On November 17, 2021 BeiGene reported that was approved to stage a $3 billion IPO on Shanghai’s STAR Exchange, the company’s third listing (Press release, BeiGene, NOV 17, 2021, View Source [SID1234595836]). Previously, the company completed an $182 million IPO on NASDAQ in 2016 and a $900 million Hong Kong IPO in 2018. It will be the first biopharma to list on the three exchanges. The China Securities Regulatory Commission (CSRC) signed off on the IPO this week, the last requirement for the process. Founded in 2010, BeiGene focuses on developing molecularly targeted and immuno-oncology drug candidates.

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On November 17, 2021 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the third quarter of 2021 and provided an update on strategic and operational developments (Press release, EDAP TMS, NOV 17, 2021, View Source [SID1234595795]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "We are pleased with the continued strong growth in U.S. HIFU treatment volumes, which increased 58% year-to-date over the comparable period in 2020. This is a very positive sign as it reflects the growing adoption of focal therapy by urologists. Regarding our third quarter revenue, the COVID-19 pandemic continued to weigh on hospital capital spending, and this was further impacted by several machine placements that were delayed until the early days of the fourth quarter due to logistical challenges that were exacerbated by the resurgence of the pandemic in many parts of the world. Our leading indicators are strong, we are well financed, and I believe we are well positioned to exit the year with renewed momentum."

Nine Months 2021 Results

Total revenue for the nine months ended September 30, 2021 was EUR 30.1 million (USD 35.9 million), an increase of 14.4% from total revenue of 26.3 million (USD 29.8 million) for the same period in 2020.

Total revenue in the HIFU business for the nine months ended September 30, 2021 was EUR 5.7 million (USD 6.8 million), a decline of 18.9% as compared to EUR 7.1 million (USD 8.0 million) for the nine months ended September 30, 2020.

Total revenue in the LITHO business for the nine months ended September 30, 2021 was EUR 7.7 million (USD 9.1 million), an decrease of 7.4% from EUR 8.3 million (USD 9.4 million) for the nine months ended September 30, 2020.

Total revenue in the Distribution business for the nine months ended September 30, 2021 was EUR 16.7 million (USD 19.9 million), a 52.4% increase compared to EUR 11.0 million (USD 12.4 million) for the nine months ended September 30, 2020.

Gross profit for the nine months ended September 30, 2021 was EUR 12.2 million (USD 14.6 million), compared to EUR 11.4 million (USD 12.8 million) for the year-ago period. Gross profit margin on net sales was 40.6% for the nine months ended September 30, 2021, compared to 43.2% for the comparable period in 2020. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 14.3 million (USD 17.0 million) for the nine months ended September 30, 2021, compared to EUR 12.8 million (USD 14.5 million) for the same period in 2020.

Operating loss for the nine months ended September 30, 2021 was EUR 2.1 million (USD 2.5 million), compared to an operating loss of EUR 1.5 million (USD 1.6 million) for the nine months ended September 30, 2020.

Net loss for the nine months ended September 30, 2021 was EUR 0.7 million (USD 0.8 million), or EUR (0.02) per diluted share, as compared to a net loss of EUR 2.5 million (USD 2.8 million), or EUR (0.09) per diluted share in the year-ago period.

Third Quarter 2021 Results

Total revenue for the third quarter 2021 was EUR 9.4 million (USD 11.1 million), roughly flat with total revenue of EUR 9.4 million (USD 11.2 million) for the same period in 2020.

Total revenue in the HIFU business for the third quarter 2021 was EUR 1.9 million (USD 2.3 million), a decline of 25.6% as compared to EUR 2.6 million (USD 3.0 million) for the third quarter of 2020.

Total revenue in the LITHO business for the third quarter 2021 was EUR 2.5 million (USD 2.9 million), an increase of 3.0% from EUR 2.4 million (USD 2.9 million) for the third quarter of 2020.

Total revenue in the Distribution business for the third quarter 2021 was EUR 5.0 million (USD 5.9 million), a 13.4% increase compared to EUR 4.4 million (USD 5.2 million) for the third quarter of 2020.

