argenx SE (ARGX) 2017 Q2 法說會逐字稿

Welcome to argenx Second Quarter 2017 Business Update and Half Year Financial Results Conference Call. (Operator Instructions)

I would now like to introduce Joke Comijn, Corporate Communications Manager at argenx.

Good afternoon. A press release with the argenx second quarter business update and half year 2017 financial results became available at 7:00 a.m. Central European Time today, can also be found on the News and Event section of our website.

Before we start, I'd like to go to Slide 2. As a reminder, forward-looking statements may be presented during this teleconference. They may include statements about our future expectations, clinical development and regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from these indicated by the statements. Argenx is not under any obligation to update statements regarding the future or to confirm these statements in relation to actual results unless this is required by law. I'm joined on the call today by Tim Van Hauwermeiren, CEO of argenx; and Eric Castaldi, CFO.

On Slide 3, you will see a brief agenda for the call. Tim will highlight recent news, including our initial public offering on NASDAQ in May, and the use of proceeds as well give an update on our clinical programs. Eric will then provide recent news about our collaborations and the financial results for the year, and finally, Tim will lay out upcoming milestones before we turn the call over to Q&A.

I would like now to introduce Tim Van Hauwermeiren, CEO of argenx.

Thank you, Joke, and welcome, everyone. I'd like to go to Slide #4. The first half of 2017 has been a time of very meaningful growth and development for argenx, where we made advancements in our product candidate pipeline, continued to strengthen and broaden our strategic collaborations and created significant flexibility around our financial position, driven much in part through our successful NASDAQ IPO in May of this year. Our initial public offering in the United States consisted of 6,744,750 American Depository Shares at a price of $17 per ADS for gross proceeds of approximately $115 million. The U.S. public listing provided us a substantial source of capital and an added level of exposure, which will enable us to carry out our corporate mission to make significant advancements for patients with cancer and severe autoimmune diseases.

With this additional funding and broader access to capital, we intend to use the proceeds to first, fund our research and development efforts of our lead pipeline candidates into further clinical developments, and second, to fund early-stage pipeline opportunities through our Innovative Access Program and to further advance our antibody engineering technology platform. As shown on Slide #5, our 2 lead programs; ARGX-110 and ARGX-113 are progressing well, and remain on track with our outlined guidance.

In the second quarter, we had important updates from both programs. In April, we launched a Phase II monotherapy trial of ARGX-110 in relapsed refractory cutaneous T-cell lymphoma patients, and in May, we announced that we reached 50% enrollment in the Phase II trial of ARGX-113 for the treatment of myasthenia gravis. We also had important news out of our collaborations during the second quarter. In May, we announced that we received the first preclinical milestone payment from AbbVie for ARGX-115, our collaborative cancer immunotherapy asset, and in June, we received the second preclinical milestone payment from LEO Pharma for ARGX-112.

As you can see on Slide 6, we have developed a rich and deep product pipeline using our antibody technology platform. We plan to continue these expansion efforts by funding the discovery and development of new antibody candidates through our Innovative Access Program as well as pushing forward our wholly-owned assets ARGX-113 and ARGX-110. I will discuss our partnership strategy and our Innovative Access Program later in the call.

Slide 7 shows ARGX-113, our most advanced candidate focused on severe autoimmune disease. It's currently in Phase II proof-of-concept trials for the treatment of patients with myasthenia gravis and immune thrombocytopenia. Both of these diseases are IgG-mediated. So circulating autoantibodies are a key driver of disease. Few innovative biological treatments have been approved to address autoantibody-driven flares associated with these conditions and patients are left without effective disease management. ARGX-113 works by targeting FcRn with high affinity, making the receptor inaccessible to circulating IgGs, which are then degraded. With this candidate, we used our antibody technology to pioneer novel biology and potentially universal pathway into the disease biology of severe autoimmune diseases.

