West Announces First-Quarter 2018 Results

On April 26, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the first-quarter 2018 and reaffirmed financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344775 [SID1234525757]).

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(PRNewsfoto/West Pharmaceutical Services, I)

Executive Summary

First-quarter 2018 reported net sales of $415.7 million grew 7.2% over the prior-year quarter. At constant currency, organic sales growth was 0.2%.
First-quarter 2018 reported-diluted EPS was $0.58. Excluding restructuring and other costs, first-quarter 2018 adjusted-diluted EPS was $0.62, as compared to $0.81 in the prior-year quarter. Tax benefits associated with share-based payment transactions were $0.03 in the first-quarter 2018, below our expectations of approximately $0.05 and below the $0.21 impact in the same quarter last year.
The Company is reaffirming full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. This assumes a translation exchange rate of $1.20 per Euro, unchanged from prior guidance. This represents a conservative assumption given current spot rates.
The Company continues to expect 2018 organic sales growth to be within a range of 6% to 8%.
The Company is reaffirming full-year 2018 adjusted-diluted EPS range of $2.80 to $2.90.
"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

"Our first-quarter 2018 results were in line with our expectations given the headwinds that we addressed in our last earnings release," said Eric M. Green, President and Chief Executive Officer. "We were pleased to see continued momentum in our Generics market unit and our Contract-Manufactured Products segment. After experiencing customer inventory management issues for much of 2017, our Generics team posted high-single digit organic sales growth, representing the third consecutive quarter of accelerating performance. Contract-Manufactured Products again saw strong growth led by diagnostic devices and injection devices associated with diabetes.

Mr. Green concluded, "We are reaffirming our full-year 2018 financial guidance. We anticipate accelerating organic sales growth over the remainder of the year, as the order flow in our Pharma market unit is expected to follow a similar pattern of improvement that we are experiencing in our Generics market unit. We continue to be the leader in the containment and delivery of injectable biologics and expect a return to normal long-term growth rates in the back half of the year. With sales growth returning to expected levels, gross and operating profit margins should improve as well. We remain on track for initial commercial sales from our Waterford facility later this year and are adding manufacturing capacity to address a growing demand for our administration systems."

First-Quarter 2018 Financial Results (comparisons to prior-year period)

First-quarter 2018 reported net sales of $415.7 million grew 7.2% over the prior-year quarter. At constant currency, organic sales growth was 0.2%. The deconsolidation of operations in Venezuela and the loss of a consumer-product contract manufacturing customer negatively impacted organic sales growth by 390 basis points.

Proprietary Products segment organic sales declined by 1.8%. The impact from the Venezuela deconsolidation negatively affected organic sales growth by 310 basis points. By market unit, first-quarter 2018 Proprietary Products segment sales growth was led by high-single digit growth in Generics, offset by a low-single digit decline in Biologics and a high-single digit decline in Pharma. The Pharma market unit experienced strong growth in the first-quarter last year, which made for an unfavorable growth comparison in Q1 2018. Contract-Manufactured Products segment organic sales growth was 7.9%, despite the loss of a consumer-product contract manufacturing customer.

First-quarter 2018 gross profit margin was 32.3%, compared to 34.6% in the same period last year, a decline of 230 basis points. Two main drivers of this decline were the deconsolidation of Venezuelan operations and the loss of a consumer-product contract manufacturing customer, which cumulatively accounted for $10.7 million of gross profit in the first quarter of last year and adversely affected gross profit margin by 150 basis points. Additionally, under-absorbed overhead from our Waterford facility more than offset gross profit margin improvement from higher efficiencies and price increases.

Effective January 1, 2018, the Company adopted the new accounting rules, which require an acceleration of the timing of revenue recognition on the sale of certain products and tooling agreements in both segments of our business. The cumulative effect had an immaterial negative impact to first-quarter 2018 net sales of $3 million. For the full-year 2018, the Company expects a reduction of $6 million to expected net sales.

