Jan. 30, 2026 Conference on Q3 FY2025 Financial Results transcript（PDF/3,079KB）

Q3 Financial Results Briefing for FY2025 January 30, 2026

(Total: 52 minutes, Presentation: 18 minutes, Q&A: 34 minutes)

Toru Kimura Representative Director, President and CEO

Motoyuki Sakai Representative Director, Executive Vice President Global Corporate Strategy; Global Finance Administration External Affairs; Corporate Governance; IT Management & Data Analytics

Tsutomu Nakagawa Member, Board of Directors, Managing

Executive Officer North America Business President and CEO, Sumitomo Pharma America, Inc.

Yumi Sato Managing Executive Officer Research and Development Division Senior Vice President, Head of Research and Development Division Chief Development Officer, Sumitomo Pharma America, Inc.

Yutaka Wakemi Executive Officer Global Corporate Strategy;

Global Finance

Koichi Kino Vice President, Head of Corporate Governance

Seiji Wakao JPMorgan Securities

Shinichiro Muraoka Morgan Stanley MUFG Securities Hiroshi Wada SMBC Nikko Securities

*Analysts that SCRIPTS Asia was able to identify from the audio who spoke during Q&A or whose questions were read by moderator/company representatives.

My name is Koichi Kino from the Corporate Governance Department, and I will be serving as moderator today.

This briefing will be conducted via live Zoom webinar streaming from our Tokyo head office. Before we begin, we have a brief announcement and request. We kindly ask that you change the participant information displayed on your Zoom screen to show your company name and your name.

As for today's agenda, after we provide explanations based on the presentation materials posted on our website, we will move on to a Q&A session, first with analysts and investors, followed by members of the press. The scheduled end time is 6:15 PM.

Now, allow me to introduce today's participants. We are joined by Representative Director, President and CEO, Mr. Kimura; Representative Director and Executive Vice President, Mr. Sakai; Member of the Board and Managing Executive Officer, Mr. Nakagawa; Managing Executive Officer, Ms. Sato; and Executive Officer, Mr. Wakemi. Thank you all for joining us.

We will now begin with an explanation of our Q3 FY2025 performance and the current status of clinical development, presented by Mr. Kimura.

Mr. Kimura, please go ahead.

First, please turn to page three. Here we present our business performance for Q3 FY2025 on a core basis.

As you can see, revenue amounted to JPY347.7 billion, gross profit was JPY202.6 billion, core operating profit was JPY109.4 billion, and net profit attributable to owners of the parent was JPY107.7 billion. Compared with the same period last year, revenue increased by JPY54.6 billion, while core operating profit increased by JPY87.9 billion YoY.

On the cost side, selling, general and administrative expenses were restrained by JPY8 billion, and R&D expenses by JPY7.5 billion. As a result, profit attributable to owners of the parent increased by JPY86.5 billion to JPY107.7 billion.

At our Q2 financial results announcement on October 31, we revised our full-year performance forecast. Even relative to that revised forecast, we achieved an overperformance, with core operating profit reaching an achievement rate of 112.8%. We had previously believed that H2 of the fiscal year would represent the bottom of our profit and loss profile, but the Q3 results exceeded our expectations, and we interpret this as steady progress in profit improvement.

At the same time, we believe that foreign exchange effects and inventory buildup beyond our initial assumptions also contributed in part to these results. Traditionally, for our company, Q4 tends to see insurance resets in North America and a concentration of expenses. For that reason, we have left our full-year performance forecast unchanged. While we expect the final full-year results to exceed the October forecast by a comfortable margin, we also believe there is a possibility that operating profit in Q4 may come in slightly below the Q3 level.

We are now showing revenue from our major products in North America.

If you look at the center of the slide, ORGOVYX recorded JPY115.6 billion, MYFEMBREE JPY10.9 billion, and GEMTESA JPY72.3 billion, for a total of JPY257.5 billion, representing an increase of JPY78.1 billion YoY.

As indicated by the YoY changes shown for each of the major products, ORGOVYX was nearly double, and GEMTESA increased by 67.5%, meaning that performance has been very strong. Compared with the full-year forecast we announced on October 31, although three quarters of the fiscal year has already passed, progress remains extremely strong.

From here, I will explain each of the three major products one by one.

For ORGOVYX, compared with our internal plan for Q3, the actual results I have just described represent an achievement rate of 105%, exceeding the plan by USD35 million, and amounting to 205% compared with the same period last year. Both volume and price are progressing smoothly. At the same time, we recognize that there was a modest inventory buildup during Q3.

As shown in the topics below, since January of last year, the number of new patients has increased significantly in 2025. Contributing factors include the lowering of the out-of-pocket maximum, which has made it easier for Medicare patients to use the drug, as well as the fact that in this therapeutic area treatment had previously relied on injectable drugs, whereas our ORGOVYX is an oral formulation. In addition, the appeal of product value, such as the rapid onset of efficacy, has increasingly gained traction.

In December, both the number of new patients and volumes reached record highs.

Next is MYFEMBREE.

Q3 performance came in at USD73 million, exceeding our plan by USD7 million and resulting in an achievement rate of 110%. Both volume and price trended largely in line with our expectations.

We ended our sales partnership with Pfizer in January of last year and transitioned to in-house sales. Under those circumstances, we have implemented measures to improve sales efficiency in combination with GEMTESA.

At the same time, while promotion by competing products has been scaled back and the GnRH market has softened, we were still able to firmly maintain volumes.

In addition, through online promotion and the use of co-pay cards, that is, discount cards for patients, we are encouraging patients to continue using the product for several months, during which they can clearly experience its benefits. As a result, beginning this fiscal year, the product on a standalone basis is contributing to profits. This qualitative change represents one of the key topics for this year.

Next is GEMTESA.

Against a Q3 plan of USD453 million, actual performance reached USD486 million, exceeding the plan by USD33 million for an achievement rate of 107%. This represents an increase of roughly 70% YoY.

As the β3 market within overactive bladder treatments continues to expand, we have steadily increased volumes and achieved our plan. In addition, the proportion of payer channels with higher discount rates was lower than expected, which served as a positive factor for pricing.

Here as well, the clinical superiority of our product has become more widely recognized, and with the reduction in patients' out-of-pocket maximums under the IRA system, which were lowered starting in calendar year 2025, the number of Medicare patients has increased. As a result, December volumes also reached a record high for this product.

New prescriptions are growing faster than those of competing products, and we are also gradually advancing awareness activities for a new indication, overactive bladder associated with benign prostatic hyperplasia.

Next, we present revenue from our major products in Japan.

The total came to JPY69.2 billion, representing a decrease of JPY9.3 billion YoY. This is largely attributable to the expiration of the exclusive sales period for Equa and EquMet shown in the center of the slide, and the fact that sales of these products themselves ended in December.

On the other hand, compared with the forecast we presented on October 31, the achievement rate stands at 74.8%, and we believe you can understand that overall performance has been solid and is progressing in line with our plan.