Arrowhead Pharmaceuticals (NasdaqGS:ARWR) 2025 Conference November 19, 2025 06:00 AM ET Company ParticipantsChristopher Anzalone - CEOConference Call ParticipantsMaury Raycroft - AnalystMaury RaycroftHi, everyone. My name is Maury Raycroft. I'm one of the biotech analysts at Jefferies. I'd like to welcome Chris Anzalone, the CEO of Arrowhead. Thanks so much for joining us today, Chris, and congrats on the FCS approval yesterday.Christopher AnzaloneThanks very much. It's a pleasure to be here, as always, and ...

Arrowhead Pharmaceuticals Conference Call Summary Company Overview - **Company**: Arrowhead Pharmaceuticals - **Product**: Redemplo (FDA approved for reducing triglycerides in adults with Familial Chylomicronemia Syndrome, FCS) Key Points FDA Approval and Product Launch - Redemplo is the first RNAi-based medicine approved by the FDA for reducing triglycerides in adults with FCS [4][5] - The product demonstrated unprecedented median triglyceride reductions of 80% from baseline in clinical trials [4][20] - Redemplo is administered as a subcutaneous injection once every three months, making it convenient for patients [5][20] Clinical Data and Efficacy - The Palisade phase III study included both genetically confirmed and clinically defined FCS patients, showing similar responses [4][25] - The drug has a strong safety profile with no contraindications or warnings, and common adverse reactions include hyperglycemia, headache, and nausea [5][20][28] - The median triglyceride levels were reduced to below 500 mg/dL, a critical threshold for FCS patients [20][26] Market Opportunity and Pricing Strategy - Approximately 6,500 adults in the U.S. have either genetically confirmed or clinical FCS, representing a significant market opportunity [30] - The annual wholesale acquisition cost (WAC) for Redemplo is set at $60,000, reflecting its value in the high-risk severe hypertriglyceridemia (SHTG) population [12][37] - Arrowhead aims to establish a consistent pricing model across current and future indications, emphasizing sustainable innovation [12][37] Future Development and Pipeline - Arrowhead has ongoing phase III studies for SHTG patients, with results expected in Q3 2026, and plans to file for an SNDA in Q4 2026 [8][40] - The company is also developing Zodasiran for treating homozygous familial hypercholesterolemia (HoFH) and Arrow Dimer PA for mixed hyperlipidemia [15][41] - Arrowhead's goal is to create 2 to 4 new drug candidates annually, leveraging its TRIM platform to address various diseases [38][39] Healthcare Burden of FCS - FCS patients face significant healthcare challenges, including a high incidence of acute pancreatitis, which can exceed $60,000 in direct medical costs per event [9][10] - The condition often requires multiple specialist consultations before diagnosis, leading to delays in treatment [9][10] Commercial Strategy - Arrowhead's commercial strategy targets approximately 5,000 healthcare professionals specializing in lipid disorders, with a focus on personal engagement [30][31] - The "Redemplo Go Low" campaign aims to promote the importance of lowering triglyceride levels for FCS patients [31][32] Competitive Landscape - Arrowhead acknowledges competition from other companies but emphasizes the unique value proposition of Redemplo, particularly its efficacy and safety profile [55][56] - The company is preparing for a European launch and is open to partnerships for commercialization outside the U.S. [49][50] Conclusion - Arrowhead Pharmaceuticals is poised to make a significant impact in the treatment of FCS with Redemplo, backed by strong clinical data and a comprehensive commercial strategy aimed at addressing the needs of patients and healthcare providers [36][42]

Core Viewpoint - Huaxi Biological reported a decline in revenue and net profit for the first three quarters of 2025, indicating challenges in its core business despite a slight recovery in the third quarter [1][2]. Financial Performance - For the first three quarters of 2025, the company achieved revenue of 3.163 billion yuan, a year-on-year decrease of 18.36% [1][2]. - The net profit attributable to shareholders was 252.38 million yuan, down 30.29% year-on-year [1][2]. - In Q3 2025, revenue was 903 million yuan, a decline of 15.16% compared to the same period last year, while net profit increased by 55.63% to 31.53 million yuan [2][3]. Cost Management - The increase in Q3 net profit was attributed to a reduction in promotional expenses and an optimized brand communication model, with the sales expense ratio dropping to 34.26%, the lowest in five years [3]. - The company recognized credit impairment losses of 17.54 million yuan and inventory impairment losses of 5.71 million yuan in Q3 2025, impacting total profit by 23.25 million yuan [3][4]. Strategic Investments - Huaxi Biological invested 138 million HKD in Saintno Pharmaceutical, acquiring a 9.44% stake, aiming for business synergy in the innovative drug and medical aesthetics sector [7]. - The investment is expected to leverage Huaxi's expertise in hyaluronic acid to enhance RNAi therapy development, particularly in targeted delivery technologies [7]. Market Position and Challenges - Saintno Pharmaceutical is currently in a "zero revenue, continuous loss" phase, with significant losses reported and no products on the market [8]. - Despite the potential in the weight loss drug market, competition is intense, and the success of integrating innovative drugs with medical aesthetics remains uncertain [7][8].

