MA-TAKEDA-PHARMACEUTICAL

Takeda (TOKYO:4502/NYSE:TAK) today announced strong financial results for fiscal year 2022 (period ended March 31, 2023), delivering or exceeding management guidance, driven by the performance of its Growth & Launch Products.

Takeda president and chief executive officer, Christophe Weber, commented:
“FY2022 was another strong year for Takeda, reflecting successful execution against our business strategy and advancements in our innovative pipeline—enabling us to deliver truly transformative treatments to patients. Important pipeline milestones included the first approvals for our dengue vaccine QDENGA^®, positive late-stage readouts for TAK-755 and fazirsiran, and the acquisition of TAK-279 for immune-mediated diseases.

“We have updated our capital allocation policy as a reflection of our deleveraging progress and our new phase of investment for growth and shareholder returns. We have adopted a progressive dividend policy of increasing or maintaining the dividend each year, and in FY2023 we intend to raise the dividend to underscore confidence in our future growth profile.

“While we expect to face temporary headwinds in FY2023 from generic entrants and lower demand for coronavirus vaccines, we are confident that strong momentum in our Growth & Launch Products will drive a return to growth in the near-term. We will continue to strengthen our long-term competitiveness through investments in R&D and data and technology, as we deliver on our purpose to bring better health for people and a brighter future for the world.”

Takeda chief financial officer, Costa Saroukos, commented:
“I’m pleased to report that Takeda delivered or exceeded management guidance in FY2022 and booked a record core operating profit of almost 1.2 trillion yen. Our topline and profit performance was driven by our Growth & Launch Products, which grew 19% at constant exchange rate.

“Strong financial discipline and free cash flow have enabled us to deleverage rapidly while investing in growth. As a result, we are forecasting a dividend increase for the first time in 15 years, from 180 yen to 188 yen per share.

“Our outlook for FY2023 reflects the challenges of anticipated generic impact and lower coronavirus vaccine contributions, but we still anticipate delivering core operating profit above 1 trillion yen. Our forecasted reported EPS growth rates are also impacted by one-time items which are not reflective of our core business momentum. We remain confident in our future growth outlook and our planned dividend increase underscores that confidence.”

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Growth in Takeda’s key business areas in FY2022 was driven largely by Growth & Launch Products¹, which delivered reported revenue of 1,594.8 billion yen, marking a 19% increase on a constant exchange rate (CER) basis.

• Gastroenterology (GI), with 1,094.5 billion yen in reported revenue, grew 8.7% on a CER basis driven by ENTYVIO^® (for ulcerative colitis (UC) and Crohn’s disease (CD)), which is expanding through continued launches of the subcutaneous formulation, and in the U.S. has become the number one biologic for inflammatory bowel disease (UC and CD combined, supported by quarterly share data that better accounts for differences in dosing schedules).
• Rare Diseases, with 723.4 billion yen in reported revenue, grew 4.8% on a CER basis. Sales of TAKHZYRO^® (for hereditary angioedema (HAE)) grew 25% on a CER basis, primarily due to expansion of the prophylactic market, continued geographic expansion and strong patient demand. Sales of LIVTENCITY^® (for post-transplant cytomegalovirus infection/disease) were 10.5 billion yen, driven by the strong launch momentum in the U.S. and geographic expansion with the European Commission granting approval in November 2022.
• Plasma-Derived Therapies (PDT) Immunology, with 678.4 billion yen in reported revenue, delivered outstanding growth of 15.3% on a CER basis. Growth was driven by higher sales of immunoglobin products (for primary immunodeficiency, multifocal motor neuropathy and subcutaneous immunoglobin therapies), with 16% growth on a CER basis, particularly in the U.S. amid easing of pandemic pressures coupled with increasing supply. Robust growth for albumin products (primarily used for hypovolemia and hypoalbuminemia), at 19% on a CER basis, was driven by strong demand in the U.S. and China.
• Oncology, with 438.7 billion yen in reported revenue, declined 14.4% on a CER basis as a result of the entry of multiple VELCADE^® generics that began in the U.S. in May 2022. Besides VELCADE, all other revenue totaled 411.0 billion yen, a year-over-year increase of 5% on a CER basis, mainly driven by ADCETRIS^® (for malignant lymphomas), which grew 14% on a CER basis, due to growth in Argentina, Italy, and Japan. ALUNBRIG^® (for non-small cell lung cancer) also grew 35% on a CER basis with strong demand in Europe, China, and Growth & Emerging Markets. During FY2022, EXKIVITY^® was approved for EGFR exon20 insertion+ non-small cell lung cancer in China, and both ALUNBRIG and ADCETRIS were included in the 2022 National Reimbursement Drug List in China.
• Neuroscience, with 637.7 billion yen in reported revenue, grew 12.1% on a CER basis, driven by increased adult ADHD demand for VYVANSE^® in the U.S., Europe, and Canada for VYVANSE/ELVANSE. Sales of TRINTELLIX grew at 2% on a CER basis due to strong market share gains in Japan, while demand in the U.S. grew in line with the anti-depressant market growth.

