Earnings Transcript for 4568.T - Q3 Fiscal Year 2023

Koji Ogawa: Ogawa speaking. Thank you very much for joining Daiichi Sankyo's Financial Results Presentation out of your very busy schedule today. I am going to explain FY 2023 Third Quarter Financial Results we announced at 1 p.m. on Wednesday, January 31, JST, based on our presentation materials. Please turn to Page 3. This is the agenda for today. We will cover FY 2023 third quarter consolidated financial results, FY 2023 forecast and annual dividend forecast, business update and R&D update in that order. R&D update will be explained by Wataru Takasaki, Head of Japan R&D. We will entertain your questions at the end. Please turn to Page 4. This is an overview of FY 2023 third quarter consolidated results. Revenue increased by ¥225 billion or 23.7% year-on-year to reach ¥1,173.3 billion. Cost of sales increased by ¥52.9 billion from the previous year. SG&A expenses rose by ¥103.1 billion and R&D expenditure increased by ¥15.1 billion year-on-year. As a result, co-operating profit increased by ¥53.9 billion or 45.5% year-on-year to reach ¥172.2 billion. Operating profit including temporary gains and losses, increased by ¥67.4 billion or 53% year-on-year to ¥194.6 billion. Profit attributable to owners of the company increased by ¥76.9 billion or 88.7% year-on-year to reach ¥163.6 billion. As for the actual currency rates, the U.S. dollar was ¥143.29. The yen depreciated by ¥6.76 year-on-year. The euro was ¥155.28. The yen depreciated by ¥14.68. Please turn to Page 5. From here, let me explain positive and negative factors for revenue, compared to the previous year. Revenue increased by ¥225 billion year-on-year. I will explain its breakdown by business unit. First, in Japan business, revenue increased by ¥57.9 billion as sales increased for anti-influenza viral agent Inavir, direct oral anticoagulant Lixiana, anti-cancer agent ENHERTU, pain treatment Tarlige, and also for vaccine business including COVID-19 vaccine DAICHIRONA, which I will explain later. Next, let me explain our overseas business unit. ForEx impact is excluded here. In oncology business, revenue increased by ¥97.2 billion due to the growth of ENHERTU in the United States and Europe. The contribution of anti-cancer agent VANFLYTA launched in the United States in August last year. As for American region, sales decreased for iron deficiency anemia treatment Injectafer, but sales increased for iron deficiency anemia treatment Venofer and generic injectables. So, revenue increased by ¥1.3 billion. Revenue for EU specialty business increased by ¥12.1 billion as sales rose for Lixiana and hypercholesterolemia treatment Nilemdo and Nustendi. In ASCA business responsible for Asia, South and Central American regions, revenue rose by ¥21 billion, due to the growth of ENHERTU mainly in Brazil. As for upfront payment and regulatory sales milestone, et cetera, related to alliance with AstraZeneca and U.S. Merck, 3.46 out of the deferred revenue related to upfront payment in a strategic alliance with U.S. Merck for three DXD ADC products including HER3-DXd, we booked revenue for the period from the signing of the agreement up to the end of December. On the other hand, regarding multiple ENHERTU-related regulatory milestones achieved last fiscal year, we booked lump sum revenue last fiscal year for the period from the signing of the agreement up to the milestone achievement. So, this led to revenue decrease of ¥4.5 billion. ForEx impact increased our revenue by ¥40 billion in total. Page 6, shows positive and negative factors for our core operating profit. I will explain the profit increase of ¥53.9 billion by item. As I explained earlier, revenue increased by ¥225 billion including the increase of ¥40 billion due to ForEx impact. Next, I will explain cost of sales and expense items excluding ForEx impact. Cost of sales increased by ¥44 billion due to the revenue increase. SG&A expenses increased by ¥87.1 billion due to an increase in ENHERTU-related profit sharing with AstraZeneca, et cetera. R&D expenditure rose by ¥5.2 billion due to an increase in 5DXd-ADCs R&D investments. Cost increased due to ForEx impact by ¥34.8 billion in total. Core operating profit increased by ¥48.6 billion excluding ForEx impact. Next Page 7 shows positive and negative