Takeda Pharmaceutical Co Ltd

TSE:4502

Earnings Call Transcript 2021-Q3

[Operator]

Good day, and welcome to the conference call of Takeda Pharmaceutical Company Limited. [Operator Instructions] Now we'll start the conference. Mr. O'Reilly, please go ahead.

[Christopher David O'Reilly, executive]

[Interpreted] Thank you very much for your participation in this conference call for the financial results for the third quarter of fiscal year 2020. My name is Christopher O'Reilly, Global Head of Investor Relations.

Before starting, I'd like to remind everyone that we will be discussing forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those discussed today. The factors that could cause our actual results to differ materially are discussed in our most recent Form 20-F and in our other SEC filings. Please also refer to the important notice on Page 1 of this presentation.

Now please let me introduce today's presenters and panel. Christophe Weber, President and CEO; Costa Saroukos, Chief Financial Officer; Andrew Plump, President of R&D; Masato Iwasaki, President of the Japan Pharma Business Unit; Ramona Sequeira, President of the U.S. Business Unit and Global Portfolio Commercialization; and Julie Kim, President of the PDT Business Unit.

First, we would like to start with the presentation followed by a question-and-answer session. Now I'd like to begin.

[Christophe Weber, executive]

Thank you for spending this time with us today. Well, in Q3, we are delivering on our goal and commitment in spite of the pandemic situation, which I think is demonstrating the grit of Takeda's people. If you look at our revenue, we have been accelerating our growth in Q3. And once again, I think it's a remarkable performance considering the coronavirus pandemic evolution in Q3 in many countries. This revenue growth and revenue performance is positively impacting our profitability, and you will have seen that we have a very strong profitability and very strong core operating profit margin.

Another goal that we have is that -- is to progress our pipeline, and we have seen great development. As we all know, 2021 will be a very special year when it comes to our pipeline progression. Andy Plump will come back on that, but we did share already with you very strong result with maribavir, for example, or also mobocertinib. And we filed already TAK-721 as well in the United States. So we are starting to really see momentum in our pipeline progression on our Wave 1 progression.

I will mention -- before having and the developing our pipeline progression, I will mention that -- a few points. In 2020, we achieved carbon neutrality for the first time in our history, and that was a key commitment we had regarding our carbon emissions. So we're really, really pleased with this performance. We have been named Global Top Employer for the fourth consecutive year. We want to be an organization which provides the best people environment for our employees.

We have been ranked #6 in the Access to Medicine Index. As you know, this is our key commitment. We are developing life-transforming medicines, but we want this life-transforming medicines to reach many patients across the world, as many patients as possible across the world. And last but not least, we -- in December, on December 22, we filed our remediation report regarding our Hikari site remediations. We are very pleased that we believe that we have progressed so that we have been able to file this report, and we are now awaiting answer from the FDA as the next step in terms of auditing our progress.

So once again, we are delivering on our goal and commitment. We are very pleased with this performance considering the environment and the headwinds that we are facing. And I think it puts us in a very strong position to finish the fiscal year 2020.

Without further ado, I will let Andy to develop our progress regarding our pipeline. Thank you very much.

[Andrew Plump, executive]

Thank you very much, Christophe. And Chris, if we can please go to Slide 8. So good morning, and good evening, everybody. It's a pleasure to have the opportunity to give you a brief update on what's been going on in our pipeline. And we have great palpable progress with our pipeline.

We have waves of innovation. We have a Wave 1 pipeline that is constituted, as Christophe said, of 12 innovative new molecular entities that we expect approval decisions by FY 2024. We have a sustainable pipeline with a deep research engine and a dynamic Wave 2 pipeline that we'll deliver after FY '24 that today has approximately 30 new molecular entities in it.

And something that you may have seen in Christophe's slide, very committed to developing these medicines globally, including China. And we expect by the end of our Wave 1 period to have over 15 approvals of our current global brands and new molecular entities in China. Today, a lot of what we do in China is catch-up. But our intent, our aspiration is for -- to globally register all of our NMEs across the globe at the same time, U.S., Japan, Europe and China, and we're making great headway in that regard.

2021 will be an inflection year for us. It's going to be a very exciting year with data readouts, with approvals, with submissions. By the end of 2021, we expect that for all 12 of our Wave 1 new molecular entities, they will either have an approval decision by a major regulatory body that will be submitted for consideration or they will be in pivotal studies.

Next slide, please, Chris. So as many of you know, we've changed the nature of how we communicate our pipeline from a very static pipeline that's defined by phase to one that's defined by time that we expect to deliver. It's very courageous, it's very difficult to have these kinds of projections, particularly years out. But we thought that given where we were as an organization and given the pace of innovation in our industry, that this is the more appropriate way to do this. And many of you are becoming familiar with this visualization.

I won't dive deeply today into this, only to mention 1 new program that's come back into our portfolio, and that's TAK-071. This is a Takeda discovered muscarinic 1 receptor positive allosteric modulator, very specific. It's completed Phase I, dosed in over 200 patients. We've paused the program about 1.5 years ago only for strategic reasons. And now we've brought it back and it's already started a Phase II study in Parkinson's disease.