Gross profit for the third quarter 2021 was EUR 3.6 million (USD 4.3 million), compared to EUR 4.0 million (USD 4.7 million) for the year-ago period. Gross profit margin on net sales was 38.4% in the third quarter of 2021, compared to 42.0% in the year-ago period. The decrease in gross profit year-over-year was due to lower sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 5.5 million (USD 6.5 million) for the third quarter of 2021, compared to EUR 4.3 million (USD 5.0 million) for the same period in 2020.

Operating loss for the third quarter of 2021 was EUR 1.9 million (USD 2.2 million), compared to an operating loss of EUR 0.3 million (USD 0.3 million) in the third quarter of 2020.

Net loss for the third quarter of 2021 was EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share, as compared to a net loss of EUR 1.0 million (USD 1.2 million), or EUR (0.03) per diluted share in the year-ago period.

As of September 30, 2021, the company held cash and cash equivalents of EUR 45.4 million (USD $52.6 million), as compared to EUR 24.7 million (USD 30.2 million) as of December 31, 2020.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, November 18, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On November 17, 2021 La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported that it will commence a share repurchase plan for up to $10 million of the Company’s common stock. Repurchases may be made from time to time at the Company’s discretion (Press release, La Jolla Pharmaceutical, NOV 17, 2021, View Source [SID1234595790]). The plan has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases.

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"The decision to repurchase shares reflects our confidence in our team and the ability to execute against our strategic initiatives for growth, which is supported by the strength of our balance sheet," said Larry Edwards, President and Chief Executive Officer of La Jolla.

On November 17, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and EQRx, a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, reported a collaboration to design, discover and develop new therapeutic options for patients (Press release, Evotec, NOV 17, 2021, View Source [SID1234595761]). The collaboration will help accelerate EQRx’s pipeline expansion efforts by leveraging Evotec’s unique data-driven, fully integrated R&D-platform, applied across different drug modalities and therapeutic areas. This approach aims to expedite the invention and development of novel drugs and helps ensure superior translation from research ideas to safe and efficacious medicines.

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The collaboration will focus on multiple therapeutic targets in oncology and immunology. Under the terms of the agreement, EQRx and Evotec will collaborate on drug discovery, pre-clinical and clinical development. Evotec will lead drug discovery and pre-clinical development efforts, and EQRx will be responsible for clinical development, regulatory and commercialisation efforts. In addition to jointly funded research and development activities, Evotec will benefit from the potential commercial success of the assets developed within the partnership through a variable profit share mechanism.

Dr Craig Johnstone, Chief Operating Officer of Evotec, commented: "EQRx’s ambitious and transformative mission to deliver important new therapies to patients at more affordable prices makes them an ideal partner for us. This exciting new partnership will expand the reach of our unique data-driven integrated R&D platform. We look forward to leveraging our combined knowledge, expertise and leading-edge technologies to advance new medicines against validated targets as rapidly as possible to make the biggest possible impact for patients."

"We continue to rapidly expand our early-stage development pipeline through access to innovative, next-generation drug discovery and engineering technologies," said Carlos Garcia-Echeverria, PhD, chief of Rx creation at EQRx. "This collaboration with Evotec will enable us to engineer and develop precision medicines in immunology and oncology with high quality and speed of execution. We look forward to a productive collaboration to bring innovative, affordable and accessible treatment options to people in need."

On November 17, 2021 CymaBay Therapeutics, Inc. (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases with high unmet medical need, reported that it has commenced an underwritten public offering of its common stock and pre-funded warrants (Press release, CymaBay Therapeutics, NOV 17, 2021, View Source [SID1234595759]). All shares of common stock and pre-funded warrants to be sold in the offering will be offered by CymaBay. CymaBay intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the number of shares of its common stock offered in the public offering (including shares underlying the pre-funded warrants). The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. CymaBay anticipates using the net proceeds from the offering to fund ongoing development of seladelpar and for working capital and general corporate purposes.

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Piper Sandler and Raymond James are acting as the joint book-running managers for the offering.

The securities described above are being offered by CymaBay pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC") on July 2, 2020, which became effective on July 13, 2020. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at 800-747-3924, or by email at [email protected]; or Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction