Chugai Pharmaceutical : Q1 Results (Jan-Mar 2024)

2. Dividends

3. Consolidated forecasts for FY 2024 (January 1, 2024-December 31, 2024)

Notes: 1. Except for Core dividend payout ratio, percentages represent changes compared with the same period of the previous fiscal year for the forecasts, and the percentage of forecast levels that have been achieved to date for the results.

1. Whether the most recent forecasts for consolidated figures have been revised: No
2. The figures for the consolidated forecasts and actuals are calculated based on Core basis indicators established by Chugai and used on a consistent basis. Core EPS is diluted earnings per share attributable to Chugai shareholders on a Core basis.

4. Others

1. Changes in the state of material subsidiaries during the period (Changes in the state of specific subsidiaries with change in scope of consolidation): None
2. Changes in accounting policies and changes in accounting estimates
3. 1. Changes in accounting policies required by IFRS: None
   2. Changes in accounting policies other than those in (a) above: None
   3. Changes in accounting estimates: None

The quarterly financial statements are not subject to quarterly reviews.

Explanation of the appropriate use of performance forecasts and other related items

1. Portions of this report that refer to performance forecasts or any other future events are believed to be reasonable under information available at the time of the forecasts. Actual results may differ from these forecasts due to potential risks and uncertainties.
2. The forecast which is published for shareholders and investors is based on the internal management indicator Core basis under International Financial Reporting Standards ("IFRS"). Core results are the results after adjusting non-recurring items recognized by Chugai to IFRS results. Chugai's recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an indicator for managing internal business performance, explaining the status of recurring profits both internally and externally, and as the basis for payment-by- results such as shareholder returns. The difference between IFRS results and Core results will be explained at each event and presentation for the period.
3. For the specifics of the forecasts, please refer to "Consolidated Forecasts and Other forward-looking Statements" on page 6 of the attachment.
4. Chugai is scheduled to hold a presentation of the financial statements as noted below. The presentation materials will be posted on Chugai's website at the time of first quarter results announcement.
   Presentation for institutional investors, securities analysts and the media (Online conference with simultaneous interpretation): April 24, 2024, Wednesday (Japan time).
   English translation of the scripts including Q&A will be posted on the website within two business days.

Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

1. Qualitative Information

(1) Consolidated operating results in billions of yen

Consolidated financial highlights (IFRS results)

Revenue for the three months under review was ¥236.9 billion (a decrease of 24.1% year on year), operating profit for the three months under review was ¥99.9 billion (an increase of 1.6% year on year), and net income for the three months under review was ¥74.4 billion (an increase of 1.2% year on year). These results include non-Core items, which are excluded from the Core results that Chugai adopts to manage recurring business activities, such as amortization of intangible assets of ¥0.4 billion, impairment loss of intangible assets of ¥0.1 billion, business rebuilding expenses of ¥1.4 billion, and restructuring expenses of ¥0.4 billion.

Consolidated financial highlights (Core results)

Revenue for the three months under review was ¥236.9 billion (a decrease of 24.1% year on year), due to a decrease in sales, despite an increase in other revenue.

Of revenue, sales were ¥204.5 billion (a decrease of 29.8% year on year). In domestic sales, sales of new products Phesgo and Vabysmo grew, and the mainstay product Enspryng performed favorably. However, primarily due to the effects of the supply of Ronapreve to the government, which was recognized in the same period of the previous fiscal year, the NHI drug price revisions, and the market penetration of generic drugs, domestic sales declined from the same period of the previous fiscal year. Overseas sales increased compared to the same period of the previous fiscal year, due to the significant increase in the export of Hemlibra, despite the decline in the export of Actemra to Roche. Other revenue was ¥32.5 billion (an increase of 57.0% year on year) primarily due to the increase in lump- sum income. Furthermore, cost to sales ratio was 35.5%, a 16.3 percentage point improvement year on year, reflecting a change in product mix and other factors. As a result, gross profit amounted to ¥164.3 billion (an increase of 1.9% year on year).

Research and development expenses amounted to ¥41.2 billion (an increase of 14.1% year on year) due to investments into drug discovery/early development and increases associated with the progress of development projects, etc. Selling, general and administration expenses were comparable to the results for the same period of the previous fiscal year at ¥21.2 billion (an increase of 1.0% year on year). Other operating income (expense) was income of ¥0.2 billion (¥1.3 billion of income for the same period of the previous fiscal year due to gain on sale of property, plant and equipment, and others). As a result, core operating profit was ¥102.1 billion (a decrease of 3.1% year on year) and core net income was ¥76.0 billion (a decrease of 3.1% year on year).

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Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

Note: Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its transition to IFRS. Core results are the results after adjusting non-recurring items recognized by Chugai to IFRS results. Chugai's recognition of non- recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the status of recurring profits both internally and externally, and as the basis for payment-by-results.

