Verastem Oncology to Announce Second Quarter 2019 Financial Results and Corporate Update on August 1, 2019

On July 25, 2019 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019 (Press release, Verastem, JUL 25, 2019, View Source [SID1234537750]).

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The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 6256817. The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

4SC AG: Positive safety review of Phase Ib/II EMERGE study of domatinostat + avelumab in gastrointestinal cancer

On July 25, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported, that the Safety Review Committee consisting of clinical and drug safety experts evaluated the safety data from the first dose cohort and recommended continuation with the second dose cohort in the ongoing Phase Ib/II EMERGE study (ClinicalTrials.gov identifier: NCT03812796) (Press release, 4SC, JUL 25, 2019, View Source [SID1234537749]). Patient recruitment for the second dose cohort has been initiated. The study is being conducted by Prof. David Cunningham, MD FRCP FMedSci, Head of the Gastrointestinal and Lymphoma Unit and Director of Clinical Research at The Royal Marsden NHS Foundation Trust (London, UK).

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The multi-center, single-arm, open-label study initiated in January 2019, is a dose escalation study, conducted initially in up to 15 patients with microsatellite-stable gastrointestinal cancer. The study evaluates domatinostat in combination with the checkpoint inhibitor avelumab. The study is conducted in two parts, an initial part to evaluate the safety of domatinostat in combination with a checkpoint inhibitor and to determine a recommended Phase II dose, potentially followed by a second "expansion" part in order to obtain a larger data-set through the addition of more patients at the preferred dose.

Prof. Cunningham said: "Safety and tolerability are key requirements for patients and physicians considering a drug. We are encouraged by the positive outcome of the first safety review and are looking forward to enrolling patients into the second dose cohort, especially as checkpoint inhibitors alone so far have not shown clinical activity in patients with microsatellite-stable gastrointestinal cancer."

Jason Loveridge, Ph.D., CEO of 4SC, added: "We are happy to support investigator-sponsored research conducted by third parties on our drug candidates. This research can provide valuable information regarding the safety, efficacy, pharmacology and tolerability of 4SC’s drug candidates and supplement the data generated in our own clinical studies, such as the SENSITIZE trial of domatinostat in combination with pembrolizumab, another checkpoint inhibitor, in patients with advanced-stage melanoma.

We plan to initiate several clinical trials of domatinostat in combination with checkpoint inhibitors both in melanoma and Merkel cell carcinoma (MCC) in late 2019 and early 2020 with the intention that one of the MCC studies would be potentially sufficient for registration purposes."

argenx to report half year 2019 financial results and second quarter business update on August 1, 2019

On July 25, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it will host a conference call and live audio webcast on Thursday, August 1, 2019 at 3:00 pm CEST (9:00 am ET) to discuss its financial results for the first half of 2019 and to provide a second quarter business update and outlook for the remainder of the year (Press release, argenx, JUL 25, 2019, View Source [SID1234537748]).

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To participate in the conference call and Q&A session, please select your phone number below and use the confirmation code 7539308. The live webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

Shortly after the webcast, a replay will be made available on the argenx website.

Dial-in numbers:
Please dial in 5–10 minutes prior to 3 pm CEST/ 9 am ET using the number and confirmation code below.

Confirmation Code: 7539308

Belgium +32 (0)2 400 9874
Belgium 0800 48740
France +33 (0)1 767 00794
France 0805 103028
Netherlands +31 (0)20 714 3545
Netherlands 0800 0249557
United Kingdom +44 (0)844 571 8892
United Kingdom 0800 376 7922
United States +1 (631) 510 7495
United States +1 (866) 966 1396

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.

Syros to Report Second Quarter 2019 Financial Results on Thursday, August 1, 2019

On July 25, 2019 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, August 1, 2019 to report its second quarter 2019 financial results and provide a corporate update (Press release, Syros Pharmaceuticals, JUL 25, 2019, View Source [SID1234537745]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 7254685. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.