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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 ...
Organogenesis (ORGO) - 2023 Q1 - Earnings Call Transcript
2023-05-11 03:50
Organogenesis Holdings Inc. (NASDAQ:ORGO) Q1 2023 Earnings Conference Call May 10, 2023 5:00 PM ET Company Participants Gary Gillheeney - President and CEO Dave Francisco - CFO Conference Call Participants Ryan Zimmerman - BTIG Operator Welcome, ladies and gentlemen to the First Quarter of Fiscal Year 2023 Earnings Conference Call for the Organogenesis Holdings Inc. At this time, all participants have been placed in a listen-only mode. Please note that this conference call is being recorded and that the rec ...
Organogenesis (ORGO) - 2023 Q1 - Quarterly Report
2023-05-10 20:47
Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 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. UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact Name of Registrant as Specified in Its Charter) WASHINGTON, DC 20549 Delaware 98-1329150 (State or Other Jurisdiction of Incorporation or Organizat ...
Organogenesis (ORGO) - 2022 Q4 - Earnings Call Transcript
2023-03-02 03:17
Financial Data and Key Metrics Changes - Net income for Q4 2022 was $7.5 million, a decrease of $43.5 million compared to $51 million in Q4 2021, primarily due to a prior year tax benefit of $32 million [2] - Adjusted EBITDA for Q4 2022 was $14.1 million, or 12% of net revenue, down from $26.3 million, or 21% of net revenue, in the previous year [2] - Operating income for Q4 2022 was $8.7 million, a decrease from $19.8 million in the prior year [67] Business Line Data and Key Metrics Changes - Net revenue for Advanced Wound Care products in Q4 2022 was $108.8 million, down 10% year-over-year, while Surgical & Sports Medicine products revenue was $6.7 million, down 6% [21][29] - PuraPly products generated $56.8 million in revenue for Q4 2022, a decline of 9% [29] - Excluding certain products, there was low double-digit growth in the number of accounts served in both hospital outpatient and physician office settings [23] Market Data and Key Metrics Changes - The company experienced a 10% decline in sales of non-PuraPly products due to reimbursement uncertainty and competitive pressures [22] - The company expects sales of non-PuraPly products to increase approximately 28% year-over-year in 2023 [3][73] Company Strategy and Development Direction - The company is in the second year of a strategic repositioning, focusing on expanding its commercial reach beyond spine fusion and foot and ankle procedures [5] - The company aims to strengthen its competitive position in the surgical sports medicine market and enhance its product offerings [34][71] - The company plans to optimize independent agency relationships and pilot new commercial strategies [5] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a challenging operating environment in Q4 2022, with expectations for continued competitive noise in 2023 [70] - The company remains confident in its long-term growth potential, targeting sustainable low double-digit growth on a normalized basis [71] - Management expects to navigate challenges in the office setting due to competitive pressures but anticipates stable growth in wound care centers and hospital outpatient settings [52][70] Other Important Information - The company has paused construction of its Canton manufacturing facility due to increased costs, with a 40% rise in estimated project investment [26] - The company has $103.3 million in cash and cash equivalents and $70.8 million in debt obligations as of December 31, 2022 [31] Q&A Session Summary Question: What are the assumptions underpinning the guidance from a macro perspective? - Management acknowledged competitive noise but indicated expectations for market growth in 2023 [6] Question: Why has PuraPly seen drastic declines in usage for 2023? - Management noted a pause in acquisition due to the publication of the physician fee schedule, which is expected to improve over time [7] Question: Can you elaborate on potential rebates from CMS? - Management indicated uncertainty regarding potential refund amounts owed to CMS [8][57] Question: What is the outlook for competitive pressures? - Management believes competitive pressures may improve as the market absorbs new product information and efficacy becomes a key differentiator [12][62]
Organogenesis (ORGO) - 2022 Q4 - Annual Report
2023-03-01 21:45
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, 2022 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) - 2022 Q3 - Earnings Call Transcript
2022-11-10 02:24
Financial Data and Key Metrics Changes - The company reported net revenue of $116.9 million for Q3 2022, a 3% increase year-over-year, driven by a 2% increase in advanced wound care products and a 15% increase in surgical and sports medicine products [7][33] - Gross profit for Q3 2022 was $90.7 million, approximately 77.6% of net revenue, compared to 77% in the previous year [34] - Operating income decreased to $1.8 million from $16.3 million year-over-year, while net income fell to $0.2 million from $12.6 million [39][40] - Adjusted EBITDA for Q3 2022 was $11.6 million, or 10% of net revenue, down from $21.7 million, or 19% of net revenue, in the prior year [40] Business Line Data and Key Metrics Changes - Advanced wound care net revenue was $109.5 million, up 2% year-over-year, while surgical and sports medicine products generated $7.3 million, up 15% [33] - Sales of PuraPly products increased by 12% year-over-year, contributing $63.7 million to net revenue [34][33] - Non-PuraPly product sales declined by 6% year-over-year, primarily due to a 21% decline in PMA and other products [15][16] Market Data and Key Metrics Changes - The company experienced a challenging operating environment in the physician office setting, impacted by competitive pressures and staffing challenges [9][10] - The hurricane Ian affected demand in Florida during the last week of the quarter, which contributed to lower sales results [8] - The company anticipates continued competitive pressure in the amniotic products market until CMS publishes ASPs [21][22] Company Strategy and Development Direction - The company aims to diversify revenue across physician specialties and sites of care, targeting product development and commercial strategies to drive growth [12] - The company paused the construction of a manufacturing facility in Canton, Massachusetts, due to a 40% increase in expected investment costs [24][25] - The company plans to continue launching innovative