On July 26, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the second quarter of 2018, which were highlighted by strong sales for Eliquis (apixaban) and Opdivo (nivolumab), and important regulatory progress in the company’s Immuno-Oncology portfolio (Press release, Bristol-Myers Squibb, JUL 26, 2018, View Source [SID1234527896]).

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"We had a very good second quarter where we delivered strong performance for Eliquis and Opdivo, and achieved important regulatory and data milestones supporting our Immuno-Oncology portfolio," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "Looking forward, we are focused on robust commercial execution and the evolution of our diversified pipeline to deliver transformational medicines to the patients we serve."

SECOND QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted second quarter 2018 revenues of $5.7 billion, an increase of 11% compared with the same period a year ago. Revenues increased 9% when adjusted for foreign exchange impact.
U.S. revenues increased 13% to $3.2 billion in the quarter compared to the same period a year ago. International revenues increased 9%. When adjusted for foreign exchange impact, international revenues increased 4%.
Gross margin as a percentage of revenue increased from 69.5% to 71.5% in the quarter primarily due to an impairment charge for a manufacturing site in the prior period.
Marketing, selling and administrative expenses decreased 5% to $1.1 billion in the quarter.
Research and development expenses increased 45% to $2.4 billion in the quarter, which includes a $1.1 billion charge resulting from the Nektar collaboration in the second quarter of 2018.
The effective tax rate was 26.1% in the quarter, compared to 28.8% in the second quarter last year. The effective tax rate includes a nondeductible equity investment loss in the second quarter of 2018.
The company reported net earnings attributable to Bristol-Myers Squibb of $373 million, or $0.23 per share, in the second quarter compared to net earnings of $916 million, or $0.56 per share, for the same period in 2017.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.6 billion, or $1.01 per share, in the second quarter, compared to $1.2 billion, or $0.74 per share, for the same period in 2017. An overview of specified items is provided under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable securities were $8.2 billion, with a net cash position of $805 million, as of June 30, 2018.
SECOND QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

Global revenues for the second quarter of 2018, compared to the second quarter of 2017, were driven by:

Eliquis , which grew by $474 million or a 40% increase
Opdivo , which grew by $432 million or a 36% increase
Orencia , which grew by 9%
Sprycel , which grew by 6%
Yervoy , which decreased by 2%
Opdivo

Regulatory

In July, the company announced the U.S. Food and Drug Administration (FDA) approved Opdivo plus low-dose Yervoy (injections for intravenous use) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.
In June, the company announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended expanded approval of the current indications for Opdivo to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The CHMP recommendation will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union.
In June, the company announced the FDA accepted its supplemental Biologics License Application for Opdivo plus low-dose Yervoy for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb).
In June, the China National Drug Administration approved Opdivo for the treatment of locally advanced or metastatic NSCLC after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations.
In May, the EMA validated a type II variation application for the Opdivo plus Yervoy combination for treatment in adult patients with first-line metastatic NSCLC who have TMB ≥10 mut/Mb.
Clinical

In June, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the company announced important new data and analysis from four studies evaluating Opdivo as monotherapy and in combination with Yervoy, chemotherapy or NKTR-214:
CheckMate -227: Results from a part of the Phase 3 trial evaluating Opdivo plus low-dose Yervoy and Opdivo plus chemotherapy versus chemotherapy in patients with first-line advanced NSCLC with PD-L1 expression <1%, across squamous and non-squamous tumor histologies (Part 1b). (link)
CheckMate -238: Results from the Phase 3 trial evaluating Opdivo versus Yervoy in patients with stage IIIB/C or stage IV melanoma who are at high risk of recurrence following complete surgical resection. (link)
CheckMate -214: Patient-reported outcomes from the Phase 3 trial evaluating Opdivo plus low-dose Yervoy versus sunitinib over a two-year follow-up period in intermediate- and poor-risk patients with advanced renal cell carcinoma. (link)
Results from the Phase 1/2 dose-escalation study with Nektar Therapeutics, evaluating the safety, efficacy and biomarker data of NKTR-214 in combination with Opdivo for patients enrolled in the Phase 1 dose-escalation stage of the study and for the first patients consecutively enrolled in select dose expansion cohorts in Phase 2. (link)
Sprycel