If you go to the next slide, please, Chris, so how have we been doing so far in a very challenging year given the pandemic? I would say that our progress has been quite strong, in fact better than I would have expected, particularly given the dynamics of the past year. We've hit almost all of our key milestones that we set out and described to you at the beginning of the year in H1, and we're making good headway on the milestones that are coming in the second half of the year.

Just mentioned 2 milestones, 2 -- very briefly. Great data. As Christophe mentioned on maribavir, and I'll come back and dive a bit deeper into that at the end of this presentation.

And then just a clarification on TAK-007. TAK-007, which is our CD19 CAR-NK, our collaboration with MD Anderson Cancer Center, we're still very excited about this program, and we've seen terrific progress in our development of cryo-formulation that will allow us to now deliver this product off the shelf in a Takeda-driven IND Phase II proof of concept, and hopefully, registration-enabling study. Our hope is to start that study this fiscal year. That was a stretch objective for us, and we'll miss that, but we do hope to start that study very early in FY '22. And it is a program that had some slight delays because of COVID.

If we go to the next slide, this is Slide 11. Let me just spend a minute. We don't talk too much about the work that we're doing with respect to supporting our global brands. And there are just 4 programs that I'd like to highlight to you on this slide. The first is ICLUSIG. ICLUSIG is the most potent tyrosine kinase inhibitor, a BCR-ABL inhibitor that's marketed for patients with late-stage and resistant forms of CML, and also effective in Philadelphia positive ALL. In fact, it is the most potent and it's the only agent that's available for patients with resistant forms of disease. And unfortunately, many patients who should be getting ICLUSIG don't get ICLUSIG. And we -- through our research and discussions with physicians, it became clear that a big reason for this was the complexity of the label.

We work very closely with FDA to advance, very rapidly, the approval of our OPTIC study into the label, and we now have a greatly simplified and patient accessible label that has clarity around indication, around dose, around safety, and very importantly, it's now a simplified black box warning. This is -- I think for many of you, the [ trackers ] don't follow ICLUSIG quite closely, but this is a very important event for us.

The second I'll mention in our Rare group is TAKHZYRO. We started life cycle management program. As many of you know, TAKHZYRO is an agent that we use for patients with hereditary angioedema. There are other forms of bradykinin mediated angioedema and we're now studying the potential benefits of TAKHZYRO in a pivotal study for that group of patients.

In GI, I'd like to mention 2 programs. I know all of you are very interested in hearing about the ENTYVIO subcutaneous program. I'll only say that there are no new updates since the last time we spoke. We're still on track to have that approved and launched in FY '22.

And then finally, ALOFISEL, we had aspirations to extend indications beyond the perianal fistulas that exist in Crohn's disease, and to pursue additional indications such as complex cryptoglandular fistulas. And based on our discussions with regulatory agencies, we -- our hope was that we could go quickly into a pivotal study. Based on those discussions, we felt that, that might be more complex and so we've decided to wait for the readout of our large global ADMIRE 2 study, which we'll see data from next year.

Next slide, please. So as I mentioned earlier, all 12 of our Wave 1 NMEs will have pivotal milestones in the near future. While maribavir has achieved its FY '20 goal, let me quickly tell you what's happening with the other programs.

Essentially all of them are on track, and we expect them to hit over the next 2 months and achieve their FY '20 goal with 2 exceptions. One, pevonedistat, probably good news. It's the PANTHER study. I'll remind you that, that study enrolled over target. It was an accelerated enrollment. But we're seeing it's an event-driven study, and we're seeing a slowing of events. And based on our projections, we expect that study to read out in the first quarter or first half of FY '22. And one could look at that as good news. It's certainly good news for the patients in the trial.

And the second is TAK-609. This is a very niche program. We think it has -- will have benefits for a subset of patients with Hunter's disease. We'd have discussions with regulatory agencies. And right now, we don't have a package that can be submitted, but we're hopeful, through these discussions, to have something that will go in, in early FY '22.

Next slide, please. So just quickly on 2 programs. I'd like to share some data with you. One is on mobocertinib, and hopefully, you had a chance to see our oncology leadership, Teresa Bitetti and Chris Arendt present at the World Conference for Lung Cancer last week, and we're very pleased with the results from our second-line study with mobocertinib, patients with a particularly virulent form of lung cancer, those that are characterized by mutations in Exon20 of the EGF receptor gene. And as Chris and Teresa highlighted last week, we see a profile that's very consistent with a molecule that we'll file on and we're expecting to file that molecule in the next month or 2.

Next slide. Let me end with data that I suspect that many of you have not seen. This is maribavir. This is a molecule - it's a molecule that's a novel anti-CMV agent. It is a molecule that came in with the Shire acquisition. It was one that -- with the acquisition, our intent was to include, as part of our $10 billion divestiture target. But when we looked at the data, the Phase II data, and we looked at the streamlined commercial resourcing that would be needed to bring this to patients, we decided that this, in fact, was very much in line with our strategy, perhaps not our therapeutic area strategy, but our strategy to raise the innovation bar and to go after high unmet medical need.

