Elutia(ELUT)
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Elutia(ELUT) - 2024 Q1 - Earnings Call Transcript
2024-05-12 16:21
Financial Data and Key Metrics Changes - The company reported net sales of $6.7 million for the quarter, compared to $6.4 million in the first quarter of 2023, indicating growth led by the SimpliDerm product line, which saw a 55% increase [31][70]. - The adjusted gross margin was 55% in Q1, down from 66% a year ago, primarily due to noncash amortization expenses [13]. - Operating expenses were $11.3 million for the quarter, slightly down from $11.7 million a year ago, with $2 million attributed to noncash stock-based compensation [32]. Business Line Data and Key Metrics Changes - SimpliDerm was the standout performer with a 55% growth in sales, while CanGaroo maintained consistent revenue compared to the previous year despite a smaller commercial organization [31][70]. - The company is preparing for the launch of CanGarooRM, which is expected to enter a $600 million market for device protection in pacemakers [92][61]. Market Data and Key Metrics Changes - The breast reconstruction market in the U.S. is approximately a $1.6 billion addressable market, with significant opportunities for innovation [79]. - The pacemaker market has about 500,000 placements annually, with Medtronic holding a 40% market share, and the company aims to disrupt this market with its CanGarooRM product [71][98]. Company Strategy and Development Direction - The company is focused on pioneering drug-eluting biologics, with CanGarooRM expected to provide superior outcomes in the pacemaker space [35][92]. - The strategy includes expanding the commercial infrastructure and preparing for the launch of CanGarooRM, targeting existing customers familiar with the CanGaroo product [100][58]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in receiving FDA clearance for CanGarooRM in June, which is anticipated to be a positive decision [38][61]. - The company is optimistic about the growth trajectory of SimpliDerm and the potential for CanGarooRM to capture market share from existing competitors [30][61]. Other Important Information - The company ended the quarter with $12.6 million in cash, excluding approximately $15 million in warrants that are nearly 100% in the money [108]. - The company is actively preparing for the commercialization of CanGarooRM, including scaling production and training the sales force [63][39]. Q&A Session Summary Question: What is the status of the FDA conversations regarding CanGarooRM? - Management indicated that discussions with the FDA have been positive, and they expect clearance in June [54][61]. Question: What preparations are being made for the commercial launch of CanGarooRM? - The company is investing in expanding its commercial infrastructure and preparing VAC packages for hospitals [20][58]. Question: How does the company view the growth of SimpliDerm moving forward? - Management noted that SimpliDerm has been performing exceptionally well, with a robust growth rate and plans to continue expanding the sales team [30][42]. Question: What is the expected timeline for the VAC process after CanGarooRM approval? - The VAC process is expected to vary, with some centers potentially completing it in as little as a month [49][64].
Elutia(ELUT) - 2024 Q1 - Quarterly Results
2024-05-09 21:26
Exhibit 99.1 · Generated strong revenue growth for proprietary product lines in the first quarter of 2024, led by SimpliDerm net sales increasing 55% compared to the first quarter of 2023 · FDA interactions regarding CanGarooRM, Elutia's antibiotic-eluting biologic envelope, continue to be positive · Addressing the final details for CanGarooRM clearance; anticipate FDA decision in the second quarter of 2024 · Preparing for launch of CanGarooRM in the second half of 2024 First Quarter 2024 Financial Results ...
Elutia to Present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1
Newsfilter· 2024-04-24 20:05
SILVER SPRING, Md., April 24, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (NASDAQ:ELUT) ("Elutia"), a company pioneering drug-eluting biomatrix products, today announced that Dr. Randy Mills, President and Chief Executive Officer, and Matt Ferguson, Chief Financial Officer, will present at the Planet MicroCap Showcase: VEGAS 2024 on Wednesday, May 1, 2024, at 3:00 p.m. ET (12:00 p.m. PT). Planet MicroCap Showcase: VEGAS 2024Presentation Date: Wednesday, May 1, 2024Presentation Time: 3:00 p.m. ET (12:00 p.m. PT)Web ...
Elutia(ELUT) - 2023 Q4 - Annual Report
2024-03-10 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 For transition period from to Commission File Number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (Address of principal executive offices and Z ...
Elutia(ELUT) - 2023 Q4 - Earnings Call Transcript
2024-03-08 01:43
Elutia, Inc. (NASDAQ:ELUT) Q4 2023 Results Conference Call March 7, 2024 4:30 PM ET Company Participants Matt Steinberg - Finn Partners Randy Mills - President and Chief Executive Officer Matt Ferguson - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Ross Osborn - Cantor Fitzgerald Operator Greetings. Welcome to the Elutia Fourth Quarter and Full-Year 2023 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answe ...
