Innate Pharma (NasdaqGS:IPHA) Q3 2025 Earnings Call November 13, 2025 08:00 AM ET Speaker2Ladies and gentlemen, thank you for joining us and welcome to the Innate Pharma Q3 2025 business update and financial results. After today's prepared remarks, we will host a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. I will now hand the conference over to Stéphanie Corne ...

Core Viewpoint - Genmab announced the acquisition of Merus N.V. for approximately $8 billion, marking its largest acquisition to date [1][7]. Group 1: Acquisition Details - Genmab will acquire all shares of Merus at $97.00 per share, with the total transaction value around $8 billion [1]. - This acquisition is expected to significantly accelerate Genmab's transition to a fully integrated model and diversify its revenue sources [7][8]. Group 2: Merus and Its Key Asset - Merus, founded in 2003 and based in the Netherlands, has a core asset, petosemtamab (MCLA-158), which is an EGFR/LGR5 bispecific antibody [3]. - Petosemtamab has shown promising results in a Phase II clinical trial for locally advanced head and neck squamous cell carcinoma (HNSCC), with an overall response rate of 63% and a median progression-free survival of 9 months [6]. Group 3: Market Reaction and Future Prospects - Following the positive clinical data, Merus's stock price surged over 60%, reaching $68.89 per share, with a market capitalization of $5.2 billion [7]. - Genmab plans to integrate petosemtamab into its late-stage development pipeline, aiming for multiple new drug launches by 2027 [7][8]. - Petosemtamab has received two Breakthrough Therapy Designations from the FDA and is expected to have a sales potential of at least $1 billion annually by 2029 [8][9].

Core Viewpoint - Dongcheng Pharmaceutical announced that its subsidiary, Lanna, has received approval from the National Medical Products Administration for the clinical trial of the 225Ac-LNC1011 injection, which will commence shortly [1] Group 1: Product Information - The 225Ac-LNC1011 injection is a targeted alpha-particle radiotherapy drug aimed at treating patients with advanced prostate cancer who express PSMA [1] - There are currently no similar products available in the domestic or international markets, nor are there any related sales data [1]

Core Viewpoint - The stock of药捷安康-B (02617) has surged over 18%, reaching a new high of 129.3 HKD, with a market capitalization exceeding 50 billion HKD, driven by positive clinical trial news for its core product, Tinengotinib [1] Company Developments -药捷安康 announced that its core product, Tinengotinib (TT-00420), in combination with Fulvestrant, has received clinical implied approval from the National Medical Products Administration (NMPA) in China for a Phase II trial targeting hormone receptor-positive (HR+) and HER2-negative or low-expressing recurrent or metastatic breast cancer, with the trial set to commence on September 10, 2025 [1] - The company highlighted that Tinengotinib targets FGFR/VEGFR, JAK, and Aurora, and currently, no other MTK inhibitors possess the same targeted combination, showcasing its unique value in treating certain diseases [1] Regulatory Approvals - Tinengotinib has been recognized as a breakthrough therapy for cholangiocarcinoma by the NMPA and has received fast track designation from the FDA for both cholangiocarcinoma and metastatic castration-resistant prostate cancer [1] - Additionally, the FDA has granted orphan drug designation for cholangiocarcinoma and the European Medicines Agency (EMA) has also awarded orphan drug status for cholangiocarcinoma treatment [1]

Core Viewpoint - Fukan Biotech (Shanghai) Co., Ltd. has submitted its main board listing application to the Hong Kong Stock Exchange, with several financial institutions acting as joint sponsors [1] Company Overview - Fukan Biotech was established in 2015, focusing on both commercialization and clinical development in the field of cancer treatment, as well as innovative drugs for viral and age-related diseases [4] - The company's core products include CVL009 and CVL218, with CVL009 currently undergoing Phase II clinical trials for specific cancer patients [4] - As of August 22, 2025, Fukan Biotech has a diversified product portfolio consisting of one commercialized product, two core products, two key products, and twelve other candidates [4] Financial Performance - The company reported revenues of 0, 17.825 million, and 34.675 million CNY for the years 2023, 2024, and the first half of 2025, respectively, with corresponding net losses of 94.655 million, 74.525 million, and 35.934 million CNY [6] - Research and development expenses for the same periods were 75.792 million, 54.425 million, and 24.421 million CNY [7] Customer Dependency - Fukan Biotech's revenue is highly dependent on a single customer, with nearly 99% of sales from its commercialized product, Han Naijia®, attributed to its largest customer, Fuhong Hanlin [8] - Fuhong Hanlin is a leading biopharmaceutical company in China, and the collaboration allows for a synergistic effect in breast cancer treatment [8] Market Potential - The global breast cancer drug market is projected to grow from approximately 29.2 billion USD in 2019 to about 41 billion USD by 2024, with a compound annual growth rate (CAGR) of 7.0% [5] - The Chinese breast cancer drug market is expected to expand from around 450 billion CNY in 2019 to approximately 683 billion CNY by 2024, with a CAGR of about 8.7% [5] Funding and Valuation - Fukan Biotech has completed six rounds of financing prior to its IPO, with post-money valuations increasing significantly from 95 million CNY in 2019 to approximately 3.188 billion CNY in 2025 [10][13] - The company's valuation has grown 32.56 times since its angel round financing [13] Ownership Structure - As of August 22, 2025, the founder and key stakeholders control approximately 55.58% of the company's issued share capital [13]

