieve 32%. This is despite the strict lockdowns seen in Germany in late Q4 of last year. There are compelling reasons for this strong trend. The Anti-IL-23 class has a strong efficacy profile, with the key attribute being a proven lasting efficacy, convenient dosing and no significant safety concerns. Within this class that has strong competition, Ilumetri's product profile is compelling with long-term sustained efficacy, very good tolerance, delivering maintained control psoriasis patients and ease of use as its key attributes. In addition, Ilumetri is the first Anti-IL-23 to deliver a data set with a consistent long-term safety profile through 5 years. This demonstrates the long-term psoriasis control with reassuring long-term safety profile. Volker will explain the significance of this day as said shortly. As you can see here, Ilumetri has a strong performance with sales growing sequentially and with 125% increase year-on-year to achieve EUR 44 million for 2020. The performance in Germany has continued to drive growth, achieving our highest monthly unit volumes since last. Across the different markets in Europe, the majority of countries are surpassing pre-COVID levels despite the increased restrictions seen across the EU at the end of last year. We are starting to get traction in Spain and Italy following virtual launches. And in France, we are pleased that the launch is underway with scripts already being filled and we expect to have meaningful contribution from this market by summer. We remain fully confident in Ilumetri's growth potential going forward with the latest data being very encouraging and showing continued momentum of new patient shares. As we come through the pandemic, we strongly believe the profile of Ilumetri with a quarterly dosing regimen and a cost-effective price is a product physicians can turn to, which supports further growth in the winning class. Now let's take a look at Seysara. 2021 has been a typical -- atypical year with the oral antibiotic market in the U.S. being adversely impacted by COVID, with lack of physician access for the patients and our reps. In Q4, we've seen a positive but modest recovery of TRxs despite the COVID-related restrictions. However, we've seen a faster recovery of generics versus banded products as generics are much easier for the physicians to prescribe as there are no pre-approval requirements needed. We will continue to dedicate resources to further differentiate Seysara based on the microbiology label and to optimize patient support to enable affordable access for patients. One comment if you're comparing IQVIA data to Bloomberg, there are differences in where the data is sourced. The IQVIA data is more accurate as it captures a larger pool of suppliers and retail channels, which provides a more accurate picture of the TRx data. I will now pass over to Volker to discuss updates on some key products. -------------------------------------------------------------------------------- Volker Koscielny, Almirall, S.A. - Chief Medical Officer & Member of Management Board [5] -------------------------------------------------------------------------------- Thanks, Mike, and good morning, everybody. As Mike mentioned, I will give you in a couple of slides, some highlights on our Biologics portfolio, which is, of course, key to Almirall. I will start with lebrikizumab, a novel high affinity monoclonal antibody targeting the IL-13 pathway. This is an opportunity we are extremely excited about. Now we are very pleased with the uptake of patient enrollment in the pivotal trials in the U.S. and in Europe, which have been paused, of course, due to COVID-19 restrictions during the lockdown. We are working now towards the next catalyst, which we estimate in the second half of '21. This will give us important top line results of the 16-week induction phase of the studies. We will then have, in the first half of '22, for the 52-week maintenance data that is required for submission -- for regulatory submission, which puts us right on track to launch in '23. If the Phase III data confirms what we have seen in the Phase IIb program, we believe lebrikizumab will deliver reliable skin efficacy, possibly superior itch relief and the favorable safety profile. In addition, and importantly, lebrikizumab may also have the convenience of once-monthly maintenance dosing as another competitive advantage. As you know, the atopic dermatitis market is expensive, growing and diverse, where there remains a large unmet need to provide new options to patients. So we believe there's a clear need for a new and differentiated therapy with a reassuring safety profile. With lebrikizumab in our pipeline, a potentially best-in-class IL-13 antibody and the central agent in the therapeutic paradigm, we think we have a unique opportunity here to really help these patients live a better life. Let me please move on to Ilumetri. As we know, psoriasis is a chronic disease that needs to be managed often over decades. It is clear that dermatologists are looking for reliable therapy options that effectively can control the disease without incurring safety risks in the long term. Mike has shown us the strong uptake of the class, and we do believe this is a reflection of clinicians' confidence in the sustainable efficacy and reassuring safety profile of agents hitting the IL-23 pathway. Now in this context, we just published the first full analysis set of the 2 key vital studies over 5 years in the reputable British Journal of Dermatology. This data boosts the longest follow-up investigation with more than 5,400 patient years of exposure. So let me give you a little bit more detail on this data. Let me say that the reception of the data with the dermatology community is extremely positive as the findings really do connect with their clinical need, which is to control the disease in the long-term without incurring safety risks. You can see here in the graph that 8 out of 10 patients maintained a good level of disease control over 5 years. Absolute party here is a commonly used measurement of skin involvement and a party of less than 3 is considered very well controlled disease. Importantly, we did not see any new safety signals, in particular, no maces, so major adverse cardiovascular events. This is consistent across populations. So for example, at risk populations, such as the elderly, we are highly encouraged by this data and feel that we are very competitively positioned within the IL-23 class. On the basis of this data, we will now start in the next month, a large Phase IV study across Europe. This study will deepen our understanding of the benefits of disease control to patients and their families, focusing really on patient-centric care. We are extremely confident that this study will build nicely on the positive 5-year data and further reflects what really matters to health care professionals in achieving optimized outcomes for their patients. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [6] -------------------------------------------------------------------------------- Thanks, Volker. Now I want to take you through the strategic in-licensing of a topical product from MC2 therapeutics we announced last week. Wynzora, the brand name approved in the U.S. and under review in the EU is a topical calcipotriene/betamethasone DP combination cream being developed using PAD formulation technology for adult patients suffering from mild to moderate psoriasis. This technology, PAD formulations, are highly tolerable even on sensitive tissue, which is an important feature of the product. Almirall has acquired the EU rights in which it's currently under regulatory review as a topical treatment supported by 2 Phase III trials. This includes an EU head-to-head trial against active comparator, Daivobet and Daivobet Gel, we expect EU approval in Q2 2021 and launch in the second half. In the U.S., Wynzora has already received FDA approval last year. Wynzora cream was designed to provide patients a new treatment option in their daily routines by focusing on all elements of efficacy, tolerability and convenience in 1 single product. This has resulted in differentiation from the other products on the market with the potential becoming the patient's preferred formulation due to superior cosmetic and convenience benefits, faster onset of action, good tolerability and higher efficacy. The market represents a significant opportunity for us as the calcipotriene and betamethasone dipropionate segment accounts for approximately 35% of share of volume and annual sales of more than $300 million as a class. The product has a clear strategic fit with our portfolio, providing a full range of psoriasis products that covers the patient journey, strengthening our position in the EU psoriasis market. Almirall will be the only pharma company with a full portfolio of psoriasis products. We expect peak sales of the expanded franchise of more than $300 million for Ilumetri, Skilarence and Wynzora combined. With that, let's look at how the overall late-stage pipeline is looking. Here you see the excellent progress we've made. Firstly, as I've discussed the Wynzora license, which provides Almirall with access to a late-stage topical therapy, which we will be able to launch in Europe this year. Early in the presentation, I discussed the launch of Klisyri small field in the U.S., and we are also preparing for the approval and launch in EU. Volker has also elaborated on the large field opportunity. For Bioniz opportunity, we have now received the end of Phase II FDA meeting minutes, which started the 60-day period to review and make a decision on the option. Let me remind you that this is a very complex disease with multiple stages that requires a very thorough analysis of the patient data to ensure that there is a mode of action to support this orphan disease opportunity as well as to understand the requirements in full time lines for a Phase III clinical trial. Detailed review of the data will be key in making a responsible decision on the commercial opportunity. We also have an update on the legacy portfolio. As we have previously stated, we have been actively looking for alternatives to license out terbinafine and finasteride as the molecules do not fit our commercial strategy. Both products have been approved, so they are no longer in the pipeline. As I've already mentioned, that Seysara received the acceptance of our clinical trial application in China, this means we are on track to start the Phase III trials as planned. We think this is an interesting opportunity, and we'll give you updates on the go-to-market plan as it develops. And finally, the exciting lebri opportunity, which Volker has already explained in depth. So now let's go on to the financials. As I mentioned in the introduction, we have seen a resilient performance in 2020, despite the tough realities of the impact of COVID with dermatology as a disease area being more heavily impacted than most others. The key highlights are as follows: year-to-date net sales declined 5.4%, however, if we exclude the Aczone generic impact, net sales were flat, which gives a better sense of the resilience for the rest of the portfolio. Going forward, we will see a reduced drag on the net sales from Aczone as the generic impact is now fully annualized. Other income decreased significantly year-on-year. Gross margin is in line with our expectations, given the adverse impact of generic competition to Aczone. In terms of OpEx, SG&A declined in line with net sales as increased new product investments were offset by lower promotion activity due to the COVID situation. The combination of all these elements resulted in a decline in EBITDA of 21.7% for the year. Consistent with previous quarters, we're providing visibility on our product sales to help you better understand the dynamics of our business. The discrepancy between our European and U.S. business is clear, as we've seen relative resilience of the European portfolio and the growth of our Dermatology business there. However, our U.S. portfolio is still significantly impacted by the combination of the generic impact of Aczone and the COVID impact on the general acne market. In Europe, we saw a slowdown of our products in Q4, particularly Ebastel and the OTC portfolio in general. The cough and cold season has been very slow due to social distancing and the use of masks. We expect a progressive recovery throughout 2021 with a slow start in the first half. Our rest of the world business benefited from strong orders from partners in the first half. The other net sales includes the impact of the accelerated recognition of deferred income that we mentioned in previous quarters. For 2020, that figure is EUR 52 million in total. And for 2021, which will be the last year that we have this deferred income, it will be EUR 17 million. The majority of the impact for Aczone is now behind us. In 2021, there could be another step down with other generics entering the