Abeona Therapeutics (NasdaqCM:ABEO) Q3 2025 Earnings Call November 12, 2025 08:30 AM ET Speaker1Good morning, everyone, and welcome to the Abeona Therapeutics third quarter 2025 conference call. At this time, all participants are in a listen-only mode, and the floor will be open for questions following the presentation. If anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note this conference is being recorded. I will now turn the conferenc ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $2.7 million, down from $5.4 million in Q3 2024, primarily due to restructuring efforts [15] - Gross profit for Q3 2025 was $1.3 million, or 49% of revenue, compared to $3.1 million, or 58% of revenue in Q3 2024 [15] - Operating expenses were $10.9 million, a decrease of 29% compared to the prior year, with an operating loss of $9.6 million, narrowed by 22% year-over-year [9][10] - Adjusted net operating loss was $6.9 million, a 39% improvement compared to the prior year [10][17] Business Line Data and Key Metrics Changes - The restructuring in Q3 focused on accounts and distributors promoting metabolically healthy weight loss, which is expected to lead to long-term growth [7][8] - Sales and marketing expenses decreased to $3.1 million from $5.2 million in Q3 2024, driven by increased operational efficiency [15][16] - Research and development expenses were reduced to $2.0 million from $3.2 million in Q3 2024, reflecting cost reductions related to the Audacity trial [16] Market Data and Key Metrics Changes - The company is seeing a trend where patients who discontinue GLP-1 treatments represent a significant opportunity for Allurion, as over half of these patients seek alternative therapies [9][18] - The company anticipates that the reduction in GLP-1 prices in the U.S. will drive more uptake and subsequently increase churn rates, leading to more patients looking for alternative therapies [27] Company Strategy and Development Direction - The company is advancing preparations for the U.S. launch of the Allurion Smart Capsule, with a focus on combination therapies with low-dose GLP-1s [6][11] - Allurion is exploring the development of a drug-eluting balloon in collaboration with a strategic partner, which could address adherence challenges in obesity therapy [12][19] - The company is retooling its R&D pipeline and manufacturing capabilities to enhance operational efficiency and expand capacity [11][13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA approval process for the Allurion Smart Capsule, highlighting successful inspections and a positive Day 100 meeting outcome [5][6] - The company believes that the Allurion program is uniquely positioned to capitalize on the success of GLP-1s and set the stage for long-term growth in the obesity management market [18][19] Other Important Information - As of September 30, 2025, cash and cash equivalents were $6.1 million, not including a recent private placement financing of $5 million [17] - The company is on a path to being debt-free through a transaction to exchange outstanding debt for convertible preferred equity [10][11] Q&A Session Summary Question: How is the company applying learnings from international strategy to the U.S. market? - Management noted that they are learning from international experiences, particularly regarding the churn rates of GLP-1 patients, and are mapping out U.S. clinics that utilize GLP-1s [21][23] Question: What is the outlook for international revenues over the next 12 to 24 months? - Management expects continued growth in Q4 and into 2026 as clinics embrace GLP-1s and combination therapies [25][26] Question: Can you provide details on the development program for the Smart Capsule as a platform technology? - Management discussed the potential of the Smart Capsule to deliver various drugs and the initiation of a longer-term balloon project that could last beyond four months [29][32]

Financial Data and Key Metrics Changes - Research and development expenses totaled $5.3 million, down from $6.2 million in Q2 2025 and $6 million in Q3 2024, reflecting the completion of the SHIELD II phase 3 trial [12] - General and administrative expenses were $1.8 million, compared to $1.2 million in Q3 2024, while marketing and business development expenses increased to $0.4 million from $0.2 million in the same period last year [12] - The net loss for the quarter was $7.5 million, or $0.37 per share, an improvement from the net loss of $7.8 million, or $1.22 per share in Q3 2024 [12] - For the nine months ended September 30, 2025, net loss was $25.7 million, or $1.72 per share, compared to $20.5 million, or $3.82 per share for the same period in 2024 [13] Business Line Data and Key Metrics Changes - The successful completion of the Israeli Ministry of Health Good Manufacturing Practice inspection marked an important step towards commercial manufacturing readiness for D-PLEX100 [6] - A new US market access study confirmed strong interest from both surgeons and hospital