On April 23, 2020 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the first-quarter 2020 and updated full-year 2020 financial guidance (Press release, West Pharmaceutical Services, APR 23, 2020, View Source [SID1234556522]).

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First-Quarter 2020 Summary (comparisons to prior-year period)

Net sales of $491.5 million grew 10.8%; organic sales growth was 12.7%.
Reported-diluted EPS of $0.99 increased 36%.
Adjusted-diluted EPS of $1.01 increased 36%.
The Company is maintaining full-year 2020 net sales guidance and is updating full-year 2020 adjusted-diluted EPS guidance to a new range of $3.52 to $3.62, compared to a prior range of $3.45 to $3.55.
"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.

"During these unprecedented times, our priorities are focused on the well-being and safety of our team members as well as ensuring the supply of critical, high-quality components and solutions to our customers," said Eric M. Green, President and Chief Executive Officer. "I am extremely pleased that we delivered a strong performance in the first quarter given the challenging environment that the COVID-19 pandemic has had on our customers, our suppliers and our team members. In particular, we continued to deliver strong sales growth in high-value products, as demand trends from our worldwide customer base were similar to trends we saw last year. Additionally, our teams are partnering with a broad range of customers working to support efforts to develop solutions that address the global COVID-19 pandemic such as diagnostics, anti-viral therapeutics and vaccines."

Mr. Green continued, "I am proud with the way our team across the globe is responding during these challenging times. They exemplify our One West philosophy in the way they are supporting our customers, patients and the local communities where our team members live and work."

Proprietary Products Segment
Net sales grew by 9.7% to $373.5 million. Organic sales growth was 11.8% with currency translation decreasing sales growth by 250 basis points. High-value products (components and devices) represented 63% of segment sales and generated double-digit organic sales growth. The segment saw good demand for Westar, Daikyo, NovaPure and FluroTec components as well as for devices such as Daikyo Crystal Zenith syringes and cartridges and our self-injection platforms.

The Biologics market unit had strong double-digit organic sales growth. The Generics market unit had high-single digit organic sales growth, and the Pharma market unit had mid-single digit organic sales growth.

Contract-Manufactured Products Segment
Net sales grew by 14.5% to $118.1 million. Organic sales growth was 15.9% with currency translation decreasing sales growth by 140 basis points. Segment performance was led by sales of components for diagnostic devices as well as drug-injection delivery devices.

Financial Highlights
Operating cash flow was $57.1 million, an increase of 20%. Capital expenditures in the quarter were $32.1 million. Free cash flow (operating cash flow minus capital expenditures) was $25.0 million, an increase of 33%.

During the quarter, the Company repurchased 761,500 shares for $115.5 million at an average share price of $151.65 under its share repurchase program.

Our capital and financial resources, including overall liquidity, remain strong. We believe that cash on hand and cash generated from operations, together with availability under our Credit Facility, will be adequate to address our foreseeable liquidity needs based on our current expectations of our business operations, capital expenditures and scheduled payments of debt obligations.

Full-Year 2020 Financial Guidance

Full-year 2020 net sales guidance continues to be in a range of $1.95 billion to $1.97 billion.
Organic sales growth is expected to be approximately 8%, compared to a prior guidance range of 7% to 8%.
Net sales guidance includes an estimated full-year headwind of $26 million for the full-year 2020 based on current foreign exchange rates, compared to prior guidance of $15 million.
Full-year 2020 adjusted-diluted EPS is expected to be in a range of $3.52 to $3.62, compared to prior guidance range of $3.45 to $3.55.
Full-year adjusted-diluted EPS guidance includes an estimated headwind of approximately $0.07 based on current foreign currency exchange rates, compared to prior guidance of approximately $0.04.
The revised guidance includes a $0.07 EPS impact from first-quarter tax benefits from stock-based compensation.
For the remainder of the year, our EPS guidance range assumes a tax rate of 24% and does not include potential tax benefits from stock-based compensation. Any tax benefits associated with stock-based compensation beyond those recorded in the first-quarter 2020 would provide a positive adjustment to our full-year EPS guidance.
First-Quarter 2020 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 1865786.

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, April 30, 2020, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 1865786.

On April 23, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2020 (Press release, Chugai, APR 23, 2020, View Source [SID1234556520]).

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"We had a strong start to the year with record-high first quarter results driven by increased income related to our in-house product Hemlibra. In terms of research and development, I am very pleased that we have initiated a clinical study for the first antibody project which applies our proprietary Switch Antibody engineering technology, and have also filed for regulatory approval of the liquid biopsy-based genomic profiling test FoundationOne Liquid CDx. Going forward, the domestic market will be affected by drug price revisions, and we anticipate that the spread of the novel coronavirus will have an impact on business and performance in Japan and overseas. Nevertheless, we will continue striving to help realize advanced and sustainable patient-centric healthcare," said Tatsuro Kosaka, Chugai’s Chairman and CEO.

[First quarter results for 2020]

Chugai reported record high revenues and operating profit for the first quarter (Core-basis), both achieving double-digit growth year-on-year.

Revenues increased by 16.3% due to increases both in sales and royalty and other operating income. Among sales, domestic sales increased by 2.6% driven by the contribution of mainstay products including the immune checkpoint inhibitor Tecentriq and the hemophilia A treatment Hemlibra. Overseas sales increased by 10.9% mainly due to the commencement of export of Hemlibra to Roche at a regular shipment price. Royalties and other operating income increased by 110.2% due to a large increase in royalties and profit-sharing income for Hemlibra as well as an increase in other operating income with one-time income.

Operating profit increased by 54.7% due to the strong increase in royalties and profit-sharing income, and a better cost to sales ratio. Cost to sales ratio improved by 4.1 percentage point at 42.2% mainly due a larger proportion of in-house products in the total product mix.