market after summertime. However, overall, the sales risk is small, and we've essentially annualized the impact of generic Aczone. Our portfolio has limited patent risk going forward in the near term. Now we focus on the dermatology sales. As you can see, the strong performance in Europe, driven by the growth of Ilumetri as well as the strong trends for our Ciclopoli franchise. Furthermore, you can see the generic impact of Aczone in the U.S. and the full year comparison. The decrease in sales of Aczone in Q4 and 2019 is due to the impact of the anticipated authorized generic launching in early 2020, lower stock trade in stock levels and affecting the associated rebates of the product. The rest of the portfolio in the U.S. is still seeing impacts of COVID situation. Our assumption is that COVID will continue to influence business in 2021, and we expect the first half to be impacted with a slower uptake of new launches and softer demand in some areas, similar to what we've seen in Q4. By summer, we should see progress as the vaccines take hold. And by autumn, we will start to see things more normalize. Additionally, I'd like to point out the basket of others in the U.S. where we had released in 2019 supervisions primarily related to government rebates. The rebate reversal in 2019 did not repeat in 2020. The rest of the world business was impacted by declines in Asia, mainly due to competition to our Ciclopoli franchise. I would note that in the midterm, we expect an improving product mix, which will be further enhanced by our future growth drivers. We now move to the high level net sales evolution. And here, there are a couple of things I'd like to point out for you. The existing portfolio of net sales increased to around EUR 27 million, of which EUR 22 million was due to deferred income released in the first quarter. As you're aware, the deferred income in other net sales will normalize in 2021. On the opposite side of this, we took a hit of close to EUR 77 million in the U.S., of which EUR 48 million was due to generic Aczone. To repeat my other -- earlier comments, this impact is now annualized. Without this impact, net sales for the company would have been relatively flat versus 2019. We've now reviewed the sales performance, and I've already highlighted the key factors here, however, let me make some additional comments on the P&L. Net sales decreased in Q4 due to the lower sales in Germany and Spain as well as the decline in the U.S. legacy portfolio. Other income reduced as expected, as we've previously communicated as AstraZeneca milestone payments fell away. We expect this to be in the range of EUR 5 million to EUR 10 million going forward. While we continue to invest in our recent product launches, SG&A has decreased with reduced spend during the COVID-impacted periods, which also impacted our R&D spending compared to 2019 due to lower Phase IV studies and some canceled early-stage clinical trials. Despite this lower OpEx, the net result is that our decline in other revenues, other income and the COVID impact led to a nearly 22% reduction in our EBITDA to EUR 238 million. Continuing down the P&L, there's nothing particular to note for you, except that the Q2 impairment charge on the legacy portfolio in the U.S., which impacted our pretax profit. I'd also like to highlight the lower tax rate in 2020, which is mainly driven by tax credits in our U.S. due to the use of loss carryback provisions. We finished the year having generated normalized net income of EUR 95 million and a normalized earnings per share of EUR 0.53. If we now look at the balance sheet, there are quite a few comments provided on the slide, so I'll just highlight one of the most important factors. We finished the year with a leverage of 1.6x net debt-to-EBITDA. This gives us flexibility in the current environment and also additional opportunity for M&A or licensing activity. Let's look at the cash flow statement now. We delivered a solid operating cash flow, generating EUR 165 million this year. We had a negative charge in working capital, which was mainly caused by increased inventories for recently launched products. We expect to normalize this situation in 2021. Also to note, there was a tax refund received in December 2019 from our Spanish business, but the corresponding refund for 2020 was not received until January 2021, as allowed by tax law. As you are aware, the dividend payment was delayed as a result of the COVID-19 situation as we postponed our Annual General meeting. In October, the gross dividend was paid of EUR 0.203 per share, with a significant preference for a script dividend option. Now I'd like to move on to the outlook for 2021. For some time now, we've discussed looking at the core business as a way to focus on our underlying operations. This is something you will be very familiar with from our peers, and I want to clearly lay out our focus here going forward. In the future, our business will have less dependence on income from the respiratory business previously divested to AstraZeneca. Therefore, moving forward, we will focus on the growth of the core business, clearly, spelling out the nonoperational items and providing a clear operational guidance. And of course, as you'd expect, we provided you in the appendix with the quarterly core, noncore comparative numbers, so you can see the transition. Net sales in this new core P&L excludes the deferred income, which in 2020 was EUR 52 million. And additionally, EUR 5 million of other income, which was related to AstraZeneca royalties. The reconciliation is at the bottom of the P&L. I'm now moving to core net sales evolution. And here, you see a couple of things I'd like to pull out for you. This now excludes the deferred income and other income. As you can see, the growth drivers had a good contribution during the year, while our U.S. business was adversely impacted by COVID restrictions and the Aczone generic competition. Here, I'd like to present you with our 2021 guidance. In 2021, we expect core net sales to grow by mid single-digit growth compared to 2020 core net sales of EUR 755 million. In terms of core EBITDA, we expect to land between EUR 190 million and EUR 210 million for the full year, representing solid growth versus our current core EBITDA 2020 number of EUR 181 million. This range includes the expected risk of impact from COVID restrictions, which we will continue to manage diligently. The core guidance implies operating leverage at the midpoint coming from 2 