Regulatory

In July, the company announced the EC has expanded the indication for Sprycel to include the treatment of children and adolescents aged 1 year to 18 years with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, and to include a powder for oral suspension formulation.
Empliciti

Clinical

In June, the company announced the Phase 2 study evaluating the addition of Empliciti to pomalidomide and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma showed a statistically significant and clinically meaningful improvement in progression free survival for patients treated with EPd compared with pomalidomide and dexamethasone alone. (link)
SECOND QUARTER BUSINESS DEVELOPMENT UPDATE

In July, the company and Tsinghua University announced a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers. The collaboration brings together the respective scientific expertise and capabilities of both organizations with a focus on validating new targets and generating early drug candidates for clinical development.
In April, the company and Nektar Therapeutics completed the agreement for the development and commercialization of NKTR-214 with Opdivo and Opdivo plus Yervoy, originally announced in February 2018.
In April, the company and Flatiron Health announced a three-year agreement to curate regulatory-grade real-world data for cancer research and real-world evidence generation.
2018 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2018 GAAP EPS guidance range from $2.70 – $2.80 to $2.68 – $2.78 and increasing its non-GAAP EPS guidance range from $3.35 – $3.45 to $3.55 – $3.65. 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- to high-single digits.
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 July 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: 4235170. 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 July 26, 2018 through 1:30 p.m. EDT on August 9, 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: 4235170.

On July 26, 2018 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2018. Key results include (Press release, Amgen, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360351 [SID1234527895]):

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Total revenues increased 4 percent versus the second quarter of 2017 to $6.1 billion.
Product sales grew 2 percent globally. New and recently launched products including Repatha (evolocumab), KYPROLIS (carfilzomib), Prolia (denosumab) and XGEVA (denosumab), showed double-digit growth.
GAAP earnings per share (EPS) increased 20 percent to $3.48 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.
GAAP operating income increased 5 percent to $2.8 billion and GAAP operating margin increased 1.5 percentage points to 49.9 percent.
Non-GAAP EPS increased 17 percent to $3.83 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.
Non-GAAP operating income increased 2 percent to $3.1 billion and non-GAAP operating margin decreased 0.1 percentage points to 55.1 percent.
2018 EPS guidance revised to $11.83-$12.62 on a GAAP basis and $13.30-$14.00 on a non-GAAP basis; total revenues guidance revised to $22.5-$23.2 billion.
The Company generated $1.9 billion of free cash flow in the second quarter versus $2.1 billion in the second quarter of 2017.

Product Sales Performance

Total product sales increased 2 percent for the second quarter of 2018 versus the second quarter of 2017.
Repatha sales increased 78 percent driven primarily by higher unit demand, offset partially by net selling price.
BLINCYTO (blinatumomab) sales increased 40 percent driven by higher unit demand.
KYPROLIS sales increased 25 percent driven by higher unit demand, offset partially by net selling price.
Prolia sales increased 21 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.
XGEVA sales increased 14 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.
Nplate (romiplostim) sales increased 9 percent driven by higher unit demand, offset partially by net selling price.
Vectibix (panitumumab) sales increased 3 percent driven primarily by higher unit demand, offset partially by net selling price.
Neulasta (pegfilgrastim) sales increased 1 percent driven by an increase in net selling price and, to a lesser extent, favorable changes in inventory, offset partially by lower unit demand.
Sensipar/Mimpara (cinacalcet) sales decreased 2 percent driven by unfavorable changes in inventory and lower unit demand as a function of Parsabiv uptake, offset partially by higher net selling price.
Parsabiv (etelcalcetide) was launched in the U.S. in the first quarter of 2018.
Enbrel (etanercept) sales decreased 11 percent driven primarily by unfavorable changes in inventory and lower unit demand.
Aranesp (darbepoetin alfa) sales decreased 12 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.
EPOGEN (epoetin alfa) sales decreased 14 percent driven primarily by lower net selling price and, to a lesser extent, lower unit demand.
NEUPOGEN (filgrastim) sales decreased 26 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 4 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin decreased by 0.4 points due to favorable royalty cost and lower acquisition-related intangible amortization, partially offset by higher manufacturing cost and unfavorable product mix. Research & Development (R&D) expenses were flat. Selling, General & Administrative (SG&A) expenses increased 12 percent due to investments in product launches and marketed product support.
Operating Margin improved by 1.5 percentage points to 49.9 percent.
Tax Rate decreased by 2.1 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.
On a non-GAAP basis:

Total Operating Expenses increased 7 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin increased by 0.4 points driven by higher manufacturing cost and unfavorable product mix, partially offset by lower royalty expense. R&D expenses were flat. SG&A expenses increased 14 percent due to investments in product launches and marketed product support.
Operating Margin decreased by 0.1 percentage points to 55.1 percent.
Tax Rate decreased by 3.2 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.

