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

On July 26, 2018 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will announce financial results for the Second Quarter 2018 and provide a general business update before the U.S. markets open on Thursday August 2, 2018 (Press release, Adaptimmune, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360328 [SID1234527891]). Following the announcement, the company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) on the same day.

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The press release and the live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address.

To participate in the live conference call, please dial (833) 652-5917 (U.S.) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (8149978).

On July 26, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2018 and reaffirmed financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, JUL 26, 2018, View Source [SID1234527882]).

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Executive Summary

Second-quarter 2018 reported net sales of $447.5 million grew 12.6% over the prior-year quarter. At constant currency, organic sales growth was 9.0%.
Second-quarter 2018 reported-diluted EPS was $0.75, as compared to $0.51 in the same period last year. Excluding restructuring charges and a non-recurring tax benefit, second-quarter 2018 adjusted-diluted EPS was $0.70, as compared to adjusted-diluted EPS of $0.66 in the same period last year.
The Company reaffirms full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion and full-year 2018 adjusted-diluted EPS range of $2.80 to $2.90.
Last week, West officially opened its Waterford, Ireland facility, a global center of excellence for West’s advanced manufacturing network. The Waterford site will also be among the first in West’s global manufacturing network to commercialize Westar Select, the latest in its portfolio of high-value product solutions.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"Second-quarter 2018 sales performance was fueled by solid Proprietary Products segment sales, led by double-digit high-value products growth, and robust growth in the Contract-Manufactured Products segment," said Eric M. Green, President and Chief Executive Officer. "The Generics market unit generated double-digit sales growth and, as expected, the Pharma and Biologics market units had improved sales growth over the first-quarter 2018.

"We expanded both gross profit and reported- and adjusted-operating profit margins. A combination of high-value product sales growth and cost efficiencies more than offset unabsorbed overhead at our Waterford facility, as well as start-up costs and low-margin tooling sales associated with increasing customer demand in our Contract-Manufactured Products segment."

Mr. Green concluded, "With a solid second-quarter, we are on track to achieve our full-year 2018 organic sales growth and adjusted earnings targets. Our markets are stable, and West continues to address the needs of our customers by providing the quality, availability and scientific excellence required to support their regulated injectable and diagnostic products."

Second-Quarter Financial Results (comparisons to prior-year period)

Second-quarter 2018 reported net sales of $447.5 million grew 12.6% over the prior-year quarter. At constant currency, organic sales growth was 9.0%.

Proprietary Products segment organic sales growth was 6.9%. By market unit, second-quarter 2018 Proprietary Products segment sales growth was led by double-digit growth in Generics and high-single digit growth in Pharma, along with low-single digit growth in Biologics. High-value products returned to double-digit organic sales growth, led by solid adoption in the Pharma and Generics market units.

Contract-Manufactured Products segment organic sales growth was 16.9%, despite the loss of a consumer-product contract manufacturing customer in early 2018. This growth was fueled by demand for diagnostic and drug delivery devices, offsetting declines in the mature consumer-product category. Second-quarter 2018 performance also benefited from timing of tooling orders, as well as initial orders from recent competitive takeaways.

Second-quarter 2018 gross profit margin was 31.8%, compared to 31.4% in the same period last year, an increase of 40 basis points. Correlated with double-digit sales of high-value products, Proprietary Products segment gross margin increased year-over-year by 180 basis points, more than offsetting unabsorbed overhead from the start-up of our Waterford facility. Contract-Manufactured Products segment gross margin declined year-over-year by 370 basis points due to unabsorbed overhead from plant consolidation activities and start-up costs associated with the launch of new programs.

The Company has adopted new rules for pension accounting. Instead of recognizing pension gains or losses in the "Selling, general and administrative expenses" line on the income statement, these gains or losses are now located "below the line" in nonoperating income. The Company has restated all prior periods to allow year-over-year comparisons with 2018 performance.

Second-quarter 2018 reported operating profit margin was 13.5%, as compared to 10.6% in the same period last year. Excluding restructuring charges and charges associated with the Venezuela deconsolidation last year, second-quarter 2018 adjusted operating profit margin was 14.0%, compared to 13.4% in the same period last year. Higher gross profit margin, coupled with lower other expense, more than offset moderately higher SG&A expense as a percentage of reported net sales. SG&A expense in the second-quarter 2018 was higher than the same period last year due to increased accruals for incentive compensation and the impact of changes in foreign currency exchange rates.