factors for profit attributable to owners of the company. As I explained earlier, core operating profit increased by ¥53.9 billion including ForEx impact due to factors such as lump sum payment received from Novartis following the settlement of Plexxikon's patent infringement lawsuit. Temporary income expenses increased our profit by ¥13.5 billion year-on-year. Financial income expenses, et cetera increased our profit by ¥4.5 billion year-on-year, due to increase in interest income and improvement in investment securities valuation gains losses despite deterioration in ForEx gains losses. Pre-tax profit increased, but due to the impact of the tax effect accounting associated with our decision to transfer Daiichi Sankyo ESPHA, income taxes, et cetera decreased by ¥5 billion year-on-year. As a result, profit attributable to owners of the company increased by ¥76.9 billion year-on-year to reach ¥163.6 billion. Page 8 and 9 show revenue increase, or decrease in Japanese yen by business unit, and by major product in Japan. Earlier on Page 5, I explained the situation of each unit by excluding the ForEx impact, but here we are showing the results including the ForEx impact. Next, I will explain FY 2023 forecast. Please turn to Page 11. Revenue has been revised upward by ¥30 billion from the October forecast to ¥1,580 billion to reflect the positive ForEx effect by the yen's depreciation and sales increase of Inavir due to the outbreak of influenza and sales increase of DAICHIRONA with 1.4 million doses we supplied in December. We are expecting cost of sales to increase, due to the revenue increase and ForEx impact. On the other hand, due to the improvement in the COGS ratio by product mix changes, we are expecting cost of sales to increase by just ¥3 billion. We are expecting SG&A expenses to increase by ¥9 billion based on ADC production expansion. R&D expenditure is forecast to decrease by ¥7 billion, by increase of cost sharing for 3DXd ADC products with U.S. Merck. As a result, core operating profit has been revised upward by ¥25 billion to ¥180 billion. Operating profit has been revised upward by ¥50 billion to ¥200 billion mainly to reflect, the temporary income increase, due to payment received from Novartis following the settlement of Plexxikon's patent infringement lawsuit. Pre-tax profit has been revised upward by ¥45 billion to ¥205 billion mainly to reflect increase in financial expenses, due to deterioration in ForEx gains, losses and others. Profit attributable to owners of the company, has been revised upward by ¥40 billion to ¥175 billion in response to the upward revision of pre-tax profit. Our fourth quarter currency rate are ¥145 for the U.S. dollar and ¥155 for the euro according to assumptions. Due to the ongoing yen's depreciation vis-a-vis our October forecast, ForEx is expected to have an impact to increase our revenue and co-operating profit by about ¥8.5 billion and about ¥5.5 billion respectively. Page 12 is about the revision of annual dividend forecast. We will increase FY 2023 annual dividend forecast per share to ¥50. As of April last year, we were planning to increase annual dividend per share to ¥34 up by ¥4 from FY 2022, due to increased likelihood of achieving KPIs for FY 2025 driven by sales growth of ENHERTU and others. As of October last year, we revised our plan to increase dividend by ¥6 to ¥40, compared to our April forecast, due to received upfront payment related to strategic collaboration with U.S. Merck with 3DXd ADC products and strong performance of Enhertu and others. Based on continuous strong business performance and lump sum payment received from Novartis following the settlement of Plexxikon's patent infringement lawsuit in the United States, we made an upward revision of FY 2023 consolidated forecast. So, we are increasing the dividend per share to ¥50 up by ¥10, compared to our October forecast and up by ¥20 from FY 2022. We will continue to increase capital efficiency, further enhance returns to shareholders and aim for DOE of 8% or higher in FY 2025, which is set as a KPI in the fifth midterm business plan. Next, I would like to talk about the business update. Slide 14 shows the breakdown of Enhertu revenue. The sales in the first nine months of fiscal year '23 grew by ¥136.3 billion year-on-year to ¥276.0 