This abstract that will be presented at the transplant and cellular therapeutics (sic) [ Transplantation & Cellular Therapy ] or TCT meeting next week was published a couple of weeks ago. You may not have seen it so I wanted to share some of those data with you. And I'll say that those data from this first pivotal study that we will register on affirm our decision to keep this molecule. It is a transformative profile for patients with relapsed and refractory CMV disease, both in terms of its safety profile and its efficacy profile, which are both challenges for patients and for transplant physicians.

Our intent is to file this molecule in the early part of fiscal year '22. And then to follow that filing on with the second one based on data that we'll read out from a frontline study, the TAK-302 trial that's currently more than 80% enrolled, and we expect data from later in the year.

So with that said, I will hand it over to Costa, please.

[Costa Saroukos, executive]

Thank you, Andy, and hello, everyone. This is Costa Saroukos speaking. Let me start with a summary of the key financial highlights on Slide 16.

Overall, I'm very delighted to report an acceleration of growth in quarter 3, once again demonstrating the resilience of our portfolio and our disciplined OpEx control. Underlying revenue growth was 1.1% year-to-date, driven by our 14 global brands. In particular, I want to highlight that growth in the third quarter, that is October to December, accelerated to 2.1%, our strongest quarter of the year so far.

The underlying core operating profit margin was 32.1%, benefiting from continued synergies and OpEx efficiencies. And reported operating profit was up 121%, reflecting lower acquisition-related costs. Operating cash flow grew by approximately 26% versus prior year. And free cash flow was JPY 717.5 billion or approximately USD 7 billion.

Based on this resilient performance, we are confident to once again confirm our full year management guidance for fiscal year 2020. Furthermore, we are upgrading our reported EPS forecast on a more favorable tax rate assumption, and we're increasing our outlook for free cash flow to reflect additional sales of marketable securities.

Finally, we continue to make great progress towards our midterm financial commitments with an additional noncore asset divestiture announced in China, taking the total of announced deals up to $11.6 billion. We also remain solidly on track to reach our target of mid-30s margin and 2x net debt to adjusted EBITDA within fiscal year 2021 to 2023.

Turning to Slide 17, this is a summary of the fiscal 2020 quarter 3 year-to-date results. The reported revenue was JPY 2.427 trillion, down 3.6% versus prior year, mainly due to foreign exchange and also impacted by divestitures. Underlying revenue growth, which adjusts for FX and divestitures, was 1.1% growth. Reported operating profit was JPY 358.7 billion, a significant improvement of 121% versus prior year. This was mainly due to lower purchase accounting and integration expenses related to the Shire acquisition.

Core operating profit, which adjust for the purchase accounting and nonrecurring items, was JPY 780.6 billion. This is a decline of 1.5% versus prior year due to FX and divestitures. Now if we adjust for those, underlying core operating profit growth was strong at 8.5%. Importantly, we continue to deliver margin improvement with our core and underlying cooperating profit margins, both over 32%. Reported EPS was JPY 115 and core EPS was JPY 333 . Underlying core EPS growth was up 4.5% and we're confident that this will further improve in quarter 4 to reach our full year guidance of low-teen growth due to phasing of tax expenses.

Finally, cash flow for the quarter was robust with operating cash flow growing at 25.9%. Free cash flow was an impressive JPY 717.5 billion or approximately USD 7 billion.

Slide 18 gives you more insight into the magnitude of the FX and divestiture impact on our year-to-date revenue and core operating profit. As you can see, appreciation of the yen had a negative impact of 3.2 percentage points on revenue. This was due to appreciation of the yen versus the U.S. dollar and several emerging market currencies, including the Brazilian real, Russian ruble and Mexican peso. Completed divestitures impacted year-on-year growth by 1.5 percentage points.

On Slide 19, I'll discuss the revenue drivers for the period. Our 5 key business areas representing 82% of total revenue continued to grow steadily at 4% on an underlying basis. GI, which accounts for approximately 1/4 of our revenue, continues to grow exceptionally well at 14%. Now this was spearheaded by ENTYVIO, which continues to gain market share globally, particularly in UC in Japan. ENTYVIO was also recently launched in China with accelerated national reimbursement.

Rare diseases declined 3% with rare metabolic impacted by NATPARA recall in the U.S. and competition, as expected, in rare hematology. On the other hand, our HAE franchise is expanding well with growth of 16%, driven by the continued excellent performance of TAKHZYRO, which was also recently approved in China.

PDT Immunology growth remained strong at 9%. This was driven by the immunoglobulin portfolio as well as growth from first leader products, such as GLASSIA. However, we did see a decline of albumin due to a temporary interruption to a batch release of albumin in China. We are confident to find a solution to this, but as a result, we do not expect growth in albumin revenue this fiscal year.

