Innate Pharma S.A. (IPH) Earnings Call Transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Innate Pharma Half Year 2020 Results Conference Call. [Operator Instructions] I must advise you that this conference is being recorded today. I would like to -- now like to hand the conference over to your first speaker today, Mondher Mahjoubi. Thank you. Please go ahead.

Thank you, and welcome, everyone. This morning, Innate issued a press release reporting our financial results for the first half of 2020 and the business update. The press release and today's presentation are available on the IR section of the company website. Let's move to Slide 2. And before we start, I would like to remind you that we will make forward-looking statements regarding the financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Let's move to Slide #3, please. I will begin today's call with an executive summary of our progress to date; and Laure-Hélène Mercier, our Executive VP, Chief Financial Officer and member of the Executive Board, will provide an overview on the financials. Mr. Joyson Karakunnel, EVP and Chief Medical Officer; as well as Jennifer Butler, EVP and U.S. General Manager, will also be available during the Q&A. Moving to Slide 4, please. Since our foundation more than 20 years ago, we have generated a lot of effort and time to work on how to harness the potential of the innate immune system and to discover and develop differentiated medicines in immuno-oncology. In 20 years, we've built a broad and balanced portfolio of innovative assets with the vision of becoming a fully integrated pharmaceutical company. This is illustrated through the 3 pillars of our strategy: science, commercial and finance. And let me move to Slide 5 to provide you an update on where we are with those 3 pillars. We are now on the verge of realizing this vision as we prepare to assume full U.S. commercial responsibility for Lumoxiti, our first marketed product in the U.S., and lay the foundation to support a rare hem-onc franchise. And turning back to our pipeline, as our company has matured, we have remained committed to pioneering novel science and advancing potential new therapies to late-stage development with the goal of reaching patients. We have made meaningful progress against this strategy in the first half of this year. And this includes, first, we quickly resumed enrollment in our Phase II lacutamab study in T-cell lymphoma, Sézary syndrome and mycosis fungoides. We supported the late-stage development of monalizumab in combination with cetuximab for IO-pretreated patients with recurrent or metastatic head and neck squamous cell cancer as AstraZeneca prepares to initiate the first Phase III study of the program that was developed by Innate Pharma. And last, but not least, with external expertise, we advanced avdoralimab in inflammatory disease, including and beyond COVID-19 infection. Actually, we are fortunate that these research and development efforts have enabled us to build a robust portfolio of product candidates, some of which have attractive -- I'm sorry, non-dilutive financial support from pharma partner, French government as well as from investors. And indeed, this is a key aspect on how to make sure we remain in a position of financial strength in order to fuel the growth of our portfolio. And as a result, we have been able to focus our internal effort and resources primarily on advancing our wholly owned programs. I'll touch on these -- on each of these molecules in more depth as we go through our program. On today's call, we would like to focus on updates from clinical candidates, beginning with our lead wholly owned candidate, lacutamab, which is on Slide #6. As you know, lacutamab is a first-in-class humanized cytotoxicity-inducing antibody that targets KIR3DL2 as tumor antigen that is specifically expressed in T-cell lymphoma. TELLOMAK, our Phase II clinical trial, is an international open-label multi-cohort study, evaluating the efficacy and safety of lacutamab as a single agent in patients with different subtypes of T-cell lymphoma. Initially, the study has been in Sézary syndrome, mycosis fungoides and peripheral T-cell lymphoma, or PTCL. And if you will recall, this trial has been interrupted end of last year due to GMP deficiency at our manufacturing subcontractor sites, which managed the fill and finish operation of lacutamab clinical trial -- clinical vial. Importantly, there were no safety issue related to the trial medication. We were very pleased to resolve these GMP issues and get the TELLOMAK study back on track and Sézary syndrome and mycosis fungoides. These 2 indications face high unmet medical need and lack currently available standard of care, whereas since there are options available to patients with PTCL, we have decided not to enroll for the patient for this indication until a new GMP-certified batch is available and took the opportunity actually to review the development strategy and plan, covering different setting of the disease. We will update you in the future on this program in PTCL. Now let's focus on cutaneous T-cell lymphoma. And as we engage with each national regulatory agency, Spain, Germany, France, the U.K. and the U.S., they have all agreed to resume enrollment. We are on track to report data from the mycosis fungoides cohort in 2021 and the Sézary syndrome cohort in 2022. We are particularly excited about this program for several reasons. First of all, the commercial opportunity is very synergistic with the rare hem-onc franchise that we are building around Lumoxiti. Second, data to date have shown promise, offering immense potential in rare and underserved indication, in particular, Sézary syndrome which offers potential first-to-market opportunity, and this Phase II study could serve as a pivotal trial, while in mycosis fungoides, which is the largest subset of cutaneous T-cell lymphoma, as it represents a broader market in which lacutamab will be evaluated as a single-agent therapy. We further believe data here will serve as a proof-of-concept beyond just this indication, including for peripheral T-cell lymphoma, which is an even larger opportunity. Let's turn now on Slide #7. Moving to monalizumab, and beginning with few updates from our Phase II program. In May of this year, as part of the ASCO 2020 Virtual Scientific Program, we presented efficacy data from the extension Cohort 2 of our Phase II trial, investigating the combination of monalizumab and cetuximab in IO-pretreated patient with recurrent or metastatic head and neck cancer. Those data showed an overall response rate in line with previously reported data and a very manageable safety profile. In addition, we expanded Cohort #3 of this study, exploring the triplet of monalizumab, cetuximab and durvalumab in IO-naïve patients with head and neck cancer from 40 to 20 patients. We have completed enrollment for this cohort and expect to publish related data in 2021. This is the update on the Phase II program. Now the great news that we said this morning, and we are very excited that AstraZeneca will be advancing monalizumab into Phase III deal share, as we previously announced. Similar to Cohort 2, AZ study will be evaluating monalizumab and cetuximab in IO-pretreated patient with recurrent or metastatic head and neck cancer. Importantly, the advancement of monalizumab into Phase III represents a significant clinical and financial milestone for Innate. As with the dosing of the first patient in the Phase III, we will be progressing Innate's first-ever Phase III asset. You may recall, Innate was eligible to receive $100 million from AstraZeneca after the