On April 26, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported the financial results for fiscal year 2017 ending March 31, 2018 ("FY2017") (Press release, Astellas Pharma US, APR 26, 2018, View Source [SID1234525731]).

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"Key global products including XTANDI continued to demonstrate steady growth in FY2017. We also have made continual investments in the creation of future innovation, including the acquisition of Universal Cells, Inc. in February 2018. The additional cell therapy capabilities of Universal Cells, including proprietary Universal Donor Cell technology, enables Astellas to accelerate our innovative research and development focus within cell therapy," said Kenji Yasukawa, Ph.D., president and CEO, Astellas. "We remain committed to creating medical solutions from a multi-dimensional perspective – including disease, biology and modality – to turn innovative science into value for patients."

Sales Highlights
Sales in FY2017 decreased 0.9% compared to those in the previous fiscal year ("year-on-year") to ¥1,300.3 billion due to the impact of certain items such as the transfer of the global dermatology business in April 2016 and the transfer of long-listed products in Japan in April 2017.

Oncology franchise
Sales of XTANDI increased 16.8% year-on-year to ¥294.3 billion. Sales grew steadily in all regions of the world.

Urology OAB franchise
Sales of Betanis / Myrbetriq / BETMIGA increased 27.2% year-on-year to ¥125.7 billion. Sales increased in all regions of the world. Sales of Vesicare, however, decreased 11.9% year-on-year to ¥102.3 billion.

Transplantation franchise
Sales of Prograf increased 6.6% year-on-year to ¥198.5 billion, and continued to grow in EMEA1 and the Asia and Oceania regions.

Other new and key products
In the Japanese market, continued growth was achieved for products such as Celecox for the treatment of inflammation and pain, Symbicort for the treatment of bronchial asthma, Suglat for the treatment of type 2 diabetes, and Cimzia for the treatment of adult patients with rheumatoid arthritis. Meanwhile, we have been working on steadily increasing market penetration for new products Repatha for the treatment of hypercholesterolemia (launched in April 2016) and Linzess for the treatment of irritable bowel syndrome with constipation (launched March 2017). In the Americas, sales of azole antifungal CRESEMBA grew.

Sales by Region2
Sales in Japan and EMEA decreased, while sales in the Americas and the Asia and Oceania increased. As for the Japanese market, sales decreased 15.3% year-on-year to ¥383.4 billion largely due to the impact of transferring 16 long-listed products in April 2017, and the introduction of generics for Micardis for the treatment of hypertension in June 2017. In EMEA, sales decreased due to the continued impact of transferring the dermatology business in April 2016, yet sales increased when excluding this item.

FY2018 Guidance
The forecasts for fiscal year 2018 ending March 31, 2019 ("FY2018") (core basis) are as shown in the following table. The sales forecast is ¥1,278.0 billion (- 1.7% year-on-year). Core operating profit is forecasted at ¥262.0 billion (-2.5% year-on-year). In FY2018, we expect negative impact on sales and profit due to a decreased amount of recognized deferred income following the transfer of the global dermatology business and the transfer of long-listed products in Japan, foreign exchange, and other factors. Despite the negative impact of the NHI drug price revision in Japan and other factors, we are forecasting sales and core operating profit, excluding the factors associated with previously discussed business transfers and the impact of foreign exchange, to remain largely unchanged year-on-year.

Strategic Highlights in FY2017

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 many accomplishments against these strategies as outlined below:

Maximizing the Product Value

Continued to maximize the growth of the Oncology franchise centered on XTANDI and the Urology OAB franchise including Vesicare and Betanis / Myrbetriq / BETMIGA with new launches across various countries and a growth in franchise sales globally.

In January 2018, Amgen Astellas BioPharma K.K. launched sales in Japan of the Repatha SC injection 420 mg Auto Mini Doser, an additional dosage formulation of Repatha.

In November 2017, executed a co-promotion agreement in Japan with MSD K.K. for SUJANU Combination Tablets, a combination drug of the DPP-4 inhibitor sitagliptin phosphate hydrate (JANUVIA Tablets) and Suglat Tablets.

Creating Innovation
The following are highlights of developments with external partners announced during FY2017.

