On February 24, 2021 Vividion Therapeutics, Inc., a biotechnology company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, reported the completion of a $135 million Series C financing, co-led by new investors, Logos Capital and Boxer Capital of Tavistock Group (Press release, Vividion Therapeutics, FEB 24, 2021, View Source [SID1234575504]). Additional new investors in the raise include SoftBank Investment Advisers, Avoro Capital Advisors, funds and accounts managed by BlackRock, RA Capital Management, funds and accounts advised by T. Rowe Price Associates, Inc., Surveyor Capital (a Citadel company), Woodline Partners LP, Acuta Capital and Driehaus Capital Management, alongside existing investors ARCH Venture Partners, BVF Partners L.P., Casdin Capital, Mubadala Capital, Nextech Invest and Versant Ventures.

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"Vividion has made significant progress advancing drug discovery beyond the traditional boundaries of druggability. By leveraging our unique platform technologies, we are building a robust pipeline of precision oncology and immunology programs," said Jeffrey Hatfield, chief executive officer of Vividion. "We’re excited to have attracted such a distinguished group of healthcare investors, whose support will be instrumental in fueling the continued maturation of our broad pipeline, with the intention of beginning to advance programs into the clinic next year."

Vividion has integrated multiple emerging technologies in its platform that enable the company to discover and develop potential therapies for well-known but previously undruggable targets. The platform conveys the unique ability to: find unknown or cryptic functional pockets on high value targets; interact with those pockets using its first-in-kind, proteome-trained covalent chemistry library; and ensure precise selectivity across the entire proteome with its industrial scale chemoproteomics capabilities. Leveraging this platform, Vividion is advancing a pipeline of potent and selective small molecule therapies across a range of oncology and immunology indications. The company’s initial wave of wholly owned assets includes programs targeting the KEAP1-NRF2 axis, with antagonists for the treatment of NRF2 mutant and NRF2 addicted cancers, as well as agonists for the treatment of inflammatory diseases. Also in the initial wave, and in partnership with Bristol Myers Squibb, the company is advancing a program against a highly pursued yet unsolved transcription factor for the treatment of both oncology and immunology indications.

"The science behind Vividion’s approach to drugging the undruggable space and accessing some of the world’s most highly sought-after targets has the potential to solve a wide range of devastating cancer and immune disorders," said Arsani William, M.D., M.B.A. and Graham Walmsley, M.D., Ph.D. of Logos Capital. "Our investment philosophy at Logos is centered upon propelling innovation that meaningfully advances the standard of care for patients. The combination of a leading-edge platform, robust pipeline, strategic partnerships with leading pharmaceutical companies BMS and Roche, and a deeply experienced team sets Vividion apart. We are honored to support the team’s efforts in both the near- and longer-term."

Aaron Davis, chief executive officer of Boxer Capital, LLC, added, "We believe this company is building a remarkable early pipeline of precision oncology and immunology therapies that can have transformative value for patients in traditionally unserved or vastly underserved disease indications. At Boxer, our mission is to enable the most innovative biotechnology companies to drastically improve medicine, and we are delighted to help Vividion accelerate into the next phase of its evolution and toward achieving that goal."

On February 24, 2021 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported financial results and business highlights for the fourth quarter and year ended December 31, 2020, and provided full-year 2021 financial guidance (Press release, Vericel, FEB 24, 2021, View Source [SID1234575528]).

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Fourth Quarter 2020 Financial Highlights

Total net revenue increased 15% to $45.2 million, compared to $39.4 million in the fourth quarter of 2019
MACI net revenue of $34.7 million, Epicel net revenue of $9.6 million and NexoBrid revenue of $1.0 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for national response preparedness
Gross margin of 74%, compared to gross margin of 73% in the fourth quarter of 2019
Net income of $12.2 million, or $0.25 per share, compared to $9.5 million, or $0.20 per share, in the fourth quarter of 2019
Non-GAAP adjusted EBITDA of $16.0 million, or 35% of net revenue, compared to $12.8 million, or 33% of net revenue, in the fourth quarter of 2019
Operating cash flow of $11.3 million
Full-Year 2020 Financial Highlights

