Core Insights - Jefferies has released a report on the outlook for the U.S. biotech industry in 2026, highlighting key clinical trial data disclosures, new drug approvals, and policy dynamics that could lead to value re-evaluation for companies in the sector [1] Six Preferred Stocks - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - Dianthus Therapeutics (DNTH.US), target price $66: Focused on claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion [2] - Taysha Gene Therapies (TSHA.US), target price $11: TSHA-102 for Rett syndrome, with peak revenue potential of $2 billion and a key trial data disclosure expected by the end of 2026 [2] - Tyra Biosciences (TYRA.US), target price $32: Dabogratinib for bladder cancer and achondroplasia, with critical data expected next year [3] - Tango Therapeutics (TNGX.US), target price $14: Collaboration with Revolution Medicines for a pancreatic cancer treatment, with data expected in mid-2026 [3] - ORIC Pharmaceuticals (ORIC.US), target price $23: Two potential assets targeting prostate cancer and lung cancer, with key data expected next year [4] - Solid Biosciences (SLDB.US), target price $15: Focused on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [4] Seven Undervalued Companies - The report also highlighted seven undervalued companies with significant catalysts: - Ultragenyx Pharmaceutical (RARE.US), target price $114: Expected key catalysts in 2026, including data for treatments for osteogenesis imperfecta and Angelman syndrome [5] - Beam Therapeutics (BEAM.US), target price $41: Updates on AATD therapy and SCD therapy expected in 2026, showcasing strong potential [5] - Aurinia Pharmaceuticals (AUPH.US), target price $21: Steady growth in lupus nephritis treatment, with new drug development paths expected to expand growth [6] - Kodiak Sciences (KOD.US), target price $39: Anticipated data from three pivotal trials in 2026, with significant potential for stock volatility [7] - Intellia Therapeutics (NTLA.US), target price $45: Key data for hereditary angioedema therapy expected in mid-2026, with sufficient cash reserves to support operations [7] - Compass Therapeutics (CMPX.US), target price $8: Data for cholangiocarcinoma therapy expected in early 2026, with a significant market opportunity [8] - KalVista Pharmaceuticals (KALV.US), target price $38: First oral treatment for hereditary angioedema expected to see rapid growth in 2026 [8] Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - Arrowhead Pharmaceuticals (ARWR.US): Strong RNAi product line for cardiovascular and metabolic diseases [9] - Celcuity (CELC.US): Unique efficacy of gedatolisib in breast cancer [9] - ORIC Pharmaceuticals: High-value prostate and lung cancer projects [9] - Travere Therapeutics (TVTX.US): Potential for significant market expansion in rare kidney diseases [9] - KalVista Pharmaceuticals: First-mover advantage in oral HAE treatment [9]

Core Viewpoint - KalVista Pharmaceuticals has received marketing and manufacturing approval for EKTERLY® (sebetralstat) in Japan, marking a significant advancement in the treatment of hereditary angioedema (HAE) [1] Group 1: Product Approval - The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted approval for EKTERLY® for the treatment of acute attacks of hereditary angioedema in adults and adolescents aged 12 years and older [1] - EKTERLY is noted as the first and only oral on-demand treatment for HAE approved in Japan [1]

Company Overview - KalVista Pharmaceuticals is a commercial pharmaceuticals company that recently received FDA approval for its first product, EKTERLY, which has been launched for the on-demand treatment of acute attacks of Hereditary Angioedema (HAE) [2] - EKTERLY is now approved in the U.S. and multiple other countries, marking a significant advancement in the treatment of HAE, a genetically driven disease characterized by episodic bouts of severe swelling [2][3] Product Innovation - EKTERLY represents a critical innovation as it allows patients to treat HAE using an oral therapy for the first time, differentiating it from existing therapies that are available [3]