In April 2017, the Alliance Station was opened by Astellas and Kyoto University as part of a new open innovation initiative to develop advanced medical treatments.

In May 2017, completed the acquisition of Ogeda SA in Belgium and gained the NK3 receptor antagonist fezolinetant (ESN364), which is in development for menopause-related vasomotor symptoms.

In May 2017, signed an agreement to broaden the scope of an existing collaborative research agreement with the Institute of Medical Science of the University of Tokyo utilizing the MucoRice rice-based oral vaccine. Furthermore, in December 2017, a collaborative research agreement was signed aiming at the practical application of the rice-based oral vaccine MucoRice-CTB with the Institute of Medical Science of the University of Tokyo, Chiba University, and ASAHI KOGYOSHA CO., LTD.

In October 2017, launched "JOINUS," a new drug discovery program using a drug-repositioning compound library jointly conducted by Astellas, Mitsubishi Tanabe Pharma, and Daiichi Sankyo.

In October 2017, entered into an exclusive worldwide license agreement with Universal Cells Inc. for the worldwide research, development, and commercialization of new cell therapies and acquired Universal Cells Inc. in February 2018.

In November 2017, exercised an exclusive option right to acquire Mitobridge, Inc. and in January 2018, Mitobridge, Inc. became a wholly-owned subsidiary of Astellas.

In February 2018, entered into a global exclusive licensing agreement on development / commercialization of an immunostimulating gene loading oncolytic virus with Tottori University.

The following are the main development advances achieved during FY2017.

In January 2018, filed applications in Europe and the U.S. for approval of an additional indication for non-metastatic castration-resistant prostate cancer based on the results of the Phase 3 PROSPER trial obtained in September 2017. Furthermore, in February 2018, an approval of XTANDI Tablets (additional dosage form) was received in Japan for castration-resistant prostate cancer.

FLT3/AXL inhibitor gilteritinib (ASP2215) was granted Orphan Drug designation in the U.S. in July 2017, in Europe in January 2018, and in Japan in March 2018. Furthermore, gilteritinib received Fast Track Designation in the U.S. in October 2017 for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia.

In May 2017, MSD K.K filed an application for approval in Japan with regard to the indication of type 2 diabetes for SUJANU Combination Tablets, a combination drug of JANUVIA Tablets and Suglat Tablets. In March 2018, MSD K.K. obtained the approval.

In June 2017, filed an application for approval in the U.S. for the use of mirabegron in combination with solifenacin 5 mg.

In July 2017, filed an application for marketing approval in Japan with regard to fidaxomicin for the treattment of infectious enteritis.

In August 2017, Amgen Astellas BioPharma K.K. obtained approval in Japan for the Repatha SC Injection 420 mg Auto Mini Doser (additional dosage formulation).

In September 2017, filed an application for approval for Linzess in Japan, as an additional indication for chronic constipation.

In November 2017, submitted a new drug application in Japan for a 12-week extended-release formulation of Gonax for the treatment of prostate cancer (additional dosage formulation).

In January 2018, Amgen Astellas BioPharma K.K. submitted an application in Japan for the bispecific CD19-directed CD3 T cell engager antibody construct blinatumomab (AMG103) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

In January 2018, submitted an application for the additional indication of Suglat for the treatment of type 1 diabetes mellitus in Japan.

In February 2018, obtained approval in Europe for solifenacin (YM905) oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 to 18 years.

In March 2018, enfortumab vedotin, an Antibody-Drug Conjugate (ADC), was granted Breakthrough Therapy Designation in the U.S.

Pursuing Operational Excellence
The following are the main operational excellence initiatives engaged during FY2017.

In April 2017, the asset purchase agreement to allow the transfer of 16 long-listed products in Japan to LTL Pharma Co., Ltd. came into effect. In FY2017, the affected products were transferred to LTL Pharma Co., Ltd.

In April 2017, we established a new global function that will manage the respective regional legal functions and intellectual property functions of Japan, the Americas, EMEA, and Asia and Oceania.

In October 2017, transferred to Maruho Co., Ltd. the manufacturing and marketing approvals in Japan for Protopic, a treatment for atopic dermatitis.

Terminated research operations of Agensys, Inc. by March 2018.