Financial Data and Key Metrics Changes - Total revenue grew by 19% in the first half of 2025, driven by increased recurring revenue [4][29] - Operating profit increased by 56%, reflecting strong financial performance despite strategic investments [5][33] - Cash reserves at the end of the first half were approximately $3 billion, providing flexibility for growth and expansion [5][29] - Recurring revenues represented 97% of total revenue, up from 90% in the same period last year [31] Business Line Data and Key Metrics Changes - Sales for Epkinley reached $211 million, a 74% year-over-year increase, contributing significantly to total revenue growth [22][29] - TIVDAC sales totaled $78 million, a 30% increase compared to the previous year, with strong performance in the US and Japan [26][29] - The growth of commercialized medicines is expected to increasingly contribute to overall revenue growth over time [21][29] Market Data and Key Metrics Changes - Epkinley has received regulatory approvals in over 60 countries, with nearly 50 countries approving it for both DLBCL and FL indications [24][29] - The FDA accepted the supplemental BLA for epiritamab with a target action date of November 30, 2025, indicating strong market potential [7][55] Company Strategy and Development Direction - The company aims to accelerate the development of high-impact late-stage programs and maximize the potential of commercialized medicines [4][39] - Plans to broaden the reach of RINA S with three Phase III trials expected to be underway by the end of the year [10][39] - The company is focused on expanding utilization of its medicines and bringing them to more patients globally [28][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, highlighting a strong financial foundation and disciplined capital allocation strategy [5][37] - The company anticipates continued growth in recurring revenues and operating profit, with improved financial guidance for 2025 [34][35] - Management is closely monitoring geopolitical situations but does not foresee significant impacts on financial guidance for 2025 [37] Other Important Information - The company completed a share buyback in June, reinforcing confidence in its future [5] - The Phase III Epcor FL1 trial met its dual endpoints, supporting the potential to transform treatment paradigms for patients [12][14] Q&A Session Summary Question: Positioning of EPCO versus other CD20 bispecifics - Management feels confident about their broad and aggressive development plan, with a head start in second-line follicular lymphoma [43][44] - They have received positive feedback from physicians and are moving into earlier lines of therapy [47][48] Question: Confidence in filing RAINFALL-one for accelerated approval - Management is confident in filing for accelerated approval based on strong data and ongoing engagement with the FDA [54][55] Question: Initial launch strategy for Epkinley - The focus will be on earlier lines of therapy, particularly in the community setting, with significant opportunities for patient expansion [62] Question: Development plans for RINA S outside ovarian cancer - The Phase II trial will explore RINA S in both monotherapy and combination settings, with a focus on EGFR mutated non-small cell lung cancer [93] Question: ADC combinations in lymphoma - Management sees potential for ADC combinations and believes bispecifics will become a backbone for novel combinations in the future [87][88]

