Takeda FY2020 Q3 Results Demonstrate Growth Acceleration and Continued Resilience; Full-Year Management Guidance for FY2020 Confirmed, Forecast Raised for Free Cash Flow and Reported EPS

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) (“Takeda”) today announced financial results for the third quarter of fiscal year 2020 (period ended December 31, 2020).

TAKEDA CHIEF FINANCIAL OFFICER COSTA SAROUKOS commented:

“Our third-quarter results demonstrate the resilience of our business model and the depth of our portfolio, with strong growth generated by our 14 global brands. As a values-based and R&D driven biopharmaceutical company, we remain focused on bringing life-transforming treatments to people with high unmet needs around the world. With the first of our seven potential filings in the next 12 months complete, we look forward to delivering the next generation of potentially transformative medicines and maintaining our commitment to patients, our people and the planet.

“While maintaining business momentum, we also continue to deliver on our financial commitments, realizing strong year-to-date margins and cash flow, and exceeding our target for non-core asset divestitures. This progress reflects our ability to effectively and efficiently integrate the operations of Takeda and Shire, as we capture synergies and focus investment in our key business areas.

“Takeda’s strong financial performance in Q3 allows us to confirm management guidance for FY2020, with further growth acceleration expected in Q4 as we conclude the fiscal year. Reflecting on the transformation of Takeda over the past few years and the world-class R&D engine we have built, we look to 2021 as an important inflection point, filled with a number of pivotal milestones that will position us for long-term sustainable growth.”

FINANCIAL AND BUSINESS HIGHLIGHTS
Results for Q3 FY2020 YTD (Nine-Month Period Ended December 31, 2020)

⁽¹⁾ _{Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at} https://www.takeda.com/investors/reports/quarterly-announcements/
⁽²⁾ _{Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.}
⁽³⁾ _{Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.}
⁽⁴⁾ _{Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, and including proceeds from sales of plant, property and equipment, as further adjusted to exclude the acquisition of intangible assets and the acquisition of investments, and to include the proceeds from sales and redemption of investments and proceeds from sales of business, net of cash and cash equivalents divested.}

FY2020 Q3 YTD RESULTS DEMONSTRATE TAKEDA’S CONTINUED RESILIENCE

Reported revenue, at JPY 2,427.5 billion (~$23.5B), was impacted primarily by foreign exchange and divestitures, however Takeda delivered year-to-date underlying revenue growth of 1.1% in the third quarter of FY2020, which was driven by strong growth in ENTYVIO, TAKHZYRO, and Immunoglobulin, and was consistent with full year guidance of “low-single-digit growth.”

Takeda delivered reported operating profit of JPY 358.7 billion (~$3.5B), which grew 120.7%, reflecting lower purchase price accounting (PPA) and integration costs. Core operating profit, which adjusts for PPA and non-recurring items, declined year-on-year to JPY 780.6 billion (~$7.6B) owing to foreign exchange impact and divestitures. The core operating profit margin was 32.2%. Underlying core operating profit grew 8.5% year-on-year. Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, was 32.1%, driven by synergies and OPEX efficiencies.

Takeda’s reported net profit was JPY 178.9 billion, a 320.8% increase compared with the same period in the prior year.

Operating cash flow increased by 25.9% to JPY 610.0 billion, strengthening Takeda’s balance sheet and more than enabling the Company to satisfy dividend, debt, and interest payments. Free cash flow, which also reflects capital expenditures and proceeds from asset sales, was JPY 717.5 billion (~$7.0B). This represented a decrease of 3.8% in reported free cash flow versus the prior year; the growth rate was impacted by the ~JPY 375.5BN cash received in July 2019 for XIIDRA^®. Robust cash flow enabled further de-leveraging in Q3 and led to a 3.6x net debt/adjusted EBITDA ratio at the end of the period.

The overall impact of the global spread of COVID-19 on Takeda’s consolidated financial results for the nine-month period ended December 31, 2020 was not material, with several offsetting factors. There were adverse effects due to COVID-19 observed in certain therapeutic areas, especially in Neuroscience during periods when stay-at-home restrictions were in place reducing patient visits to medical care providers. This trend has fluctuated throughout the nine-month period, especially in recent months, as transmission of COVID-19 has increased significantly in many parts of the world. These adverse impacts have been partially offset by benefits from prescribing trends during the pandemic, such as an expansion of certain products with a more convenient administration profile that was observed in the early phase of the outbreak. With regard to operating expenses, voluntary suspension of certain business activities such as business travel and events in response to COVID-19 led to lower spending. As a result of these factors, the impact on Takeda’s profit was immaterial.