Summary of KalVista Pharmaceuticals Conference Call Company Overview - **Company**: KalVista Pharmaceuticals - **Product**: Ekterly, an oral therapy for the on-demand treatment of acute attacks of Hereditary Angioedema (HAE) - **FDA Approval**: Received in July 2025, with a launch shortly thereafter [4][5] Key Points Product Launch and Market Penetration - **Patient Adoption**: Over 1,000 patients currently on Ekterly, representing over 10% of the market, with expectations to reach 12-13% [5][6] - **Treatment Guidelines**: Ekterly encourages early treatment of attacks, aligning with guidelines that suggest treating all attacks, even mild ones [6][7] - **Patient Satisfaction**: High satisfaction reported among patients, attributed to the convenience of oral administration [7] Prescription and Refill Mechanics - **Initial Prescription Process**: Patients receive a free drug sample and then transition to commercial coverage, which may take 6-8 weeks initially [10][14] - **Refill Rates**: Patients with severe disease (15-20% of the population) are the highest users, refilling every 3-4 weeks [17][18] - **Stockpiling**: Patients are expected to stockpile Ekterly due to its convenience, although dramatic stockpiling is not anticipated [28][29] Market Dynamics and Competition - **Market Transition**: The market is expected to shift towards oral therapies, reducing the reliance on injectables [24][44] - **Pharvaris Competition**: Upcoming data from Pharvaris is viewed as a data event for investors but is not expected to impact KalVista's commercial trajectory significantly [38][39] - **Market Leadership**: Confidence expressed in maintaining market leadership post-Pharvaris entry due to patient satisfaction and the advantages of Ekterly [44] International Expansion - **Global Launch Plans**: First shipment to Germany in October 2025, with launches in the U.K. and Japan expected in early 2026 [46] - **Pricing Strategy**: International pricing is anticipated to be significantly lower than U.S. pricing, with estimates around 20% of U.S. prices [48][52] Pediatric Market Insights - **Pediatric Need**: Approximately 500 pediatric patients in the U.S. with HAE, highlighting an unmet need for non-injectable therapies [57][58] - **Efficacy in Pediatrics**: Initial data shows that pediatric patients experience similar efficacy and safety profiles as adults, with previously unrecognized higher attack rates [59][60] Additional Insights - **Patient Services**: Robust patient services are in place, contributing to high patient retention and satisfaction [33] - **Safety Profile**: No significant adverse events reported post-launch, maintaining a pristine safety profile [35] This summary encapsulates the key aspects of KalVista Pharmaceuticals' conference call, focusing on the company's product, market dynamics, and future outlook.

Group 1 - Kalvista Pharmaceuticals Inc. is recognized as a promising investment opportunity, particularly due to its growth trajectory linked to the successful launch of EKTERLY, an oral therapy for hereditary angioedema (HAE) [2][3] - The company has achieved significant market penetration with EKTERLY, having 937 start forms that cover approximately 8% of diagnosed HAE patients in the US, translating to a potential revenue of about $31 million [2] - Kalvista reported $13.7 million in net product revenue during the third quarter and ended the quarter with $309.2 million in cash and cash equivalents, indicating a strong financial position to support future growth [3] Group 2 - The company has received regulatory approvals for EKTERLY in five regions, including Germany and Australia, showcasing its expanding market presence [3][4] - Kalvista focuses on developing oral therapies for rare diseases, specifically targeting the plasma kallikrein enzyme, which is crucial in the pathophysiology of HAE attacks [4]

Summary of KalVista Pharmaceuticals Conference Call Company Overview - **Company**: KalVista Pharmaceuticals (NasdaqGM: KALV) - **Industry**: Pharmaceuticals, specifically focusing on treatments for Hereditary Angioedema (HAE) - **Product**: EKTERLY, the first and only oral therapy for HAE attacks, launched on July 7, 2025 after receiving approval on July 3, 2025 [2][3] Key Points Launch and Market Uptake - EKTERLY has achieved a conversion rate of approximately 10%-12% of patients within the first four months of launch, indicating strong market uptake [3] - Revenues exceeded expectations for the initial commercial quarter, reflecting high patient demand [3][4] Revenue Insights - The revenue reported includes a stocking element typical for high-priced therapies, but a large portion is attributed to actual patient sales [4] - The company is still assessing the breakdown between new starts and refills due to limited experience [4][5] Payer Coverage and Market Dynamics - Payer coverage is progressing as anticipated, with smaller formularies approving policies faster than larger ones [6][7] - Most prescriptions in the initial quarter were medical exceptions due to the lack of established policies [7] - Prior authorization is required for prescriptions, with some policies necessitating a trial of generic Icatibant before EKTERLY [8] Patient Demographics - A significant portion of early adopters are patients with high attack rates (two or more attacks per month), validating the company's hypothesis about this patient population [10][11] - These high-attack patients are expected to have higher refill rates due to their increased need for on-demand therapy [11][12] Future Growth and Market Potential - The market for EKTERLY is estimated to be around 8,000 to 9,000 patients, with a potential shift towards oral therapies over time [17][18] - The company anticipates that the majority of patients will eventually switch to oral therapies, which could lead to sustained growth [18][19] Competitive Landscape - The company is aware of potential competition from other oral therapies but believes EKTERLY's strong launch and patient satisfaction will position it well in the market [21][22] - The company expects to maintain a competitive edge due to its extensive data set and high patient satisfaction [22] International Expansion - KalVista has launched EKTERLY in Germany and plans to expand into the UK and other European markets, with a focus on maintaining a cost-effective operational model [29][30] - Pricing power in Europe is limited, with prices expected to be around 20%-25% of US prices [31] Long-term Strategy - The company aims to grow into a leading rare disease commercial entity, considering additional high-quality assets for future development [28] - KalVista has established a strong commercial and regulatory framework, with five global regulatory approvals as of the conference date [26][27] Clinical Development - The company has conducted the largest clinical trial program in HAE, with plans to file an NDA for a pediatric indication in Q3 of the following year [35] Additional Insights - The company emphasizes the importance of maintaining operational efficiency and managing administrative challenges related to prior authorizations [20] - The focus remains on building a robust company rather than seeking acquisition opportunities [28]

