Summary of Innoviva (INVA) 2025 Conference Call Company Overview - **Company**: Innoviva (INVA) - **Industry**: Healthcare, specifically focusing on respiratory, infectious disease, and critical care therapeutics - **Key Products**: ANORO® ELLIPTA®, RELVAR®/BREO® ELLIPTA®, GIAPREZA®, ZEVTERA®, zoliflodacin Core Business Segments 1. **Royalties**: - Generates approximately **$250 million** in annual revenue, considered resilient and durable [3][26] - Royalties stem from respiratory products co-developed with Glaxo Group Limited (GSK) [2] 2. **Innoviva Specialty Therapeutics (IST)**: - Focuses on infectious disease and critical care, generating over **$100 million** in revenue last year, with a growth rate of **50%** [4][6] - Recent product launches include ZEVTERA® and upcoming zoliflodacin, with aspirations for revenues exceeding **$500 million** in the U.S. [7][20] 3. **Strategic Healthcare Assets**: - Portfolio valued at just under **$500 million**, includes stakes in companies with disruptive potential [4] Growth Potential and Strategy - The IST business is designed for differentiated assets in high unmet medical needs, with plans for both organic and inorganic growth [8][10] - The company is exploring additional investments outside the IST business, particularly in strategic healthcare assets [11] Product Insights - **GIAPREZA®**: - Rapid revenue growth post-relaunch, with potential tailwinds from updated sepsis guidelines [13] - **ZEVTERA®**: - Launched in July, approved for three indications, with positive initial reception [17] - **zoliflodacin**: - Targets uncomplicated gonorrhea, addressing a significant unmet need with a once-dosed oral option [19][20] - Anticipated PDUFA date in December, with potential for telehealth prescriptions [21] Market Dynamics - Drug resistance is a global issue, with Innoviva's products positioned to address rising resistance rates [15][16] - The company is aware of competitive pressures but believes in the resilience of its existing products [29] Strategic Investments - Innoviva has extended credit to Armata, a bacteriophage company, which has shown promising clinical results [30][31] - Investment in Sindeo, focused on neuroscience and depression, with potential for significant value creation [36] Financial Position - Innoviva is well-capitalized with approximately **$400 million** in cash and generating cash flow, allowing for strategic capital deployment [38] Conclusion - Innoviva is positioned for growth through its diversified business segments, innovative product pipeline, and strategic investments, while maintaining a strong financial foundation to navigate market volatility [39]

Financial Data and Key Metrics Changes - The company reported over 50% year-over-year growth in the Innoviva Specialty Therapeutics (IST) business for Q2 [26] - The royalty portfolio has consistently exceeded analyst expectations, with projections of over $1 billion in royalty revenue over the next five years [26][27] - The company expects to achieve over $100 million in net sales in the U.S. this year, with peak portfolio sales potentially exceeding half a billion dollars [21] Business Line Data and Key Metrics Changes - The royalty portfolio includes two major products: RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which are well-established and provide stable revenues [9][10] - The IST business has seen significant growth driven by products like GIAPREZA® and XACDURO®, with the latter being one of the most successful antibiotic launches in recent years [15][16] - The company recently launched ZEVTERA®, which is expected to contribute positively to the IST business [17][27] Market Data and Key Metrics Changes - The majority of sales for RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® are generated outside the U.S., with these regions showing higher growth potential due to less competition [10][11] - The IST business is positioned to benefit from the growing threat of antimicrobial resistance, which is a major public health concern [16] Company Strategy and Development Direction - The company has a unique business model that includes a royalty portfolio, a fully integrated biopharma business focused on critical care and infectious disease, and strategic healthcare assets [4] - The strategy involves identifying undervalued assets in areas of high unmet medical need, with a focus on long-term growth and profitability [24][25] - The company aims to leverage its stable revenue base from royalties to support growth in its therapeutics business and strategic investments [32] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the current macroeconomic uncertainty but views it as an opportunity to find attractive investments [6][8] - The company is optimistic about the upcoming FDA PDUFA decision for zoliflodacin, which targets a significant market need [19][20] - Management expects continued growth in the IST business and stable revenue from the royalty portfolio [29] Other Important Information - The company has made significant progress in its strategic healthcare assets, including a promising phase two trial result from Armada Pharmaceutical [27][28] - The company has a history of returning capital to shareholders, including a $100 million share buyback last year [33] Q&A Session Summary Question: What are the growth drivers for the IST business? - Major growth drivers include commercial execution for GIAPREZA® and the successful launch of XACDURO® [15][16] Question: How significant is the upcoming FDA PDUFA decision for zoliflodacin? - The decision is seen as a major milestone with significant market potential due to the high incidence of gonorrhea and resistance issues with current treatments [19][20] Question: What is the sales magnitude opportunity for the IST division? - The company expects over $100 million in net sales this year, with potential peak sales exceeding half a billion dollars [21] Question: How does the company prioritize capital allocation between its business segments? - The IST business is generating revenue on its own, allowing for thoughtful and opportunistic capital allocation [31][32] Question: What types of assets is the company looking to acquire? - The company is interested in both unique situations and more mainstream assets needing capital, focusing on areas where it can add value [34][35]

