Sawai Group Holdings Co., Ltd. (TYO:4887)
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Sep 14, 2026, 3:30 PM JST
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Earnings Call: Q2 2024

Nov 10, 2023

Speaker 1

Good afternoon. I will now explain about summary of our results for the second quarter in fiscal year 2023. Page two is summary of consolidated results. We had steady growth in both revenue and core operating income, in line with our annual forecast. In Japan, revenue increased 13.4% year-on-year, thanks to the strong sales of new products launched in FY 2022 and 2023.

Despite the impact of NHI price revisions, cost inflations, and recovery costs for some items, core operating profit increased by 29.2% year-on-year due to higher gross margins, the reflection of cost increases in selling prices, and the postponement of SG&A and R&D expenses to later periods. As for the status of products with limited shipments, there were 300 of them as of March 2023. However, now it has been reduced to 244.

Due to requests from medical institutions and the government, we are strengthening our production to reduce the items with limited shipments even further. In the United States, despite a decline in existing products, revenue and earnings performed well against the annual plan, with steady sales of products launched in FY 2021 or later. Core operating profit was lower than in the same period last year, mainly due to the impact of restructuring costs, but progress was better than originally planned.

Page three shows the summary of financial results I have explained so far in numbers. On a combined Japanese-U.S. consolidated basis, revenues amounted to approximately JPY 106.8 billion, an increase of 10.8% year-on-year. Core operating profit was around JPY 13.5 billion, an increase of 16.1% compared to the same period last year. Page four is core operating income analysis.

In Japan, in addition to write-downs and disposal losses on some products, SG&A expenses increased due to the total replacement of PCs and product recall costs. On the other hand, gross profit increased by approximately JPY 4.3 billion compared to the same period last year, resulting in a combined increase of approximately JPY 2.9 billion in core operating profit. In the U.S. business, the core operating profit decreased by approximately JPY 0.8 billion due to lower gross profit as a result of the decline in sales.

As a result, the overall increase in Japan and the U.S. was approximately JPY 1.9 billion compared with the same period of the previous year. Page five is about full base operating income analysis, and there is no particular difference from the core operating income analysis. Page six is about sell-in by medical institution channels in Japan for Sawai Pharmaceutical.

Overall increase was 12.1% thanks to the growing sales of products launched in 2022 onward and other mainstay products. This is Sawai Pharmaceutical's non-consolidated sales by product launch year in Japan. Sales were driven by products listed in FY 2022, such as esomeprazole and azacitidine, and those listed in FY 2023, such as zinc acetate and azilsartan. Page eight is U.S. sales analysis by segment. Growth was driven by products launched in FY 2021 or later. Progress against the annual plan has been steady in both dollar and yen terms.

Page nine is progress towards FY 2023 forecast as consolidated. The progress has been steady against our plan for the year in both Japan and the United States. Profits are well above the plan. As we expect SG&A and R&D expenses in the second half of the year, we do not revise consolidated full year outlook this time. Page 10 is about progress of Trust Pharmatech and construction of new solid preparations in our second Kyushu factory.

The transfer of items to Trust Pharmatech is progressing well, and the production volume for the current financial fiscal year is expected to be approximately 300 million tablets. In terms of GMP and other compliance measures, Trust Pharmatech has already achieved the same standards as Sawai Pharmaceutical plants and is working to improve on a daily basis to further raise the level of quality. The construction of a new solid dosage building at the second Kyushu plant was originally expected to start shipping in April 2024.

Due to delays in construction, partly caused by poor weather conditions with more rainfall and higher average temperatures than in previous years, the start of operations is currently set for July 2024. Page 11 is about the launch of Pitavastatin tablets as a Paragraph IV product in the U.S. This is the first ANDA filing, approval, and launch under Paragraph IV as a Japanese dedicated maker of generic drugs, and also the first generic drug developed by Sawai Pharmaceutical and sold through Upsher-Smith Laboratories in the United States. Page 12 is about progress of new businesses.

As for digital therapeutic app for NASH, phase III trials are starting within this fiscal year. Introduction to our personal health record app, SaluDi, to medical facilities has been steadily expanding to enhance cooperation with regional medical care and the generic drug business. That's all for the outline of results. Now allow me to hand over to Mr. Kimura, President of Sawai Pharmaceutical, to give you a summary about the investigation about misconduct in stability monitoring to Teprenone Capsules and the preventive measures.

Motohiko Kimura
President, Sawai Pharmaceutical

My name is Kimura, President of Sawai Pharmaceutical. Thank you for today. I would now like to provide an overview of the investigation into misconduct in the stability monitoring at our subsidiary, which we recently announced in a press release on October 23rd, and the measures taken to prevent a reoccurrence of such misconduct. As for the Teprenone Capsules 50 mg Sawai, testing at shipments has been done securely.

However, we found out that in the dissolution test for long-term stability monitoring, inappropriate tests had been conducted. In response to this incident, the company established a special investigation committee, including external GMP experts and lawyers, and conducted interviews with relevant people, investigated the causes, and considered measures to prevent reoccurrence. The history so far is as described. The table shows the history from April to October 2023. Please turn to next page.

This page outlines the cause analysis and the recurrence prevention measures. As for the cause, there are issues caused by two different factors: human and structural. Based on this analysis, we have identified three recurrence measures, as described here. First, commence a corporate culture reform project under the direct leadership of the President. Second, reevaluate existing marketed products in terms of manufacturing and quality and implement corrective measures.

Third, implementation of recurrence prevention measures in our subsidiaries and production headquarters. As for the first one, the project, which reports directly to me, has already been set up and started its activity. As for the second, we have already confirmed the specific workflow at the management meeting and have a list of target items to be reviewed. We are now moving on to more specific discussions.

Thirdly, in order to reinforce compliance, a monthly compliance week is to be set up, and an e-learning program on the Pharmaceuticals and Medical Devices Act and GMP for all employees has already started today. That's all for the Teprenone Capsules.

Speaker 1

From page 16 onward are new products in Japan to be listed in NHI price list in December and other reference information such as financial data. This concludes the presentation of the summary of the financial results for the second quarter of 2023. Thank you very much for your attention.