Oncology grew 3% with growth brands NINLARO, ALUNBRIG, ICLUSIG and ADCETRIS, more than offsetting the declines of VELCADE and Leuprorelin.

Neuroscience declined slightly with both VYVANSE and TRINTELLIX still seeing some impact from COVID-19 stay-at-home restrictions. New patient starts recovering, but are not yet back to pre-COVID levels.

Finally, other noncore products declined minus 13%. As mentioned previously, this is the group of products which have been the target of our divestiture program.

I'll skip over the next few slides. Please refer to them for more details on each of our key business areas.

So please turn to Slide 26. So Slide 26 shows the revenue of our main products within our key business areas. In particular, we have focused on maximizing our 14 global brands indicated here by the red globe symbol. In total, these products generated JPY 910 billion year-to-date or approximately $8.8 billion with growth of 15% on an underlying basis. In particular, ENTYVIO, TAKHZYRO, Immunoglobulin and our oncology brands performed well.

Moving now to Slide 27, which shows the bridge from reported to core operating profit. Reported operating profit was JPY 358.7 billion. From this, we adjust out approximately JPY 377 billion in total of noncash items related to purchase accounting, such as unwind of inventory step-up and amortization and impairment cost. We also adjust out the JPY 58.5 billion of onetime Shire integration-related costs, which are enabling us to realize our synergy targets.

Adjusting for these and other onetime or noncash items, we arrive at core operating profit for the 9-month period of JPY 780.6 billion. This is well on track towards our full year guidance of JPY 984 billion.

Moving to Slide 28, where we show our underlying core operating profit margin, as you can see, we continue to make great progress towards our medium-term target of top teen margins in the mid-30s. In quarter 3 year-to-date of fiscal year 2020, we achieved an underlying core operating profit margin of 32.1%, which means we are well on track towards the full year target of low 30s.

Now switching gears to cash flow on Slide 29 shows the evolution of our cash balance over the first 9 months of the fiscal year. Operating cash flow was JPY 610 billion, comfortably covering the full year dividend payment, the debt repayment and interest costs. Free cash flow, which also takes into consideration CapEx and proceeds from the sale of noncore assets was JPY 717.5 billion. This included cash from marketable securities, sale of real estate and noncore asset divestitures that closed by December, including deals in Europe and Asia Pacific. As a result of our robust cash flow, we ended December maintaining our strong liquidity profile of approximately $12.8 billion.

Slide 30 shows the net debt evolution over the period with an improvement of JPY 287.5 billion between March and December 2020. Our robust cash flow enabled us to end quarter 3 with net debt to adjusted EBITDA at 3.6x, an incremental reduction from quarter 2 despite second half year dividend being paid in December. With the full year dividend completely paid, we expect leverage to further improve in quarter 4 especially with the anticipated cash from divestitures we expect to close by March 31.

Let me provide further update on the divestitures on the next slide. So on Slide 31, you can see here, it's our noncore asset divestiture program. As of quarter 2, we had already exceeded the $10 billion target. And since then, we've announced 1 incremental deal or the sale of noncore products in China. This brings the pretax total of announced deals to up to $11.6 billion. Importantly, we are making great progress towards completing these divestitures with 5 deals closing since our quarter 2 announcement.

Please note that 2 of these deals for noncore assets in Latin America and for TachoSil closed within the past week, and therefore the cash is not recognized yet on our quarter 3 balance sheet.

On the right side of the presentation, you can see that we have made great progress with the sale of real estate and marketable securities as well. Versus our initial target of $700 million for the year, we have now delivered approximately $1.4 billion.

Next, Slide 32, which shows our updated debt maturity ladder. With the abundant cash flow generated year-to-date, we have paid down all bonds maturing in fiscal year 2020, and we have announced cause to prepay the majority of bonds maturing in fiscal year 2021. The structure of the debt ladder, along with our expectation for continued strong cash flow into the coming years, underlies our financial resilience.

On this slide, I also wanted to underscore the progress we have made in reducing debt since the close of the Shire acquisition. Including the prepay course we have made for 2021, in total, we have reduced the face value of our debt by JPY 1.3 trillion or $12.5 billion since March 2019.

Moving now to Slide 33, where we are confirming management guidance. We are confirming low single-digit underlying revenue growth, high single-digit underlying core operating profit growth, low 30s underlying core operating profit margin and low-teen underlying core EPS growth. For our reported forecast, we are upgrading our EPS forecast from JPY 79 up to JPY 116 due to a more favorable tax assumption. This reflects a reduction of planned tax restructuring expenses and this is a result of Takeda being able to accelerate the legal entity integration and optimizing programs at a lower overall cost.

We are also raising our free cash flow forecast range by JPY 50 billion to JPY 750 billion to JPY 850 billion. This reflects the incremental sale of marketable securities we completed in quarter 3. Our forecast for core operating profit is unchanged at JPY 984 billion, and core EPS is unchanged at JPY 420.

