Advaxis Submits Conditional Marketing Authorization Application for Axalimogene Filolisbac for the Second-Line Treatment of Metastatic Cervical Cancer in European Union

On February 13, 2018 Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of cancer immunotherapies, reported that it has submitted a conditional Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the company’s lead Lm Technology product candidate, axalimogene filolisbac, for the treatment of adult women who progress beyond first-line therapy of persistent, recurrent or metastatic carcinoma of the cervix (PRmCC) (Press release, Advaxis, FEB 15, 2018, View Source [SID1234523996]).

"The submission of the MAA represents a significant regulatory milestone for Advaxis and the ongoing development of our Lm Technology Platform," stated Anthony Lombardo, interim Chief Executive Officer of Advaxis. "The submission is based on the improvement in 12-month survival rates observed in the Phase 2 GOG-0265 study. We feel that these data support axalimogene filolisbac as a potential therapeutic option for patients living with PRmCC who are in desperate need of new treatment options beyond first-line therapy," added Lombardo.

The MAA submission is built around data from the GOG-0265 study which examined overall survival rates in 50 women and showed a 12-month overall survival rate (primary efficacy endpoint) of 38% (n=19/50) in women with PRmCC, representing a 55% improvement over an expected, model-predicted,12-month survival rate of 24.5%.2 More than 50% of treated women in this study had previously received multiple prior lines of therapy including treatment with bevacizumab and subsequently experienced progression of their disease.2

"Despite the availability of preventative measures, metastatic cervical cancer continues to be a major public health concern associated with high mortality rates within Europe," said Mansoor Mirza, M.D., Chief Oncologist at the Copenhagen University Hospital in Denmark and Medical Director of the Nordic Society of Gynaecological Oncology (NSGO). "The results from GOG-0265 are encouraging and could represent a meaningful step forward in the care of women suffering from PRmCC, which has seen very little innovation in almost 30 years."

In the GOG-0256 study, axalimogene filolisbac was generally well-tolerated with mostly Grade 1 and 2 flu-like adverse events associated with cytokine release which were managed with standard medical care. This safety profile is consistent with the ongoing clinical experience of axalimogene filolisbac across all clinical trials.

The EMA will evaluate the totality of the data, including results from GOG-0265 as well as supportive data from other clinical trials evaluating axalimogene filolisbac. In parallel with the MAA review process, the company will continue assessing partnership opportunities for the potential commercialization of axalimogene filolisbac in Europe.

The company has also decided to align and simplify its strategy by using axalimogene filolisbac exclusively in all ongoing and planned HPV-related cancer clinical trials, including the upcoming ADVANCE trial, previously planned with ADXS-DUAL. The strategic decision to harmonize all trials to axalimogene filolisbac is based on its clinical profile to date in over 250 patients, and its demonstration of similar activity in both HPV 16 and 18 subtypes in GOG-0265. The company believes that harmonizing to a single product candidate for all HPV-related programs will streamline developmental, regulatory and commercialization strategies.

About Axalimogene Filolisbac

Axalimogene filolisbac is a targeted Listeria monocytogenes (Lm)-based investigational immunotherapy that attacks HPV-associated cancers by altering a live strain of Lm bacteria to generate cancer-fighting T cells against cancer antigens while neutralizing the tumor’s natural protections that guard the tumor microenvironment from immunologic attack.

Axalimogene filolisbac has already achieved multiple regulatory milestones, including classification as an EMA advanced therapy-medicinal product for the treatment of cervical cancer, receipt of the U.S. Food and Drug Administration (FDA) Fast Track Designation as an adjuvant therapy for treating high-risk, locally advanced cervical cancer (HRLACC), receipt of a Special Protocol Assessment agreement with the FDA for the Phase 3 AIM2CERV trial, and orphan drug designations in three HPV-associated indications (PRmCC, head and neck, and anal cancer). In addition, axalimogene filolisbac will be studied in combination with nivolumab in the ADVANCE trial, a potential registrational trial for patients with PRmCC, which is planned to begin in 2018.

