On October 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the third quarter ended September 30, 2019 (Press release, Agios Pharmaceuticals, OCT 31, 2019, View Source [SID1234550097]).

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"The third quarter was marked by strong commercial execution, now a full year since the U.S. launch of TIBSOVO, and several meaningful clinical updates spanning our early and late stage oncology programs that advance our strategy," said Jackie Fouse, Ph.D., chief executive officer at Agios. "As we look ahead to the remainder of 2019, we are focused on achieving our remaining key milestones, including completing enrollment in our mitapivat PK deficiency pivotal program, establishing proof of concept for mitapivat in thalassemia, initiating our pivotal trial of vorasidenib in low-grade glioma and submission of the TIBSOVO supplemental new drug application for IDH1 mutant cholangiocarcinoma. These milestones are critical steps toward realizing the value-creation potential for both our oncology and rare genetic disease portfolios in 2020 and beyond."

THIRD QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS

Presented data from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. The data demonstrated that AG-270 induces reductions in the biomarkers of methionine adenosyltransferase 2A (MAT2A) inhibition, notably plasma concentrations of S-adenosylmethionine (SAM) and tumor levels of symmetrically demethylated arginine (SDMA), at well tolerated doses.
Presented results from the Phase 3 ClarIDHy study of TIBSOVO in previously treated isocitrate dehydrogenase-1 (IDH1) mutant cholangiocarcinoma at the European Society for Medical Oncology Congress in September, demonstrating significant improvement in progression free survival compared to placebo.
Initiated two combination arms for the Phase 1 study of AG-270 in MTAP-deleted tumors, one evaluating AG-270 in combination with docetaxel in MTAP-deleted second-line non-small cell lung cancer and another in combination with nab-paclitaxel and gemcitabine in MTAP-deleted first or second-line pancreatic ductal adenocarcinoma.
Published new data from the core and extension phases of the DRIVE PK Phase 2 study of mitapivat in adults with pyruvate kinase (PK) deficiency in the September 5, 2019 issue of the New England Journal of Medicine, demonstrating sustained increases in hemoglobin for up to 35 months.
KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in the remainder of 2019:

Oncology:

Submit a supplemental new drug application to the FDA for TIBSOVO for previously treated IDH1 mutant cholangiocarcinoma by year-end.
Initiate the registration-enabling Phase 3 INDIGO study of vorasidenib in Grade 2 non-enhancing glioma with an IDH mutation by year-end. The study will evaluate 366 patients in 1:1 double-blind randomization to either 50 mg of vorasidenib once daily or placebo. The primary endpoint is progression free survival.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with PK deficiency by year-end:
ACTIVATE-T: A single-arm trial of up to 40 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of up to 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
REMAINING 2019 DATA PRESENTATIONS

Updated data from the perioperative study of TIBSOVO and vorasidenib in low-grade glioma have been accepted for presentation at the Society for Neuro-Oncology Annual Meeting taking place in Phoenix from November 22-24, 2019.
Data from the IDH and PKR programs have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in Orlando, Fla. from December 7-10, 2019, including new data from the extension phase of the Phase 2 DRIVE PK study of mitapivat in adults with PK deficiency and important translational data from the Phase 1 combination study of TIBSOVO and azacitidine in frontline acute myeloid leukemia (AML).
THIRD QUARTER 2019 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2019 was $26.0 million, which includes $17.4 million of net product revenue from U.S. sales of TIBSOVO, $5.5 million in collaboration revenue and $2.7 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to total revenue of $15.2 million for the third quarter of 2018.

Cost of Sales: Cost of sales were $0.4 million for the third quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $101.7 million for the third quarter of 2019 compared to $82.6 million for the third quarter of 2018. The increase in R&D expense was primarily attributable to start-up costs for the Phase 3 INDIGO study of vorasidenib in IDH mutated low-grade glioma, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and costs of the ongoing Phase 3 TIBSOVO combination trials in the frontline AML setting.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $33.0 million for the third quarter of 2019 compared to $31.1 million for the third quarter of 2018.