[Enhancing and strengthening the corporate governance system]

Resolved at the meeting of the Board of Directors held in January 2018 to transition to a company with an Audit & Supervisory Committee. This results in further enhancing deliberation on matters such as business strategy in the Board of Directors and further strengthening the supervisory functions of the Board of Directors.

The transition is subject to approval at the Company’s 13th Term Annual Shareholders Meeting to be held in June 2018.

On April 26,2018 Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotech company focused on rare diseases, reported unaudited results for the three months ended March 31, 2018 (Press release, Shire, APR 26, 2018, View Source [SID1234525749]).

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Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

"Shire is off to a good start in 2018 delivering on our key priorities of commercial execution, pipeline progression, debt pay down, and portfolio optimization. We generated product sales growth of 7% in the first quarter reaching $3.6 billion with important contributions from our Immunology franchise, recently-launched products, and international markets. We delivered $1.0 billion in net operating cash flow allowing us to remain on track towards our debt pay down target.

"We continue to advance our innovative pipeline with seven programs in registration including lanadelumab, the first monoclonal antibody being evaluated to prevent hereditary angioedema attacks, with the potential to change the treatment paradigm for this serious and sometimes life threatening rare disease.

"As part of the ongoing review of our portfolio, we recently announced an agreement for the sale of our Oncology franchise for $2.4 billion allowing us to unlock embedded value and sharpen our focus."

Product and Pipeline Highlights

Regulatory updates

Advanced lanadelumab with accelerated approval pathways underway in the U.S. (PDUFA date of August 26, 2018), Europe, and Canada.
Gained FDA acceptance for additional key filings: CINRYZE sBLA for pediatric use, including Priority Review; prucalopride NDA; and Calaspargase Pegol BLA.
Achieved marketing approval of XIIDRA (lifitegrast ophthalmic solution 5%) in Canada and ADYNOVI in E.U.
Obtained Breakthrough Therapy Designation for maribavir for cytomegalovirus (CMV) infection in transplant patients from FDA.
Clinical and business development updates

Agreed to divest Oncology franchise to Servier S.A.S. for $2.4 billion.
Formed pre-clinical research collaboration to evaluate a potential enzyme replacement therapy using NanoMedSyn’s proprietary synthetic derivatives.

1) The Non GAAP financial measures included within this release are explained on pages 26 – 27, and are reconciled to the most directly comparable financial measures prepared in accordance with U.S. GAAP on pages 20 – 22.
(2) In 2018, Shire created two business segments: a Rare Disease division and a Neuroscience division. As a result, Shire now reports its financial results based on these new segments. Segment contribution margin represents total revenue less cost of sales, direct R&D, and direct selling and marketing expenses. Segment contribution margin percentage represents segment contribution margin as a percentage of segment revenue. For further information, refer to Note 3: Segment reporting on page 19.
(3) Diluted weighted average number of ordinary shares of 912.1 million.
(4) Percentage point change (ppc).
(5) Calculated as a percentage of total revenues.

Product sales growth

Achieved product sales growth of 10% in our Rare Disease division, with increases across all franchises on a reported basis, driven by Immunology, Hematology, Internal Medicine, and Ophthalmics.
Delivered growth of recently launched products of 77%, primarily due to ADYNOVATE, CUVITRU, and GATTEX, as well as XIIDRA with script growth of 27% since Q1 2017.
Experienced decline of 2% in product sales in our Neuroscience division due to the genericization of LIALDA in the second half of 2017. Excluding the impact of LIALDA, Neuroscience grew 12%, primarily driven by VYVANSE.
Operating performance

Generated Non GAAP diluted earnings per ADS of $3.86, an increase of 6%, as Q1 2018 benefited from higher product sales and a lower tax rate, which were partially offset by lower gross margins due to Q1 2017 favorability from the timing of changes in the costs to manufacture certain products.
Reported Non GAAP EBITDA margin of 43%, a slight decline from Q1 2017, with continued benefit from operating efficiencies in SG&A offset by lower gross margins as discussed above.
Rare Disease reported contribution margin of $1,367 million, or 48%, and Neuroscience reported contribution margin of $770 million, or 82%.
Strong cash flow

Strong free cash flow enabled an $866 million reduction in Non GAAP net debt during the quarter.
FINANCIAL SUMMARY – FIRST QUARTER 2018 COMPARED TO FIRST QUARTER 2017

