Pharvaris (NasdaqGS:PHVS) FY Conference February 26, 2026 09:20 AM ET Company Participants Berndt Modig - CEO Maggie Beller - Executive Director and Head of Corporate and Investor Communications Conference Call Participants Jeff Jones - Managing Director and Senior Analyst of Biotechnology Berndt Modig Jeff Jones Morning, everyone, and welcome back to Oppenheimer's Healthcare Conference. I'm Jeff Jones, one of the analysts on the biotech team, and I'm delighted to welcome this morning, Berndt Modig, CEO of ...

Market Overview - U.S. stock futures showed a recovery from earlier losses, with major benchmark indices trading higher [1] - Rising unrest in Iran influenced investor sentiment, leading to an increase in WTI Crude futures [1] Economic Indicators - The U.S. Supreme Court is expected to announce a ruling on tariffs imposed by President Trump [2] - Investors are anticipating the December jobs report, with the 10-year Treasury bond yielding 4.18% and the two-year bond at 3.50% [2] - The CME Group's FedWatch tool indicates an 86.2% likelihood of the Federal Reserve maintaining current interest rates in January [2] Futures Performance - Dow Jones increased by 0.05%, S&P 500 by 0.08%, Nasdaq 100 by 0.15%, and Russell 2000 by 0.11% [3] - SPDR S&P 500 ETF Trust (SPY) rose by 0.067% to $689.97, while Invesco QQQ Trust ETF (QQQ) advanced by 0.084% to $620.99 [3] Company Highlights - General Motors (NYSE: GM) saw a decline of 0.63% after reporting a $7.1 billion loss from electric vehicle investments [5] - Rio Tinto PLC ADR (NYSE: RIO) dropped 2.46% amid merger talks with Glencore [5] - Tilray Brands Inc. (NASDAQ: TLRY) surged by 8.32% after exceeding earnings expectations in its second-quarter report [5] - Offerpad Solutions Inc. (NYSE: OPAD) surged by 38.82% following a new proposal by President Trump impacting the housing market [13] - Kalvista Pharmaceuticals Inc. (NASDAQ: KALV) shares increased by 13.65% after reporting preliminary global net product revenue of $35 million to $49 million for the fourth quarter [13] Sector Performance - U.S. markets experienced broad gains, particularly in the Energy and Consumer Staples sectors, while Information Technology and Health Care sectors posted losses [7] Analyst Insights - Scott Wren from Wells Fargo Investment Institute emphasizes the importance of focusing on economic and policy trends rather than daily news [9] - Wren identifies four key pillars for the year: resilient AI capital spending, significant tax benefits, continued Federal Reserve rate cuts, and deregulation [9] - He sees opportunities in Industrials and Utilities, as well as Midstream Energy and Industrial Metals like copper, to support infrastructure development [10][11]

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]

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]

Core Insights - KalVista Pharmaceuticals has received FDA approval for EKTERLY, the first oral on-demand treatment for hereditary angioedema (HAE), which is expected to drive significant growth for the company [1] Financial Performance - For the quarter ending September 11, 2025, KalVista reported an earnings per share (EPS) of -$1.12, missing the estimated EPS of -$0.91, resulting in a negative surprise of 23.08% [2] - The company's revenue for the quarter was approximately $1.43 million, falling short of the expected $2.09 million, indicating a shortfall of 20.91% [2] - KalVista has exceeded consensus EPS estimates only once in the past four quarters, highlighting ongoing financial challenges [2] Financial Metrics - The company has a negative price-to-earnings (P/E) ratio of approximately -3.73 and an enterprise value to operating cash flow ratio of about -3.89, indicating difficulties in achieving profitability and generating positive cash flow [3] - The earnings yield is negative at approximately -26.83%, further emphasizing the company's financial struggles [3] Debt and Stability - KalVista's debt-to-equity ratio of 0.07 suggests a relatively low level of debt compared to its equity, indicating financial stability [4] - The recent FDA approval of EKTERLY positions the company for potential future growth, although the immediate impact on stock price and future earnings expectations remains uncertain [4]

Financial Data and Key Metrics Changes - The company reported $1.4 million in net revenue for EKTERLY during the launch period, primarily from stocking orders by specialty pharmacies [13] - Total operating expenses for the period were $60.4 million, with approximately $15 million in R&D expenses and $45 million in SG&A expenses, driven by external spending related to the EKTERLY launch [13] - The company had approximately $191 million in cash and investments as of July 31, 2025, expected to fund operations into 2027 [14] Business Line Data and Key Metrics Changes - EKTERLY is positioned as the first and only oral on-demand therapy for acute HAE attacks, with initial launch metrics showing that nearly 5% of the U.S. HAE population has submitted a prescription [4][7] - The company has activated 253 unique prescribers, with 38% starting multiple patients on EKTERLY [11] - Early demand has come from patients previously on other therapies, with strong interest from a broad base of providers [11][12] Market Data and Key Metrics Changes - In Europe, sebetralstat received a positive CHMP opinion for the treatment of acute HAE attacks, with a final decision expected in October [7] - The UK MHRA granted marketing authorization for EKTERLY, with a commercial launch anticipated in the first half of 2026 [8] - The company is progressing towards anticipated approval in Japan by the end of the year [8] Company Strategy and Development Direction - The company aims to transform the treatment paradigm for HAE with EKTERLY, focusing on global expansion and establishing it as the foundational therapy for HAE [4][15] - The management emphasizes the importance of executing a disciplined commercial strategy and driving meaningful long-term value creation for shareholders [8][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong early response to EKTERLY, highlighting the unmet need in HAE and the transformational potential of the therapy [15] - The company anticipates that operating expenses will remain consistent as they continue to invest in the EKTERLY launch [13] Other Important Information - The company is changing its fiscal year end to December 31, starting with the quarter ending September 30, 2025 [14] - The quick start program provides immediate access to EKTERLY at no charge while working with physician offices to gain paid access [19][29] Q&A Session Summary Question: Can you further speak to the quick start program and expectations for timing to paid drug? - The quick start program provides immediate access to EKTERLY at no charge, with efforts to gain paid access through medical exceptions [19][20] Question: How many of the 4,000 patients in the database are individual patients or caregivers? - The majority of patients in the database are individual patients, with efforts to engage them through local education programs [23] Question: What are your expectations for launch metrics moving forward? - The company plans to share more KPIs as the launch progresses, including repeat prescribers and utilization rates [28] Question: Can you provide a breakdown of the 460 start forms? - All 460 start forms received quick start access, with some paid shipments already going out [34] Question: What feedback have you received regarding side effects observed so far? - Adverse events reported have been minimal, with no significant GI-related issues noted during the launch [37][38]