Cash Flow and Balance Sheet

The Company generated $1.9 billion of free cash flow in the second quarter of 2018 versus $2.1 billion in the second quarter of 2017 driven by higher cash taxes resulting from the first installment of the repatriation tax paid in the second quarter of 2018, partially offset by a lower ongoing income tax liability as well as higher net income.
The Company’s second quarter 2018 dividend of $1.32 per share was paid on June 8, 2018, a 15 percent increase versus the second quarter of 2017.
During the second quarter, the Company repurchased 18.2 million shares of common stock at a total cost of $3.2 billion. At the end of the second quarter, the Company had $5.4 billion remaining under its stock repurchase authorization.

2018 Guidance

For the full year 2018, the Company now expects:

Total revenues in the range of $22.5 billion to $23.2 billion.
Previously, the Company expected total revenues in the range of $21.9 billion to $22.8 billion.
On a GAAP basis, EPS in the range of $11.83 to $12.62 and a tax rate in the range of 12.5 percent to 13.5 percent.
Previously, the Company expected GAAP EPS in the range of $11.30 to $12.28. Tax rate guidance is unchanged.
On a non-GAAP basis, EPS in the range of $13.30 to $14.00 and a tax rate in the range of 13.5 percent to 14.5 percent.
Previously, the Company expected non-GAAP EPS in the range of $12.80 to $13.70. Tax rate guidance is unchanged.
Capital expenditures to be approximately $750 million.
Second Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:

AimovigTM (erenumab-aooe)

In May, the U.S. Food and Drug Administration (FDA) approved Aimovig for the preventive treatment of migraine in adults.
In June, the Company submitted a supplemental Biologics License Application (BLA) to the FDA for the 140 mg Sureclick autoinjector device and 140 mg prefilled syringe.
KYPROLIS

In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a label variation for KYPROLIS to include the overall survival (OS) data from the Phase 3 ASPIRE trial.
In June, the FDA approved the supplemental New Drug Application to add the OS data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information.
BLINCYTO

In June, the European Commission (EC) granted a full marketing authorization for BLINCYTO based on the OS data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Repatha

In May, the EC approved a new indication for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering lipoprotein cholesterol (LDL-C) levels.
Prolia

In May and June, the FDA and EC, respectively, approved a new indication for the treatment of glucocorticoid-induced osteoporosis in adults.
EVENITYTM (romosozumab)

In July, Amgen and UCB announced the resubmission of the BLA to the FDA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
KANJINTITM (ABP 980)

In May, the EC granted marketing authorization for KANJINTI, a biosimilar to Herceptin (trastuzumab), for the treatment of HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.
In May, the Company received a complete response letter from the FDA on its BLA.
ABP 710 (biosimilar infliximab)

In June, the Company announced results from the primary analysis of a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE (infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm noninferiority compared to infliximab but could not rule out superiority based on the primary efficacy endpoint.
Amgen Announces Succession Plans for Two Executive Officers
As part of Amgen’s planned executive succession to address upcoming retirements, the Company announced that Sean E. Harper, M.D., executive vice president of Research and Development, will be retiring from his current role at Amgen and will be succeeded by David M. Reese, M.D., currently senior vice president of Translational Sciences and Oncology at Amgen. The Company also announced that Anthony C. Hooper, executive vice president of Global Commercial Operations, will be retiring from his current role in September and will be succeeded by Murdo Gordon, chief commercial officer of Bristol-Myers Squibb Company. Details of these plans are the subject of a separate Amgen press release.