Revenues

Delivered total revenues of $3,766 million representing growth of 5%.
Rare Disease product sales increased 10% to $2,719 million (Q1 2017: $2,472 million), with growth across all franchises on a reported basis and growth from recently launched products. Rare Disease product sales also benefited from favorable foreign currency exchange in our international markets.
Neuroscience product sales decreased 2% to $918 million (Q1 2017: $940 million), due to the launch of generic competition for LIALDA in the second half of 2017. Excluding the impact from LIALDA, Neuroscience product sales grew 12%.
Royalties and other revenues decreased 20% to $129 million (Q1 2017: $160 million), primarily due to the reclassification of ADDERALL XR from royalty revenue to product sales and other accounting changes as required under the new revenue accounting standard as well as lower SENSIPAR royalties.
Operating results

Rare Disease contribution margin percentage was approximately 48% (Q1 2017: 51%), a slight decline from the prior year due to lower gross margins on sales, partially offset by lower selling and marketing costs.
Neuroscience contribution margin percentage was flat at 82% (Q1 2017: 82%), as the decline in sales due to LIALDA was offset by lower costs.
Operating income increased 40% to $694 million (Q1 2017: $497 million), primarily due to lower expense related to the unwind of inventory fair value adjustments, partially offset by higher amortization of acquired intangible assets and integration and acquisition costs.
Non GAAP operating income increased 1% to $1,467 million (Q1 2017: $1,454 million), with the benefit of our on-going cost reduction initiatives and operating synergies offset by lower gross margins as Q1 2017 reflected favorability from the timing of changes in the costs to manufacture certain products.
Non GAAP EBITDA margin was slightly down to 43% (Q1 2017: 44%), primarily due to the lower gross margin referred to above offset by ongoing cost reduction initiatives and operating expense synergies.
Earnings per share (EPS)

Diluted earnings per American Depository Share (ADS) increased 47% to $1.81 (Q1 2017: 1.23). The increase was primarily driven by operating income as noted above, combined with lower expense related to the unwind of inventory fair value adjustments.
Non GAAP diluted earnings per ADS increased 6% to $3.86 (Q1 2017: 3.63) as Q1 2018 benefited from higher product sales and a lower tax rate partially offset by a lower gross margin.
Cash flows

Net cash provided by operating activities increased 120% to $1,010 million (Q1 2017: $459 million), driven by improvements in working capital, higher operating profitability, and a favorable comparison period as the Q1 2017 period included a payment of $346 million associated with the settlement of the DERMAGRAFT litigation.
Non GAAP free cash flow increased 272% to $918 million (Q1 2017: $247 million), primarily due to the growth in net cash provided by operating activities noted above and a decrease in capital expenditures.
Debt

Non GAAP net debt as of March 31, 2018 decreased $866 million since December 31, 2017, to $18,203 million (December 31, 2017: $19,069 million). A combination of Shire’s Non GAAP free cash flow and existing cash balances were utilized to repay debt during the quarter. Non GAAP net debt represents aggregate long and short term borrowings of $18,172 million, and capital leases of $350 million, partially offset by cash and cash equivalents of $318 million.
OUTLOOK

Our 2018 guidance, which continues to include our Oncology franchise, remains unchanged. It will be updated to remove the Oncology franchise upon the close of this pending sale later this year. Similarly, our 2020 guidance remains unchanged and will be updated to remove the Oncology franchise upon the close of this pending sale later this year.

The Non GAAP diluted earnings per ADS forecast assumes a weighted average number of 915 million fully diluted ordinary shares outstanding for 2018.

Our U.S. GAAP diluted earnings per ADS outlook reflects anticipated amortization, integration, and reorganization costs.

Risks associated with this outlook include the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited that it is considering making a possible offer for Shire.

On April 26, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the first quarter of 2018 which were highlighted by strong sales for Opdivo, Eliquis, and Orencia, important regulatory progress in Immuno-Oncology and strategic business development transactions (Press release, Bristol-Myers Squibb, APR 26, 2018, View Source [SID1234525732]).