Based on the drug's unique mode of action and the Phase I healthy volunteer data, we believe this drug has the potential to change disease in a fundamental way. There are many IgG-mediated diseases that will benefit from the degradation of circulating autoantibodies. Meaning, we have the opportunity to create a pipeline within a product around several potential indications as shown on Slide 8. We had a three-pronged rationale to selecting our first indications of study. First, based on the ability of ARGX-113 to reduce levels of circulating IgGs, we looked at indications where pathogenic IgG levels predominantly mediate disease. We then considered indications we could confidently bring forward ourselves, namely orphan indications that would require smaller, more focused trials and which we believe had clear regulatory paths.

Finally, we selected indications for which clinical POC will be strong enough to have an impact in adjacent indications. With this criteria in mind and based on significant unmet medical needs, we decided to focus on myasthenia gravis and immune thrombocytopenia. We believe there are other autoimmune diseases that would benefit from this mechanism of action and we plan to expand our development of efforts into other diseases mediated by pathogenic IgGs.

Today we're on track with our ARGX-113 program, I will refer to Slide #9. We were very excited to reach 50% enrollment in May in the Phase II clinical trial of ARGX-113 in MG, which is a double-blind placebo-controlled study, enrolling up to 24 MG patients with confirmed generalized muscle weakness. All patients enrolled were on a stable dose of standard of care and will continue their treatment regimen throughout the trial. Patients will receive full weekly doses for a 3-week period and follow-up will continue for 8 weeks after the last dose.

On Slide 10, the recruitment for the Phase II study in ITP trials is also going according to plan, which has three 12 patient arms, 2 drug doses and a placebo. The dosing schedule is similar to the MG study and patients will remain on a stable dose of standard of care. The primary endpoints for both are safety and tolerability. And secondary endpoints include evaluation of efficacy, immunogenicity and PK-PD effects. Looking ahead, we expect topline data from both of the ARGX-113 Phase II studies in 2018; MG in the first quarter and ITP in the second half.

Slide 11, the dose of ARGX-113 in the ongoing Phase II trials is dosed as an IV formulation, but we are actively developing a subcutaneous product formulation as well to enable administration to larger patient populations, including those requiring chronic therapy. Slide 11 shows our head-to-head studies of the 2 formulations in a preclinical monkey model, suggesting comparable half-life in circulation, favorable bio-availability for the subcu and the comparable PD effect. We plan to initiate a Phase I trial in healthy volunteers with the subcu formulation in the upcoming months.

Let's move now to Slide 12. Our second program ARGX-110, our lead oncology candidate, which targets CD70 and which is currently being evaluated in a Phase II combination trial, with standard of care is azacitidine in patients with newly diagnosed acute myeloid leukemia and high-risk myelodysplastic syndrome as well as in a Phase II trial in patients with relapsed refractory CTCL. Our target CD70 is a cell surface protein that is overexpressed in hematological cancers. CD70 interacts with its receptor CD27 to provide tumor cells a potent proliferation and survival signal. CD70 expressed on tumor cells can also interact with regulatory T cells, thereby contributing to immunosuppression in the tumor microenvironments.

Importantly, soluble CD27 is released as the result of CD70, CD27 interaction and may serve as a biomarker for disease burden and drug activity. ARGX-110 functions by blocking the CD70, CD27 interaction and by potently killing CD70 expressing cells. We are currently focused on cutaneous T-cell lymphomas in which CD70 cells are overexpressed, and importantly, leukemias will be more specifically interfered with leukemic stem cell biology. In June, we presented updated data from our Phase Ib expansion study of ARGX-110 in patients with CTCL at the International Conference of Malignant Lymphoma in Lugano, shown on Slide 13.