EVENITY and KANJINTI trade names provisionally approved by FDA
EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan
Aimovig is developed in collaboration with Novartis
Herceptin is a registered trademark of Genentech
Remicade is a registered trademark of Johnson and Johnson

Non-GAAP Financial Measures
In this news release, management has presented its operating results for the second quarters of 2018 and 2017, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2018 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2018 and 2017. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

On July 26, 2018 Amgen (NASDAQ:AMGN) reported financial results for the second quarter of 2018 (Press release, Amgen, JUL 26, 2018, View Source [SID1234527894]). Key results include:

Total revenues increased 4 percent versus the second quarter of 2017 to $6.1 billion.

Product sales grew 2 percent globally. New and recently launched products including Repatha (evolocumab), KYPROLIS (carfilzomib), Prolia (denosumab) and XGEVA (denosumab), showed double-digit growth.

GAAP earnings per share (EPS) increased 20 percent to $3.48 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.

GAAP operating income increased 5 percent to $2.8 billion and GAAP operating margin increased 1.5 percentage points to 49.9 percent.

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Non-GAAP EPS increased 17 percent to $3.83 driven by higher product sales, a lower tax rate and lower weighted-average shares outstanding.

Non-GAAP operating income increased 2 percent to $3.1 billion and non-GAAP operating margin decreased 0.1 percentage points to 55.1 percent.

2018 EPS guidance revised to $11.83-$12.62 on a GAAP basis and $13.30-$14.00 on a non-GAAP basis; total revenues guidance revised to $22.5-$23.2 billion.

The Company generated $1.9 billion of free cash flow in the second quarter versus $2.1 billion in the second quarter of 2017.

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Product Sales Performance

Total product sales increased 2 percent for the second quarter of 2018 versus the second quarter of 2017.

Repatha sales increased 78 percent driven primarily by higher unit demand, offset partially by net selling price.

BLINCYTO (blinatumomab) sales increased 40 percent driven by higher unit demand.

KYPROLIS sales increased 25 percent driven by higher unit demand, offset partially by net selling price.

Prolia sales increased 21 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.

XGEVA sales increased 14 percent driven primarily by higher unit demand and, to a lesser extent, net selling price.

Nplate (romiplostim) sales increased 9 percent driven by higher unit demand, offset partially by net selling price.

Vectibix (panitumumab) sales increased 3 percent driven primarily by higher unit demand, offset partially by net selling price.

Neulasta (pegfilgrastim) sales increased 1 percent driven by an increase in net selling price and, to a lesser extent, favorable changes in inventory, offset partially by lower unit demand.

Sensipar/Mimpara (cinacalcet) sales decreased 2 percent driven by unfavorable changes in inventory and lower unit demand as a function of Parsabiv uptake, offset partially by higher net selling price.

Parsabiv (etelcalcetide) was launched in the U.S. in the first quarter of 2018.

Enbrel (etanercept) sales decreased 11 percent driven primarily by unfavorable changes in inventory and lower unit demand.

Aranesp (darbepoetin alfa) sales decreased 12 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.

EPOGEN (epoetin alfa) sales decreased 14 percent driven primarily by lower net selling price and, to a lesser extent, lower unit demand.

NEUPOGEN (filgrastim) sales decreased 26 percent driven primarily by the impact of competition on unit demand and, to a lesser extent, net selling price.

Operating Expense, Operating Margin and Tax Rate Analysis

On a GAAP basis:

Total Operating Expenses increased 4 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin decreased by 0.4 points due to favorable royalty cost and lower acquisition-related intangible amortization, partially offset by higher manufacturing cost and unfavorable product mix. Research & Development (R&D) expenses were flat. Selling, General & Administrative (SG&A) expenses increased 12 percent due to investments in product launches and marketed product support.

Operating Margin improved by 1.5 percentage points to 49.9 percent.

Tax Rate decreased by 2.1 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

On a non-GAAP basis:

Total Operating Expenses increased 7 percent due to investments in newer and recently launched products, and all expense categories also reflect savings from our transformation and process improvement efforts. Cost of Sales margin increased by 0.4 points driven by higher manufacturing cost and unfavorable product mix, partially offset by lower royalty expense. R&D expenses were flat. SG&A expenses increased 14 percent due to investments in product launches and marketed product support.

Operating Margin decreased by 0.1 percentage points to 55.1 percent.

Tax Rate decreased by 3.2 percentage points due to the impacts of U.S. corporate tax reform, offset partially by a prior year benefit associated with the effective settlement of certain state and federal tax matters.

