Affirm (NasdaqGS:AFRM) FY Conference September 10, 2025 08:15 AM ET Company ParticipantsBrooke Major-Reid - CCOZane Keller - Head of Investor RelationsConference Call ParticipantsAllison Gelman - Research AnalystAllison GelmanAre we good to start? Great. Good morning, everyone. Thank you for joining us for our next Fireside Chat with Affirm here at the Barclays Global Financial Services Conference. My name is Allison Gelman, and I am a Research Analyst here at Barclays. Today, we have Brooke Major-Reid, Chi ...

Chewy (NYSE:CHWY) Q2 2026 Earnings Call September 10, 2025 08:00 AM ET Company ParticipantsRupesh Parikh - MDDavid Bellinger - DirectorWill Billings - CAO and IPFONathan Feather - Equity Research AssociateNatalie Nowak - Director of IRSumit Singh - CEOShweta Khajuria - MDDoug Anmuth - MDConference Call ParticipantsMichael Morton - Senior Research AnalystDylan Carden - Research AnalystOperatorHello everyone, and welcome to the Chewy Second Quarter 2025 Earnings Call. My name is Emily, and I'll be coordinatin ...

Chewy (NYSE:CHWY) Q2 2026 Earnings Call September 10, 2025 08:00 AM ET Company ParticipantsNatalie Nowak - Head - IRSumit Singh - CEO & DirectorWill Billings - Chief Accounting Officer & Interim Principal Financial OfficerNathan Feather - Equity Research AssociateShweta Khajuria - MD - Global InternetConference Call ParticipantsDouglas Anmuth - MD & Internet AnalystDavid Bellinger - Director & Senior AnalystRupesh Parikh - MD & Senior Analyst - Food, Grocery & Consumer ProductsMichael Morton - Senior Resear ...

Summary of BridgeBio Pharma's Investor Webinar on Incalerit for ADH1 Company and Industry Overview - **Company**: BridgeBio Pharma (NasdaqGS:BBIO) - **Industry**: Pharmaceuticals, specifically focusing on treatments for genetic disorders, particularly Autosomal Dominant Hypocalcemia Type 1 (ADH1) Core Points and Arguments 1. **Introduction of Incalerit**: Incalerit is a small molecule being developed for the treatment of ADH1, a rare genetic disorder characterized by low calcium levels due to mutations in the calcium-sensing receptor [2][17] 2. **Patient Experience**: A video presentation highlighted the challenges faced by patients with ADH1, emphasizing the need for effective treatment options [3][4] 3. **Mechanism of ADH1**: ADH1 is caused by heterozygous activating variants in the calcium-sensing receptor, leading to decreased parathyroid hormone (PTH) secretion and low blood calcium levels [10][11] 4. **Clinical Manifestations**: Symptoms of ADH1 include neuromuscular irritability, muscle cramps, and long-term complications such as kidney stones and chronic kidney disease [11][12] 5. **Current Treatment Limitations**: Conventional therapies do not address the underlying pathophysiology of ADH1 and can worsen long-term complications [13][14] 6. **Incalerit's Mechanism of Action**: Incalerit acts as a negative allosteric modulator of the calcium-sensing receptor, aiming to restore normal PTH secretion and calcium metabolism [16][17] 7. **Clinical Development Program**: The Phase IIb study showed that Incalerit effectively restored mineral homeostasis in patients with ADH1, with significant improvements in blood calcium and PTH levels [22][23] 8. **Market Opportunity**: The prevalence of ADH1 is estimated at 1 in 25,000 individuals, translating to approximately 12,000 individuals in the U.S., with 3,000 to 5,000 currently addressable based on symptoms [27][28] 9. **Genetic Testing Initiatives**: BridgeBio is sponsoring genetic testing programs to identify potential genetic variants causing hypoparathyroidism, which may accelerate diagnosis rates for ADH1 [30][31] 10. **Regulatory Pathway**: The company has had fruitful discussions with the FDA and international regulators regarding the trial design and is confident in its ability to file for approval based on Phase III results [71][72] Additional Important Content 1. **Safety and Tolerability**: Incalerit was well tolerated in the Phase II study, with few adverse events reported, primarily transient low blood phosphate concentrations [21][22] 2. **Long-term Efficacy**: Nearly 70% of patients achieved normal blood and urine calcium levels after 42 months of treatment with Incalerit, a significant improvement over standard care [23][24] 3. **Phase III Study Design**: The ongoing Phase III Calibrate study aims to confirm the efficacy of Incalerit, with top-line results expected in the fall [24][25] 4. **Differentiation from PTH Therapy**: Incalerit offers advantages over PTH replacement therapy, including oral administration and a focus on reducing urinary calcium excretion, which is crucial for preventing kidney complications [35][55] 5. **Genetic Variants and Treatment Response**: The Phase III study will include a broader range of genetic variants, allowing for a better understanding of treatment responses across different genotypes [66][82] This summary encapsulates the key points discussed during the investor webinar, highlighting the potential of Incalerit as a groundbreaking treatment for ADH1 and the strategic direction of BridgeBio Pharma in addressing this rare genetic disorder.

