On May 11, 2021 Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) ("Takeda") reported financial results for fiscal year 2020 (period ended March 31, 2021) (Press release, Takeda, MAY 11, 2021, View Source [SID1234579702]).
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TAKEDA PRESIDENT AND CHIEF EXECUTIVE OFFICER CHRISTOPHE WEBER commented:
"Over the course of FY2020, Takeda remained resilient as we operated in new ways through the COVID-19 pandemic. This is a testament to the dedication of our employees, and Takeda’s unwavering commitment to serving patients, our people, and the planet to bring better health for people and a brighter future for the world. We maintained business continuity, ensured patient access to our medicines and safeguarded the health and well-being of our employees while helping to address the pandemic.
"This focus enabled us to deliver on our full-year management guidance, with underlying revenue growth driven by our 14 global brands, and the acceleration of cost synergies contributed to strong margins and a robust cashflow. Furthermore, we continued to experience growth momentum in our pipeline, including receiving 12 approvals across Takeda’s key markets.
"With FY2021 anticipated to serve as a critical inflection year, we remain focused on leveraging our expected topline growth to ramp up our R&D investment and further fuel our transformative pipeline. We are well-positioned to reach our goal of mid-single-digit revenue growth over the next decade amounting to JPY5 trillion ($47 billion) by FY2030.1
"As we celebrate Takeda’s 240th anniversary next month, I am extremely proud of our progress and confident in our outlook for the future. We will advance on our growth trajectory, maximize value creation for all of our stakeholders, and continue to position the company for long-term success."
FINANCIAL AND BUSINESS HIGHLIGHTS
Results for FY2020 Ended March 31, 2021
(a) Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(b) 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.
(c) 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.
(d) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, intangible assets and investments, and any other cash that is not available to Takeda’s immediate or general business use, 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 of property, plant, sales and redemption of investments and businesses, net of cash and cash equivalents divested.
FY2020 RESULTS DEMONSTRATE TAKEDA’S RESILIENT PORTFOLIO
Reported revenueat JPY 3,197.8 billion (~$28.9B)2, declined by 2.8% impacted primarily by foreign exchange and divestitures. Underlying revenue growth in FY2020 was +2.2% driven by the growth of Takeda’s 14 global brands, up 16% year-on-year.
Takeda delivered reported operating profit of JPY 509.3 billion (~$4.6B)2, which grew 407.2% with gains from non-core asset sales and acquisition-related expenses. Core operating profit, which adjusts for purchase price accounting ("PPA") and non-recurring items (including gains on sales of assets), increased year-on-year to JPY 967.9 billion (~$8.8B)2. The core operating profit margin was 30.3%. Underlying core operating profit, which further adjusts for the impact of foreign exchange and divestitures, grew 13% year-on-year. The underlying core operating profit margin was 30.2%.
Takeda’s reported net profit was JPY 376 billion, a 749.9% increase compared with the same period in the prior year.
Operating cash flow increased by 50.9% to JPY 1,010.9 billion. There was an increase in other financial liabilities of JPY 175.5 billion primarily attributable to an increase of deposits restricted to certain vaccines operations.
Free cash flow, which adjusts out deposits restricted to certain vaccine operations and reflects capital expenditures and proceeds from asset sales, was JPY 1,237.8 billion (~$11.2B)2. This represented an increase of 27.9% versus the prior year, comfortably covering the full year dividend, debt repayment and interest. Robust cash flow enabled further de-leveraging in Q4.
The overall impact of the global spread of COVID-19 on Takeda’s consolidated financial results for the twelve-month period ended March 31, 2021, was not material, with several offsetting factors. There were adverse effects due to COVID-19 observed in certain therapeutic areas, especially in Neuroscience when stay-at-home restrictions reduced patient visits to medical care providers. This trend has fluctuated throughout the twelve-month period. These adverse effects 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. Regarding 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 2,623.7 billion of reported revenue representing approximately 82% of total FY2020 revenues – delivered year-on-year underlying revenue growth of 4.7%. Takeda’s 14 global brands, with reported revenue of JPY 1,215.3 billion (~$11.0B) 2 in aggregate, delivered a 16% increase in FY2020 underlying revenue growth compared to a year before.