Net Loss: Net loss was $106.2 million for the third quarter of 2019 compared to $94.7 million for the third quarter of 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2019 were $540.5 million compared to $805.4 million as of December 31, 2018. The net decrease of $264.9 million in cash position was primarily driven by net expenditures to fund operations. The company expects that its cash, cash equivalents and marketable securities as of September 30, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2019 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 5996044. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.

On October 31, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the third quarter of 2019, which were highlighted by strong sales and a robust operating performance, along with the continuing advancement of the company’s pipeline (Press release, Bristol-Myers Squibb, OCT 31, 2019, View Source [SID1234550096]).

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"In the third quarter, we delivered strong business performance and made important progress with our pipeline, including the potential to bring our dual Immuno-Oncology combination to patients with lung cancer, a disease where the unmet need remains high," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "With strong momentum in our R&D and commercial organizations, I am looking forward to the tremendous opportunity when Bristol-Myers Squibb and Celgene come together as one, to deliver innovative medicines and transform patients’ lives."

Third Quarter

$ amounts in millions, except per share amounts

2019

2018

Change

Total Revenues

$6,007

$5,691

6%

GAAP Diluted EPS

0.83

1.16

(28)%

Non-GAAP Diluted EPS

1.17

1.09

7%

THIRD QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted third quarter revenues of $6.0 billion, an increase of 6% compared to the same period a year ago. Revenues increased 7% when adjusted for foreign exchange impact.
U.S. revenues increased 7% to $3.5 billion in the quarter compared to the same period a year ago. International revenues increased 3%. When adjusted for foreign exchange impact, international revenues increased 7%.
Gross margin as a percentage of revenue decreased from 71.0% to 69.9% in the quarter primarily due to product mix.
Marketing, selling and administrative expenses decreased 4% to $1.1 billion in the quarter.
Research and development expenses increased 8% to $1.4 billion in the quarter.
The effective tax benefit rate was 1.3% in the quarter, compared to an effective tax rate of 11.8% in the same period a year ago. The decrease in the effective tax rate was due to jurisdictional tax rates and other tax impacts attributed to pension settlement charges and the UPSA business divestiture gain in 2019.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.4 billion, or $0.83 per share, in the third quarter, compared to net earnings of $1.9 billion, or $1.16 per share, for the same period a year ago.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.9 billion, or $1.17 per share, in the third quarter, compared to net earnings of $1.8 billion, or $1.09 per share, for the same period a year ago. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable securities were $33.5 billion as of September 30, 2019. The net cash position was $8.5 billion as of September 30, 2019.
ACQUISITION OF CELGENE CORPORATION

In August, the company announced Celgene Corporation entered into an agreement with Amgen under which Amgen would acquire the global rights to OTEZLA. (link)
In July, the company announced the European Commission (EC) has granted unconditional approval of the company’s pending acquisition of Celgene Corporation. The company expects to close the Celgene transaction by the end of 2019. (link)
OTEZLA is a trademark of Celgene Corporation.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

Growth in global revenues for the third quarter of 2019, compared to the third quarter of 2018, was driven by:

Eliquis , which grew by 22%
Opdivo , which grew by 1%
Orencia , which grew by 14%
Sprycel , which grew by 14%
Yervoy , which decreased by 8%
Opdivo

Regulatory

In October, the company announced the EC approved Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks or 480 mg infused over 60 minutes every four weeks for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
In August, the company and Nektar Therapeutics announced the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin in combination with Opdivo for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Clinical

In October, the company announced that CheckMate -9LA, a pivotal Phase 3 trial evaluating Opdivo plus low-dose Yervoy (ipilimumab) given concomitantly with two cycles of chemotherapy for the first-line treatment of advanced non-small cell lung cancer, met its primary endpoint of superior overall survival at a pre-specified interim analysis. (link)
In September, at the European Society for Medical Oncology 2019 Congress, the company announced important new data and analysis from four studies evaluating Opdivo as monotherapy and in combination with Yervoy:
ATTRACTION-3: Results from the Phase 3 study evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma. The trial was sponsored by Ono Pharmaceutical Co. Ltd. (link)
Checkmate -227: Results from Part 1 of the Phase 3 study evaluating Opdivo plus low-dose Yervoy as first-line treatment for patients with advanced non-small cell lung cancer. (link)
Checkmate -067: Five-year results from the Phase 3 study evaluating the first-line combination of Opdivo plus Yervoy or Opdivo monotherapy, versus Yervoy alone, in patients with advanced metastatic melanoma. (link)
Checkmate -238: Three-year results from the Phase 3 study evaluating adjuvant use of Opdivo versus Yervoy in patients with Stage III or Stage IV melanoma who were at high risk of recurrence following complete surgical resection. (link)
In September, at the 20th World Conference on Lung Cancer of the International Association for the Study of Lung Cancer, the company announced long-term pooled efficacy and safety results from the Phase 3 CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer. (link)
In September, the company announced results from the Phase 3 CheckMate -548 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated. The study did not meet its primary endpoint of progression-free survival. The study remains ongoing for OS. (link)
Eliquis

Clinical

In September, at the European Society of Cardiology Congress 2019, the company and its alliance partner Pfizer announced findings from NAXOS (EvaluatioN of ApiXaban in strOke and Systemic embolism prevention in patients with nonvalvular atrial fibrillation in the real-life setting in France), the largest real-world data analysis on oral anticoagulant effectiveness and safety in Europe among patients with non-valvular atrial fibrillation. (link)
Empliciti

Regulatory

In August, the EC approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
2019 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2019 GAAP EPS guidance range from $3.73 – $3.83 to $3.46 – $3.56 and increasing its non-GAAP EPS guidance range from $4.20 – $4.30 to $4.25 – $4.35. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2019 GAAP and non-GAAP line-item guidance assumptions are:

An effective tax rate of 13% to 14% for GAAP and approximately 16% for non-GAAP
The financial guidance for 2019 excludes the impact of any potential future strategic acquisitions and divestitures, including any impact of the pending Celgene acquisition other than expenses incurred in 2019, and any specified items that have not yet been identified and quantified. The non-GAAP 2019 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

Guidance inclusive of the Celgene acquisition will be provided after the close of the transaction.

Use of Non-GAAP Financial Information

This earnings release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges or other income resulting from up-front or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, divestiture gains or losses, pension, legal and other contractual settlement charges, interest expense on the new notes issued in May 2019 in connection with our pending acquisition of Celgene and interest income earned on the net proceeds of those notes and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. This earnings release also provides international revenues excluding the impact of foreign exchange. Non-GAAP information is intended to portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. In addition, this information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram. For more information about Bristol-Myers Squibb’s pending acquisition of Celgene, please visit View Source

There will be a conference call on October 31, 2019 at 8:30 a.m. ET during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by calling the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 532230. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on October 31, 2019 through 11:45 a.m. ET on November 14, 2019. The replay will also be available through View Source or by calling the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 532230.

On October 31, 2019 Ipsen (Euronext: IPN; ADR: IPSEY) reported that results from a network meta-analysis (NMA) in advanced renal cell carcinoma (aRCC), and a UK-focused budget impact study assessing long-acting somatostatin analogues (LA-SSAs) for the treatment of acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP NET) will be presented at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Europe 2019 Annual Conference (Press release, Ipsen, OCT 31, 2019, View Source [SID1234550095]). ISPOR takes place in Copenhagen, Denmark from 2 – 6 November 2019.

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Key studies to be presented at ISPOR Europe 2019:

An assessment of the budget impact of LA-SSAs in the treatment of acromegaly and GEP NET, considering attributes related to the drug delivery of LA-SSAs in the UK.
An NMA analyzing cabozantinib versus standard-of-care comparators in progression free survival (PFS) and overall survival (OS) in the first-line treatment of advanced renal cell carcinoma.

"We’re excited to be sharing two interesting sets of results – namely a comparison of first-line therapies and budget impact of a treatment approach for acromegaly and gastroenteropancreatic neuroendocrine tumors," said Ulf Staginnus, Senior Vice President, Head Global Market Access and Pricing, Ipsen. "With more than 5,000 global healthcare leaders, seeking robust health solutions and new insights, ISPOR Europe 2019 is the perfect stage to share these results."

