On July 26, 2018 McKesson Corporation (NYSE:MCK) reported that revenues for the first quarter ended June 30, 2018, were $52.6 billion, up 3% compared to $51.1 billion a year ago (Press release, McKesson, JUL 26, 2018, View Source [SID1234527910]). On a constant currency basis, revenues increased 2% over the prior year. On the basis of U.S. generally accepted accounting principles ("GAAP"), first-quarter loss per diluted share from continuing operations was $(0.69), compared to earnings per diluted share of $1.44 a year ago. GAAP loss per diluted share included a pre-tax and after-tax non-cash goodwill impairment charge of $570 million, or $2.81 per diluted share, in the European Pharmaceutical Solutions segment, primarily triggered by additional U.K. government reimbursement reductions announced on June 29, 2018, as well as the change to the company’s segment reporting structure.

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First-quarter Adjusted Earnings per diluted share was $2.90, up 18% compared to $2.46 a year ago, driven by a lower tax rate and share count, and growth in the U.S. Pharmaceutical and Specialty Solutions segment.

For the first quarter, McKesson used $1.1 billion in cash from operations, and invested $145 million internally, resulting in negative free cash flow of $1.2 billion, in line with the company’s expectations. During the quarter, McKesson also paid $826 million for acquisitions, repurchased approximately $300 million of its common stock, paid $71 million in dividends and the company ended the quarter with cash and cash equivalents of $2.2 billion.

"McKesson’s first quarter adjusted earnings results were in line with our expectations. We are, however, disappointed by the recent government-initiated reimbursement cuts in the U.K. These incremental cuts create ongoing challenges in our U.K. retail pharmacy business," said John H. Hammergren, chairman and chief executive officer. "During the quarter, we began executing against our multi-year strategic growth initiative, which included our acquisition of Medical Specialties Distributors. And I am pleased with the initial progress made on transforming our operating model, which will allow us to become a more efficient organization, and drive savings that will help fund investments in our priority growth areas."

New Segment Financial Reporting Effective Fiscal Year 2019

As previously disclosed on May 24, 2018, McKesson revised its reportable segments effective with the first quarter of Fiscal 2019. McKesson’s new reportable segments are:

U.S. Pharmaceutical and Specialty Solutions;
European Pharmaceutical Solutions; and
Medical-Surgical Solutions.
All remaining operating segments and business activities are included in Other. Other primarily includes McKesson Canada, McKesson Prescription Technology Solutions (MRxTS) and the company’s equity method investment in Change Healthcare.

Segment Results

U.S. Pharmaceutical and Specialty Solutions revenues were $41.0 billion for the quarter, up 2%, driven primarily by market growth and acquisitions, partially offset by previously announced customer losses and branded to generic conversions. Segment GAAP operating profit was $543 million and GAAP operating margin was 1.33%. Segment adjusted operating profit was $540 million and adjusted operating margin was 1.32%.

European Pharmaceutical Solutions revenues were $6.9 billion for the quarter, up 9% on a reported basis and 1% on a constant currency basis, driven primarily by market growth and acquisitions, largely offset by the previously disclosed increased competition in France and a reduction in owned retail pharmacies in the U.K. versus the prior year. Segment GAAP operating loss was $560 million and GAAP operating margin was (8.07)%. Segment adjusted operating profit was $74 million and adjusted operating margin was 1.07%. On a constant currency basis, adjusted operating profit was $69 million and adjusted operating margin was 1.07%.

Medical-Surgical Solutions revenues were $1.7 billion for the quarter, up 11%, driven primarily by market growth and an acquisition. Segment GAAP operating profit was $93 million and GAAP operating margin was 5.46%. Segment adjusted operating profit was $125 million and adjusted operating margin was 7.34%.

Other revenues were $3.0 billion for the quarter, up 5% on a reported basis and 1% on a constant currency basis, driven primarily by market growth, mostly offset by the impact of government actions on the McKesson Canada business. Other GAAP operating profit was $114 million and adjusted operating profit was $213 million. On a constant currency basis, adjusted operating profit was $204 million.

Fiscal Year 2019 Outlook

McKesson expects Adjusted Earnings per diluted share of $13.00 to $13.80 for the fiscal year ending March 31, 2019.