dosing of the first patient in the Phase III side. And following the review and the maturation of the data and discussion with AstraZeneca, the company has agreed to amend the agreement, and it will now receive USD 50 million payment after AstraZeneca dosing of the first patient in the Phase III and a $50 million payment after the interim analysis demonstrates that the combination meets the predefined threshold of clinical activity. All other potential development and commercial milestones related to the agreement remain unchanged, including our participation to the financing of the Phase III under the terms to owner. Together with AstraZeneca, we are very excited by the opportunity for monalizumab and believe the novel combination for mona, an anti-EGFR monoclonal antibody with cetuximab has the potential to provide the new targeted option for patients who fail immunotherapy. In addition, we continue to believe this is promising potentially first-in-class treatment for IO-pretreated patients with this certain and this type of malignancy. As you know, it has a poor prognosis and novel and effective, tolerable therapy continue to be needed. In fact, we believe this will be the first-ever program to advance into a Phase III study for these patients with head and neck cancer previously treated by PD-1 or PD-L1 inhibitors. And we look forward to learning more about this novel combination from AstraZeneca's Phase III and plan to share updated and longer data from Cohort 2 of our Phase II study at future scientific meeting. Let's move now to avdoralimab on Slide 8, please. Based on data from the non-small cell lung cancer and IO-naïve hepatocarcinoma cohort of our STELLAR study, we have decided to stop enrollment in this Phase I/II study. We continue to advance our effort for COVID-19 and, in July, we published translational data, supporting our trial in -- the data were published in Nature. The study found that patients who progress towards severe COVID-19 disease, including those with severe pneumonia and acute respiratory distress syndrome exhibit an activation of the C5a/C5aR1 pathway. Specifically, our research has actually observed that a high level of circulating C5aR and an overactivation of the C5a-dependent myeloid cell pathway, which is believed to contribute to the inflammation in the lungs. The analysis supported avdoralimab mechanism of action, the C5a/C5aR axis blockade as a means to limit myeloid cell infiltration at inflammatory sites and prevent the excessive lung inflammation that is associated with the acute respiratory distress syndrome in these patients. It's a potential therapeutic approach for patients with severe COVID pneumonia. The recruitment for our FORCE study had declined due to improving condition in France, but enrollment has now resumed due to the recent increase in COVID-19 cases in France. And as we have opened new centers in the country, we continue to monitor the situation and also assessing the feasibility to expand into other geographies. It is important to note that our efforts in France are covered by a non-dilutive financing from the French government that we received in August of this year. In addition, based on this strong scientific rationale for C5aR pathway and also informed by the competitive environment, including external clinical data, which validates our mechanism of C5aR complement inhibition for inflammation. We have also elected to explore this program for chronic inflammatory diseases beyond COVID-19. Actually, we are excited by the interest in our avdoralimab program to advance our efforts forward, and we will collaborate with leading experts and key opinion leader who will sponsor and launch 2 expected studies in chronic spontaneous urticaria and in bullous pemphigoid later this year. While our expertise in inflammation goes back to the origin of Innate, and we have the scientific acumen to understand the opportunities in inflammation, we recognize that much of our work has been in oncology and believe external insights will enhance our efforts and ensure we are making smart early clinical decisions to build value in the program. That's why we decided to work with external investigators as this will allow us to accelerate the effort in inflammation more quickly than we would have been able to do, if we did it on our own, and without distracting internal resources from ongoing efforts with lacutamab and our earlier-stage pipeline. So this is the science part of the presentation today. Now let's move to the commercial section. And on Slide 9, we'll provide an update on our commercial operation with Lumoxiti. Firstly, as you remember, in 2018, we in-licensed Lumoxiti from AstraZeneca. It's a unique asset because, first of all, it has been approved in hairy cell leukemia who failed prior therapy, so relapsed and refractory in hairy cell leukemia, addressing then an unmet medical need since nothing was approved for more than 20 years. But because also, we believe it would be -- it would lay the foundation for our long-term strategic objective. And in fact, over the past 18 months, we have established our U.S. and global commercial operations. Late last year, for example, all sales and medical affairs activity for Lumoxiti transitioned from AZ, making Innate the sole commercial entity promoting these products in 2020. Throughout 2019, we further transitioned additional activity: BLA transfer, marketing and digital activity as well as patient support activity. All of these infrastructural capabilities are now with Innate, which is a testament to the vision and hard work of our teams in both the U.S. and France. Now as we prepare to assume the final transition piece from AstraZeneca, which includes setting up the Innate trade and distribution channel by the end of the year, we want to provide some further context around this program as well and our progress for this year. So it's on Slide 10. Hairy cell leukemia -- sorry for that. Slide 10, please. Just to provide some context on the market opportunity even though hairy cell leukemia is a rare disease and we estimate just less than 400 patients would fall within our label integration. Since the launch, we have seen that the third-line hairy cell leukemia patients are more dispersed throughout the U.S. and therefore, our reach to patients and physicians beyond centers of excellence is a critical component of our commercial model and strategy. It is also important to remember that there has been no new treatment for hairy cell leukemia over the past 20 years, as I said. Therefore, we need time to convert physician behavior and increase brand awareness. Unfortunately, COVID-19 had some positive effect, impacting Lumoxiti performance so far in 2020. Physicians have reported in market research that they are delaying infusion and/or prescribing existing oral agent, which has meant slower update for Lumoxiti. However, we remain confident that the fit-to-purpose commercial strategy we are executing will drive adoption and change the treatment paradigm over time. But we also remain diligent in our flexibility to adjust to the changing market dynamics, and we look forward to updating you as we begin booking sales in the fourth quarter of this year. In Europe, we continue to work closely with the EMA to advance our marketing authorization filing. We continue to look at Lumoxiti as strategic opportunity to build out a commercial infrastructure that can support our broader rare hem-onc franchise and believe we are on our way to achieving that vision. With that, I will now introduce Laure-Hélène, our CFO, to provide our financial overview. Laure-Hélène, to you.

