Recordati Industria Chimica e Farmaceutica S.p.A. (REC) Earnings Call Transcript & Summary
February 22, 2021
Earnings Call Speaker Segments
Operator
operatorGood afternoon. This is the Chorus Call conference operator. Welcome, and thank you for joining the Recordati Preliminary Full Year 2020 Results Conference Call. [Operator Instructions] At this time, I would like to turn the conference over to Ms. Federica de Medici, Investor Relations and Corporate Communications. Please go ahead, madam.
Federica De Medici
executiveThank you very much. Good morning, good afternoon, everyone, and thank you for attending the Recordati conference call today. I am pleased to be here on this call by our CEO, Andrea Recordati; and Luigi La Corte, our CFO, that will be presenting our 2020 preliminary full year results and '21 target. They will be running you through the presentation. As usual, the second slide is available on our website under the Investors section. After that, we will open up for Q&A. And I will now leave the floor to Andrea. Please go ahead.
Andrea Recordati
executiveThank you, Federica. Good afternoon, ladies and gentlemen, and thank you for joining our 2020 results -- preliminary results conference call and the '21 targets conference call. So I would like to start by saying that I think that Recordati has delivered a resilient performance despite a challenging condition in an unprecedented environment. The revenue is slightly down by 2.2% versus the previous year and/or 0.4% up at constant exchange rates. In 2020, our group faced and successfully overcome various challenges, some of which were expected, such as a loss of the marketing exclusivity for 2 corporate products and the entry of a new drug competing with Panhematin in the U.S. whilst others emerged during the year at the onset of the COVID-19 pandemic. The decline in the specialty care and primary care reflects a loss of exclusivity of silodosin in quarter 1 and pitavastatin in quarter 3. Strong FX headwinds, especially on the Turkish lira and the ruble -- Russian ruble, and COVID-19, a second key market segment, particularly on the cough and cold and products linked to hospital procedures and more discretional items with product for chronic therapies holding up better, as you will see in more detail later in the call. The [global] activities dedicated to the treatment of rare diseases was strong, recording an increase of 27.9%. Now this business segment represents 22% of total revenues. Signifor and Signifor LAR reported double-digit in market growth, and we're very happy with Isturisa's launch uptake to date and the initial 12 million sales we booked in 2020. The U.S. business was further strengthened with strong initial uptake of Cystadrops following its launch in Q4 and also with the Carbaglu indication for organic acidemia, which was approved by the FDA in January 2021. Despite pressure on top line, we were able to deliver solid operating performance. EBITDA growth was up 4.7% to EUR 569.3 million or 39.3% of sales, significantly above last year. Adjusted net income at EUR 410.4 million, which was up 7.3% versus 2019 and equals 28.3% of sales from the 25.8% last year. The group continues to deliver a strong cash generation of around EUR 360 million before milestones, net share purchases and dividends distributed. We have also further reinforced our portfolio, specifically in support of our specialty and primary care business through new licensing agreement. The license agreement with ARS Pharmaceuticals for ARS-1 is such an example, and also, obviously, the late -- just announced agreement for the licensing of Eligard, in Europe, Turkey, Russia and other countries from Tolmar. Before handing over to Luigi La Corte, who will provide more detail on our financial performance, let me provide some more updates on our endocrinology portfolio and some details on the Eligard agreement. So please switch to the next page. So regarding the endocrinology franchise, the commercialization of Signifor and Signifor LAR is on track, recording net revenue of EUR 67 million. The transfer of distribution from Novartis is now completed. Major [EU] market [M&A] transfers were completed during June and July, and the smaller CEE market that took place in Q4 of last year. We have new patient acquisitions across all approved indications, and Signifor grew double digits in in-market sales compared to 2019. Moving to Isturisa. The launch sequence was successfully initiated in the U.S. and parts of EU, despite the many challenges posed by the COVID-19 pandemic, which we can surely appreciate has quite an impact on the uptake of a launch product. We are satisfied with the early performance of Isturisa in this market, which is in line with our expectations, contributing net revenues of around EUR 12 million, mainly in the U.S. and France. We have strong support from top KOLs and patient organizations. The regulatory process started in March with a new drug application in Japan is on track, and we are expecting to launch in the second half of 2021. Based on what we see so far, we confirm our longer-term focus for Isturisa. Therefore, to achieve a leading market share with peak year sales estimated between EUR 300 million and EUR 350 million, and potential further upside from the expansion of indication to Cushing's syndrome in the U.S. and through our geo expansion strategy in new territories. Now let's move to our latest business development deal finalized in January 2021 with Tolmar International Ltd. Last month, we announced the closing of a license supply agreement with Tolmar International Ltd to commercialize Eligard, leuprorelin acetate, in Europe, Turkey, Russia and other countries. Eligard is a marketed medicinal product for the treatment of hormone dependent advanced prostate cancer. The agreement provides us with a new product that strengthens our presence in the urological area and fits very well with our geographical footprint. Eligard is a very well-established medication in a slightly growing market, which is worth about EUR 1 billion, according to IMS in Europe referring to 2019 sales, half of which is represented by leuprorelin-based products. Among this product category, Eligard has around 20% market share. Annual revenues in recent years were around EUR 100 million. Under the terms of the agreement, we will have economic benefits from the 1st of January 2021. Reported net revenue in 2021 will depend on the exact timing of transfer of sales and distribution market by market. So for our estimation for 2021, net revenue is around above EUR 70 million with an EBITDA contribution of around EUR 20 million. We paid an upfront cash consideration of EUR 35 million plus milestones up to a total of EUR 105 million plus royalties on sales. Milestones are linked to a submission of regulatory filing and subsequent approval of a new device, which would be easier to handle and is currently under development. EUR 35 million, first regulatory milestones is expected in Q4 2021 linked to the regulatory evaluation, which is expected to be submitted by the 31st of October 2021. So this -- at this point, I will leave the floor to Luigi to take you through in more detail on our 2020 results. Thank you.