Selumetinib granted Orphan Drug Designation by the US FDA for neurofibromatosis type 1

On February 15, 2018 AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) reported that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1) (Press release, AstraZeneca, FEB 15, 2018, View Source [SID1234523985]).

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NF1 is an incurable genetic condition that affects one in 3,000 births,[i] with highly-variable symptoms, including cutaneous (skin), neurological (nervous system) and orthopaedic (skeletal) manifestations. NF1 can cause secondary complications including learning difficulties, visual impairment, pain, disfigurement, twisting and curvature of the spine, high blood pressure and epilepsy. Plexiform neurofibromas (PNs) are a neurological manifestation of NF1 and arise from nerve fascicles that tend to grow along the length of the nerve. PNs occur in approximately 20-50% of NF1 patients causing pain, motor dysfunction and disfigurement.[ii]

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, at AstraZeneca, said: "Neurofibromatosis type 1 is a devastating condition that can lead to life-threatening complications. There is no known cure for neurofibromatosis and there are limited treatment options to manage symptoms."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, at MSD Research Laboratories, said: "We’re looking forward to working with our colleagues at AstraZeneca to develop selumetinib and understand how it may benefit patients with NF1."

The potential benefit of selumetinib in NF1 is being explored in the US National Cancer Institute-sponsored Phase I/II SPRINT trial in paediatric patients with symptomatic NF1-related PNs. Phase II trial results are expected later in 2018.

The FDA’s ODD programme provides orphan status to medicines that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

In addition to NF1, selumetinib is being investigated in the Phase III ASTRA trial of patients who are diagnosed with differentiated thyroid cancer (DTC) following surgery and treatment with radioactive iodine. Selumetinib was granted ODD by the US FDA for the adjuvant treatment of stage III/IV DTC in 2016. It is also being explored as a monotherapy and in combination with other treatments in Phase I trials.

NOTES TO EDITORS
About neurofibromatosis type 1 (NF1)

NF1 is caused by a spontaneous or inherited mutation in the NF1 gene. The disease is associated with many symptoms, including soft lumps on and under the skin (subcutaneous neurofibromas), skin pigmentation (cafe au lait spots) and, in 20-50% of patients, tumours on the nerve sheaths (plexiform neurofibromas). These plexiform neurofibromas can cause morbidities such as pain, motor dysfunction and disfigurement. Patients with NF1 may experience a number of other complications such as learning difficulties, visual impairment, twisting and curvature of the spine, high blood pressure, and epilepsy. People with NF1 also have an increased risk of developing other cancers, including malignant brain and peripheral nerve sheath tumours, and leukaemia. Symptoms begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years.[iii]

About selumetinib

Selumetinib is an investigational MEK 1/2 inhibitor licensed by AstraZeneca from Array BioPharma Inc. in 2003.

The NF1 gene provides instructions for making a protein called Neurofibromin, which negatively regulates the RAS/MAPK pathway, helping to control cell growth, differentiation and survival. Mutations in the NF1 gene may result in dysregulations in RAS/RAF/MEK/ERK signalling, which can cause cells to grow, divide and copy themselves in an uncontrolled manner, and may result in tumour growth. Selumetinib inhibits the MEK enzyme in this pathway, potentially leading to inhibition of tumour growth.

About the AstraZeneca and MSD Strategic Oncology Collaboration

In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza (olaparib), the world’s first PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. The collaboration is based on increasing evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumour types. Working together, the companies will develop Lynparza and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop Lynparza and selumetinib in combination with their respective PD-L1 and PD-1 medicines.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance New Oncology as one of AstraZeneca’s five Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death

Cancer Research UK to invest £45 million in clinical trials

On February 15, 2018 Cancer Research UK reported that £45 million will be invested into its network of clinical trials units across the UK, one of the charity’s largest investments in clinical research to date (Press release, Cancer Research UK, FEB 15, 2018, View Source [SID1234523966]).