For the latest Takeda communications regarding COVID-19, please click here to visit the COVID-19 Information Center on Takeda’s website.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS
Takeda’s five key business areas — Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience — with JPY 1,982.1 billion of reported revenue representing approximately 82% of total Q3 YTD revenues – delivered year-on-year underlying revenue growth of 4.4%. Takeda’s 14 global brands, with reported revenue of JPY 910.3 billion (~$8.8B) in aggregate, delivered a 15.4% increase in Q3 YTD underlying revenue growth compared to a year before.

Gastroenterology
The Gastroenterology franchise with JPY 588.8 billion in reported revenue represented 24% of sales, with underlying revenue growth of 14%. This was spearheaded by continued exceptional growth through expanded first line share of gut-selective ENTYVIO in the U.S., EU, and Japan.

Rare Diseases
The Rare Diseases franchise with JPY 446.7 billion in reported revenue represented 18% of sales, with underlying revenue growth declining 3%. The hereditary angioedema portfolio saw 16% underlying revenue growth, driven by continued excellent performance from TAKHZYRO, which continues to expand the hereditary angioedema prophylaxis market. Rare Hematology declined 11% on an underlying basis, with the competitive landscape in line with expectations. Rare Metabolic declined 1% on an underlying basis, but excluding NATPARA the portfolio saw 7% growth. Takeda is working closely with the U.S. Food and Drug Administration (FDA) on a proposed plan to resupply NATPARA in the U.S. and had announced earlier in FY2020 that the required device modifications and product testing will likely delay availability beyond FY2020.

PDT Immunology
PDT Immunology with JPY 313.0 billion in reported revenue represented 13% of sales, with underlying revenue growth of 9% driven by continued strong Gammagard-Liquid demand in the U.S. and subcutaneous IG worldwide. Albumin sales declined 10% versus prior year, partially due to phasing and supply dynamics in China in 2019 and in some part due to a temporary interruption in submitting batches of Albumin Glass for release in China in Q3, for which we expect a resolution soon.

Oncology
Oncology with JPY 318.5 billion in reported revenue represented 13% of sales, with underlying revenue growth of 3%. Takeda’s portfolio continues to expand indications as growth brands offset the decline of older products in the portfolio.

Neuroscience
Neuroscience with JPY 315.1 billion in reported revenue represented 13% of sales, declining 2% on an underlying basis. The portfolio experienced a slowdown in momentum attributable to COVID-19 stay-at-home restrictions that reduced patient visits and diagnoses. A recovery of prescribing trends has been noted, but new patient starts are not yet back to pre-COVID levels.

COST SAVINGS AND DIVESTITURES
Synergy deliverables and operational efficiencies supported margin performance, as Takeda delivered a year-to-date underlying core operating profit margin of 32.1%. Takeda is also deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.6x at the end of Q3 (December 31, 2020), down from 3.8x in March 2020, even after the full-year dividend payment. Gross debt principal has reduced JPY 1.3TN (~$12.5B) in two years since the quarter ending March 31, 2019 (close of the Shire acquisition was announced on January 8, 2019), and Takeda is on course to meet its medium-term deleveraging goal of 2x within FY2021-FY2023.ⁱ

Takeda exceeded its $10B non-core asset divestiture target and has announced 11 deals since January 2019 to date for a total aggregate value of up to ~$11.6 billion, most recently including:

• The completion of the previously announced sale of a portfolio of select OTC and prescription products to Hypera S.A. for a total value of $825 million USD. (Press Release)

• The completion of the previously announced sale of TachoSil^® Fibrin Sealant Patch to Corza Health, Inc. for €350 million. (Press Release)

• The completion of the previously announced sale of a portfolio of select prescription products to Cheplapharm for a total value of $562 million USD. (Press Release)

• The completion of the previously announced sale of a portfolio of select products to Celltrion Inc. for a total value of $278 million USD inclusive of milestone payments. (Press Release)

• An agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. for $322 million USD, subject to customary legal and regulatory closing conditions. (Press Release)

Takeda further exceeded its original $700 million target and Q2 total of $1.1B for incremental cash from sales of real estate and securities, receiving ~$1.4B to date. As a result, the Company is raising its full year FY2020 Free Cash Flow forecast by JPY 50 billion to JPY 750 – 850 billion.