Luigi Felice Corte
executiveSo thank you, Andrea, and good morning, good afternoon, everyone. So I'll start as usual by giving a little bit more granularity on our sales performance and starting with sales of our key corporate products, which represents 69% of revenue. Zanidip, which currently remains our biggest products with EUR 134.6 million of revenue in 2020. We finished the year flat, marginally ahead of 2019 with growth in -- across several markets, but notably in Italy, Germany, Poland and Russia, offset by erosion in France due to new measures introduced at the beginning of 2020, famous Article 66, which we have mentioned a few times over past quarters and also due to the effect of currency changes, particularly impacting Turkey and international markets; 40% roughly of Zanidip sales are to our international affiliates. The Article 66 measures in France also accounted for most of the decline in the combination product Zanipress, which, again, is declining by close to 18% for the year. Our metoprolol franchise, which is now our second biggest franchise for the group grew nicely at 7.5% with total revenue of EUR 105.7 million, with broad-based growth, particularly in -- particularly strong in Central and Eastern Europe, and particularly in those markets, where we have set up a direct selling organization most recently. Urorec reflects clearly the impact of loss of exclusivity. You'll recall generic entered majority of markets in February of 2020, impacting, particularly revenue in Italy, Spain, Portugal and Germany. In fact, in most of markets, our Urorec sales held up better than expected. In fact, erosion was somewhat lower than we anticipated at the beginning of the year. Some of that, unfortunately, offset by, again, measures favoring dispensing of generics in France issued in early 2020. Notably, Urorec continues to grow in markets where generics have not entered, Turkey, Greece and Switzerland, in particular. Similarly Livazo, revenue down by 1.8% at close to EUR 53 million, reflects loss of exclusivity starting in August, which offset the growth that we saw in the first part of the year for pitavastatin. Again, here, the product is still growing in markets where generics -- we don't expect generics, mainly Turkey, Greece and Switzerland. Other corporate products of EUR 270 million roughly is where, as we commented in previous calls, we saw the brunt of the impact of the COVID-19 restrictions. Other corporate products include OTC, as you will recall. And here, we've seen and we commented before a significant impact in our cough and cold franchises, which is particularly strong in Russia and other markets in Central and Eastern Europe, impacting sales of Isofra and Polydexa and equally pandemic restrictions also impacting the sales of anti-infective products in general. In many cases across Europe, we saw restrictions and reduction -- significant reductions in elective hospital procedures, which impacted sales of CitraFleet and Enema Casen in Spain and Portugal. And generally, a lower consumption of over-the-counter drugs and more discretionary medications. Within corporate products, as you note, the good growth of Reagila, up more than 60% versus previous year. And growth also of some of our key products within OTC, Procto-Glyvenol and Casenlax in particular. Finally, drugs for rare diseases were up significantly, with growth of close to 28%. They now represent close to 22% of revenue. Majority of the growth being driven clearly by our endocrinology franchise and Signifor, in particular, which added EUR 57 million to revenue, which was already recorded in Q4 of last year, and Isturisa contributed, as Andrea mentioned, EUR 12 million of revenue. Noteworthy, we saw growth during the year also on Carbaglu, Cystagon, Cystadrops, Ledaga and Juxtapid so amongst the several of our product franchises, which offset the erosion in the U.S. on PANHEMATIN following the launch of a competitor. We're pleased to see that following a somewhat sharper than expected decline over the April to June months at the peak of the restrictions, we have seen sales stabilize, and with a degree of erosion which is now more in line with our expectations as patients flow readjusted to the COVID restrictions. So then on the next slide, on Slide 6, you'll see as we also show the composition of our portfolio. As I commented, rare diseases now represents 22% of group revenue, up from 16.9% in 2019. OTC is slightly down to 18.1% from 18.6% in '19. And the incidence of local product portfolios also continued reducing and is now under 16% from 17% in 2019. Switching to Slide 7 and looking at revenues for key geographies. The picture is very much consistent with one that we commented in the last quarter and illustrates the differential impact that the pandemic has had on different parts of the portfolio and, therefore, also different markets. Sales in Italy were down close to 5%, reflecting generic erosion on pantoprazole and lanso, which started in the second half of 2019, but also the loss of exclusivity of Urorec and lower market levels for some of our OTC products, and REUFLOR we did see in Italy strong performance and growth of more chronic medications, namely Cardicor, Zanidip and of Reagila and also clearly a strong contribution of the rare disease portfolio, offsetting some of those pressures from the COVID restrictions. France, down by 8.4%, and this was one of the painful notes of 2020, as we commented throughout the year with measures introduced in January of 2020, which favored the dispensing of generic medicines. This impacted both our lercanidipine and combination sales and particularly