Gastroenterology
Gastroenterology with JPY 777.8 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
Rare Diseases with JPY 591.7 billion in reported revenue represented 19% of sales, with underlying revenue declining 2% driven by a decline in rare hematology that was in line with expectations. The hereditary angioedema (HAE) portfolio saw 10% underlying revenue growth, driven by continued excellent performance from TAKHZYRO, which continues to expand the hereditary angioedema prophylaxis market, as well as launching into additional geographies. Rare Metabolic increased 2% on an underlying basis but excluding NATPARA the portfolio saw 8% underlying growth.
PDT Immunology
PDT Immunology with JPY 420.4 billion in reported revenue represented 13% of sales, with underlying revenue growth of 10% driven by strong Gammagard-Liquid demand in the U.S. and subcutaneous IG worldwide. Albumin underlying revenue declined 13% in FY2020, mostly due to H2 sales impact caused by temporary interruption in submitting batches of Albumin Glass for release in China, and in some part due to phasing and supply dynamics in China in FY2019. COVID-19 has impacted plasma collections industry-wide, but operational excellence, implementation of digital initiatives and ongoing center expansion helped limit plasma collection volume decline to only -11%.
Oncology
Oncology with JPY 416.5 billion in reported revenue represented 13% of sales, with underlying revenue growth of 1% driven by NINLARO, ADCETRIS and ALUNBRIG. Takeda’s strong oncology portfolio continues to expand indications as growth brands offset the decline of older products in the portfolio.
Neuroscience
Neuroscience with JPY 417.3 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 an underlying core operating profit margin of 30.2%. Takeda is also deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.2x at the end of Q4, down from 3.8x in March 2020. Net debt has decreased by JPY 1,668.5 billion in two years since March 31, 2019 (the Shire Acquisition closed on January 8, 2019), and Takeda is on course to meet its medium-term deleveraging goal of 2x (low-twos) within FY2021-FY2023.
Takeda exceeded its $10B non-core asset divestiture target and has announced 12 deals since January 2019 to date for a total aggregate value of up to ~$12.9 billion3, most recently including:
The completion of the previously announced sale of a portfolio of four type 2 diabetes products to Teijin Pharma Limited for a total value of JPY 133.0 billion.4 (Press Release)
The completion of the previously announced sale of a portfolio of approximately 130 select over the counter and prescription products, and two manufacturing sites to Orifarm for a total value of up to $670 million USD. (Press Release)
The completion of the previously announced sale of Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates, for a total value of JPY 227.7 billion.5 (Press Release)
Takeda has also exceeded its original $700 million target for incremental cash from sales of real estate and marketable securities in FY2020, receiving a total of ~$1.4B.
PIPELINE UPDATE: FY2021 – ANTICIPATED TO BE AN INFLECTION YEAR WITH FIVE TO SIX WAVE 1 NMES SUBMITTED AND UNDER REGULATORY REVIEW BY THE FDA WITH THE POTENTIAL FOR FOUR APPROVALS
Takeda’s world-class R&D engine is fueled by leveraging internal research capabilities and actively engaging with innovative ecosystems around the world. This efficient R&D model has enabled us to focus on more targeted patient populations where there is potential for greater therapeutic benefit, smaller and less costly development programs, and faster tracks to registration with enhanced patent protection and marketing rights. We plan to increase our R&D investment to 522 billion JPY to further advance our 40+ prioritized NMEs and new partnerships, as well as building additional capabilities in oncology, clinical trial initiation and data and digital sciences. In FY2020, we obtained 12 global and regional brand approvals with the U.S., EU, China and Japan, demonstrating our drive to develop best-in-class therapies for patients with high unmet needs around the world. FY2021 is expected to be an inflection year for Takeda as we anticipate up to six regulatory submissions by year-end FY2021, with the potential for four approvals.