McKesson does not provide forward-looking guidance on a GAAP basis as the company is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure without unreasonable effort, as items are inherently uncertain and depend on various factors, many of which are beyond the company’s control.

Dividend Declaration

The company’s Board of Directors yesterday declared a regular dividend of $0.39 cents per share of common stock, a 15% increase from $0.34 cents per share in the prior quarter. The dividend will be payable on October 1, 2018, to stockholders of record on September 4, 2018.

Adjusted Earnings

McKesson separately reports financial results on the basis of Adjusted Earnings. Adjusted Earnings is a non-GAAP financial measure defined as GAAP income from continuing operations, excluding amortization of acquisition-related intangible assets, acquisition-related expenses and adjustments, LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments. A reconciliation of McKesson’s GAAP financial results to Adjusted Earnings is provided in Schedules 2 and 3 of the financial statement tables included with this release.

The company does not provide forward-looking guidance on a GAAP basis prospectively as McKesson is unable to provide a quantitative reconciliation of this forward-looking non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring and asset impairment charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

Constant Currency

McKesson also presents its financial results on a constant currency basis. The company conducts business worldwide in local currencies, including the Euro, British pound and Canadian dollar. As a result, the comparability of the financial results reported in U.S. dollars can be affected by changes in foreign currency exchange rates. Constant currency information is presented to provide a framework for assessing how the company’s business performed excluding the effect of foreign currency exchange rate fluctuations. The supplemental constant currency information of the company’s GAAP financial results and Adjusted Earnings (Non-GAAP) is provided in Schedule 3 of the financial statement tables included with this release.

Free Cash Flow

McKesson also provides free cash flow, a non-GAAP measure. Free cash flow is defined as net cash provided by operating activities less property acquisitions and capitalized software expenditures, as outlined in the company’s condensed consolidated statements of cash flows.

Risk Factors

Except for historical information contained in this press release, matters discussed may constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties that could cause actual results to differ materially from those projected, anticipated or implied. These statements may be identified by their use of forward-looking terminology such as "believes", "expects", "anticipates", "may", "will", "should", "seeks", "approximately", "intends", "plans", "estimates" or the negative of these words or other comparable terminology. The discussion of financial trends, strategy, plans or intentions may also include forward-looking statements. It is not possible to predict or identify all such risks and uncertainties; however, the most significant of these risks and uncertainties are described in the company’s Form 10-K, Form 10-Q and Form 8-K reports filed with the Securities and Exchange Commission and include, but are not limited to: changes in the U.S. healthcare industry and regulatory environment; managing foreign expansion, including the related operating, economic, political and regulatory risks; changes in the Canadian healthcare industry and regulatory environment; exposure to European economic conditions, including recent austerity measures taken by certain European governments; changes in the European regulatory environment with respect to privacy and data protection regulations; fluctuations in foreign currency exchange rates; the company’s ability to successfully identify, consummate, finance and integrate acquisitions; the performance of the company’s investment in Change Healthcare; the company’s ability to manage and complete divestitures; material adverse resolution of pending legal proceedings; competition and industry consolidation; substantial defaults in payment or a material reduction in purchases by, or the loss of, a large customer or group purchasing organization; the loss of government contracts as a result of compliance or funding challenges; public health issues in the U.S. or abroad; cyberattack, natural disaster, or malfunction of sophisticated internal computer systems to perform as designed; the adequacy of insurance to cover property loss or liability claims; the company’s proprietary products and services may not be adequately protected, and its products and solutions may be found to infringe on the rights of others; system errors or failure of our technology products or services to conform to specifications; disaster or other event causing interruption of customer access to data residing in our service centers; changes in circumstances that could impair our goodwill or intangible assets; new or revised tax legislation or challenges to our tax positions; general economic conditions, including changes in the financial markets that may affect the availability and cost of credit to the company, its customers or suppliers; changes in accounting principles generally accepted in the United States of America; withdrawal from participation in multiemployer pension plans or if such plans are reported to have underfunded liabilities; inability to realize the expected benefits from the company’s restructuring and business process initiatives; difficulties with outsourcing and similar third party relationships; risks associated with the company’s retail expansion; and the company’s inability to keep existing retail store locations or open new retail locations in desirable places. The reader should not place undue reliance on forward-looking statements, which speak only as of the date they are first made. Except to the extent required by law, the company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