billion, due to growth in the U.S., Europe and other regions. The sales situation in each country will be explained later. The development milestones are as follows. With the approval of the second-line treatment of HER2 Mutant NSCLC in Europe in October last year, the development milestone of ¥3.6 billion was listed in the third quarter of fiscal year '23. For development milestones achieved in the last fiscal year, the amount equivalent to those from the signing of the agreement, to the achievement of the milestone, was recorded as a lump sum revenue for the last fiscal year. As a result, it decreased by ¥9.7 billion from the same period last year to ¥10 billion. As a result, ENHERTU total revenue including upfront and quit-related payments and development and sales milestone payments was ¥294.4 billion, an increase of ¥126.8 billion over the last year. The full year forecast for FY '23 is ¥436.5 billion, an increase of ¥2.9 billion from the October forecast. Slide 15 and 16 show the sales of ENHERTU in each country region. First, I would like to talk about the U.S. For the nine months was ¥162.8 billion or US$1,136 million, ¥63 billion from the same period of the previous year. The full year forecast for fiscal year '23 is ¥226.3 billion, a decrease of ¥3.2 billion from the October forecast. Although we have lowered our full year forecast slightly, the market share for each indication is growing steadily and we have no concern about the future growth of the market. The current indications are as shown here. Market share in each indication remains favorable. The market share of new patients and the second-line treatment of HER2-positive breast cancer, has increased to approximately 60%, maintaining a market leadership position. The market share of new patients with HER2-low breast cancer previously treated with chemotherapy also remained at approximately 50% and number one in the market. The company also maintained its leading position in new patients for second-line HER2-positive gastric cancer and second-line HER2 mutant NSCLC. Furthermore, following endometrial cancer and cervical cancer in September, head and neck cancer in December 2023 and ovarian cancer this month were included in the NCCN guidelines. Sales in Europe are also on track. The sales for the first nine months of fiscal '23 increased by ¥42.4 billion from the same period of the previous year to ¥64.7 billion. The full year forecast for '23 is ¥94.5 billion, an increase of ¥1.7 billion from the October forecast. The share of new patients in each market to the country region, is also steadily increasing. The share of new patients with HER2-positive breast cancer in second-line treatment is in the 60% range in France and 50% in Germany and Spain, maintaining the leading positions. In Italy, the share of new patients increased to the 60% level, achieving the market leader. The share of new patients with chemotherapy treated breast cancer with low HER2 expression was in the 40% range in Germany, and 30% range in France, with the market leader's positions. Slide 16 shows performance of HER2 in Japan and the ASCA region. Sales in Japan for the nine months ended December 31, '23, were ¥72.7 billion, up ¥9.2 billion from the same period of the previous year. The full year forecast for FY '23 is ¥22.8 billion, an increase of ¥1.3 billion from the October forecast. In November, the HER2 Mutant NSCLC second-line and later treatment, was approved as a recommended regimen in the guidelines for the diagnosis and treatment of lung cancer. The share of new patients in each indication, is steadily increasing. The market share of new patients in the second-line treatment of HER2-positive breast cancer is increased to mid-40%, maintaining the leading position. The share of the new HER2-positive breast cancer patients pretreated with chemotherapy, has also increased to approximately 20%, the market leader. The market share of HER2-positive gastric cancer third-line treatment, is also about 70%, consolidating the leading position. The share of new patients in the second-line HER2 Mutant NSCLC is also expanding steadily. Sales in the ASCA region for the first nine months were ¥30.8 billion, an increase of ¥21.6 billion from the same period of the previous year. The full year forecast for fiscal year '23 is ¥40.3 