On July 27, 2022 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it will release second quarter 2022 financial results after the market closes on Wednesday, August 3, 2022 (Press release, Xencor, JUL 27, 2022, View Source [SID1234617021]).

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Xencor management will host a webcast and conference call the same day at 4:30 p.m. ET (1:30 p.m. PT) to discuss the financial results and provide a corporate update.

The live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at investors.xencor.com and will be archived for at least 30 days. Participants may register for the conference call at the following link: register.vevent.com/register/BI8b3886bf9772414c8dd5900d3aa4457b.

On July 27, 2022 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported that strong financial results for the second quarter of fiscal year 2022 (Press release, Samsung BioLogics, JUL 27, 2022, View Source [SID1234617037]).

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John Rim, CEO of Samsung Biologics, stated, "Samsung Biologics delivered another strong quarterly performance ahead of our guidance with our revenue exceeding KRW 1 trillion for the first half of the year. Operations are seamless across all our plants, and the partial completion of Plant 4 is just around the corner, scheduled to commence operations in October this year. We completed a deal to fully acquire Samsung Bioepis, expanding and diversifying our revenue base and business portfolio. More recently, we have officially signed an agreement to purchase land for Bio campus II. All these factors signal that we have a strong momentum going, and that we are well on track in our expansion plans to serve the increasing market demands."

SECOND QUARTER 2022 RESULTS

Samsung Biologics demonstrated strong operational excellence and business agility in the second quarter with earnings exceeding initial projections.

Reporting under the consolidated approach for the first time since the acquisition in April, Samsung Biologics and Samsung Bioepis in the second fiscal quarter recorded a revenue of KRW 651.4 billion, operating profit of KRW 169.7 billion, and net profit of KRW 152 billion with EBITDA margin of 39.7%.

On a standalone basis, the second quarter 2022 revenue for Samsung Biologics was KRW 503.7 billion, an increase of 22.2% from KRW 412.2 billion reported for the second quarter in the previous year, due to efficiency in operations despite a scheduled slow-down of Plant 2, and attributable to the expansion of product sales.

Samsung Biologics also reported an operating profit of KRW 171.9 billion, 3.18% higher than the prior-year period, and a net profit of KRW 101.8 billion with an operating profit margin of 34.1% for the same quarter.

On a standalone basis, Samsung Bioepis earned KRW 232.8 billion in revenue, 24.2% higher than the prior-year period attributable to the increase in sales of its biosimilar products in global markets including the US and Europe. Samsung Bioepis’s operating profit increased significantly by 95.7% compared to the prior-year period, at KRW 58.5 billion.

FISCAL YEAR 2022 OUTLOOK

The construction of Samsung Biologics Plant 4 is on schedule with 6 X 10KL production capacity expected to commence operations in October. The company has secured a number of large scale manufacturing contracts with active presales activities for Plant 4, and at the close of Q2, in the first half of 2022 alone, the company had secured over USD 7.9 billion in sales backlog including deals with Janssen, Merck, GSK, Lilly, and Novartis to name a few.

Earlier this month, Samsung Biologics secured additional land sized at 357,366 ㎡ and approximately 30% larger than its current site, to support the build out of its second campus. At the newly acquired site, the company will host additional large-scale manufacturing facilities as well as an open innovation facility.

Samsung Biologics also published its second annual ESG Report this month, reflecting the company’s latest sustainability efforts to address a wide range of environmental, social, and governance (ESG) activities related to its business. The company aims to build an eco-friendly business environment and achieve net zero GHG emissions in its operations, and continue to enhance its social contribution activities that strive to support the health of its local communities.

Samsung Bioepis has a total of six biosimilar products approved and commercially available in different markets[1], and its revenue has steadily grown driven by increases in global product sales and milestone payments.

Of the six products, SB4, a biosimilar to Enbrel (etanercept), which was launched in Europe in 2016, has surpassed its originator’s sales in Europe by overtaking the majority of the market share, and the company recently launched SB11, a biosimilar to Lucentis (ranibizumab), in June 2022 in the US. With four additional biosimilar candidates in late stage development, Samsung Bioepis is solidifying its position as a leading company in the biosimilars industry.