PIPELINE UPDATE: R&D PROGRESS WITH SUBMISSION OF TAK-721, THE FIRST OF SEVEN POTENTIAL FILINGS IN THE NEXT 12 MONTHS

Takeda has built a world-class, state of the art R&D engine and has generated a diverse and dynamic pipeline of approximately 40 clinical-stage new molecular entities (NMEs) that is beginning to deliver. The company’s Wave 1 pipeline NMEs, representing potential best-in-class/first-in-class therapies, has a number of notable anticipated near-term late-development milestones, pivotal data readouts or pivotal study starts.

Takeda’s pipeline portfolio has the potential to contribute significantly to its growth over the next decade, and remains on track to deliver on its milestone goals. Since Q2, one of its twelve near-term pivotal milestones has already been met (Maribavir phase 3 data readout). This is also one of five pivotal data readouts expected through fiscal year 2022, with additional near-term development milestones expected across all Wave 1 programs.

Takeda’s R&D engine continued to advance its Wave 1 pipeline, with recent highlights including:

• TAK-721 has been granted priority review from the FDA and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis. TAK-721 previously received both Breakthrough Therapy designation and Orphan Drug designation from the FDA. (Press Release)

• TAK-003, Takeda’s tetravalent dengue vaccine candidate, continued to protect against dengue illness with an acceptable safety profile in the two years safety and efficacy follow-up published in The Journal of Infectious Diseases in December 2020. Regulatory submissions to the EMA and dengue endemic countries are expected in FY2020 Q4, containing three years of safety and efficacy follow-up; this data is to be presented at a medical meeting in FY2021.

• Mobocertinib (TAK-788), a potential new oral standard of care for NSCLC patients with EGFR Exon20 insertion mutations, demonstrated clinically meaningful and durable responses in data presented at the 2020 World Conference on Lung Cancer (WCLC), with a confirmed objective response rate of 35% as assessed by investigator and a median duration of response of 17.5 months. It remains on track for FDA submission in Q4 2020 for Platinum Pretreated Patients with EGFR Exon20 insertion mutations. (Press release)

• Maribavir (TAK-620) met its phase 3 primary endpoint for the treatment of transplant recipients with refractory/resistant cytomegalovirus infections (Press release). Positive Phase 3 data for TAK-620 will be presented at the Transplantation & Cellular Therapy Meetings (TCT) on February 12 and the European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting on March 14-17. Takeda anticipates FDA filing for maribavir as a treatment for CMV infection and disease in transplant patients resistant or refractory to prior therapy in H1 FY2021.

Other Notable Updates
In 2020, Takeda ranked first in NDA approvals in China, with four approvals including TAKHZYRO (Press Release), ENTYVIO, ADCETRIS, and REPLAGAL.

At the virtual 62^nd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2020, Takeda presented nine abstracts on key learnings from real-world data and retrospective studies. Takeda continues to gather and apply real-world evidence in the treatment of hemophilia, von Willebrand disease (VWD) and sickle cell disease (SCD) and advance personalized treatment in its ongoing commitment to people living with bleeding disorders. (Press Release)

At the 2020 American College of Allergy, Asthma and Immunology (ACAAI) Virtual Annual Scientific Meeting, Takeda shared final results from the Phase 3 HELP Study™ Open-Label Extension that demonstrate TAKHZYRO (lanadelumab-flyo) injection as a potential long-term preventive treatment option in patients with Hereditary Angioedema. The results were also published in the November 2020 issue of ACAAI’s journal Annals of Allergy, Asthma & Immunology. (Press Release)

Lastly, Takeda is excited about the recent regulatory progress of a number of transformative therapies, including the FDA approval for the Supplemental New Drug Application (sNDA) of ICLUSIG (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML. (Press Release)

KEY CORPORATE INITIATIVES

Several examples of corporate achievements in Q3 demonstrate Takeda’s progress toward its vision — “discover and deliver life-transforming treatments, guided by our commitment to Patients, our People and the Planet.”

Patients:
Takeda Demonstrates Industry Leadership in 2021 Access to Medicines Index
Takeda was ranked sixth overall in the 2021 Access to Medicine (AtM) Index. A rigorous, biennial research project, the AtM Index combines data-collection, verification, scoring and analysis to compare 20 of the world’s largest pharmaceutical companies on their efforts to address access to medicines. The company achieved notable high scores in all three technical areas evaluated by the Index, including being ranked first in “Governance of Access”. Takeda also demonstrated strong performance in the areas of health strengthening and compliance. This ranking demonstrates Takeda’s values-driven strategy and how an ‘Access First’ approach across its Growth & Emerging Markets region is helping patients overcome access challenges in a more sustainable manner. (Press Release)