impacted Urorec revenue upon generic entry where erosion was higher than expected. All of this partly offset by with what we saw being a very strong growth of the diseases and also of the local methadone franchise. Germany, revenue held up better at minus 2.1%, with most of the decline actually being due to generic competition on tenders of Ortoton with good growth in Germany, once again from the addition of Signifor and also initial sales of Isturisa, which is off to a really strong start in Germany. U.S., revenue up by 14% in local currency or 11.8% on a reported basis at EUR 122.5 million. We did see a strengthening of the euro against the dollar in the back part of the year. Growth, as we have commented, mostly driven by the endocrinology franchise, but also good growth of Carbaglu and Cystadrops, following its launch in the later part of the year. Once again, all of those more than offsetting the erosion on PANHEMATIN. Russia, other CIS and Ukraine, revenue of just over EUR 100 million. These markets really saw an impact -- combined impact of both of the COVID restrictions on the cough and cold portfolio, but also of FX, with FX impact in Russia, in particular, of 11.7%, which led to -- accounted for a significant part of the decline in the reported figures there. Sales in Russia, as I said before, have a significant incidence of cough and cold medications and medications for acute conditions, which were amongst the most impacted by the pandemic. We did see in the market, double-digit growth in local currency on Procto-Glyvenol, Alfavit, Zanidip, Urorec and Livazo, which partly offset that. Revenue in smaller Central Eastern European markets and other Western European markets both grew by double digits, driven by the strong growth of metoprolol, particularly in Poland, Czech, Baltics and Romania, but also good growth of Livazo and Reagila in Switzerland and the Nordics, and of course, here again, the contribution of rare diseases. Revenue in Spain down by 11.5% to just under EUR 84 million. Spain reflecting both the loss of exclusivity of silodosin and pitavastatin, but also, as I said, a significant impact from hospital procedures being put on hold for a large part of the year, which impacted sales of CitraFleet, which is one of our biggest franchises in the market and used for endoscopies and Enema Casen, and also softer market for pediatrics and probiotics products. Turkey continued to grow double-digit in local currency terms with local growth of 11.6%, but reflects a staggering 23% headroom in terms of foreign exchange with significant erosion and decline of the Turkish lira over the course of the year. Growth of the Turkish business was broad-based and really driven both by our corporate products and also the local product portfolio. Portugal revenue of EUR 42.7 million, down by 3.9%, reflects very similar dynamics to the ones I mentioned for the Spanish market, with good growth of Reagila both in the case of Portugal and Spain, partially offsetting the pressures from the loss of exclusivity on silodosin and pitavastatin. North Africa sales up by 2.3%, reflecting -- actually slightly down versus double-digit growth in the first part of the year, reflecting a bit of weakness of the currency against the euro in the later part of the year and also some restrictions to exports to some markets in North Africa in Q4. And finally, other international sales of just over EUR 200 million, broadly flat with 2019 with growth of rare diseases, in particular EMEA and Mexico, offset by the impact of foreign currency weakness against the euro and also some discontinuation of licenses for markets where we've taken back distribution of our products over the course of 2019. On Slide 8, once again the composition of revenue by key geographies, very much unchanged, very similar to the snapshot last year. And just confirming the diversified footprint of the group, which, we believe, this year allowed us to put -- to deliver the kind of solid and resilient performance that Andrea alluded to, with revenues slightly down to plus 0.4% at a constant exchange rate basis. Switching over to Slide 9 and looking at the P&L. The slight decline on the revenue line is, as you see, almost fully offset already at the gross profit level, thanks to improvement in gross margin to 71.9% of sales, driven mostly by the shift in mix of our portfolio towards rare diseases. SG&A at EUR 421.9 million is down versus '19, reflecting the lower level of activity spend in the face of COVID. We estimate we had roughly EUR 35 million of savings which we achieved this year versus 2019 in -- to offset the impact on the top line, particularly in selling cost, which are around 24.1% of sales. The G&A expenditure of 5% of sales, broadly flat with 2019. R&D expenses are up by 12.8% at 10% -- just over 10% of revenue, with the majority of the increase being driven by the additional amortization charges arising from the new products that we acquired from the markets and also some of the studies that we inherited. We do expect R&D expense as a percent of revenue to stay broadly at this level as we go into 2021. Other expenses of EUR 4.9 million reflect mostly the nonrecurring costs of roughly EUR 6 million, which we had in 2020 being mostly the COVID-19 related [donations]. It also includes EUR 0.5 million of nonrecurring costs are linked to the reverse merger transaction, which we announced earlier in the year. That leads to an operating income of EUR 469 million, 32.4%, and slightly above our prior year. And EBITDA of EUR 569.3 million or 39.3% of sales, up 4.7% versus 2019, which, once again, we believe, is a very