Ipsen SA

PAR:IPN

Earnings Call Transcript 2020-Q1

[Operator]

Ladies and gentlemen, thank you for standing by, and welcome to the Ipsen First Quarterly 2020 Sales Conference Call.I would now like to hand the call over to your speaker today, Mr. Aymeric Le Chatelier. Please go ahead.

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Good. Good morning, good afternoon, and thank you for joining us for first quarter 2020 sales conference call. I am Aymeric Le Chatelier, CEO and CFO of Ipsen, and I will provide you an update on the business before opening up for questions with Eugenia Litz, Vice President, Head of Investor Relations at Ipsen.Before we start, I would like to send my best to all of you and your families during these unprecedented times. I hope you are all keeping well and staying healthy. I would also like to express my deep gratitude to all of the dedicated employees at Ipsen who have been working diligently to ensure our patients are still able to receive all their treatments.So as usual, here, you see our safe harbor statement that outlines the routine risks and uncertainty contained within this presentation.So we are really pleased to report very solid Q1 2020 sales growth of 8.7% driven by the continued strong momentum of our Specialty Care business, which grew 12.5%. As you see, the impact of COVID-19 has been limited during the quarter with some stocking in selected European country for oncology products and a lower demand in China. This clearly demonstrates the resilience of our business with our Specialty Care product portfolio comprised mostly of diversified and highly differentiated treatment for critical conditions. As a consequence, as you see, we maintain a solid financial position with a strong balance sheet and cash flow generation.Regarding our pipeline, the palovarotene program made some encouraging progress in the last few weeks. And earlier this week, along with our partners, Exelixis and BMS, we reported positive top line results for the Phase III Cabometyx CheckMate 9ER trial in combination with nivolumab for first-line RCC. I will discuss more in detail a little bit later.But let's start with the most important today, which is really COVID-19. And as you see at Ipsen, our priority remains the safety of our employee, ensuring business continuity and access to our important medicines for patients around the world. As I mentioned earlier, in Q1, the resilience of our Specialty Care portfolio, along with stocking in some European country for oncology products in anticipation of potential drug shortage, was able to more than offset the weakness we see in -- we saw in China, which impacted significantly our Consumer Healthcare business. In terms of manufacturing, we have always taken great pride in our excellent supply chain management, which has been an ongoing objective at Ipsen. We have today adequate inventory and do not anticipate any shortage in this current situation.Further, we have seen limited impact to date for clinical trials with minimum disruption to drug supply for ongoing patients despite the general slowdown in the recruitment of new patients as well as new site activation across Europe and the U.S. We are clearly focused today on ensuring patients continue to have access to their treatment, and our team is working very diligently to this end. Most Ipsen employees around the world, excluding mainly those at the manufacturing and distribution site, are working from home today, and the commercial organization continue to support health care providers virtually.Going forward, we are encouraged to see the situation in China improving and business starting to resume. However, while our oncology portfolio remains resilient, we expect some impacts from delayed diagnosis and lower new patient gains. We also expect to see more of a negative impact on Dysport sales and revenues from both aesthetic and therapeutic indications as a result of delayed injection. We will, of course, keep you updated as the situation continue to evolve for COVID-19.Now looking at our Q1 sales in more detail. You see that Somatuline continue to drive Specialty Care with a 20% growth, North America growth of 20%, resulting mainly from volume increase and continuing market share gain and double-digit growth in Europe driven by favorable market trend as well as COVID-19 stocking impact in some countries and a limited impact of generic. I will provide some updates on the generic in a few minutes.Cabometyx sales showing a growth of 34% reflect the continued steady launch across geographies and indications and some positive COVID-19 stocking impact in Europe. As expected, we are gradually seeing IO combination, secure reimbursement and move into first-line RCC in Europe. And like the dynamics, which has played out in the U.S market, we expect the market opportunity for Cabometyx to expand in second-line RCC as IO combination becomes standard of care in first-line RCC markets. I will comment later the results of CheckMate 9ER.Moving on to Onivyde. Sales were down 13% year-over-year, reflecting lower sales to our ex-U.S. partner despite a continued growth in the U.S. As a reminder, there was a particularly large shipment in Q1 2019. And overall, for the full year, we expect the same trend with a decrease in 2020 in the sales to our partner due to lower volume but with limited impact on profitability.As for Decapeptyl, the growth of 9% in Q1 was driven by a good performance and a positive COVID-19 stocking impact in some European country, which has more than offset the negative impact of lower demand in China from COVID-19 also.Turning to Neuroscience. Dysport sales were down 1% as a result of shipment delays in the Middle East, in Africa but also in Mexico. There were also reduced demand at the end of the quarter due to the first impact of COVID-19, especially some delayed injection. Galderma shipment was still very solid in the aesthetic market both in Europe and in North America.And finally, for our consumer business, sales were down 22%, and this was driven by mainly Smecta with sales down 42%. And this was mainly due to China where not only we had the negative impact of COVID-19 but also the