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"We delivered strong commercial performance with continued growth for our key franchises, Opdivo and Eliquis, and obtained FDA approval for Opdivo plus Yervoy in renal cell carcinoma, a disease with high unmet need which represents an important opportunity for the company," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "I am confident that strong commercial execution, upcoming Phase 3 readouts across our oncology pipeline and continued strategic use of business development position us well for future growth."

FIRST QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted first quarter 2018 revenues of $5.2 billion, an increase of 5% compared to the same period a year ago. Revenues increased 1% when adjusted for foreign exchange impact.

U.S. revenues increased 1% to $2.8 billion in the quarter compared to the same period a year ago. International revenues increased 10%. When adjusted for foreign exchange impact, international revenues increased 1%.

Gross margin as a percentage of revenue decreased from 74.3% to 69.5% in the quarter primarily due to product mix.

Marketing, selling and administrative expenses decreased 10% to $980 million in the quarter.

Research and development expenses decreased 4% to $1.3 billion.

The effective tax rate was 16.0% in the quarter, compared to 21.9% in the first quarter last year.

The company reported net earnings attributable to Bristol-Myers Squibb of $1.5 billion, or $0.91 per share, in the first quarter compared to net earnings of $1.6 billion, or $0.94 per share, for the same period in 2017.

The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.5 billion, or $0.94 per share, in the first quarter, compared to $1.4 billion, or $0.84 per share, for the same period in 2017. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.

Cash, cash equivalents and marketable securities were $9.0 billion, with a net cash position of $1.3 billion, as of March 31, 2018.

Opdivo
Regulatory

In April, the European Commission approved an every four-week Opdivo dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma (RCC) as well as the approval of a two-week Opdivo flat dose option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the European Union.

In April, the company announced the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is August 16, 2018.

In April, the company announced the FDA approved the combination of Opdivo plus Yervoy for previously untreated patients with intermediate- and poor-risk advanced RCC.

In March, the company announced the FDA accepted for priority review a sBLA for the Opdivo plus Yervoy combination for the treatment of adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. The FDA action date is July 10, 2018.

In March, the company announced the FDA approved a sBLA updating the Opdivo dosing schedule to include 480 mg infused every four weeks for a majority of approved indications as well as a shorter 30 minute infusion across all approved indications.

In April, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the company presented results from numerous studies of novel agents and Opdivo-based combinations. Key clinical data presented at the meeting include:

CheckMate -227: First presentation of data from the Phase 3 study assessing the Opdivo plus Yervoy combination versus platinum-doublet chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients with high tumor mutational burden (≥10 mutations/megabase). (link)

CheckMate -568: First presentation of data from a Phase 2 study evaluating Opdivo plus Yervoy in treatment naïve patients with advanced NSCLC. Results demonstrated Opdivo 3 mg/kg plus low-dose Yervoy (1mg/kg) identified high tumor mutational burden of ≥10 mutations/megabase (mut/Mb) as an effective cutoff for selecting which patients were most likely to respond to first-line treatment of Opdivo plus Yervoy regardless of tumor PD-L1 expression.

CheckMate -078: First presentation of data from the Phase 3 study evaluating Opdivo monotherapy versus docetaxel in a predominantly Chinese patient population with previously treated advanced NSCLC. (link)

CheckMate -141: Announced a two-year overall survival (OS) update from the Phase 3 study evaluating patients treated with Opdivo over standard of care in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after failure on platinum-based therapy. (link)

Eliquis
Clinical

In March, at the American College of Cardiology’s 67th Annual Scientific Session & Expo, the company and Pfizer Inc. announced the largest real-world data analysis from studies evaluating different direct oral anticoagulants, including Eliquis, rivaroxaban and dabigatran, for non-valvular atrial fibrillation patients. (link)

FIRST QUARTER BUSINESS DEVELOPMENT UPDATE

In April, the company and Illumina, Inc. announced a collaboration that will utilize Illumina’s next-generation sequencing technology to develop and globally commercialize in-vitro diagnostic assays in support of Bristol-Myers Squibb’s oncology portfolio.

In April, the company and Janssen Pharmaceutical Companies of Johnson & Johnson announced a worldwide collaboration to develop and commercialize Bristol-Myers Squibb’s Factor XIa inhibitor program, including BMS-986177, an anticoagulant compound being studied for prevention and treatment of major thrombotic conditions.