Cash Flow and Balance Sheet

The Company generated $1.9 billion of free cash flow in the second quarter of 2018 versus $2.1 billion in the second quarter of 2017 driven by higher cash taxes resulting from the first installment of the repatriation tax paid in the second quarter of 2018, partially offset by a lower ongoing income tax liability as well as higher net income.

The Company’s second quarter 2018 dividend of $1.32 per share was paid on June 8, 2018, a 15 percent increase versus the second quarter of 2017.

During the second quarter, the Company repurchased 18.2 million shares of common stock at a total cost of $3.2 billion. At the end of the second quarter, the Company had $5.4 billion remaining under its stock repurchase authorization.

2018 Guidance

For the full year 2018, the Company now expects:

•
Total revenues in the range of $22.5 billion to $23.2 billion.

•
Previously, the Company expected total revenues in the range of $21.9 billion to $22.8 billion.

•
On a GAAP basis, EPS in the range of $11.83 to $12.62 and a tax rate in the range of 12.5 percent to 13.5 percent.

•
Previously, the Company expected GAAP EPS in the range of $11.30 to $12.28. Tax rate guidance is unchanged.

•
On a non-GAAP basis, EPS in the range of $13.30 to $14.00 and a tax rate in the range of 13.5 percent to 14.5 percent.

•
Previously, the Company expected non-GAAP EPS in the range of $12.80 to $13.70. Tax rate guidance is unchanged.

•
Capital expenditures to be approximately $750 million.

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 6

Second Quarter Product and Pipeline Update

The Company provided the following updates on selected product and pipeline programs:

AimovigTM (erenumab-aooe)

•
In May, the U.S. Food and Drug Administration (FDA) approved Aimovig for the preventive treatment of migraine in adults.

•
In June, the Company submitted a supplemental Biologics License Application (BLA) to the FDA for the 140 mg Sureclick autoinjector device and 140 mg prefilled syringe.

KYPROLIS

•
In April, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending a label variation for KYPROLIS to include the overall survival (OS) data from the Phase 3 ASPIRE trial.

•
In June, the FDA approved the supplemental New Drug Application to add the OS data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information.

BLINCYTO

•
In June, the European Commission (EC) granted a full marketing authorization for BLINCYTO based on the OS data from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Repatha

•
In May, the EC approved a new indication for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering lipoprotein cholesterol (LDL-C) levels.

Prolia

•
In May and June, the FDA and EC, respectively, approved a new indication for the treatment of glucocorticoid-induced osteoporosis in adults.

EVENITYTM (romosozumab)

•
In July, Amgen and UCB announced the resubmission of the BLA to the FDA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

KANJINTITM (ABP 980)

In May, the EC granted marketing authorization for KANJINTI, a biosimilar to Herceptin (trastuzumab), for the treatment of HER2-positive metastatic breast cancer, HER2-positive early breast cancer and HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction.

In May, the Company received a complete response letter from the FDA on its BLA.

ABP 710 (biosimilar infliximab)

In June, the Company announced results from the primary analysis of a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE (infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm noninferiority compared to infliximab but could not rule out superiority based on the primary efficacy endpoint.

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Page 7

Amgen Announces Succession Plans for Two Executive Officers

As part of Amgen’s planned executive succession to address upcoming retirements, the Company announced that Sean E. Harper, M.D., executive vice president of Research and Development, will be retiring from his current role at Amgen and will be succeeded by David M. Reese, M.D., currently senior vice president of Translational Sciences and Oncology at Amgen. The Company also announced that Anthony C. Hooper, executive vice president of Global Commercial Operations, will be retiring from his current role in September and will be succeeded by Murdo Gordon, chief commercial officer of Bristol-Myers Squibb Company. Details of these plans are the subject of a separate Amgen press release.

EVENITY and KANJINTI trade names provisionally approved by FDA

EVENITY is developed in collaboration with UCB globally, as well as our joint venture partner Astellas in Japan

Aimovig is developed in collaboration with Novartis

Herceptin is a registered trademark of Genentech

Remicade is a registered trademark of Johnson and Johnson

AMGEN REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

Non-GAAP Financial Measures

In this news release, management has presented its operating results for the second quarters of 2018 and 2017, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2018 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the second quarters of 2018 and 2017. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor’s overall understanding of the financial performance and prospects for the future of the Company’s ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company’s liquidity.

The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

On July 26, 2018 Alkermes plc (Nasdaq: ALKS) reported financial results for the second quarter of 2018 (Press release, Alkermes, JUL 26, 2018, View Source [SID1234527893]).

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"Our strong second quarter results were driven by the solid growth of our proprietary commercial products, the continued strength of our royalty and manufacturing business, as well as the receipt of a $50 million payment related to our collaboration with Biogen for BIIB098," commented James Frates, Chief Financial Officer of Alkermes. "The business is performing as planned and today we are reiterating our financial expectations for 2018. As we head into a catalyst-rich second half of the year, we are well-positioned financially to drive value, grow our portfolio of commercial products and advance our late-stage pipeline."

Quarter Ended June 30, 2018 Financial Highlights

• Total revenues for the quarter were $304.6 million. This compared to $218.8 million for the same period in the prior year, representing an increase of 39%. Proprietary product net sales for VIVITROL and ARISTADA were $109.8 million for the quarter, reflecting a 24% increase compared to the same period in the prior year.

• Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $32.6 million for the quarter, or a basic and diluted GAAP net loss per share of $0.21. This compared to GAAP net loss of $43.0 million, or a basic and diluted GAAP net loss per share of $0.28, for the same period in the prior year.

• Non-GAAP net income was $45.6 million for the quarter, or a non-GAAP basic and diluted earnings per share of $0.29. This compared to non-GAAP net income of $1.2 million, or non-GAAP basic and diluted earnings per share of $0.01, for the same period in the prior year.

"VIVITROL and ARISTADA continue to demonstrate solid growth and perform in-line with our expectations. Our proprietary commercial portfolio is a key growth driver for Alkermes, and we are confident about the prospects ahead for these important products," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "In particular, the launch of ARISTADA INITIO is an important opportunity to support continuity of care and address a critical unmet need for patients, as ARISTADA is now the first and only long-acting atypical antipsychotic that can be fully dosed on day one for up to two months. ARISTADA INITIO represents a key addition to the treatment paradigm for schizophrenia and provides a platform to further expand utilization of ARISTADA."

Quarter Ended June 30, 2018 Financial Results

Revenues

• Net sales of VIVITROL were $76.2 million, compared to $66.1 million for the same period in the prior year, representing an increase of approximately 15%.

• Net sales of ARISTADA were $33.6 million, compared to $22.7 million for the same period in the prior year, representing an increase of approximately 48%.

• Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $85.2 million, compared to $82.2 million for the same period in the prior year.

• Manufacturing and royalty revenues from AMPYRA/FAMPYRA1 were $19.7 million, compared to $25.3 million for the same period in the prior year.

• License revenues from the collaboration with Biogen for BIIB098 (formerly ALKS 8700) were $48.3 million.

• Research and development revenues were $18.3 million, of which $17.2 million related to the collaboration with Biogen for BIIB098.

Costs and Expenses

• Operating expenses were $304.7 million, compared to $263.4 million for the same period in the prior year, primarily reflecting increased investment in the commercialization of VIVITROL and ARISTADA.

• Other expense during the quarter included a $19.6 million charge due to a decrease in the fair value of contingent consideration related to Recro Pharma, Inc.’s receipt of a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for IV Meloxicam.

"With a growing proprietary commercial portfolio and partnered royalty and manufacturing business approaching $1 billion in revenue in 2018, Alkermes is in a strong position to create significant long-term value. As we head into the second half of 2018, we are on the threshold of important value inflections across our development portfolio," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 5461 for major depressive disorder, the regulatory review is underway and we are preparing for an Advisory Committee meeting in the fourth quarter. For ALKS 3831 for schizophrenia, enrollment of the ENLIGHTEN-2 pivotal study is complete and we expect topline data in the fourth quarter of 2018. In addition, we are on track to submit the NDA for BIIB098 toward year-end, and we look forward to presenting initial data from the ALKS 4230 phase 1 study and expanding into combination therapy later this year."

Recent Events

• ARISTADA INITIO: Following recent FDA approval, ARISTADA INITIO is now commercially available. The ARISTADA INITIO regimen2 provides physicians with an opportunity to initiate patients onto any dose of ARISTADA on day one.