areas. First, a better gross margin mix on the core business because of higher growth and contribution from high-margin products; and secondly, we expect to grow sales faster than expenses during the year. I also want to explain to you some of the guidance assumptions that we're using for 2021. There are multiple moving parts. However, we anticipate an increase in core net sales and core EBITDA, with growth supported by the continued momentum of the psoriasis franchise in Europe. I've also mentioned Seysara and the work we have to do there to leverage the microbiology label. This will take some time and resources. We plan to increase investment in SG&A to support the expansion of Ilumetri, particularly in France, the launches of Klisyri in the U.S. and EU and our new topical product in the EU. Additionally, we note that the second generic impact of Aczone in the second half of the year. Finally, underlying all of this is the COVID-related impact, which we expect to continue through the first half of '21, and then to gradually normalize as we progress into the second half. Here is a slide to clearly present our focus on the core business. This is looking at our core EBITDA, excluding the deferred income and other income. We've been building a strong base of core EBITDA over the years, which was aided in late 2018 and the full year 2019 by the acquisition of the dermatology portfolio in the U.S., which included Aczone. 2020 saw a significant impact related to the generic competition to Aczone, which annualized at the end of this year. We now believe that Almirall is set for a period of sustained growth of our core business over the coming years to be further accelerated by the launches of Klisyri in the U.S. and EU, the new topical product in the EU and the midterm launch of lebrikizumab in the EU. Now to the closing remarks. On this slide, we'd like to reiterate our priorities when it comes to capital allocation. First, our priority goes to invest behind our exciting new product launches in the EU and the U.S. markets. It's clear we've created ourselves a lot of opportunity in the midterm. Second, we are focused on strengthening our R&D pipeline, which is at the core of being a specialty pharmacy -- pharma company. Third, we want to provide a regular dividend to our shareholders. The AGM will be proposed a dividend of EUR 0.19 per share, which is similar to payments made in previous years. Finally, we will focus M&A activity on accretive bolt-on and licensing deals that will reinforce our core business and bring critical mass to further leverage our footprint, very similar to the Wynzora dealing. And to wrap up, today, we've provided you with extensive detail to help you understand our business and the different moving parts. 2020 was a very challenging year, however, we demonstrated the resilience of our business and the commitment to our patients. Going forward, there are many aspects we can be optimistic about, including the performance of Ilumetri, and our strong financial management and balance sheet. Furthermore, as I highlighted at the start of the presentation, we are progressing nicely with our exciting innovative pipeline. We now have a number of attractive late-stage opportunities with the potential for significant future growth. The new CEO is starting in May and brings significant experience with commercial launches that will further help us drive the growth in the business. Almirall's future looks bright in the coming years if we execute well on our launches, invest thoughtfully in key initiatives and bring our pipeline products to market on schedule. Then as you've heard from us before, a key component of our strategy remains to search for additional external opportunities to further complement our growth profile and to generate sustainable value for our shareholders. With that, I'll hand it back to Pablo for the Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Pablo Divasson del Fraile, Almirall, S.A. - Head of IR & Corporate External Communication [1] -------------------------------------------------------------------------------- Thank you, Mike. Joana, back to you for the Q&A, please. -------------------------------------------------------------------------------- Operator [2] -------------------------------------------------------------------------------- (Operator Instructions) Your first question comes from the line of KC Arikatla from Goldman Sachs. -------------------------------------------------------------------------------- Krishna Chaitanya Arikatla, Goldman Sachs Group, Inc., Research Division - Research Analyst [3] -------------------------------------------------------------------------------- I have a few of them, please. I appreciate you can't really provide many comments on 2022 at this moment. But if I look at consensus, let's say, core EBITDA, it implies more than 30% growth. Mike, are you comfortable with consensus expectations for 2022? Because even if I look at sales, there's almost more than a 20 -- or 15% growth rate there. So if you're comfortable, what would be the big growth drivers here, please? So that's the first one. On the second one, if I look at the U.S. business, you've put in significant resources here to drive portfolio's performance, but it hasn't really delivered. Of course, COVID was a major headwind here. It kind of reminds me of the 2017 situation and a way you've solved that is acquire Allergan assets and expand the portfolio, drive operating leverage. Is -- will that be the playbook now? Or are you only focused on maximizing margins from your current portfolio and consider selling some U.S. assets? A couple of other housekeeping questions. One is, what are the time lines for announcement regarding BNZ-01, please? And on the fourth quarter results. Other net sales, there was a 57% growth here. What was driving that, please? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [4] -------------------------------------------------------------------------------- Okay. Thanks, KC. That's a lot of questions. So let me kind of take them through there. And if I don't cover them all, just let me know. So first, we've given 2021 guidance. It's a little too early to give something clear on '22. But I would expect those trends to continue. I would expect '22, we will see mid- to high single-digit growth in the sales and hopefully, double-digit growth in the profit. But that will really rely on us doing a couple of things, continuing the growth of Ilumetri, turning Seysara around, having a good launch of Klisyri and then starting to gain some traction with the new topical product in Europe, the brand name Wynzora from the U.S. So I think we're in a good shape. If you go in from '21 to '22, you shouldn't see any major drags. We don't have any products that are going to be facing new generic competition. So that kind of gives you a little bit of a view there. When it comes to the U.S., I mean, the situation is not really comparable to 2017. 