We observed partial response in stable disease, respectively, in 3 and 7 out of 16 patients with highly refractory relapsed CTCL and confirmed overexpression of CD70. The data confirmed that ARGX-110 continues to show a favorable safety and tolerability profile as well as evidence of clinical and/or biological anti-tumor activity across different CTCL subtypes and all disease stages. Biopsies were collected to further explore the modes of action in the skin of the CTCL patients. Finally, the dose of 5 milligram per kilogram was selected for the current Phase II monotherapy trial.

Moving on now to the ongoing AML combination study of ARGX-110 with standard of care. Slide 14 and 15 illustrate a preclinical rationale supporting our study of ARGX-110 in patients with AML or MDS, often a precursor to AML. Using soluble CD27 as a biomarker for CD70 CD27 activity, we saw elevated levels in AML patients independent of the patient's other characteristics. CD70, CD27 interaction is also shown to be specific to leukemic stem cells, since the protein is not overexpressed on normal hematopoietic stem cells. On Slide 15, you can see that in the preclinical Miles efficacy model, our anti-CD70 antibody reduces leukemic stem cell function and prolong survival.

Slide 16. In December 2016, we initiated the open-label dose escalating Phase I/II clinical trial of ARGX-110 in combination with azacitidine in newly diagnosed AML or high-risk MDS patients. We expect to present interim data from the Phase I/II study of ARGX-110 in AML and Phase II study in CTCL during a workshop in conjunction with ASH this year in Atlanta, and topline data from Phase II study in CTCL is expected by the end of 2018.

Moving on to Slide 17. We continue to adopt a disciplined portfolio management approach as a pillar of our business strategy and to manage risk across our wholly-owned and partnered programs. As a company, it has been our goal to focus on novel cancer and severe autoimmune targets, where the lack of treatment options will allow us to pioneer new candidates to address these unmet needs. With our wholly-owned products, we focused on manageable indications, where the development process is efficient and where we can credibly and reliably develop drug candidates through Phase II proof-of-concept trials. We're advancing our 2 lead programs with proceeds from the IPO as well as broadening our pipeline to include new antibody candidates for development alone and in partnership with strategic collaborators.

On Slide 18, we continue to invest in our Innovative Access Program and further expand our pipeline through strategic collaborations with academic centers of excellence and emerging biotech companies. Our Innovative Access Program secures access to exciting novel targets, where proof-of-concept in disease models is yet to be demonstrated. Target validation requires cutting edge comprehensive antibody technologies, which argenx brings to academic scientists.

We apply our unique platform presented on Slide 19, which combines the diversity of the llama immune system with engineering technologies, consisting of our SIMPLE Antibody discovery platform and our Fc engineering technologies to create differentiated product candidates. Our platform offers us a real competitive advantage that allows us to explore novel and complex targets for maximum therapeutic effect, and therefore, develop therapeutically-relevant antibodies to help patients in need. All of these technologies are novel and have substantial patent life, and additionally, all our product candidates are protected by multiple layers of patents, which run until 2024 to 2032, not taking any patent term extension into account. Today, we have 128 granted patents and 68 pending patent applications.

I would now like to turn the call over to our CFO, Eric Castaldi.

Thank you, Tim. So we're now moving on Slide 20. Our strong cash position allows us the opportunity to evaluate collaborations in a very strategic and judicious capacity and to only move forward with those that are the most aligned with our goals. In the first half of 2017, we had several announcements across our collaborations highlighted on this slide.

In March 2017, argenx announced that Staten Biotech exercised its exclusive option to license ARGX-116, an anti-ApoC3 SIMPLE Antibody with therapeutic potential in dyslipidemia. By utilizing Staten's specialized knowledge of this dyslipidemia in combination with our novel SIMPLE Antibody platform, we are able to develop a novel antibody. We are very excited that Staten will continue to pursue further developments, where we are eligible to receive a double-digit royalty on any ARGX-116 related income.