billion, an increase of ¥2.4 billion from the October forecast. The sales in ASCA region include the promotion revenue in China, Hong Kong, and other markets where AstraZeneca booked the sales. Sales in the region are favorable, with significant revenue growth in Brazil, China, and Taiwan and others. In November, the drug was approved in Brazil for second-line treatment of HER2-positive gastric cancer and second-line treatment of HER2-mutated NSCLC and started sales promotion. We will continue to strive for market penetration and expansion of countries, regions, and obtain new indications. Thus, we will deliver in HER2 to as many patients as possible who need it. Slides 17 and 18 show the major updates of the patent disputes. First, I would like to talk about the U.S. patent dispute over U.S. subsidiary Plexxikon. This is in relation to Novartis BRAF inhibitor Tafinlar. Plexxikon filed a claim in the U.S. District Court, and Novartis filed an appeal to the U.S. Court of Appeal. In December last year, Plexxikon and Novartis entered into a comprehensive settlement agreement. As a result of this settlement, Plexxikon received a lump-sum payment of US$182 million, or ¥26.1 billion from Novartis, resulting in the dismissal of Novartis' appeal. The amount received was recorded as temporary income in the third quarter of the current fiscal year. Next, I would like to inform you of ADC technology-related dispute with Seagen. The arbitral tribunal rendered the final award in November last year. The final award followed an incorporated the August 22 decision, by the arbitrator and required Seagen to pay US$46 million of the cost of the arbitration. This award confirms that arbitration court totally denied the Seagen's claim. With this decision, the arbitration proceedings were concluded. In this slide 18, I would like to talk about the dispute regarding Seagen's U.S. patent. The U.S. District Court in Texas ruled in October last year in the first instance. In November last year, we filed an appeal. In addition, we filed a request with the U.S. Patent and Trademark Office for a post-grant review to examine the validity of the patent on the grounds that Seagen's U.S. patent is invalid. And this month, U.S. Patent and Trademark Office rendered final written decision that Seagen's patent is invalid. We appreciate this decision. The patent is the only patent on, which Seagen found basis for the claim in the pending patent infringement lawsuit. In the next slide, we show the other regional initiatives. In Japan, COVID-19 vaccine, DAICHIRONA, Omicron strain XBB.1.5 monovalent vaccine, was supplied as the first messenger RNA vaccine made in Japan last December. As a Japanese pharmaceutical company, we will continue to contribute to the safety and security of the society and health of people. In Europe, we announced that our subsidiary, DSE and Esperion, signed an amended agreement this month. The manufacturing and supply responsibilities are transferred from Esperion to DSE. In addition, DSE has acquired the rights to develop and market the three drug combination in Europe and in other regions. Furthermore, DSE will lead the regulatory affairs with European Medical Medicines Agency, for the additional indication of nustendi/nustendi based on the clear outcome study results. As a result of this contract amendment, DSE will pay Esperion $125 million, $100 million upon execution of the amended agreement and $25 million after EMA's approval of the additional indication. There is a difference of opinion regarding the requirement for development milestone payments based on the results of the clear outcome study Esperion had filed a lawsuit against DSE. However, Esperion dismissed the pending litigation against DSE, due to the results of this new agreement. Slide 20 is on meeting information. In February, we will hold an ESG meeting. Speakers will include Kama, outside Director and Chairperson of the Board, Manabe, CEO, Okuzawa, COO, and Fukuoka, Chief Strategy Officer. In March, we will hold and HER2 business briefing. The speakers will be Manabe, CEO, and Ken Keller, Global Head of Oncology Business Unit. We will inform you of the details when they are finalized. Now we would like to present the R&D update. I will now hand over to Mr. Takasaki, Director of the R&D division.