2017, there was a probably an earlier-than-anticipated generic loss of a large product called Acticlate from the former Aqua portfolio. And right now, we've seen what we expected to happen with Aczone. It was probably a little bit more impacted because of COVID taking the overall equity market down. But we lost about the volume we would have expected. The real key to the U.S. is the performance of Seysara. Clearly, 2020 was not a good year for Seysara. We lost some momentum with the COVID impact, really making it difficult for the branded product in the OAB market. Because of the COVID restrictions and less access of patients to physicians, there was much more of a reaction just to use generics. And you saw that in the overall oral antibiotic market. The rest of the branded products really suffered. We suffered as well, but not to the same extent. So I think the key to driving the U.S. business forward is a couple of things. One, get off to a good launch with Klisyri. Two, get more access for Seysara, that's going to be a real key going forward. We didn't make very good progress there in 2020 due mainly to the COVID situation. We need to leverage the new label to do that and to get some excitement. And then we will need to look for some new opportunities. I don't see us doing a major business purchase like we did with the Allergan transaction, but we do need to see if we can license in or find some more assets to continue to add to that portfolio. The third question, BNZ, we're reviewing the data and the FDA feedback. This is a complicated one because this is a very complicated disease. It goes all the way from skin manifestations in the early stages of CTCL to being really an oncology disease as it later develops. What's very clear to us from the FDA feedback is they're expecting this to be an oncology product in an oncology trial. We're now looking at what that means in terms of time lines, in terms of how we feel about the oncology aspect of the product and where we see the commercial case coming out. So we need to make a decision by middle of March. And we'll take our time to make the right decision on that. And I think what was the last question. I missed the full... -------------------------------------------------------------------------------- Krishna Chaitanya Arikatla, Goldman Sachs Group, Inc., Research Division - Research Analyst [5] -------------------------------------------------------------------------------- Net sales for Q4. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [6] -------------------------------------------------------------------------------- Next sales for Q4 and the other. We did have a little bit of extra income there from the out-licensing of the terbinafine and finasteride products to some minor markets. So that might be the little bit of a blip that you saw there. So did that answer everything, KC? -------------------------------------------------------------------------------- Krishna Chaitanya Arikatla, Goldman Sachs Group, Inc., Research Division - Research Analyst [7] -------------------------------------------------------------------------------- Yes. Thanks for the comprehensive answers, Mike. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- And your next question comes from the line of Francisco Ruiz from Exane. -------------------------------------------------------------------------------- Francisco Ruiz, Exane BNP Paribas, Research Division - Research Analyst [9] -------------------------------------------------------------------------------- I have 3 questions. The first one is regarding your bond that matures at the end of this year. So have you taken already a decision on how you're going to refinance? The second one is on the working capital that -- where we have seen some increase during this year probably because of the new launches, do you expect similar amounts to come on 2021? And last, I don't know if you could tell us in which way the new CEO has been involved on this new guidance? Or this is something that is -- could be subject to change when he joins the company in May? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [10] -------------------------------------------------------------------------------- Okay. Thanks for your questions. First, on the convertible bond. Yes, it does mature in December. It has a strike price over EUR 18. So so we're already starting to look at what could be some different ways that we would look at refinancing that. The markets for our credit rating are pretty good right now. So we'll be working with our key partners to figure out what's the best way. I think with our stock price right now, where it is, and we feel it's still a little bit undervalued, I think we would shy away from rolling over into a new convertible just because we would have a large dilution impact if we took another EUR 250 million into a convertible bond for another 3 years. So more likely to be something of a different financial instrument. But we'll come and let you know when we get closer to taking something to market. The second question on working capital, we saw about a EUR 30 million drag this year, mainly due to inventories. We had more inventory of Ilumetri as it was growing. We purchased some API of Sarecycline, which is the Seysara API. So that was probably a onetime transition. I would say that I would expect the working capital drag to be much lower next year as we go into 2021. And then the last was the new CEO. I mean the new CEO, of course, is still with another company. But I think the guidance that we put forward is based on what we see right now in the market. We see a slow start due to the COVID impact. We do see that we're going to be able to drive sales growth, primarily through Ilumetri and some of the new launches. But I think we have to be a little cautious to see how that's going to turn out throughout the year. So when he comes in May, we'll review ideally, if things are moving forward and COVID is dissipating a little bit more rapidly, we'll take a look at the guidance and see if we need to adjust it. But for right now, we're very confident in what we've put forward to the market. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- Your next question comes from the line of Guilherme Sampaio from CaixaBank. -------------------------------------------------------------------------------- Guilherme Macedo Sampaio, Banco BPI, S.A., Research Division - Analyst [12] -------------------------------------------------------------------------------- The first one, can you update us on your expectations regarding potential voluntary measures in Spain? The second one related to your guidance. To what extent are you including these potential measures? And what are you assuming in terms of Klisyri and the Wynzora contribution? And third, lebri headline results, you provide the guidance for the second half of the year. Should we expect results closer to June or closest to December? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [13] -------------------------------------------------------------------------------- Okay. First of all, when it comes to specific measures in Spain, we don't have anything specific in our guidance. Right now, there's not a lot of momentum in anything that's related to a major health care reform. Who knows that could pick up some pace later on in the year. But we think that Spain, just like all the other governments in Europe are really focused on getting through the COVID period. So we don't have anything specific in the mind. The second question, the guidance range, the range does have several things in it. It's what could happen with COVID. Could there be a little bit of additional price pressures in Europe and different things like that. So there's nothing specific, but it's kind of encapsulated in that range. And then third, when it comes to the lebri headline data, it's too early to give you an exact date. And we say second half. Of course, we'd like it to be earlier rather than later, but we'll just have to see, we need to work through all the process together with our partner but we're very excited when the data comes out. We really are enthusiastic about the opportunity to bring this product to the atopic dermatologists patients in Europe. -------------------------------------------------------------------------------- Guilherme Macedo Sampaio, Banco BPI, S.A., Research Division - Analyst [14] -------------------------------------------------------------------------------- Can you just confirm me what are you assuming in terms of Klisyri and Wynzora in your guidance? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [15] -------------------------------------------------------------------------------- Wynzora will be negligible because it will be later in the year. So we do have some launch costs in there, but I would say sales won't be significant in 2021 as the launch will probably happen later in the second half. And what was the other, was it Klisyri? -------------------------------------------------------------------------------- Guilherme Macedo Sampaio, Banco BPI, S.A., Research Division - Analyst [16] -------------------------------------------------------------------------------- Yes. Correct. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [17] -------------------------------------------------------------------------------- I would say, Klisyri, let's see how it takes off. But I would say something in the low double digits would be a nice target for this year. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- Your next question comes from the line of Peter Welford from Jefferies. -------------------------------------------------------------------------------- Peter James Welford, Jefferies LLC, Research Division - Senior Equity Analyst & European Pharmaceuticals Analyst [19] -------------------------------------------------------------------------------- I got a few left over. So firstly, just continuing on Klisyri. I wonder if you can give us any initial commentary on discussions with payers on that in the U.S. and how that's going and what your goals are for coverage this year? Secondly, then just on the outlook. I'm curious if you can just comment, if we were to see a return to lockdowns or higher infections or anything similar due to COVID. Do you still feel confident in the outlook for the various COVID scenarios that could happen, I guess, worse case is that vaccines don't prove the sort of what the gold miner looking for? Any comments on that will be appreciated. And also then on 2021 spend, could you just give some sort of directional indication of how we should think about SG&A and R&D in 2021? And then just on the gross margin in the fourth quarter, that seems quite high. Is this just a mix effect? Or is there any one-off more other factors that you should consider for the fourth quarter gross margin? And then just finally, I guess, more -- that's an opinion rather than necessarily a question, but just curious why you haven't decided to also potentially report a core earnings number EPS. And perhaps would you consider providing us the tax impact of the Astrazeneca payments in future, so we can adjust for a core EPS number if we choose to? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [20] -------------------------------------------------------------------------------- Okay. Thanks, Peter. That's quite a list. Let me try to go through it. So with Klisyri, the discussion with payers are going very well. I think they're very interested in having a branded option there, particularly as Picato has been withdrawn late last year. So I think we'll make good progress there, and we'll definitely update you in May when we get to that call, but so far, so good there. With the outlook, I think we've encompassed what we see as the likely COVID scenarios. Of course, if we get to the summer and vaccines aren't working and things get worse again, we may need to take a look at it. But we don't see that as a very likely scenario from everything we've talked about with the external world. So I think we're comfortable that the majority of likely COVID scenarios are in our guidance. At the same side, a scenario where it's all gone by April, and things are back to normal earlier isn't in our guidance either. So I think the 2 extremes we don't have, but the majority of the middle cases are in our guidance. 