strong performance in a challenging environment, and as we've commented in the past, the difference in growth rates between EBITDA and operating income being driven by the increased amortization year-on-year, and also the nonrecurring costs, which are adjusted EBITDA, but not at an operating income level. Net income of EUR 355 million, down 3.8%. That reduction really due to the exceptional or nonrecurring benefit of -- tax benefit of EUR 27 million, related to patent box linked to prior years, which was recorded at the end of 2019. We did have a small positive nonrecurring tax item of EUR 2 million in 2020. Adjusting for these, growth of net income would be 3.2%. And adjusted net income at EUR 410 million is up 7.3% relative to 2019. This is on the back of the strong operating performance, but also thanks to lower financing charges. And this is -- whilst currency movements did put, particularly in the back end of the year, a bit of pressures on our operating margins, but they did have a positive impact, which is accounted for in financial expenses, due principally to the positive impact of these add-on transactions no longer treated as hedges, which we recorded in the first half of the year and which were closed in April, and also to some exchange rate gains on certain of currency transactions. Switching to Slide 10. Clearly, rare diseases account for a growing share of both revenue and operating results. Over 25% of both EBIT and EBITDA is contributed from our rare disease business with margins clearly in 2020 reflecting also a little bit the launch investments behind Isturisa. And noteworthy though, specialty and primary care business despite the LOEs and COVID impact delivered on an absolute basis, operating results which were almost in line with 2019, which, again -- once again, we believe, is a very resilient and solid performance. Last from my side, net financial position with net debt, on Slide 11. Net debt of just under EUR 866 million, down versus EUR 902.7 million at the end of '19. This equates to roughly 1.5x EBITDA, which is in line with where we said we would be in our planned assumptions and really reflects the strong underlying cash flow performance of the group. Over the course of 2020, we paid USD 90 million of milestones to Novartis for the endo franchise transaction, EUR 50 million to ARS Pharmaceuticals for the rights to ARS-1, dividend of EUR 212.5 million and have the net share repurchases of EUR 12.2 million with, therefore, an underlying cash generation of EUR 360 million approximately, which remains in line with our track record of delivering cash of roughly 100% of net income. And with that, I will hand over to Andrea to talk about the expectations for 2021.
Andrea Recordati
executiveThank you very much, Luigi. So if you please turn to Page 12 of the presentation. So the assumptions behind our '21 targets are summarized in the slide. Regarding the 2021 guidance, assuming that -- and this is very important, assuming a gradual recovery of our reference markets after the COVID-19, we expect this to occur in the second half of 2021. So we still expect, obviously, some degree of uncertainty and volatility in the markets until the end of the first half. And obviously, also despite the continued FX headwind of roughly minus 2%, we expect to achieve net revenue growth of 10% in 2021. Our key assumptions are the following. So specialty and primary care returning to low single-digit organic growth, following silodosin and pitavastatin loss of exclusivity in 2020 and an assumed return to more normal market conditions, like I said, in the second half of the year. Of course, please keep in mind that the Q1 of 2020 was mostly free of COVID impact. And in fact, reflected overstocking by wholesalers and was only partially affected by the loss of exclusivity impact on silodosin. We expect Eligard revenues of around EUR 70 million or over EUR 70 million, I should say, subject to the exact timing of in-market distribution as already highlighted. High double-digit growth of the rare disease business, driven by continued strong uptake of the endo franchise. Signifor and Isturisa net revenue is expected to be around EUR 120 million to EUR 140 million for the year with further growth also coming from Cystadrops, Ledaga, Juxtapid offsetting the Panhematin decline in the U.S. We expect R&D costs to remain around 10% of revenue, reflecting the incremental [payment sales] to support the endo franchise and the amortization charges related to the recent asset acquisitions. Assuming partial normalization of activities post COVID-19, EBITDA margin will be above 38%, reflecting as well the transition costs on Eligard. Financing costs of around EUR 22 million to EUR 24 million are expected with no FX gains/losses assumed on this item. Tax rate to be around 20%, reflecting also EUR 12.9 million of nonrecurring ACE benefit from the reverse merger transaction. To be noted that no new undisclosed acquisitions or business development initiatives are included in our 2021 targets. And last but not least, dividend payout policy is confirmed at 60% of total net income. Please switch to the last slide of the presentation, Slide 13, which sums up the 2021 targets. So we expect to have revenues ranging from EUR 1.570 billion to EUR 1.620 billion, EBITDA in a range that goes from EUR 600 million to EUR 620 million and adjusted net income of between EUR 420 million and EUR 440 million. As previously mentioned, we also plan to provide an update to our 3-year business plan in May. So this brings us to the end of our presentation, and I think we can at this point move to the Q&A. Thank you.
