West Announces Second-Quarter 2019 Results and Announces an Increase to Fourth-Quarter 2019 Dividend

On July 25, 2019 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2019 and updated full-year 2019 financial guidance (Press release, West Pharmaceutical Services, JUL 25, 2019, View Source [SID1234537746]).

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Second-Quarter 2019 Summary (comparisons to prior-year period)

Net sales of $469.7 million grew 4.9%, organic sales growth was 8.1%; sales from a recent acquisition contributed an additional 20 basis points of growth.
Reported-diluted EPS of $0.88 increased 17%.
Adjusted-diluted EPS of $0.89 increased 27%.
Company is raising full-year 2019 net sales guidance to a new range of between $1.810 billion and $1.825 billion.
Company is raising full-year 2019 adjusted-diluted EPS guidance to a new range of between $3.00 and $3.10.
The Company is also announcing the Board of Directors has approved a fourth-quarter 2019 dividend of $0.16 per share, a 6.7% increase over the $0.15 per share declared for each of the four preceding quarters. This is the twenty-seventh consecutive annual increase in the Company’s dividend. The fourth-quarter dividend will be paid on November 6, 2019, to shareholders of record as of October 23, 2019.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"I am pleased with the second-quarter results led by strong Proprietary Products performance, especially in our Biologics market unit," said Eric M. Green, President and Chief Executive Officer. "Double-digit organic sales growth in our high-value product portfolio fueled both overall organic sales growth as well as increases in gross and operating profit margin. We are raising our outlook for the full-year 2019 given the underlying strength in our end markets as demonstrated by our growing book of committed orders."

Proprietary Products Segment
Net sales grew by 4.1% to $360.3 million. Organic sales growth was 7.5%, with currency translation decreasing sales by 3.7% and incremental sales from a recent acquisition contributing 30 basis points of Proprietary Products growth. High-value products (HVP) represented 62% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had double-digit organic sales growth, led by customer purchases of Westar and NovaPure components as well as Crystal Zenith and SmartDose technology. Our Generics market unit posted high-single digit organic sales growth, led by sales of Westar and film-coated components. Our Pharma market unit saw a low-single digit organic decline due to the impact of a previously-reported voluntary recall of our Vial2Bag product.

Contract-Manufactured Products Segment
Net sales grew by 7.7% to $109.4 million. Organic sales growth was 10.2% with currency translation decreasing sales by 2.5%. Segment performance was led by strong sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first six months of 2019)
Operating cash flow was $152.7 million, an increase of 20%. Capital expenditures were $57.1 million. Free cash flow (operating cash flow minus capital expenditures) was $95.6 million, an increase of 21%.

The Company recorded $2.0 million of restructuring and related charges through the first six months of 2019 from actions we have taken that are intended to streamline our manufacturing network. This plan is expected to be completed by the end of 2019 and result in $7.0 million of restructuring and related charges in 2019. Implemented in first-quarter 2018, the Company expects cumulative expenses over the plan period to be approximately $16.0 million. Once fully completed, the Company anticipates that the plan will provide annualized savings of approximately $14.0 million.

Full-Year 2019 Financial Guidance

The Company is raising full-year 2019 net sales guidance to a new range of between $1.810 billion and $1.825 billion, compared to the prior guidance range of between $1.795 billion and $1.820 billion.
Organic sales growth guidance is now expected to be at the higher end of the previously communicated range of 6% to 8%.
Net sales guidance includes a headwind of $42 million for the full-year 2019 based on current foreign exchange rates, compared to prior guidance of a full-year negative impact of between $34 million and $37 million.
The Company is raising adjusted-diluted EPS to a new range of between $3.00 and $3.10, compared to the prior guidance range of between $2.80 and $2.90.
Includes an estimated headwind of approximately $0.10 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.08.
Second-Quarter 2019 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 6143018.

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

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, August 1, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 6143018.