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"Our clinical research enables us to translate discoveries from the lab in order to improve cancer diagnostics and treatments, giving more patients the best chance of beating their disease." – Professor Charles Swanton, Cancer Research UK

Cancer Research UK’s clinical trials units (CTUs) bring together world leading researchers and clinicians to find life-saving new treatments and tests for cancer patients.

Clinical trials are the only way to find out if a new treatment is safe to use, and if it’s better than existing treatments. Each year, around 25,000 people take part in a clinical trial that’s supported by Cancer Research UK.

The huge sum will be divided over 5 years across 8 CTUs in Cardiff, Birmingham, Glasgow, Southampton, Leeds and London (at The Institute of Cancer Research, London, UCL, and Queen Mary University of London)*.

Professor Charles Swanton, Cancer Research UK’s chief clinician, said: "Our clinical research enables us to translate discoveries from the lab in order to improve cancer diagnostics and treatments, giving more patients the best chance of beating their disease.

"This is particularly important for patients with hard to treat cancers, including pancreatic, oesophageal, lung and brain tumours, where options for treatment are limited and survival rates remain poor."

Cancer Research UK’s CTUs specialise in the design, delivery and analysis of trials that bring the latest scientific developments to patients all over the UK. They’re a vital part of the charity’s research network, helping shape the clinical research landscape in the UK and internationally.

Each of the charity’s CTUs has a different specialist focus including children’s cancer trials, cancer screening, and population research.

In Birmingham, there will be dedicated funding for finding new treatments for children with cancer.

Professor Pamela Kearns, director of Birmingham’s Cancer Research UK Clinical Trials unit and Cancer Research UK’s children’s cancer expert, said: "Clinical trials are vital to test new treatments and improve the care of children with cancer. For example, within my team, with support from Cancer Research UK, we run the International BEACON** trial, testing new combinations of therapies for children and young people with a type of childhood cancer called neuroblastoma, at a stage where they have failed to respond to standard treatments.

"One question this trial is trying to answer is if a drug called bevacizumab can help treat their neuroblastoma. Bevacizumab is a type of biological therapy called a monoclonal antibody that targets the tumour’s blood supply. Doctors already treat adult cancers with this drug and we want to see if it works for children with neuroblastoma."

Trials are also helping us to find kinder treatments with fewer side effects.

Oliver Waugh, aged 54 from London, was diagnosed with tonsil cancer in 2009. As part of his treatment, he took part in a Cancer Research UK funded clinical trial which investigated a new type of radiotherapy called Intensity Modulated Radiotherapy (IMRT). Researchers wanted to find out if IMRT caused fewer side effects and if it worked as well as standard radiotherapy for head and neck cancers.***

He said: "I was really pleased to have joined because I know the side effects from regular radiotherapy could have been far more severe. My mouth started to produce saliva again not long after treatment, and I slowly started to put weight back on.

"Now I eat what I want, including curries and other spicy food and feel lucky that the high quality of my treatment has helped me lead a regular life again and I can honestly say I’m fitter than I’ve ever been.

"I feel fortunate to have been offered the chance to help medical research and I hope that many more patients like me will get to lead full and healthy lives because of these improvements in treatment."

Spectrum Pharmaceuticals to Present Corporate Update at the 2018 RBC Capital Markets Global Healthcare Conference on February 22nd

On February 15, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology Company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that an overview of the Company’s business strategy and commercial and development-stage programs will be given at the 2018 RBC Capital Markets Global Healthcare Conference being held at the Lotte New York Palace Hotel in New York (Press release, Spectrum Pharmaceuticals, FEB 15, 2018, http://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-present-corporate-update-2018-rbc [SID1234524018]). The Company presentation is on Thursday, February 22, 2018, at 10:30 AM ET.

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A live webcast of Spectrum’s presentation will be available at View Source

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.