CANTON, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today reported financial results for the fourth quarter and the year ended December 31, 2024. Fourth Quarter 2024 Financial Results Summary: Net revenue of $126.7 million for the fourth quarter ...

CANTON, Mass., Jan. 27, 2025 (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 and Sports Medicine markets, today announced that fourth quarter and fiscal year 2024 financial results will be reported after the market closes on Thursday, February 27th. Management will host a conference call at 5:00 p.m. Eastern Time on February 27th ...

CANTON, Mass., Nov. 22, 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 and Sports Medicine markets, announced plans to expand manufacturing capacity with a long-term lease for a 122,000-square foot state-of-the-art biomanufacturing facility located at 100 Technology Way in Smithfield, Rhode Island. “We are pleased to join t ...

CANTON, Mass., Nov. 15, 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 and Sports Medicine markets, commends today’s decision by the U.S. Centers for Medicare & Medicaid Services (CMS) on local coverage determination (LCD) based on peer-reviewed and evidence-based data of clinical efficacy. The LCD covers skin substitute g ...

Financial Data and Key Metrics Changes - Net revenue for Q3 2024 was $115.2 million, up 6% year-over-year, exceeding previous guidance [25] - Gross profit for Q3 was $88 million, representing 76.7% of net revenue, compared to 76.2% last year [26] - Operating income decreased to $6.2 million from $8.1 million year-over-year, a decline of 22% [27] - Adjusted net income increased to $12.9 million from $5.3 million year-over-year, primarily due to a change in income tax [28] - Adjusted EBITDA for Q3 was $13.4 million, or 12% of net revenue, down from 14.7% last year [29] Business Line Data and Key Metrics Changes - Advanced wound care net revenue was $108 million, up 7% year-over-year [26] - Net revenue from surgical and sports medicine products was $7 million, up 1% [26] Market Data and Key Metrics Changes - The company expects net revenue for 2024 to be between $455 million and $480 million, representing a year-over-year increase of 5% to 11% [32] - Advanced wound care products are expected to generate revenue between $429 million and $452 million, a year-over-year increase of 6% to 11% [33] Company Strategy and Development Direction - The company is focused on leveraging clinical data to secure coverage for additional products and is actively engaging with CMS for payment reform [22][37] - The RENEW program is on track for a BLA submission by the end of Q4 2025, which could transform pain management for knee osteoarthritis [11][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the challenging operating environment and highlighted strong execution from the commercial team [7][35] - The company anticipates potential near-term disruptions in Q4 due to LCDs but remains optimistic about long-term growth opportunities [32][49] Other Important Information - The company completed a private placement of Series A convertible preferred stock, raising $100 million to fund strategic growth initiatives [30][31] - CMS has not proposed changes to payment policies for skin substitutes for 2025, but the company is advocating for a value-based payment methodology [16][19] Q&A Session Summary Question: Update on broadening the salesforce and focus on sports medicine - The company increased its rep count in the quarter, with good performance noted, particularly in wound care [42] Question: Insights on operating expenses and R&D spending - R&D expenses were lower than expected, with a return to Q2 spending levels anticipated in Q4 [43][44] Question: Guidance for Q4 and impacts from LCDs - The company expects limited impact in Q3 but maintains a wide range for Q4 guidance due to potential customer spending pullback [46][49] Question: Timeline for RENEW program and interim analysis - The last patient visit was completed in June, with an interim analysis expected by Q4, keeping the BLA submission on track for Q4 2025 [50][51]

CANTON, Mass., Nov. 12, 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 it has entered into a Subscription Agreement with affiliates of Avista Healthcare Partners (“Investors”) for the sale of its Series A Convertible Preferred Stock (“Preferred Stock”) in a private placement f ...

Organogenesis Holdings, Inc. (NASDAQ:ORGO) Q2 2024 Earnings Conference Call August 8, 2024 5:00 PM ET Company Participants Gary Gillheeney - President, Chief Executive Officer & Chair Dave Francisco - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Brooks O'Neill - Lake Street Drew Ranieri - Morgan Stanley Matthew Park - Cantor Fitzgerald Operator Please stand by. Welcome ladies and gentlemen to the Second Quarter 2024 Earnings Conference Call for Organogenesis Holdings Inc. At th ...

