Portola Pharmaceuticals to Announce Fourth Quarter and Full Year 2017 Financial Results and Host Conference Call on Wednesday, February 28, 2018

On February 15, 2018 Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the fourth quarter and full year ended December 31, 2017, and provide a general business overview on Wednesday, February 28, 2018, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332869 [SID1234524013]).

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Conference Call Details
The live conference call on Wednesday, February 28, 2018, at 4:30 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 4893459. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Puma Biotechnology to Host Conference Call to Discuss Fourth Quarter and Full Year Financial Results

On February 15, 2018 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, March 1, 2018 following release of its fourth quarter and full year 2017 financial results (Press release, Puma Biotechnology, FEB 15, 2018, http://investor.pumabiotechnology.com/press-release/puma-biotechnology-host-conference-call-discuss-fourth-quarter-and-full-year-financial [SID1234524014]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least ten minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on the company’s website for 90 days.

Acorda Provides Financial and Pipeline Update for Fourth Quarter and Year End 2017

On February 15, 2018 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported a financial and pipeline update for the fourth quarter and full year ended December 31, 2017 (Press release, Acorda Therapeutics, FEB 15, 2018, View Source [SID1234523984]).

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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

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"We continue to prepare for the potential approval and launch of INBRIJA, our investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease. We look forward to working with the FDA during the NDA review process, and to bringing this new treatment option to the Parkinson’s community to help address an important unmet need," said Ron Cohen, M.D., Acorda’s President and CEO. "Based on our continued market research, as well as the strength of our Phase 3 data, we believe INBRIJA’s US market opportunity to be greater than $800 million."

Fourth Quarter 2017 Financial Results

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended December 31, 2017, the Company reported AMPYRA net revenue of $167.2 million compared to $132.3 million for the same quarter in 2016.

Royalty Revenue – For the quarter ended December 31, 2017, the Company reported royalty revenue of $16.1 million as compared to $4.4 million for the same quarter in 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $3.1 million compared to $2.7 million for the same quarter in 2016. Additionally, the Company completed a transaction that provides a fully paid-up, royalty-free license for Selincro in exchange for $13.0 million which was recorded as royalty revenue in the quarter ended December 31, 2017. During the quarter ended December 31, 2017, the Company completed a royalty purchase transaction for its Fampyra royalty revenue in exchange for an upfront payment of $40 million. The transaction was recorded as a liability in accordance with US GAAP which will be reduced over time as royalty revenue is recognized.

Research and development (R&D) expenses for the quarter ended December 31, 2017 were $35.1 million, including $2.2 million of share-based compensation compared to $53.8 million, including $3.0 million of share-based compensation for the same quarter in 2016.

Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2017 were $39.5 million, including $5.4 million of share-based compensation compared to $59.0 million, including $6.0 million of share-based compensation for the same quarter in 2016.

The Company recorded non-cash asset impairment charges of $233.5 million for tozadenant as a result of the termination of this program, and $23.8 million for SYN120 as a result of the trial not meeting key primary and secondary endpoints. The Company assessed the valuation assumptions for both programs and determined the assets were fully impaired. Both of these charges were recorded in the quarter ended December 31, 2017.

Benefit from income taxes for the quarter ended December 31, 2017 was $51.9 million, including $2.7 million of cash taxes, compared to a provision for income taxes of $1.0 million, including $0.7 million of cash taxes for the same quarter in 2016.

The Company reported a GAAP net loss attributable to Acorda of $(171.1) million for the quarter ended December 31, 2017, or $(3.70) per diluted share. GAAP net loss in the same quarter of 2016 was $(3.1) million, or $(0.07) per diluted share.

Non-GAAP net income for the quarter ended December 31, 2017 was $28.5 million, or $0.61 per diluted share. Non-GAAP net income in the same quarter of 2016 was $2.5 million, or $0.05 per diluted share. This quarterly non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets and acquisition-related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

Financial Results – Full Year Ended December 31, 2017

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the full year ended December 31, 2017 net revenue was $543.3 million compared to $492.8 million for full year 2016. Full year 2017 net revenue increased 10.2% over 2016.