Wataru Takasaki: Takasaki speaking. I am going to talk about R&D update. An update on 5DXd ADCs. Please turn to Page 23. This is a repost of the DESTINYPanTumor02 study data we presented at ESMO last year. The study was performed in advanced folic tumors in the second line settings and beyond where HER2 directed therapies, are not yet available such as HER2 expressing folic tumors including endometrial, cervical, ovarian, and biliary tract cancers. ORR, our primary endpoint was 37.1% in all patients and 61.3% in patients with IHC3+. Clinically meaningful response was confirmed in both groups. In addition, safety profile was consistent with the known profile including ILD. We included in the submission package this data, DESTINY-CRC02 study and other data. Under the real-time oncology review program, our filing was accepted by U.S. FDA and priority review was granted for tumor agnostic therapy in HER2 expressing folic tumors in the second line settings and beyond. PIDUFA date is set for the 30th of May, 2024. From Page 24, let me explain two new Phase 3 studies for Dato-DXd. First, TROPION-Breast04 study. TROPION-Breast04 is a Phase 3 study in patients with previously untreated stage 2 or 3 triple negative breast cancer, and hormone receptor low, HER2 low, or negative breast cancer. We started the study in November last year. We are evaluating the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy, compared to pembrolizumab-based neoadjuvant and adjuvant therapies. Primary endpoints are pathological complete response, PCR, and event-free survival, EFS. Next, on Page 25, I will explain another new Phase 3 study, TROPION-Breast05 study. This study is evaluating the efficacy and safety of Dato-DXd alone and in combination with durvalumab in patients with first-line PD-L1 positive locally recurrent inoperable or metastatic TNBC versus chemotherapy plus pembrolizumab. Like TROPION-Breast04, this study also started in November last year. Primary endpoint is PFS, progression-free survival. From Page 26, I am going to use two pages to explain the progress of HER3-DXd, which is a potential first HER3-directed cancer drug in the world. The current status of HERTHENA-Lung01 study. In this study, HER3-DXd demonstrated promising efficacy across diverse mechanisms of EGFR-TKI resistance and across a broad range of pre-treatment HER3 membrane expression. In December last year, under the real-time oncology review program, a filing was accepted by U.S. FDA based on the study results and priority review was granted. PIDUFA date is set for the 26th of June, 2024. In EGFR-mutated NSCLC, HERTHENA-Lung02 study is ongoing in the second-line settings. Top-line results are expected in FY 2024. Also, Phase 1b study in combination with osimertinib is ongoing in earlier treatment line. On Page 27, I will explain HER3-DXd's new Phase 2 study. HERTHENAPanTumor01 is a study aiming to expand indications to new tumor types. We will evaluate per cohort new tumor targets selected, based on our in-house nonclinical research and other data. We are planning to start the study first in melanoma, squamous cell carcinoma of head and neck, and HER2-negative gastric cancer in FY 2023. Slide 28 discusses the new Phase 3 study of I-DXd. I-DXd is an abbreviation for the generic name of DS-7300. In addition to the international generic name, the Japanese generic name was finalized last December as Ifinatamab deruxtecan or in English Ifinatamab deruxtecan. With favorable test results of I-DXd, a pivotal study in patients with advanced small cell lung cancer, IDeate-Lung02 study is planned to be initiated in the first half of FY 2024. The study will be conducted in patients, who have received at least one prior therapy including platinum-based chemotherapy to evaluate the efficacy and safety of I-DXd, compared to physician's choice of therapy including Topotecan and Amrubicin. The primary endpoints are ORR and overall survival. As shown in the figure on the left, we intend to provide optimal treatment options to as many patients as possible and as quickly as possible, by evaluating multiple products of DXd ADCs in each segment of lung cancer. Slide 29 describes a new DS-6000 study. The REJOICE-Ovarian01 study is the Phase 2/3 study of DS-6000 in platinum-resistant ovarian cancer, designed based on the positive data from the DS-6000 Phase 1 trial. It is scheduled to start in the fourth quarter of this fiscal year. The Phase 2 part will determine the recommended dose for Phase 3 and the Phase 3 part will evaluate the efficacy of DS-6000, compared with the physician's choice of treatment. The primary endpoints of the Phase 3 part are PFS and ORR. On Slide 30, I will discuss other clinical trial progress and of regulatory updates of five DS-6000 ADCs. For ENHERTU, in December of last year, filing was accepted in China for HER2-positive gastric adenocarcinoma or gastroesophageal junction adenocarcinoma based on DESTINY-Gastric06 study data. For Dato-DXd, it is expected to obtain filing acceptance in U.S. in the fourth quarter of this year based on data from the TROPION-Lung01 and TROPION-Breast01 trials, respectively. Slide 31 and after give next wave update. Slide 32 shows Valemetostat. In the VALENTINE-PTCL01 study, Valemetostat showed clinically meaningful benefit for patients with relapsed or refractory peripheral T-cell lymphoma. Ministry of Health, Labor and Welfare gave SAKIGAKE designation for Valemetostat in PTCL and the filing was accepted based on the data from this study today. In this Slide 33, I would like to explain about DAICHIRONA. DAICHIRONA is the first messenger RNA vaccine made in Japan that employs our proprietary cationic lipid. It was approved in Japan last November as an anti-COVID-19 vaccine for omicron XBB.1.5 strain. Slide 34 shows DS-2325. DS-2325 is a KLK5 inhibitor developed for Netherton syndrome, a rare genetic disease affecting ichthyosis and atopic dermatitis. In the U.S., it has received orphan drug fast track and also orphan pediatric disease designations. A Phase 1b/2 study was initiated last December. Slide 36 shows the future news flow. First of all, as I mentioned earlier about ENHERTU, it is expected that the results of the approval review of ENHERTU for second or later lines of ENHERTU expressing solid tumors across cancer types will be received in the first half of the fiscal '24. In addition, for HER3-DXd, the company expects to receive the results of the review in the U.S. for the third line treatment of EGFR mutated and non-small cell lung cancer based on the data from the HERTHENA-Lung01 study in the first half of fiscal '24. The data for the ongoing DESTINY-Breast06 trial for ENHERTU was previously expected in the second half of the current fiscal year, but it will be available in the first half of the fiscal '24. This change in timeline is not unexpected, due to the event-driven nature of the trial and the trial itself is progressing smoothly. The slides after 37 are appendix. We have lists of milestones and pipelines for your reference. That's all from myself.

