Athenex, Inc. to Report Third Quarter 2019 Earnings Results on November 7, 2019

On October 24, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release third quarter and nine-months ended September 30, 2019 financial results on Thursday, November 7, 2019, before the market opens, and host a conference call and live audio webcast 8:00am Eastern Time to discuss the financial results and provide a business update (Press release, Athenex, OCT 24, 2019, View Source [SID1234573884]).

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13694941. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at View Source

West Announces Third-Quarter 2019 Results

On October 24, 2019 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2019 and updated full-year 2019 financial guidance (Press release, West Pharmaceutical Services, OCT 24, 2019, View Source [SID1234542478]).

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

Net sales of $456.1 million grew 5.7%; organic sales growth was 7.9%; sales from a recent acquisition contributed an additional 20 basis points of growth; currency translation reduced sales by 240 basis points.
Reported-diluted EPS of $0.75 increased 3%.
Adjusted-diluted EPS of $0.79 increased 4%.
Company is raising its full-year 2019 net sales guidance to a new range of between $1.815 billion and $1.825 billion.
Company is raising full-year 2019 adjusted-diluted EPS guidance to a new range of between $3.10 and $3.15.
"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.

"Our third-quarter results demonstrate the forward momentum we have seen throughout 2019. In line with our expectations, we are seeing strong customer uptake of our high-value products (HVPs), especially in the Biologics market unit," said Eric M. Green, President and Chief Executive Officer. "With the anticipated growing demand for our HVPs and positive trends in the marketplace, we expect our performance to continue to be strong for the remainder of the year and are raising our outlook for the full-year 2019."

Mr. Green continued, "Earlier this month, we announced an increase in our minority equity stake to 49 percent in Daikyo Seiko, Ltd. The expansion of our long-standing relationship, on an exclusive basis, will ensure our continued success and strengthen our partnership with Daikyo."

Proprietary Products Segment

Net sales grew by 6.2% to $345.2 million. Organic sales growth was 8.5%, with incremental sales from a recent acquisition contributing 30 basis points of Proprietary Products growth and currency translation decreasing sales by 260 basis points. HVPs (components and devices) represented 63% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by customer purchases of NovaPure, Daikyo and Flurotec components as well as products incorporating Daikyo’s Crystal Zenith technology. Our Generics market unit posted mid-single digit organic sales growth, led by sales of Daikyo components, products incorporating Crystal Zenith technology, self-injection platforms and Westar RU. Our Pharma market unit saw a mid-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 4.2% to $111.1 million. Organic sales growth was 6.0% with currency translation decreasing sales by 180 basis points. Segment performance was led by sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2019)

Operating cash flow was $260.8 million, an increase of 21%. Capital expenditures were $88.8 million, compared to $74.7 million over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $172.0 million, an increase of 22%.

The Company recorded $3.8 million of restructuring and related charges through the first nine months of 2019 from actions we have taken that are intended to streamline our manufacturing network. This restructuring 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 its full-year 2019 net sales guidance to a new range of between $1.815 billion and $1.825 billion, compared to the prior guidance range of between $1.810 billion and $1.825 billion.
Organic sales growth is expected to be approximately 8%.
Net sales guidance includes a headwind of $54 million for the full-year 2019 based on current foreign exchange rates, compared to prior guidance of a full-year negative impact of $42 million.
The Company is raising full-year adjusted-diluted EPS guidance to a new range of between $3.10 and $3.15, compared to the prior guidance range of between $3.00 and $3.10.
This includes an estimated headwind of approximately $0.13 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.10.
The acquisition of an incremental minority stake in Daikyo Seiko, Ltd., is not expected to have a material impact to West’s full-year 2019 financial outlook.
Third-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 9278868.

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, October 31, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9278868.

VBI Vaccines to Present New Immuno-Oncology Data at the World Vaccine Congress Europe 2019

On October 24, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported that David E. Anderson, Ph.D., VBI’s Chief Scientific Officer, will present new immuno-oncology data in a presentation titled, "eVLPs as an Antigen Delivery & Immunomodulatory Platform in Cancer," at the World Vaccine Congress Europe to be held October 29-31, 2019, in Barcelona (Press release, VBI Vaccines, OCT 24, 2019, View Source [SID1234542497]).