Yesterday, we announced the publication of new preclinical data in Nature Medicine on ApoC3 that provides further rationale for the therapeutic potential of ARGX-116 for the treatment of dyslipidemia. In March 2017, we also announced a new collaboration with Broteio Pharma to develop an antibody against a novel target in the complement cascade with therapeutic potential in autoantibody and complements mediated indications, including autoimmune hemolytic anemia and antibody-mediated rejection following organ transplantations.

In April 2017, argenx received the first of 2 potential preclinical milestone payments on its way through the investigational new drug filing of ARGX-115 targeting GARP, which triggered $10 million milestone payments from AbbVie, which occurred 1 year after our collaboration began with the company in April 2016. In June 2017, we announced the achievement of the second preclinical milestones from our collaboration with Leo Pharma to develop and commercialize ARGX-112, which began in May 2015.

Additionally gerilimzumab ARGX-109, a monoclonal antibody that neutralizes the IL-6 cytokine is in development through a collaboration with Bird Rock Bio. The most recent update from this collaboration was in March 2016, when we announced positive results from a Phase 1 healthy volunteer study that we believe are supportive of our Phase II trial in rheumatoid arthritis. And finally, we extended our strategic partnership with Shire to advance the discovery and development of novel human therapeutic antibodies for diverse, rare and unmet disease until May next year.

Moving to Slide 21 and 22. We also have 1 wholly-owned pipeline candidate that we are working to partner, our ARGX-111 program. In July 2017, at the Best of ASCO Asia 2017 Conference in Singapore, we presented Phase Ib data from ARGX-111 in patients with advanced cancers overexpressing the MET protein, which showed a favorable safety profile and preliminary antitumor activity. We are really pleased to see these results, as the consistency seen in this data in comparison to the original Phase I trial was the goal of this expansion study. We feel this recently presented data offer compelling path forward for our partner to further examine the compound in a Phase II trial.

Moving to Slide 24, as you can see on this slide, our financial results reflect principally research and development expenses and operating income. Operating income reached EUR 23.9 million in the first half of 2017 compared to EUR 7 million for the same period of 2016. The significant increase in operating income in 2017 results primarily from the deferred revenue recognized from our collaboration agreement with AbbVie in April 2016 and the milestone payments received in the first half of 2017 from AbbVie $10 million and from Leo Pharma. The group, as a business model, which relies heavily on outsourcing its R&D activities through external collaborations. Therefore, most of our operating expenses are variable expenses.

On June 30, 2017, research and other expenses amounted to EUR 25.6 million compared to EUR 11.3 million in the first half of 2016. The increase in R&D expenses in the first half of 2017 is mainly related to the advancements of the clinical development of ARGX-113 and ARGX-110 and other preclinical and discovery stage product candidates. Our G&A expenses remained relatively low and reflect our lean and efficient structure. G&A expenses totaled EUR 5 million and EUR 3.1 million for the 6 months period ended June 30, 2017, and 2016, respectively. The increase seen in the first half of 2017 is mainly due to higher personnel expenses, office costs and consulting fees incurred to support our growth and prepare us to become and operate as a NASDAQ listed company.

As a result, the company generated a total comprehensive loss of EUR 8.2 million during the first 6 months of 2017 compared to a net loss of EUR 7.4 million in the same period of 2016. We closed out the first half of 2017 with a very strong cash position, including cash, cash equivalents and current financial assets of EUR 173.4 million compared to EUR 108.7 million on June 30, 2016. The significant increase in our cash position in the first half of 2017 results from our initial public offering on NASDAQ in May 2017.

Let's move now to Slide 25. This slide shows that so far we have been highly efficient in managing our capital. Since inception, we have raised a total of EUR 236 million of capital, including the proceeds from our NASDAQ IPO completed in May 2017. And we have received EUR 73 million of non-dilutive funding, including most notably the EUR 50 million from our collaboration with AbbVie. As indicated, we still had EUR 173.4 million of cash at the end of June 2017. We also maintained a lean and efficient corporate structure. At the end of June 2017, we have employed 67 people, of which, 54 were in R&D and 13 in G&A.