Takeda’s pipeline portfolio has the potential to contribute significantly to its growth over the next decade, with recent highlights including:
TAK-003:Takeda’s tetravalent dengue vaccine candidate, has completed its first regulatory submissions with possible approval in the EU and some endemic countries in FY2021. (Press release)
Mobocertinib (TAK-788): A potential new oral standard of care for adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC), has completed its New Drug Application (NDA) submission with a potential approval in FY2021. (Press release)
Maribavir (TAK-620): A robust primary analysis from the Phase 3 trial showed significantly more patients achieved cytomegalovirus (CMV) clearance versus conventional therapies in transplant recipients with CMV infection. Met key secondary endpoints, maintaining superior CMV viremia clearance, on track for NDA submission. Takeda continues to investigate Maribavir in the ongoing 302 Phase 3 study for First-Line Treatment of CMV in Hematopoietic Cell Transplant Recipients. (Press release)
Soticlestat (TAK-935): Takeda recently re-acquired global rights from Ovid Therapeutics to develop and commercialize this potential first-in-class therapy, with a novel mechanism of action for the treatment of developmental and epileptic encephalopathies. We intend to initiate Phase 3 studies of soticlestat in children and young adults with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in FY2021. If successful, it has the potential to bring new treatment options that provide greater seizure control, tolerability and function to DS and LGS patients around the world. (An Inflection Year for Our Wave 1 Pipeline)
Orexin (TAK-994): Potentially the first therapy to treat orexin deficiency, Takeda plans to move this asset into registrational trials, first in narcolepsy type 1 (NT1) — a rare, underdiagnosed and undertreated condition caused by an orexin deficiency which disrupts the sleep awake cycles, with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) to follow as potential additional indications. (An Inflection Year for Our Wave 1 Pipeline)
TAK-186: A conditionally active T-cell engager, first in its class to enter the clinic with recent phase 1/2 study initiation in EGFR-expressing solid tumors. TAK-186 is one of the latest additions to our pipeline through the acquisition of Maverick Therapeutics. In addition to TAK-186, Takeda also obtained Maverick’s T-cell engager COBRA platform and TAK-280 which is expected to enter the clinic in the second half of FY2021 for the treatment of patients with B7H3-expressing solid tumors. (Press release)
KEY CORPORATE INITIATIVES
Several recent examples of Takeda’s corporate achievements in FY2020 demonstrate Takeda’s progress toward its purpose of "better health for people, brighter future for the world":
Patients:
Launched R&D Center for Health Equity and Patient Affairs to identify and address health inequities.
Developed the Health Outcomes Observatory (H20) project, which brings together diverse public and private partners to amplify the patient voice in Europe.
Awarded the 2021 Facility of the Year Awards (FOYA) by the International Society for Pharmaceutical Engineering (ISPE) in two categories. Takeda’s new solid pharmaceutical packaging building in Hikari, Japan, was recognized with the 2021 "Process Intelligence and Innovation" category award and the end-to-end high potent drug facility in Grange Castle, Ireland, was selected as "Facility Integration" category winner.
Earned an industry-leading position within the 2021 Access to Medicine (AtM) Index where the company ranked sixth overall and led the pharmaceutical industry in Governance of Access.
People:
Launched our first Global DE&I Council, led by members of the Takeda Executive Team, to further embed DE&I into our culture.
Achieved global Top Employer certification for fourth consecutive year and was named as a Top Employer in four regions and 38 countries.
Preparing for post-pandemic ways of working with new hybrid working models that foster a flexible working culture, aligned to local business needs, that optimize employee engagement.
Planet:
Achieved carbon neutrality in the value chain for fiscal year 2019.
Named to Corporate Knights Global 100 Most Sustainable Corporations in the World (Global 100) for the sixth consecutive year.