Chewy (NYSE:CHWY) Q2 2026 Earnings Call September 10, 2025 08:00 AM ET Company ParticipantsRupesh Parikh - MDDavid Bellinger - DirectorWill Billings - CAO and IPFONathan Feather - Equity Research AssociateNatalie Nowak - Director of IRSumit Singh - CEOShweta Khajuria - MDDoug Anmuth - MDConference Call ParticipantsMichael Morton - Senior Research AnalystDylan Carden - Research AnalystOperatorHello everyone, and welcome to the Chewy second quarter 2025 earnings call. My name is Emily, and I'll be coordinatin ...

Exelixis (NasdaqGS:EXEL) FY Conference September 10, 2025 08:00 AM ET Company ParticipantsChristopher Senner - EVP & CFOAndrew Peters - SVP - StrategyConference Call ParticipantsRobert Burns - MD & Senior Healthcare AnalystRobert BurnsWelcome to our first fireside chat of the morning. I'm Robert Burns, Managing Director and Senior Biotech Analyst at HC Wainwright, and I'm joined today by Chris Senner, the Chief Financial Officer of Exelixis, as well as Andrew Peters, Senior Vice President of Strategy at Exe ...

Summary of Avidity Biosciences Update / Briefing (September 10, 2025) Company Overview - **Company**: Avidity Biosciences (NasdaqGM:RNA) - **Focus**: Development of RNA therapeutics, particularly for neuromuscular diseases such as Duchenne Muscular Dystrophy (DMD), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy [2][3] Key Points and Arguments Industry and Product Development - Avidity is preparing to launch three drugs in the neuromuscular space: DELBRAX for FSHD, Aldosterone for Myotonic Dystrophy, and Delzota for DMD [3][4] - The company aims to be the first to receive global approval for treatments targeting these rare diseases [4] DMD Focus - DMD is a severe condition affecting young boys, leading to loss of mobility and reduced life expectancy [5] - Approximately 900 boys in the US and Europe are amenable to exon 44 skipping treatment [5] Clinical Data and Efficacy - The EXPLORER 44 study showed unprecedented functional improvements in patients treated with Delzota, with significant reductions in creatinine kinase (CK) levels, indicating muscle health [6][22] - At the one-year mark, about 50% of participants had CK levels within the normal range, demonstrating long-term muscle protection [22][70] - Delzota treatment resulted in a 25% increase in dystrophin levels, approaching levels associated with a normal phenotype [18][21] Functional Improvements - Delzota-treated patients showed significant improvements in functional endpoints compared to matched natural history controls, with absolute improvements of over two seconds in various mobility tests [26][30] - The improvements are unprecedented in the context of DMD treatment, indicating a potential reversal of disease progression [34] Safety Profile - The safety profile of Delzota remains favorable, with most adverse events being mild or moderate [15][16] - Only one serious adverse event was deemed related to the treatment, highlighting the overall tolerability of the drug [16] Regulatory and Commercial Strategy - Avidity plans to submit its first Biologics License Application (BLA) by the end of 2025, with subsequent submissions for the other two drugs within a year [8][45] - The company is building a commercial infrastructure that leverages synergies across its product launches in the same therapeutic area [46][47] Future Outlook - Avidity anticipates continued functional improvements as long-term muscle protection is maintained [41] - The company is also exploring platform designation for future exon-skipping therapies, which could expedite development timelines [66] Additional Important Information - The company emphasizes the importance of delivering RNA therapeutics effectively to achieve significant clinical outcomes [40][73] - Avidity is committed to redefining possibilities for boys and young men living with DMD, aiming for a future where they can engage in normal activities [36][37] This summary encapsulates the critical insights from the Avidity Biosciences briefing, highlighting the company's innovative approach to treating neuromuscular diseases and the promising data supporting its lead product, Delzota.