With EUR 173.4 million of cash at the end of June 2017, we believe that we are well-capitalized to execute on our strategic plan. Our burn rate is expected to increase significantly as we will continue to focus our investments on our most advanced clinical development pipeline. In parallel, we will also develop and expand our preclinical product pipeline looking to access novel targets and technologies, whilst we develop this company. To conclude on this financial slide, you can see on the right, the current fully diluted shareholding structure of the company.

As a result of the 2 private placements completed in 2016 and of our IPO in NASDAQ in May 2017, we have reduced our VC overhang to about 25.6% of the outstanding shares compared to 73% at the time of our IPO on Euronext 3 years ago, and we have also increased the liquidity and the free float of our stock. But more importantly, we have been able to attract Blue Chip long-term institutional investors who now hold more than 50% of our shares.

And now, I will turn back the call to Tim.

Thank you, Eric. As you can see, 2017 has already been a very exciting and productive year for argenx. We look forward to continuing this momentum as we remain highly committed to advancing our business plan and pipeline. We have several milestones to highlight on Slide 26. Top line data from both Phase II studies of ARGX-113 MG is expected in 1Q 2018, and ITP is expected in the second half of 2018. We are on track for the Phase I clinical trial initiation of ARGX-113 for subcutaneous dosing in healthy volunteers expected before the end of 2017. We also expect interim data from the Phase I/II trials of ARGX-110 in AML and Phase II trial in CTCL by the end of 2017 and top line data from Phase II study in CTCL is expected by the end of 2018. In addition to our pipeline milestones, we're excited to continue to work closely with our Innovative Access Program collaborators and build new relationships. Thank you very much for listening today to our first earnings call as a U.S.-listed public company.

And with that, we would like to turn the call over for questions.

So I would like to turn the call over to the operator who will coordinate the Q&A.

(Operator Instructions) We can now take our first question. It comes from Sandra Cauwenberghs of KBC Securities.

I have 2 questions with regard to the pipeline programs. So I saw that you mentioned 8 additional potential indications for ARGX-113. Could you give us some insight on when you could potentially see one of those translating into first clinical trial? And then the second question is with regard to the Broteio Pharma collaboration. So you mentioned that the target is undisclosed. But could you give us some insight on whether this could be a first-in-class program? With regard to the financials, if you could give us some insight on whether your full year '17 cash burn is estimated around $45 million or higher?

Thank you for these excellent questions. With regards to additional indications for ARGX-113, you are absolutely right to say that this is a pipeline and a product opportunity. We believe that not only myasthenia gravis and ITP may benefit from the mechanism of action of ARGX-113, and indeed, we have identified a number of additional indications where the patient would really benefit from a removal of pathogenic autoantibodies. Indications which are high on the list would be skin listing diseases but also lupus, multiple sclerosis. Whenever we plan to launch a third indication, Sandra, we will communicate about it at that point in time. Concerning the Broteio collaboration, I'm happy to confirm to you that indeed this fits the business model. This would be the first-in-class compound on a novel target in the complement cascade. We're currently going through some really important biology derisking experiments. If these experiments turn out to be positive, we will certainly announce the exercise of our option and we would also disclose the identity of the targets. For the third question, I would like to hand over to Eric about the cash burn -- expected cash burn for this company.

Yes. So Sandra, you mentioned a figure of EUR 45 million, which we believe more or less is going to be a good indication of what we should be burning in the year, excluding any costs related to the NASDAQ listing.

We can now move along to our next question. It comes from Boris Peaker of Cowen.

My first question is on ARGX-113. I'm just curious once the subcu formulation is available, do you then use it in MG and ITP going forward or do you plan to bring the IV formulation to market first? I just want to kind of find how these 2 formulations will play out later.