• ALKS 5461: Data on the long-term safety, tolerability and durability of antidepressant effect of ALKS 5461 were presented at the American Psychiatric Association (APA) and American Society of Clinical Psychopharmacology (ASCP) annual meetings.

• ALKS 3831: The company presented data from the ALKS 3831 preclinical program and phase 1 translational medicine study evaluating the metabolic profile of ALKS 3831 compared to olanzapine.

• BIIB098: Alkermes received a $50 million payment from Biogen in June 2018. This payment follows Biogen’s review of preliminary gastrointestinal tolerability data from the ongoing clinical development program for BIIB098.

Financial Expectations for 2018

Alkermes reiterates its financial expectations for 2018 set forth in its press release dated April 26, 2018.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, July 26, 2018, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call

may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, July 26, 2018, through 5:00 p.m. ET (10:00 p.m. BST) on Thursday, Aug. 2, 2018, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.

On July 26, 2018 Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) reported financial results for the second quarter of 2018 (Press release, Alexion, JUL 26, 2018, View Source [SID1234527892]). Total revenues in the second quarter were $1,045.0 million, a 14 percent increase compared to the same period in 2017. The benefit of foreign currency on total revenues year-over-year was 1 percent, or $10.9 million, net of hedging activities. Second quarter revenues include approximately $18 million due to order timing ahead of the July 4th holiday in the United States. On a GAAP basis, diluted earnings per share (EPS) in the quarter was $(2.05) per share, a 381 percent decrease versus the prior year, inclusive of $803.7 million of expense related to the value of the in-process research and development asset acquired in connection with our acquisition of Wilson Therapeutics AB in the second quarter of 2018. Non-GAAP diluted EPS for the second quarter of 2018 was $2.07 per share, a 33 percent increase versus the second quarter of 2017.

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"In the second quarter of 2018, we are pleased to have once again delivered strong top and bottom-line growth," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "We see continued momentum from both our in-line business and our gMG launch. We have advanced our ALXN1210 programs with the goal of improving the standard of care for patients and have filed regulatory submissions for PNH in the U.S. and EU, and pending regulatory approval, plan to launch next year. We also completed the Wilson Therapeutics acquisition and began a collaboration with Complement Pharma, important initial steps in building out our clinical pipeline. In light of our financial performance, we have updated guidance to reflect the strength of our business."

Second Quarter 2018 Financial Highlights

Soliris (eculizumab) net product sales were $898.2 million, compared to $813.3 million in the second quarter of 2017, representing a 10 percent increase. Soliris volume increased 11 percent year-over-year.
Strensiq (asfotase alfa) net product sales were $125.1 million, compared to $83.6 million in the second quarter of 2017, representing a 50 percent increase. Strensiq volume increased 55 percent year-over-year.
Kanuma (sebelipase alfa) net product sales were $21.4 million, compared to $15.3 million in the second quarter of 2017, representing a 40 percent increase. Kanuma volume increased 51 percent year-over-year.
GAAP cost of sales was $95.3 million, compared to $83.6 million in the same quarter last year. Non-GAAP cost of sales was $89.3 million, compared to $78.0 million in the same quarter last year.
GAAP R&D expense was $173.4 million compared to $198.2 million in the same quarter last year. Non-GAAP R&D expense was $158.3 million, compared to $177.6 million in the same quarter last year.
GAAP SG&A expense was $277.3 million, compared to $265.6 million in the same quarter last year. Non-GAAP SG&A expense was $230.4 million, compared to $227.5 million in the same quarter last year.
GAAP acquired in-process research and development expense was $803.7 million, compared to $0.0 million in the same quarter last year, related exclusively to the value of the in-process research and development asset acquired in connection with the Wilson Therapeutics AB acquisition completed in the second quarter of 2018.
GAAP income tax expense was $38.8 million, compared to $41.1 million in the same quarter last year. Non-GAAP income tax expense was $77.1 million, compared to $53.4 million in the same quarter last year.
GAAP diluted EPS was $(2.05) per share, inclusive of $803.7 million of expense related to the value of the in-process research and development asset acquired in connection with the Wilson Therapeutics AB acquisition, compared to $0.73 per share in the same quarter last year. Non-GAAP diluted EPS was $2.07 per share, compared to $1.56 per share in the second quarter of 2017.
Research and Development

