On October 29, 2020 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported financial results for the first half of fiscal year 2020 (period ended September 30, 2020) (Press release, Takeda, OCT 29, 2020, View Source [SID1234569380]).
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TAKEDA PRESIDENT & CHIEF EXECUTIVE OFFICER CHRISTOPHE WEBER commented:
"Takeda’s performance in the first half of FY2020 demonstrates the resilience of our business model, the depth of our portfolio and the commitment of our employees, who continue to serve patients and communities globally while overcoming challenges created by the COVID-19 pandemic.
"Our results were once again driven by underlying growth of our 14 global brands across the five key business areas, which enabled us to generate strong margins and cash flow. Our R&D Engine continued to advance our Wave 1 pipeline, with 7 new regulatory filings anticipated within the next 12 months, and we expanded our cell therapy capabilities, both of which will help drive Takeda’s future growth. We also exceeded our divestiture target, with more than $11 billion of non-core disposals announced since January 2019, enabling us to continue to rapidly reduce debt.
"Takeda continues to focus on developing potential therapies to treat COVID-19 with, for example, the enrollment of the first patients in the CoVIg-19 Plasma Alliance Phase 3 clinical trial — an outstanding achievement in such a short time.
"We are confirming our full-year management guidance and raising forecasts for free cash flow, reported operating profit and reported earnings per share, reflecting our confidence in Takeda’s growth momentum. This is borne out by today’s encouraging results, despite the challenges posed by the COVID-19 pandemic. I am proud of all that we continue to achieve at Takeda and look forward to continuing to build on our strengths in the second half of FY2020."
FINANCIAL AND BUSINESS HIGHLIGHTS
Results for H1 FY2020 Ended September 30, 2020 [1],[2],[3],[4]
(billion yen, except percentages and per share amounts)
REPORTED
CORE
UNDERLYING
H1 FY2020
vs. PRIOR YEAR
H1 FY2020
vs. PRIOR YEAR
Revenue
1,590.8
-4.2%
1,590.8
-4.2%
+0.5%
Operating Profit
215.6
+97.7%
507.6
-6.3%
+1.9%
Margin
13.6%
+7.0pp
31.9%
-0.7pp
31.6%
Net Profit
86.5
+15.8%
345.5
-9.2%
EPS (JPY)
55 yen
+7 yen
221 yen
-23 yen
-0.4%
Operating Cash Flow
392.0
+14.9%
Free Cash Flow (Non-IFRS)
425.5
-37.1%
1 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.
2 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.
3 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.
4 Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
Takeda delivered a resilient performance in H1 FY2020
Reported revenue, at JPY 1,590.8 billion (~$15.1B)1, was impacted primarily by foreign exchange and divestitures, however Takeda delivered underlying revenue growth of 0.5% in the first half of FY2020, consistent with full year guidance of "low-single-digit growth".
We delivered reported operating profit of JPY 215.6 billion (~$2.0B)1, which grew 97.7%, 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 507.6 billion (~$4.8B)1 owing to foreign exchange impact and divestitures. The core operating profit margin was 31.9%. Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, grew to 31.6% year-on-year, driven by synergies and OPEX efficiencies.
Takeda’s reported net profit was JPY 86.5 billion, a 15.8% increase compared with the same period in the prior year.2 This is attributable mainly to lower purchase price accounting and integration costs.
Operating cash flow increased by 14.9% to JPY 392.0 billion. Free cash flow, which also reflects capital expenditures and proceeds from asset sales, was JPY 425.5 billion (~$4.0B)3, with the year-on-year growth rate impacted by the JPY 375.5 billion cash received for Xiidra in July 2019. Further de-leveraging in H1 led to a 3.7x 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 six-month period ended September 30, 2020 was not material. An adverse effect on revenue has been observed in some of our therapeutic areas, such as Neuroscience, for reasons such as patients visiting their medical care providers less frequently for non-life-threatening and chronic diseases. However, we have seen expansion of certain products with a more convenient administration profile. Voluntary suspension of certain business activities such as business travel and events in response to COVID-19 led to lower spending, which resulted in limited impact on Takeda’s profit. We continue to drive towards achieving our key deliverables in FY2020, while recognizing the potential for delays due to the pandemic, as detailed in Takeda’s Quick Report for the quarter ended September 30, 2020, released today. 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 OUR FIVE KEY BUSINESS AREAS
Takeda’s five key business areas — Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience — with JPY 1,298.9 billion of reported revenue representing approximately 82% of total H1 revenues – delivered year-on-year underlying revenue growth of 4.0%. Our 14 global brands, with reported revenue of JPY 595.9 billion in aggregate, delivered a 15.4% increase in underlying revenue growth compared to a year before.