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, including $1.4 million recorded in July, indicating strong early demand [22][24] - Total operating expenses for the period were $59.7 million, comprising approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net revenue came in toward the low end of the expected range, primarily due to lower copay utilization typical for this time of year [22] Business Line Data and Key Metrics Changes - The U.S. launch of EKTERLY has seen 937 start forms, representing over 10% of the HAE community, with rapid uptake across all patient segments [15][21] - The average number of cartons per shipment is on the high end of expected ranges, aligning with utilization among high-burden patients [22] - Patients refilling prescriptions are doing so every three to four weeks, compared to the typical three to four refills per year for most injectable therapies [17] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia and ongoing discussions for pricing and reimbursement in the U.K. and Japan [5][20] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and global expansion [24][25] - The strategy includes evaluating optimal access strategies in geographies where the company will not launch independently and completing more agreements for distribution [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in EKTERLY's potential to become the leading treatment for HAE, supported by strong early adoption and patient satisfaction [4][24] - The company anticipates some seasonal slowdown in demand during the holiday period but remains optimistic about long-term growth as awareness and confidence in EKTERLY build [52][72] Other Important Information - The company has recently hired key personnel, including a Chief Operating Officer and a Chief People Officer, to support its growth strategy [7] - The company is fully financed through profitability following a recent convertible note offering, allowing it to focus on executing the EKTERLY launch [7][23] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Management noted that roughly half of the patients switching to EKTERLY report two or more attacks per month, indicating a high burden of disease [28][29] Question: Refill rates and access dynamics - Refill rates for high-burden patients are significantly higher than typical, with expectations for normalization as the patient population broadens [37][38] Question: Insurance negotiations and payer policies - The company is seeing favorable policies from regional and national payers and anticipates wrapping up discussions with larger payers early in 2026 [71] Question: Expected patient trialing EKTERLY - Management expects oral therapies to displace injectables over time, with a broad distribution of patients switching to EKTERLY, including those with lower disease burdens [59][60] Question: Inventory and shipment dynamics - The company is experiencing inventory builds as specialty pharmacies prepare for expected demand, indicating a disciplined approach to growth [69]

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, including $1.4 million recorded in July [22] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - EKTERLY's adoption in the U.S. has been steady and linear, with strong demand for treating HAE attacks [4] - The company has received 937 start forms, representing more than 10% of the HAE community, indicating strong early engagement [15] - The average number of cartons per shipment is on the high end of the expected range, aligning with utilization among high-burden patients [22] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][20] - In Germany, the launch recorded first-day commercial sales, validating prescriber enthusiasm [19] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and global expansion [24] - Plans to complete more agreements for expanding access in geographies where the company will not launch on its own [5] - The company is committed to demonstrating the real-world benefits of EKTERLY through ongoing data generation and patient education [6] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by EKTERLY's early momentum and rapid growth, reinforcing the belief in its long-term success [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] - Management acknowledges potential disruptions to demand during the holiday season but remains optimistic about the fundamentals of demand [51] Other Important Information - The company has recently hired key personnel to strengthen its capabilities, including a Chief Operating Officer and a Chief People Officer [7] - The recent convertible note offering has fully financed the company through profitability, allowing a focus on executing the EKTERLY launch [7] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Approximately half of the patients who have switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [28] Question: Refill rates and access dynamics - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the typical three to four months for other therapies [38] Question: Insurance negotiations and payer policies - The company anticipates wrapping up discussions with larger payers and PBMs to establish favorable policies for EKTERLY early in 2026 [71]

