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Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary

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Takeda has completed the acquisition of Nimbus Lakshmi, Inc., acquiring full shares from Nimbus Therapeutics for about 4 billion USD. This significant transaction, announced on December 13, 2022, and finalized on February 8, 2023, includes acquiring the promising asset TAK-279, a selective oral TYK2 inhibitor. Phase 2b data is scheduled for release in Q4 FY2022, with a Phase 3 study aimed at psoriasis expected to commence in 2023. The acquisition enhances Takeda's late-stage pipeline, with potential applications across various immune-mediated diseases, supporting long-term growth.

Positive
  • Acquisition of TAK-279 strengthens late-stage pipeline.
  • Potential for best-in-class efficacy in treating psoriasis and other diseases.
  • Strategic alignment with Takeda's expertise in immune-mediated diseases.
Negative
  • Significant upfront payment of 4 billion USD may pose financial strain.
  • Milestone payments of 1 billion USD each contingent on achieving high sales targets could impact future cash flow.

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) today announced that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. (“Lakshmi”) from Nimbus Therapeutics, LLC (“Nimbus”), on February 8, 2023 (EST), as set forth in the share purchase agreement, following clearance from the United States Federal Trade Commission and a satisfaction of other closing conditions. The agreement had been announced on December 13, 2022: “Takeda to Acquire 100% Ownership of Nimbus Therapeutics’ TYK2 Program Subsidiary”.

Following the completion of this transaction, Takeda has now acquired TAK-279, formerly known at Nimbus as NDI-034858. With Phase 2b data to be presented in Q4 FY2022 and Phase 3 study in psoriasis expected to start in 2023, TAK-279 has the potential to demonstrate best-in-class efficacy, safety and convenience in psoriasis as well as multiple other immune-mediated diseases, including inflammatory bowel disease, psoriatic arthritis and systemic lupus erythematosus. This acquisition strengthens Takeda’s growing late-stage pipeline and potentially expands its portfolio and patient impact across multiple indications, reinforcing Takeda’s ability to maintain strong growth globally in the mid- to long-term.

“With our plan to acquire announced in December, we are excited to have promptly added TAK-279, a highly selective oral TYK2 inhibitor with truly transformative potential for patients in multiple diseases, to our late-stage pipeline,” said Ramona Sequeira, president, global portfolio division, at Takeda. “This program closely aligns with our strategy and expertise in immune-mediated diseases, and we look forward to sharing more details of our development plans soon.”

Under the terms of the agreement and following the closing of the transaction, Takeda will pay Nimbus approximately 4 billion USD upfront, after adjusting items including closing indebtedness and closing account payable of Lakshmi. Takeda will also make two milestone payments to Nimbus of 1 billion USD each upon achieving annual net sales of 4 billion USD and 5 billion USD of products developed from the TAK-279 program.

Takeda expects that the financial impact on its consolidated operating results for the fiscal year ending March 31, 2023 (FY2022), as a result of the completion of the transaction, is immaterial. There is no change in Takeda’s FY2022 consolidated forecasts for operating results or the management guidance.

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI), with expertise in immune and inflammatory diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this press release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could”, “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); the extent to which our internal energy conservation measures and future advancements in renewable energy or low carbon energy technology will enable us to reduce our greenhouse gas emissions; and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this report or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this report may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

Investor Relations

Christopher O’Reilly

christopher.oreilly@takeda.com

+81 (0) 3-3278-2543

Media Relations

U.S. and International

Megan Ostrower

Megan.ostrower@takeda.com

+1 (772) 559-4924

Japan

Jun Saito

Jun.saito@takeda.com

+81 (0) 3-3278-2325

Source: Takeda Pharmaceutical Company Limited

FAQ

What is the significance of Takeda's acquisition of Nimbus Lakshmi?

The acquisition enriches Takeda's late-stage pipeline, particularly with the promising TAK-279 asset, aimed at treating various immune-mediated conditions.

What are the financial terms of the Takeda and Nimbus Lakshmi acquisition?

Takeda is paying approximately 4 billion USD upfront, along with potential milestone payments of 1 billion USD each based on sales thresholds.

When is the Phase 3 study of TAK-279 expected to start?

The Phase 3 study for TAK-279 is expected to begin in 2023.

How does this acquisition impact Takeda's growth strategy?

This acquisition aligns with Takeda's strategy to enhance its portfolio in immune-mediated diseases and supports its long-term growth trajectory.

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of

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