ALXN1210- Paroxysmal Nocturnal Hemoglobinuria (PNH): Alexion submitted applications in the U.S. and the EU for the approval of ALXN1210 in patients with PNH. These submissions are based on previously announced positive results from Phase 3 studies of ALXN1210 in complement inhibitor treatment-naive patients and in patients who switched from Soliris to ALXN1210. In both studies, which collectively comprise the largest ever clinical program in PNH, ALXN1210 administered intravenously every eight weeks, demonstrated non-inferiority to Soliris administered intravenously every two weeks, on all 11 primary and key secondary endpoints. Alexion also plans to file for regulatory approval in Japan later this year. In addition, a Phase 3 study of ALXN1210 in children and adolescents with PNH is currently underway.
ALXN1210- Atypical Hemolytic Uremic Syndrome (aHUS): Enrollment was completed in late May 2018 in a Phase 3 trial of ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Data from this study are now expected in early 2019. Alexion intends to file for regulatory approval in aHUS following approval of ALXN1210 in PNH. A Phase 3 study of ALXN1210 in children with aHUS is currently underway.
ALXN1210- Subcutaneous: In late 2018, Alexion plans to initiate a single, PK-based Phase 3 study of ALXN1210 delivered subcutaneously once per week to support registration in PNH and aHUS.
ALXN1810- Subcutaneous: Alexion filed a Clinical Trial Application (CTA) in the EU for subcutaneous ALXN1210 co-administered with Halozyme’s ENHANZE drug-delivery technology, PH20, and plans to initiate a Phase 1 study in the second half of 2018. Pending co-formulation data, this next-generation subcutaneous formulation will be called ALXN1810 and has the potential to further extend the dosing interval to once every two weeks or once per month.
Soliris (eculizumab)- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): Enrollment was completed in October 2017 in the PREVENT study, a single, multinational, placebo-controlled Phase 3 trial of Soliris in patients with NMOSD; Alexion expects to report data by the end of 2018.
WTX101- Wilson Disease: In the second quarter, Alexion announced the closing of the tender period for the acquisition of Wilson Therapeutics AB, a biopharmaceutical company, based in Stockholm, Sweden, that developed novel therapies for patients with rare copper-mediated disorders, and assumed control of the company. WTX101 is in Phase 3 development as a treatment for Wilson disease, a rare genetic disorder with devastating hepatic and neurological consequences. WTX101 is a first-in-class oral copper-binding agent with a unique mechanism of action to access and bind to serum copper and promote its removal from the liver.
CP010- Complement Pharma: In the second quarter, Alexion began a collaboration with Complement Pharma to co-develop CP010, a preclinical C6 inhibitor that has the potential to treat multiple neurological disorders.
2018 Financial Guidance

(1) GAAP R&D (% of total revenues) previously included our preliminary financial impact for Wilson Therapeutics AB. The actual impact is now reflected in "Acquired in-process research and development" within the Statement of Operations and therefore excluded from updated GAAP R&D (% of total revenues) guidance.

Updated 2018 financial guidance assumes the following:

A foreign currency tailwind, net of hedging activities, of approximately $25 million.
Unfavorable Soliris revenue impact of $90 to $110 million from ALXN1210 and other clinical trial recruitment versus prior year.
$803.7 million of expense related to the value of the in-process research and development asset acquired in connection with Wilson Therapeutics AB.
GAAP effective tax rate of 39 to 40 percent; non-GAAP effective tax rate of 14.5 to 15.5 percent.
Alexion expects to incur additional restructuring and related expenses in 2018 of approximately $10 million to $60 million related to the Company’s 2017 restructuring activities. As the Company continues to execute its strategic business plan and global footprint, we may incur restructuring expenses that are materially different from the current estimate.

Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of acquisitions, license and collaboration agreements, intangible asset impairments, litigation charges, changes in fair value of contingent consideration or restructuring and related activity outside of the previously announced activities that may occur after the day prior to the date of this press release.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the second quarter 2018 results today at 8:00 a.m. Eastern Time. To participate in the call, dial 866-762-3111 (USA) or 210-874-7712 (International), conference ID 9096048 shortly before 8:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The audio webcast can be accessed on the Investor page of Alexion’s website at: View Source