The Company has also adopted the 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 non-operating income. The Company has restated Q1 2017 and full-year 2017 results to allow year-over-year comparisons with 2018 performance. The impact on the first-quarter 2018 from this pension accounting change was the reclassification of $1.6 million to Other Non-Operating Income. For the full-year 2018, we estimate that the total reclassification will be approximately $7 million.

In February 2018, the Company announced a restructuring program, expected to be implemented over the following twelve to twenty-four months, 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. 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. During the three months ended March 31, 2018, the Company recorded $3.3 million in restructuring and related charges.

First-quarter 2018 operating profit margin was 12.8%. On an adjusted basis (excluding restructuring and related charges), operating profit margin was 13.6%, compared to 15.6% in the same period last year. The decline was primarily caused by lower gross profit margin.

For the first-quarter 2018, income tax expense was $12.5 million. Excluding restructuring costs and a net tax charge related to U.S. tax reform, the adjusted effective tax rate was 22.5%, compared to 3.6% in the same period last year. Tax benefits from stock-based compensation were $2.1 million in the first-quarter 2018 as compared to $15.9 million in the same period last year. Excluding benefits from stock-based payments, the effective tax rate was 26.3% as compared to 30.2% last year, which reflects the lower U.S. tax rate enacted at the end of 2017.

During the first-quarter 2018, the Company repurchased 540,000 shares of common stock at a cost of $47.9 million under its buyback program. There are up to 260,000 additional shares available to be repurchased under the program authorized by our Board of Directors that expires in December 2018.

Full-Year 2018 Financial Guidance

The Company continues to expect 2018 organic sales growth 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 loss of a consumer-product contract manufacturing customer and deconsolidation of our Venezuelan operations), the Company expects 2018 organic sales growth to be at the higher end of that range.

The Company is reaffirming full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. This assumes a translation exchange rate of $1.20 per Euro. Given recent volatility in currency exchange rates, the Company believes it is prudent to use a conservative exchange. Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 to $2.90.

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

First-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 9889627.

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, May 3, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9889627.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "expected," "continue," "increase," "will," "estimated," "believe," "expect," "estimate," "see," "continued," "anticipate," "remain," 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. 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 item excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted diluted EPS for the three months presented in the accompanying tables:

Restructuring and related charges – During the three months ended March 31, 2018, the Company recorded $3.3 million in restructuring and related charges, consisting of $2.0 million for severance charges, $0.1 million for non-cash asset write-downs, and $1.2 million for other non-cash charges.

Tax law changes – During the three months ended March 31, 2018, following additional analysis, the Company recorded a net tax charge of $0.3 million for the estimated impact of U.S. tax reform. During the three and twelve months ended December 31, 2017, the Company had recorded a provisional charge for the estimated impact of U.S. tax reform, based upon its then-current understanding of the U.S. tax reform and the guidance available at the time. The Company will continue to actively monitor the developments relating to U.S. tax reform, and will adjust its estimate as necessary during the one-year measurement period.

ADC Therapeutics Announces the Termination of its ADCT-502 Program Targeting HER2 Expressing Solid Tumors

On April 25, 2018 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported that it has terminated the Phase I clinical trial to evaluate its antibody drug conjugate (ADC) ADCT-502 in patients with advanced solid tumors with HER2 expression (Press release, ADC Therapeutics, 25 25, 2018, View Source [SID1234525671]).

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Dr. Jay Feingold, Chief Medical Officer and Senior Vice President of Clinical Development at ADCT said: "We are very pleased with the efficacy and tolerability achieved with our lead hematological PBD-based ADC programs, but regrettably this has not been the case with our HER2 targeted ADC. PBD’s (pyrrolobenzodiazepine dimers) are extremely potent and have a well characterized safety profile that includes fluid retention and pulmonary edema. For most PBD ADCs this can be managed by selecting dosing regimens that are efficacious with manageable toxicities. However, during dose escalation in this trial we did not achieve the necessary efficacy at tolerated doses required for patient benefit. This was possibly due to the extensive expression of HER2 in pulmonary tissue. Our next two solid tumor ADCs progressing into the clinic over the next nine months incorporate site specific conjugation technology which based on pre-clinical models has the potential to substantially improve tolerability and efficacy in difficult to treat solid tumors. Preclinical data on these programs was presented at the recent American Association of Cancer Research conference."