Conference Call Details

The company has scheduled a conference call for today, Thursday, July 26th, at 8:00 AM ET. The dial-in number for individuals wishing to participate on the call is 323-994-2093. Craig Mercer, senior vice president, Investor Relations, is the leader of the call, and the password to join the call is ‘McKesson’. A telephonic replay of this conference call will be available for five calendar days. The dial-in number for individuals wishing to listen to the replay is 719-457-0820 and the pass code is 1175861. An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Shareholders are encouraged to review the company’s filings with the Securities and Exchange Commission.

On July 26, 2018 Roche reported very strong performance in the first half of 2018(Press release, Hoffmann-La Roche, JUL 26, 2018, View Source [SID1234528785])

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Group sales increase 7%1 at constant exchange rates and in Swiss francs
Pharmaceuticals Division sales up 7%, driven mainly by Ocrevus, Perjeta, Alecensa and Tecentriq
Diagnostics Division sales grow 6%, primarily due to demand for immunodiagnostic solutions
Core earnings per share grow ahead of sales at 19%, or 8% excluding the effect of the US tax reform
On IFRS basis, net income increases 33% due to the strong underlying results and lower impairments of intangible assets compared to 2017

Approvals in the second quarter: European Commission approves Perjeta for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence; FDA approves new indications for existing medicines: subcutaneous formulation of Actemra/RoActemra for a form of juvenile idiopathic arthritis; MabThera/Rituxan for pemphigus vulgaris; Avastin for a form of ovarian cancer
Outlook raised for 2018: Roche expects mid-single digit sales growth, at constant exchange rates. Core earnings per share are targeted to grow in the mid-teen digits, at constant exchange rates. Excluding the US tax reform impact, core earnings per share are targeted to grow broadly in line with sales.

Commenting on the Group’s results, Roche CEO Severin Schwan said: "In the first half of the year, both our Pharmaceuticals and Diagnostics Divisions achieved very strong results. Given the very good, continuously growing uptake of our new medicines, we are well on track to rejuvenate our portfolio. The growth of our business will continue, also beyond the current year. Based on the performance in the first half of the year, we are increasing the outlook for the full-year 2018 to mid-single digit sales growth, and targeting core earnings per share to grow in the mid-teen digits, at constant exchange rates."

Group results
Very strong performance in both divisions
In the first half of 2018, Group sales rose 7% to CHF 28.1 billion and core EPS grew 19%. Excluding the effect of the US tax reform, core EPS grew 8%, ahead of sales. Core EPS growth reflects the strong underlying business performance. IFRS net income increased 33%, due to the underlying core results and lower impairment of intangible assets compared to 2017.

Sales in the Pharmaceuticals Division increased 7% to CHF 21.8 billion. Key growth drivers were the recently launched medicines Ocrevus, used to treat two forms of multiple sclerosis, and cancer medicines Perjeta, Alecensa and Tecentriq. Tamiflu contributed with high sales at the beginning of the year due to a severe flu season. As expected, the strong growth reported for the Pharmaceuticals Division was partially offset by lower sales of MabThera/Rituxan and of Tarceva.

In the US, sales increased 15%, led by Ocrevus, Herceptin and Perjeta. Ocrevus sales were supported by continued strong new patient demand. The 27% sales increase of Perjeta was driven by its use for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer at high risk of recurrence.2

In Europe (-8%), strong launches of our new medicines Ocrevus, Tecentriq and Alecensa, especially in Germany, partially offset declining sales of MabThera/Rituxan (-47%), which were affected by biosimilar impact. Perjeta sales continued to grow, specifically in the metastatic and neoadjuvant settings. In the International region, sales grew 5%, led by the Latin America and Asia–Pacific subregions. In Japan, sales were stable, despite government price cuts.

Diagnostics Division sales increased 6% to CHF 6.3 billion. Centralised and Point of Care Solutions (+6%) was the main contributor, led by the growth of its immunodiagnostics business (+9%). Sales increased in all business areas. In regional terms, growth was driven by Asia-Pacific (+14%) and North America (+7%). Sales increased 1% in EMEA3 and 6% in Latin America. In Japan, sales decreased 2% due to lower sales in the molecular diagnostics business.