Royalty Revenue – For the full year ended December 31, 2017, the Company reported royalty revenue of $29.5 million compared to $17.2 million for the full year 2016. The Company reported FAMPYRA royalties from sales outside of the U.S. of $11.6 million compared to $10.6 million for the full year 2016. Royalty revenue related to the authorized generic version of Zanaflex was $2.6 million compared to $3.9 million for the full year 2016. Additionally, the Company reported $15.3 million in royalties for Selincro for the full year 2017, which includes $13.0 million of royalty revenue related to the Selincro royalty transaction.

Research and development (R&D) expenses for the full year ended December 31, 2017 were $166.1 million, including $9.7 million of share-based compensation, compared to $203.4 million, including $10.6 million of share-based compensation for the full year 2016

Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2017 were $181.6 million, including $23.1 million of share-based compensation, compared to $235.4 million, including $25.8 million of share-based compensation for the full year 2016.

Asset impairment charges for the full year ended December 31, 2017 include $233.5 million for tozadenant, $23.8 million for SYN120, and $39.4 million for Selincro.

Benefit from income taxes for the full year ended December 31, 2017 was $28.5 million, including $14.1 million of cash taxes compared to a benefit from income taxes of $6.7 million, including $4.3 million of cash taxes for the full year 2016.

For the full year ended December 31, 2017, the Company reported a GAAP net loss of $(223.4) million, or $(4.86) per diluted share. GAAP net loss for the full year 2016 was $(34.6) million, or $(0.76) per diluted share.

Non-GAAP net income for the full year ended December 31, 2017 was $80.7 million, or $1.75 per diluted share. Non-GAAP net income for the full year ended December 31, 2016 was $11.5 million, or $0.25 per diluted share. This full year non-GAAP net income measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, gain on sale of assets, realized foreign currency loss (gain) and acquisition related expenses. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At December 31, 2017, the Company had cash and cash equivalents of $307.1 million.

2018 Financial Guidance

AMPYRA net revenue is expected to be $330-$350 million. The Company expects to maintain exclusivity of AMPYRA at least through July 30, 2018; this guidance is subject to change based on the appellate court’s decision.
R&D expenses for the full year 2018 are expected to be $100-$110 million and include manufacturing expenses associated with INBRIJA. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
SG&A expenses for the full year 2018 are expected to be $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Year-end cash balance for 2018 is projected to be over $300 million
Fourth Quarter 2017 Pipeline and Corporate Updates

INBRIJA (levodopa inhalation powder) Next Steps
The Company resubmitted the NDA for INBRIJA in December 2017. The FDA is expected to inform the Company if the submission has been deemed complete and permits a full review in February 2018.
The Company expects to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in Q1 2018.
AMPYRA (dalfampridine) Patent Appeal
In November, 2017, the Company and the defendants filed reply briefs for the appeal to the U.S. Court of Appeals for the Federal Circuit of the District Court’s decision in the AMPYRA patent litigation. The date for oral argument is expected in the first half of 2018.
Both BIO and PhRMA filed amicus briefs in support of the Company’s appeal, raising important issues in conjunction with biopharmaceutical innovation.
Royalty Monetization Transactions/ZANAFLEX (tizanidine hydrochloride) Franchise Sale
In November, 2017, the Company announced royalty monetization transactions of $53 million for FAMPYRA and SELINCRO.
The Company also announced the sale of ZANAFLEX and ZANAFLEX CAPSULES for $4 million.
SYN120 Phase 2 Data in Parkinson’s disease
Data from the Phase 2 proof-of-concept study for SYN120 showed that several of the outcome measures trended in favor of drug versus placebo; neither the primary nor key secondary endpoints achieved statistical significance.
The Company continues to review the data, which will be presented at an upcoming medical meeting.
Tozadenant Program Discontinued
In November, 2017, the Company discontinued its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease. The Company made this decision based on the emergence of serious adverse events in its Phase 3 program.
Webcast and Conference Call

The Company will host a conference call today at 8:30 a.m. ET. To participate, dial (866) 393-4306 (domestic) or (734) 385-2616 (international); access code 8789908. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 11:30 a.m. ET on February 15, 2018 until 11:59 p.m. ET on March 15, 2018. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international); reference code 8789908. The archived webcast will be available in the Investor Relations section of the Acorda website.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain historical and forward-looking non-GAAP financial measures. In particular, Acorda has provided non-GAAP net income, adjusted to exclude the items below, and has provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of non-GAAP net income, when viewed in conjunction with our GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) non-cash interest charges related to the accounting for our outstanding convertible debt which are in excess of the actual interest expense owing on such convertible debt as well as non-cash interest related to the Fampyra monetization, non-cash interest charges related to our asset based loan which was terminated in 2017 and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) acquisition related expenses and related foreign currency losses and gains that pertain to a non-recurring event, (v) corporate restructuring expenses that pertain to a non-recurring event, (vi) asset impairments which are non-cash charges that relate to program terminations that are not routine to the operation of the business, and (vii) gain on sale of assets that pertains to a non-recurring event. The Company believes its non-GAAP net income measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.