Verastem Oncology Signs an Exclusive License Agreement with Sanofi for the Development and Commercialization of COPIKTRA® (duvelisib) in Russia and CIS, Turkey, the Middle East and Africa

On July 25, 2019 Verastem, Inc. (NASDAQ: VSTM) operating as Verastem Oncology, (or "the Company"), reported their entry into an exclusive licensing agreement with Sanofi to develop and commercialize Verastem Oncology’s COPIKTRA (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, for the treatment of all oncology indications in Russia and CIS, Turkey, the Middle East and Africa (Press release, Verastem, JUL 25, 2019, View Source [SID1234537762]).

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Under the terms of the agreement, Verastem Oncology shall receive an upfront payment of $5 million USD. Verastem Oncology is also eligible to receive up to an additional $42 million USD in development and sales milestone payments, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. Sanofi will receive exclusive rights to develop and commercialize COPIKTRA, and hold the marketing authorization and product license for COPIKTRA, in the licensed territories. Sanofi will also have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.

"Sanofi brings world-class capabilities in developing and commercializing products, making them an ideal partner to bring COPIKTRA to patients in these territories," said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. "Establishing this third partnership outside the U.S. validates the global potential of COPIKTRA and underscores our commitment to bring COPIKTRA to patients worldwide."

David Khougazian, Head of Sanofi Genzyme, China & Emerging Markets, commented, "As a specialty care leader, we welcome partnerships that have the potential to bring value for patients and caregivers. This agreement adds to our pipeline an oncology medicine with an innovative mechanism of action and a significant potential of new hope for the patients suffering from those types of blood malignancies with high unmet medical need. Partnering with Verastem Oncology for the development and commercialization of COPIKTRA is consistent with our goals to deliver enhanced patient care and to expand our presence in oncology in Emerging Markets."

COPIKTRA was approved in September 2018 by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. In addition, COPIKTRA has been granted accelerated approval by the FDA for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. COPIKTRA includes a Boxed Warning for fatal and serious toxicities including infections, diarrhea or colitis, cutaneous reactions and pneumonitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

LABCORP ANNOUNCES 2019 SECOND QUARTER RESULTS AND UPDATES 2019 GUIDANCE

On July 25, 2019 LabCorp (or the Company) (NYSE: LH) reported results for the second quarter ended June 30, 2019, and updated 2019 guidance (Press release, LabCorp, JUL 25, 2019, View Source [SID1234537728]).

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"This quarter again highlighted the strength and balance of our businesses," said David P. King, chairman and CEO of LabCorp. "Revenue grew 4.1% excluding non-operational headwinds from PAMA, disposition of businesses, and currency translation. Diagnostics performed well during the quarter, with the LaunchPad business transformation initiative largely offsetting known headwinds, while Drug Development continued to deliver strong top-line growth and margin expansion. We deployed capital to share repurchase and acquisitions, returning capital to shareholders and adding to our repertoire of innovative customer solutions that deliver value our customers want. We remain well-positioned to drive growth in 2019 and the years to come."

Consolidated Results

Second Quarter Results

Revenue for the quarter was $2.88 billion, an increase of 0.5% from $2.87 billion in the second quarter of 2018. The increase in revenue was primarily due to acquisitions of 1.4% and organic growth of 1.7% (which includes the negative impact from PAMA of 0.9%), partially offset by the disposition of businesses of 1.9% and foreign currency translation of 0.7%.

Operating income for the quarter was $335.7 million, or 11.6% of revenue, compared to $369.2 million, or 12.9%, in the second quarter of 2018. The decrease in operating income and margin was primarily due to lower Medicare and Medicaid pricing as a result of PAMA, higher personnel costs, cybersecurity expenses, and higher special items from acquisition and disposition-related costs, partially offset by increased demand and LaunchPad savings. The Company recorded restructuring charges, special items, and amortization, which together totaled $111.2 million in the quarter, compared to $94.3 million during the same period in 2018. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $446.9 million,

or 15.5% of revenue, compared to $463.5 million, or 16.2%, in the second quarter of 2018. The $16.6 million decline in adjusted operating income from 2018 included the negative impact from PAMA of $27.1 million.