Total net revenue increased 5% to $124.2 million, compared to $117.9 million in 2019
MACI net revenue of $94.4 million, Epicel net revenue of $27.5 million and NexoBrid revenue of $2.2 million related to the BARDA procurement for national response preparedness
Gross margin of 68%, compared to gross margin of 68% in 2019
Net income of $2.9 million, or $0.06 per share, compared to a net loss of $9.7 million, or $0.22 per share, in 2019
Non-GAAP adjusted EBITDA of $18.6 million, or 15% of net revenue, compared to $21.2 million, or 18% of net revenue, in 2019
Operating cash flow of $17.6 million
As of December 31, 2020, the company had $100 million in cash and investments, compared to $79 million as of December 31, 2019, and no debt
Business Highlights and Updates

Record fourth-quarter and full-year total net revenue
Record quarterly gross margin, net income and operating cash flow
Record quarterly and full-year MACI implants and net revenue
Record fourth-quarter and full-year Epicel grafts and net revenue, and the second highest quarterly Epicel grafts and revenue in history
Received MACI biopsies from approximately 1,500 surgeons in 2020, an increase from approximately 1,400 surgeons in 2019
Record quarterly high in the number of surgeons taking MACI biopsies in the fourth quarter
Double-digit growth in MACI biopsies in the fourth quarter, achieving a record quarterly high and a record monthly high in December
Announced expansion of MACI coverage by UnitedHealthcare to include patella and multiple cartilage defects in the knee
Appointed Joe Mara as Chief Financial Officer
"We delivered a record fourth quarter across multiple financial and operational metrics and ended the year in a very strong financial position," said Nick Colangelo, President and CEO of Vericel. "With revenue growth for both products in 2020, we demonstrated the resiliency of the Company’s growth profile and are on track for significant growth in the years ahead. Our guidance for 2021 reflects a return to MACI’s pre-COVID growth trajectory, continued momentum for Epicel, and significant adjusted EBITDA growth."

2021 Financial Guidance

Total net revenue for 2021 expected to grow 30%-32% to approximately $161 million to $164 million
Gross margin expected to be 70% to 71%
Adjusted EBITDA margin expected to be 21% to 23%
Fourth Quarter 2020 Results
Total net revenue for the quarter ended December 31, 2020 increased 15% to $45.2 million, compared to $39.4 million in the fourth quarter of 2019. Total net product revenue for the quarter included $34.7 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.6 million of Epicel (cultured epidermal autografts) net revenue compared to $33.6 million of MACI net revenue and $5.8 million of Epicel net revenue, respectively, in the fourth quarter of 2019. Total net revenue for the quarter also included $1.0 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

Gross profit for the quarter ended December 31, 2020 was $33.6 million, or 74% of net revenue, compared to $28.8 million, or 73% of net revenue, for the fourth quarter of 2019.

Total operating expenses for the quarter ended December 31, 2020 were $21.4 million, compared to $19.6 million for the same period in 2019. The increase in operating expenses was primarily due to incremental employee expenses related to the MACI sales force expansion.

Net income for the quarter ended December 31, 2020 was $12.2 million, or $0.25 per share, compared to $9.5 million, or $0.20 per share, for the fourth quarter of 2019.

Non-GAAP adjusted EBITDA for the quarter ended December 31, 2020 was $16.0 million, or 35% of net revenue, compared to $12.8 million, or 33% of net revenue, in the fourth quarter of 2019. A table reconciling non-GAAP measures is included in this press release for reference.

Full-Year 2020 Results
Total net revenue for the year ended December 31, 2020 increased 5% to $124.2 million, compared to $117.9 million in 2019. Total net product revenue for the year included $94.4 million of MACI net revenue and $27.5 million of Epicel net revenue compared to $91.6 million of MACI net revenue and $26.2 million of Epicel net revenue, respectively, in 2019. Total net revenue in 2020 also included $2.2 million of revenue related to the procurement of NexoBrid by BARDA for emergency response preparedness.

