Phase 1
Phase 2
Phase 3
Application
Therapeutic
area
Cardiovascular-
Metabolics
Oncology
Others

Edoxaban (JP)
(DU-176b / AF / FXa inhibitor)

Prasugrel (JP)
(CS-747 / Ischemic stroke / Anti-
platelet agent)

Esaxerenone (JP)
(CS-3150 / Hypertension /
MR antagonist)

Edoxaban (ASCA etc.)
(DU-176b / AF / FXa inhibitor)

Edoxaban (ASCA etc.)
(DU-176b / VTE / FXa inhibitor)

Tivantinib (US/EU)
(ARQ 197 / HCC / MET inhibitor)

Denosumab (JP)
(AMG 162 / Breast cancer adjuvant /
Anti-RANKL antibody)

Nimotuzumab (JP)
(DE-766 / Gastric cancer / Anti-EGFR
antibody)

Vemurafenib (US/EU)
(PLX4032 / Melanoma Adjuvant / BRAF
inhibitor)

Quizartinib (US/EU/Asia)
(AC220 / AML-2
nd
/ FLT3-ITD inhibitor)

Quizartinib (US/EU/Asia)
(AC220 / AML-1
st
/ FLT3-ITD inhibitor)

Pexidartinib (US/EU)
(PLX3397 / TGCT / CSF-1R/KIT/FLT3-ITD
inhibitor)

Laninamivir (US/EU)
(CS-8958 / Anti-influenza /
out-licensing with Biota)

Mirogabalin (US/EU)
(DS-5565 / Fibromyalgia / α2δ ligand)

Mirogabalin (JP/Asia)
(DS-5565 / DPNP/ α2δ ligand)

Mirogabalin (JP/Asia)
(DS-5565 / PHN / α2δ ligand)

Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor regulator)

CHS-0214 (JP)
(Etanercept BS / Rheumatoid
arthritis / TNFα inhibitor)

VN-0105 (JP)
(DPT-IPV / Hib vaccine)

Laninamivir (JP)
(CS-8958 / Anti-influenza / nebulizer)

Esaxerenone (JP)
(CS-3150 / DM nephropathy / MR
antagonist)

DS-8500 (JP/US)
(Diabetes / GPR119 agonist)

Patritumab (EU)
(U3-1287 / Anti-HER3 antibody)

Pexidartinib (US)
(PLX3397 / CSF-1R/KIT/FLT3-ITD
inhibitor)

DS-1647 (JP)
(Glioblastoma / G47Δ virus)

DS-1040
(Acute ischemic stroke / TAFIa inhibitor)

DS-2330
(Hyperphosphatemia)

DS-9231/TS23
(Thrombosis / α2-PI inactivating antibody)

DS-9001
(Dyslipidemia / Anti-PCSK9 Anticalin-Albumod)

DS-3032 (US/JP)
(MDM2 inhibitor)

PLX7486 (US)
(FMS / TRK inhibitor)

PLX8394 (US)
(BRAF inhibitor)

DS-6051 (US/JP)
(NTRK/ROS1 inhibitor)

PLX9486 (US)
(KIT inhibitor)

DS-3201 (JP)
(EZH1/2 inhibitor)

PLX73086 (US)
(CSF-1R inhibitor)

PLX51107 (US)
(BRD4 inhibitor)

DS-1971
(Chronic pain)

DS-1501
(Osteoporosis / Anti-Siglec-15 antibody)

DS-7080 (US)
(AMD / Angiogenesis inhibitor)

DS-2969
(
Clostridium difficile
infection
/GyrB inhibitor)

DS-5141 (JP)
(DMD / ENA oligonucleotide)

VN-0102/JVC-001 (JP)
(MMR vaccine)

Hydromorphone (JP)
(DS-7113 / Cancer pain / Opioid μ-
receptor agonist)

CL-108 (US)
(Acute pain / Opioid μ-receptor
agonist)

Intradermal Seasonal
Influenza Vaccine (JP)
(VN-100 / prefilled i.d. vaccine for
seasonal flu)

VN-0107/MEDI3250 (JP)
(Nasal spray flu vaccine)

Denosumab (JP)
(AMG 162 / Rheumatoid arthritis /
Anti-RANKL antibody)
Major R&D Pipeline

DS-8895 (JP)
(Anti-EPHA2 antibody)

DS-8273 (US)
(Anti-DR5 antibody)

DS-5573 (JP)
(Anti-B7-H3 antibody)

DS-8201 (JP/US)
(Anti-HER2 ADC)

U3-1784 (EU)
(Anti-FGFR4 antibody)

DS-1123 (JP)
(Anti-FGFR2 antibody)

U3-1402 (JP)
(Anti-HER3 ADC)
As of January 2017
Red: Major changes after the FY2016 Q2 financial announcement on October 31, 2016
11. Major R&D Pipeline (Innovative pharmaceuticals
）
◆
Oncology (Late-stage pipeline products)
Generic Name/Project Code Number
(Brand Name)
Class
Target indication
Region Stage
Dosage
Form
Partner
Target FY for
approval/launch
Anti-RANKL antibody
Breast cancer adjuvant
JP
P3 Injection
Amgen
2020
BRAF inhibitor
Melanoma adjuvant
US/EU
P3
Oral
–
–
MET inhibitor
Hepatocellular cancer
US/EU
P3
Oral
ArQule, Inc.
2018
US/EU/Asia P3
2018
US/EU/Asia P3
2021-
JP
P1
–
Tenosynovial Giant Cell Tumor (TGCT)
US/EU
P3
2019
Solid tumor
Asia
P1
–
Glioblastoma
US
P2
–
c-KIT Melanoma
Asia
P1/2
–
Melanoma, solid tumor
US
P1/2
Merck & Co., Inc.
–
Anti-EGFR antibody
Gastric cancer
JP
P3 Injection InnoClMAb Pte Ltd
2020
Anti-HER3 antibody
Head & neck cancer
EU
P2 Injection
–
–
Oncolytic HSV-1
Glioblastoma
JP
P2 Injection
ActiVec Inc.
–
Remarks
Denosumab/AMG 162
Ranmark (JP)
Additional indication
The fully human monoclonal antibody to target RANK Ligand, an essential mediator of osteoclast formation.
Vemurafenib/PLX4032
Zelboraf
Additional indication. Licensee Roche is conducting the
study. Submission in 2017 is planned.
The molecular-targeted agent to inhibit BRAF V600E mutation.
Tivantinib/ARQ 197
HCC with MET high patients
The molecular-targeted agent to inhibit HGF(hepatocyte growth factor) receptor, MET which has multiple roles in intracellular signal transductions such as cancer cell proliferation, angiogenesis, invasion, and apoptosis
induction.
Nimotuzumab/DE-766
Patritumab/U3-1287
Pexidartinib/PLX3397
CSF-1R/KIT/FLT3-ITD inhibitor
Oral
–
Quizartinib/AC220
FLT3-ITD inhibitor
Acute myeloid leukemia
Oral
–
Relapsed and refractory AML patients
Newly diagnosed AML patients
Kinase inhibitor against a receptor-type tyrosine kinase, FLT3. Therapeutic effect for patients with acute myeloid leukemia harboring FLT3-ITD mutation is expected.
DS-1647(G47
D
)
Received SAKIGAKE Designation from MHLW
Investigator Initiated Study is on-going
The third generation oncolytic herpes simplex virus type 1(HSV-1), ghenetically-engineered to restrict virus replication to tumor cells. This oncolytic virus therapy is expected equal or better safety and better efficacy profile
compare to existing oncolytic virus.
Underline: change after FY2016 Q2 Financial Announcement in October 2016
As of January 2017
The humanized monoclonal antibody to target Epidermal Growth Factor Receptor(EGFR). This antibody is expected to be a best in class EGFR, safety against the skin toxicity and the efficacy comparable to the other
antibodies.
The fully human monoclonal antibody to target HER3, one of the Epidermal Growth Factor Receptor (EGFR) family of proteins. HER 3 is overexpressed in many tumors of epithelial origin and HER2/HER3 dimers and
EGFR/HER3 dimers are expected more potent to induce tumor cell proliferation than homodimers of HER2 or EGFR.
Including pigmented villonodular synovitis
Including TGCT
Combination with pembrolizumab in collaboration with
Merck
The molecular-targeted agent to inhibit CSF-1R, KIT and FLT3-ITD. This agent is expected to reduce tumor cell proliferation and expansion of metastases.