The delivery attributes of both LA-SSAs were considered in the UK-focused study assessing the budget impact of the LA-SSAs, lanreotide versus octreotide in the treatment of acromegaly and GEP-NET. Model inputs (including drug acquisition and administration costs) were based on publicly available sources. The analysis compared the current and hypothetical market share scenarios from three perspectives in the UK: the National Health Service (NHS), a regional clinical commissioning group (CCG), and a local institution (hospital). Results suggested that increasing the use of lanreotide to a hypothetical 80% market share for lanreotide in the UK would reduce overall LA-SSAs patient treatment expenses by £2.9 million annually in the UK (a reduction of 3.6% from the current budget estimate of £80.6 million).

In the area of treatment provision in aRCC, Ipsen used an NMA to respond to the challenge presented to healthcare professionals by the introduction of targeted therapies in the last year with no way to objectively compare them. While randomized trials are the gold standard for comparative effectiveness research, they are not always available for clinically and economically important treatment comparisons. In this case, the NMA may offer some helpful insights as it suggests that cabozantinib significantly increases progression free survival (PFS) in intermediate and poor-risk patients when compared with standards-of-care and concludes that cabozantinib may be considered as an efficient treatment option in first-line aRCC.

"Modern quantitative data reviews of available agents offer additional insights into existing healthcare," said Bartek Bednarz, Senior Vice-President, Global Product and Portfolio Strategy, Ipsen. "The network meta-analysis (NMA) for cabozantinib and budget impact model for somatostatin analogues shared at ISPOR Europe 2019 are just part of Ipsen’s ongoing commitment to demonstrating benefit for payers and improving options for patients with high unmet needs."

Follow Ipsen on Twitter via @IpsenGroup and keep up to date with ISPOR Europe 2019 Conference news and updates by using the hashtag #ISPOREurope.

Overview of key Ipsen presentations at ISPOR Europe 2019:

Medicine Abstract title Abstract number/timing (CEST)
Cabometyx

(cabozantinib)

Cabozantinib versus standard-of-care comparators: a network meta-analysis of progression free survival and overall survival in the first-line treatment of advanced renal cell carcinoma
PCN42; Board D5

RESEARCH POSTER SESSION 2

CANCER

Monday, November 4, 2019

Display Hours: 15:30 – 19:00

Somatuline Autogel (lanreotide autogel/depot) Budget impact analysis of somatostatin analogues in the treatment of GEP-NET and acromegaly in the UK
PDG23; Board J3

RESEARCH POSTER SESSION 4

DRUGS & GENERICS

Tuesday, November 5, 2019

Display Hours: 15:45 – 19:00

N/A Retrospective Gesetzliche Krankenversicherung (statutory health insurance) (GKV) research study on the initial treatment of bladder carcinoma (BCA) by transurethral bladder resection (TURB) – a comparative analysis of costs and urological follow-up therapies using standard white light- (WL-) vs. Blue light- (WL-)TURB
PCN502; Board W12

RESEARCH POSTER SESSION 2

CANCER

Monday, November 4, 2019

Display Hours: 15:30 – 19:00

N/A Assessing the human and economic burden of short stature: a systematic literature review
PMU142; Board V19

RESEARCH POSTER SESSION 4

MULTIPLE DISEASES

Tuesday, November 5, 2019

Display Hours: 15:45 – 19:00

On October 31, 2019 The New England Journal of Medicine published detailed results from the Phase 3 ADMIRAL trial, which found that Astellas Pharma Inc.’s (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. "Astellas") XOSPATA (gilteritinib) demonstrated significantly longer Overall Survival (OS) than salvage chemotherapy in adult patients with relapsed (disease that has returned) or refractory (resistant to treatment) Acute Myeloid Leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation (Press release, Astellas, OCT 31, 2019, View Source [SID1234550086]). Common adverse events from the study of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).1 The results appear in the October 31 print edition of the Journal and are currently available online.1

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"These data show that in a very high-risk leukemia population, single agent FLT3-targeted therapy leads to superior clinical outcomes compared to salvage chemotherapy," said Alexander Perl, MD, associate professor of Hematology-Oncology in the Abramson Cancer Center at the University of Pennsylvania, and the trial’s principal investigator. "This is an important result for patients who previously had quite limited treatment options."