Federica De Medici
executiveOperator, we are now ready to take questions.
Operator
operator[Operator Instructions] The first question is from James Vane-Tempest from Jefferies.
James Vane-Tempest
analystI'll start off with two, and I have a follow-up, if I may. Just on the guidance, the consolidated guidance. The organic growth of around 10%. Thank you for the detail on the slide, but I'm just curious, what does this assume for Livazo and Urorec? So these are losing -- are these losing exclusivity this year? And then second is just on EBITDA guidance. At least sort of looking what this might be ex the Eligard and Isturisa, is it basically declining to flat in 2021? And if so, what's driving that?
Luigi Felice Corte
executiveJames, so thanks for the question. So first of all, just to be clear, the overall revenue growth, which is quoted on Slide 12 of 10% is the total revenue growth, which does reflect the 2% FX. You will see underneath it, we also mentioned the Eligard revenue. So just to be clear, overall revenue growth of around 10% is the total growth, and it's consistent with the range that we've provided for total revenue. You asked about silodosin and pitavastatin further erosion next year. We assume an extra EUR 10 million for both with silodosin, obviously, being a larger product, but having gone generic in the early part of the year. With regards to Eligard, we are expecting an EBITDA contribution this year of around EUR 20 million, which reflects this being first year also some transition costs. I'm not going to give sort of a detailed EBITDA number for endo. So hopefully, that gives at least sort of answer to most of your questions.
James Vane-Tempest
analystAnd then just a follow-up, the EUR 35 million of SG&A savings from COVID. How much of that is expected to return as normal activities renew? And does your guidance assume any further price erosion in Europe, please?
Andrea Recordati
executiveI'll answer this one, James. So we expect basically 50% of operational savings that we delivered in 2020, that will be retained in 2021, approximately.
Operator
operatorThe next question is from Martino De Ambroggi with Equita.
Martino De Ambroggi
analystMy first question is on the R&D. Because in 2020, was 10% of sales, mainly because of lower sales. So I suppose the total amount was more or less in line with your expectation. You are guiding for another 10% in 2021, which is a quite high level compared to the past few years. Never achieved 10% for many, many years. So should we take this as a normal level going forward? Or is it because of specific studies you are financing right now?
Luigi Felice Corte
executiveYes. Thanks for the question, Martino. I mean, the growth also in 2021 will be in part, the additional amortization that comes from the Eligard deal. We're assuming a 20-year sort of amortization and assuming that in both the upfront and additional milestone, which will be paid, we assume, over the course of 2021 with a little bit of additional investment behind the endo franchise but the majority really is the amortization, which is doing that. But again, the forecast is for it to remain sort of flat in terms of percent of revenue. There is a little bit of studies, as we said, that will be continuing on the endo portfolio as well. And we do have some of our programs, which are progressing [indiscernible] in particular. But again, the majority of it is amortization increase.
Martino De Ambroggi
analystOkay. So we can take 10% as an indication also going forward or is probably declining?
Luigi Felice Corte
executiveWe haven't sort of -- we're not providing for an updated plan today. But I mean it will depend a little bit also on the type of deal that we may do in the future, as always, which is -- and would they come with significant -- if it were to be an M&A transaction with a significant part of the purchase price allocated to goodwill, we won't have any amortization. We won't have any kind of increase in R&D. If it's intangible, specific assets then -- which is why we sort of kind of shifted the emphasis on EBITDA and adjusted net income, which adjusts for amortization, if that makes sense.
Martino De Ambroggi
analystOkay. The second question is on the 2021 guidance. In the past, you provided the guidance, including acquisitions. I know I'm not asking you anything because it's impossible to predict. But do you feel confident to reiterate the guidance, including acquisitions? Because I ask you -- because last year, I remember the M&A processes were a little bit slowed down because of the COVID pandemic and so on. So probably, I don't know, maybe you are more confident today in either new license drugs or acquisitions. So just your feeling.
Andrea Recordati
executiveWell, I mean, I will answer this. I mean in 2020, we delivered on the acquisition side because, as you know, acquisitions are essential in business development, obviously, I'm talking about Eligard, which is a substantial business development initiative for Recordati and ended up reinforcing our SPC business. There was a slowdown, but we did not perceive such a slowdown in 2020 due to the COVID pandemic, honestly. So things on the business development, M&A kind of front did progress. We looked at various opportunities, but clearly not all opportunities pan out for a variety of reasons and they're all different from one another. We don't give guidance in our yearly targets. We give guidance in our 3-year planned targets. And we've always done this in the past, and we will keep on doing this. So obviously, we will be building some sort of objective on the M&A target in our business plan, which we'll present in May. Clearly, we have -- we continue scouting, and we have actually very kind of focused and intensive scouting activity, both in SPC and rare diseases. And honestly, we're not seeing any shortage of opportunities. So obviously, the objective is to deliver also this year. But as I said, you cannot kind of celebrate until you have the cat in the bag. So we'll give some more outlook on this in the 3-year plan.