IO Biotech (NasdaqGS:IOBT) FY Conference September 10, 2025 08:00 AM ET Company ParticipantsMai-Britt Zocca - CEOMai-Britt ZoccaGood morning and welcome to this presentation here at the HC Wainwright conference, where I'm going to present an update from IO Biotech. Let me first share the forward-looking statements. We have them here, and then jump forward into what it's all about in today's presentation. SilentBio, this is really showcasing the power of our approach, where we are combining innovation with s ...

Financial Data and Key Metrics Changes - Q2 net sales grew by nearly 9% year over year to $3.1 billion, exceeding the high end of guidance range [5][17] - Gross margin reached 30.4%, expanding by nearly 80 and 90 basis points sequentially and year-over-year, respectively [6][17] - Adjusted net income for Q2 was $141.1 million, representing a 34.8% increase year over year [18] - Free cash flow for Q2 was nearly $106 million, with a robust liquidity position of approximately $1.4 billion [7][20] Business Line Data and Key Metrics Changes - Autoship customer sales reached $2.58 billion, representing 83% of Q2 net sales and a nearly 15% increase [5][6] - Hardgoods business grew over 15% in Q2, driven by structural volume growth [5] - Chewy Plus program showed strong growth, with approximately 3% of total monthly sales attributed to members [9][10] Market Data and Key Metrics Changes - Active customers increased to 20.9 million, reflecting a 4.5% year-over-year growth [6] - NESPAC (Net Effective Sales Per Active Customer) reached $591, representing a 4.6% year-over-year growth [6] - The overall industry growth is in the low to mid-single digits, while Chewy is growing at a 7% to 8% rate [61] Company Strategy and Development Direction - Chewy is focusing on expanding its Chewy Plus membership and private brands, with a new product line "Get Real" launched in August [10][12] - The company plans to open 8 to 10 new Chewy Vet Care practices in fiscal year 2025 [8] - Chewy aims to mitigate tariff-related costs and invest in growth initiatives to enhance market share [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Chewy's ability to navigate macroeconomic pressures and continue gaining market share [15][21] - The second half of 2025 is expected to be dynamic, with plans to invest in growth while maintaining profitability [15][21] - Management anticipates continued gross margin expansion and a strong performance from the Chewy Plus program [21][22] Other Important Information - The company repurchased approximately 3 million shares for about $125 million in Q2 [19] - Chewy remains debt-free with a strong cash position, allowing for strategic investments [20] Q&A Session All Questions and Answers Question: Can you talk more about the investments required in the back half and into 2026? - Management indicated that investments will focus on enhancing customer discoverability and increasing awareness of new offerings like Chewy Plus and Get Real, primarily through existing customer engagement rather than external marketing [25][26] Question: How should we think about the leverage path into the back half? - Management expects SG&A leverage to improve in the back half of the year, driven by the ramp-up of fulfillment centers and structural growth [34][39] Question: Can you unpack the Q2 gross margin improvement and the drivers for Q3 and Q4? - Management noted that gross margin expansion is driven by product mix, increasing Autoship penetration, and a rational promotional environment, with expectations for continued growth [42][44] Question: How big do you think the fresh and frozen business can go over time? - Management estimates the total addressable market for the fresh and frozen category to grow from $3 billion to $4 billion currently to between $8 billion and $12 billion in the coming years [51][52] Question: What are your expectations regarding the advertising environment? - Management reported high competitive intensity in the advertising market but noted strong metrics in net traffic and mobile app engagement [57][62] Question: What are the competitive advantages Chewy has over retail giants? - Management emphasized Chewy's unique value proposition that combines e-commerce efficiency with personalized service, allowing for a strong position in the pet care market [67][70]

Myriad Genetics (NasdaqGS:MYGN) FY Conference September 10, 2025 07:45 AM ET Company ParticipantsSam Raha - President and CEOBen Wheeler - CFOConference Call ParticipantsYuko Oku - Research AnalystYuko OkuHi everyone. My name is Yuko Oku, and I'm on the Life Science Tools and Diagnostics team here at Morgan Stanley. Before we begin, for important disclosures, please see Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to you ...