In addition to non-GAAP net income, we have provided 2018 guidance for R&D and SG&A expenses on a non-GAAP basis. Due to the forward looking nature of this information, the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. The Company believes that these non-GAAP measures, when viewed in conjunction with our GAAP results, provide investors with a more meaningful understanding of our ongoing and projected R&D and SG&A expenses. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance..

West Announces Fourth-Quarter and Full-Year 2017 Results and Announces Quarterly Dividend

On February 15, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the fourth-quarter and full-year 2017 and provided financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, FEB 15, 2018, View Source;p=RssLanding&cat=news&id=2332657 [SID1234524017]).

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(PRNewsfoto/West Pharmaceutical Services, I)

Executive Summary

Fourth-quarter 2017 reported net sales of $415.6 million grew 8.7% over the prior-year quarter. At constant currency, organic sales growth was 4.5%. Excluding impacts from the deconsolidation of operations in Venezuela and hurricane-related shutdowns, organic sales growth would have been 6.0%.
Full-year 2017 reported net sales of $1.599 billion grew 6.0% over the prior year. At constant currency, organic sales growth was 5.2%.
Fourth-quarter 2017 reported-diluted EPS was $0.00, reflecting a charge related to U.S. tax reform that reduced EPS by $0.64. Excluding this impact, fourth-quarter 2017 adjusted-diluted EPS was $0.64, as compared to $0.54 in the prior-year quarter.
Full-year 2017 reported-diluted EPS was $1.99, including the aforementioned tax charge. Full-year 2017 adjusted-diluted EPS was $2.78, as compared to $2.18 in the prior year, representing 28% growth.
For full-year 2018, net sales at constant-currency growth is expected to be within our long-term projected 6-8% range. Excluding 2017 net sales that will not recur in 2018, constant-currency sales growth is expected to be at the high end of that 6-8% range.
Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 and $2.90, an increase of 1% to 4%, respectively, compared to $2.78 in 2017.
The Company announced that its Board of Directors has approved a second-quarter 2018 dividend of $0.14 per share. The dividend will be paid on May 2, 2018, to shareholders of record as of April 18, 2018. The Board of Directors also authorized a share repurchase program for calendar-year 2018 of up to 800,000 shares.
In conjunction with the ongoing Global Operations strategy, our Board of Directors has approved a restructuring program that will help streamline our manufacturing plant network. These changes are expected to be implemented over the next twelve to twenty-four months. The plan will require restructuring expense in the range of $8.0 million to $13.0 million.
"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

"We had a solid finish to the year with fourth-quarter 2017 organic sales growth in line with our expectations," said Eric M. Green, President and Chief Executive Officer. "We were pleased to see a return to double-digit growth in our Biologics market unit and high-single digit growth in our Generics market unit."

Mr. Green concluded, "We expect 2018 will be another year of above-market sales growth and operating profit margin expansion. We have been growing in excess of the 2-3% underlying unit growth of the injectable drug market we serve, as we continue to leverage the demand for our high-value products. Our teams continue to work closely with our global customer base to deliver the highest-quality critical components and solutions in a demanding regulatory backdrop for the packaging and delivery of injectable medicines."

Fourth-Quarter and Full-Year 2017 Financial Results (comparisons to prior-year periods)

Fourth-quarter 2017 reported net sales of $415.6 million grew 8.7% over the prior-year quarter. At constant currency, organic sales growth was 4.5%. Excluding impacts from the deconsolidation of operations in Venezuela and hurricane-related shutdowns, we estimate that organic sales growth would have been 6.0%. Proprietary Products segment organic sales growth was 1.4%. By market unit, fourth-quarter 2017 Proprietary Products segment sales growth was led by double-digit growth in Biologics and high-single digit growth in Generics, offset by a low-single digit decline in Pharma. Contract-Manufactured Products segment organic sales growth was 14.2%.