Luigi Felice Corte
executiveSorry, 1 follow-up. I sort of just realized I hadn't fully addressed. I think there was a third element to earlier question from James around profit evolution as implied in the guidance for 2021 ex the Eligard portion. Let's -- just to not forget in the context, we are still factoring in, in our guidance, a 2% headwind of FX versus 2.6% of this year. We are anticipating, and I think this is consistent across the sector, COVID still to impact, to some extent, the first half of the year. And obviously, as I said, the sort of detail of the loss of exclusivity impact on silodosin and pitavastatin. So clearly, there's still a little bit of [ headwind ] from that as we go into 2021.
Andrea Recordati
executiveOperator, next question?
Martino De Ambroggi
analystIf I may, am I still online? No? Hello?
Andrea Recordati
executiveYes, you are.
Martino De Ambroggi
analystOkay. Sorry, just the very last question on Signifor, Isturisa. Could you provide the split between the 2 like last year? And just to understand that Japan will be launched in the second half, but probably this year, it doesn't represent a significant contribution. And for Eligard, is it possible to have a peak sales potential or EUR 100 million is the reference point for the long term?
Andrea Recordati
executiveOkay. Let me answer this. Regarding the first question of a split of our guidance of EUR 120 million to EUR 140 million for the endo franchise. We will not be providing the product split for the 2021 estimate. We have given a split of the 2020 results and an indication of the 2020 growth rates we have seen so far on Signifor with the sales achieved in 2019. Clearly, we also -- it's important to say that we also expect Isturisa to account for a significant part of the growth in 2021. Japan, yes, obviously, as you correctly said, it's not going to be a major contributor in 2021. So no, I will reconfirm that. And regarding Eligard, just for the moment, I think we will confirm that the EUR 100 million sales -- full year sales that we mentioned before, starting from 2022.
Operator
operatorThe next question is from KC Arikatla from Goldman Sachs.
Krishna Arikatla
analystI have a few modeling ones, please, and 1 big picture question. On the modeling ones, if -- is the EUR 13 million tax benefit, the nonrecurring one that you have mentioned, will -- is that part of your adjusted net income guidance or not, please? And second one, if I look at the M&A environment and the appetite from your side to do M&A, is it fair to say that we can expect some M&A in this year beyond what you have announced? Or is that not likely to be the case? And the third one on Eligard. You've mentioned EUR 70 million in sales and EUR 20 million in EBITDA. Assuming you get the marketing rights all transferred, that becomes EUR 100 million in sales. What would be the right EBITDA number, please? Is that still EUR 20 million?
Luigi Felice Corte
executiveKC, thanks for the question. So first of all, in terms of adjusted net income guidance. So to be clear, the EUR 27 million nonrecurring one-off was a 2019 item, just to be clear. We have included it in our guidance or in fact, as you know, adjusted net income is -- does not include the nonrecurring items. So we've mentioned -- we've mentioned it could have -- we have reminded you of the nonrecurring benefit from the reverse merger, so that if you're wanting to model net income, you know that we have that additional benefit, which doesn't go into adjusted net income. So again, the EUR 12.9 million nonrecurring benefit, tax benefit from the reverse merger, would not be included because it would be adjusted in the guidance that we have provided. On -- I think the Eligard one, expectations on EBITDA thereafter, I think you should model on the basis of a normal sort of SPC level margins, whether or not how quickly we get to that, whether that's already 2022, we'll see, and we'll provide an update when we do the 3-year plan. But the number that we're quoting for this year is very much reflective of transition. And for M&A, in terms of expectations, for this year, I mean, all I can say is M&A remains an integral part of the...
Andrea Recordati
executiveI replied to that question before. I mean, it remains an integral part of our business development activity and growth strategy. As I said, there's no shortage of opportunities that we're seeing. But again, until they materialize, it's difficult to make any projections. And we're not going to give -- like we've never given targets for M&A for 1-year target. We will give you an outlook on what we expect for the 3-year plan.
Luigi Felice Corte
executiveAnd so just to be clear, the targets we've read out do not include further M&As in that.
Andrea Recordati
executiveThat was mentioned in the presentation.
Operator
operatorNext question is from Jo Walton with Crédit Suisse.