Yes. Thank you, Mondher, and good day, everyone. So moving to the finance, I will start with one of our key metrics, as usual, our cash position. Our cash and cash equivalents amounted to EUR 184.6 million as of June 30 of this year from EUR 256 million at the end of 2019. Together with the anticipated $50 million milestone payment on dosing of the first patient in AstraZeneca Phase III study for monalizumab, we are in a strong financial position with cash to fund plant operation through 2022. In addition, as you can see, we are efficiently managing our resources and sizing opportunities to accelerate our impact by [ nimbly following ] data, leveraging the pharma partners and investigators to explore strategic and opportunistic indications, and building out commercial infrastructure that is synergistic with our internal development focus. We believe this effort ensures we remain in position to strategically invest in our vision for Innate. Now going to the P&L. And again, as usual, I will only comment the main and most significant slide, and you have very detailed comments in the appendix of the press release that you can refer to for more information. I'll start with our revenue from collaborations. So our revenue and other income amounted to EUR 36.7 million, and they mainly result from revenue from collaboration and licensing agreements and, to a lesser extent, from government funding. This revenue mainly results from the spreading of the upfront and opt-in payments received from AstraZeneca for monalizumab and IPH5201 which, I remind you, are recognized on the basis of the percentage of completion of the work performed by the company. I also remind you, obviously, that this has no impact on cash. Now operating expenses. So for the first half of 2020, they amounted to EUR 46 million, essentially flat compared to the first half of 2019. R&D expenses increased by EUR 5.1 million to EUR 31.5 million, representing close to 70% of our operating expenses. They primarily relate to external costs related to our profile in clinical development, sub costs and depreciation and amortization for monalizumab, IPH5201 and Lumoxiti intangible assets. The main reason for the decrease is the completion of some regulatory work for certain of our programs such as Lumoxiti for the European filing or IPH5201, which transitioned to Phase I under the responsibility and financing of AstraZeneca of the IND filing for IPH5301 now. All of these were only partially offset by the increasing cost of some other programs such as lacutamab. Turning to selling and general and administrative expenses. They increased by EUR 5.2 million to EUR 14.5 million for the period and primarily relate to staff costs and consulting. The increase in terms -- in staff cost is notably in the context of the recruitment completed during the second half of 2019 and the first half of 2020 by our U.S. subsidiaries, including the staff allocated to the commercialization of Lumoxiti. As of June 30 this year, we had 74 employees in SG&A compared to 43 employees last year, at the same period, to give you magnitude. This increase mainly results from the recruitment in the United States. Consulting expenses mostly consist of fees related to audit, accounting and legal fees. Now one word on the net income from distribution agreements. We have declined under the operating expenses and it shows the Lumoxiti net global inflows and outflows received from the Phase II AstraZeneca for the commercialization of Lumoxiti. As a reminder, in the current context of the transition of the responsibilities with effect to Lumoxiti from AstraZeneca to Innate, AstraZeneca is still considered as principal, and as Mondher said, Innate will become the principal and some booking sales in the fourth quarter. So under the Lumoxiti agreement, we recognized a net profit of EUR 0.9 million during the period as a result of the transfer of the commercial activities from AZ to the company. It also include a onetime positive true-up relating to the rebates applied to the gross sales generated over the whole period of commercialization. So I think this concludes the remark on the financial part of the review, and I turn back the call to Mondher.