For further details regarding the adjustment to IFRS results, please refer to the Supplementary Materials for Consolidated Financial Results for the First Quarter of the Fiscal Year 2024. 12 (IFRS), dated April 24, 2024 on page 1, entitled "Reconciliation of IFRS results to Core results."

Sales breakdown in billions of yen

Domestic sales

Domestic sales were ¥103.2 billion (a decrease of 46.4% year on year) due to the effects of the supply of Ronapreve to the government, which was recognized in the same period of the previous fiscal year, the NHI drug price revisions, and the market penetration of generic drugs, despite the sales growth of new products and mainstay products.

Oncology products sales were ¥56.1 billion (a decrease of 6.5% year on year). While sales of the new product Phesgo (antineoplastic agent/anti-HER2 humanized monoclonal antibody/hyaluronan-degradation enzyme combination drug) were strong, sales of mainstay products including Avastin (an anti-VEGF humanized monoclonal antibody, anti-cancer agent) decreased due to the effects of the NHI drug price revisions and the market penetration of generic drugs. In addition, sales of Perjeta (an anti-HER2 humanized monoclonal antibody, anti- cancer agent) decreased compared to the same period of the previous fiscal year due to the effects of the market penetration of Phesgo, a subcutaneous combination drug containing Perjeta.

Specialty products sales were ¥47.0 billion (a decrease of 64.6% year on year). This was primarily due to the supply of Ronapreve (an anti-SARS-CoV-2 monoclonal antibody) to the government (¥81.2 billion), which was recognized in the same period of the previous fiscal year, and the decline in sales of Tamiflu (an anti-influenza agent) to government stockpiles. In addition, sales of Mircera (a long-acting erythropoiesis stimulating agent) decreased due to the effects of NHI drug price revisions and market penetration of generic drugs. Meanwhile, in addition to the continuing favorable sales of the mainstay product Enspryng (a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody), sales of the new product Vabysmo (an ophthalmic VEGF/Ang-2 inhibitor, anti-VEGF/anti-Ang-2 humanized bispecific monoclonal antibody) increased.

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Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

Overseas sales

Overseas sales amounted to ¥101.3 billion (an increase of 2.5% year on year). In terms of exports to Roche, the export of Actemra (a humanized anti-humanIL-6 receptor monoclonal antibody) decreased compared to the same period of the previous fiscal year, while the export of Hemlibra (a blood coagulation factor VIII substitute/anti- coagulation factor IXa/X humanized bispecific monoclonal antibody) significantly increased.

R&D activities

R&D expenses on a Core basis for the first three months under review totaled ¥41.2 billion (an increase of 14.1% year on year), and the ratio of R&D expenses to revenue was 17.4%.

Progress made in R&D activities during the period from January 1, 2024 to March 31, 2024 was as follows.

Oncology

• We filed for an anti-CD20/CD3 bispecific antibody RG7828 for the treatment of follicular lymphoma (3rd Line) in March 2024.
• We filed for an antineoplastic agent/humanized anti-PD-L1 monoclonal antibody RG7446 (Product name: Tecentriq) for the treatment of alveolar soft part sarcoma in March 2024. We decided to discontinue the development for head and neck carcinoma (adjuvant) in consideration of the results of global Phase III study IMvoke010.

Immunology

• We filed for an immunosuppressant (Product name: CellCept) for the treatment of systemic sclerosis with interstitial lung disease based on public knowledge in February 2024.
• We started Phase I study for an antisense oligonucleotide targeting complement factor B mRNA RG6299 for the treatment of IgA nephropathy in February 2024.

Neuroscience

• We filed for a therapeutic agent for spinal muscular atrophy RG7916 (Product name: Evrysdi) for the additional indication for pre-symptomatic spinal muscular atrophy in February 2024.
• We decided to discontinue the development of an engineered anti-tau humanized monoclonal antibody RG6100 for Alzheimer's disease in consideration of the results of overseas clinical studies conducted by Roche.
• We decided to discontinue the development of a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody SA237/RG6168 (Product name: Enspryng) for the treatment of generalized myasthenia gravis in consideration of the results of global Phase III study Luminesce.

Hematology

• A pH-dependent binding humanized anti-complement (C5) monoclonal antibody SKY59/RG6107 (Product name: Piasky) was approved in China by the National Medical Products Administration (NMPA) of People's Republic of China for the treatment of adults and adolescents (12 years of age and above) with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors in February 2024. In addition, we obtained approval in Japan for the treatment of PNH in March 2024.

Ophthalmology

• We obtained approval for an ophthalmic VEGF/Ang-2 inhibitor, anti-VEGF/anti-Ang-2 humanized bispecific monoclonal antibody RG7716 (Product name: Vabysmo) for an additional indication of the treatment of macular edema associated with retinal vein occlusion in March 2024.