PIPELINE UPDATE
Takeda has continued to deliver on its ability to bring new therapies to patients and capitalize on existing momentum within its dynamic and diverse pipeline. Updates since the FY2022 Q3 announcement include:

• The U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO (lanadelumab-flyo) for prophylaxis to prevent attacks of HAE in pediatric patients 2 to <12 years of age. Prior to this approval, the only approved routine prophylaxis treatment options for children 6 to <12 years of age required dosing every three to four days. Children with HAE 2 to <6 years of age had no approved prophylaxis treatment, making TAKHZYRO the first prophylaxis treatment option for this age group.
  Additional information related to this announcement is available here.
  

• A Phase 2b study of TAK-279, a highly selective once-daily oral tyrosine kinase 2 (TYK2) inhibitor, showed positive results in patients with moderate-to-severe plaque psoriasis. The study met its primary and secondary endpoints, and 33% of patients achieved clear skin at 12 weeks (PASI 100) at the highest dose (30mg). Most adverse events were mild to moderate in severity. TAK-279 will progress to a Phase 3 study in psoriasis in FY2023. Additionally, Takeda expects topline results from a Phase 2b study of TAK-279 for psoriatic arthritis in FY2023.
  Additional information related to this announcement is available here.
  

• QDENGA, Takeda’s dengue vaccine, which has received several approvals to date, was most recently approved by Brazil’s National Health Surveillance Agency (ANVISA) in March 2023 for use in individuals between 4 years and 60 years to protect against all four serotypes. QDENGA is the only dengue vaccine that is approved for use regardless of previous exposure and without need of pre-vaccination testing. This approval marks the first approval of QDENGA in Latin America as Takeda continues to progress additional regulatory filings in other dengue-endemic countries.
  Additional information related to this announcement is available here.
  

• ENTYVIO subcutaneous injection received manufacturing and marketing approval in Japan as a maintenance therapy for patients with moderate to severe ulcerative colitis who have had inadequate response to conventional treatment.
  Additional information related to this announcement is available here.
  

• Results from Phase 4 EARNEST study of vedolizumab (ENTYVIO) demonstrated efficacy and met primary endpoints in the treatment of chronic or recurrent pouchitis. Primary endpoints were met with vedolizumab patients achieving remission at weeks 14 and 34 as compared to placebo. The New England Journal of Medicine published the data in an article titled “Vedolizumab for the Treatment of Chronic Pouchitis.”
  Additional information related to this announcement is available here.
  

• The U.S. FDA has accepted for review its Biologics License Application (BLA) resubmission in April 2023 for the investigational subcutaneous administration of ENTYVIO (vedolizumab) for maintenance therapy in adults with moderately to severely active UC after induction therapy with Entyvio intravenous.
  Additional information related to this announcement is available here.

OTHER NOTABLE PROGRESS
Takeda is committed to creating long-term value consistent with our corporate values. Significant social and environmental sustainability milestones in FY2022 include:

• At the World Economic Forum Annual Meeting 2023, Takeda signed the Global Health Equity Network Zero Health Gaps Pledge reinforcing the company’s commitment to identify global inequities and deliver solutions to address them. Additionally, Takeda continues to make progress in fostering an inclusive ecosystem where everyone has access to equitable care including efforts ranging from early access and patient assistance programs to driving clinical trial diversity efforts with the Pharmaceutical Research and Manufacturers of America (PhRMA) and a partnership with Discovery Education, a worldwide edtech leader, that nurtures a health equity mindset for students and educators.
• Takeda’s aspiration is to also create an environment that encourages lifelong learning and a growth mindset, enabling our people to thrive inside and outside of Takeda. To provide opportunities for individual, personalized learning, and career growth we introduced Bloom LXP, an online learning experience platform which provides a single-entry point for all learning at Takeda in October 2022. This platform has been accessed by over 65% of our employees since its launch.
• The company also completed a virtual power purchase agreement with Enel North America for its Seven Cowboy Wind Project, which is now operational. Through the agreement, Takeda is expected to create up to 350,000 megawatt hours (MWh) of renewable energy and associated credits per year, accounting for approximately 20% of Takeda’s current enterprise-wide scope 1 and 2 greenhouse gas (GHG) emissions. In accordance with the Science Based Targets initiative’s Corporate Net-Zero Standard, the agreement also accelerates Takeda’s progress towards its goal to be net-zero in its operations (scopes 1 and 2) before 2035 and underscores the company’s commitment to delivering a high standard of environmental leadership as climate change and pollution both impact patient and human health.

About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare disease, plasma-derived therapies, neuroscience, oncology and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit 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.

Financial information and Certain Non-IFRS Financial Measures
Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”).

This press release and materials distributed in connection with this press release include certain financial measures not presented in accordance with IFRS, such as Core Revenue, Core Operating Profit, Core Net Profit, Core EPS, Constant Exchange Rate (“CER”) change, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this presentation. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda’s performance and core results, including when controlling for the effect of fluctuations in exchange rates. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the definitions and reconciliations of non-IFRS financial measures to their most directly comparable IFRS measures, which are in the financial appendix at the end of Takeda's FY2022 investor presentation (available at takeda.com/investors/financial-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.

¹Please refer to slide 20 of Takeda’s FY2022 investor presentation (available at takeda.com/investors/financial-results) for the definition of Growth & Launch Products.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230510005066/en/