negative impact of the implementation of the hospital central procurement in China.So now let's provide you a short update on the octreotide generic situation in Europe. Since we reported our full year results in mid-February, there has not been any additional country to launch a generic. So today, we have Germany, the Netherlands, France and the U.K., which are really the only 4 key countries that have launched to date. We see a very encouraging trend with Somatuline market share being stable in this country and limited pricing decrease related to the octreotide generic launch. Going forward, in 2020, we expect to see a staggered launch in Europe based on the different reimbursement time lines for individual country. There should continue to be minimal patient switches, no interchangeability and a limited pricing impact that will vary country by country. So clearly, Somatuline continued to be well differentiated with a strong value proposition, including a superior clinical profile and improved delivery system and patient services to a loyal base. We continue to expect no impact of octreotide generic in the U.S. in 2020 and have not seen much progress in the lanreotide generic program in Europe.Now moving on to our pipeline updates. I'm pleased to first provide you an update on some of the recent positive developments in our palovarotene program. During the quarter, first, we received clearance from the FDA and other regulatory authority to reinitiate palovarotene dosing in FOP patients below -- over 14 years of age. And this was really an encouraging step forward in this program. And it integrates that the FDA does not have any serious concerns about the efficacy or the safety of palovarotene in this patient population. The additional data from the Phase III MOVE trials and the Phase II extension study will be used as a supplemental data to support the regulatory file.Also, we recently submitted a complete response to address the FDA question related to the partial clinical hold on patients under 14 years of age in palovarotene trials, MO and FOPs.Regarding the MO program, we decided to terminate the Phase II MO-Ped trial. The partial clinical hold in place since early December has led to a significant gap in dosing, which compromised the integrity of the data, and there is no efficacy available in this patient population. We decided to terminate and unblind the study to analyze the accumulated data to better inform on the efficacy, safety and future of palovarotene in MO.Regarding the next step, we'll engage with the FDA and other regulatory authorities on the appropriate patient population eligible for treatments and the potential regulatory path forward for palovarotene in FOPs. Importantly, we are encouraged after a few challenging months, the palovarotene program is now progressing.Next, good news on the pipeline is clearly, as you noticed, on Monday, the announcements regarding, along with our partner, Exelixis and BMS, positive top line results for the pivotal Phase III CheckMate 9ER trial of Cabometyx in combination with nivolumab for first-line RCC. We are very encouraged that the trial met all 3 efficacy endpoints, including the primary endpoint of PFS and the secondary endpoints of both OS and overall response rates. And the safety profile in this trial reflects the known safety of the IO and TKI components in first-line RCC. We believe strongly that this data set is highly competitive with available TKI/IO combination results in Phase III trial in front-line RCCRegarding the next steps, detailed results will be submitted for presentation at an upcoming medical conference, and we are preparing for the regulatory submission in Europe and other territory in the next few months. We look forward to keeping you updated on further developments in both the palovarotene and the Cabometyx programs.Next, concerning our guidance remains suspended due to the general economic slowdown, reduced interaction with health care professionals and the uncertainty about the duration and scale of the COVID-19 pandemic going forward. Overall, we expect to continue to see a limited financial impact from COVID-19 given our resilient Specialty Care portfolio, as I said, comprised mainly of highly differentiated treatments for critical and chronic -- critical condition in chronic disease. However, despite the restart in China, Q2 sales will be impacted from delayed diagnoses and lower new patient gains in oncology, and a more negative impact on Dysport is anticipated in both the therapeutic and aesthetic markets with delayed injections. We will provide updated guidance as soon as the situation evolves and when we gain increased visibility.I would like to reiterate that we have a solid financial position with a strong balance sheet and cash flow, and we are also confirming our proposed dividend of EUR 1 per share for the 2019 financial year, and our shareholders' meeting to be held on May 29.To close the call and the presentation, I just wanted to share with you as we are focused today on our short-term 2020 priorities, especially for Q2. First, we continue to effectively manage the developing COVID-19 situation by ensuring the safety of our employees and business continuity, so patients worldwide can maintain access to our important medicines. And as the situation evolves, we are preparing for a smooth business recovery, which will be crucial to minimize the impact, including protecting our profitability and cash flow generation. We have flexibility in our business model and multiple levers pull in order to do this.Second, the Board is progressing in the search for a new CEO, which remains a top priority for the company, and there have not been any delays in time lines due to COVID-19.And finally, third priority, we'll remain focused on the next step in the palovarotene program to engage with the FDA and other regulatory authority on the appropriate patient population eligible for treatment and the potential regulatory path forward for palovarotene in FOPs. We remain very hopeful and determined to bring this first therapeutic treatment to FOP patients.So now operator, Eugenia and I are ready to open the call for any question.