Other Diseases

• We started Phase II study for anti-IL-8 recycling antibody AMY109 for the treatment of endometriosis in January 2024.

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Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

(2) Consolidated financial position

Assets, liabilities and net assets in billions of yen

Net operating assets (NOA) at March 31, 2024 were ¥862.7 billion, a decrease of ¥38.2 billion since the end of the previous fiscal year. Of NOA, net working capital was ¥376.1 billion, a decrease of ¥46.5 billion from the end of the previous fiscal year, due mainly to a decrease in accounts receivable. Long-term net operating assets increased by ¥8.3 billion to ¥486.6 billion since the end of the previous fiscal year, mainly due to the investments in the manufacturing building for bio drug substance (UT3) in the Utsunomiya Plant and the manufacturing building for active pharmaceutical ingredients (FJ3) in the Fujieda Plant.

As indicated in "Cash flows" on the next page, net cash, including marketable securities and interest-bearing debt, increased by ¥25.6 billion since the end of the previous fiscal year to ¥764.6 billion. Other non-operating assets - net increased by ¥29.1 billion since the end of the previous fiscal year to ¥14.8 billion due to a decrease in current income tax liabilities and other items.

As a consequence, total net assets were ¥1,642.0 billion (an increase of ¥16.4 billion since the end of the previous fiscal year).

Note: Net operating assets (NOA) and Net assets

The consolidated balance sheet has been prepared in accordance with International Accounting Standards (IAS) No. 1, "Presentation of Financial Statements." On the other hand, Net operating assets (NOA) and Net assets are a reconfiguration of the consolidated balance sheet as internal indicators and are identical to the indicators disclosed by Roche. Furthermore, no items from Net operating assets (NOA) and Net assets have been excluded, as the Core results concept only applies to the income statement.

For further details, please refer to the Supplementary Materials on page 8, entitled "Financial position."

Note: Net operating assets (NOA)

Net operating assets allow for an assessment of the Group's operating performance of the business independently from financing and tax activities. Net operating assets are calculated as net working capital, long-term net operating assets that includes property, plant and equipment, intangible assets etc. minus provisions.

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Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

Cash flows in billions of yen

Operating profit, net of operating cash adjustments, amounted to ¥108.2 billion (a decrease of 14.7% year on year), which was calculated by adjusting for depreciation and other items that are included in operating profit but are not accompanied by cash inflows or outflows and all inflows and outflows related to NOA that are not accompanied by profit and loss.

Operating free cash flows for the three months under review amounted to a net inflow of ¥137.9 billion (a decrease of 37.8% year on year) mainly due to a decrease in net working capital, etc. of ¥44.1 billion, despite expenditures of ¥12.4 billion for the purchase of property, plant and equipment, etc. Factors accounting for the decrease in net working capital, etc. are as indicated in "Assets, liabilities and net assets" on the previous page.

Free cash flows were a net cash inflow of ¥87.2 billion (a decrease of 24.3% year on year) due mainly to income taxes paid of ¥41.0 billion from operating free cash flows.

The net change in net cash calculated by adjusting for dividends paid of ¥65.0 billion, etc. from free cash flows was an increase of ¥25.6 billion.

The net change in cash and cash equivalents, excluding changes in marketable securities and interest-bearing debt, was a net cash inflow of ¥4.2 billion. The cash and cash equivalents balance at the end of this period amounted to ¥462.9 billion.

Note: Free cash flows (FCF)

The consolidated statement of cash flows has been prepared in accordance with International Accounting Standard (IAS) No. 7, "Statement of Cash Flows." FCF is a reconfiguration of the consolidated statement of cash flows as internal indicators and is identical to the indicators disclosed by Roche. Furthermore, no items from FCF have been excluded, as the Core results concept only applies to the income statement.

For further details, please refer to the Supplementary Materials on page 9, entitled "Cash flows."

(3) Consolidated forecasts and other forward-looking statements

Chugai has not made any changes in its forecast of consolidated results for the fiscal year ending December 31, 2024 since the announcement regarding the forecast issued on February 1, 2024.

Note: In "1. Qualitative Information," amounts less than ¥0.1 billion have been rounded to the nearest ¥0.1 billion. Figures for changes in amounts and percentages have been calculated using data denominated in ¥0.1 billion units.

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Chugai Pharmaceutical Co., Ltd. (4519) CONSOLIDATED FINANCIAL STATEMENTS (1st quarter of FY 2024)

2. Interim Condensed Consolidated Financial Statements and Major Notes

1. Interim condensed consolidated income statement and interim condensed consolidated statement of comprehensive income
   1) Interim condensed consolidated income statement in millions of yen

First three months ended March 31

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