2021 spend, I think we're going to have to reinvest in the launches I've talked about. I think a good way to frame it is probably the 2019 is the ceiling of what we would invest in 2021. So you saw from '19 to '20, we went down 5% or 6% in SG&A. You'll probably see a rebound in that as we go through the 2021. And I'd say that 2019's level is probably the ceiling for this year. And it will all depends on how we can get the right return of our investment, given how COVID is evolving in the different geographies. Look, the fourth quarter gross margin was good. Like I said, we had a little bit in the other net sales of some of these minor licensing out to terbinafine and finasteride, which which helped a little bit because that's pure margin. But we do expect that over the course of 2021, that our gross margin will improve as we grow the new launch products, which tend to be higher margin. And last, the core EPS, I think that's a good comment. We'll take that back and look at it. We wanted to definitely put a core EBITDA out there because we think that, that is something that will be very useful to the investors. We'll take a look about taking that down to core EPS because it's really only the tax rate impact of the deferred income that has a real meaningful impact there. And I think that we'll see in the next quarter how we can help give more clarity on that. Thanks, Peter. -------------------------------------------------------------------------------- Operator [21] -------------------------------------------------------------------------------- And your next question comes from the line of Alvaro Lenze from Alantra Equity. -------------------------------------------------------------------------------- Alvaro Lenze Julia, Alantra Equities Sociedad de Valores, S.A., Research Division - Research Analyst [22] -------------------------------------------------------------------------------- Just quick ones. First, on Seysara. I wanted to know whether the weak launch of the product, of course, due to COVID-19, whether it affects your competitive position going forward? Or whether you expect to achieve the same peak sales that you were targeting when you first launched the product? And also, if you could provide some more color on SG&A as to how much the marketing expenses that will contribute to the SG&A growth next year? And -- yes, and that's about it. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [23] -------------------------------------------------------------------------------- So first, I'll take the SG&A. I think I kind of just mentioned that in the previous responses. I'd say the ceiling for SG&A in 2021 will be roughly in line with the 2019. And it's really driven by marketing expenses. It's expansion of the sales force in France, a little bit of an addition in the U.S. because of Klisyri and then the prelaunch of Klisyri as well as the Wynzora product. When it comes to Seysara, I think we have to be very honest that 2020 was a step back in terms of the progress of the product. The original peak sales were built on building a very good access and having good traction with the microbiology label, which we had expected to get. So far, we're not on track with that. We need to get more access. Right now, we're in about the mid 30s in terms of unrestricted access, most of which still has a step through generic -- I mean, oral antibiotics. So we need to turn that around, and we need to gain more access. If we do not see that happen in the next couple of years, then we'll probably reach roughly half of what we had as the original peak sales. However, we're also looking at bringing the product to China, which will maybe help offset a little bit of that downside. Now if we can get access increased and we can really get the traction on the label, we will see being able to get closer to those original peak sales. So I think the next 18 months are going to be really critical for Seysara to tell where this product is going to go in the long term. And part of the reason why we weren't able to get additional access traction in 2020 is that with all of the COVID impacts across the health care system, the payers really just didn't see the acne market as a priority. And we've got to do a better job of turning that around. But it's really on us to execute now. So that's kind of the range of where we could see Seysara in the U.S. ending up. Too early to give you a precise number on China, but we think there could be quite a good opportunity there if we can get it through the Phase III clinical trial. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- Your next question comes from the line of Trung Huynh from Crédit Suisse. -------------------------------------------------------------------------------- Trung Chuong Huynh, Crédit Suisse AG, Research Division - Research Analyst [25] -------------------------------------------------------------------------------- I Have a few left. On Wynzora, can you perhaps talk about the peak sales that you have for this product, and the margin that you can get on it and how quick you're able to grow these sales? And then on Klisyri, can you talk about the level of sampling that you have for it? If it's a tube for 5 days application period, how do you give some away for free? And then on the tax rate, for 2020, it was 5%, somewhat flattered by the U.S. tax credits you mentioned. What's your expectations for the tax rate in '21? Do you have any more of those U.S. tax credits available? And then finally, the big readout for this year is lebri. Can you perhaps talk about the level of disclosure that we should expect for the headline data when that comes out? Should we see the EASI-75, IGA 0, 1 and 0 at week 16? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [26] -------------------------------------------------------------------------------- Okay. Thanks, Trung, let me try to go through these, and I may get some of my colleagues to help me on the fourth one. Wynzora, we're very excited about the product, as I mentioned in the slides. We're not giving individual peak sales for the product. But we think the addition of this to that psoriasis franchise will take it from a EUR 250 million peak sales opportunity to EUR 300 million , which is Ilumetri, Skilarence, and now the new product, Wynzora. So how quickly we can ramp that up will just depend on how fast we can get the approval and the reimbursement. But we see this as a very exciting product, and we'd like to get it into the double digits next year. And then on its way to a peak sales within a 4 to 5-year period. So very exciting opportunity for us. When it comes to Klisyri in the U.S., the sample is pretty straightforward because it's actually a 5-sachet package as the treatment. So it's not 1 tube. So you are able to give individual sachets in a 2-sachet packet as a sample. And we think it's going to be very important to get this product out there as sample because the tolerability and the less side effect profile will be a very big selling point for both patients and the physicians. Number three, tax rate, yes, we had a lower tax rate because of the U.S. loss carrybacks. We don't expect that opportunity to pop up again because it was partially related to the COVID measures the U.S. government put into place. But I would expect the tax rate in 2021 to normalize more in line with what we saw in 2019. So it should be a normal tax rate year in 2021. And then last with lebri, I'll turn to my colleague, Volker, to maybe give you a little bit more detail on that one. -------------------------------------------------------------------------------- Volker Koscielny, Almirall, S.A. - Chief Medical Officer & Member of Management Board [27] -------------------------------------------------------------------------------- Yes. Thanks for the question. No. As you rightly stated, I mean, it's the conventional outcomes. Really, it's an IGA score of 0 and 1 at week of 16. It's an EASI-75, so a 75% reduction in EASI score is primary outcome measurements, but then importantly, really. And as I previously mentioned, I think we're particularly interested in each in pruritus. So you have a numerical rating scale reduction from baseline. You have pruritus inner risk score of more than 4-point reduction. And linked to that, again, importantly, measurements of sleep loss. So I think we will get a very comprehensive idea of the clinical value of the therapy. -------------------------------------------------------------------------------- Alvaro Lenze Julia, Alantra Equities Sociedad de Valores, S.A., Research Division - Research Analyst [28] -------------------------------------------------------------------------------- And can I just clarify the comment on the sampling for Klisyri? So if you get 2 sachets for free, then the patient would -- or payer would have to then buy a further 3. Is that the case? -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [29] -------------------------------------------------------------------------------- I think they would just have to get a script for the full package. So I think it's still kind of a work in process with sampling. So we'll try to update you as we get a little bit more clarity of exactly how that's going to work with transition from the samples onto the full prescription. -------------------------------------------------------------------------------- Operator [30] -------------------------------------------------------------------------------- (Operator Instructions) Your next question comes from the line of Jaime Escribano from Banco Santander. -------------------------------------------------------------------------------- Jaime Escribano, Grupo Santander, Research Division - Equity Analyst [31] -------------------------------------------------------------------------------- So I'm -- regarding the guidance for 2021, maybe you can help us to reconcile a little bit with company gathered consensus at EUR 250 million EBITDA. So you are guiding around EUR 225 million, you mentioned about SG&A, but maybe you can tell us as well on R&D, what should we expect and also, where do you think the consensus maybe is high in terms of sales so that we can model this better? And yes, mainly, this is the question. -------------------------------------------------------------------------------- Michael McClellan, Almirall, S.A. - Executive VP of Finance, CFO & Member of Management Board [32] -------------------------------------------------------------------------------- Thanks, Jaime. I think if we look at the consensus versus ours, I think there's a couple of different areas. When it comes to sales, I think the effect of COVID on the other portfolio, which is the OTC in Spain, our allergy portfolio, the Ebastel and a few others, I don't know if that was fully really understood that those would be declining as well as the non-focused products in the U.S., the legacy portfolio, plus some of the ones that we'd acquired in the Allergan transaction like Tazorac like Cordran Tape. Everything has kind of suffered from COVID. So I think if I look at that across all those baskets, that's probably a EUR 15 million to EUR 20 million sales miss versus the consensus just based on what we're seeing the trends in the 2021 with COVID. In addition, I think we're going to invest a little bit more in SG&A than the consensus. And part of that is the new product we announced last week. I don't think that would have been in the consensus clearly. And the need to invest in Klisyri to ramp up France for Ilumetri, and a few other rebounds in the second half to a more normal activity, I think is probably a little bit more than the consensus was expecting on the SG&A. For R&D, I would expect us to bounce back a little bit in terms of spending, and that will be really dependent on how the portfolio develops. But I would see R&D coming back a little bit more towards the 2019 figure. And then overall, I think there's been a little bit probably over ambitious numbers for Seysara in the consensus versus the reality we're seeing in terms of the access we've had to date. So we're going to do everything we can to grow the product, but I think there was a little bit higher expectations externally. I hope that's been helpful. -------------------------------------------------------------------------------- Jaime Escribano, Grupo Santander, Research Division - Equity Analyst [33] -------------------------------------------------------------------------------- Yes, very helpful. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- We have no further questions. I would now like to hand the conference back to Pablo Divasson for the closing comments. -------------------------------------------------------------------------------- Pablo Divasson del Fraile, Almirall, S.A. - Head of IR & Corporate External Communication [35] -------------------------------------------------------------------------------- Thank you, Joana. We are now going to close our Q&A session. And with this, we will complete our conference today. We want to thank you for your participation. You may now disconnect.