Thank you, Laure-Hélène. So in summary, on Slide 13, as you can see, we've made significant progress across our portfolio in the first half of this year, and we remain committed to executing on our long-term growth strategy. Our internal efforts are focused on advancing lacutamab for the treatment of T-cell lymphoma as we build commercial infrastructure to support the launch of Lumoxiti in the U.S. In parallel, our partner, AstraZeneca, is advancing monalizumab for recurrent or metastatic head and neck cancer as well as IPH5201 for advanced solid tumors. And we are collaborating with external experts to initiate studies of avdoralimab in complement-driven inflammatory diseases. We believe this strategy allows us to best maximize our internal resource, while accelerating development across our broad portfolio. Lastly, we have a strong cash position to fund our development program and are eligible for potential substantial program milestone payment in the future. On Slide 14, I also want to take a moment to introduce you all to Dr. Joyson Karakunnel, who joined us in July as EVP and Chief Medical Officer, following the retirement of Pierre Dodion. We are very excited to welcome Joyson, who most recently served as CMO at Tizona and earlier held position at Arcus, AstraZeneca and MedImmune. He is a practicing medical oncologist, and he brings in-depth immunology, oncology and hematology experience and a proven track record in clinical development. Joyson will be available with us during the Q&A as well. Finally, on Slide 15, the newsflow. And just to recap, the upcoming milestone across our portfolio, what do you -- would expect? For lacutamab, we expect to share data from the TELLOMAK trial next year in mycosis fungoides, and in 2022 for the Sézary syndrome port. I remind you, the Sézary syndrome port is the one that is potentially pivotal, for which of course it's important not only to have the risk-constraint data but also the longer-term data in terms of PFS and duration of response, and that's why we elected to disclose the data in 2022 once we have interacted with the health authority and the FDA in particular. For monalizumab, we expect AstraZeneca to enroll the first patient in their Phase III in the second half of this year, which will trigger a $50 million payment to Innate, and we expect to report as well early data from Cohort 3 of our Phase II trial in 2021. Finally, for avdoralimab, we expect the IST trials in CSU and BP to initiate in the second half of this year. And Lumoxiti, as I said, we are transitioned and we'll assume full U.S. commercial operation in the fourth quarter of 2020, while we continue to work closely with the European agency to advance our MAA filing for the approval in Europe. And in parallel, of course, we are progressing the avdoralimab FORCE trial in COVID-19 and the rest of our broad and managed pipeline. So it's the end of this short presentation. It's been a rich first half of the year, and I'm sure you have tons of questions that I'm happy to take with Laure-Hélène and with Joyson as well. So operator, you may now open up the line to Q&A.