Elutia(ELUT) - 2023 Q4 - Annual Results
2024-03-06 16:00
Exhibit 99.1 Elutia Reports Fourth Quarter and Full Year 2023 Financial Results: Anticipates CanGarooRM Clearance Decision in First Half of 2024 SILVER SPRING, Md., March 7, 2024 — Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company") today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023. Business Highlights: "After years of pioneering development, we are on the verge of introducing the drug-eluting biomatrix that promises to remove com ...
Elutia(ELUT) - 2023 Q3 - Earnings Call Transcript
2023-11-17 17:30
Elutia, Inc. (NASDAQ:ELUT) Q3 2023 Results Conference Call November 13, 2023 4:30 PM ET Company Participants David Carey - Finn Partners Randy Mills - President and Chief Executive Officer Matt Ferguson - Chief Financial Officer Conference Call Participants Ross Osborn - Cantor Fitzgerald Frank Takkinen - Lake Street Capital Markets Operator Greetings. Welcome to the Elutia Q3 2023 Financial Results Call. [Operator Instructions]. Please note this conference is being recorded. I will now turn the conference ...
Elutia(ELUT) - 2023 Q3 - Quarterly Report
2023-11-13 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 For the transition period from to Commission file number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...
Elutia(ELUT) - 2023 Q2 - Earnings Call Transcript
2023-08-20 16:41
Financial Data and Key Metrics Changes - For Q2 2023, the company generated net sales of $10.3 million, a decrease from $12.6 million in the same period last year, impacted by a $3 million revenue reversal due to the viable bone matrix recall [30][31] - Gross profit for Q2 2023 was $1 million, with a gross margin of 9.5%, significantly down due to the recall, which decreased gross profit by $5 million and gross margin by 35 percentage points [31][32] - The net loss for Q2 2023 was $10.6 million, compared to a net loss of $9.4 million in the prior year [39] Business Line Data and Key Metrics Changes - The SimpliDerm product line saw a 32% increase in sales compared to Q2 2022, while sales of the CanGaroo product line remained consistent despite a reduction in sales headcount [36] - The Cardiovascular product line, now under LeMaitre Vascular, experienced a significant increase in volume, although this was primarily due to distributor transfer pricing rather than end-user pricing [37] Market Data and Key Metrics Changes - The company expects cash burn to increase in the current quarter due to the loss of revenue from viable bone matrix products, but anticipates moderating this impact through optimization efforts and growth in SimpliDerm and CanGaroo [33] Company Strategy and Development Direction - Aziyo is transforming into a drug-eluting biomatrix company, focusing on high-value assets like CanGaroo and SimpliDerm [14][16] - The company has signed an exclusive distribution partnership with LeMaitre Vascular for its Cardiovascular product lines, which is off to a strong start [14] - Aziyo is in the process of divesting its Orthopedics business, having received strong interest and negotiating multiple letters of intent [15] Management's Comments on Operating Environment and Future Outlook - Management emphasized patient safety as a priority following the recall of viable bone matrix products and is cooperating with health authorities for further investigation [10][11] - The approval of CanGaroo RM is seen as a significant opportunity, potentially creating several hundred million dollars of value for the company [20][28] - The company is optimistic about the partnerships with LeMaitre and Sientra, expecting them to enhance sales and market coverage [42][43] Other Important Information - The company is working on obtaining FDA clearance for CanGaroo RM, with expectations to submit updated information by the end of the year [28] Q&A Session Summary Question: Does the $3 million revenue reversal reflect an entire quarter's worth of revenue for the viable bone matrix? - Yes, the recall reflected the outstanding viable bone matrix product for the quarter, and this is a good assumption for ongoing revenue reduction [41] Question: How are the sales teams of LeMaitre and Sientra performing? - LeMaitre is further ahead in the transition process and performing well, while Sientra is just starting to launch products [42] Question: What is the status of the relationship with Boston Scientific regarding CanGaroo? - There has been positive interaction and recognition of CanGaroo's clinical benefits, leading to further collaboration between Aziyo and Boston Scientific [46]
Elutia(ELUT) - 2023 Q2 - Earnings Call Presentation
2023-08-20 16:11
Forward-Looking Statements This presentation may also contain statistical data, estimates and/or other information or data made by independent parties and/or by us relating to market size and growth, as well about our industry and business. Any such data or information that is based on estimates, forecasts, projections, market research, or similar methodologies, involve a number of assumptions and limitations and are inherently subject to uncertainties, and we have not independently verified the accuracy or ...