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On January 31, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported improved production times utilizing its non-viral platform to engineer chimeric antigen receptor (CAR)-modified T cells in an ongoing Phase 1 study of second-generation Sleeping Beauty CD19-specific CAR+ T cells (Press release, Ziopharm, JAN 31, 2017, View Source [SID1234517599]). Plans to progress the Company’s point-of-care (POC) approach with administration of CAR-T cell therapy in less than 2 days are also underway helping expand access to innovative T-cell therapies.

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"Through the application of Intrexon’s industrial engineering components and principles, we have enhanced our non-viral approach to T-cell therapies. Shortening the manufacturing process and avoiding the complexity of viral-based approaches with Sleeping Beauty represents a significant advance which dramatically reduces barriers to broadening delivery of CAR-expressing T cells to a wide range of institutions and importantly cancer patients in need," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.

In contrast to the multi-step methods to produce virus-modified CAR- and TCR-expressing T cells, the non-viral Sleeping Beauty system offers the ability to rapidly generate genetically modified products through a simplified process. The improvements include avoiding activation and propagation of T cells as well as reduced time in culture.

In the clinical setting, data published in the Journal of Clinical Investigation in August 2016 from two Phase 1 trials, infusing first-generation Sleeping Beauty CD19-specific CAR T cells produced in 4 weeks, demonstrated positive long-term survival data for patients with acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). In the ongoing Phase 1 study utilizing second-generation Sleeping Beauty CD19-specific CAR+ T cells for lymphoid malignancies, compressed production times with younger T cells are being deployed:

A patient with multiple-relapsed B-cell ALL received Sleeping Beauty-modified CD19-specific CAR+ T cells with the manufacturing time reduced to 3 weeks and achieved a complete remission with normalization of PET/CT tumor imaging.
A patient with triple-hit NHL treated in January 2017 was the first to receive Sleeping Beauty-modified CD19-specific CAR+ T cells with the manufacturing time reduced to 2 weeks.
In the pre-clinical setting, the time to administration of third generation Sleeping Beauty CAR+ T cells co-expressing a membrane-bound version of IL-15 (mbIL15) has been reduced to less than two days. This shortened process delivers genetically modified T cells with superior proliferative potential. Data presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2016, supported by an earlier publication in the Proceedings of the National Academy of Sciences, revealed promising results:

Third generation Sleeping Beauty CAR+ T cells demonstrated that a single low-dose of T cells co-expressing a CD19-specific CAR and mbIL15 resulted in sustained in vivo persistence that produced potent anti-tumor effects and superior leukemia-free survival.
These clinical and pre-clinical data support the Company’s POC plans to rapidly infuse Sleeping Beauty CAR+ T cells in a Phase I trial to be launched later this year. With the intent to administer clinical-grade Sleeping Beauty CAR+ T cells in less than 48 hours, this non-viral CAR-T approach has the potential to outpace viral-based methods.

"Together with ZIOPHARM, we are realizing the promise of engineered T cells and are excited to advance the POC approach. Our ability to generate T cells that co-express immunoreceptors and cytokines such as membrane-bound IL-15 through non-viral gene transfer, plus integration of our RheoSwitch Therapeutic System enabling conditional control of these and other essential components, represents what we believe will be the best-in-class platform in CAR-T and TCR-based cellular therapy," stated Geno Germano, President of Intrexon Corporation (NYSE:XON).plete remission with normalization of PET/CT tumor imaging.
A patient with triple-hit NHL treated in January 2017 was the first to receive Sleeping Beauty-modified CD19-specific CAR+ T cells with the manufacturing time reduced to 2 weeks.
In the pre-clinical setting, the time to administration of third generation Sleeping Beauty CAR+ T cells co-expressing a membrane-bound version of IL-15 (mbIL15) has been reduced to less than two days. This shortened process delivers genetically modified T cells with superior proliferative potential. Data presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2016, supported by an earlier publication in the Proceedings of the National Academy of Sciences, revealed promising results:

Third generation Sleeping Beauty CAR+ T cells demonstrated that a single low-dose of T cells co-expressing a CD19-specific CAR and mbIL15 resulted in sustained in vivo persistence that produced potent anti-tumor effects and superior leukemia-free survival.
These clinical and pre-clinical data support the Company’s POC plans to rapidly infuse Sleeping Beauty CAR+ T cells in a Phase I trial to be launched later this year. With the intent to administer clinical-grade Sleeping Beauty CAR+ T cells in less than 48 hours, this non-viral CAR-T approach has the potential to outpace viral-based methods.