"The detailed findings from our Phase 3 ADMIRAL trial further validate that XOSPATA is a significant addition to the treatments available for people with FLT3 mutation positive relapsed or refractory AML," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head at Astellas. "We are especially pleased to see the results published in the New England Journal of Medicine, which is widely regarded as one of the most prestigious scientific medical journals."

The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) in May of 2019 to update the U.S. product labeling for XOSPATA to include final analysis OS data from the ADMIRAL trial.2

XOSPATA was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and commercialize XOSPATA.

XOSPATA was approved by the Japan Ministry of Health, Labor and Welfare (MHLW) for relapsed or refractory AML with FLT3 mutations and launched as XOSPATA 40 mg Tablets in 2018.3 In October 2019, the European Commission (EC) approved XOSPATA as a monotherapy for the treatment of adult patients with relapsed or refractory AML with a FLT3 mutation.4 XOSPATA has been designated an orphan medicinal product and also received accelerated assessment from the European Medicines Agency (EMA) earlier this year, which reduced the timeframe for approval.5,6,7 Astellas is currently investigating gilteritinib in various FLT3 mutation-positive AML patient populations through several clinical trials. Visit View Source to learn more about ongoing gilteritinib clinical trials.

On October 31, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK) (Press release, Takeda, OCT 31, 2019, View Source [SID1234550063]):

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Underlying Revenue declined -0.2% vs FY2018 H1 pro-forma revenue2

Takeda’s 14 global brands with reported revenue of 547.0 billion yen in aggregate posted a strong year-over-year underlying growth of +21%, driven by ENTYVIO growing +33.9%, ALBUMIN/FLEXBUMIN growing +16.9%, and NINLARO growing +32.7%, offset by the negative impact of intensified competition and generic erosion.
Underlying growth in key business areas for FY2019 H1: GI (+9%), Oncology (+11%), Neuroscience (+6%), and Plasma Derived Therapy (PDT) Immunology (+4%), offset by Rare Disease (-11%) due to decline as expected in Rare Hematology.
Within Rare Disease, Rare Hematology continues to be impacted by competition and price pressure, and growth in Hereditary Angioedema (HAE) was negatively affected by stocking in the prior year as well as generic entry for FIRAZYR.
Immunoglobulin returned to growth as expected in the 3 months of FY2019 Q2 at an underlying growth rate of +7.6% and +3% for H1, over the same period of last year.
Underlying Core Operating Profit Margin of 32.2% for FY2019 H1 with cost synergies and OPEX efficiencies driving margins

Reported Operating Profit declined -70.7% to 50.3 billion yen, largely impacted by non-cash purchase accounting expenses including unwinding of inventory step-up, increased amortization of intangibles, as well as one-time integration costs.
Core Operating Profit increased +155.5% to 541.6 billion yen primarily due to the acquisition of Shire, solid performance of 14 global growth brands and improved operating efficiency partially offset by the negative impact of intensified competition and generic erosion.
Underlying Core Operating Profit Margin for FY2019 H1 was 32.2% reflecting continued OPEX discipline and cost synergies.
Underlying Core EPS for H1 was 249 yen.
Investing in future growth by adding 23 plasma collection centers since the closing of the Shire acquisition, acquiring license for first-in-class celiac disease therapy (TAK-101) from COUR Pharmaceuticals, and continued investment in our R&D engine.
1

Please refer to note iii in Reported Results for H1 (April – June) FY2019 table for Core Operating Profit definition.

2

Growth versus FY2018 H1 pro-forma revenue (6-month April-September 2018 combined revenue of Legacy Takeda and Legacy Shire, excludes its oncology business and US GAAP results were conformed to IFRS, without material differences). Please see the appendix for more details.