The Company also made good progress in research and development. Chugai started phase I study for STA551 for the treatment of solid tumors. STA551 is the first Switch Antibody project applying Chugai’s proprietary antibody engineering technology. The regulatory application for FoundationOne Liquid CDx, a liquid biopsy-based genomic profiling test, was submitted in March for further contribution to cancer genomic medicine. Other projects also went well. A phase II study started in Japan for the oncolytic type 5 adenovirus OBP-301(telomelysin), an oncolytic virus therapy from Oncolys BioPharma Inc., in esophageal cancer. For the engineered antibody AMY109 from Chugai research, the Company started a phase I study in solid tumors.

[Impact on business and performance due to the spread of new coronavirus infection]

Chugai’s response to the new coronavirus is to set up an Emergency Response Headquarters to take measures to prevent infection of employees and related business personnel, and to build a business continuity system centered on maintaining the product supply system. At present, there are no concerns about the product supply. During the three months under review, the impact of the new coronavirus on performance was minor. On the other hand, the Company anticipates that the impact on its business will be extensive from April, when the situation has worsened. Regarding the specific impact on business and performance, Chugai is currently collecting information from domestic and overseas.

On April 23, 2020 EpimAb Biotherapeutics, an emerging Shanghai-based biopharmaceutical company specializing in bispecific antibodies, and the QIMR Berghofer Medical Research Institute (QIMR Berghofer), a non-profit research organization based in Brisbane, Australia, reported a research collaboration and license agreement to evaluate novel target combinations for their application using EpimAb’s bispecific antibody format, Fabs-In-Tandem Immunoglobulin (FIT-Ig) (Press release, EpimAb Biotherapeutics, APR 23, 2020, View Source [SID1234556509]). Under the terms of the agreement, EpimAb will be granted an exclusive license to QIMR Berghofer’s novel target combinations identified by Professors Bill Dougall and Mark Smyth to develop novel bispecific antibodies. During the collaboration, EpimAb’s novel bispecific antibodies will be tested in QIMR Berghofer’s pre-clinical models. Financial details were not disclosed.

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"QIMR Berghofer is one of the pioneering institutes in the discovery of immuno-oncology mechanisms which are playing an important role in today’s treatment of cancer. We are proud to collaborate with QIMR Berghofer to identify novel target combinations as EpimAb enters the next stage of growth," said Dr. Chengbin Wu, CEO and founder of EpimAb. "With our lead program in clinical trials and several to follow, we have shown the ability of our FIT-Ig technology to rapidly generate innovative bispecific antibodies. We look forward to using the technology to evaluate novel bispecific target pairs developed under our collaboration and select viable pairs to broaden our pipeline."

"The bispecifics field has opened up new potential avenues to treat cancer and EpimAb’s bispecific antibody format has unique capabilities and features. EpimAb’s proprietary platform technology and experienced team will allow us to further evaluate some of our most recent discoveries, hopefully bringing novel immunotherapies to future cancer patients," said Professor Mark Smyth, Senior Scientist and Immunology Department Coordinator at QIMR Berghofer.

On April 22, 2020 Samsung Biologics (207940.KS) and ImmuneOncia Therapeutics Inc. reported the successful FDA IND approval of IMC-002 under a development and manufacturing agreement with Samsung Biologics since 2018 (Press release, Samsung BioLogics, APR 22, 2020, View Source [SID1234556602]). As a result, ImmuneOncia will begin Phase 1 clinical trials of the pipeline product.

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IMC-002 is an immune checkpoint inhibitor antibody, which blocks CD47-SIRP- α interaction between tumor cells and macrophages. According to ImmuneOncia, IMC-002 is expected to help patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.

Leveraging Samsung Biologics’ global CDO capabilities, IMC-002 IND was approved by the FDA without significant comments. Samsung Biologics provided ImmuneOncia with services in cell line development, process development, non-clinical and clinical material production.

Samsung Biologics is currently providing support to 51 CDO development projects and is distinctly able to help clients achieve the most optimal path to IND approval by providing Faster & Better services. Samsung’s presence as a CDO in the global biopharma market has demonstrated rapid growth, and the company has announced plans to expand geographically to support even more clients globally and domestically.

"We are very impressed with the outstanding service Samsung Biologics provided in the full development scope – from cell line development, process development, preclinical and clinical manufacturing, and IND filing support," said Yun Jeong Song, CEO of ImmuneOncia. "The two companies collaborated exceptionally well together during the whole development process including the IND evaluation period, allowing us to enter phase I clinical trials for IMC-002 much quicker."

"We are excited to join in ImmuneOncia’s success," said Dr. Tae Han Kim, CEO of Samsung Biologics. "This IND approval is the product of the strong collaboration between Samsung Biologics and ImmuneOncia. As a world-leading CMO, CDO and CRO partner, we will continue to support ImmuneOncia and ensure client satisfaction through Samsung’s competitive advantages: faster timeline, excellent quality, and outstanding capability."

About IMC-002

IMC-002 is a fully human IgG4 monoclonal antibody designed to block the CD47–SIRPα interaction in order to promote the phagocytosis of cancer cells by macrophages. It binds to human CD47 with an optimal affinity that maximizes efficacy without binding to RBCs or causing anemia which is often seen in other CD47 blocking agents under development. For more information about the upcoming Phase 1 clinical trial, visit clinicaltrials.gov, identifier number NCT04306224.

On April 22, 2020 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, April 29, 2020 to discuss the company’s first quarter 2020 financial results (Press release, Alkermes, APR 22, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-first-quarter-2020-financial-results-301044765.html [SID1234556542]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, April 29, 2020, through Wednesday, May 6, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13701480.