Full-year reported net sales of $1.599 billion grew 6.0% over the prior year. At constant currency, organic sales growth was 5.2%. Proprietary Products segment organic sales growth was 3.2%. By market unit, 2017 Proprietary Products segment sales growth was led by high-single digit growth in Biologics and mid-single digit growth in Pharma with flat performance in Generics. Contract-Manufactured Products segment organic sales growth was 12.0%.

Gross profit margin in fourth-quarter 2017 was 30.9%, a decline of 140 basis points from the same period last year, mainly due to higher unabsorbed overhead from new capacity at our Waterford and Dublin, Ireland and Kinston, North Carolina sites and due to Contract-Manufactured Products constituting a higher percentage of total sales. Fourth-quarter 2017 operating profit margin was 14.7%, a 30-basis point increase from the same quarter last year (excluding prior-year restructuring and related charges and a pension curtailment gain). SG&A as a percent of sales dropped from 15.9% in Q4 2016 to 14.2% in Q4 2017, due to lower stock-based compensation and U.S. pension expense, slightly offset by higher compensation and benefits and incremental costs associated with foreign currency rate translation.

Gross profit margin in full-year 2017 declined by 110 basis points, mainly due to higher sales of lower-margin Contract-Manufactured Products and unabsorbed overhead from newly-commissioned facilities.

Full-year 2017 reported operating profit margin was 14.3%. Adjusted operating profit margin was 15.0%, an increase of 20 basis points over the prior year (please see reconciliation data at the end of this press release). The decrease in gross profit margin was more than offset by lower SG&A expense as a percentage of sales and other income of $9.1 million for reimbursed costs associated with a technology license.

For the full-year 2017, income tax expense was $80.9 million, which represented an effective tax rate of 36.4%. Excluding a $48.8 million charge from U.S. tax reform in the fourth quarter of 2017 and a $33.1 million benefit from changes associated with accounting for share-based payment transactions, the effective tax rate in 2017 would have been 29.3%. We believe, as a result of U.S. tax reform, our effective 2018 tax rate (excluding any tax benefits from stock-based compensation expense) will be reduced by approximately three percentage points from the 2017 effective tax rate of 29.3%.

During the fourth-quarter 2017, the Company repurchased 475,000 shares of common stock at a cost of $47.4 million. For the full-year 2017, the Company repurchased 800,000 shares of common stock at a cost of $74.4 million.

Full-Year 2018 Financial Guidance

The Company expects 2018 organic sales growth is expected to be within our long-term projected 6-8% range. Excluding sales that will not recur in 2018 ($32.6 million of 2017 sales will not recur in 2018 due to the cessation of a single customer contract, who opted to bring in-house its consumer plastics contract manufacturing operations, and deconsolidation of our Venezuelan operations), the Company expects 2018 sales growth to be at the higher end of that range. Full-year 2018 sales are expected to be in the range of $1.720 billion to $1.730 billion, using an assumed translation exchange rate of $1.20 per Euro.

The Company expects to expand both gross and operating profit margins in 2018. Excluding items from 2017 that will not recur in 2018 (e.g., the Company does not expect any 2018 income from the sale of a technology license that occurred in 2017), operating profit margin is expected to increase in excess of 100 basis points, which includes investments we are making for future growth such as required validation testing at our Waterford facility in advance of commercial production later this year.

In conjunction with the ongoing Global Operations strategy, our Board of Directors has approved a restructuring program that will help streamline our manufacturing plant network and enable us to make investments to drive our high-value proprietary products and healthcare-related contract manufacturing business, and drive margin expansion.

These changes are expected to be implemented over the next twelve to twenty-four months. The plan will require restructuring expense 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.

Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 to $2.90, an increase of 1% to 4%, respectively, compared to $2.78 in 2017. This estimate excludes any expense or benefits from the Global Operations restructuring plan. Excluding tax-benefits from stock-based compensation expense ($0.44 of diluted EPS benefits in 2017, an estimated $0.14 of diluted-EPS benefits in 2018), the Company expects full-year 2018 adjusted-diluted EPS to increase by 14% to 18%.

The Company estimates its 2018 capital spending will be approximately $150 million.

Fourth-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 9393569.