Chris Martin, CEO at ADCT said: "Patients with HER2 expressing tumors have multiple therapeutic options including novel therapies in clinical development that are producing encouraging data. ADC Therapeutic’s strategy is to progress a deep pipeline of ADCs into Phase I in order to assess their clinical and market potential based on actual human data, and only to progress into later stage development those ADCs that demonstrate the potential to be best in class in areas of high unmet medical need. We currently have three other ADC programs in the clinic, and we plan to commence clinical trials for three additional programs in the next 9 months, including a third hematological program. Moreover, our two most advanced clinical programs are progressing into later stage development over 2018."

At this time, ADC Therapeutics is collecting and evaluating the study data from the ADCT-502 Phase I trial, which will be presented for publication later this year.

About ADCT-502

ADCT-502 is an investigational antibody drug conjugate (ADC) composed of the humanized monoclonal antibody trastuzumab directed against the human epidermal growth factor receptor 2 (HER2). The antibody is site-specifically conjugated to the PBD-based linker-drug tesirine. Once bound to the HER2 receptor on the cell surface, ADCT-502 is internalized into the cell where enzymes release the PBD-based warhead. HER2 is a well-established, clinically validated target expressed in a wide variety of solid tumors, including breast, gastric, esophageal, bladder and lung cancer

Genmab Announces Data to be Presented at 2018 ASCO Annual Meeting

On April 25, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) announced today that nine industry sponsored daratumumab abstracts, one industry sponsored ofatumumab abstract and one tisotumab vedotin abstract have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 1-5 (Press release, Genmab, APR 25, 2018, View Source [SID1234525692]). The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation of a subgroup analysis of the MMY1001 (EQUULEUS) trial, two poster discussion sessions regarding the PAVO (MMY1004) and ANDROMEDA (AMY3001) studies, as well as trial in progress poster presentations on multiple other Phase III trials. These include SMM3001 (AQUILA) in smoldering multiple myeloma and MMY3012 (COLUMBA), the study comparing subcutaneous with intravenous daratumumab administration. In addition there are two posters on MMY3007 (ALCYONE) in patients with newly diagnosed multiple myeloma. One abstract on ofatumumab maintenance treatment in relapsed chronic lymphocytic leukemia (CLL), sponsored by Novartis, will be presented in a poster discussion session. One abstract regarding the Phase II study of tisotumab vedotin in cervical cancer was also accepted for a trial in progress poster presentation. The titles of the abstracts are currently available on the ASCO (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 16, 2018.

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"We are pleased with the selection of these abstracts for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting in Chicago. Attendees of this prestigious conference will be able to view for themselves both some of the very exciting data generated by these products, as well as additional information on a variety of currently running key clinical trials," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Daratumumab:

Daratumumab in Combination with Carfilzomib and Dexamethasone in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma: Subgroup Analysis of MMY1001 – Oral presentation, Friday, June 1, 3:09 PM – 3:21 PM CDT

Subcutaneous Daratumumab Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA (AMY3001) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) (MMY1004) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Phase 3 Study of Subcutaneous Daratumumab Versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: AQUILA (SMM3001) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA (MMY3012) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Pomalidomide and Dexamethasone with or without Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: a Multicenter, Randomized, Phase 3 Study (APOLLO) (MMY3013) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-label, Phase 2/3 Study of Daratumumab with or without JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Relapsed/Refractory Multiple Myeloma (MMY2036) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 y) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Improved Health-related Quality of Life for Patients with Newly Diagnosed Multiple Myeloma who are Ineligible for Stem Cell Transplantation: Results from the ALCYONE Trial (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Tisotumab vedotin
A single arm, Phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF ADC) in previously treated, recurrent or metastatic cervical cancer – Poster presentation, Monday, June 4, 1:15 PM – 4:45 PM CDT