[Operator]

[Operator Instructions] And we have our first question coming from the line of Thibault Boutherin.

[Thibault Boutherin, Equity Analyst]

This is Thibault from Morgan Stanley. Maybe the first one on palovarotene. Just trying to understand exactly what has changed and what new elements you have. So you are currently resuming dosing of FOP trials, but it -- I understand that [indiscernible] decided to stop the trial. So you had no request for it to stop. And you submitted an answer to the FDA regarding the clinical hold. But did you get any new feedback from the FDA and from other agencies? Or did you see anything really new in the data that makes you more confident in the filing? And then second question, on Somatuline. You mentioned the stocking in Europe. So could you maybe very roughly quantify how much of the growth in the first quarter is due to stocking? And regarding the U.S. situation, could you confirm that there was no stocking? And do you expect any stocking in the U.S. in the second quarter for Somatuline or also for Onivyde?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you for the questions. So maybe I will start with palovarotene and maybe clarify exactly the situation. So as you know, at the end of January, based on the futility analysis and despite the recommendation from the IDMC, we decided to stop dosing on the MOVE trial. Then we were able to -- based on the specific data sets or analysis that we shared with FDA to receive a clearance from FDA to be able to restart the dosing of patients within MOVE. In parallel of that, we have used all the data available to be able to address the FDA later on the partial clinical hold for the patients below 14 years old. And this was the response that we submitted recently to the FDA, including all the data available prior to the MOVE futility analysis and also of the MOVE futility analysis. And I cannot comment any more at this stage. But based on this level of information that was shared with FDA, we received clearance for restarting dosing. And today, we are expecting the outcome from the response we submitted to FDA.Regarding Somatuline, yes, it is true that some of the performance in Q1 is related to the stocking. So not only on Somatuline but also on all the oncology products, so including Cabometyx and Decapeptyl. We are talking about potentially 1 week of extra stocking on the last 2 weeks of March. I think many companies have seen that in Europe. We do not see such a dramatic move in the U.S. even if the structure of the business is different, and we should not anticipate any long-term impact. Talking about long term for a quarter, this was really a cutoff between March and April. And we have seen some situation normalizing in April. So it's more like a one-off timing impact of the crisis. Based on our scenario, we expect things to get back to normal during Q2. So no specific impact in the U.S.

[Operator]

And we will now take our next question. And that question comes from Louise Pearson from Redburn.