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, February 22, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9393569.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "expected," "continue," "are," "increase," "will," "estimated," "believe," "expect," "include," "estimate," 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, 2016.

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. In order 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 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 twelve months presented in the accompanying tables:

Tax law changes – During the three and twelve months ended December 31, 2017, the Company recorded a net tax charge of $48.8 million due to the estimated impact of U.S. tax reform, including the repatriation tax on accumulated foreign earnings and the remeasurement of deferred tax assets and other tax liabilities, as well as the impact of changes in enacted international tax rates on previously-recorded deferred tax asset and liability balances. During the three and twelve months ended December 31, 2016, the Company recorded a discrete tax charge of $0.7 million and $1.0 million, respectively, resulting from the impact of changes in enacted tax rates on its previously-recorded deferred tax asset and liability balances.

Venezuela deconsolidation – During the twelve months ended December 31, 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.

Restructuring and related charges – During the three months ended December 31, 2016, the Company recorded $2.7 million in restructuring and related charges, consisting of $1.1 million for severance charges, $1.4 million for non-cash asset write-downs associated with the discontinued use of certain equipment, and $0.2 million for other charges. During the twelve months ended December 31, 2016, the Company incurred $26.4 million in restructuring and related charges, including $8.9 million for severance charges, $17.3 million for non-cash asset write-downs associated with the discontinued use of certain trademarks and certain equipment, and $0.2 million for other charges.

Pension curtailment gain – During the three and twelve months ended December 31, 2016, the Company recorded a pension curtailment gain of $2.1 million in connection with its decision to freeze both its U.S. qualified and non-qualified defined benefit pension plans as of January 1, 2019.

Venezuela currency devaluation – During the twelve months ended December 31, 2016, the Company recorded a charge of $2.7 million related to the devaluation of the Venezuelan Bolivar from the previously-prevailing official exchange rate of 6.3 Bolivars to U.S. Dollars to 10.0 Bolivars to U.S. Dollars.

WEST PHARMACEUTICAL SERVICES, INC.

CONSOLIDATED STATEMENTS OF INCOME

(UNAUDITED)

(in millions, except per share data)

Three Months Ended

December 31,

Twelve Months Ended

December 31,

2017

2016

2017

2016

Net sales

$415.6

100%

$382.3

100%

$1,599.1

100%

$1,509.1

100%

Cost of goods and services sold

287.1

69

258.9

68

1,086.5

68

1,008.0

67

Gross profit

128.5

31

123.4

32

512.6

32

501.1

33

Research and development

9.7

2

9.6

2

39.1

3

36.8

2

Selling, general and administrative expenses

58.9

14

60.9

16

242.6

15

239.8

16

Other (income) expense, net

(1.1)

(1.4)

2.0

27.7

2

Operating profit

61.0

15

54.3

14

228.9

14

196.8

13

Interest expense, net

1.7

1

1.1

6.5

7.0

Income before income taxes

59.3

14

53.2

14

222.4

14

189.8

13

Income tax expense

61.8

15

16.1

4

80.9

5

54.4

4

Equity in net income of affiliated companies

2.5

1

2.0

9.2

8.2

1

Net income

$ –

-%

$39.1

10%

$150.7

9%

$143.6

10%

Net income per share:

Basic

$ –

$0.53

$2.04

$1.96

Diluted

$ –

$0.52

$1.99

$1.91

Average common shares outstanding

74.2

73.2

73.9

73.3

Average shares assuming dilution

75.9

74.9

75.8

75.0

WEST PHARMACEUTICAL SERVICES

REPORTING SEGMENT INFORMATION

(UNAUDITED)

(in millions)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

Net Sales:

2017

2016

2017

2016

Proprietary Products

$306.4

$290.0

$1,236.9

$1,189.9

Contract-Manufactured Products

109.2

92.4

362.5

320.2

Eliminations

(0.1)

(0.3)

(1.0)

Consolidated Total

$415.6

$382.3

$1,599.1

$1,509.1

Operating Profit (Loss):

Proprietary Products

$54.0

$56.3

$242.2

$241.9

Contract-Manufactured Products

18.2

12.6

48.3

38.2

U.S. pension expense

(1.1)

(2.2)

(4.3)

(8.8)

Stock-based compensation expense

(2.5)

(5.4)

(16.1)

(19.5)

General corporate costs

(7.6)

(6.4)

(30.1)

(28.0)

