TELA Bio(TELA)

Search documents
TELA Bio to Announce First Quarter 2025 Financial Results
Globenewswire· 2025-04-17 20:05
Core Viewpoint - TELA Bio, Inc. is set to report its first quarter 2025 financial results on May 8, 2025, and will host a conference call and webcast to discuss these results and provide a corporate update [1]. Group 1: Financial Reporting - The first quarter 2025 financial results will be reported on May 8, 2025 [1]. - A conference call and webcast will take place at 4:30 p.m. ET on the same day to discuss the financial results [1]. Group 2: Company Overview - TELA Bio, Inc. is a commercial-stage medical technology company focused on innovative soft-tissue reconstruction solutions [3]. - The company aims to optimize clinical outcomes by preserving and restoring the patient's own anatomy while minimizing long-term exposure to synthetic materials [3].
TELA Bio Announces U.S. Commercial Launch of Larger Sizes of OviTex® PRS for Plastic and Reconstructive Surgery
Newsfilter· 2025-03-31 11:00
To learn more, visit ovitexprs.com. About TELA Bio, Inc. MALVERN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- TELA Bio, Inc. (NASDAQ:TELA), a commercial- stage medical technology company focused on advancing soft-tissue reconstruction solutions, today announced the U.S. launch of larger sizes of OviTex PRS Reinforced Tissue Matrix, the only tissue-based device reinforced with polymer suture embroidery specifically engineered for plastic and reconstructive surgery. Designed for consistency in thickness, stretch, ...
TELA Bio(TELA) - 2024 Q4 - Annual Report
2025-03-21 20:05
Revenue Dependence and Sales Performance - Sales of OviTex products accounted for 66%, 67%, and 70% of total revenue for the years ended December 31, 2024, 2023, and 2022, respectively[254]. - The company expects that sales of OviTex products will continue to account for the majority of revenue for the foreseeable future[254]. - The company is highly dependent on the commercial success of its OviTex product line, which poses a risk to its financial condition if sales do not increase[254]. - The company’s ability to grow revenue will depend on increasing sales of OviTex products and successfully introducing new products[260]. - The company may experience lower than expected sales if there is a decrease in consumer spending or negative reactions to pricing[249]. - Approximately 15%, 10%, and 8% of the company's revenue for the years ended December 31, 2024, 2023, and 2022, respectively, came from sales in markets outside of the U.S.[273]. Regulatory Compliance and Risks - The company must comply with various regulatory requirements, including FDA clearances, to commercialize its OviTex products[281]. - The company may face enforcement actions from the FDA for non-compliance, which could result in fines, recalls, or delays in product sales[335]. - Compliance with EU MDR is essential for selling products in EEA, with CE mark obtained for OviTex products[348]. - Regulatory compliance failures could lead to significant penalties, including fines, product recalls, and operational restrictions[356]. - Changes in regulatory policies or new legislation could delay or complicate future product approvals and market entry[370]. - The transition period for compliance with the new MDR regulations ends on May 26, 2024, necessitating a quality management system[372]. - Ongoing regulatory scrutiny requires periodic safety and effectiveness reports to the FDA, with non-compliance risking enforcement actions[353]. - Future modifications to products may necessitate new regulatory clearances, impacting the timely introduction of enhanced products[348]. Intellectual Property and Competitive Position - The company owns twenty-three issued or allowed U.S. patents and has twelve pending U.S. patent applications, with rights to a total of twenty-five issued or allowed U.S. patents as of December 31, 2024[299]. - The company may face significant expenses to enforce or defend its intellectual property rights, which could harm its competitive position[298]. - The company may encounter ownership disputes regarding intellectual property developed by employees or contractors, which could interfere with its ability to capture commercial value[306]. - The company may face challenges in protecting its proprietary rights in non-U.S. countries, which could hinder its competitive position[304]. - Recent changes in U.S. patent laws could limit the company's ability to obtain and enforce patents, creating uncertainty regarding the value of existing patents[325]. Market and Competitive Landscape - The medical device industry is highly competitive, with larger competitors having greater market share and resources, which could hinder the company's ability to compete effectively[412]. - The company may struggle to renew contracts with Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs), affecting sales and operations[418]. - The commercial success of the company's products will depend on market acceptance among surgeons and medical professionals[255]. - The company may face challenges in maintaining market acceptance if competing products are introduced that are more cost-effective[258]. Supply Chain and Manufacturing Risks - The company relies on Aroa as the exclusive manufacturer and supplier of its OviTex and OviTex PRS products, which poses risks if Aroa fails to meet production demands[277]. - The company is dependent on the supply of ovine rumen sourced through Aroa in New Zealand, which may be vulnerable to disruptions[290]. - Any disruption in Aroa's manufacturing activities could materially affect the company's revenue and market acceptance of its products[287]. - Aroa expanded its manufacturing capacity by approximately 15,000 square feet in 2022 to meet anticipated demand[286]. Financial and Operational Risks - The company's financial results may fluctuate significantly due to various factors, making period-to-period comparisons less meaningful[406]. - Changes in political and regulatory environments could have a material adverse effect on the company's financial condition and operations[405]. - The company faces risks related to cybersecurity incidents that could disrupt operations and damage reputation[441]. - The company does not have redundant facilities, which poses risks of operational disruption due to natural or man-made disasters[440]. - Accurate forecasting of customer demand is critical, as mismanagement could lead to inventory issues and reputational damage[430]. Healthcare and Economic Environment - Rising inflation rates may negatively impact revenues and profitability, potentially leading to lower volumes of elective surgeries[249]. - Future healthcare reforms may limit government payments for healthcare products, potentially reducing demand and revenue for the company[400]. - The Affordable Care Act significantly impacts the healthcare industry by broadening access to health insurance and imposing new taxes on pharmaceutical manufacturers[398]. - Changes in healthcare laws, such as the Affordable Care Act, may increase the difficulty and cost of commercializing products[397]. Clinical and Market Research - The BRAVO study fully enrolled 92 patients to support the marketing of OviTex products, but long-term effects of certain products remain unstudied[425]. - Interim or preliminary data from clinical trials may change as more patient data become available, impacting business prospects[427].