pharmacy directors, with 80% of surgeons indicating they are extremely likely to use D-PLEX100 for their next eligible patients [10] Market Data and Key Metrics Changes - The market access study showed that D-PLEX100 was viewed as more valuable than current SSI prevention measures, with 70% of hospital pharmacy directors reporting a high likelihood to add and stock D-PLEX100 [10] - The study indicated that D-PLEX100 addresses a significant unmet need in the market for surgical site infection prevention [10] Company Strategy and Development Direction - The company is focused on bringing D-PLEX100 to market, with a pre-NDA meeting with the FDA scheduled for early December and an NDA submission expected in early 2026 [5] - Strategic discussions with potential US partners are ongoing, building on the positive momentum from the SHIELD II trial results [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in passing the upcoming FDA inspection, highlighting ongoing improvements in facility and quality control processes [17] - The company anticipates that the pre-NDA meeting will align on the data package and submission format, setting the stage for an early 2026 submission [24] Other Important Information - The company reported a cash balance of $18.8 million as of September 30, 2025, up from $15.6 million at year-end 2024, indicating a strong cash runway into 2026 [14] - Significant progress was made in reducing debt, with current maturities decreasing from $6.5 million to $2.4 million [15] Q&A Session Summary Question: Insights on the Israeli Ministry of Health inspection - Management confirmed the successful inspection and expressed confidence in passing the upcoming FDA inspection, noting ongoing improvements in their facility [17] Question: Specific items for the pre-NDA meeting - The focus will be on reviewing the data package, submission format, and label scope to ensure alignment with the FDA [24] Question: Pricing strategy for D-PLEX100 - Management indicated strong interest in premium pricing based on market research and stakeholder feedback, suggesting that there is room to stretch pricing higher [26] Question: Growth of the PolyPid pipeline post-partnership - Management outlined plans for expanding the pipeline in oncology, obesity, and diabetes, while also emphasizing the importance of a US partner for the abdominal indication [33] Question: Market research sample size and decision-making involvement - The market research included 20 participants, all of whom were involved in the decision-making process regarding formulary inclusion [42] Question: Challenges in commercializing D-PLEX100 in the U.S. - Management acknowledged the need for future facility expansion to meet peak sales demands and is considering local manufacturing trends in their planning [46]

Autolus Therapeutics (NasdaqGS:AUTL) Q3 2025 Earnings Call November 12, 2025 08:30 AM ET Speaker2Thank you for standing by. Welcome to Autolus Therapeutics' third quarter 2025 financial results conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please ...

Financial Data and Key Metrics Changes - In Q3 2025, the company reported revenue of approximately $1.2 million from 2,841 EsoGuard tests, maintaining volume and revenue levels consistent with the previous quarter [5][22] - The quarterly burn rate was $10.3 million, slightly better than the average burn rate of the previous four quarters [22][28] - The company ended the quarter with $47.3 million in cash, bolstered by a public offering that netted approximately $27 million [9][22] Business Line Data and Key Metrics Changes - EsoGuard test volume remained within the target range of 2,500-3,000 tests per quarter, essential for ongoing engagements with commercial payers [5][8] - Revenue recognition for the majority of claims is based on the probability of collection, with 76% of claims submitted in Q3 adjudicated [26][30] Market Data and Key Metrics Changes - The company is focusing on expanding its market access, particularly targeting Medicare patients, which represent about 50% of the 30 million target population [7][8] - The company has strengthened its market access leadership team to enhance payer engagement and secure broader commercial insurance coverage [6][11] Company Strategy and Development Direction - The company is in the final stages of securing positive Medicare coverage policy outcomes, following a successful Contractor Advisory Committee meeting [4][9] - The strategy includes transitioning to target Medicare patients while maintaining volume with commercial payers [5][8] - The company is also hosting events to strengthen relationships with fire departments, focusing on esophageal cancer prevention [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Medicare coverage, anticipating a draft local coverage determination soon [12][14] - The company is actively engaging with commercial payers and has seen positive movement in discussions, indicating a shift in strategy to pursue coverage even