[Operator Instructions] And first question comes from the line of Graig Suvannavejh from Goldman Sachs.

Thanks for the update and congrats on the progress. I've got some questions related to monalizumab and then also Lumoxiti. Maybe first on monalizumab. Can you just walk us through the rationale for the restructuring of the financial milestone from $100 million to now being split up into 2? I'm wondering if this is something that AstraZeneca initiated and wanted. Obviously, having $100 million for the first patient dose in the Phase III is better than $50 million. So if you could just walk us through kind of what drove that. Sort of a follow-up on monalizumab is on the receipt of the second half of that payment or the $50 million, a, when do you expect, if I'm looking at the time lines, is it a post '22 event where you would think you'd get this interim data that would then trigger that? And then the follow-up on that would be, can you share with us some of those criteria that would allow you to receive that $50 million? And then I've got a follow-up on Lumoxiti.

Thanks, Graig, and just -- forgot to mention that we have also Jen Butler on the phone. So she will also contribute to this Q&A session and address any specific question you have on Lumoxiti. Let me just say that with monalizumab, we are really very excited and very proud with the achievement that is -- we got today. I mean remember, this is the first asset in 20 years for Innate Pharma to get so far and to reach the Phase III and to be so close to the market. So this is a major, major achievement that we are extremely proud, not only because it is, of course, a key milestone from a clinical development viewpoint, but also, I think an opportunity for patient with this type of disease. Because, as I said, there is an emerging unmet medical need, and nothing has been at least tested in Phase III so far to address this emerging unmet medical need for patients who are progressing on PD-1 or PD-L1 inhibitors. As you know, when it comes to clinical development, in Phase II, you have 2 options or 2 routes. The classic route is to do a randomized Phase II to establish with enough granularity, the contribution of components of your combination to get additional confidence and then move into Phase III. That's what most of the people do. The second approach, of course, is to go right away from single-arm Phase II to a randomized Phase III. Usually, this happens when you have outstanding activity in Phase II. And then outstanding activity means a high response rate, a high complete response rate and you have the classic end points in oncology. We elected with AstraZeneca to go with the first approach in order to -- with this approach, in order to maintain the pace and expedite the development instead of going through a randomized Phase II/III trial. It is more attractive to build the Phase III based on the data we have. And in order to give you a little bit more sense of what we have gone through and answer your second question about the interim analysis, I'm going to hand it over to Joyson to explain the rationale behind this restructuring as well as the elements about the implementing.

Yes. So I think, let me look at this just to kind of add on to what Mondher was just saying. The Phase III, the interim and then the final analysis, of course, as everyone is aware on the call, an interim analysis is to help to sort of give us the confidence of what the final analysis would be. So in this restructuring, basically, the way it was kind of -- it was approached to us is that the interim analysis would help to guide that final analysis. Now I want to step back and say that doesn't change the confidence in the program. So in fact, between AstraZeneca and us, we're still confident. But to what Mondher was saying, when we look at the data, we look at the totality of the data. And that totality of the data to help from a business perspective to basically help to spread out that -- the pace.

And the question about the when and whether we can disclose the predefined criteria or threshold for activity.

So looking at the predefined criteria, I think as many people know on the call, usually our interim analysis, we don't really get into the gritty -- nitty-gritty details. But from what AstraZeneca has told us is they're expecting this interim to occur within -- between 18 to 24 months. And I want to emphasize, they are the ones who are executing the trial at this point.