"Together with ZIOPHARM, we are realizing the promise of engineered T cells and are excited to advance the POC approach. Our ability to generate T cells that co-express immunoreceptors and cytokines such as membrane-bound IL-15 through non-viral gene transfer, plus integration of our RheoSwitch Therapeutic System enabling conditional control of these and other essential components, represents what we believe will be the best-in-class platform in CAR-T and TCR-based cellular therapy," stated Geno Germano, President of Intrexon Corporation (NYSE:XON).. Plans to progress the Company’s point-of-care (POC) approach with administration of CAR-T cell therapy in less than 2 days are also underway helping expand access to innovative T-cell therapies.

"Through the application of Intrexon’s industrial engineering components and principles, we have enhanced our non-viral approach to T-cell therapies. Shortening the manufacturing process and avoiding the complexity of viral-based approaches with Sleeping Beauty represents a significant advance which dramatically reduces barriers to broadening delivery of CAR-expressing T cells to a wide range of institutions and importantly cancer patients in need," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM.

In contrast to the multi-step methods to produce virus-modified CAR- and TCR-expressing T cells, the non-viral Sleeping Beauty system offers the ability to rapidly generate genetically modified products through a simplified process. The improvements include avoiding activation and propagation of T cells as well as reduced time in culture.

In the clinical setting, data published in the Journal of Clinical Investigation in August 2016 from two Phase 1 trials, infusing first-generation Sleeping Beauty CD19-specific CAR T cells produced in 4 weeks, demonstrated positive long-term survival data for patients with acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL). In the ongoing Phase 1 study utilizing second-generation Sleeping Beauty CD19-specific CAR+ T cells for lymphoid malignancies, compressed production times with younger T cells are being deployed:

A patient with multiple-relapsed B-cell ALL received Sleeping Beauty-modified CD19-specific CAR+ T cells with the manufacturing time reduced to 3 weeks and achieved a complete remission with normalization of PET/CT tumor imaging.
A patient with triple-hit NHL treated in January 2017 was the first to receive Sleeping Beauty-modified CD19-specific CAR+ T cells with the manufacturing time reduced to 2 weeks.
In the pre-clinical setting, the time to administration of third generation Sleeping Beauty CAR+ T cells co-expressing a membrane-bound version of IL-15 (mbIL15) has been reduced to less than two days. This shortened process delivers genetically modified T cells with superior proliferative potential. Data presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2016, supported by an earlier publication in the Proceedings of the National Academy of Sciences, revealed promising results:

Third generation Sleeping Beauty CAR+ T cells demonstrated that a single low-dose of T cells co-expressing a CD19-specific CAR and mbIL15 resulted in sustained in vivo persistence that produced potent anti-tumor effects and superior leukemia-free survival.
These clinical and pre-clinical data support the Company’s POC plans to rapidly infuse Sleeping Beauty CAR+ T cells in a Phase I trial to be launched later this year. With the intent to administer clinical-grade Sleeping Beauty CAR+ T cells in less than 48 hours, this non-viral CAR-T approach has the potential to outpace viral-based methods.

"Together with ZIOPHARM, we are realizing the promise of engineered T cells and are excited to advance the POC approach. Our ability to generate T cells that co-express immunoreceptors and cytokines such as membrane-bound IL-15 through non-viral gene transfer, plus integration of our RheoSwitch Therapeutic System enabling conditional control of these and other essential components, represents what we believe will be the best-in-class platform in CAR-T and TCR-based cellular therapy," stated Geno Germano, President of Intrexon Corporation (NYSE:XON).

On January 31, 2017 Kyowa Hakko Kirin Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo; President and CEO: Nobuo Hanai, hereinafter, "Kyowa Hakko Kirin"), reported that it has established Kyowa Kirin Frontier Co., Ltd. (hereinafter, "Kyowa Kirin Frontier") on January 18, 2017 as part of "CSV(Note 1) management based on our unique business structure," one of the core strategies set forth by Kyowa Hakko Kirin in its current Mid-term Business Plan (Press release, Kyowa Hakko Kirin, JAN 31, 2017, View Source [SID1234517604]).