before Medicare approval [45][48] Other Important Information - The company has a strong pipeline of contracted testing events and is expanding its efforts to drive Medicare testing [20][19] - The company reported a non-GAAP net loss of $10.3 million for Q3, consistent with previous quarters [28][30] Q&A Session Summary Question: Can you provide insights on the recent CCLA meeting and its implications? - Management highlighted that the meeting was positive, with significant time spent discussing the company's CAC meeting, reinforcing confidence in the Medicare coverage process [34][35] Question: What is the expected timeline for the draft LCD? - Management indicated that they believe the timeline for the draft LCD publication is reasonable, with expectations for it to be issued by year-end 2025 [43][44] Question: How is the company engaging with commercial payers? - Management noted that there has been increased activity and positive movement in discussions with commercial payers, with expectations for positive coverage policies to emerge soon [45][48] Question: What is the conversion rate for referrals to EsoGuard tests? - Management stated that the conversion rate for patients referred for EsoGuard tests is over 90%, indicating strong follow-through on testing [78]

Summary of C4 Therapeutics FY Conference Call Company Overview - C4 Therapeutics is a targeted protein degradation company focused on developing medicines that utilize the body's natural system to destroy disease-causing proteins rather than inhibiting them [4][5] - The company is celebrating its 10th anniversary and currently has two active clinical programs: - **Sensitamide**: An IKZF1/3 degrader for multiple myeloma, with plans for further studies in early 2026 [4][5] - **EGFR L858R degrader**: In phase one with Beta Pharmaceuticals in China, targeting a specific mutation [4][5] - C4 has collaborations with Roche, Merck KGAA, and a completed collaboration with Biogen [5] - Recent financing provides operational runway through the end of 2028 [6] Core Product Insights Sensitamide - Designed as a highly targeted and potent degrader of IKZF1 and IKZF3, which are implicated in myeloma and lymphoma proliferation [7] - Key features include: - Low protein binding, allowing for effective drug concentration in the bone marrow [7] - No renal clearance, enabling treatment for patients with renal insufficiency [8] - A half-life of 48 hours, facilitating dosing [8] - Clinical data indicates: - A 33% overall response rate across all patients, with a 53% response rate in late-line refractory patients at the highest dose [12] - Mild toxicity profile with no significant gastrointestinal or neurological side effects [10] - T cell activation observed, enhancing immune response [13] Market Dynamics and Competitive Landscape - The myeloma treatment landscape is evolving, with a shift towards introducing effective treatments earlier in the therapy regimen [18] - Sensitamide is positioned to compete against CAR-T and BITE therapies, with potential for combination therapies to enhance efficacy [20][42] - The company anticipates a growing market for late-line treatments as newer agents lead to longer patient survival but not cures [42] - Estimated market opportunity for Sensitamide is projected at $1 billion to $1.5 billion in late-line settings and $2.5 billion to $4 billion when considering second-line treatments [43] Clinical Development Strategy - Plans to initiate a phase one B study in early 2026, combining Sensitamide with Pfizer's ELREXFIO [21][22] - The study will evaluate multiple dose levels to determine optimal safety and efficacy [22] - A non-randomized phase two study will also be initiated to confirm efficacy in late-line patients [24] - The strategy includes potential for accelerated approval based on early efficacy signals [23][24] Collaboration and Future Directions - Collaboration with Pfizer is focused on leveraging expertise in BITEs for the development of combination therapies [38][39] - The company is open to exploring additional combinations as resources allow, including with CD38 and carfilzomib [25] - Continuous updates on trial progress and safety data will be provided to investors [40] Conclusion - C4 Therapeutics is well-positioned in the evolving myeloma treatment landscape with its innovative approach to targeted protein degradation, particularly through Sensitamide, which shows promising clinical data and a strong market opportunity [4][43]

BiomX (NYSEAM:PHGE) Q3 2025 Earnings Call November 12, 2025 08:30 AM ET Speaker1Good morning and welcome to BiomX's third quarter 2025 financial results and program update conference call. Currently, all participants are in a listen-only mode. At the end of this call, there will be a question-and-answer session. As a reminder, this conference call is being recorded. I would now like to turn the call over to Marina Wolfson, Chief Financial Officer of BiomX. Please proceed.Speaker3Thank you and welcome to the ...