Core operating profit increased 11% in the Pharmaceuticals Division while it remained stable in the Diagnostics Division. The IFRS results include lower intangible asset impairment charges of CHF 0.3 billion compared to CHF 1.5 billion in the first half of 2017.

Milestones for Roche medicines
In the second quarter, health authorities granted several approvals for Roche medicines. The European Commission approved Perjeta in combination with Herceptin and chemotherapy for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast cancer (eBC) at high risk of recurrence. This approval is based on results from the phase III Aphinity study.

The US Food and Drug Administration (FDA) approved the subcutaneous formulation of Actemra for the treatment of active polyarticular juvenile idiopathic arthritis in patients two years of age and older.

MabThera/Rituxan received FDA approval for the treatment of adults with moderate to severe pemphigus vulgaris, a rare, serious, life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes. This is the first biologic therapy approved by the FDA for pemphigus vulgaris and the first major advancement in the treatment of the disease in more than 60 years.

Approval was granted by the FDA for Venclexta in combination with Rituxan/MabThera for the treatment of people with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised with AbbVie in the US and commercialised solely by AbbVie outside of the US. Sales of Venclexta are reported by AbbVie.

The FDA granted Priority Review for Roche medicines including Hemlibra for adults and children with haemophilia A without factor VIII inhibitors. This decision is based on data from the phase III Haven 3 study. Priority Review was also granted for Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).

Breakthrough Therapy Designation was granted by the FDA for the combination of Tecentriq and Avastin as an initial (first-line) treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer.

The FDA granted Priority Review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older. Baloxavir marboxil is a first-in-class, single-dose, investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains (H7N9, H5N1).4

Clinical trial results on Roche medicines
Results from a number of late-stage studies were announced during the second quarter, with Tecentriq in particular continuing its news flow with six positive out of seven readouts during the quarter. These represent important achievements in a highly competitive and dynamic environment.

The phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year.

The phase III IMpassion130 study met its co-primary endpoint of PFS. Results demonstrated that the combination of Tecentriq plus nab-paclitaxel, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to-treat and PD-L1-positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival was encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Currently, Roche has seven ongoing phase III studies investigating Tecentriq in TNBC, an aggressive disease with limited treatment options.

The phase III IMpower133 study met its co-primary endpoints of OS and PFS at its first interim analysis. The study demonstrated that initial (first-line) treatment with the combination of Tecentriq plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared to chemotherapy alone. The Tecentriq-based combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone. There has been limited treatment progress for people with ES-SCLC in the past 20 years.

Results from the phase III IMpower131 study showed Tecentriq plus chemotherapy (carboplatin and albumin-bound paclitaxel) reduced the risk of disease worsening or death (PFS) by 29 percent compared with chemotherapy (carboplatin and nab-paclitaxel) alone in the initial (first-line) treatment of people with advanced squamous non-small cell lung cancer (NSCLC) (median PFS=6.3 vs. 5.6 months).

The phase III IMpower130 study met its co-primary endpoints of OS and PFS. The combination of Tecentriq plus chemotherapy (carboplatin and albumin-bound paclitaxel; nab-paclitaxel) helped people live significantly longer compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous NSCLC. In addition, the Tecentriq combination reduced the risk of disease worsening or death (PFS) compared with chemotherapy alone.

Positive OS results were announced from the phase III IMpower150 study of Tecentriq and Avastin plus carboplatin and paclitaxel (chemotherapy) for the initial (first-line) treatment of chemotherapy-naïve people with metastatic non-squamous NSCLC. This interim analysis showed that Tecentriq and Avastin plus carboplatin and paclitaxel helped people live significantly longer compared with Avastin plus carboplatin and paclitaxel (median OS = 19.2 versus 14.7 months).

The phase III IMblaze370 study evaluating the combination of Tecentriq and Cotellic did not meet its primary endpoint of OS compared to regorafenib. The study evaluated the combination in people with difficult-to-treat, locally advanced or metastatic colorectal cancer whose disease progressed or who were intolerant to at least two systemic chemotherapy regimens.

