Organogenesis (ORGO)

Search documents
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]
Organogenesis (ORGO) - 2022 Q1 - Quarterly Report
2022-05-10 20:34
Table of Contents ORGANOGENESIS HOLDINGS INC. 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 March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37906 (Exact Name of Registrant as Specified in Its Charter) Delaware 98-1329150 (State or Other Jurisdiction of (I.R ...
Organogenesis Holdings (ORGO) Investor Presentation - Slideshow
2022-03-20 10:12
Organogenesis Empowering Healing Oppenheimer Annual Healthcare Conference 3/15/22 Organogenesis Empowering Healing 2 Forward Looking Statements and Other Important Cautions This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as "forecast," "intend," "seek," "target," "anticipa ...
Organogenesis (ORGO) - 2021 Q4 - Earnings Call Transcript
2022-03-02 01:21
Organogenesis Holdings Inc. (NASDAQ:ORGO) Q4 2021 Earnings Conference Call March 1, 2022 5:00 PM ET Company Participants Gary Gillheeney - President and Chief Executive Officer Dave Francisco - Chief Financial Officer Conference Call Participants Ryan Zimmerman - BTIG Danielle Antalffy - SVB Leerink Steven Lichtman - Oppenheimer Operator Good afternoon, ladies and gentlemen and welcome to the Fourth Quarter 2021 Earnings Conference Call for Organogenesis Holdings Inc. [Operator Instructions] Please note tha ...