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KalVista Pharmaceuticals, Inc. (KALV) Presents at Jefferies London Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-11-24 15:53
PresentationHi, everyone. My name is Maury Raycroft, and I'm one of the biotech analysts at Jefferies. I'm happy to introduce Ben Palleiko, the CEO of KalVista. It's a fireside chat format. Thanks so much for joining us today, Ben.Maury, thanks, as always, for the invite and grateful to Jefferies for all they've done with us over the years. So happy to be here.And maybe starting off, if you can give a 1-minute intro to the company for people who may not be familiar with the company.Benjamin PalleikoCEO & Di ...
KalVista Pharmaceuticals (NasdaqGM:KALV) 2025 Conference Transcript
2025-11-19 14:32
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.
Citizens Touts KalVista Pharmaceuticals, Inc. (KALV) Growth Trajectory on EKTERLY Prospects
Yahoo Finance· 2025-11-18 11:16
Kalvista Pharmaceuticals Inc. (NASDAQ:KALV) is one of the best breakout stocks to invest in. On November 11, analysts at Citizens lowered their price target of the stock to $28 from $29 while reiterating a Market Perform rating. Despite the cut, the price target remains well above the current trading range, indicating significant upside potential. Citizens Touts KalVista Pharmaceuticals, Inc. (KALV) Growth Trajectory on EKTERLY Prospects Copyright: kadmy / 123RF Stock Photo The research firm remains con ...
KalVista Pharmaceuticals (NasdaqGM:KALV) 2025 Conference Transcript
2025-11-12 14:42
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]
KalVista Pharmaceuticals(KALV) - 2025 Q3 - Earnings Call Transcript
2025-11-11 14:32
KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Company ParticipantsBen Palleiko - CEONicole Sweeny - Chief Commercial OfficerBrian Piekos - CFOPaul Audia - CMORyan Baker - Head of Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystJoe Schwartz - AnalystStacy Ku - AnalystDebanjana Chatterjee - AnalystMaury Raycroft - AnalystNone - AnalystOperatorThank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial upd ...
KalVista Pharmaceuticals(KALV) - 2025 Q3 - Earnings Call Transcript
2025-11-11 14:32
KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Company ParticipantsBen Palleiko - CEONicole Sweeny - Chief Commercial OfficerBrian Piekos - CFOPaul Audia - CMORyan Baker - Head of Investor RelationsConference Call ParticipantsNone - AnalystNone - AnalystJoe Schwartz - AnalystStacy Ku - AnalystDebanjana Chatterjee - AnalystMaury Raycroft - AnalystNone - AnalystOperatorThank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial upd ...
KalVista Pharmaceuticals(KALV) - 2025 Q3 - Earnings Call Transcript
2025-11-11 14:30
KalVista Pharmaceuticals (NasdaqGM:KALV) Q3 2025 Earnings Call November 11, 2025 08:30 AM ET Speaker0Thank you for standing by. Welcome to KalVista Pharmaceuticals' 2025 third-quarter financial update and operating 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 this session, you will need to press star 11 on your telephone. You will then hear an automated message advisi ...
KalVista, Health Catalyst, Bio-Techne Lead After-Hours Gains On Earnings Updates
RTTNews· 2025-11-11 04:19
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]
KalVista Pharmaceuticals(KALV) - 2026 Q2 - Quarterly Report
2025-11-10 21:45
FDA Approval and Product Launch - EKTERLY (sebetralstat) received FDA approval on July 3, 2025, as the first and only oral, on-demand therapy for hereditary angioedema (HAE) in patients aged 12 years and older[89]. - The company generated revenue from product sales for the first time in the three months ended September 30, 2025, following FDA approval of EKTERLY on July 3, 2025[104]. - EKTERLY is under review with regulatory authorities in Japan and Singapore, indicating potential future market expansion[87]. Financial Performance - Product revenue for the three months ended September 30, 2025, was $13.7 million, a 100% increase compared to the same period in 2024, attributed to the commercial launch of EKTERLY in the U.S.[96]. - The operating loss for the three months ended September 30, 2025, was $46.1 million, a 6% increase from the prior year[96]. - The total operating expenses for the nine months ended September 30, 2025, were $168.4 million, a 26% increase compared to the same period in 2024[97]. - Other (expense) income decreased by $5.7 million for the three months ended September 30, 2025, primarily due to an increase in interest expense and unfavorable changes in foreign currency exchange rates[103]. Expenses and Cash Flow - Research and development expenses decreased by $6.7 million (36%) for the three months ended September 30, 2025, primarily due to reduced spending on sebetralstat[99]. - Selling, general and administrative expenses increased by $21.7 million (88%) for the three months ended September 30, 2025, driven by higher personnel costs and commercial expenses[102]. - Cash used in operating activities was $127.0 million for the nine months ended September 30, 2025, compared to $91.7 million for the same period in 2024, representing a 39% increase[114]. - Cash provided by financing activities was $164.4 million for the nine months ended September 30, 2025, primarily from the sale of convertible notes of $139.4 million[116]. - Cash provided by investing activities was $19.9 million for the nine months ended September 30, 2025, compared to cash used of $55.7 million in the same period in 2024, a change of 136%[115]. Strategic Agreements and Payments - The company received a one-time payment of $22 million from DRI Healthcare following FDA approval, increasing the royalty rate on initial sales from 5% to 6%[94]. - The company received an upfront payment of $100.0 million from a royalty purchase agreement with DRI, along with a one-time cash payment of $22.0 million after obtaining FDA approval of sebetralstat[109]. - The company entered into a License, Supply and Distribution Agreement with Kaken Pharmaceutical Co., Ltd., receiving an upfront payment of $11.0 million and potential milestone payments totaling approximately $13.0 million[110]. Cash Position - As of September 30, 2025, the company had an increase in cash, cash equivalents, and restricted cash of $61.3 million, a significant increase of 799% compared to the prior year[113]. - The company filed a registration statement with the SEC to offer and sell securities with an aggregate public offering price of up to $300 million[106].
KalVista Pharmaceuticals(KALV) - 2026 Q2 - Quarterly Results
2025-11-10 21:35
Exhibit 99.1 KalVista Pharmaceuticals Provides Operational Update and Reports Third Quarter Financial Results US launch of EKTERLY® gaining strong momentum with $13.7 million in net product revenue for the third quarter 937 patient start forms received through October, reflecting rapid adoption as first and only oral on-demand treatment for hereditary angioedema (HAE) $309M in cash expected to fund the Company through profitability Management to host conference call Tuesday, November 11th at 8:30 a.m. ET FR ...