Adjusted Operating Profit

$61.0

$54.9

$240.0

$223.8

Adjusted Operating Profit Margin

14.7%

14.4%

15.0%

14.8%

Venezuela deconsolidation

(11.1)

Venezuela currency devaluation

(2.7)

Restructuring and related charges

(2.7)

(26.4)

Pension curtailment gain

2.1

2.1

Reported Operating Profit

$61.0

$54.3

$228.9

$196.8

Reported Operating Profit Margin

14.7%

14.2%

14.3%

13.0%

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Reported and Adjusted Operating Profit, Net Income and Diluted EPS

Three months ended December 31, 2017

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$61.0

$61.8

$ –

$ –

Tax law changes

(48.8)

48.8

0.64

Adjusted (Non-GAAP)

$61.0

$13.0

$48.8

$0.64

Twelve months ended December 31, 2017

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$228.9

$80.9

$150.7

$1.99

Tax law changes

(48.8)

48.8

0.64

Venezuela deconsolidation

11.1

11.1

0.15

Adjusted (Non-GAAP)

$240.0

$32.1

$210.6

$2.78

Three months ended December 31, 2016

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$54.3

$16.1

$39.1

$0.52

Restructuring and related charges

2.7

0.9

1.8

0.02

Pension curtailment gain

(2.1)

(0.8)

(1.3)

(0.01)

Tax law changes

(0.7)

0.7

0.01

Adjusted (Non-GAAP)

$54.9

$15.5

$40.3

$0.54

Twelve months ended December 31, 2016

Operating
profit

Income
tax
expense

Net
income

Diluted
EPS

Reported (GAAP)

$196.8

$54.4

$143.6

$1.91

Restructuring and related charges

26.4

9.0

17.4

0.23

Venezuela currency devaluation

2.7

2.7

0.04

Pension curtailment gain

(2.1)

(0.8)

(1.3)

(0.01)

Tax law changes

(1.0)

1.0

0.01

Adjusted (Non-GAAP)

$223.8

$61.6

$163.4

$2.18

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Net Sales to Net Sales at Constant Currency (1)

Three months ended December 31, 2017

Proprietary

CM

Eliminations

Total

Reported net sales (GAAP)

$306.4

$109.2

$ –

$415.6

Effect of changes in currency translation rates

(12.3)

(3.6)

(15.9)

Net sales at constant currency (Non-GAAP) (1)

$294.1

$105.6

$ –

$399.7

Twelve months ended December 31, 2017

Proprietary

CM

Eliminations

Total

Reported net sales (GAAP)

$1,236.9

$362.5

$(0.3)

$1,599.1

Effect of changes in currency translation rates

(8.4)

(3.8)

(12.2)

Net sales at constant currency (Non-GAAP) (1)

$1,228.5

$358.7

$(0.3)

$1,586.9

(1)

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.

WEST PHARMACEUTICAL SERVICES

RECONCILIATION OF NON-GAAP MEASURES (UNAUDITED)

Please refer to "Non-GAAP Financial Measures" for more information

(in millions, except per share data)

Reconciliation of Reported Diluted EPS Guidance to Adjusted Diluted EPS Guidance

2017 Actual

2018 Guidance

% Change

Reported diluted EPS

$1.99

$2.80 to $2.90

40.7% to 45.7%

Venezuela deconsolidation

0.15

Tax law changes impact

0.64

Adjusted diluted EPS

$2.78

$2.80 to $2.90

0.7% to 4.3%

Stock comp tax benefit

(0.44)

(0.14)

Adjusted diluted EPS

excl. stock comp tax benefit

$2.34

$2.66 to $2.76

13.7% to 17.9%

Notes:

See "Full-Year 2018 Financial Guidance" and "Non-GAAP Financial Measures" in today’s press release for additional information regarding adjusted diluted EPS.

Guidance includes various currency exchange rate assumptions, most significantly the Euro at $1.20 for 2018. 2017 results were translated at an average rate of $1.13. Each $0.01 change in the Euro exchange rate results in approximately a $0.01 change in EPS.

Guidance excludes possible cost and benefits from the announced Global Operations restructuring plan.