Jo Walton
analystJust a few, please. On Isturisa, you've told us that you're off to a great start in Germany. I wonder if you could just help us with the landscape in the rest of Europe. Where you've got pricing, where you've got reimbursement, whether that reimbursement level that you're getting in other countries is coming in at the same level? I mean, in Germany, you can sort of choose your level currently for at least a year or so. So just give us a little bit more of the flavor of the landscape, please, for Isturisa in Europe. Second question would be the trough level that we could get down to for Livazo and Urorec. Now I know they're not your products, like Zanidip but Zanidip, years past patent expiry, is still an incredibly important driver for you. I'm just wondering whether the EUR 10 million of erosion that you talk about for this year is where new countries are getting some generics or whether you feel that has continued erosion? I'm just trying to get at the sort of level that we should be thinking of going forward with the level of support. And I'm thinking particularly because you did so well with Seloken up 8% again, is Seloken now do you think at a stable level? Or do you think that you'll be able to get some further growth from that product as you move it into some of your more peripheral markets? And my final question would be about the savings. Actually now, I've got 2 more, I apologize. The savings from COVID, you talk about EUR 35 million of marketing savings. How quickly do you think that you will come back to spend that again? I assume, not in 2021 because you told us that COVID will keep going for at least part of the year. But if we were to look further out and given the fact that you've got new more specialist products coming through, do you think we should be ramping up our SG&A? And my final question is a big picture question. You talked about the new measures that came in in France last year, which eroded some of your products more than you expected because the minute there was a patent expiry, it went to full genericization. Given that European governments are going to be short of cash post COVID, are there any other markets where you have any visibility of the same sort of, let's use a true generic rather than a branded generic coming in that we might have to think about?
Luigi Felice Corte
executiveOkay. Thank you, Jo. I'll do my best. A lot of questions there. So I'll start with the last one because it's a relatively straightforward one. No, we're not foreseeing sort of significant new measures being introduced across Europe as a result of the pandemic. Yes, governments are facing significant budget deficits. But one, at least from our sort of vantage point, they don't seem in a hurry necessarily to claw those back. And hopefully, they are working on a number of fronts in partnership with the pharmaceutical industry. And I think they've realized also the importance of a well-funded health care system. So I think I've mentioned in prior calls, mentioned a number of anecdotes where we see actually things going at the opposite way. So of course, it can happen, and it does happen from time to time, and that has been the history of the sector over the last 10 years. But we're not anticipating at this stage very significant pricing pressure or new generic measures across key markets. Isturisa and how it's going in Europe. First of all, my apology, I probably -- I put the emphasis on Germany. And of course, we're on track in Germany as well. France is right now the market where the launch is most advanced across Europe, and that's on the back of the strong, early access program that was in place in the country, that also benefits from a more centralized management of these patients. But for -- so both France and Germany is where we're seeing a strong initial adoption. We are anticipating Isturisa to gain endorsement in a number of European markets over the course of the year, but it will be later in the year. Currently, let's say, we are still in negotiation -- pricing negotiation discussions across in France and in Italy. Germany, as you mentioned, we're allowed to launch at our sort of set price and then initiating negotiations 1 year post. So that's still all to play out, frankly. I mean, all I can say to that is that the product, as Andrea mentioned, has strong endorsement from KOLs. It has a strong endorsement from the European authorities themselves when confirming the orphan drug status. So we have no reason to believe we will not be getting the kind of recognition of the value of Isturisa that we think the product deserves. Livazo and Urorec, just to be clear, sort of when I said EUR 10 million sort of further erosion, that was EUR 10 million on each of the 2, and that's really just due to it being a full year impact more than anything. In fact, we've started to see in markets where sort of generics have entered, for example, in the case of Urorec in February, early March of 2020, we have started to see volumes stabilize. So I think those are more sort of full year effects rather than the reflection of significant further erosion to come on a market-by-market basis. Seloken was a good growth driver, strong growth driver this year. We do still see opportunity for growth, as I said, particularly in those markets, Central and Eastern Europe, Nordics, Baltics, where we've set up our own direct-selling operations more recently. I won't provide a sort of exact sort of number for that. But certainly, we do see an opportunity there. And I think in terms of the savings on COVID, I think we've been quite consistent actually over the course of 2020 to signal that not 100% of the savings that we will be able to retain. But certainly, some we think are potentially here to stay. I think inevitably, we all are in a position where we'll get used to doing, particularly large -- where spend is linked to large events and gatherings, whilst hopefully, we'll return to face-to-face at some point, I don't think they will be at the same scale as in the past. I'm sure international travel will be restricted for a while. So I would not be sort of ramping up. Again, we haven't sort of done a sort of 3-year plan update, we'll do that in May. But no, I would not be sort of foreseeing a sort of major ramp-up of spend in the years to come. Hopefully, that has addressed most of your questions or all your questions, Jo. Shout, if not.
Operator
operatorNext question is from Giorgio Tavolini with Intermonte.
Giorgio Tavolini
analystI would like to have some color on the intangible amortization. I mean, in order to proper modeling the adjusted net income line for 2021, on what period do you expect to amortize the license regarding Eligard? Is it fair to assume an overall EUR 80 million amortization of intangible assets before taxes, I mean, EUR 65 million for 2021 net of tax? And the second question is on the financial cost in 2020. What is the detail on the -- this line? And the third one is on the vaccines. I mean, are you interested in accommodating at your production plant, some production for vaccines by acquiring rights and sublicense in order to contribute to the speed up of the vaccine rollout?
Andrea Recordati
executive[ Simple ] one. If I understand correctly, you're asking if we're doing anything with our manufacturing facilities to actually participating in the manufacturing of vaccines. Did I understand this correct?
Giorgio Tavolini
analystYes, yes.
Andrea Recordati
executiveWell, no, the vaccines, let's say, industry is a very specific one. You need special manufacturing facilities, which are very kind of -- adopt and designed specifically for the manufacturing of vaccines. So no, it's not something that we would be able to be to -- to set up, notwithstanding over regulatory hurdles to approve them and so forth and the heavy CapEx investment. So it's something which is completely out of our core business.
Luigi Felice Corte
executiveYes. Amortization charges for 2021, we are amortizing the Eligard upfront and first milestone over 20 years. Of course, we start amortization on Isturisa sort of on a country basis as of the time when the product is launched in the market. You should assume an amortization after charge in 2021 of over EUR 70 million, roughly, Giorgio. And financial items for 2020, the gains from currency movements, we are in the range of, say, EUR 6 million, EUR 7 million to give you an indication.
Operator
operator[Operator Instructions] The next question is from Isacco Brambilla with Mediobanca.
Isacco Brambilla
analystJust a couple of questions from my side. The first one is on your, let's say, your new ambitions to the orphan drug portfolio. I mean, Cystadrops and certain indications for Carbaglu. Can you remind us how we should look at these products, if we were to rank your statements for rare disease in terms of market opportunities? And the second question is on your cash deployment. Arguably, the large acquisition in regards to license of Eligard drove an overall cash out lower than what we were expecting for acquiring EUR 100 million [indiscernible]. How you intend to redeploy this additional firepower, which we have now available?
Luigi Felice Corte
executiveSo thank you, Isacco. So Cystadrops in the U.S., we see sort of opportunity, which is sort of in terms of distributor scale below USD 20 million over time. The launch has started quite well, actually. In fact, if anything, it's ahead of our expectations. So, so far, so good. But that is the indication. It is a fairly -- it is a sort of quite rare condition. So it's great news for patients. But yes, it's clearly sort of more limited in scale relative to some of the other more recent additions. And Carbaglu OA, similarly, I think it will contribute to the continued growth of Carbaglu in the U.S., but the indication is for use in acute setting. And therefore, it's not going to be sort of a very material driver on its own. In terms of cash, I mean, clearly, when looking at our firepower, we don't just look at the sort of cash on the balance sheet, but where we are in terms of leverage overall. And as I said, we're 1.5x EBITDA, which is very much in line with where we said we would be. We did say when the plan was refreshed that we will grow up to a maximum of 3, but only if and when very specific opportunity of -- came about. And so nothing has changed really in terms of -- from our perspective. We did a very significant deal in 2019 with over EUR 400 million sort of cash outlay. We've done this one now. And of course, we'll continue to scout. We're continuing discussions for same type of opportunities that we've discussed in the past, both on the SPC side and the rare disease side. So I'm not sure we see it as being sort of very different position in terms of cash and leverage from where we thought we were going to be. I think we're pretty much in line with where we said we would be actually from that perspective. I hope that makes sense.
Isacco Brambilla
analystYes. So just one very brief follow-up, if I may. In terms of market multiples, have you seen any kind of change because of the health care emergency or nothing really material compared to the past?
Andrea Recordati
executiveNo. Honestly, I'd say no. We are not seeing anything there -- in market multiples due to COVID. Thank you.
Operator
operator[Operator Instructions] The next question is a follow-up from Jo Walton with Crédit Suisse.
Jo Walton
analystJust a quick one on your share buyback program. Is that purely to offset expected share issuance? Or does that have some element of you thinking that the shares are particularly undervalued and you haven't got anything else that you need to spend your money on at the moment, and therefore, you're making a deliberate share buyback?
Luigi Felice Corte
executiveThank you for the question, Jo, but it is really a technical one. We have existing sort of stock option program in place. Our programs actually do not foresee the issuance of new shares. So the programs that foresee that any exercises would be fulfilled through treasury shares. And all we're doing is sort of making sure that we have what is required to fulfill any potential sort of shares vesting, which other -- are already vested or vesting between now and May. So no, it's not because of -- as we said, from our perspective, where we are in terms of net debt is exactly where we thought we would be in the plan.
Operator
operator[Operator Instructions] Gentlemen, there are no more questions registered at this time.
Andrea Recordati
executiveThank you very much. Thank you, everybody, for listening in. Take care. Be safe. Bye-bye.
Operator
operatorLadies and gentlemen, thank you for joining. The conference is now over, and you may disconnect your telephones.
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