Welcome to our dedicated page for Organogenesis Hldgs news (Ticker: ORGO), a resource for investors and traders seeking the latest updates and insights on Organogenesis Hldgs stock.
Organogenesis Holdings Inc. develops, manufactures and sells regenerative medicine and tissue-innovation products for the Advanced Wound Care and Surgical & Sports Medicine markets. News about the company commonly covers product revenue by those markets, gross margin and profitability trends, and corporate updates tied to its Nasdaq-listed Class A common stock.
Company updates also focus on clinical and regulatory activity across its portfolio. Recurring subjects include PuraPly AM clinical evidence in diabetic foot ulcers, ReNu as a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis, FDA interactions, Biologics License Application activity, and coverage or payment developments affecting skin-substitute and wound-care products.
Organogenesis Holdings Inc. (Nasdaq: ORGO) has announced its participation as a Platinum Sponsor at the upcoming 2021 Symposium on Advanced Wound Care Spring. The company will showcase its advanced wound care product lines, including PuraPly® AM and Apligraf®, with a focus on clinical evidence supporting their efficacy. On May 14, a presentation titled 'Clinical Evidence Outlines the Need for Early Advanced Standard of Care' will discuss a pooled analysis of 434 wounds. Other research highlights include podium and video presentations on the effectiveness of various wound care solutions.
Organogenesis Holdings Inc. (Nasdaq: ORGO) will announce its first quarter fiscal year 2021 financial results after market close on May 10. A conference call is scheduled for the same day at 5:00 p.m. ET to discuss the results and provide corporate updates. Interested participants can join by dialing 866-795-3142, with international callers using 409-937-8908, and using access code 9199306. A live webcast will also be available on their investor relations website, with a replay accessible for two weeks following the call.
Organogenesis Holdings (Nasdaq: ORGO) reported Q4 2020 net revenue of $106.8 million, a 43% increase YoY, driven by strong sales in Advanced Wound Care, which rose 48% to $93.6 million. Net income surged to $18.5 million from a loss of $4.4 million in Q4 2019. For FY 2020, total revenue reached $338.3 million, up 30%, with net income of $17.9 million. Looking ahead, the company expects FY 2021 revenue between $390 million and $405 million, reflecting a projected 15-20% growth.
Organogenesis Holdings (Nasdaq: ORGO) appointed David C. Francisco as Chief Financial Officer, effective February 15, 2021. Francisco, who has over 25 years of finance experience, previously held leadership roles at PerkinElmer, where he oversaw significant revenue growth. CEO Gary Gillheeney expressed optimism about Francisco's strategic insights, aiming to enhance operational performance and profitability amid growth opportunities. However, the company has faced substantial losses and competitive pressures, making its future profitability uncertain.
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leader in regenerative medicine, has announced its participation in several upcoming investor conferences. These include the BTIG Virtual MedTech Conference on February 18 at 1:00 p.m. ET, the SVBLeerink Global Healthcare Conference on February 24 at 8:40 a.m. ET, and the Oppenheimer Healthcare Conference on March 17 at 10:40 a.m. ET. Live audio webcasts will be available on the company's website, with archives accessible for 30 days post-conference.
Organogenesis Holdings Inc. (Nasdaq: ORGO) will announce its fourth quarter and fiscal year 2020 financial results on March 16, 2021, after market closure. A conference call will follow at 5:00 p.m. ET to discuss the financial outcomes and provide corporate updates. Interested participants can join by calling 866-795-3142 (international callers: 409-937-8908) and using access code 6766924. A live webcast will be available on the company's investor relations website, with a replay accessible for two weeks thereafter.
Organogenesis Holdings has initiated a pivotal Phase 3 clinical trial for ReNu®, a cryopreserved amniotic suspension allograft, targeting knee osteoarthritis treatment, with the first patient enrolled. The trial involves 474 subjects in a randomized controlled study comparing ReNu to a saline placebo. The primary endpoint will assess pain reduction over six months using the WOMAC index. The company's RMAT designation from the FDA supports expedited review processes, addressing a significant market demand as knee OA affects over 14 million Americans, with increasing knee replacement surgeries.
Organogenesis Holdings (Nasdaq: ORGO) reported preliminary financial results for Q4 and fiscal year 2020. Q4 net revenue is projected between $104.6 million and $106.0 million, marking a 40% to 42% increase year-over-year. Advanced Wound Care revenues rose by 45% to 47%, while Surgical & Sports Medicine grew by 12% to 14%. For the full year, revenue reached $336.1 million to $337.5 million, up 29% from 2019. The company anticipates reporting positive GAAP net income and adjusted EBITDA for both periods.
Organogenesis announces that the FDA has granted ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis management, Regenerative Medicine Advanced Therapy (RMAT) designation. This designation allows closer interactions with the FDA to support accelerated approval, enhancing the therapy's development pathway. The RMAT was granted based on a randomized controlled trial showing a significant reduction in pain and improved function in patients treated with ReNu compared to standard treatments.
Organogenesis Holdings (Nasdaq: ORGO) has announced its participation in the ICR Conference 2021, scheduled to take place virtually from January 11th to 14th. Management will engage in a fireside chat on January 14th at 1:45 p.m. Eastern Time. A live audio webcast of the presentation will be accessible via the company’s Investor Relations page, with an archive available for replay for 30 days post-conference. Organogenesis specializes in regenerative medicine, offering solutions in advanced wound care and sports medicine.