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Kyowa Kirin Frontier will work toward obtaining approval to manufacture and market "Authorized version (Note 2)" of NESP, a core product of Kyowa Hakko Kirin, in Japan. Through such efforts by Kyowa Kirin Frontier, it will be possible to respond to the changes in the social environment surrounding healthcare in Japan and the diversification of the needs thereof, and to meet social demands for medical cost containment.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. Note 1: CSV stands for "Creating Shared Value." It ref

On January 31, 2017 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2016 (Press release, Thermo Fisher Scientific, JAN 31, 2017, View Source [SID1234517606]).

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Fourth Quarter and Full Year 2016 Highlights

Fourth quarter revenue increased 6% to $4.95 billion.
Full year revenue grew 8% to $18.27 billion.
Fourth quarter GAAP diluted earnings per share (EPS) increased 6% to $1.59.
Fourth quarter adjusted EPS grew 14% to $2.41.
Full year GAAP diluted EPS increased 3% to $5.09.
Full year adjusted EPS grew 12% to $8.27.
Invested more than $750 million in R&D in 2016, and launched significant new products, including Q Exactive BioPharma mass spectrometry and Integrion chromatography systems, TSX laboratory freezers, Ion Torrent cancer assays, and new tests for drugs-of-abuse and autoimmune disease.
Strengthened capabilities in Shanghai, Seoul and Singapore during the year to build on industry-leading presence in Asia-Pacific and emerging markets and continued to deliver strong growth in the region, led by outstanding performance in China.
Deployed approximately $7 billion of capital in 2016, with $5.5 billion spent on strategic acquisitions, including FEI Company and Affymetrix, and $1.5 billion returned to shareholders through a combination of stock buybacks and dividends.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"I’m pleased to report that we achieved the goals we laid out for 2016, and successfully executed our strategy to deliver another excellent year," said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific.

"We effectively deployed the largest R&D budget in our industry, and launched new high-impact products across all of our technology platforms. In Asia-Pacific and emerging markets, we leveraged our industry-leading scale to drive strong growth, especially in China, where we’re capturing opportunities aligned with the new five-year plan.

"We also continued to successfully execute our capital deployment strategy to create value for our shareholders. I’m really excited about our acquisition of FEI – the third largest in our history – and look forward to the opportunities we have to leverage these complementary technologies to drive growth.

"To sum it up, with a strong 2016 behind us, we’re positioned for another great year ahead."

Fourth Quarter 2016

As previously communicated, the company’s 2016 fiscal calendar had four fewer selling days in the fourth quarter versus the fourth quarter of 2015. Consequently, revenue and organic growth results in the 2016 quarter were negatively affected by the fewer days, and operating margin benefited due to fewer days of costs. Revenue for the quarter grew 6% to $4.95 billion in 2016, versus $4.65 billion in 2015. Organic revenue growth was essentially flat; acquisitions increased revenue by 8% and currency translation reduced revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter increased to $1.59, versus $1.50 in the same quarter last year. GAAP operating income for the fourth quarter of 2016 grew to $753 million, compared with $690 million in the fourth quarter of 2015. GAAP operating margin increased to 15.2%, compared with 14.8% in the fourth quarter of 2015.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2016 rose 14% to $2.41, versus $2.12 in the fourth quarter of 2015. Adjusted operating income for the fourth quarter of 2016 grew 14% compared with the year-ago quarter. Adjusted operating margin expanded 160 basis points to 24.8%, compared with 23.2% in the fourth quarter of 2015.

Full Year 2016

Revenue for the full year grew 8% to $18.27 billion in 2016, versus $16.97 billion in 2015. Organic revenue growth was 4%; acquisitions increased revenue by 4% and currency translation reduced revenue by 1%.

GAAP Earnings Results

GAAP diluted EPS for the full year increased to $5.09, versus $4.92 in 2015. GAAP operating income for 2016 grew to $2.45 billion, compared with $2.34 billion a year ago. GAAP operating margin was 13.4% in 2016, compared with 13.8% in 2015. GAAP operating results reflect acquisition-related charges in the 2016 period.