Core Viewpoint - Sanofi Pharmaceutical has signed a subscription agreement with four investors, including Huaxi Biotechnology, to issue approximately 17.35 million new shares at a price of HKD 12 per share, raising around HKD 208 million, which is crucial for addressing its commercialization challenges and funding needs [2][6]. Group 1: Investment Details - The share placement represents about 16.50% of the current issued share capital and is expected to account for approximately 14.16% of the total share capital post-placement [2]. - The subscription price reflects a discount of approximately 19.84% compared to Sanofi Pharmaceutical's closing price of HKD 14.97 per share on September 5 [2]. - Huaxi Biotechnology will hold a 9.44% stake in Sanofi Pharmaceutical, becoming its second-largest shareholder after the transaction [2][6]. Group 2: Company Background and Challenges - Sanofi Pharmaceutical, established in 2007 and listed on the Hong Kong Stock Exchange in 2021, focuses on RNAi technology for drug development, with its lead candidate STP705 targeting two tumor indications [2][6]. - The company has not yet commercialized any products and has been operating at a loss, with net losses narrowing from USD 216 million in 2021 to USD 50 million in 2024, but still recording a loss of USD 3.49 million in the first half of 2025 [6]. - As of June 30, 2025, the company's current assets were only USD 14 million, highlighting the need for sufficient funding to support clinical pipelines and market preparations [6]. Group 3: Strategic Implications for Huaxi Biotechnology - Huaxi Biotechnology's investment is not merely financial but a strategic move to position itself in the small nucleic acid and RNAi technology sectors, with potential applications in targeted fat reduction [7][8]. - The investment aims to open new growth avenues for Huaxi Biotechnology, which has faced declining revenues, with a 19.57% year-on-year drop in the first half of 2025 [8]. - The collaboration is expected to enhance clinical progress for Sanofi Pharmaceutical's core pipeline while also allowing Huaxi Biotechnology to explore further investments and partnerships if market and technology validations are successful [7][8]. Group 4: Market Context and Future Outlook - The investment reflects Huaxi Biotechnology's response to increasing competition in the cosmetic market, particularly in traditional areas like hyaluronic acid, which has seen a decline in growth [8][10]. - The strategic partnership aims to leverage Sanofi Pharmaceutical's innovative technology to create synergies, although challenges remain in integrating the distinct business models and technologies of both companies [14]. - The success of this collaboration will depend on the clinical validation of Sanofi Pharmaceutical's technology and the ability to commercialize products effectively [7][14].

Group 1 - The core point of the article is that 圣诺医药-B (02257) experienced a significant stock price increase, rising over 5% in the afternoon trading session, with a current price of 19.46 HKD and a trading volume of 32.44 million HKD [1] - 圣诺医药-B received a substantial investment from Bloomage Biotechnology (Hong Kong) Limited and its affiliates, acquiring 11.57 million shares valued at approximately 139 million HKD [1] - 华熙生物, through its wholly-owned subsidiary, subscribed to the strategic placement of shares in 圣诺医药 at a price of 12 HKD per share, amounting to about 138 million HKD, resulting in 华熙生物 holding approximately 9.44% of 圣诺医药's total equity post-placement [1] Group 2 - 华熙生物 plans to leverage 圣诺医药's leading advantages in RNAi technology and PNP platform to explore the industrialization of small nucleic acid drugs in targeted fat reduction [1] - The collaboration will focus on discussing clinical development and commercial cooperation for the STP705 targeted fat reduction project, accelerating the layout in the aesthetic medicine sector [1]

Core Viewpoint - Saint Noble Pharmaceuticals-B (02257) experienced a significant increase in stock price, rising over 5% in the afternoon trading session, with a current price of 19.46 HKD and a trading volume of 32.44 million HKD [1] Group 1: Shareholding and Investment - Bloomage Biotechnology (Hong Kong) Limited and its affiliates have acquired 11.57 million shares of Saint Noble Pharmaceuticals, valued at approximately 139 million HKD [1] - Huaxi Biotechnology, through its wholly-owned subsidiary, subscribed to shares in Saint Noble Pharmaceuticals at a price of 12 HKD per share, totaling around 138 million HKD, resulting in a 9.44% ownership stake in the company [1] Group 2: Strategic Collaboration - Huaxi Biotechnology aims to leverage Saint Noble Pharmaceuticals' leading advantages in RNAi technology and PNP platform to explore the industrialization of small nucleic acid drugs in targeted fat reduction [1] - The focus will be on discussing clinical development and commercial cooperation for the STP705 targeted fat reduction project, accelerating the layout in the aesthetic medicine sector [1]

Core Insights - Arrowhead Pharmaceuticals is an RNAi company with a broad platform for delivering therapies to various tissues [2][3] - The company is currently developing 20 individual drug candidates that are either in clinical studies or on the market by the end of this year [3] - Arrowhead Pharmaceuticals is approaching its first PDUFA date on November 18, marking a potential transition from an R&D-only company to one that also engages in commercial activities [3]

Group 1 - The core viewpoint is that starting from 2024, Chinese companies are accelerating the overseas expansion of their siRNA pipelines, while also proactively laying out the siRNA sector domestically, leading to increased transactions [1][4] - Novartis reported a significant increase in sales for its long-acting siRNA drug Leqvio, with sales rising from $0.12 million in 2021 to $7.54 million in 2024, and achieving $5.55 million in H1 2025, representing a 66% increase [2] - The development of siRNA drugs is complex and involves multiple dimensions such as nucleotide modification, sequence screening, target gene selection, delivery vector optimization, and breakthroughs in non-liver targeting, indicating substantial room for improvement [1][4] Group 2 - The siRNA drug development landscape is expanding, with a shift from rare diseases to chronic disease indications like hyperlipidemia, hepatitis B, and obesity, suggesting a rapidly opening market space [3][4] - In 2023, there were 13 global siRNA drug transactions, with Chinese companies leading in transaction numbers, indicating a strong presence in the siRNA market [4] - Recommended stocks benefiting from the siRNA sector include Yuyuan Pharmaceutical, Innovent Biologics, East China Pharmaceutical, and others, highlighting potential investment opportunities [5]