WEST PHARMACEUTICAL SERVICES

CASH FLOW ITEMS

(UNAUDITED)

(in millions)

Twelve Months Ended December 31,

2017

2016

Depreciation and amortization

$96.7

$90.7

Operating cash flow

$263.3

$219.4

Capital expenditures

$130.8

$170.2

WEST PHARMACEUTICAL SERVICES

FINANCIAL CONDITION

(UNAUDITED)

(in millions)

As of
December 31, 2017

As of
December 31, 2016

Cash and cash equivalents

$235.9

$203.0

Debt

$197.0

$228.6

Equity

$1,279.9

$1,117.5

Net debt-to-total invested capital (2)

N/A

2.2%

Working capital

$464.0

$400.9

(2)

Net debt and total invested capital are Non-GAAP measures. Net debt is determined by reducing total debt by the amount of cash and cash equivalents, and for purpose of measuring net debt to invested capital, total invested capital is the sum of net debt and shareholders’ equity. Please refer to "Non-GAAP Financial Measures" in this release for additional information regarding those measures.

ISA Pharmaceuticals and Scancell enter collaboration agreement for the manufacturing, development and commercialisation of Modi-1 / AMPLIVANT® combination

On 15 February, 2018 ISA Pharmaceuticals B.V. (‘ISA’), a clinical-stage immunotherapy company, and Scancell Holdings plc, (‘Scancell’ or the ‘Company’), the developer of novel immunotherapies for the treatment of cancer, reported that they have entered into a worldwide licensing and collaboration agreement to use ISA’s AMPLIVANT adjuvant technology for the manufacturing, development and commercialisation of Scancell’s first Moditope development candidate, Modi-1 (Press release, ISA Pharmaceuticals, FEB 15, 2018, https://www.isa-pharma.com/isa-pharmaceuticals-and-scancell-enter-collaboration-agreement-for-the-manufacturing-development-and-commercialisation-of-modi-1-amplivant-combination/ [SID1234612392]). This partnership has the potential to provide a new treatment option for patients with triple negative breast cancer, ovarian cancer, sarcomas, and other solid tumours.

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Under the terms of this agreement, ISA has granted Scancell an exclusive worldwide license to manufacture, develop and commercialise the AMPLIVANT:Modi-1 conjugate therapy and will contribute know-how and expertise related to AMPLIVANT. Clinical studies will be conducted by Scancell and are expected to commence in H1 2019.

In return, ISA will receive an upfront payment from Scancell and is entitled to milestone and royalty fees following achievement of certain criteria as defined in the agreement. Financial details were not disclosed.

Previous pre-clinical data demonstrated that conjugation of the Modi-1 peptides to AMPLIVANT enhances anti-tumour immune responses 10-100 fold and resulted in highly efficient tumour eradication, including protection against tumour re-challenge.

ISA’s AMPLIVANT technology can be applied to any type of targeted immunotherapy, significantly enhancing its efficacy. It is based on a proprietary and synthetic small molecule TLR1/2 ligand with enhanced immunostimulatory activity that can be chemically coupled to the respective immunotherapeutic. AMPLIVANT conjugates allow lower dosing with higher efficacy through better dendritic cell antigen processing and presentation, as well as enhanced T cell priming.

Scancell’s Moditope platform acts by stimulating the production of CD4+ T cells using citrullinated tumour-associated peptide epitopes. This technology overcomes the immune suppression induced by tumours themselves, allowing activated T cells to seek out and kill tumour cells that would otherwise be hidden from the immune system.

"This collaboration is an important step to advance new adjuvant technologies such as AMPLIVANT to clinical-stage programmes and bring patients better treatments," said Ronald Loggers, CEO of ISA Pharmaceuticals. "The partnership will further validate the power of AMPLIVANT conjugates for use in therapeutic cancer vaccines that carry a variety of epitopes, including post-translationally modified epitopes such as Scancell’s Moditope products."

Cliff Holloway, CEO of Scancell, commented: "This collaboration with ISA Pharmaceuticals is an important step in the continued development and commercialisation of our first Moditope immunotherapy, Modi-1, which has the potential to treat patients with triple negative breast cancer, ovarian cancer and sarcoma who are resistant to other immunotherapies. Our pre-clinical studies have demonstrated Modi-1 induces potent anti-tumour responses and significant improvements in survival. We believe that combining Modi-1 with an enabling adjuvant technology such as AMPLIVANT has the potential to significantly enhance its efficacy in patients and we are looking forward to moving this important and novel therapy into the clinic in the first half of 2019."

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).