products and expanding its sales force to enhance market penetration [23][11] Management's Comments on Operating Environment and Future Outlook - Management noted that competitive pressures and reimbursement confusion are significant challenges, particularly in the office setting [52][58] - The company updated its full-year 2022 guidance, expecting net revenue between $448 million and $465 million, reflecting a decline of approximately 2% year-over-year [20][43] - Management expressed confidence in the company's unique value proposition and broad product portfolio to navigate current challenges [22][23] Other Important Information - The company is progressing in its Phase 3 clinical trial for ReNu for knee osteoarthritis, with over 82% of patients enrolled [27] - The company plans to submit an IND amendment to the FDA and expects to launch a second Phase 3 trial by mid-2023 [28] Q&A Session Summary Question: What factors contributed to the decline in the amnion business? - Management indicated that competitive pressure and confusion regarding reimbursement have persisted, impacting sales [52] Question: Any updates on Novachor and its impact on TransCyte? - Novachor is currently in a soft launch phase, with expectations for a more significant impact next year. Alternatives for TransCyte manufacturing are being explored [54] Question: How do the recent challenges affect the fourth quarter outlook? - Management acknowledged that the hurricane and competitive pressures impacted sales, but they expect to remain at the lower end of guidance [57] Question: What is the expectation for pricing strategies moving forward? - Management confirmed that pricing has been affected by competition, and they are focused on understanding account dynamics to navigate the situation [61] Question: What are the expectations for growth in 2023? - Management refrained from providing specific guidance for 2023 but noted that a larger sales force and new products should positively impact growth [64] Question: How will the company manage costs in the upcoming year? - Management emphasized a prudent investment approach based on revenue outlook while maintaining strong fundamentals [66]
Organogenesis (ORGO) - 2022 Q3 - Quarterly Report
2022-11-09 21:41
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, 2022 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) - 2022 Q2 - Earnings Call Transcript
2022-08-09 22:50
Organogenesis Holdings Inc. (NASDAQ:ORGO) Q2 2022 Earnings Conference Call August 9, 2022 5:00 PM ET Company Participants Gary Gillheeney - President and Chief Executive Officer Dave Francisco - Chief Financial Officer Conference Call Participants Steve Lichtman - Oppenheimer Ryan Zimmerman - BTIG Operator Good afternoon, ladies and gentlemen, and welcome to the Second Quarter 2022 Earnings Conference Call for Organogenesis Holdings Inc. At this time, all participants have been placed in a listen-only mode. ...
Organogenesis (ORGO) - 2022 Q2 - Quarterly Report
2022-08-09 20:53
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, 2022 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 ...
Organogenesis (ORGO) - 2022 Q1 - Earnings Call Transcript
2022-05-11 01:49
Financial Data and Key Metrics Changes - The company reported net revenue of $98.1 million for Q1 2022, a decrease of 4% year-over-year, primarily due to flat growth in Advanced Wound Care products and a 39% decline in Surgical & Sports Medicine products [8][26] - Adjusted net revenue, excluding ReNu and NuCel, increased by 1% year-over-year [9][26] - Gross profit for Q1 2022 was $73 million, approximately 74% of revenue, compared to 75% in the previous year [27] - Operating income decreased to $0.9 million from $12.6 million year-over-year [31] - Net income for Q1 2022 was $0.1 million, down from $9.9 million in the prior year [32] Business Line Data and Key Metrics Changes - Advanced Wound Care net revenue was $91 million, essentially flat year-over-year [26] - Surgical & Sports Medicine products generated $7.2 million in revenue, down 39% due to the suspension of ReNu and NuCel marketing [26] - PuraPly products saw a 29% increase in sales year-over-year, reaching $53.3 million [27][12] - Amniotic products experienced a 32% decline year-over-year, reflecting the impact of Omicron on the national launch of Affinity [12] Market Data and Key Metrics Changes - The overall operating environment in Q1 was impacted by rising Omicron case counts, affecting patient consultations and elective procedures [15] - The company expects steady improvement in the operating environment as COVID-related headwinds diminish throughout 2022 [16] Company Strategy and Development Direction - The company aims to diversify revenue across physician specialties and sites of care through targeted product development and commercial strategies [14] - The midpoint of the full-year revenue range assumes amniotic growth of approximately 12% year-over-year in 2022 [13] - The company plans to launch new products and line extensions to drive demand and expand market presence [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the full-year 2022 guidance, expecting net revenue between $485 million and $515 million, representing growth of 4% to 10% year-over-year [17][34] - The company anticipates stronger growth trends in the second half of 2022, driven by new product contributions and a return to a normalized operating environment [17][34] Other Important Information - The company appointed Michele Korfin and Gilberto Quintero to the Board of Directors, enhancing the board's experience and diversity [23][24] - The company is making progress in its Phase III clinical trial of ReNu for knee osteoarthritis, with enrollment on track [21] Q&A Session Summary Question: Update on amniotic product line and Affinity - Management noted that Q1 performance for Affinity was as expected, with positive trends observed in recent weeks and confidence in continued expansion throughout the year [45] Question: Update on commercial organization growth - The company plans to add approximately 50 new direct sales representatives and is evaluating agency relationships for competency [51] Question: Medicare pricing expectations - Management indicated that pricing changes would be reflected in the average selling price (ASP) as they occur, but no specific pricing strategy was discussed [60] Question: Restructuring program and gross margins - The restructuring aims to increase capacity and efficiency, with expectations for gross margins to improve as revenue increases throughout the year [63]