Governance:
Takeda recently announced candidates for its Board of Directors that will be proposed at the 145th Ordinary General Meeting of Shareholders to be held on June 29, 2021. As part of its commitment to exercising strong corporate governance practices, Takeda decided that all members of the Audit and Supervisory Committee will be external directors (as defined under the rules of the Tokyo Stock Exchange) to further enhance the independence of the Committee. This change will promote the long-term interests of shareholders and all its stakeholders as well as strengthening its Board of Directors and management accountability. (Press release)
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.
While the results of our CoVIg-19 Plasma Alliance clinical trial were not favorable, the effort strengthened relationships within and outside the industry, enabled a renewed perspective toward pragmatic regulation based on scientific evidence and need, and provided a well-defined, legally compliant framework for future collaborative opportunities to address urgent public health needs. Takeda has also undertaken several efforts to help the world respond to COVID-19, and our most recent accomplishments include:
Takeda is making two COVID-19 vaccines available in Japan, by manufacturing Novavax’ recombinant vaccine candidate and distributing Moderna’s mRNA vaccine candidate, with the support of the Ministry of Health, Labour and Welfare and the Japan Agency for Medical Research and Development (AMED). Pending regulatory approval, Takeda intends to start distributing TAK-919 (Moderna) in the first half of 2021 and aims to start distributing TAK-019 (Novavax) in late 2021 or early 2022. (Press Release)
Takeda and IDT Biologika GmbH (IDT) have a mutual agreement to support manufacturing of Johnson & Johnson’s COVID-19 vaccine for three months utilizing capacity previously reserved for Takeda’s dengue vaccine candidate. (Press Release)
FY2021 GUIDANCE: Growth Momentum Expected to Continue
Takeda has solid growth momentum heading into FY2021 and expects underlying revenue growth to accelerate to "mid-single-digit" driven by continued momentum of Takeda’s 14 global brands.
Reported revenue is forecast to be 3,370 billion JPY, a year-on-year increase of 172.2 billion JPY or +5.4% from FY2020, with underlying revenue momentum and a one-time gain from the sale of diabetes portfolio in Japan fully offsetting impacts from divestitures completed in FY2020.
Underlying Core Operating Profit and Underlying Core EPS are expected to also grow at "mid-single-digit", reflecting revenue growth and continued cost efficiencies, whilst also incorporating a significant increase in R&D expenses to support Takeda’s innovative pipeline.
Reported Operating Profit is expected to be 488 billion JPY, a decrease of 21.3 billion JPY, or -4.2%, impacted by a significant increase in R&D expenses as well as lower one-time gains on asset sales. Core Operating Profit is expected to decrease by 37.9 billion JPY, or -3.9%, to 930 billion JPY, reflecting a significant increase in R&D expenses. Reported net profit for the year is expected to be 250 billion JPY, a decrease of 126 billion JPY, or -33.5%, reflecting the impacts on reported operating profit as well as an expected increase in the effective tax rate.
Key Assumptions in FY2021 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.
FY2021 guidance also reflects the following key assumptions: (i) The gain on sale of a diabetes portfolio in Japan is booked as revenue (JPY 133 billion), and adjusted out of Core Operating Profit for FY2021; (ii) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (iii) Takeda does not expect to restart sales of NATPARA in the U.S. market in FY2021; (iv) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.
Based on currently available information, Takeda believes its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda’s FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, 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 FY2021 forecast.
For more details on Takeda’s FY2020 results and other financial information, please visit: View Source
Further Information
Takeda will share details regarding its commercial strategies in oncology and finance at its upcoming Oncology Strategic Update Call in June 2021 and Finance Strategy Day in June/July 2021, respectively (dates to be confirmed). Additionally, Takeda will share details regarding COVID-19 efforts, the current state of the business, and the short- and long-term outlook of the Company at the Annual General Meeting of Shareholders on June 29, 2021.