Financial Data and Key Metrics Changes - Sales of EKTERLY reached $13.7 million for the launch period through September 30, which includes $1.4 million recorded in July [21] - Total operating expenses for the period were $59.7 million, consisting of approximately $12 million in R&D expenses and approximately $46.5 million in SG&A expenses [23] - Gross to net came in toward the low end of the expected range this quarter, driven largely by lower copay utilization typical for this time of year [23] Business Line Data and Key Metrics Changes - The U.S. launch of EKTERLY has seen strong adoption, with 937 start forms received, representing over 10% of the HAE community [15] - The average number of cartons per shipment is on the high end of expected ranges, aligning with utilization among high-burden patients [22] - Patients refilling prescriptions are doing so every three to four weeks, indicating a growing reliance on EKTERLY [17] Market Data and Key Metrics Changes - The approval footprint for EKTERLY continues to grow, with recent approvals in Australia, Germany, and ongoing discussions for launches in the U.K. and Japan [5][19] - Awareness levels among healthcare providers are exceptionally high, with 100% of tier one HCPs and 95% of all target HCPs reporting awareness of EKTERLY [16] Company Strategy and Development Direction - The company aims to establish EKTERLY as the foundational therapy for HAE treatment, focusing on aggressive execution and scaling in the U.S. while expanding access globally [24] - The strategy includes evaluating optimal strategies to expand access in geographies where the company will not launch on its own, with more agreements anticipated [5] Management's Comments on Operating Environment and Future Outlook - Management is encouraged by the early momentum and rapid growth of EKTERLY, reinforcing the belief in its long-term success as market awareness continues to grow [24] - The company expects refill patterns to normalize as adoption expands beyond the highest burden patients [17] Other Important Information - The company has recently hired key personnel, including a Chief Operating Officer and a Chief People Officer, to support its growth [6] - The company is fully financed through profitability, allowing it to focus on executing the EKTERLY launch while evaluating additional growth opportunities [6] Q&A Session Summary Question: Trends for types of patients switching to EKTERLY - Management noted that roughly half of the patients who switched to EKTERLY self-report an attack rate of two or more attacks per month, indicating a high burden [27] Question: Proportion of paid versus free drug - The paid rate for EKTERLY continues to grow, with successful use of medical exceptions for access [31] Question: Refill rates for high-burden patients - Refill frequencies for high-burden patients are currently about once a month, significantly higher than the average for other therapies [38] Question: Insurance negotiations and payer policies - The company is seeing favorable policies being established by regional and national payers, with expectations to finalize discussions early in 2026 [73] Question: Revenue trajectory in the next couple of quarters - Initial fills are expected to continue, but refill rates may decline as the burden of disease on patients decreases [75]

Summary of Key Points Core Insights - Several healthcare and biotech stocks experienced significant gains in after-hours trading following earnings updates and guidance revisions Company Performance - **KalVista Pharmaceuticals Inc. (KALV)**: Stock rose 11.29% to $12.12 after reporting a third-quarter net loss of $49.5 million ($0.92 per share), compared to a loss of $39.1 million ($0.84 per share) in the same period last year. Net product revenue for the quarter was $13.7 million [1] - **Health Catalyst Inc. (HCAT)**: Stock advanced 13.24% to $3.23 after reporting a third-quarter net loss of $22.2 million ($0.32 per share), compared to a loss of $14.7 million ($0.24 per share) a year ago. Revenue declined to $76.3 million from $86.4 million. For Q4 2025, projected revenue is about $73.5 million with adjusted EBITDA of $13.4 million. Full-year expectations are $310 million in revenue and $41 million in adjusted EBITDA [2] - **Bio-Techne Corp. (TECH)**: Stock climbed 8.72% to $62.47. The company reported first-quarter GAAP EPS of $0.24, up from $0.21 last year, while adjusted EPS remained flat at $0.42. Revenue declined 1% year-over-year to $286.6 million [3] - **Assertio Holdings Inc. (ASRT)**: Stock gained 8.30% to $0.87 after reporting third-quarter GAAP net income of $11.4 million ($0.11 per share), compared to a loss of $2.9 million ($0.03 per share) last year. Adjusted EPS rose to $0.18 from $0.02. Net product sales reached $49.5 million, up from $28.7 million [4] - **Abeona Therapeutics Inc. (ABEO)**: Stock moved up 8.51% to $4.59. The company is scheduled to report third-quarter results on November 12, with analysts expecting a loss of $0.34 per share on revenue of $5.53 million [5]