PULSE BIOSCIENCES SCHEDULES SECOND QUARTER 2022 FINANCIAL RESULTS CONFERENCE CALL FOR AUGUST 10, 2022

On July 27, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported it will report financial results for the second quarter of 2022 after market close on Wednesday, August 10, 2022 (Press release, Pulse Biosciences, JUL 27, 2022, View Source [SID1234617096]). Company management will host a corresponding conference call beginning at 1:30pm PT.

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Investors interested in listening to the conference call may do so by dialing 1-877-704-4453 for domestic callers or 1-201-389-0920 for international callers. A live and recorded webcast of the event will be available at View Source

Turning Point Therapeutics Provides Regulatory Update for Repotrectinib for the Treatment of ROS1+ Advanced NSCLC

On July 27, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a clinical-stage precision oncology company designing and developing novel targeted therapies for cancer treatment, reported receipt of positive feedback from the U.S. Food and Drug Administration (FDA) at a pre-New Drug Application (NDA) meeting completed within the second quarter (Press release, Turning Point Therapeutics, JUL 27, 2022, View Source [SID1234617095]). The feedback focused on the planned patient follow-up within the ROS1+ advanced non-small cell lung cancer (NSCLC) patient cohorts of the ongoing TRIDENT-1 registrational study of repotrectinib, the company’s lead drug candidate, which is a potential best-in-class ROS1 tyrosine kinase inhibitor that has received two breakthrough therapy designations within ROS1+ advanced NSCLC.

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The purpose of the pre-NDA meeting was to discuss the company’s planned NDA for repotrectinib for the treatment of ROS1+ advanced NSCLC. The FDA agreed with the company’s plan to provide data for ROS1+ TKI-naïve and TKI-pretreated advanced NSCLC patients with at least six months of follow-up from the first post-baseline scan at the time of NDA submission.

"We continue to be encouraged by our collaborative meetings with the FDA," said Mohammad Hirmand, M.D., Chief Medical Officer. "The planned NDA submission represents an important milestone for our company. The unmet need in ROS1+ advanced NSCLC patients is significant, and we continue to believe that repotrectinib could offer a best-in-class profile for the treatment of these patients."

Theratechnologies Announces Closing of Funding of $40 Million Under the Terms of its Credit Agreement

On July 27, 2022 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that it has received funding of $40 million under the terms of its credit agreement with affiliated funds of Marathon Asset Management (Press release, Theratechnologies, JUL 27, 2022, View Source [SID1234617043]). All dollar amounts are expressed in U.S. dollars, unless otherwise stated.

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This initial amount will be used to purchase $30 million of the principal amount of the convertible notes due June 2023 (the "Notes"). The purchase of the Notes is expected to occur on or about July 29, 2022.

On July 13, 2022, the Company announced that it entered into a binding commitment letter for a non-dilutive term loan of up to $100 million with affiliated funds of Marathon Asset Management. This credit facility is available to Theratechnologies in four various tranches with today’s first tranche of $40 million having been drawn down and funded. The credit agreement is available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov under Theratechnologies’ filings.

Samsung Biologics Reports Second Quarter 2022 Financial Results

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.

Ionis to hold second quarter 2022 financial results webcast

On July 27, 2022 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) reported that it will host a live webcast on Tuesday, August 9th at 11:30 a.m. Eastern Time to discuss its second quarter financial results and report on pipeline and business progress (Press release, Ionis Pharmaceuticals, JUL 27, 2022, View Source [SID1234617036]).

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The webcast may be accessed at View Source A replay will be available for a limited time at the same address.