For more details on performance and financials, please refer to the Earnings Release.

On July 27, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, reported that it will present its second quarter 2022 financial results and operational highlights in a conference call on August 4, 2022, at 8 a.m. ET (Press release, Intellia, JUL 27, 2022, View Source [SID1234616988]).

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To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 4, 2022, at 12 p.m. ET.

On July 27, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report second quarter financial results on Wednesday, August 3, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, JUL 27, 2022, View Source [SID1234617006]).

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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 call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On July 27, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes (T1D), reported that Paul Sekhri will lead the company as President and Chief Executive Officer, effective August 1, 2022 (Press release, vTv Therapeutics, JUL 27, 2022, View Source [SID1234617022]). Rich Nelson, who has been serving as Interim Chief Executive Officer since March 2, 2022, will continue to support the company as Executive Vice President, Corporate Development and as a member of the Board of Directors. Mr. Sekhri will also join vTv’s Board of Directors.

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Paul joins vTv as it sets to launch Phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) in April 2021 as an oral adjunctive therapy for the treatment of T1D.

Positive results from the Phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful 40% decrease in the frequency of severe and symptomatic hypoglycemia.

Last month, vTv announced a $25 million investment by G42 Investments AI Holding RSC Ltd. and entry into a collaboration and license agreement with affiliates of G42 Healthcare whereby G42’s affiliate will be funding a significant portion of the Phase 3 clinical trials for TTP399.

"While I’ve served in the Interim CEO role for the past four months, we diligently searched for the right candidate to steer the company through this final stage of TTP399 development and are highly confident that Paul is the right person for the role," said Rich Nelson. "We are thrilled to have Paul join vTv at this very exciting time in the company’s lifecycle as we actively engage in activities in preparation of the initiation of our Phase 3 trials and continue to have positive discussions with institutions in the biotech community about further investment in vTv. Paul brings extensive experience as CEO of several prominent healthcare companies and has strong ties to the biotech investment community. We are very excited to have Paul on board and I look forward to continuing to support vTv in my new role and to support Paul in his."

Mr. Sekhri brings nearly 30 years of healthcare experience, including serving as President and CEO of several healthcare companies such as eGenesis, Lycera Corp., Cerimon Pharmaceuticals, as well as senior business development and strategy roles at Sanofi, Teva Pharmaceutical Industries Ltd., TPG Biotech, Cerimon, Ariad Pharmaceuticals and Novartis Pharma AG. He has been a director on more than 30 private, public company and non-profit boards and is currently a Director at Ipsen, S.A., Compugen, Pharming N.V., Veeva Systems, Longboard, Spring Discovery and eGenesis. Additionally, he is on the Board of Directors of the Metropolitan Opera.

"During my long career as a biotechnology executive, I have been attracted to truly novel therapeutic approaches that address serious medical challenges and/or improve patient care," said Mr. Sekhri. "T1D is a challenging enough disease for patients to manage without also having to worry about hypoglycemia. A treatment that significantly reduces the risk of hypoglycemia while also improving Hb1Ac would be a significant advance for treating this disease. I look forward to working with the vTv team to initiate and successfully complete our Phase 3 trials."

On July 26, 2022, Mr. Sekhri was granted stock options (the "Options") to purchase 2,200,000 shares of the Class A common stock of vTv at an exercise price of $0.79 per share pursuant to an inducement award agreement (the "Inducement Award Agreement"). Subject to potential acceleration upon the achievement of certain performance metrics as set forth in the Inducement Award Agreement, 25% of the Options will vest on the first anniversary of the grant date and thereafter the Options will vest in equal quarterly installments over the next three years. Upon certain terminations of employment, a portion of the Options will vest on a pro rata basis based on the number of days employed during the four-year term. The grant of Options was made as an inducement grant under NASDAQ Listing Rule 5635(c)(4).