Workflow
Organogenesis (ORGO)
icon
Search documents
Organogenesis Holdings Inc. to Participate in the Truist Securities MedTech Conference
GlobeNewswire News Room· 2024-06-06 20:05
CANTON, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today announced that management will participate in the Truist Securities MedTech Conference, which is being held at the InterContinental Boston in Boston, MA on Tuesday, June 18th. Management will participate in 1x1 meetings. ...
Organogenesis (ORGO) - 2024 Q1 - Quarterly Report
2024-05-09 20:25
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q 85 Dan Road Canton, MA 02021 (Address of principal executive offices) (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Cha ...
Organogenesis (ORGO) - 2024 Q1 - Quarterly Results
2024-05-09 20:05
Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports First Quarter 2024 Financial Results CANTON, Mass., (May 9, 2024) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the first quarter ended March 31st, 2024. First Quarter 2024 Financial Results Summary: "We deliver ...
Organogenesis (ORGO) - 2023 Q4 - Annual Report
2024-02-29 21:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of (I.R.S. Employer Incorporatio ...
Organogenesis (ORGO) - 2023 Q4 - Annual Results
2024-02-29 21:05
Exhibit 99.1 FOR IMMEDIATE RELEASE Organogenesis Holdings Inc. Reports Fourth Quarter 2023 and Fiscal Year 2023 Financial Results; Introduces Fiscal Year 2024 Guidance CANTON, Mass., (February 29, 2024) – Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets, today reported financial results for the fourth quarter and the year en ...
Organogenesis (ORGO) - 2023 Q3 - Earnings Call Presentation
2023-11-10 03:19
Financial Performance - Q3 2023 - Net revenue for Q3 2023 was $108.5 million, a decrease of $8.3 million or 7% compared to $116.9 million in Q3 2022[3, 20] - Advanced Wound Care product revenue decreased by $8.2 million or 7% to $101.4 million [3, 20] - Surgical & Sports Medicine product revenue decreased by $0.2 million or 2% to $7.2 million [3, 20] - Net income for Q3 2023 was $3.2 million, an increase of $3.0 million compared to $0.2 million in Q3 2022[3, 5] - Adjusted EBITDA for Q3 2023 was $16.0 million, an increase of $4.4 million or 38% compared to $11.6 million in Q3 2022[3, 5] Financial Performance - Nine Months Ended September 30, 2023 - Net revenue was $333.5 million, a decrease of $1.9 million or 1% compared to $335.4 million for the same period in 2022[6, 21] - Advanced Wound Care products decreased by $1.0 million or less than 1% to $312.3 million [6, 21] - Surgical & Sports Medicine products decreased by $0.8 million or 4% to $21.1 million [6, 21] - Net income was $5.5 million, a decrease of $2.5 million compared to $8.0 million for the same period in 2022[6] - Adjusted EBITDA was $35.1 million, a decrease of $0.1 million or less than 1% compared to $35.2 million for the same period in 2022[6] Fiscal Year 2023 Guidance - Net revenue is expected to be between $433 million and $446 million, a decrease of approximately 1% to 4% year-over-year compared to $450.9 million in 2022[7] - Advanced Wound Care products revenue is expected to be between $406 million and $418 million, a decrease of 1% to 4% year-over-year compared to $422.2 million in 2022[7] - Surgical & Sports Medicine products revenue is expected to be between $27 million and $29 million, an approximately 6% decrease to 0% increase year-over-year compared to $28.7 million in 2022[7]
Organogenesis (ORGO) - 2023 Q3 - Earnings Call Transcript
2023-11-10 03:16
Financial Data and Key Metrics Changes - The company reported net revenue of $108.5 million for Q3 2023, down 7% year-over-year [4][27] - Operating expenses for Q3 were $74.7 million, a decrease of 16% from $88.9 million last year [10] - Operating income increased to $8.1 million from $1.8 million last year, while net income rose to $3.2 million from $0.2 million [11] - Adjusted net income for Q3 was $5.3 million, slightly up from $5.1 million last year [11] - The company expects 2023 net revenue to be between $433 million and $446 million, reflecting a year-over-year decrease of 1% to 4% [12] Business Line Data and Key Metrics Changes - Sales of Advanced Wound Care products decreased by 7% to $101.4 million, while Surgical & Sports Medicine products saw a 2% decline to $7.2 million [4][27] - The gross profit margin for Q3 was approximately 76.2%, down from 77.6% last year, primarily due to decreased pricing and a shift in product mix [27] Market Data and Key Metrics Changes - Sales trends in regions affected by local coverage determinations (LCDs) declined in the high teens year-over-year, while non-LCD impacted regions experienced a modest decline [22] - The company noted that confusion and uncertainty among customers due to LCDs significantly impacted sales [7][43] Company Strategy and Development Direction - The company is focusing on expanding manufacturing capacity