Thanks for joining us in the call today. The idea really is to go to market as fast as possible. So there is a high likelihood that we would be able to accomplish that with what I would call a plain vanilla IV product. What we learned through our market research is that subcutaneous product presentation could actually be very beneficial in both myasthenia gravis and immune thrombocytopenia when it comes to outpatient treatment. We could follow patients longer outside of hospital setting. We would also be able to address different patient segments in the market. So we believe the subcu investment is of strategic importance for both indications.

Great. And also on ARGX-113, can you remind me, was the Phase I data published? And if it hasn't, when is the publication expected?

I do realize that we had promised the publication for the first half of this year. Actually, the manuscript is in final draft form today. And actually the reason that the presentation or the publication got slightly delayed is for 2 reasons. First of all, we have been adding really important data from a mechanistic understanding point of view. And because of that, of course, we have also been filing additional patents. So I think that we'll be in a position to submit that manuscript in the coming weeks. Exactly when that's going to be published depends, of course, on the review process. But again, we will certainly give you a small alert when that publication comes out.

Okay. And lastly on ARGX-110. With data coming up at ASH and certainly many competing AML programs ongoing, in general, a very hot area of research, I'm curious what specifically do you want to be in this first update to show that the drug is competitive in this phase?

Well, remember that the translational data, which we published earlier this year in the Journal of Experimental Medicine shed a unique light on CD70. First of all, we believe this is one of the few targets which is truly present across cytogenetic risk factors and age classes in newly diagnosed AML patients. Secondly, we also believe that CD70 is one of the cleanest expressed targets in AML. It is overexpressed on leukemic stems cells. We have also shown that the highlighted pathway for the survival and proliferation plus CD70's absence on normal hematopoietic cells. So this is kind of unique target with important biology for leukemic stem cell survival proliferation. What we would really like to do is replicate these published ex vivo and mouse data in our patients. So I would call this a patient-poor and data-rich clinical trial. We will be showing data from the dose escalation with lots of data points both from the blast in circulation but also what happens in the bone marrow. And what we look to present this proof of biology data rather than statistically significant overall survival and response data.

We can now move along to our next question. It comes from Mike King of JMP Securities.

Wanted just maybe to probe a little more deeply on AML questions and then perhaps CTCL as well. Tim, you said that it's going be a patient-poor but data-reach presentation. I'm just wondering if we could get maybe a little bit of more color on sort of the size of the patient population that you will be presenting and maybe some thoughts on how much follow-up there will be available on those patients at the time you present? And maybe I can ask the same question on CTCL?

Yes, definitely. So the dose escalation -- the trial under dose escalation in AML is a 3 plus 3 design, where we are escalating from 1 milligram per kilogram to 3-milligram per kilogram to 10 milligrams per kilogram. So if there is no toxicity seen or limiting toxicity seen, I think the dose escalation could be done in 9 patients. If there would be tox seen in the high dose cohort because we are already there today, you would need to add an additional 3 patients. So you're going to get data from, let's say, roughly speaking 9 patients. Of course, a number of these patients will have been freshly enrolled. So we will not be able to say too much about how long they have been on study drug. For CTCL, we will give you an update on those patients, which are still on study drug from the Phase Ib study, the expansion cohort. So those patients which were still on study when we presented an update in Lugano, and we will give you an update on patients in the currently recruiting Phase II study. We hope to have that study fully recruited by ASH but, of course, we're not there yet so to be seen. So 10 CTCL patients roughly speaking for the Phase II, couple of patients still ongoing on the Phase Ib and roughly speaking 9 patients for AML.

Great. That's very helpful. And then just on subcu, Tim, what would you -- I want to understand what you are expecting or what would be a win for you as far as PK? And will it be clear from the data that you present later this year that it can then proceed to further development?

So first a clarification. We will start the trial before the end of the year. We will not report data before the end of the year.

Okay. My bad.