Gastroenterology
The Gastroenterology franchise with JPY 379.8 billion in reported revenue represented 24% of sales, spearheaded by exceptional growth through expanded patient share of gut-selective ENTYVIO in the U.S., EU, and Japan.
Rare Diseases
The Rare Diseases franchise with JPY 295.4 billion in reported revenue represented 19% of sales, with the hereditary angioedema portfolio experiencing double digit growth driven by continued strong performance and successful launches of TAKHZYRO. The competitive landscape in Rare Hematology, including a -19% decline in ADVATE sales partially driven by ADYNOVATE and competitive uptake, was in line with our expectations. Additionally, Takeda is working closely with the FDA on a proposed plan to resupply NATPARA in the U.S. and anticipates that the required device modifications and product testing will likely delay availability beyond 2020.
PDT Immunology
PDT Immunology with JPY 205.9 billion in reported revenue represented 13% of sales, driven by strong Gammagard-Liquid demand in the U.S. and subcutaneous IG worldwide. Albumin sales decreased versus H1 last year (-13%) due to phasing and high FY19 H1 sales as a result of supply dynamics in China following a blackout period. However, we expect this to recover in H2, driven by demand and capacity expansion.
Oncology
Oncology with JPY 210.0 billion in reported revenue represented 13% of sales as our portfolio continues to expand indications in metastatic non-small cell lung cancer, chronic myeloid leukemia, myeloma, and ovarian cancer.
Neuroscience
Neuroscience with JPY 207.8 billion in reported revenue represented 13% of sales, with slowing momentum attributable to COVID-19 stay-at-home restrictions that reduced patient visits and diagnoses and created opportunities for discontinuing medication. A normalization of sales was noted toward the end of Q2.
Global Brand Highlights
Business areas
Product
Reported Product Revenue
JPY (billion)
Year-over-Year Underlying
Revenue Growth
Gastroenterology
ENTYVIO
207.0
+25.8%
Rare Diseases
TAKHZYRO
43.7
+45.5%
PDT Immunology
Immunoglobulin
162.7
+ 14.2%
Oncology
NINLARO
44.4
+ 19.2%
Oncology
ALUNBRIG
4.3
+30.2%
COST SAVINGS AND DIVESTITURES
Operational efficiencies and cost savings supported margin performance and we are on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021. Takeda is deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.7x at the end of Q2, down from 3.8x in March 2020. We are on course to meet our medium-term deleveraging goal of 2x within FY2021-FY2023.
Takeda exceeded its $10B non-core asset divestiture target and has announced 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion, including:
Agreement to divest 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 242.0 billion. The transaction is expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions. (Press release)
Agreement to divest non-core assets in Europe and Canada to Cheplapharm for approximately $562 million, subject to customary legal and regulatory closing conditions (Press Release)
Agreement to divest its TACHOSIL Fibrin Sealant Patch to Corza Health, Inc. Takeda will receive €350 million in cash upon closing of the transaction expected by March 31, 2021, which is subject to customary legal and regulatory closing conditions. (Press release)
Additionally, Takeda exceeded its $700 million target for incremental cash from real estate and securities, receiving $1.1 billion to date.
PIPELINE UPDATE: MOMENTUM IN OUR DYNAMIC R&D GROWTH ENGINE
Takeda has built a world-class R&D engine leveraging our internal research capabilities, while also actively engaging with innovative ecosystems around the world to translate science into highly innovative medicines. The main drivers for targeted new product launches are 12 unique New Molecular Entities (NMEs) in Wave 1, which represent several potential best-in-class / first-in-class therapies targeted for launch by FY2024 with aggregate potential peak sales of more than $10 billion.
As announced in the Q1 FY2020 results release, Takeda has seven of these potential Wave 1 NME filings targeted for the next 12 months: TAK-721, TAK-609, CoVIg-19, TAK-003, mobocertinib, pevonedistat and maribavir.
During Q2, Takeda’s R&D engine continued to advance its Wave 1 pipeline and expanded its capabilities in cell therapy. Wave 1 Q2 highlights include:
TAK-721 completed the rolling NDA submission and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis.