Net earnings in the quarter were $190.4 million, compared to $233.8 million in the second quarter of 2018. Diluted EPS were $1.93 in the quarter, a decrease of 15.0% compared to $2.27 in the same period in 2018. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $2.93 in the quarter, a decrease of 1.7% compared to $2.98 in the second quarter of 2018.

Operating cash flow for the quarter was $253.5 million, compared to $387.4 million in the second quarter of 2018. The decrease in operating cash flow was primarily due to higher working capital requirements to support growth. Capital expenditures totaled $85.2 million, compared to $87.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $168.3 million, compared to $300.2 million in the second quarter of 2018.

At the end of the quarter, the Company’s cash balance and total debt were $265.4 million and $6.6 billion, respectively. During the quarter, the Company invested $656.4 million in acquisitions and repurchased $199.9 million of stock, representing approximately 1.3 million shares. As of June 30, 2019, the Company had $1.05 billion of authorization remaining under its share repurchase program.

Year-To-Date Results

Revenue was $5.67 billion, a decrease of 0.7% from $5.71 billion in the first half of last year. The decline in revenue was primarily due to the disposition of businesses of 1.9% and foreign currency translation of 0.8%, partially offset by acquisitions of 1.0% and organic growth of 1.0% (which includes the negative impact from PAMA of 1.0%).

Operating income was $653.9 million, or 11.5% of revenue, compared to $674.6 million, or 11.8%, in the first half of 2018. The decrease in operating income and margin was primarily due to lower Medicare and Medicaid pricing as a result of PAMA, personnel costs, disposition of businesses, cybersecurity expense, and a favorable one-time legal settlement in 2018, partially offset by organic demand, the Company’s LaunchPad initiatives, acquisitions, and a decrease in costs related to special items. The Company recorded restructuring charges, special items, and amortization which together totaled $204.4 million in the first half of the year, compared to $224.7 million during the same period in 2018. Adjusted operating income (excluding amortization, restructuring charges, and special items) was $858.3 million, or 15.1% of revenue, compared to $899.3 million, or 15.7%, in the first half of 2018. The $41.0 million decline in adjusted operating income from 2018 included the negative impact from PAMA of $54.1 million.

Net earnings in the first half of 2019 were $376.0 million, or $3.79 per diluted share, compared to $407.0 million, or $3.94 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $5.55, a decrease of 3.5% compared to $5.75 in the first half of 2018.

Operating cash flow was $419.3 million, compared to $567.1 million in the first half of 2018. The decrease in operating cash flow was primarily due to higher working capital requirements to support growth. Capital expenditures totaled $179.4 million, compared to $159.7 million during the same period in 2018. As a result, free cash flow (operating cash flow less capital expenditures) was $239.9 million, compared to $407.4 million in the first half of 2018.

The following segment results exclude amortization, restructuring charges, special items, and unallocated corporate expenses.

Second Quarter Segment Results

LabCorp Diagnostics
Revenue for the quarter was $1.76 billion, a decrease of 2.9% from $1.81 billion in the second quarter of 2018, primarily due to the negative impact from the disposition of businesses of 2.8%, currency translation of 0.2% and lower organic revenue of 0.3% partially offset by acquisitions of 0.4%. The organic revenue decline of 0.3% includes the negative impact of 1.5% from PAMA and 0.6% due to fewer revenue days.

Total volume (measured by requisitions), excluding the disposition of businesses, decreased by 0.9%, as acquisition volume contributed 0.2% and organic volume declined by 1.2%. Organic volume was negatively impacted by approximately 2.5% from the combination of lower consumer genetics demand, managed care contract changes, and fewer revenue days. Excluding the disposition of businesses, revenue per requisition increased by 1.0%, despite the negative impact from PAMA of 1.5%.

Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $345.4 million, or 19.6% of revenue, compared to $376.0 million, or 20.7%, in the second quarter of 2018. The $30.6 million decline in adjusted operating income was primarily due to the negative PAMA impact of $27.1 million. The negative impact from the disposition of businesses, managed care contract changes, cybersecurity expenses, fewer revenue days and personnel expense was predominantly offset by LaunchPad savings, other organic revenue growth, and acquisitions. The Company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Covance Drug Development
Revenue for the quarter was $1.13 billion, an increase of 6.8% compared to $1.05 billion in the second quarter of 2018. The increase in revenue was primarily due to organic growth of 5.5% and acquisitions of 3.3%, partially offset by foreign currency translation of 1.6% and a business disposition of 0.3%.

Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $141.7 million, or 12.6% of revenue, compared to $123.4 million, or 11.7%, in the second quarter of 2018. The increase in adjusted operating income and margin was primarily due to organic demand, LaunchPad savings, acquisitions, and currency translation, partially offset by higher personnel costs, cybersecurity investments, and facilities expenses to support the Company’s global expansion. The Company is on track to deliver $150 million of net savings from its three-year Covance LaunchPad initiative by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $5.52 billion and 1.26, respectively. Backlog at the end of the quarter was $10.29 billion compared to $9.95 billion last quarter, and the Company expects approximately $4.1 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2019
The following guidance assumes foreign exchange rates effective as of June 30, 2019, for the remainder of the year and includes the estimated impact from currently anticipated capital allocation.

Revenue growth of 1.0% to 2.0% over 2018 revenue of $11.33 billion, which includes the negative impact from the disposition of businesses of approximately 1.5% and foreign currency translation of 0.5%. This is a narrowing of the range from the prior guidance of 0.5% to 2.5%.

Revenue in LabCorp Diagnostics is expected to be -3.0% to -2.0% as compared to 2018 revenue of $7.03 billion, which includes the negative impact from the disposition of businesses of approximately 2% and foreign currency translation of 0.2%. This is an improvement over the prior guidance of -4.0% to -2.0%.

Revenue growth in Covance Drug Development of 5.5% to 8.5% over 2018 revenue of $4.31 billion, a narrowing of the range as compared to the prior guidance of 5.0% to 9.0%. This guidance includes the negative impact from foreign currency translation of 0.9%.

Adjusted EPS of $11.10 to $11.40, which is an increase of 0.7% to 3.4% over 2018 adjusted EPS of $11.02, and a narrowing of the range as compared to the prior guidance of $11.05 to $11.45.

Free cash flow (operating cash flow less capital expenditures) of $950 million to $1.05 billion, which is an increase of 2.6% to 13.4% over 2018 and unchanged from the prior guidance.

Use of Adjusted Measures
The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. EDT and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 9679477. A telephone replay of the call will be available through August 8, 2019, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 9679477. A live online broadcast of LabCorp’s quarterly conference call on July 25, 2019, will be available at View Source or at View Source beginning at 9:00 a.m. EDT. This webcast will be archived and accessible through July 24, 2020.

IMV Inc. to Announce Second Quarter 2019 Results and Host a Conference Call and Webcast on August 9, 2019

On July 25, 2019 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical stage immunotherapy company, reported that it will hold a conference call and webcast on Friday, August 9, 2019 at 8:00 a.m. ET to discuss the company’s second quarter 2019 financial and operational results (Press release, IMV, JUL 25, 2019, View Source [SID1234537763]).

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Financial analysts are invited to join the conference call by dialing (844) 461-9932 (U.S. and Canada) or (636) 812-6632 (international) using the conference ID: 7148568.

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and available on the IMV website for 30 days following the call.

GlycoMimetics to Report Second Quarter 2019 Financial Results on August 1, 2019

On July 25, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it will host a conference call and webcast to report its second-quarter 2019 financial results on Thursday, August 1, 2019, at 8:30 a.m. ET (Press release, GlycoMimetics, JUL 25, 2019, View Source [SID1234537729]).

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The dial-in number for the conference call is (844) 413-7154 (U.S. and Canada) or (216) 562-0466 (international) and entering passcode 8268638. To access the live audio webcast, or the subsequent archived recording, visit the "Investors – Events & Presentations" section of the GlycoMimetics website at www.glycomimetics.com. The webcast will be recorded and available for replay on the GlycoMimetics website for 30 days following the call.