[Louise Hinds Pearson, Research Analyst]

I've got 3 questions, please. So on generic octreotide, so Cabometyx is in just 4 countries, and you mentioned staggered reimbursement. But I was wondering, does your competitive intelligence indicate any supply or capacity constraints on their side? And do you expect any launches in the near future for Italy or Spain? And secondly, on Dysport, could you talk about what you've seen so far in the first few weeks of Q2 in terms of any preliminary sales impact, given the lockdown situations that are ongoing? And could you confirm if the delayed shipments in the first quarter made it out in Q2?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. So regarding the first question, if I get this is whether we see any supply and constraints from the generic octreotide. We don't have any information today. We still see the product being commercialized in the 4 key countries that I was mentioning. I think the time line are longer for some other country. We do not have the details and the explanation for that. So this is why you are expecting that this is going to be a staggered launch for the generic octreotide, and there may be different consideration to be taken. So we don't have any specific information here.Regarding Dysport, I think that we had some strong shipments regarding Galderma in Q1, and you should expect in Q2 that the situation is going to be very different because we see Dysport as being the most impacted product in our portfolio where clearly, it's today not on the essential list in most of the country. And especially in aesthetic, there will be a significant impact. We expect to catch up on some of the shipments that impacted U.S. in Q1. But overall, the demand of Dysport is going to be impacted in Q2. We expect that based on the scenario with the potential quick recovery of the crisis during H2 to be able to come back to normal situation.

[Operator]

[Operator Instructions] We have another question coming from Emily Field.

[Emily Field, Research Analyst]

I know we only just got the data the other day, but I believe in your current guidance for peak sales for Cabometyx, you have EUR 300 million for RCC. So that would be just only usage as a monotherapy. I was just wondering if you could make any preliminary commentary on what the opportunity could be assuming the combination is approved, given that one would think that there could be some cannibalization of the second-line monotherapy usage. Then also, for Dysport, you kind of alluded to this, but it would seem that the cosmetic or aesthetic usage was classified as elective. So that would go to almost 0 in a lockdown situation. Was there still -- was that a similar application for the therapeutic usage? And then do you expect that the filing of palovarotene in the adult population will be a 2020 event?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you, Emily, for the good questions. So let's start with Cabometyx. You're right that today, I mean, our picture expectations for Cabometyx was set at EUR 400 million. And this was consistent since we signed the transaction in 2016. And that was made of EUR 300 million for RCC and approximately EUR 100 million for HCC, much smaller indication. We do not have a number today to share with you. Clearly, the very positive news of CheckMate 9ER will be an upside to the EUR 300 million for RCC, which, right, we're only considering the use of Cabometyx as a monotherapy, mainly in second line and after and with limited front line, given the combination taking the majority of the share. You are right that there will be cannibalization between the very significant market shares that we expect as the TKI of choice on Somatuline. But we see that the size of the front line and potentially the duration of treatment could be an upside. This will highly depend on, first, I mean, the quality of the data and the way to be able to compare the various IO combination, IO/TKI or IO/IO combination and also to all the market access discussion that we will engage country by country where we are operating. And as you know, situation is pretty different as compared to the U.S. market for that.Regarding Dysport, you have to make a distinction between, I mean, clearly, the aesthetic market where you are right that the lockdown is significantly impacting the demand. And so as long as we have a lockdown in some of the countries, access to clinics for aesthetic is going to be very, very limited. But once the lockdown is going to be over, we should see gradually things changing. I think the therapeutic situation is going to be impacting more than the oncology. At the same time, we expect a lower demand but still some ability. As you know, there are some critical conditions for which the toxin is required. And we are working to make sure that the most critical patients still have access to the toxins.Regarding palovarotene, I think that we do not have any view today of whether we will be able to file in 2020. What we know is that during the next few months, we have much more visibility on what is the path forward and what will be the eligible population and what will be the condition and what will be the scope of a potential filing for palovarotene.

[Emily Field, Research Analyst]

Okay. So I mean, would you then -- potentially based on how the FDA process goes, if the safety issue is resolved, then make a filing for the entire population perhaps as opposed to doing an adult first and then pediatric population after that?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

I think today, we are first addressing step by step. But it's clear that today, we have addressed our response to FDA regarding the safety issue for the patients below 14 years old. And we're going to assess based on our iteration with the FDA before deciding on the way to engage for a potential filing.