Operator: From here on, we are going to entertain questions from the audience. Thank you very much. First Mr. Yamaguchi from Citigroup Securities, please.

Hidemaru Yamaguchi: Hello, can you hear me?

Wataru Takasaki: Yes, we can hear you. Thank you.

Hidemaru Yamaguchi: Yamaguchi from Citigroup speaking. Thank you for your time. I have a few questions. First, about the downward revision of ENHERTU sales forecast in the United States. It's just $30 million and I fully understand that the product is growing. The reason why you decided to revise the forecast was not so clear to me. Could you elaborate on that point, please?

Wataru Takasaki: Thank you for your question. Regarding the downward revision, we wanted to be as accurate as possible about the numbers, which are reflected this time. As we explained during the presentation, in terms of the future growth, we have no concern at all. If you look at the current segments one-by-one, in the HER2 positive segment, ENHERTU's new patient share has reached 60% and we continue to make efforts for further growth. We are analyzing the details of the prescribing physicians, and working to understand for which physicians we implement information provision and promotional activities. We are doing something similar in the HER2 low segment as well. The current market penetration is 50%. We are working on initiatives to realize meticulous focus on physicians. We will see further new data readouts into the future, including DB-09 readout for HER2 positive and DB-06 readout for HER2 low. Based on new data, we are moving with a plan to realize further expansion and deliver the drugs to more patients.

Hidemaru Yamaguchi: Excuse me, what's the reason? What you said is not really a reason. What's the reason?

Wataru Takasaki: In reality, we are coming to a substantial level of share. That's one thing. Our penetration has come to a substantial level. As I mentioned a bit, there are doctors who are not using Enhertu at all. Doctors who are using, but not for all patients. And doctors who are using quite frequently for almost all patients. We are doing such segmentation. There can be a variety of reasons. There is a tendency for each physician. It's difficult to mention just one reason. I see. Right now, we are rolling out meticulous promotion activities so that more doctors will use our drug.

Hidemaru Yamaguchi: Understood.

Wataru Takasaki: So there is no special factor. You found that in FY 2023, in the remaining three months, according to your plan, there is a slight shortage. So using your meticulous model, you made a revision. So there has been no special factor, right? But rather, penetration has been quite fast. There was some area where it didn't increase very much. So in total, you have made a downward revision, just slightly correct. In the HER2 low segment in particular, market penetration has made progress very rapidly. If you want to grow further from now on, you need very meticulous initiatives.

Hidemaru Yamaguchi: Understood. Thank you. I want to make one confirmation about Dato-DXd. During the seminar at the conference, you made a presentation suggesting filing for lung cancer. Also today, your comment suggested filing for breast cancer as well. Submission was already filed for lung cancer. You already filed your submission for breast cancer and are now waiting for the acceptance of your filing. Is this a new update?

Wataru Takasaki: Thank you for your question. As for TROPION-Breast01, in the fourth quarter of FY 2023, we are aiming to receive acceptance of our filing. Process-wise, we are making steady progress.

Hidemaru Yamaguchi: Did you file your submission?

Wataru Takasaki: We cannot disclose yet, but we are to receive acceptance in the fourth quarter of FY 2023, for sure. When accepted, it will be subject to press release as the acceptance of filing, right?

Hidemaru Yamaguchi: No change in that plan, correct?

Wataru Takasaki: Yes, that's the plan. Please wait for some more time.

Hidemaru Yamaguchi: Yes. May I ask my third question?

Wataru Takasaki: Yes, please.

Hidemaru Yamaguchi: Thank you. As for Esperion, the payment amount was described from Novartis, you received lump sum payment, any accounting treatment of the Esperion related payments to occur in the fourth quarter? Is that already processed or it's not decided yet, so there is a possibility of accounting treatment to account from now on. And this is about payment you will make. We will examine the details of account treatment and share the information when payment occurs. Do you mean this can be a factor for downward revision in the fourth quarter?

Wataru Takasaki: It will depend on the way of looking Including the question whether it can be a major factor, we will give you an update. On this matter, nothing has been decided yet. And forecast numbers can be subject to change in the fourth quarter. We cannot rule out that possibility, but we are not disclosing the numbers as of now.

Hidemaru Yamaguchi: Okay understood, that's all from me. Thank you very much.

Operator: Next Mr. Wakao from JPMorgan Securities.