In April, the company and the Harvard Fibrosis Network of the Harvard Stem Cell Institute announced a research collaboration to discover and develop potential new therapies for fibrotic diseases, including fibrosis of the liver and heart.

In February, the company announced that Yale Cancer Center will join the International Immuno-Oncology Network, a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology science.

In February, the company and Nektar Therapeutics announced a global strategic development and commercialization collaboration for Nektar’s lead Immuno-Oncology program, NKTR-214. The companies will jointly develop and commercialize NKTR-214 in combination with Opdivo and Opdivo plus Yervoy in more than 20 indications across nine tumor types.

2018 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2018 GAAP EPS guidance range from $3.00 – $3.15 to $2.70 – $2.80 and increasing its non-GAAP EPS guidance range from $3.15 – $3.30 to $3.35 – $3.45. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2018 GAAP and non-GAAP line-item guidance assumptions are:

Worldwide revenues increasing in the mid-single digits.

Research and development expenses increasing in the low-single digits for GAAP.

An effective tax rate between 17% and 18% for both GAAP and non-GAAP.

The financial guidance for 2018 excludes the impact of any potential future strategic acquisitions and divestitures, and any specified items that have not yet been identified and quantified. The non-GAAP 2018 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.

Use of Non-GAAP Financial Information

This press 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 restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third party intellectual property rights, divestiture and equity investment gains or losses, upfront payments from out-licensed assets, pension charges, legal and other contractual settlements 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. Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators 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.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as "anticipate", "estimates", "should", "expect", "guidance", "project", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to successfully execute its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations.

There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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 and Facebook.

There will be a conference call on April 26, 2018 at 10:30 a.m. EDT 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 866-548-4713 or international 323-794-2093, confirmation code: 4713257. 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 1:30 p.m. EDT on April 26, 2018 through 1:30 p.m. EDT on May 10, 2018. 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: 4713257.

On April 26, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported it will host a teleconference and webcast with management to discuss the first quarter 2018 financial results, provide an update on the company’s business, and discuss expectations for the future on Thursday, May 3, 2018 at 4:30 p.m Eastern/1:30 p.m. Pacific. (Press release, Spectrum Pharmaceuticals, APR 26, 2018, View Source [SID1234525752]).

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Conference Call

Thursday, May 3, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 8765418

International: (973) 796-5077, Conference ID# 8765418

For interested individuals unable to join the call, a replay will be available from May 3, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through May 10, 2018 until 11:59 p.m. ET/8:59 p.m. PT.

Domestic Replay Dial-In #: (855) 859-2056, Conference ID# 8765418

International Replay Dial-In #: (404) 537-3406, Conference ID# 8765418

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on May 3, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On Apriil 26, 2018 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales for the first quarter of 2018 (Press release, Ipsen, APR 26, 2018, View Source [SID1234526809]).

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Q1 2018 Financial highlights:

Group sales growth of 23.1%, driven by Specialty Care sales growth of 27.4%, reflecting continued Somatuline momentum and increasing contribution from Cabometyx and Onivyde
Full year 2018 guidance confirmed with Group sales growth greater than 16.0% and Core Operating Income margin greater than 28.0% of net sales
Q1 2018 Pipeline highlights:

Positive opinion issued by the CHMP for Cabometyx for the first-line treatment of adults with intermediate or poor risk advanced renal cell carcinoma (aRCC)
Validation by the EMA of the filing for an additional indication for Cabometyx for patients with previously treated advanced Hepatocellular Carcinoma (HCC)

In the first quarter of 2018, Consolidated Group sales rose to €510.3 million. Sales grew by 23.1% at constant exchange rates driven by Specialty Care sales growth of 27.4%. Reported Group sales grew by 16.5%, impacted by the appreciation of the euro against a number of currencies, notably the U.S. dollar.

David Meek, Chief Executive Officer of Ipsen stated: "The first quarter of 2018 marked a robust start to the year. Specialty Care drove the growth of Group sales due to the continued strong momentum of Somatuline and the execution of the Cabometyx and Onivyde launches. We also made significant advancements during the period to expand the market potential of Cabometyx, which further strengthens our presence in Oncology. We remain focused on the execution of our commercial products and identifying new business development opportunities to maintain the sustainable longer-term growth of the company."