Non-GAAP Earnings Results

Adjusted EPS for the full year rose 12% to $8.27, versus $7.39 in 2015. Adjusted operating income for 2016 grew 10% compared with 2015, and adjusted operating margin expanded 60 basis points to 23.1%, compared with 22.5% a year ago.

Annual Guidance for 2017

The company will provide 2017 financial guidance on its earnings conference call this morning at 8:30 a.m. Eastern time.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Fourth quarter revenue results were negatively affected by the four fewer selling days in 2016 and fourth quarter operating margin benefited from fewer days of costs. Fourth quarter and full year results were negatively affected by the impact of foreign currency exchange rates. The impact of the fewer days in the fourth quarter and foreign exchange affects each of the segments to varying degrees.

Life Sciences Solutions Segment

In the fourth quarter of 2016, Life Sciences Solutions Segment revenue grew 10% to $1.34 billion, compared with revenue of $1.21 billion in the fourth quarter of 2015. Segment adjusted operating margin increased to 33.3%, versus 31.6% in the 2015 quarter.

For the full year 2016, Life Sciences Solutions Segment revenue rose 12% to $4.98 billion, compared with revenue of $4.44 billion in 2015. Segment adjusted operating margin increased to 30.4% in 2016, compared with 30.1% a year ago.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 32% to $1.22 billion in the fourth quarter of 2016, compared with revenue of $925 million in the fourth quarter of 2015. Segment adjusted operating margin increased to 24.5%, versus 22.1% in the 2015 quarter.

For the full year 2016, Analytical Instruments Segment revenue rose 14% to $3.67 billion, compared with revenue of $3.21 billion in 2015. Segment adjusted operating margin grew to 20.3%, versus 19.1% in 2015.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue in the fourth quarter was $834 million in 2016, compared with revenue of $865 million in the fourth quarter of 2015. Segment adjusted operating margin increased to 27.2%, versus 26.2% in the 2015 quarter.

For the full year 2016, Specialty Diagnostics Segment revenue grew 3% to $3.34 billion, compared with revenue of $3.24 billion in 2015. Segment adjusted operating margin increased to 27.2%, versus 2015 results of 26.9%.

Laboratory Products and Services Segment

In the fourth quarter of 2016, Laboratory Products and Services Segment revenue was $1.76 billion, compared with revenue of $1.82 billion in the fourth quarter of 2015. Segment adjusted operating margin was 14.6%, versus 14.7% in the 2015 quarter.

For the full year 2016, Laboratory Products and Services Segment revenue grew 6% to $7.03 billion, compared with revenue of $6.66 billion in 2015. Segment adjusted operating margin was 15.0% in both periods.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any regularity or predictability, tax provisions/benefits related to the previous items, benefits from tax credit carryforwards, the impact of significant tax audits or events and the results of discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, net of capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 5 to 20 years. In 2017, based on acquisitions closed through the end of 2016, our adjusted EPS will exclude approximately $2.53 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, benefits from tax credit carryforwards and the impact of significant tax audits or events (such as the effect on deferred tax balances of enacted changes in tax rates), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.

We also report free cash flow, which is operating cash flow, net of capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher’s results computed in accordance with GAAP.

On January 31, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported financial results for three quarters of fiscal year 2016 ending March 31, 2017 ("FY2016") (Press release, Astellas, JAN 30, 2017, View Source [SID1234517620]).

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"We achieved many milestones including the acquisition of Ganymed Pharmaceuticals, a Germany-based pharma company, last December. The acquisition of Ganymed will enable Astellas to further expand its oncology pipeline with a late stage antibody program for the treatment of gastroesophageal cancer," said Yoshihiko Hatanaka, President and CEO, Astellas. "We remain committed to creating innovative medical solutions and delivering value for stakeholders including patients, as we reinforce our strategic plan through maximizing the product value, creating innovation and pursuing operational excellence."