Gross profit for the year ended December 31, 2020 was $84.2 million, or 68% of net revenue, compared to $80.3 million, or 68% of net revenue, in 2019.

Total operating expenses for the year ended December 31, 2020 were $81.9 million, compared to $91.5 million for the same period in 2019. Operating expenses in 2019 included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid.

Net income for the year ended December 31, 2020 was $2.9 million, or $0.06 per share, compared to a net loss of $9.7 million, or $0.22 per share, in 2019.

Non-GAAP adjusted EBITDA for the year ended December 31, 2020 was $18.6 million, or 15% of net revenue, compared to $21.2 million, or 18% of net revenue, in 2019. A table reconciling non-GAAP measures is included in this press release for reference.

As of December 31, 2020, the company had $100 million in cash and investments, compared to $79 million as of December 31, 2019, and no debt.

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A slide presentation with highlights from today’s conference call will be available on the webcast and in the Investor Relations section of the Vericel website. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software, if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s third-quarter 2020 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at View Source until February 24, 2022. A replay of the call will also be available until 11:30am (EDT) on March 3, 2021 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 4364298.

On February 24, 2021 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that the Company’s Board of Directors has approved a second-quarter 2021 dividend of $0.17 per share (Press release, West Pharmaceutical Services, FEB 24, 2021, View Source [SID1234575544]). The dividend will be paid on May 5, 2021, to shareholders of record as of April 21, 2021.

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On February 24, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that management will present at the Cowen Health Care Conference on Tuesday, March 2, 2021 at 9:50 a.m. ET (Press release, Vertex Pharmaceuticals, FEB 24, 2021, https://investors.vrtx.com/news-releases/news-release-details/vertex-present-cowen-health-care-conference-march-2 [SID1234575561]).

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The audio portion of management’s remarks will be available live through Vertex’s website, www.vrtx.com in the "Investors" section under the "News and Events" page. A replay of the conference webcast will be archived on the company’s website.

On February 24, 2021 BriaCell Therapeutics Corp. (TSX-V:BCT) (NASDAQ: BCTX, BCTXW) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported the pricing of an underwritten public offering in the United States of 5,882,353 units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock (or units consisting of one pre-funded common stock purchase warrant ("Pre-Funded Warrant") and one warrant to purchase one share of common stock, in lieu thereof). Each unit is being sold to the public at a price of US$4.25 (inclusive of the exercise price of the Pre-Funded Warrant, in the case of the units containing Pre-Funded Warrants) (Press release, BriaCell Therapeutics, FEB 24, 2021, View Source [SID1234575505]). The gross proceeds to the Company from the offering are expected to be approximately US$25 million before deducting underwriting discounts, commissions and other offering expenses. The warrants will have a per share exercise price of US$5.3125, be exercisable immediately, and expire five years from the date of issuance. The Pre-Funded Warrants will be exercisable at any time after the date of issuance upon payment of the exercise price of $0.01 per common share. The common stock (or Pre-Funded Warrant) and warrants that are part of the units can only be purchased together in the offering but will be issued separately.

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The common shares and warrants have been approved to list on the Nasdaq Capital Market under the symbols BCTX and BCTXW respectively, and are expected to begin trading on February 24, 2021.

The Company has granted the underwriter a 45-day option to purchase up to 882,352 additional shares of common stock and/or Pre-Funded Warrants and/or up to 882,352 additional warrants to cover over-allotments, if any.

The offering is expected to close on February 26, 2021, subject to satisfaction of customary closing conditions.

ThinkEquity, a division of Fordham Financial Management, Inc., is acting as sole book-running manager for the offering.

The estimated gross proceeds to the Company are expected to be approximately US$25 million prior to deducting underwriting discounts, commissions and other estimated offering expenses. The Company intends to use the proceeds to fund clinical trials, research and development, and for general working capital and general corporate purposes.

A registration statement on Form F-1 (File No. 333-234292) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on February 23, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected]. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

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