[Operator]

And we have another question coming from the line of Matthew Weston.

[Matthew Weston, Managing Director and Co]

Two questions, if I can. The first on CheckMate 9ER. And I guess, realistic expectations for market access in Europe for what's going to be an extremely expensive regimen, not just for you, but for any IO new-generation TKI combo. So Aymeric, if you can just help us shape the market as to whether or not there is any pricing bucketing that you can do with the PD-1 in Europe or whether that's limited by competition rules, and how you see the real availability of the dual TKI PD-1 being broadly available in Europe or whether it's more likely to be niche and private pay in some emerging markets. And then a second question, I saw that Harout left for Immunomedics during Q1. Clearly, we all saw David as being heavily responsible for commercial together with Harout in his role as Chief Commercial Officer. So can you just set out in terms of the structure who is focused or how the commercial strategy is currently being led at Ipsen? That would be extremely helpful.

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you, Matthew. I mean the first very, very good question I won't be able to answer to everything because we don't have an answer to all the market access discussion. What we can say that today, I mean, there is already some TKI/IO combination being approved in Europe and mainly in Germany. So we think that as long as the quality of the data and that there is something for patients, there will be a way to get approved. Now the market size, the pricing, the reimbursement, I think this is something that at European level, all companies are working on. And we are confident that if data are really convincing and compelling and we believe that the initial data on CheckMate 9ER are really encouraging, there will be a way to access patients with those drugs. And clearly, the combination of TKI and IO is very promising. And we do not believe that it's going to be only a niche market or a private market.Regarding management structure, as you know, there are always turnover in pharma. So Harout Semerjian, which was our Head of Commercial Operations, running all of our commercial operation ex-U.S., had a really good opportunity to become the CEO of a public biotech company in the U.S. We have a very great talent at Ipsen. And today, I mean, the executive team, we have a person to replace Harout. So clearly, with a very large experience. So Patrick [indiscernible] is today our Head of Commercial, together with Richard Paulson, our Head of North America, and they are clearly running the commercial organization at Ipsen. And then we're very happy about the performance that you've seen on the first quarter and very confident on their ability to continue to drive our volume or market share and also to face the COVID-19 situation and be able to adapt to this environment, as you know, by engaging more and more virtually with HEP and to continue also the development of our portfolio, and CheckMate 9ER is a good example of that.

[Operator]

We now have the next question coming from Delphine Le Louet.

[Delphine Le Louet, Equity Analyst]

Quite a list of question on myself with a diverse profile. Aymeric, I know you don't want to speak a lot about the guidance for the full year due to the volatility in the revenue, and we clearly all understand that. What we've seen so far in terms of publication is mostly a positive impact on the gross margin due to some extra selling and stocking and so forth with the gross margin. Is it a trend that you also see since the beginning of the year? First question. Second question, regarding the CapEx level. You have quite a high level of CapEx in the past. We are in a situation, which is a bit complex right now internally due to the search for a CEO, and so no major CapEx to be extended. Is it an opportunity for you to continue at such a level of CapEx? Or do you have CapEx reduction in the remainder of the year? Third question on palovarotene. Can you be more specific regarding calendar for the 14 years old plus? And finally, your last question regarding the COVID impact internally, meaning how many of your employees are either touched or not touched or are in a position to work or not work? Is it 90% of the workforce being at work or below that level? And how do you see the future back to work at your stage?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you, Delphine, for the question. I mean the first one will be a little bit difficult to provide you much more, I mean, on the guidance 2020. Clearly, I mean, as you know, our gross margin is doing very well on Q1, given the strong quarter for Somatuline. We continue to see Somatuline as being a very strong product going forward. As you know, this is really a chronic disease, and we see limited impact. Some of it on the new patients, and potentially some lower diagnosis but to a small extent. I think we see a limited impact of generic. So globally, I think the gross margin, it should be pretty well protected in 2020. As I said, the biggest impact is going to be in Q2 for our toxin Dysport.Regarding CapEx, and I won't comment in detail on CapEx. But clearly, as many companies, we are protecting clearly, project and cost base. So there will be clearly some delay in terms of execution on CapEx given the priority, which is today on ensuring the business continuity for manufacturing site but also for all the CapEx of the entire organization. But our priority today is to continue to operate while protecting our cash flow generation. But we do not expect any significant cut on CapEx.Regarding palovarotene, I won't be able to be much more specific. I think that the plan that we described in February is really being executed as anticipated. We have clearly achieved 2 significant milestones. And our view is that once we have clarified the partial clinical hold with the FDA, we'll be able to move forward and define the next step. And we want to ensure we're doing step by step on the palo to give the more chance for this product to be the first one to bring a solution to the people population.Regarding the employees, we have today over 75% of our employees that are working from home. Our manufacturing and distribution sites are operating on-site and have been able to continue to produce. And we have also our employees in China. So the 25% are really are manufacturing and distribution people and our Chinese people, which are now progressively coming back to work. We have no case or deaths reported to date at Ipsen. But given, I mean, the scope and the number of countries, this is a situation that we are monitoring every day. And we are working like every company depending country by country, based on the regulation of each of the country to be able to get out of the lockdown and to get our employees back to work, but with the priority, which is really to ensure access of our medicines to patients.

[Operator]

[Operator Instructions] And we now have our next question from Christophe Ganet.

[Christophe-Raphael Ganet]

Actually, 3, if I may. One on Cabometyx. Can you share with us what would be the different duration for the treatment with Cabo between being approved in first line versus second line? That's the first question. Secondly, on Somatuline, would you be able to provide an order of magnitude of the percentage of the revenues for Somatuline linked to newly diagnosed patients every year? And the last question on palovarotene. Can you characterize the eligibility of the patients that should be selected and enrolled in your clinical trials? I mean one of the difference might come from the dosage. And would there be another difference coming from the characterization of patients?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you for the questions. We maybe have to be more specific on the last one. But let's answer the first 2 questions. The first question is that, clearly, on Cabometyx, what's the difference in terms of duration of treatments between front line and second line? There is 2 works. I mean there is the work before combination, and there was the previous one. I think in [indiscernible] standard of care before a combination of new treatment, we were talking about potentially up to 12 months for the front line as compared to 6 to 8 months for the second line. Now in the combination, I think we have a combination that could be used as long as 18 to 24 months. And I have no information today. I mean it's quite too early to know what will be the duration of treatment of the cabo/nivo combination. You can -- when we get more data that will be shared at the next medical conference, you will be able to get that. And clearly, the size of the population is also much higher in front line. So that's why the economics are clearly positive of switching from second line to front line, even if it's a combination treatment.Regarding Somatuline, I think there is a limited number of new patients in the sale of Somatuline. I will say, it's less than 10%, as the majority of the patients are on treatment for many, many years. We're talking about 3 to 7 years in average for MET, and even longer for acromegaly patients.And in the last question, I'm not so sure to understand the eligibility of the patient. First, I mean, there is no new patients being enrolled on FOP. I mean as you know today, we are starting to redose some existing patients in the MOVE trials, and we have terminated the MO-Ped trial. So clearly, today, we have no new patients being enrolled for palovarotene. But the drug is eligible for all patients. I think that the disease starts at 6 or 7 years. So that was the patient population. And patients can leave until 40, 40 years plus.

[Christophe-Raphael Ganet]

Okay. So the purpose is not really to select your patient, whether we talk about the trials, whether we talk about the future treatment, right?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

No. I think that the -- if the question is, why are we restarting dosing in MOVE, I think it's first to -- I mean patients and families were really expected this treatment to be available for their children or for the member of their family. And this will allow us to gather more information on safety and on efficacy. But there is no intention. I mean as the trial was unblinding end of January, and we have enough data to be able to prepare for the next phase.

[Operator]

And we now take our next question from Jean-Jacques Le Fur.

[Jean-Jacques Le Fur]

Sorry, Aymeric, to come back on the guidance. But I'm trying to understand what is preventing you to give us guidance for 2020 or range in some -- in the guidance since you told us that the business should be not financially impacted with the COVID. The gross margin should be protected in 2020. Generic octreotide should not enter the market in the U.S., and we should have a limited impact in Europe. So with all the elements, I don't understand exactly what is preventing you to give us some direction.