Conference call

Ipsen will host a conference call on Thursday 26 April 2018 at 2:30 p.m. (Paris time, GMT+1). Details provided on page 7.

Group sales reached €510.3 million, up 23.1%, driven by 27.4% growth of Specialty Care sales and 0.8% growth of Consumer Healthcare sales.

Specialty Care sales amounted to €440.4 million, up 27.4%. Oncology and Neuroscience sales grew by 36.9% and 4.7%, respectively, and Rare Diseases sales increased by 0.3%. Over the period, the relative weight of Specialty Care continued to increase to reach 86.3% of Group sales, compared to 83.7% in 2017.

In Oncology, sales reached €337.0 million, up 36.9% year-on-year, driven by the continued strong performance of Somatuline as well as the launches of Onivyde and Cabometyx. Over the period, Oncology sales represented 66.0% of total Group sales, compared to 59.6% in 2017.

Somatuline – Sales reached €195.7 million, up 25.1% year-on-year, driven by a strong growth of 39.7% in North America, a solid performance in most European countries, notably in France, the United Kingdom and Germany, as well as the contribution from Japan following the launch of the neuroendocrine tumor indication in 2017.

Decapeptyl – Sales totaled €83.1 million, up 9.2% year-on-year, positively impacted by good volume growth, notably in France, Algeria and Ukraine, and also in China despite pricing pressure.

Cabometyx – Sales reached €28.2 million, driven by good performance in Germany, France and the UK, as well as by volume growth in Spain, Italy and new launches in other European countries. In the first quarter of 2018, sales were up 37.2% versus the fourth quarter of 2017, positively impacted by inventory build up in newly reimbursed territories.

Onivyde – Sales amounted to €23.8 million. In the first quarter of 2018, sales were up 28.1% versus the fourth quarter of 2017, reflecting a progressive sales ramp in the U.S. and increasing sales to Ipsen’s European partner.

In Neuroscience, sales of Dysport reached €84.4 million, up 4.8%, driven by the resupply following the renewal of the Good Manufacturing Practices (GMP) certificate and a strong demand in Brazil in the first quarter of 2018, a good performance in North America in the therapeutics market, partly offset by lower sales in North America to Galderma as compared to the first quarter of 2017 when there was a higher phasing of shipments. Over the period, Neuroscience sales represented 16.7% of total Group sales, compared to 19.8% in 2017.

In Rare Diseases, sales of NutropinAq reached €12.2 million, down 8.2% year-on-year, impacted by lower volumes across Europe. Sales of Increlex reached €5.9 million, growing by 14.8% year-on-year, driven by performance in the U.S. Over the period, Rare Diseases sales represented 3.6% of total Group sales, compared to 4.3% in 2017.

Consumer Healthcare sales reached €69.9 million, up 0.8% year-on-year (or up 6.4% excluding the impact of the new Etiasa contractual set up in China), driven by the performance of Tanakan and of other Consumer Healthcare products, as well as the contribution of the newly acquired OTC products (including Prontalgine and Buscopan). Over the period, Consumer Healthcare sales represented 13.7% of total Group sales, compared to 16.3% in 2017.

Smecta – Sales reached €25.4 million, down 8.5% year-on-year, due to the negative impact of inventory in the first quarter of 2017 in Russia and in China, partly compensated by higher sales in France from the new OTC formulation.

Forlax – Sales reached €10.2 million, up 4.1% year-on-year, driven by growing sales to partners.

Tanakan – Sales reached €7.8 million, up 26.9% year-on-year, positively impacted by the lower inventory in Russia in the first quarter of 2017.

Fortrans/Eziclen – Sales reached €6.0 million, down 11.6% year-on-year, impacted by the negative inventory impact and high competitive pressure in Russia, partly offset by good local performance in China.

Etiasa – Sales reached only €0.1 million, due to the new contractual set up in China which started in the third quarter of 2017.

Other Consumer Healthcare – Sales reached €3.4 million, up 12.7% year-on-year, supported by the new products Prontalgine and Buscopan.