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During his presentation, Dr. Anderson will discuss new immunologic and biomarker data from Part A of the ongoing Phase 1/2a clinical study of VBI-1901, VBI’s vaccine immunotherapeutic candidate, in patients with recurrent glioblastoma (GBM). In Part A, three out of the six (3/6) patients in the high-dose cohort had evidence of stable disease by magnetic resonance imaging (MRI), which correlated with vaccine-induced T-cell responses. New assays now demonstrate that in these three vaccine responders, the frequency of harmful, immunosuppressive regulatory T-cells (Tregs) decreases over time, which also correlates with increases of beneficial CD4+ T-helper cells against both antigens contained in VBI-1901, glycoprotein B (gB) and pp65. These expanded biomarkers will also be used to assess responses of patients enrolled in Part B of the study, initial data from which are expected later this year.

"We are encouraged by the data we’ve seen to-date in Part A of the study, but also recognize that in early immuno-oncology clinical studies it is critical to establish a correlation between vaccine responses and observed tumor and clinical responses," said Dr. Anderson. "This new immunologic and biomarker data further strengthens early activity observed thus far with VBI-1901 and we look forward to seeing the initial data from Part B of the study."

Dr. Anderson will also discuss preclinical data that supports a broader utility of VBI’s proprietary enveloped virus-like-particle (eVLP) platform technology in oncology.

Presentation Details

– Event: World Vaccine Congress Europe 2019
– Location: Palau de Congressos de Catalunya, Barcelona, Spain
– Date: Tuesday, October 29, 2019
– Time: 5:15 PM CET

About the Phase 1/2a Study Design

VBI’s two-part Phase 1/2a study is a multi-center, open-label, dose-escalation study of VBI-1901 in up to 38 patients with recurrent GBM:

Part A:
Dose-escalation phase that defined the safety, tolerability, and optimal dose level of VBI-1901 in recurrent GBM patients with any number of prior recurrences
This phase enrolled 18 recurrent GBM patients across three dose cohorts of VBI-1901: 0.4 µg, 2.0 µg, and 10.0µg
Enrollment completed December 2018
Part B:
Subsequent extension of the optimal dose level, 10.0 µg, as defined in the Part A dose escalation phase
This phase will be a two-arm study, enrolling 10 patients in each arm, assessing VBI-1901 in combination with either GM-CSF or AS01B as immunomodulatory adjuvants
Part B will enroll first-recurrent GBM patients only
VBI-1901 is administered intradermally when adjuvanted with granulocyte-macrophage colony-stimulating factor (GM-CSF), and will be administered intramuscularly when adjuvanted with GSK proprietary AS01B adjuvant system. Patients in both phases of the study will receive the vaccine immunotherapeutic every four weeks until clinical progression.

Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT03382977.

Mylan to Release Third Quarter 2019 Financial Results on Nov. 5, 2019

On October 24, 2019 Global pharmaceutical company Mylan N.V. (NASDAQ: MYL) reported that it will release its third quarter 2019 financial results on Tuesday, Nov. 5 before the open of the U.S. financial markets (Press release, Mylan, OCT 24, 2019, View Source [SID1234542513]). The company also will host a webcast at 10 a.m. ET on Nov. 5 to discuss the results.

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The briefing can be accessed live by calling 855.493.3607 or 346.354.0950 for international callers (ID#: 1519969) or at the following address on the company’s website: investor.mylan.com. A replay of the webcast also will be available on the website.

Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.

AIM ImmunoTech to Present at the Dawson James Securities 5th Annual Small Cap Growth Conference

On October 23, 2019 AIM ImmunoTech Inc. (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported that it will be presenting at the Dawson James Securities 5th Annual Small Cap Growth Conference being held on October 28-29, 2019 at the Wyndham Grand Hotel in Jupiter, Florida (Press release, AIM ImmunoTech, OCT 23, 2019, View Source;id=184460&p=2170068&I=1206939-c7Z3G6f3m8 [SID1234542444]).

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Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech, is scheduled to present on Tuesday, October 29th at 1:10 p.m. Eastern Time, in Track 2 – Preserve Ballroom B, with one-on-one meetings to be held throughout the conference.

About Dawson James Securities

Dawson James Securities, Inc., a member of FINRA/SIPC, is a full-service investment bank headquartered in Boca Raton, FL. View Source