People:
Takeda Receives Global Top Employer Recognition
Takeda was one of only 16 companies to be named as a global Top Employer^® for 2021, an accolade the company has now received for a fourth consecutive year. The Top Employers Institute provides annual award certification to companies with outstanding culture, work environments, benefits and opportunities for their people based on the results of its HR Best Practices Survey. Takeda excelled globally in the areas of Values, Ethics & Integrity, Organizational Change, Leadership, Sustainability, Performance Management and Engagement and was also certified as a Top Employer in four regions and 38 countries. This honor demonstrates Takeda’s continued commitment to creating an exceptional people experience for its global workforce. (Press Release)

Planet:
Takeda Achieves Carbon Neutral Goal
Takeda recently announced it achieved carbon neutrality in its value chain for its fiscal year 2019. This milestone was met by a continued focus on internal energy conservation measures, procurement of green energy, and investment in renewable energy certificates and high-quality, verified carbon offsets. Such actions collectively address 100 percent of Takeda’s fiscal year 2019 scope 1, 2 and 3 emissions and represent a significant step forward in Takeda’s sustainability journey. Minimizing the environmental impact of its business is a critical priority for Takeda and at the heart of its purpose: achieving Better Health for People, Brighter Future for the World. (Press Release)

Read more about how Takeda continues to deliver on its commitments to patients, people and the planet through its purpose-led sustainability commitment in its 2020 Sustainable Value Report: https://www.takeda.com/corporate-responsibility/sustainable-value-report/

COVID-19 UPDATE
Guided by its values, Takeda’s response to COVID-19 has focused on protecting the health and safety of employees, striving to ensure its medicines are available to patients who rely on them and playing a part to reduce transmission and support the communities where its employees live and work. Takeda has also undertaken a number of efforts to help the world respond to COVID-19, most recently including:

FY2020 GUIDANCE
Full-Year Management Guidance Confirmed; Reported EPS Upgrade on More Favorable Tax Rate Assumption and Increased Forecast for Free Cash Flow Reflecting Additional Sale of Securities

Takeda has solid growth momentum heading into Q4 FY2020 and potential for accelerated underlying growth and achieving an underlying core operating profit margin in the mid-30s over the medium term.
Core and underlying guidance for FY2020 remains unchanged.

Key Assumptions in FY2020 Forecast
Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies.

FY2020 guidance also reflects the following key assumptions, including (i) that there will not be an additional 505(b)2 competitor for subcutaneous VELCADE launched in the U.S. within FY2020; (ii) includes the impact of divestitures disclosed by Takeda as through February 4, 2021, with the exception of the divestment of Takeda Consumer Healthcare Company and non-core assets in China; and (iii) management’s current expectations regarding COVID-19.

Based on currently available information, Takeda believes that its financial results for FY2020 will not be materially affected by COVID-19 and, accordingly, Takeda's FY2020 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2020, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in additional impacts on Takeda’s business, results of operations or financial condition, as well as resulting in significant deviations from Takeda’s FY2020 forecast.

For more details on Takeda's Q3 FY2020 results and other financial information, please visit: https://www.takeda.com/investors/reports/quarterly-announcements/

Further Information
Takeda will share details regarding its commercial strategy in emerging markets and progress on its pipeline at its upcoming Growth & Emerging Markets Strategic Update call on March 11, 2021 and part 2 of its Wave 1 Pipeline Market Opportunity call on April 6, 2021, respectively.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TOKYO: 4502/NYSE: TAK) 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 Genetic and Hematology, Neuroscience, and Gastroenterology (GI). 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. 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 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.

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; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; 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); 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/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release 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 press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Certain Non-IFRS Financial Measures
This press release and materials distributed in connection with this press release include certain IFRS financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”), such as Underlying Revenue, Core Operating Profit, Underlying Core Operating Profit, Core Net Profit, Underlying Core EPS, 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 press release. 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, core results and underlying trends. 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 reconciliation of non-IFRS financial measures to their most directly comparable IFRS measures.

Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/

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.

Financial information
Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). The revenue of Shire plc (“Shire”), which was historically, presented by Shire in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”), has been conformed to IFRS, without material difference. Convenience translations of JPY figures into USD are included for reference and have been calculated at a rate of JPY/USD of 103.19. During FY2019, Takeda completed the purchase price allocation for the assets acquired and the liabilities assumed as part of the Shire acquisition. Accordingly, PL statements for FY2019 Q3 were retrospectively adjusted.

ⁱ Please note the December 2020 debt profile assumes completion of ongoing make-whole calls on $1.25B 2021, $0.9B 2021 and $0.3B 2022 (completion scheduled for FY2020 Q4). ​

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