Financial Data and Key Metrics Changes - Third quarter revenue reached $473.9 million, reflecting substantial year-over-year growth, primarily due to two months of NV5's contribution following the acquisition [17] - On a combined basis, year-to-date revenue growth was approximately 4.7% [17] - Adjusted gross profit was approximately $171 million, with an adjusted gross margin of 36.1%, up from the prior year [19] - Adjusted EBITDA for the third quarter was $77.3 million, representing an adjusted EBITDA margin of 16.3% [20] Business Line Data and Key Metrics Changes - The Inspection and Mitigation segment generated approximately $293 million in revenue, down about 3% year-over-year [18] - The Consulting Engineering segment contributed approximately $122 million during the two-month period, with potential revenue of approximately $189 million if NV5's results were included for the full quarter, reflecting an 11% increase [18] - The Geospatial segment contributed about $62 million during the same period, with potential revenue of about $90 million if MB5 results were included for the full quarter, approximately 4% higher than last year [19] Market Data and Key Metrics Changes - The company reported double-digit growth in the consulting engineering segment, driven by data center work for hyperscaler clients, which more than doubled over the trailing twelve months [9] - Infrastructure investments supporting grid modernization and energy transition are creating new opportunities across all segments [10] Company Strategy and Development Direction - The company aims to capture meaningful synergies as integration actions move into 2026, focusing on disciplined execution and long-term growth [6][14] - The strategic vision includes expanding markets served and services provided within the TIC and engineering space [6] - The company is positioned to benefit from secular tailwinds such as infrastructure renewal and energy transition [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in demand across core markets and reaffirmed full-year 2025 guidance, expecting revenue between $1.53 billion and $1.565 billion [23] - The company anticipates revenue growth of 35% relative to the 2025 combined company baseline for the following year [24] - Management highlighted the importance of maintaining operational excellence and customer service during the integration process [30] Other Important Information - The company increased its cost synergy target from $20 million to $25 million, expected to be fully realized by mid-2027 [25] - Total liquidity as of September 30, 2025, was $282.9 million, including cash and cash equivalents of $164.4 million [22] Q&A Session Summary Question: What is the reasonable range for annual free cash flow after integration? - Management indicated that the business continues to be a high free cash flow business with low CapEx and high margins, but did not provide specific guidance on free cash flow [36] Question: Is the $400 million revenue target for data centers still in place? - Management confirmed that the data center business is growing significantly, with revenue up over 100% year-to-date, and they are excited about future growth opportunities [38] Question: What is the impact of the government shutdown on geospatial services? - Management noted limited impact from the government shutdown, with optimism for a quick reopening and resumption of work orders [46][47] Question: How is the turnaround activity trending in Q4? - Management stated that turnaround activity has not materially changed and is primarily affected by the timing of LNG projects [51] Question: Can you provide more details on the increased synergy target? - Management clarified that the increased synergy target of $25 million is purely cost synergies, primarily from back office support and organizational efficiencies [56] Question: What are the growth opportunities in the business? - Management highlighted the potential for cross-selling opportunities and filling white space in the total value chain as significant growth areas [88]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $110.5 million, representing an 8% year-over-year growth [15] - Contribution ex-TAC was $51 million, up 7% year-over-year, maintaining a healthy 46% margin [15][20] - Adjusted EBITDA increased 63% year-over-year to $12.1 million, reflecting improved operational leverage [14][20] - Non-GAAP net income was $12.5 million, resulting in a non-GAAP diluted earnings per share of $0.28, a 22% year-over-year increase [21] Business Line Data and Key Metrics Changes - CTV revenue grew 75% year-over-year, driven by demand for advanced formats [17] - Retail media revenue increased by 40% year-over-year, reflecting strong momentum in this vertical [18] - Digital out-of-home revenue rose 26% year-over-year, now accounting for 22% of total revenue [18][19] - Web revenue declined by 11% year-over-year due to lower advertiser appetite for standard display and video formats [19] Market Data and Key Metrics Changes - The retail media market in the US is projected to be a $60 billion opportunity, growing at double-digit annual rates [8] - CTV and digital out-of-home channels combined represented 37% of total revenue, up from 28% in the same quarter last year [18] Company Strategy and Development Direction - The company is focused on becoming the platform of choice for modern CMOs, unifying media, data, and outcomes through the Perion One strategy [5][6] - New products like Outmax and Soda are designed to enhance performance-driven advertising and optimize monetization for publishers [4][10] - The company is expanding its share repurchase program to $200 million, reflecting confidence in long-term value [3][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth and profitability, supported by operational efficiency and scalable technology [15][24] - The company aims to capture more market share in 2026 and beyond, with expectations for continued strong performance from core growth engines [27][30] Other Important Information - The company has a strong cash position of $315 million, providing financial flexibility for growth and capital allocation [22] - The share buyback program has repurchased a cumulative total of 10.4 million shares for $94.2 million, underscoring confidence in long-term value [22][23] Q&A Session Summary Question: What are the drivers behind the CTV strength in Q3? - Management noted that performance CTV and the new algorithm, Outmax, are performing well, contributing to significant growth [26] Question: Why is the Q4 guidance range wide? - Management indicated that the quarter is trending in line with expectations and expressed confidence in meeting guidance during the holiday season [27] Question: How does the company view the web business decline? - Management clarified that the web business decline was primarily due to strategic decisions made earlier in the year, and they expect a potential return to growth in the future [38] Question: How is the company using AI internally? - Management stated that AI is increasingly integrated into R&D and operations, aiming to reduce manual work and enhance efficiency [40] Question: What is the potential of Soda and the Digital Out-of-Home Player? - Management explained that these products are designed to be integrated into the tech stack of inventory owners, increasing predictability and visibility into revenue streams [42]

Financial Data and Key Metrics Changes - Third quarter revenue reached $473.9 million, reflecting substantial year-over-year growth, primarily due to two months of NV5's contribution following the acquisition [13][15] - Year-to-date growth for the combined business was approximately 4.7%, with a quarter growth of about 2.4% if the acquisition had occurred on January 1, 2024 [13][19] - Adjusted EBITDA for the third quarter was $77.3 million, representing an adjusted EBITDA margin of 16.3%, compared to $51.3 million with a margin of 16.9% in the prior year [17][19] Business Line Data and Key Metrics Changes - The inspection and mitigation segment generated approximately $293 million in revenue, down about 3% year-over-year, while the consulting engineering segment contributed approximately $122 million during the two-month period, with a potential full quarter revenue of about $189 million, reflecting an 11% increase [15][16] - The geospatial segment contributed about $62 million during the same two-month period, with a potential full quarter revenue of approximately $90 million, up about 4% year-over-year [16] Market Data and Key Metrics Changes - The company reported double-digit growth in the consulting engineering segment, driven by data center work for hyperscaler clients, which more than doubled over the trailing 12 months [8][9] - Infrastructure investments supporting grid modernization and energy transition are creating new opportunities across all three segments, indicating multi-year growth drivers [9][12] Company Strategy and Development Direction - The company aims to expand the markets served and services provided within the TIC and engineering space, focusing on a unified platform dedicated to reliability, innovation, and service excellence [5][6] - The integration of Acuren and NV5 is expected to create synergies and enhance capabilities, allowing the company to serve clients across the full lifecycle of critical assets and infrastructure [6][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand across core markets and reaffirmed full-year 2025 guidance, expecting revenue in the range of $1.530 billion to $1.565 billion [19][20] - The company anticipates revenue growth of 3% to 5% relative to the 2025 combined company baseline for the following year [19] Other Important Information - The company has increased its cost synergy target from $20 million to $25 million, expected to be fully realized by mid-2027 [21][22] - Total liquidity as of September 30, 2025, was $282.9 million, including cash and cash equivalents of $164.4 million [18] Q&A Session Summary Question: What is the reasonable range for annual free cash flow after integration? - Management highlighted that the business is a high-free cash flow business with low CapEx and high margins, but specific guidance on free cash flow has not been provided [28][29] Question: Is the $400 million revenue target for data centers still in place? - Management confirmed that the data center business has seen over 100% growth year-to-date and remains a significant focus area [30][31] Question: What is the status of exiting lower-margin customer contracts? - Management indicated that the softness in the third quarter was primarily timing-related and that they continue to evaluate relationships for margin improvement [32] Question: How has the government shutdown impacted the geospatial segment? - Management noted limited impact from the government shutdown, with optimism for a quick reopening and resumption of work orders [35][36] Question: What is the outlook for the chemical market and its impact on guidance? - Management expects stabilization in the chemical space and is optimistic about delivering results in Q4 and next year [56][57] Question: What are the drivers for the increased synergy target? - Management clarified that the increased target is purely cost synergies, focusing on back-office support and organizational efficiency [43][44] Question: Where does the company see the most growth opportunities? - Management highlighted the potential in filling white space between segments and expanding in Canada as key growth areas [68][70]