Follow-up data from the phase III Alex study revealed that Alecensa helped people with ALK-positive metastatic non-small cell lung cancer to live a median of almost three years without their disease worsening or death (PFS).

The phase III Capstone-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study’s primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo.

Advancing personalised healthcare
Roche and Foundation Medicine (FMI), Inc., US, have entered into a definitive merger agreement. A tender offer was launched on 2 July 2018 and the closing of the transaction is expected to take place in the second half of 2018, subject to a majority of FMI’s outstanding shares not already held by the Group being tendered and other customary conditions. This transaction broadens Roche’s personalised healthcare strategy and aims to further advance molecular insights and the broad availability of high-quality comprehensive genomic profiling, both key enablers for the development of new cancer treatments and optimal patient care.

New tools for Alzheimer’s diagnosis and diabetes management
The FDA granted Breakthrough Device Designation to Roche’s Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF assays. These in vitro diagnostic immunoassays are for the measurement of the ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebral spinal fluid (CSF) in adult subjects with mild cognitive impairment being evaluated for Alzheimer’s disease (AD) and other causes of dementia. Roche was one of the first companies to use biomarkers in clinical trials and will continue to explore high-performing diagnostic and disease-monitoring solutions for AD.

Roche’s new small, tube-free Accu-Chek Solo micropump obtained the CE mark. The micropump offers people with diabetes the option of dosing insulin either directly from the pump or from the dedicated handheld, as well as enabling them to detach and re-attach the pump without wasting insulin. It also complements Roche’s digital health solutions contributing to a more effective and personalised diabetes management. Roche signed a collaboration agreement and investment in Care Innovations. mySugr, one of Roche´s digital diabetes management solutions, will become the integrated personalised diabetes and population health management offering to Care Innovations’ broad range of customers based in the US and Canada.

Next generation of the founding families for the Board of Directors
Dr Andreas Oeri (69) has informed the Board of Directors that he will not stand for re-election as a member of the Board of Directors at the Annual General Meeting 2020. This will conclude his 24-year term of office. Dr Joerg Duschmalé (34), a fifth-generation descendant of the founder of Roche, has confirmed his interest in standing for election as a member of the Board of Directors in 2020.

Outlook increased again for 2018
Roche expects sales to grow mid-single digit, at constant exchange rates. Core earnings per share are targeted to grow in the mid-teen digits, at constant exchange rates. Excluding the US tax reform impact, core earnings per share are targeted to grow broadly in line with sales. Roche expects to further increase its dividend in Swiss francs.

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 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for second quarter 2018 after the close of trading on Wednesday, August 8, 2018 (Press release, Quanterix, JUL 26, 2018, View Source [SID1234527911]). Company management will host a conference call at 4:30 p.m. ET to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following conference ID: 4299369. A live webcast will be accessible on the investor relations section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

On July 26, 2018 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported it will host a conference call and audio webcast on Thursday, August 2, 2018 at 3:00 p.m. CEST (9:00 a.m. EDT) to discuss financial results for the first half of 2018 and to provide a second quarter business update (Press release, argenx, JUL 26, 2018, https://www.argenx.com/en-GB/news-internal/argenx-to-host-conference-call-webcast-to-report-second-quarter-business-update/30194/ [SID1234527872]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To participate in the conference call, please select your phone number below, and use the confirmation code 7669735. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

Dial-in numbers:

Please dial in 5–10 minutes prior to 3 p.m. CET/ 9 a.m. EDT using the number and conference ID below.

Confirmation Code: 7669735

United Kingdom: +44 330 336 9411

National free phone – United Kingdom: 0800 279 7204

USA: +1 929 477 0448

National free phone – USA: 888 599 8686

France: +33 1 76 77 22 57

National free phone – France: 0805 101 278

Belgium: +32 2 400 6926

National free phone – Belgium: 0800 38625

Netherlands: +31 20 703 8261

National free phone – Netherlands: 0800 265 9169

A question and answer session will follow the presentation of the results. Go to www.argenx.com to access the live audio webcast. The archived webcast will also be available (90 days) for replay shortly after the close of the call from the "Downloads" section of the argenx website.