TELA Bio(TELA) - 2024 Q4 - Earnings Call Presentation
2025-03-21 02:06
INVESTOR PRESENTATION March 2025 Forward Looking Statements This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this document, including but not limited to statements regarding possible or assumed future results of operations, business strategies, development plans, regulatory activities, market opportunity competitive position, potential growth opportunities, a ...
TELA Bio(TELA) - 2024 Q4 - Earnings Call Transcript
2025-03-21 02:04
Financial Data and Key Metrics Changes - Revenue for Q4 2024 was $17.6 million, representing a 3.8% increase compared to Q4 2023, marking the first instance of single-digit revenue growth since the COVID-19 pandemic [7][31] - Full-year revenue for 2024 reached $69.3 million, a 19% increase year-over-year [31] - Gross margin for Q4 was 64%, down from 68% in the prior year, primarily due to higher expenses related to excess and obsolete inventory [32] Business Line Data and Key Metrics Changes - OviTex revenue grew 17% for the full year, with unit sales increasing by 28% in Q4 and 33% for the year [31][32] - PRS revenue grew 21% for the full year, with unit sales increasing by 11% in Q4 and 31% for the year [31][32] Market Data and Key Metrics Changes - The company faced external headwinds, including a hurricane that impacted surgical volumes in key regions, particularly in the Southeast [10][11] - The shortage of IV fluids due to the hurricane affected elective surgeries, contributing to lower surgical volumes [10][11] Company Strategy and Development Direction - The company is implementing a revised commercial strategy, focusing on a team-based sales approach with territory managers and account specialists [12][14] - There is an emphasis on expanding the product portfolio and capturing market share in hernia repair and plastic reconstructive surgery (PRS) [18][19] - The company plans to launch larger-sized versions of existing products and a new long-term resorbable alternative for hernia products in 2025 [21][22] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in Q4 but expressed optimism for 2025, citing a strong commercial strategy and anticipated product launches [12][38] - The company expects revenue growth of 23% to 27% in 2025, with a target range of $85 million to $88 million [34][36] Other Important Information - The company ended 2024 with $52.7 million in cash and cash equivalents, indicating a strong liquidity position [34] - Management highlighted the importance of clinical validation and educational outreach to enhance product adoption [22][24] Q&A Session Summary Question: Follow-up on territory manager departures - Management reported losing 11 territory managers in Q4 due to unplanned departures, which significantly impacted performance [43][44] Question: Outlook for 2025 regarding unit versus ASP expectations - Management indicated that the introduction of new products may lead to lower average selling prices (ASP) in some areas, but they expect ASP stability in PRS [52][56] Question: Confidence in reaching breakeven with existing liquidity - Management expressed confidence in achieving profitability, citing flat operating expenses and revenue growth [60][62] Question: Revenue guidance and sales ramp for 2025 - Management expects a typical seasonal ramp-up in revenue throughout 2025, with a strong start in Q1 [68][70] Question: Compensation strategies to retain top performers - Management has enhanced the compensation plan to retain top talent and mitigate the risk of poaching [126][128]
TELA Bio, Inc. (TELA) Reports Q4 Loss, Misses Revenue Estimates
ZACKS· 2025-03-20 23:51
分组1 - TELA Bio, Inc. reported a quarterly loss of $0.23 per share, which is an improvement from a loss of $0.53 per share a year ago, aligning with the Zacks Consensus Estimate [1] - The company posted revenues of $17.65 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 24.25%, but showing a slight increase from $17 million in the same quarter last year [2] - TELA Bio shares have declined approximately 21.9% since the beginning of the year, contrasting with the S&P 500's decline of 3.5% [3] 分组2 - The earnings outlook for TELA Bio is mixed, with the current consensus EPS estimate for the coming quarter at -$0.30 on revenues of $21 million, and -$0.66 on revenues of $94.1 million for the current fiscal year [7] - The Medical - Biomedical and Genetics industry, to which TELA Bio belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable industry outlook [8] - TELA Bio has surpassed consensus EPS estimates only once in the last four quarters, indicating challenges in meeting market expectations [1][2]
TELA Bio(TELA) - 2024 Q4 - Earnings Call Transcript
2025-03-20 20:30
TELA Bio (TELA) Q4 2024 Earnings Call March 20, 2025 04:30 PM ET Company Participants Greg Chodaczek - Managing DirectorAntony Koblish - Co-Founder, CEO & PresidentRoberto Cuca - CFO & COOCaitlin Cronin - Director Conference Call Participants Frank Takkinen - Senior Research AnalystDavid Turkaly - Research AnalystMatt O'Brien - AnalystMichael Sarcone - Analyst Operator Good afternoon, ladies and gentlemen, and welcome to the TeleBio Fourth Quarter twenty twenty four Earnings Conference Call. At this time, a ...