Consolidated Financial Results (April 1, 2016 – December 31, 2016) (core basis) (Millions of yen) First nine months of FY2015 First nine months of FY2016 Change (%) Sales 1,065,666 1,005,587 -60,079 (-5.6%) Core operating profit 233,863 241,837 +7,974 (+3.4%) Core profit for the period 169,379 177,189 +7,810 (+4.6%) Basic core earnings per share (yen) 78.16 83.62 +5.46 (+7.0%)

Revenue Highlights for First Nine Months

Sales in the first nine months of FY2016 decreased by 5.6% compared to those in the corresponding period of the previous fiscal year ("year-on-year") and resulted in 1,005.6 billion yen. Sales decreased due to the impact of foreign exchange as well as the impact of the NHI drug price revision in Japan enforced in April 2016. On a constant currency basis, however, sales increased by approximately 3% year-on-year.

In terms of global products, sales of XTANDI grew while sales of overall OAB treatments Vesicare (solifenacin succinate) and Betanis / Myrbetriq / BETMIGA decreased due to the impact of foreign exchange. Prograf (tacrolimus) sales also decreased. < Sales by Region1 >

Sales in Japan decreased by 4.2% year-on-year to 380.1 billion yen. Sales in the Japanese market decreased by 7.2% year-on-year to 358.2 billion yen mainly due to the impact of the NHI drug price revision. There was growth in sales of products including overall OAB treatments (Vesicare and Betanis ), Celecox (celecoxib), Symbicort (budesonide and formoterol fumarate dihydrate) and Suglat (ipragliflozin). Sales of XTANDI decreased due to the impact of the NHI drug price revision. Sales of vaccines declined due to the continued impact of shipping restraints by the manufacturer in FY2015 (shipments of some of the products have 1 Based on location of sellers 3 already recommenced). Revenues were impacted by the decline in sales of products including Lipitor (atorvastatin calcium) and Gaster (famotidine) mainly due to the impact of generics.

Sales in the Americas decreased by 11.6% year-on-year to 308.1 billion yen; however sales on a U.S. dollar basis increased by 0.8% year-on-year to 2,889 million USD. The increase in sales of CRESEMBA (isavuconazonium sulfate) contributed to the sales growth. Sales of products including XTANDI , overall OAB treatments (VESIcare and Myrbetriq ) and Lexiscan (regadenoson) decreased due to the impact of foreign exchange, while the sales of each product on a US dollar basis increased. Sales of Prograf decreased.

EMEA2 saw a 0.6% increase in sales year-on-year to 252.9 billion yen, with growth from XTANDI . Sales on a euro basis increased by 14.6% year-on-year to 2,143 million euros. Sales of overall OAB treatments (Vesicare and BETMIGA ) and Prograf declined due to the impact of foreign exchange.

In Asia and Oceania, sales decreased by 6.3% year-on-year to 64.5 billion yen, while the sales on a constant currency exchange rate basis increased by 9.5%. XTANDI and overall OAB treatments (Vesicare and BETMIGA ) contributed to the revenue growth. Sales of Prograf and Harnal (tamsulosin hydrochloride) declined mainly due to the foreign exchange impact. Other Financial Highlights Based on the transfer of the global dermatology business in April 2016, the sales and expenses of the transferred products were not included in the first nine months of FY2016; however the consideration for the business transfer was recognized as revenue over certain periods. As a result, there were certain positive impacts on sales and profit for the first nine months of FY2016. Latest Strategic Highlights Astellas continues to create sustainable growth over the mid-to long-term through the pursuit of three main strategies – "Maximizing the Product Value," " Creating Innovation" and "Pursuing Operational Excellence." The company achieved multiple 2 EMEA: Europe, the Middle East and Africa 4 accomplishments during the third quarter of FY2016 (October 1, 2016 – December 31, 2016) including the most recent highlights outlined below. Maximizing the Product Value

Continued to maximize the growth of the oncology franchise centered on XTANDI and the OAB franchise comprised of Vesicare and Betanis / Myrbetriq / BETMIGA with new launches across various countries and growth in sales Creating Innovation

Advanced multiple strategic collaborations including: – Completion of acquisition of Ganymed Pharmaceuticals Pursuing Operational Excellence Optimal allocation of resources: – Transfer of commercial rights for Qutenza (capsaicin 8% patch) to Grünenthal in Europe, Middle East and Africa

Continually enhance organization structure: – Outsourcing of facility and equipment management support in Japan, and dissolution of Astellas Business Service Company Limited NOTE: For further information on the results, please refer to the reference documents: Financial Results, Supplementary Documents, Overview of R&D Pipeline and Presentation Material for Information Meeting available on the Astellas website.