The CoVIg-19 Plasma Alliance began enrolling patients in the ITAC Phase 3 clinical trial to evaluate the safety, tolerability and efficacy of its investigational anti-coronavirus H-Ig medicine for treating hospitalized adults at risk for serious complications of COVID-19. (Press release)
TAK-003 is on track for a regulatory filing for Dengue vaccine in endemic countries in Asia and Latin America, and in the EU in Q4 FY2020.
Mobocertinib (TAK-788) demonstrated ten-month follow-up results from the Phase 1/2 trial presented at the virtual European Society for Medical Oncology Conference (ESMO) (Free ESMO Whitepaper) and achieved a duration of response (DoR) of more than one year in the trial’s study population of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC). (Press release)
Soticlestat (TAK-935/OV935): Our Phase 2 ELEKTRA Study of Soticlestat in partnership with Ovid Therapeutics Inc. met its primary endpoint for reducing seizure frequency in children with Dravet Syndrome or Lennox-Gastaut Syndrome. (Press release)
TAK-994, the first oral OX2R agonist, is in phase 2 enrolling NT1 and NT2 patients. Final data is targeted for 2H FY21.
Other notable updates
We expanded our cell therapy manufacturing capabilities in Boston, Massachusetts to support next-generation clinical programs including TAK-007, TAK-940 and TAK-102. This expansion provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas. Five collaborative oncology cell therapy programs are expected to be in clinical development by the end of FY2021 and Takeda has already initiated clinical studies testing its CAR-T candidates, TAK-940 and TAK-102 in Q2. (Press release, website)
We are excited about the transformative medium-term potential of a number of our major R&D programs, including:
TAK-999: Takeda and Arrowhead Pharmaceuticals entered into a collaboration to develop TAK-999, a first-in-class GalNAc based RNAi designed to treat the underlying cause of Alpha-1 Antitrypsin-Associated Liver Disease. (Press release)
TAK-981, a first-in-class small molecule inhibitor of sumoylation that activates type 1 interferon signaling and lymphocyte activation, is being explored in more than 10 expansion cohorts with adaptive trial designs in a broad range of tumor types with a high unmet need. Emerging data demonstrated the therapy is well tolerated and responses have been observed in single-agent dose-escalation in solid tumors and in combination with rituximab in Non-Hodgkin’s lymphoma.
Takeda will share further pipeline progress at our upcoming Wave 1 Pipeline Market Opportunity call on December 8, 2020.
KEY CORPORATE INITIATIVE
Takeda is accelerating its digital transformation through a collaboration with Accenture and AWS that will leverage cloud and data-driven insights to improve our productivity across our value chain, increase operational agility, reduce technology costs, and develop the workforce of the future.
We are investing in developing capabilities and hiring new talent in emerging fields of data and digital. We will also train employees in cloud, advanced analytics, robotic process automation (RPA), agile and innovation sprint methodologies. By moving 80% of applications to the cloud, we will remove non-differentiating technology, reduce our internal data center footprint, and decrease capital expenditures. (Press release)
FIGHTING COVID-19 UPDATE
Guided by our values, Takeda’s response to COVID-19 has focused on protecting the health and safety of our employees, striving to ensure our medicines are available to patients who rely on them and playing our part to reduce transmission and support the communities where our employees live and work. Takeda has also undertaken a number of efforts to help the world respond to COVID-19, including:
Novavax and Takeda Announce Collaboration for Novavax’ COVID-19 Vaccine Candidate in Japan
Press release
Takeda Expands COVID-19 Vaccine Supply in Japan Through Partnership with Moderna and Government of Japan
Press release
First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine
Press release
CoVIg-19 Plasma Alliance Builds Strong Momentum Through Expanded Membership and Clinical Trial Collaboration
Press release
Members of the COVID R&D Alliance and Quantum Leap Healthcare Collaborative Enroll First Patients in I-SPY COVID Trial
Press release
FY2020 GUIDANCE
Updating Full-Year Reported Forecast; Core and Underlying Guidance Confirmed
Takeda has solid growth momentum heading into H2 2020 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. Takeda upgraded its reported operating profit, reported net profit, and reported EPS forecast for FY2020 to reflect assumptions for one-time gains from several announced divestitures that were not included in the previous forecast but are now expected to be recognized within the current fiscal year, with the exception of the sale of shareholdings in Takeda Consumer Healthcare Company Limited.4 The reported revenue forecast for FY2020 has been reduced from JPY 3,250.0 billion to 3,200.0 billion, owing primarily to the impact of foreign exchange.
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 our 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 October 29, 2020, with the exception of the divestment of Takeda Consumer Healthcare Company; 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.