Financial Data and Key Metrics Changes - The company reported over 50% year-over-year growth in the Innoviva Specialty Therapeutics (IST) business for Q2 [27] - The royalty portfolio has consistently exceeded analyst expectations, with projections of over $1 billion in royalty revenue over the next five years [27][28] - The IST business is expected to achieve over $100 million in net sales in the U.S. this year, with peak portfolio sales projected to exceed half a billion dollars [22] Business Line Data and Key Metrics Changes - The royalty portfolio includes two major products: RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which are expected to maintain stable revenues due to their characteristics as maintenance therapies [9][10] - The IST business has successfully launched products like GIAPREZA® and XACDURO®, with the latter being one of the most successful antibiotic launches in recent years [16][18] - The recent launch of ZEVTERA® is anticipated to contribute positively to the IST business moving forward [28] Market Data and Key Metrics Changes - The majority of sales for RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® are generated outside the U.S., with these regions showing higher growth potential due to less competition [10][11] - The IST business is positioned to benefit from the growing threat of antimicrobial resistance, which is a significant public health concern [17] Company Strategy and Development Direction - The company aims to leverage its stable royalty revenues to invest in high-growth potential assets in areas of unmet medical need [4][24] - The strategy includes a focus on differentiated products in the hospital and infectious disease space, with a long-term vision for growth [15][16] - The company is open to evaluating opportunities to expand its IST footprint and is looking for both core and adjacent assets in the hospital space [39] Management's Comments on Operating Environment and Future Outlook - Management views the current macro environment as a time of opportunity despite uncertainties, with a focus on mitigating risks and finding attractive investments [6][8] - The upcoming FDA PDUFA decision for zoliflodacin is seen as a major milestone with significant growth potential in treating gonorrhea [20][21] - The company expects to maintain momentum in its royalty business and continue growth in the IST business, with high expectations for product launches [30] Other Important Information - The company has a diverse portfolio of strategic healthcare assets that are seen as high growth potential investments [23] - Recent achievements include a groundbreaking phase two clinical trial result from Armada Pharmaceutical, which could shift treatment paradigms for difficult-to-treat infections [28][29] Q&A Session Summary Question: What are the growth drivers for the IST business? - The growth drivers include commercial execution for GIAPREZA® and the successful launch of XACDURO®, addressing high unmet medical needs in the hospital space [16][18] Question: How does the company prioritize capital allocation between different business segments? - The company is thoughtful about capital allocation, focusing on opportunities for growth in the IST business while also supporting strategic healthcare assets [32][33] Question: What areas is the company looking to expand in the IST business? - The company is open to evaluating opportunities in both core infectious disease and critical care areas, as well as adjacent markets [39]

Financial Data and Key Metrics Changes - The company reported over 50% year-over-year growth in the Innoviva Specialty Therapeutics (IST) business for Q2 [27] - The royalty portfolio has consistently exceeded analyst expectations, with projections of over $1 billion in royalty revenue over the next five years [27][28] - The IST business is expected to achieve over $100 million in net sales in the U.S. this year, with peak portfolio sales projected to exceed half a billion dollars [22] Business Line Data and Key Metrics Changes - The royalty portfolio includes two major products: RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, which are expected to maintain stable revenues due to their characteristics as maintenance therapies [9][10] - The IST business has successfully launched products like GIAPREZA® and XACDURO®, with the latter being one of the most successful antibiotic launches in recent years [16][18] - The recent launch of ZEVTERA® is anticipated to contribute positively to the IST business moving forward [28] Market Data and Key Metrics Changes - The majority of sales for RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA® are generated outside the U.S., with these regions showing higher growth potential due to less competition [10][11] - The IST business is positioned to benefit from the growing threat of antimicrobial resistance, which is a significant public health concern [17] Company Strategy and Development Direction - The company has a unique business model that includes a royalty portfolio, a fully integrated biopharma business focused on critical care and infectious disease, and a portfolio of strategic healthcare assets [4][5] - The strategy involves identifying undervalued assets in areas of high unmet medical need, with a focus on long-term growth and profitability [24][26] - The company aims to leverage its stable revenue base from royalties to support growth in its therapeutics business and strategic investments [33][40] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the current macroeconomic uncertainty but views it as an opportunity to find attractive investments [6][8] - The company is optimistic about the upcoming FDA PDUFA decision for zoliflodacin, which targets a significant market need in treating gonorrhea [20][21] - The company expects continued growth in both the royalty and IST businesses, with a strong pipeline of products and strategic healthcare assets [30][31] Other Important Information - The company has a productive partnership with Glaxo Group Limited (GSK) for its royalty products, which are well-established and mature [11] - Recent achievements include a groundbreaking phase two clinical trial result from Armada Pharmaceutical, indicating a potential paradigm shift in treating difficult infections [28][29] Q&A Session Summary Question: What are the growth drivers for the IST business? - The major growth drivers include commercial execution for GIAPREZA® and the successful launch of XACDURO®, addressing high unmet medical needs [16][18] Question: How does the company prioritize capital allocation between different business segments? - The company is thoughtful about capital allocation, focusing on opportunities for growth in the IST business while also supporting strategic healthcare assets [32][33] Question: What areas is the company looking to expand in the IST business? - The company is open to evaluating opportunities in the hospital space, particularly in infectious disease and critical care, leveraging its operational expertise [39]