Ofatumumab

Role of ofatumumab maintenance treatment in relapsed CLL: Final analysis of PROLONG study – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM

Insmed to Host First Quarter 2018 Financial Results Conference Call on Wednesday, May 2, 2018

On April 25, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that it will release its first quarter 2018 financial results on Wednesday, May 2, 2018 (Press release, Insmed, APR 25, 2018, View Source [SID1234525672]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Wednesday, May 2, 2018 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (844) 707-0669 (domestic) or (703) 639-1223 (international) and referencing conference ID number 4567628. The call will also be webcast live on the internet on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through May 9, 2018 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and referencing conference ID number 4567628. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.

Incyte Highlights Abstracts Accepted for Presentation at the 2018 ASCO Annual Meeting

On April 25, 2018 Incyte Corporation (Nasdaq:INCY) reported that multiple abstracts from its research and development portfolio will be presented at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois from June 1-5, 2018 (Press release, Incyte, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344710 [SID1234525693]).

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Data at ASCO (Free ASCO Whitepaper) 2018 include oral presentations from a Phase 1 study of ruxolitinib (Jakafi), lenalidomide and methylprednisolone in patients with relapsed and refractory multiple myeloma, the DeCidE1 trial assessing the combination of DPX-Survivac, cyclophosphamide and epacadostat in patients with recurrent epithelial ovarian cancer, and the Phase 3 ECHO-301/KEYNOTE-252 study evaluating the safety and efficacy of epacadostat in combination with pembrolizumab in patients with unresectable or metastatic melanoma.

"Data featured in the abstracts presented at ASCO (Free ASCO Whitepaper) will contribute to the broader scientific understanding of our targeted and immuno-oncology therapies and their potential role in the treatment of cancer," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We look forward to sharing data from our portfolio at the 2018 ASCO (Free ASCO Whitepaper) annual meeting as we continue to work toward our goal of improving the lives of patients with cancer and other serious diseases."

Select key abstracts and presentations include:

Targeted therapy abstracts

A Phase 1 Trial of Ruxolitinib, Lenalidomide, and Methylprednisolone for Relapsed/Refractory Multiple Myeloma Patients. (Abstract #8005, oral abstract session)

Friday, June 1, 2018, 2:45 – 5:45 p.m. CT, E450

Immuno-oncology abstracts

Clinical Data from the DeCidE1 trial: Assessing the First Combination of DPX-Survivac, Low Dose Cyclophosphamide (CPA), and Epacadostat (INCB024360) in Subjects with Stage IIc-IV Recurrent Epithelial Ovarian Cancer. (Abstract #5510, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, S406

Epacadostat (E) Plus Pembrolizumab (P) Versus Pembrolizumab Alone in Patients (pts) with Unresectable or Metastatic Melanoma: Results of the Phase 3 ECHO-301/KEYNOTE-252 Study. (Abstract #108, clinical science symposium)

Sunday, June 3, 2018, 9:45 – 11:15 a.m. CT, Hall D1

Pilot Trial of an Indoleamine 2,3-dioxygenase-1 (IDO1) Inhibitor Plus a Multipeptide Melanoma Vaccine in Patients with Advanced Melanoma. (Abstract #3033, poster session)

Monday, June 4, 2018, 8:00 – 11:30 a.m. CT, Hall A, Poster Board #247

Epacadostat Plus Nivolumab for Advanced Melanoma: Updated Phase 2 Results of the ECHO-204 Study. (Abstract #9511, poster discussion session)

Monday, June 4, 2018, 1:15 – 4:45 p.m. CT, Hall A, Poster Board #338; Discussion at 4:45 – 6:00 p.m. CT, E451

Full session details and data presentations at the ASCO (Free ASCO Whitepaper) 2018 annual meeting can be found here.