Financial Performance - Net revenue for Q2 2024 was $130.2 million, an increase of $12.9 million or 11% compared to Q2 2023 revenue of $117.3 million[3] - The company reported a net loss of $17.0 million for Q2 2024, a decrease of $22.4 million compared to net income of $5.3 million in Q2 2023[3] - Adjusted net income for Q2 2024 was $0.2 million, down from $6.1 million in Q2 2023, representing a 97% decrease[8] - For the first half of 2024, net revenue was $240.2 million, a 7% increase from $225.0 million in the first half of 2023[9] - The company expects 2024 net revenue guidance between $445.0 million and $470.0 million, representing a year-over-year increase of approximately 3% to 9%[12] - Net revenue for the three months ended June 30, 2024, was $130,234,000, representing an increase from $117,316,000 in the same period of 2023, a growth of approximately 11.6%[15] - Gross profit for the six months ended June 30, 2024, was $182,316,000, compared to $172,035,000 for the same period in 2023, reflecting a year-over-year increase of about 6.0%[15] - The company reported a net loss of $17,043,000 for the three months ended June 30, 2024, compared to a net income of $5,316,000 in the same period of 2023[15] - Net income for June 2024 was a loss of $19,143 thousand, compared to a profit of $2,347 thousand in June 2023[16] Operating Expenses - Operating expenses for Q2 2024 were $114.9 million, an increase of 41% from $81.3 million in Q2 2023[7] - Total operating expenses for the three months ended June 30, 2024, were $114,928,000, up from $81,255,000 in the prior year, indicating a significant increase of approximately 41.3%[15] - R&D expenses rose to $15.6 million in Q2 2024, a 42% increase from $10.9 million in Q2 2023[7] - Total depreciation and amortization expenses increased to $6,438 thousand in June 2024 from $4,922 thousand in June 2023[16] Cash and Liquidity - The company had $90.5 million in cash and cash equivalents as of June 30, 2024, down from $104.3 million at the end of 2023[9] - Cash and cash equivalents decreased to $89,902,000 as of June 30, 2024, from $103,840,000 at the end of 2023, a decline of about 13.4%[14] - Cash flows from operating activities resulted in a net cash used of $5,424 thousand for June 2024, down from a net cash provided of $3,569 thousand in June 2023[16] - Cash paid for interest was $2,744 thousand in June 2024, compared to $2,608 thousand in June 2023[16] - Cash, cash equivalents, and restricted cash at the end of the period were $90,477 thousand, up from $89,508 thousand at the end of June 2023[16] - The company used $4,102 thousand in investing activities for purchases of property and equipment in June 2024, down from $15,061 thousand in June 2023[16] Assets and Liabilities - Accounts receivable increased to $105,945,000 as of June 30, 2024, compared to $81,999,000 at the end of 2023, representing a rise of approximately 29.2%[14] - Total current liabilities rose to $85,727,000 as of June 30, 2024, compared to $80,509,000 at the end of 2023, an increase of about 6.8%[14] - The accumulated deficit increased to $(60,114,000) as of June 30, 2024, from $(40,971,000) at the end of 2023, indicating a worsening of approximately 46.8%[14] - Total assets decreased to $443,163,000 as of June 30, 2024, from $460,025,000 at the end of 2023, a decline of approximately 3.7%[14] Impairments and Provisions - The company reported a significant impairment of $18,842 thousand related to a purchased building and associated unfinished construction work[19] - The company has incurred impairment charges of $19,000 related to buildings and improvements, and $4,000 for write-downs of capitalized software costs[21] - The company recorded a provision for credit losses of $2,032 thousand in June 2024, compared to $190 thousand in June 2023[16] Future Outlook and Risks - The company faces significant competition and rapid technological changes that could impact its business and financial condition[23] - The company is focused on expanding its product offerings in the advanced wound care and surgical & sports medicine markets[24] - The company has outlined risks related to changes in coverage and reimbursement levels for its products, which could affect future revenue[23] - The company is working on obtaining regulatory approval for new products, including ReNu, which is critical for its commercialization strategy[23] - The company has incurred losses in the current and prior periods and may continue to do so in the future[23] Adjusted Metrics - Adjusted EBITDA for Q2 2024 was $15.6 million, a slight increase of $0.2 million or 1% from $15.4 million in Q2 2023[8] - Adjusted EBITDA for the three months ended June 30, 2024, was $15,649 thousand, compared to $15,403 thousand for the same period in 2023[18] - Non-GAAP operating income for the six months ended June 30, 2024, was $6,792 thousand, compared to $9,985 thousand for the same period in 2023[20] - Adjusted EBITDA for the year is projected to be $16,000, while for the first half of 2024, it is projected at $35,000[21] - The company expects an adjusted net income (loss) of $(8,000) for the year ending December 31, 2024, compared to an adjusted net income of $7,000 for the first half of 2024[22]

On track to submit ReNu BLA by the end of 2025 Enrollment in second Phase 3 complete; significantly ahead of expectations Subgroup analysis demonstrated most severe (KL4) subjects responded comparably to moderate (KL3) CANTON, Mass., Aug. 08, 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 and Sports Medicine markets, today ...

CANTON, Mass., July 15, 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 second quarter of fiscal year 2024 financial results will be reported after the market closes on Thursday, August 8th. Management will host a conference call at 5:00 p.m. Eastern Time on August 8th to discu ...