Achieved Several Important Pipeline Milestones

Data presented at World Sleep Congress demonstrated early evidence of efficacy for TAK-925 in Narcolepsy Type 1.
ENTYVIO head-to-head study and TAK-620 (Maribavir) Ph-2 data published in The New England Journal of Medicine.
TRINTELLIX approved in Japan for the treatment of depression and depressed state.
Submitted a Marketing Authorization Application (MAA) in Japan for a subcutaneous formulation of ENTYVIO for patients with moderately to severely active ulcerative colitis.
8 potential best-in-class or first-in-class New Molecular Entities (NMEs) in pivotal studies.
Divesting non-core assets to accelerate deleveraging and focus the business

Paid down 584.5 billion yen of debt and de-levered from 4.7x at end of FY2018 to 3.9x Net debt / adjusted EBITDA as of September 2019. This does not include the sale of OTC and prescription pharmaceutical assets in certain Near East, Middle East and Africa countries to Acino for more than $200 million.
Negotiations ongoing for further potential divestments.
Christophe Weber, Chief Executive Officer, commented:

"We are pleased with our recent financial results, which reflect strong underlying performance across our 14 global brands and OPEX improvements that has allowed us to raise our guidance. I am particularly encouraged by the rapid de-leveraging year-to-date.
We are also satisfied with the progress of our integration efforts. Takeda employees are excited and engaged around our next phase of growth and our undeniable progress towards becoming one integrated company.
Our excitement around the future of Takeda is also derived from the strength and breadth of our pipeline. We look forward to providing some additional insight and commentary around our portfolio, pipeline, and growth strategy at our upcoming R&D Day in November."

Reported Results for FY2019 H1 (April – June)

(billion yen)

REPORTED

CORE

UNDERLYING i.

FY2019 H1

VS. PRIOR YEAR

FY2019 H1

VS. PRIOR YEAR

Revenue

1,660.2

+88.5%

1,660.2

+88.5%

-0.2% y-o-y ii.

(pro-forma)

Operating Profit

50.3

-70.7%

541.6 iii.

+155.5%

Margin

3.0%

-16.5pp

32.6%

+8.6pp

32.2%

Net Profit iv.

33.2

-73.8%

380.4

+130.3%

EPS (JPY)

21 yen

-140 yen

244 yen

+33 yen

249 yen

i.

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.

ii.

Growth versus FY2018 H1 pro-forma revenue. Pro-forma revenue is the 6-month April-September 2018 combined revenue of Legacy Takeda and Legacy Shire, US GAAP results conformed to IFRS, without material differences. The adjustments also include removal of impacts related to Shire’s oncology business which was divested in August 2018.

iii.

Core Operating Profit represents net profit adjusted to exclude income tax expenses, our 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 intangible assets associated with products and other items that management believes are unrelated to our core operations, such as purchase accounting effects and transaction related costs.

iv.

Attributable to the owners of the company.

FY2019 Management Guidance: Upgrading guidance to reflect positive business momentum

Previous Guidance
(July 31, 2019)

Revised Guidance
(October 31, 2019)

Underlying Revenue Growth i.

Flat to slightly increasing

Flat to slightly increasing

Underlying Core Operating Profit Margin

Mid-to-high-twenties %

High-twenties %

Underlying Core EPS

360 – 380 yen

370 – 390 yen

Annual Dividend per Share

180 yen

180 yen

i.
Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate of 111 JPY/USD) compared to baseline of JPY 3,300 billion (Rounded pro-forma April 2018-March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018-March 2019 average exchange rate of 111 JPY/USD; also adjusted to remove the revenue from divested assets such as Techpool, Multilab, and TACHOSIL from Legacy Takeda, and the oncology portfolio and XIIDRA from Legacy Shire) and conformed from US GAAP to IFRS, without material differences.

FY2019 Reported Forecast: Revenue decreasing due to FX impact, but profit increasing

For more details on Takeda’s FY2019 Q2 results and other financial information, please visit View Source

Takeda to Host R&D Day on November 14 in New York, Plasma-Derived Therapies Day on November 15 in Covington, GA, and R&D and Plasma-Derived Therapies Day on November 21 in Tokyo;

At each event, Takeda executives are expected to discuss, among other things, the Company’s near-term and sustained growth strategies and next-generation platforms. Each event will be accessible via a live webcast on the Investors section of the Company’s website: View Sourcequarterly-announcements/quarterly-announcements-2019/.
A replay of each webcast will be archived on the website along with the presentation slides associated with each event.