Okay. And Graig, just to recap on this question that I'm sure many people on the call have. The initial data that were used for AstraZeneca to take a decision to move into Phase III came from the Phase I trial that we conducted in 2018. That's when they first showed interest. They opted in to the oncology program, in combination with cetuximab and decided to go into Phase III. But in the meantime, actually, we developed this Phase II program. We designed a Phase II in a classical way, so with the responses to the primary end point. The primary end point of the study was met. We presented the data at ASCO a few months ago. And we actually built with AstraZeneca the evidence to go into Phase III. So the data -- if you look at -- when you do a Phase III is not just responses. We look at the other criteria, in particular, in duration of response or the progression-free survival, the overall survival, the landmark analysis, the safety profile and all that actually helps you decide letting go or you don't go. I think from a science and a clinical viewpoint, there was a sort of alignment that we have to go into Phase III because there is an opportunity, there is unmet medical need, that the data are good enough to go into Phase III. Now from a business perspective, AstraZeneca proposed that we split this payment in 2. And we are so, personally, confident with AstraZeneca that we will hit that interim analysis. So we are going to get this $50 million now for the first patient in the event, $50 million in 18 to 24 months when we got the interim analysis. I hope we covered your question, and I can get back to you on the Lumoxiti one.

Yes. No. That was very good clarity. Just maybe I'll switch to Lumoxiti. Are you able to disclose what sales were in the first half? And then my follow-up there would be, given that you -- the arrangement with AstraZeneca, should we be expecting that contribution will potentially be negative in the second half? I know you had plus EUR 900,000 in the first half, just given kind of how that commercialization agreement works and that you'll be assuming full responsibility. Is it fair to assume that, that may turn negative in the second half?

So maybe I'll hand over to Jen for the first part of the question about the commercial performance. I mean the straight answer in terms of can we give a little bit more granularity, you know that AstraZeneca is moving to sales, so we'll start booking the sales in the fourth quarter of this year. So -- but we can give you a hint of the overall performance in the COVID project, that's what Jen will do. And then Laure-Hélène will try to address the second question about the finance. So I think we'll answer the question. You have an opportunity to ask the question again to Laure-Hélène. But let's start with Jen first from the commercial part.

Thanks, Mondher. So Graig, we would expect to have, obviously, more transparency as it relates to sales lines as we book sales in the future. So there'll be a little more transparency to that. Yes, as stated in the prepared remarks, I think, for us, taking over in Q1, started kind of -- not in Q1, but really that being our first quarter, we definitely saw the impact for COVID-19. Just to provide a little additional color commentary as Mondher has mentioned. For us, in particular, with the hairy cell leukemia patient, I think there was a desire to kind of reduce the risk of exposure in some of the health care facilities and therefore, there was a bit of a delay in wanting to start infusion. We're not alone. I think you saw that in a lot of other disease states in which there was a delay to start therapy. And then in certain cases, where there was an oral option for folks, we did see folks potentially start there. We would expect though that some of the patients that were on those therapies will kind of circle back around once their disease progresses. So it's kind of been our experience kind of through 2020 as it relates to Lumoxiti in the marketplace. But I think just as we've seen in the U.S. more broadly, we are seeing offices open. We're going to be able to kind of improve that face-to-face interaction that we're seeing our team able to do. And obviously, that will put us in, I think, a more effective situation from a scientific exchange and not promotional exchange.

And Laure-Hélène, you want to answer something on the financial part?

Yes. Graig, I'm not sure I really get the second question, but just to give you some more flavor on the financial part of Lumoxiti. So it's true that it's not easy to read inside this line item of the income from the agreement. So I just want to repeat what I said during the introductory remark and maybe that didn't went through, is that the change between last semester and this first half of the year is really driven by the condition of the commercial expenses from AstraZeneca to Innate. So here, you are really seeing expenses going from these line items to our SG&A. So that explains also why SG&A gave up and a onetime true-up really that is an exceptional. So you should consider that 2020, in terms of the sales of Lumoxiti, is really going to be very much impacted by the COVID-19 health crisis, as we already alluded to. And again, the next time that we will report, you will also have more clarity since we will start booking the sales from the fourth quarter on. So does that answer also your question?

Yes, that's very good. I'll just jump back in the queue.