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. So this -- you're totally right on a lot of the statement. I think we are living a pretty unique and unprecedented time. So clearly, I mean, the visibility, and we are talking about what we know today. And as you know, there is a lot about both the duration of the pandemic. There is also a lot of element about the macro impact on the economy. I think that clearly, we are being very cautious at Ipsen. And we don't have today enough visibility both on the pandemic and both on the global economic environment to be able to provide you a guidance that will be meaningful. So this is why we prefer to provide you more information about the short term where we have visibility where we see Q2 and clearly, also indication about the strong resilience of our product portfolio. And as soon as we have visibility that we'll see, meaning, country exiting the lockdown, we see a limited chance for resurgence of the pandemic, we'll be able to provide you a better view on the full year guidance. But I think that you have also quite a number of information today to be able to make your mind on the impact for us in 2020.

[Operator]

We now have a question coming from Petrina Carcota.

[Petrina-Oana Carcota]

This is Petrina from UBS. Three questions, if I may. So first one, what does the pricing look like for so much like in Europe in Q1? And what should we expect for Q2 and onwards? If you could provide a bit more color on that. Then could you tell us what are the Somatuline dynamics in Germany relative to Q4? And lastly, when we strip out the stocking benefit for Decapeptyl and Cabometyx, what does the growth look like?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thank you for your questions. So if I understand correctly, the first question was related to price impact. So I imagine this is a pricing impact in Europe from generic. I mean in the U.S., we still have a favorable pricing impact in the U.S. But most of the performance is coming, as the previous year, from volume and market share gains. In Europe, we see some pricing impact from the generics, mainly, as we said, in France and Germany. And -- but this is still quite limited, and we don't foresee any significant change in Q2. There may be some additional country, but this should be a limited pricing impact in there.Regarding your second question, whether we see a specific dynamic in Q4 regarding Germany, I think Germany, the situation, we see that almost all of the market share gain of the generic is to our competitors, and Somatuline maintains its market share and continues to grow at a lower pace. Its volume, also, as I described before, is still enjoying good resistance to pricing.Regarding the impact of stocking, it's a tricky question. I mean the reference is not so easy. As I said, the general comment will apply to both Cabometyx, Somatuline and also Decapeptyl. Clearly, we are talking about, as I said, on average, 1 week of extra order in the end of March, which is more of a one-off. And this should not add the very strong performance of those products. I think they are clearly resilient. They continue to have a strong performance. I mean talking about Cabometyx in the various country and progressing and taking further market share in second line. Talking about Decapeptyl, which continue to enjoy a really nice volume growth in Europe, outside China. And clearly, Somatuline, as we said, we still have double-digit demand adjusted for the -- what we have identified as being a COVID-19 impact.

[Operator]

And we have a last question coming from the line of Matthew Weston.

[Matthew Weston, Managing Director and Co]

Just one quick follow-up, please, Aymeric, on palo. I just wondered, you've set out the dialogue that's ongoing with FDA about the clinical studies and what you can and can't do. Have you had any conversations with European regulators or other regulators in the world? And what has their response been to the reanalysis of some of the studies despite the futility and the safety issues?

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. Thanks again for the question, Matthew. And I mean, we have had limited dialogue with FDA at this stage. I mean to be clear, we have submitted the request for restarting the dosing. And we have done that for FDA but also for all of the local regulatory authorities. We have done that also with all the ethical committee of each of the clinical trial sites. And as you know, the analysis was mainly based on safety to allow for FDA to result. Now we have submitted a response, and we will engage with FDA. At this stage, we have not had started any dialogue with other regulatory authorities regarding a potential filing.

[Operator]

And with that, we end our question-and-answer session for today. Thank you all for asking your questions. Over to you, Aymeric.

[Aymeric Le Chatelier, Executive VP, Interim CEO & CFO]

Okay. So thank you. Thank you very much for everybody. Thank you for all your questions, and hope you have a good day and stay safe in this moment. Thank you.

[Operator]

Thank you. That does conclude our conference for today. Thank you all for participating. You may now disconnect. Thank you.