So in summary, on Slide 34, I would like to reinforce how Takeda is making steady progress towards our financial targets. We are pleased to confirm full year management guidance. We're also generating robust cash flow and are upgrading our free cash flow forecast for the year to JPY 750 billion to JPY 850 billion. We've continued to make great progress against our divestiture target and have exceeded our goal of $10 billion with 11 deals announced to date worth up to $11.6 billion. And finally, we continue to prioritize deleveraging. With ongoing contributions from our strong operating cash flow plus additional cash from divestitures expected in quarter 4, we remain on course to achieve our target of 2x leverage within fiscal years 2021 to 2023.

Finally, I want to leave you with a list of upcoming IR events on Slide 35. On March 11, we are planning an investor event focused on our growth and emerging market strategy. And on April 6, we have a Part 2 of our Wave 1 market opportunity pipeline calls where we'll talk more about our innovative Wave 1 pipeline assets, including deep dives on maribavir and Orexin. We hope that you can join us for these calls.

Thank you very much for your time today, and I'll hand it back over to Christophe to close. Thank you.

[Christophe Weber, executive]

Thank you, Costa. As you can hopefully see, we are really demonstrating steady progress towards our goal to grow in a sustainable way in the long term and in a profitable way as well. So -- and again, 2021, in spite of this pandemic situation, will be an exciting year for Takeda because of our business progress and also because of our pipeline inflection. So this start of the calendar year is exciting for us, and we are looking forward to the rest of the year. Thank you very much.

[Christopher David O'Reilly, executive]

[Interpreted] Now we'd like to questions. Operator, please.

[Operator]

[Operator Instructions] The first question is from Citigroup, Mr. Yamaguchi.

[Hidemaru Yamaguchi, analyst]

[Interpreted] This is Yamaguchi from Citi. May I ask all 3 questions at 1 time?

[Christopher David O'Reilly, executive]

[Interpreted] Yes.

[Hidemaru Yamaguchi, analyst]

[Interpreted] My first question is about the financial improvement progress. And the investors' return share buyback or dividend increase, I think the timing may be coming across. What is your comment?

Second is Mobocertinib filing is approaching. And at the same time, Johnson & Johnson have amivantamab, and very competitive data was announced. What is your evaluation of amivantamab?

Number three is IgG, globally, has been performing well, but the plasma collection, what is the most recent negative situation of the progress of the plasma collection. Is it improving?

[Christophe Weber, executive]

For the question, so Costa for the first question, I'll propose Andy second, and Julie for the third.

[Costa Saroukos, executive]

Yes, thank you, Yamaguchi-san. So firstly, we're really impressed to see our progress on deleveraging and debt reduction. We remain committed to our capital allocation policy, that is deleveraging rapidly, invest in our growth business, in particular, investing in China for growth. We're investing in our pipeline in R&D, and we're investing in PDT, our plasma business and we're maintaining the dividend.

But you're right. However, we have seen and we've discuss possible options for shareholder returns on an ongoing basis, both at executive and Board level. And we do see our shares as undervalued, and we continue to monitor this. So in principle, we are keeping a very close eye on the share price, but we do also want to remind you that we do believe that 2021 is an inflection year for the pipeline. And we'd like to see how our share price responds to these developments; and again, remind you all that our second Wave 1 pipeline event is on April 6, and please join those calls. Thank you for your question.

[Andrew Plump, executive]

Yes, Yamaguchi-san, it's Andy. Thank you very much for your question. So rather than comment on J&J's product, I'll just say that this EGF receptor Exon20 lung cancer is a brutal disease with very short life expectancy and very limited benefits in existing standards of care. You now have 2 agents that are quite distinct mechanistically. They work entirely different mechanisms that have benefits for patients.

I would look at the entire profile that we've taken. They each have their own tolerability and safety profiles. I would look carefully at duration of response. But I think in general, what you're seeing is you're seeing a real step function in terms of our ability to meet the needs of this very dire patient population.

[Julie Kim, executive]

And then I'll take the third question around plasma collections. This is Julie Kim. Thank you for the question, Yamaguchi-san. I'm happy to report that we are continuing to see good recovery in our plasma collection. So for Q3, we have seen improvements over Q2, which was an improvement over Q1. So everything is moving in the right direction and in terms of the plasma collection supply.

[Shinichiro Muraoka, analyst]

[Interpreted] This is Muraoka from Morgan Stanley MUFG.

[Christopher David O'Reilly, executive]

[Interpreted] Yes. We can hear you.

[Shinichiro Muraoka, analyst]

TAK-994 is my question. First of all, the POC data that is coming up is on [ criticaltrial.com ], it's announced on that website. Phase I, 120 patients are targets, and this is a data that is going to be announced soon. Is that correct?

And the second question, [ criticaltrial.com ] has another announcement, 202 people, Phase II study, NT1 and NT2, they have also included. And it says that it will be ending in May. The top line data, when will it be available? Will it be available in May or later?