TELA Bio(TELA) - 2024 Q4 - Annual Results
2025-03-20 20:15
Revenue Performance - Revenue for Q4 2024 was $17.6 million, a 4% increase compared to Q4 2023, while full year revenue reached $69.3 million, representing a 19% growth year-over-year[5][10] - Full year 2025 revenue guidance is projected between $85.0 million and $88.0 million, indicating a year-over-year growth of 23% to 27%[19] Product Sales - Unit sales for OviTex and OviTex PRS products grew approximately 33% and 31% respectively during 2024, driven by increased demand[6] - The launch of OviTex IHR Reinforced Tissue Matrix resulted in over 1,200 units sold in 2024 since its introduction in mid-April[6] Profitability and Expenses - Gross profit for Q4 2024 was $11.2 million, or 64% of revenue, down from 68% in Q4 2023, primarily due to higher expenses for excess and obsolete inventory[7] - Operating expenses decreased to $19.6 million in Q4 2024 from $23.9 million in Q4 2023, reflecting efficiency efforts[8] - The net loss for Q4 2024 was $9.2 million, an improvement from a net loss of $12.9 million in Q4 2023[9] - The company aims to maintain 2025 operating expenses at the same level as in 2024[6] Market Outlook - The overall market opportunity for TELA Bio remains strong, with expectations for continued growth in the hernia repair market[4] Cash Position - Cash and cash equivalents as of December 31, 2024, totaled $52.7 million, up from $46.7 million in 2023[14]
TELA Bio Reports Fourth Quarter and Full Year 2024 Financial Results
Globenewswire· 2025-03-20 20:05
Core Viewpoint - TELA Bio, Inc. reported a 19% revenue growth for 2024, despite fourth-quarter results falling short of expectations due to various disruptions. The company remains optimistic about future growth driven by its innovative products and market trends away from permanent synthetic materials in hernia repair and reconstructive surgery [3]. Financial Performance - Fourth quarter 2024 revenue was $17.6 million, a 4% increase from Q4 2023, attributed to higher unit sales and new customer additions, although offset by lower average selling prices due to a shift in product mix [4][9]. - Gross profit for Q4 2024 was $11.2 million, representing 64% of revenue, down from 68% in Q4 2023, primarily due to higher expenses related to obsolete inventory adjustments [5][10]. - Operating expenses decreased to $19.6 million in Q4 2024 from $23.9 million in Q4 2023, leading to a reduced loss from operations of $8.4 million compared to $12.3 million in the prior year [6][11]. - The net loss for Q4 2024 was $9.2 million, an improvement from a net loss of $12.9 million in Q4 2023 [7][12]. Annual Overview - For the full year 2024, revenue reached $69.3 million, a 19% increase from 2023, driven by a 33% increase in unit sales of OviTex products [8][10]. - Gross profit for the full year was $46.5 million, or 67% of revenue, slightly down from 69% in 2023 due to similar inventory expense issues [10]. - Operating expenses for 2024 totaled $88.2 million, up from $84.2 million in 2023, with a loss from operations of $34.1 million, improved from a loss of $44.1 million in the previous year [11]. - The net loss for the full year was $37.8 million, compared to a net loss of $46.7 million in 2023 [12]. Future Guidance - TELA Bio projects 2025 revenue between $85.0 million and $88.0 million, indicating a year-over-year growth of 23% to 27% [17]. - First quarter 2025 revenue is expected to range from $17.0 million to $18.0 million, reflecting a growth of 2% to 8% compared to Q1 2024 [17]. - Operating expenses for 2025 are anticipated to remain flat compared to 2024 [17].
TELA Bio to Announce Fourth Quarter and Full Year 2024 Financial Results
Globenewswire· 2025-02-27 21:05
Group 1 - TELA Bio, Inc. will report its fourth quarter and full year 2024 financial results on March 20, 2025, followed by a conference call and webcast at 4:30 p.m. ET [1] - Investors can register online to listen to the conference call, with a requirement to register at least 15 minutes before the start [2] - TELA Bio focuses on innovative soft-tissue reconstruction solutions that prioritize the preservation and restoration of the patient's own anatomy, aiming to optimize clinical outcomes [3] Group 2 - The company is committed to providing advanced and economically effective soft-tissue reconstruction solutions that leverage the patient's natural healing response while minimizing long-term exposure to synthetic materials [3]