For the second-quarter 2018, reported income tax expense was $6.0 million, representing a reported effective tax rate of 9.9%. Excluding benefits associated with a reduction in the estimated liability that we recorded in 2017 in anticipation of U.S. tax reform and the impact of restructuring charges, the adjusted income tax expense in the quarter was $11.4 million. Tax benefits from stock-based compensation were $3.4 million in the second-quarter 2018, as compared to $9.6 million in the same period last year. Excluding tax benefits from stock-based compensation and restructuring and related charges, the adjusted income tax rate would have been 24% in the second-quarter 2018.

During the second-quarter 2018, the Company repurchased 260,000 shares of common stock at a cost of $22.9 million under its share repurchase program. The second-quarter 2018 repurchase completes the 800,000 share repurchase program authorized by our Board of Directors.

Full-Year 2018 Financial Guidance

The Company reaffirms full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. The Company assumes an expected translation exchange rate of $1.15 per Euro for the second half of 2018, as compared to a prior expectation of $1.20 per Euro.

The Company also reaffirms full-year 2018 adjusted-diluted EPS guidance to be in a range of $2.80 to $2.90. The Company estimates, excluding tax benefits from stock-based compensation, a full-year effective tax rate of 24.5%.

The Company is revising its 2018 capital spending guidance to be in a range of between $120 million and $130 million, as compared to prior guidance of less than $150 million. Successful progress by our Global Operations team in managing our worldwide network of manufacturing plants in a consolidated, comprehensive system is driving efficiencies and better capacity utilization. This also results in lower infrastructure capital spending requirements to support the same future sales and profit growth goals of the Company.

Second-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 6196359.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, August 2, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 6196359.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "reaffirmed," "reaffirms," "will," "on track," "achieve," "expected," "increasing," "to be," "continue," "continues," "assumes," "offsetting," "estimates," "revising" and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. To compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP financial measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the items excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted-diluted EPS for the three and six months presented in the accompanying tables:

Restructuring and related charges – During the three months ended June 30, 2018, the Company recorded $2.2 million in restructuring and related charges, consisting of $1.3 million for severance charges, $0.3 million for non-cash asset write-downs, and $0.6 million for other charges. During the six months ended June 30, 2018, the Company recorded $5.5 million in restructuring and related charges, consisting of $3.3 million for severance charges, $0.4 million for non-cash asset write-downs, and $1.8 million for other charges. The plan will require restructuring and related charges in the range of $8.0 million to $13.0 million and capital expenditures in the range of $9.0 million to $14.0 million. Once fully completed, we expect that the plan will provide the Company with annualized savings in the range of $17.0 million to $22.0 million.

Tax law changes – During the three and six months ended June 30, 2018, the Company recorded a net tax benefit of $4.8 million to reflect a reduction to its one-time mandatory deemed repatriation tax of post-1986 undistributed foreign subsidiary earnings and profits. In April 2018, the U.S. Internal Revenue Service issued guidance, which provided that certain foreign taxes accrued by specified corporations in the toll tax year reduce post-1986 earnings and profits. In addition, during the six months ended June 30, 2018, the Company recorded a net tax charge of $0.3 million to adjust its estimated impact of the 2017 Tax Act. During the three and twelve months ended December 31, 2017, the Company had recorded a provisional charge for the estimated impact of the 2017 Tax Act, based upon its then-current understanding of the 2017 Tax Act and the guidance available at the time. The Company will continue to actively monitor the developments relating to the 2017 Tax Act and will adjust its estimate as necessary during the one-year measurement period.

Venezuela deconsolidation – During the three and six months ended June 30, 2017, as a result of the continued deterioration of conditions in Venezuela as well as its continued reduced access to U.S. dollar settlement controlled by the Venezuelan government, the Company recorded a charge of $11.1 million related to the deconsolidation of its Venezuelan subsidiary, following its determination that it no longer met the GAAP criteria for control of that subsidiary. As of April 1, 2017, the Company’s consolidated financial statements exclude the results of its Venezuelan subsidiary.