Seiji Wakao: Wakao from JPMorgan speaking. Thank you for your time. I also would like to ask you a question about ENHERTU in the United States. I was able to understand the current situation very well. Regarding your FY 2024 outlook, from your explanation, I got the impression that HER2-low second-line HER2-positive segments may not grow so much. On the other hand, that will contribute to your performance in FY 2024 would be PanTumor02 study now under rolling review. If approved, that will make contributions. Can I assume this way?

Wataru Takasaki: Yes. We believe that PanTumor will also contribute. During my presentation earlier, I might have given you a negative impression. So I'd like to add. In reality, HER2 positive segment is growing. There is still a lot of room for further growth by implementing promotional activities in our opinion. The same is true with HER2 low. Also in HER2 low segment, we think there is still a lot of room for growth.

Seiji Wakao: Understood. The current indications on PanTumor, if approved, will also contribute positively. Is my understanding correct?

Wataru Takasaki: Yes.

Seiji Wakao: Understood. Next, I have some questions about Dato-DXd. I do understand that TROPION-Lung01 OS final analysis results are event driven. So you may not be able to tell me the specific timing, could you give me a rough idea like in around which months or later? Looking at clinicaltrials.gov, primary conclusion was January, but in mid-January this year, primary completion was changed to the 29th of February. As the timing of primary completion data will become available and then analysis will start from there. So according to my image, the timing could be April or later. Can you make any comment on the timing as of now?

Wataru Takasaki: Your understanding is correct about the relationship between primary completion and top line results. Final OS data will become available in calendar year 2024 according to our plan. We are not yet in a stage to announce the timing more accurately. Please understand that it will become available in calendar year 2024.

Seiji Wakao: Understood. I also have a question about the handling of OS results. After consultation with FDA, your filing was completed. During the review period, OS final analysis results will be submitted according to my understanding. If you can achieve statistically significant difference in the final OS results in the ITT population that will be great. On the other hand, what's complicated is as follows

Wataru Takasaki: Right now, because of the negotiations with FDA, what we can disclose is limited. But our position is based on the ITT population. Even if we decide to proceed with non-squamous cell cancer, still, we believe this is highly beneficial for patients. Whatever situation we would face, we are certain that we will move forward. Regarding your question about what stage we are in, in terms of the discussions, OS data is not yet available. So once OS data becomes available, we will have full scale discussions. And I was to refrain from commenting on the situation, including whether or not we are discussing what is.

Seiji Wakao: Okay very clear. Thank you very much. That's all from me.

Operator: The first question is from Ms. Haruta of UBS, please.

Kasumi Haruta: I am Haruta of UBS. The first question concerning TROPION-Lung01, I think I heard that the base case scenario is that PFS data will allow you to get filing submission. Is it correct in my understanding that PFS data is used for review and the final decision is made with OS data? Or is there any possibility that PFS alone will lead you to the approval.

Wataru Takasaki: We conduct a trial with dual endpoints, either will be enough for regulatory purpose but we would like to provide a drug with proper product value supported by clinically meaningful data. The most desired scenario is that both endpoints are satisfied. We have a great expectation on OS data, and we would like to wait for the final OS data rather than to discuss if either is enough. I think FDA is thinking on the same line.

Kasumi Haruta: TROPION-Breast01 for HER2 low may make overlap with DB04. I think that Dato is used sequentially after a HER2 has lost its efficacy. When used sequentially, the payload is the same with different targets, resulting in additional efficacy, is it your hypothesis correct? What is your thought on sequential use of ENHERTU and Dato?

Wataru Takasaki: ENHERTU is for HER2 positive and TROPION is tested for TNBC in various settings, including first-line or earlier and new adjuvant settings. Differentiation point of ENHERTU and Dato is HER2 expression or TNBC. For late phase, key TROPION-Breast01 and DESTINY-B04 looks at second-line and later for HER2 low or HER2 ultra-low. We would like to offer treatment from late line 2 new adjuvant and HER2 positive and HER2 ultralow. The strategy for HER2 low in early line neoadjuvant and adjuvant is under discussion now.

Kasumi Haruta: Thank you.

Operator: The next question. Mr. Muraoka of Morgan Stanley MUFG.

Shinichiro Muraoka: Good afternoon. I am Muraoka of Morgan Stanley. I think you want to say that your past growth is attributable to your local rep making focused call on heavy user physicians, leading less frequent weather to nonheavy users. You said you can expect further growth if you make a little bit more effort on them. Am I right?