Summary of the Conference Call for BeiGene (1Q25) Company Overview - **Company**: BeiGene - **Industry**: Biotechnology/Pharmaceuticals Key Financial Performance - **1Q25 Revenue**: - Net product sales reached **$1.109 billion**, representing a **48% year-over-year increase** [1] - **Zebutinib Global Sales**: **$792 million**, with a **62% year-over-year increase** [1] - **U.S. Sales**: **$563 million**, up **60% year-over-year** [1] - **European Sales**: **$116 million**, up **73% year-over-year** [1] - **Tislelizumab Sales**: **$171 million**, reflecting an **18% year-over-year increase** [1] - **GAAP Net Profit**: Achieved a net profit of **$1.27 million**, marking the first quarterly profit [1] Strategic Developments - **Investor R&D Day**: Scheduled for **June 26**, focusing on breast cancer and other solid tumor pipelines [1] - **Reimbursement Expansion**: Zebutinib has been included or expanded in reimbursement in **11 markets**, including Japan, Europe, and Brazil [1] - **New Supplier**: Engaged **Siegfried** as a new supplier for active pharmaceutical ingredients for Zebutinib [1] - **Regulatory Filings**: BCL2 has been submitted for approval in China for the treatment of R/R CLL [1] - **Clinical Trials**: - Initiated a Phase III clinical trial for BTKCDAC in treating R/R CLL, comparing against physician's choice of treatment [1] - DLL3/CD3 bispecific antibody (in collaboration with Amgen) reported positive data from the Phase III trial for 2L SCLC [1] - CDK4 is expected to report Proof of Concept data in the first half of 2025 [1] Additional Insights - The significant growth in Zebutinib sales is attributed to its increasing market share in the treatment of new CLL patients, positioning it as the top seller in the U.S. BTK market [1]

Financial Data and Key Metrics Changes - UroGen Pharma reported net product revenues of $90.4 million for the full year 2024, an increase from $82.7 million in 2023, representing a year-over-year growth of approximately 9.3% [17][44] - The net loss for the fourth quarter of 2024 was $37.5 million, or $0.80 per share, compared to a net loss of $26 million, or $0.72 per share, in the same period in 2023 [47] - For the full year 2024, the net loss was $126.9 million, or $2.96 per share, compared to a net loss of $102.2 million, or $3.55 per share, in 2023 [47] Business Line Data and Key Metrics Changes - JELMYTO generated net product revenues of $24.6 million in Q4 2024, up from $23.5 million in Q4 2023, with underlying demand revenue increasing by 15% [44] - The underlying demand revenue for JELMYTO for the full year 2024 was $87.4 million, reflecting a 12% increase compared to the previous year [39][44] - The company reported a compelling complete response rate of 79.6% at three months and an 82.3% duration of response at 12 months for UGN-102, with updated data showing an 80.6% duration of response at 18 months [9][10] Market Data and Key Metrics Changes - The total addressable market for UGN-102 is estimated to be over $5 billion, significantly larger than the market for JELMYTO [15] - The anticipated launch of UGN-102 is expected to transform UroGen's market position, moving from a rare disease-focused company to a multiproduct specialty-driven team [34] Company Strategy and Development Direction - UroGen aims to enhance its commercial infrastructure by expanding its sales force from 52 to approximately 83 representatives to support the launch of UGN-102 [37][100] - The company is focused on raising awareness of unmet needs in low-grade intermediate risk non-muscle invasive bladder cancer through educational programs and scientific exchanges [35][36] - UroGen has acquired ICVB-1042, a next-generation investigational oncolytic virus, to enhance its pipeline and address critical gaps in cancer care [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data package submitted for UGN-102 and its potential to address significant unmet needs in the bladder cancer treatment landscape [14] - The company anticipates a transformative year in 2025 with the expected launch of UGN-102, which is projected to generate over $1 billion in revenue [54][109] - Management highlighted the importance of preparing for reimbursement processes and ensuring smooth integration of UGN-102 into treatment protocols [38][66] Other Important Information - UroGen ended 2024 with a strong balance sheet, holding $241.7 million in cash, cash equivalents, and marketable securities [21][43] - The company expects full-year 2025 JELMYTO revenues to be in the range of $94 million to $98 million, indicating a growth rate of approximately 8% to 12% [48] Q&A Session Summary Question: Can UGN-102 be used off-label for patients ineligible for surgery? - Management indicated that using UGN-102 in this context would be considered off-label, and it would be up to physicians to work with insurance companies for reimbursement [53][54] Question: How should investors think about the initial launch trajectory of UGN-102? - The launch trajectory is expected to be similar to JELMYTO, with a larger patient population leading to higher absolute numbers [61][72] Question: What are the expected differences in reimbursement levels with the J-code transition? - Initially, a miscellaneous J-code will be used, which may result in longer reimbursement times, but this will improve with a unique permanent J-code expected in January 2026 [66][68] Question: How will UGN-102 be positioned relative to UGN-103? - UGN-102 is expected to be phased out after UGN-103 is approved, with a focus on ensuring no automatic substitution occurs [94][95] Question: What is the rationale behind increasing the sales force size? - The increase is based on patient epidemiology, ensuring coverage of approximately 85% of the market for low-grade intermediate risk NMIBC [102][104]