And my last question, also on TAK-994, Slide 12. You talked about, in the second half of '21, pivotal study will be starting. The design of that study, is that for Phase II 202 patients? Would it be the similar design that will be adopted with the increases in the number of sites? Is that the correct interpretation? Thank you.

[Andrew Plump, executive]

Christophe, would you like me to step in, Christophe?

[Christophe Weber, executive]

Yes, of course.

[Andrew Plump, executive]

Yes, so Muraoka-san, I invite you to come to our April R&D Day. All of your questions will be answered then, so rather than dive deeply into a lot of detail that you're asking, which I can't answer right now. Let me just say that we continue to advance this program with the highest priority. We actually are still using our TAK-925 IV molecule to build out indications. You'll see additional data from TAK-925 in April. We're very pleased with the progress of TAK-925. It's in a Phase II study that you'll learn more about. It's a complex study. It's a proof-of-concept study for NT1, for NT2 and will be a dose-ranging study that will support our filing and lead into a Phase III study that we hope to start at the end of this year. And in addition, we have a third molecule, TAK-861, which we hope to enter the clinic soon. So we're making great progress. And we're very excited about the program. And you'll get more detail in April during the R&D Day.

[Operator]

[Interpreted] Next is Credit Suisse Securities, Mr. Sakai. Sakai-san, please.

[Fumiyoshi Sakai, analyst]

[Interpreted] This is Sakai, Credit Suisse. I'd like to ask you rather detailed question of 3 questions. Albumin, in China, I think there was some batch release program. And in 2019, you had a similar program. And I think China is quite strong at albumin, but I think you suffer a lot of opportunity loss due to this. So what's your share currently? I'd like to ask Julie to give us an update regarding the situation of albumin in China.

And the second question is about a domestic matter. So maybe this is a question to Iwasaki-san. The employee supporting system, including early retirement, what is the impact? As much as you can, if you can share with us some details, please. Number 3 is about TAKHZYRO. What is the progress update of development for COVID treatment?

[Julie Kim, executive]

So Christophe, would you like me to start with the first one?

[Christophe Weber, executive]

Yes.

[Julie Kim, executive]

So thank you for the question, Sakai-san. In terms of the albumin situation, let me separate the 2 challenges that you've identified. In terms of the FY 2019, where we saw lumpiness in our growth, that was due to the reregistration, the blackout period that follows reregistration which happens on an every 5-year basis for products in China.

The current situation is something different. And this is a temporary supply batch release interruption. This is something that's not a quality issue. It is due to product appearance. And we are working very closely with the relevant authorities in China to resolve the issue, and we hope to have that done very soon.

So 2 different issues, not the same challenge. I don't think that this speaks to an overall difficulty with capitalizing on opportunities in China. We continue to see very strong growth, for example, for our FLEXBUMIN albumin product, very strong double-digit growth in China. And so we will continue to support the patient demand for our albumin portfolio. And as I said, we hope to have this batch release issue resolved very soon.

[Masato Iwasaki, executive]

[Interpreted] Sakai-san, Iwasaki speaking, thank you for your question. I think you are talking about our future career program. And as we discussed last time, this program is -- if there are employees who want to develop their careers not in Takeda organizations but outside, we would like to support them. And any expenses of this program, that's already included in FY 2020, although we don't disclose specific numbers.

And highly unmet medical needs, 5 business areas are our key focuses, and we'd like to focus on those specialties and we have to be a highly innovative pharma company. And that way, we'd like to achieve transformation. We have been making steady progress and would like to obtain 31 approvals in coming 5 years so that we'll be able to meet those highly unmet medical needs.

[Christophe Weber, executive]

COVID study.

[Andrew Plump, executive]

Yes, and then Sakai-san on the COVID study, we're testing 2 molecules that are modulators of the same path, the [ metallic ] and the timing system. And just to be clear, we're using a novel drug product of lanadelumab that's in an IV formulation, not TAKHZYRO in the 1 study. We're also using FIRAZYR. Both are in platform trials. Those are trials have been multiple in single comparator on a single control arm. That FIRAZYR actually just passed its first interim analysis, a 10 of 50 interim analysis that's being tested in critically ill patients. These are patients that are hospitalized and in the ICU, often on ventilatory support. And we expect final results from that study in the first half of FY '21.

And then for IV lanadelumab, that's in a study called COMMUNITY, which is a platform study that's quite unique with very strong industry partnership; AbbVie, UCD also in that study. That study is enrolling and we expect first interim analysis also in the first half of FY '21.

[Unknown Analyst]

[Interpreted] I have 2 questions. The first question about the results performance for next fiscal year, would you be looking for increases in profit? You'll be selling off the assets and the plasma business top line? And what is your thought on the margin going forward for next fiscal year?

And the second question about ENTYVIO, about the biosimilars. At the R&D explanation session, 2032, the patent will be protected. I think that was as message given at that explanation session. So what is your thought on that?

[Christophe Weber, executive]

Thank you, [ Arai-san ] for the questions. So we believe that we will see growth acceleration. Of course, we'll not give our guidance for next year now. We'll have to wait for May to see this guidance. But what we believe is that we are in a phase of growth acceleration because of the momentum that we see with our global brands and also the headwinds that we have faced regarding generics, for example, being lower. So that's really what we have in mind. And this is already what we are starting to see in the Q3. So more to come. And Costa could comment further regarding the margin and the margin improvement. But I can just say that we are committed to our midterm goal to be in the mid-30s range.

Regarding ENTYVIO, what we said is that the scenario of biosimilar entry in May 24 in Europe, on May 26 in the U.S. is the earliest date. So it's a conservative scenario. Why? Because this is the expiration of our data exclusivity at this date, but we have some patterns which are expiring later up to 2032. So we are not saying that no biosimilar will enter. Until then, what we are seeing is that it's a complex situation and the scenario of biosimilar entry in '24 and '26 is worst case, if you like, the most conservative scenario. This is the one we prefer to use for modelization.

[Costa Saroukos, executive]

So Christophe, just reinforcing your comment, nothing's changed with our direction on margin. So we've committed to mid-30 margin by fiscal year '21 to '23. One thing to remember is the synergy deliverables, majority, most of it, would have been completed by fiscal year '21. So that's also going to help drive the acceleration to propel our margin furthermore.

[Operator]

Next is Wakao-san, JPMorgan Asset Management.

[Seiji Wakao, analyst]

I am Wakao from JPMorgan. I have 2 questions. First is the gross margin of Q3, more than I expected. It's high. You enjoy very high margins, and I think it's due to FX. But ENTYVIO performed very well. So this -- the profit, how did you see this actual result compared to your plan? If it's higher, down core operating profit, the JPY 984 billion, would it be expected to be even higher?

Next is about PDT business. Plasma collection center situations were described. And up to today, given the collection status so far, what is the expectation of this business in the next year. And if it's on recovery trend, I think maybe it's too difficult to achieve 10% to 2% -- 20%. However, if you have some forecast for the next year, PDT business, please, let us know.

[Costa Saroukos, executive]

Thank you very much, Wakao-san, some for your question. I take it when you talked about the margin, you're referencing the gross margin for quarter 3, we have improved, yes, indeed, and that was mainly because of the product mix. So we're seeing the drivers of our 14 global brands, they continue to grow. And then most of those assets, in the 14 global brands, have higher margin as well. So we're seeing that's helping deliver the improvement in the margin.

[Julie Kim, executive]

And in regards to the plasma business, for -- there were a few questions, so let me try to cover them. In terms of our growth this year, we are -- we continue to reaffirm our IG overall growth to be in the 10% to 20% range. However, as you've heard from both Costa and myself in regard to the albumin challenge that we faced this quarter, we're no longer going to have albumin growth for the year in the 10% to 20% range. It will be negative. And therefore, for overall PDT, the year will not be in the 10% to 20%, but in the 0 to 10%. So that's as reflected in the materials.

In terms of the expectations for next year, as Christophe responded to an earlier question about expectations for next year, I invite you to join us in May when we can share that information.

[Operator]

The next question is from Mr. Stephen Barker from Jefferies.

[Stephen Barker, analyst]

Steve Barker from Jefferies Securities. I have 2 questions. One is about TAK-007 and the other is about the TAKHZYRO. Regarding 007, I mean this is a very hot area. The incredible stock performance of Fate Therapeutics has drawn a lot of attention to NK cells. So I understand that the start of the trial was being delayed until next year. I was wondering if you could perhaps give us a little bit more detail about why that is. Is it something to do with the manufacturing, being able to create a viable cryogenic product? I understand, it's a major challenge.

And then Regarding TAKHZYRO, just looking at the sales trends in the U.S., it just looks like it's -- the growth is flattening out. If you can give us some comments about your -- how you view prospects for TAKHZYRO in the U.S. and overseas markets over the next several years. Thank you.

[Christophe Weber, executive]

Thank you, Steve. Andy, followed by Ramona.

[Andrew Plump, executive]

Steve, thank you very much for the question. So just with respect to the profile of TAK-007, it still has, by far and away, the greatest experience in patients and the most compelling overall profile of any of the NK therapies that are out there.

With respect to timing, we're starting a Takeda-initiated IND. That's the nature of the study, which will be proof of concept for the new cryo-formulation, and also we hope a registration-enabling study. It was aspirational when we signed the deal with MD Anderson to have that kicked off in fiscal year '20, and we missed that by a couple of months. And so we'll push that out into FY '21.

I think I'm quite pleased with the progress that we made. We have a very strong cryo-formulation. And we have a product that will enable the study that we're going to be running. I think that, going back again, it's a partnership with MD Anderson and I think COVID had effects on this program and on this program's timelines. But there's nothing technical that is holding us back. We're really on target, and I'm quite excited about next steps.