That's okay. Victory would be mine that we can replicate monkey data. So what is so unique about the monkey data is that the PK and PD profiles really overlap and we had a bioavailability of the molecule in the monkeys of more than 75%. Now that's a lot for the biological. And if this is true, it means that we have a highly concentrated stable product presentation, which would perfectly fit the more chronic dosing of either MG patients or ITP patients.

Moving along to our next question. It comes from Stéphanie Put of Degroof Petercam.

I just wanted to zoom in a bit more on the ARGX-113 and the additional indications. More specifically, where would you see the interest of pharma going or the partnering interests in which indications. I'm sure there is already some interest today, which indications would be preferable? And where do you see the timing for to partner to gain as much value as possible? And then secondly, would you consider using ARGX-113 or evaluating ARGX-113 as a monotherapy also? And then maybe finally, on ARGX-111, have you seen any increased interest from pharma following the results of the final study? And would you consider -- if no more interest, would you consider another study or would you just finalize and wait for a partner?

I will take your questions in reverse. So let's start with ARGX-111. We have always been very clear about the fact that c-MET is today out of fashion. It's not an immune checkpoint. I think there is still a lot of attention in the cancer space on immune checkpoints this being said the c-MET biology is so interesting that I think it's a matter of time and it will be again in the spotlight, especially in light of, for example, some of the more recent PARP resistance data. So that has not changed a lot. I think the Phase Ib data confirmed the profile of the molecule. We have a safe dose. We have confirmed activity. We think we know how our Phase II study could look like and we're basically in the partnering circle these days talking to interested parties. This being said, I would like to manage expectations about the speed by which we would be able to partner this molecule. We will certainly be disciplined. We told our investors that we're not going to invest on our own dollar in Phase II study for ARGX-111. So partnering is really the way to go. And back then to ARGX-113. Is this a monotherapy drug? It's certainly a drug, which I think we should give as a monotherapy, but it will most likely always be given in the background of standard of care consisting of corticosteroids and potentially broad immunosuppressant. These are drugs which are in the mainstay of disease management of both ITP and for myasthenia gravis. So I think we will always be looking to work in the background of that type of medication. In terms of indications, we're determined to take ARGX-113 to markets on our own dollar. That's why we have carefully selected myasthenia gravis and ITP as very interesting indications. I would be lying if I would be saying there would be no interest from big pharma in this type of molecule and this type of mode of action. We know that areas like lupus and MS are areas of high unmet medical need. These are typical indications in the spotlight of big pharma companies. But for the moment, we are determined to continue to add value to the molecule by holding onto rights for ARGX-113 and taking the molecule from Phase II into Phase III.

(Operator Instructions) We can now move along to our next question. It comes from David Nierengarten of Wedbush Securities.

I just had a quick one on the recent approval of Soliris on myasthenia gravis. Are there changes to the clinical trial -- the future clinical studies of ARGX-113 in MG to incorporate Soliris or how do you anticipate any changes to the clinical development?

Thank you, David, for this excellent question. There is not too much known, of course, yet about the commercial strategy of Soliris. I would like to point your attention to a recent article in BioCentury where Alexion was quoted to be thinking about launching the product in Europe and Germany first. And there was a statement made by the Alexion responsible saying that they would not change the price of Soliris for this specific launch. So he was talking about one price across indications. And that basically leaves the situation unchanged, David. So it looks like they will be getting approval or they are getting approval for refractory generalized MG. We think that's less than 10% of the total MG population. We believe that's at the end of the treatment paradigm. And we believe that from a commercial point of view, off-label use of such an expensive drug upstream in the treatment paradigm is unlikely. So it has not really changed our plans.

At this moment in time, we have no further questions remaining. (Operator Instructions) As we have no further questions, I will now hand the call back to speakers for any additional or concluding remarks.

Okay. Thank you, everybody, for joining the call about our earnings, and we are really looking forward to see you all in the near future. Thank you very much. Bye-bye.

That will conclude today's conference call. Thank you for your participation, ladies and gentlemen. You may now disconnect.