Sales in Major Western European countries reached €182.2 million, up 17.4% year-on-year. Over the period, sales in Major Western European countries represented 35.7% of total Group sales, compared to 35.5% in 2017.

France – Sales reached €68.2 million, up 11.0% year-on-year, driven by the Cabometyx launch, the sustained growth of Somatuline, the strong sales of Decapeptyl and Smecta and the contribution of Prontalgine.

Germany – Sales reached €44.2 million, up 27.7% year-on-year, driven by the Cabometyx launch and the strong growth of Somatuline.

Italy – Sales reached €26.2 million, up 10.5% year-on-year, mainly driven by the launch of Cabometyx.

United Kingdom – Sales reached €22.5 million, up 23.5% year-on-year, driven by the strong performance of Somatuline and Cabometyx.

Spain – Sales reached €21.0 million, up 23.0% year-on-year, driven by the good performance of Somatuline and Decapeptyl, as well as the contribution of Cabometyx.

Sales in Other European countries reached €107.7 million, up 13.5% year-on-year, supported by the strong growth of Dysport, the launch of Cabometyx in certain countries, Onivyde sales to Ipsen’s partner, as well as the solid performance of Somatuline and Decapeptyl. Over the period, sales in the region represented 21.1% of total Group sales compared to 22.2% in 2017.

Sales generated in North America reached €134.4 million, up 51.1% year-on-year, driven by continued strong growth of Somatuline, the good performance of Dysport in the therapeutics market and the contribution of Onivyde. Over the period, sales in North America represented 26.3% of total Group sales, compared to 23.4% in 2017.

Sales in the Rest of the World reached €86.0 million, up 11.6% year-on-year, driven by the good performance of Dysport in Brazil and Australia, and the growth of Somatuline in certain countries. Over the period, sales in the Rest of the World represented 16.9% of total Group sales, compared to 18.9% in 2017.

MAJOR DEVELOPMENTS

During the first quarter of 2018, major developments included:

12 January 2018 – Ipsen announced the appointment of Richard Paulson as Executive Vice-President and Chief Executive Officer of Ipsen North America, responsible for all commercial operations throughout the region. He joined Ipsen from Amgen where he most recently served as Vice-President and General Manager of the Oncology Business Unit.
16 January 2018 – Ipsen and Exelixis announced detailed results of the pivotal Phase 3 CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC), were presented in a late-breaking oral session at the 2018 ASCO (Free ASCO Whitepaper)-GI Symposium being held in San Francisco, January 18-20, 2018.
26 January 2018 – Ipsen announced that Sotirios G. Stergiopoulos, MD, has been appointed as Chief Medical Officer. Dr Stergiopoulos joined Ipsen in January 2017 as Senior Vice President, Head of Global Medical Affairs (GMA) and retains this position in addition to the role as the new Chief Medical Officer within the company.
21 February 2018 – Arix Bioscience plc, a global healthcare and life science company supporting medical innovation, and Ipsen announced a strategic agreement to develop and commercialize innovative therapies.
13 March 2018 – Ipsen announced the appointment of two key executive positions in its Executive Leadership Team. Ivana Magovčević-Liebisch, Ph.D., J.D., joined as Executive Vice-President, Chief Business Officer, and Régis Mulot joined as Executive Vice-President, Chief Human Resources Officer.
23 March 2018 – Ipsen announced that the Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion for Cabometyx (cabozantinib) for the first-line treatment of adults with intermediate or poor risk advanced renal cell carcinoma (aRCC).
28 March 2018 – Ipsen announced that the European Medicines Agency (EMA) has validated the filing of a new application for an additional indication for Cabometyx, for patients with previously treated advanced Hepatocellular Carcinoma (HCC).
Conference call

Ipsen will host a conference call on Thursday 26 April 2018 at 2:30 p.m. (Paris time, GMT+1). A conference call will take place and a web conference (audio and slides) will be available at www.ipsen.com. Participants should dial in to the call approximately 5 to 10 minutes prior to its start. No reservation is required to participate in the conference call.

France and continental Europe: +33 (0)1 76 74 24 28
UK: +44 (0) 1452 555 566
US: +1 631 510 7498
Conference ID: 7769826

A recording will be available for 7 days on Ipsen’s website and at the above numbers