[Ramona Sequeira, executive]

It's Ramona here, Steve. Thank you for the question on TAKHZYRO. So let me speak a little bit to the U.S. and Rest Of World as well. We're really pleased with the continuing growth in the U.S. So as you know, as this product was launched, it penetrated very quickly into the prophylactic segment in the U.S. And what we're seeing now is a much even larger group of prescribers prescribing TAKHZYRO and having numerous patients. So we kind of went from a small group of prescribers to a larger group with maybe just 1 patient, many of them. And now we're seeing more prescribers having multiple patients. So you really see the dynamic in the prophy market starting to change with people seeing TAKHZYRO as a way to help their patients [ deal with TAK-003 ] and really the best option to do that. We're also seeing the prophylactic market growing in the U.S. So we're penetrating more and more into new to Takeda and new to prophy patients as they come on board.

And then you'll see a number of TAKHZYRO launches, including China, outside the U.S. happening over the next few months. It has been happening over the last few months. So I think roughly 20 launches for TAKHZYRO in FY '20 alone. And that will continue into FY '21 as well. So you'll see the global sales of this brand start to grow as well. We had shared, at our R&D Day, a peak sales trajectory of TAKHZYRO of within $1.8 billion to $2.2 billion. We're still very confident in that. We see the momentum continuing towards that and are very pleased with the uptick.

[Christopher David O'Reilly, executive]

[Interpreted] Due to time constraint, we would like to take the final question.

[Operator]

The next question is from Ms. Stacy Ku from Cowen.

[Stacy Ku, analyst]

Hi, Stacy Ku from Cowen. I have a few. First, given argenx's recent positive FcRn interim results in CIDP, wondering if you guys have any updated thoughts in terms of the long-term immunoglobulin position there.

Second is another question on TAKHZYRO. I know it's still early days, but now with BioCryst's ORLADEYO on the U.S. market, any very early commentary on what you're seeing? Our clinicians do tell us that TAKHZYRO's efficacy is unparalleled, but how should we be thinking about this competition? And maybe any nuances on the new to prophylactic patient space?

And then last question is a follow-up on TAK-007. Would you be willing to provide any guidance on when we could see any initial results from the Takeda driven trial?

[Christophe Weber, executive]

Thank you, Stacy. Perhaps, Julie, Ramona on [ NDA ]?

[Julie Kim, executive]

Thanks for the question, Stacy. And if you look at the information that argenx has released they didn't release very much, but they did share that they had just met their predetermined analysis to continue their study. They needed 14 out of 30 subjects to be able to move forward and they achieved that 14 based on what they shared.

So from our perspective, again, innovation for patients is something that we welcome. The information that was released does not cause us to change our expectations in terms of the potential impact. We will continue to monitor and see what they release as they have more data that becomes available.

I would continue to reiterate the fact that there's still significant needs on the primary immune deficiency and secondary immune deficiency side. And that while -- if something like argenx's anti-FcRn does prove to be successful, we would expect it to have an impact. It would not mean end of growth for IGs overall. Ramona, over to you.

[Ramona Sequeira, executive]

Yes, Stacy, thanks for the question. So yes, ORLADEYO has just been recently launched in the U.S.. If you look at the market in the U.S., first of all, as you mentioned, TAKHZYRO really has a very unique profile with the patients living 8 out of 10 day attack-free, 87% reduction in attacks. Very, very strong data, really doesn't compare -- ORLADEYO really doesn't compare. The data is very different.

However, there is -- in the U.S. and globally, there's -- as you look at the market, there's kind of more mild patients, moderate and severe. In general, it's the more moderate and severe one that tend to go for prophylactic treatments, and those are the ones that we're picking up as they come off of acute treatment and go into prophylactic treatment.

There are mild patients that may prefer an oral agent because they don't have many attacks to begin with and use very little acute rescue therapy as well. It remains to be seen. I think once the patient decides to go on prophylactic therapy, the question is will they prefer something that they know is going to work because they want to become less dependent on rescue therapy. So it just remains to be seen. We're keeping a close eye, and I'd say it's really too early days now to know where the uptake might be coming from in the future.

[Andrew Plump, executive]

And Stacy, thanks for your question, it's Andy. I can't share, right now, exact timelines with you. Perhaps we'll have more data to share at the April R&D Day for TAK-007 or in the 4Q discussion.

I will say, though, that it's one of the highest priority programs. We have what we call an accelerated prioritization behind it. And then it works through a very unique operating model given that it's in cell therapy. We have a very substantive internal infrastructure that's been built around this program, and we expect that this will be a multi-site trial that will be accelerated. And we can provide more guidance as we get closer to starting that study.

And then if I may add, just unrelatedly, I made an error in my presentation in terms of time line. I sometimes get confused between calendar year and fiscal year, and I mentioned that near-term milestones for pevonedistat data readout and maribavir filing would be first half of FY '22, and that was incorrect. It's FY '21.

[Christopher David O'Reilly, executive]

[Interpreted] With that, I would like to end this conference call for today. Thank you very much for your participation despite your busy schedule. We ask for your continued support. Thank you.

[Operator]

Thank you for your taking time, and that concludes today's conference call. You may now disconnect your lines.