and driving long-term efficiencies [8] - Plans to launch new products across both Advanced Wound Care and Surgical Sports Medicine markets in 2024 [16] - The company is actively engaging with customers to clarify misinformation and regain lost accounts [24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that the second half of 2023 has been impacted by customer confusion related to LCDs, but they believe this is largely transitory [16] - Sales trends have improved in October compared to September, and management expects to regain a majority of lost accounts by the end of the year [47] Other Important Information - The company has reintroduced its 2023 financial guidance, reflecting the impact of business disruption and recovery activities [7][12] - Total interest and other expenses for the quarter were approximately $2.2 million, with a GAAP tax rate expected between 51% and 53% [31] Q&A Session Summary Question: How should the market dynamics be viewed given the recent CMS final rule? - Management indicated that while there were no significant changes in the 2024 reimbursement rules, they anticipate future changes that could stabilize the market [46] Question: How is the company preparing to inform the market post-LCD withdrawal? - Management emphasized efforts to correct misinformation and re-engage customers, particularly in hospital outpatient departments, to ensure products are back on formulary [47]
Organogenesis (ORGO) - 2023 Q3 - Quarterly Report
2023-11-09 21:11
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of I ...
Organogenesis (ORGO) - 2023 Q2 - Earnings Call Transcript
2023-08-10 00:40
Financial Data and Key Metrics Changes - The company reported net revenue of $117.3 million for Q2 2023, a decrease of 3% year-over-year, driven by a 3% decrease in Advanced Wound Care product sales and a 5% decrease in Surgical & Sports Medicine product sales [3][28] - Gross profit for Q2 was $91 million, approximately 77.6% of net revenue, compared to 78% in the previous year [28] - Net income for Q2 was $5.3 million, down from $8.7 million in the prior year, reflecting a decrease of $3.4 million [17] Business Line Data and Key Metrics Changes - Advanced Wound Care net revenue for Q2 was $110.1 million, down 3%, while Surgical & Sports Medicine products generated $7.2 million, down 5% [28] - The company experienced mid-single-digit growth in units sold year-over-year in Q2, driven by double-digit growth in the hospital outpatient setting [5] Market Data and Key Metrics Changes - The recent local coverage determinations (LCDs) from Medicare contractors have created uncertainty regarding revenue outlook for products used in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) [20][33] - The company estimates that the revenue related to DFUs and VLUs for the first half of 2023 was approximately $35 million to $40 million [23] Company Strategy and Development Direction - The company is focusing on expanding manufacturing capacity for its product portfolio, particularly for Dermagraft and TransCyte products [12] - The management expressed confidence in their strategy to maximize competitive positioning in the advanced wound care market [11] Management Comments on Operating Environment and Future Outlook - Management withdrew the fiscal year 2023 guidance due to uncertainties arising from the recent LCDs, which limit coverage for certain products [21] - The management remains optimistic about addressing the coverage issues and believes that their products meet the necessary criteria to be classified as skin substitutes [36][44] Other Important Information - The company has received FDA approval to proceed with a second Phase III trial for its ReNu product, with patient enrollment expected by the end of Q3 [13] - Adjusted net income for Q2 was $6.1 million, down from $11.3 million in the previous year [30] Q&A Session Summary Question: What is the reason for the withdrawn guidance? - Management believes that five products were improperly excluded from coverage and is engaging with relevant parties to address this issue [21][22] Question: What is the expected revenue impact from the LCDs? - The company estimates a potential revenue impact of $70 million to $80 million over the next four quarters if the LCDs remain unchanged [38] Question: How does the company plan to address the coverage issues? - The company plans to prepare a legal memo to CMS explaining the errors and will engage directly with them to rectify the situation [37][44] Question: What are the expectations for the surgical business? - The surgical business exceeded expectations in Q2, and management is optimistic about capturing incremental market share due to competitor recalls [82]
Organogenesis (ORGO) - 2023 Q2 - Quarterly Report
2023-08-09 20:34
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-37906 ORGANOGENESIS HOLDINGS INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of Incorp ...