Wataru Takasaki: Thank you for the question. It is difficult to explain this part. But the heavy user prescribers have used that in a sufficient number. They have already used that and the next target is those who have used the product, but not for all patients who are indicated and they use other drugs. Nonusers have various reasons, why not? But they are limited in number. Very important target is physician who have used a product but not to all the patients who were indicated. I don't know. It's a good way to express it, but you have a kind of ignored them. Do you have any reflection? We would like to focus in our activity so that we can better allocate resources. So far, market penetration didn't require such a focus.

Shinichiro Muraoka: The next question is on the next term. This is to confirm you. The midterm plan is up to 25%. And you said that you would have -- you will have a significant growth in fiscal year '24 toward the midterm plan. It is profit. So is it okay to expect your result in 3 months?

Wataru Takasaki: Yes, significant growth. It is very difficult to define significant, but we have updated April last year and the KPI of the midterm plan for 2025, and we are more confident in achieving this target. With the coming future plan in mind, we would like to make an update when we can make an announcement of the account settlement for this fiscal year.

Shinichiro Muraoka: The plan you made the revision three months ago and this time have some effects on MARIPOSA and in order to understand it better, I think that you have the deferred profit of ¥ 13 billion for 3 products. If I remember correctly, 3 months ago, you said that ¥ 10 billion for the sales of Medical Alliance and suppressing ¥ 10 billion for R&D, and these effects are incorporated. This is what you explained. Are there anything which is not included? Would you please explain this?

Wataru Takasaki: Yes. For the products to be developed or developing products, we have developing plans, and it is more specific, it becomes more specific through the discussion with Merck. And the projects are the items to be developed became much clearer resulting in the increase in the share received from Merck. So in October, we -- our guidance is ¥ 10 billion. But currently, we think that it would be ¥ 20 billion. Concerning the deferred profit, there is no major correction made. There is some minor adjustment made due to the change in the exchange rate.

Shinichiro Muraoka: All right. In Page 4 of your appendix, there are 3 patritumab, ifinatamab and DS-6000, the total is ¥ 13 billion. In the past, there is 0. The number is 0. So they are included, but you haven't broken down, correct?

Wataru Takasaki: Correct. Essentially, we have included these in the previous calculation. So you have just shown the breakdown.

Shinichiro Muraoka: Thank you. I understand that's all.

Operator: The next question, BOA Securities, Mamegano-san, please.

Koichi Mamegano: Can you hear me. I am Mamegano of BOA. Thank you. I have a question on DESTINY-Breast06 of ENHERTU. The top line results will be delayed a bit. I heard that it would be available in the first half of this fiscal year, and it is delayed one after another. And this time, you said that it would be in the next fiscal year or up to the September of this calendar year. So there is one year delay. It is a big delay compared to the original idea, but you are confident in achieving a good top line result.

Wataru Takasaki: As mentioned in my present, the study is event-driven, and the data cannot be collected unless the event takes place. We are waiting for that. We said that it will be available in the first half of 2024, but the first half is long. There are 6 months. So we are not so much worried about it. And we would like to make it as transparent as possible. I would like to have your kind understanding.

Koichi Mamegano: Another question is HER3-DXd. Now you are doing confirmatory Phase 3, and you are doing the Phase 3 study for the second line. This is a HERTHENA-Lung02. That's okay. But for the further ahead, the first line with the osemeltinib combinations, and there is a Phase 1b study with the combination of osemeltinib. And when we look at the competition landscapes, the competition is very harsh with a Johnson & Johnson product. Are you thinking of combining with those drugs? Or are you comparing with Johnson & Johnson.

Wataru Takasaki: For HERTHENA-Lung 01 and 02 are in progress, as you mentioned, and we are conducting the study with the combination of osemeltinib. Data will be available in the future, but these 3 would be the major pillars.

Koichi Mamegano: MARIPOSA study showed that Johnson & Johnson product wins against osemeltinib. So you are fighting with that product?

Wataru Takasaki: The direction for osemeltinib is not determined or is not finalized until the data is available. We don't know who will be the best segment, best patient? What would be the position? We are conducting HERTHENA-Lung01 and 02 to lay the foundation for HER3. And this foundation will support the whole program in the future, and we would like to share the information when the program is finalized.

Operator: There are other people who raised hands, but sorry, we have come to the scheduled time. If you have further questions, would you please hand your question to IR. This concludes today's meeting. Thank you for your kind participation.