Revenue and Sales Performance - GSK royalties for Q4 2024 were $66.0 million, with full year royalties totaling $255.6 million, reflecting a slight increase from $252.7 million in 2023[1][3] - Innoviva Specialty Therapeutics achieved U.S. net product sales of $24.9 million in Q4 2024, leading to full year sales of $80.9 million, a 47% increase year-over-year from $55.1 million in 2023[1][3] - U.S. net product sales for 2024 included $53.4 million from GIAPREZA, $12.8 million from XERAVA, and $14.7 million from XACDURO[1][3] - Total revenue for the three months ended December 31, 2024, was $91,806,000, an increase of 6% compared to $85,840,000 for the same period in 2023[13] - Net product sales increased significantly to $28,935,000 for the three months ended December 31, 2024, up 47% from $19,675,000 in the prior year[13] Income and Financial Performance - Fourth quarter 2024 net income was $20.3 million ($0.32 per share), while full year net income reached $23.4 million ($0.37 per share), driven by higher revenue[1][5] - The company reported a net income of $20,332,000 for the three months ended December 31, 2024, compared to $61,531,000 in the same period of 2023, reflecting a decrease of 67%[13] - The diluted net income per share attributable to Innoviva stockholders was $0.26 for the three months ended December 31, 2024, compared to $0.76 in the same period of 2023[13] Cash and Assets - Cash and cash equivalents totaled $305.0 million, with receivables from royalties and net product sales amounting to $86.4 million as of December 31, 2024[1][5] - Cash and cash equivalents increased to $304,964,000 as of December 31, 2024, up from $193,513,000 at the end of 2023[15] - Net cash provided by operating activities for the year ended December 31, 2024, was $188,690,000, an increase from $141,064,000 in 2023[17] - Total assets as of December 31, 2024, were $1,301,060,000, compared to $1,243,507,000 at the end of 2023, representing a growth of 5%[15] - The company reported a total of $64,275,000 in other long-term liabilities as of December 31, 2024, down from $71,870,000 in 2023[15] Expenses - The company’s selling, general and administrative expenses rose to $31,326,000 for the three months ended December 31, 2024, compared to $26,319,000 in the same period of 2023, an increase of 19%[13] - Research and development expenses decreased to $3,665,000 for the three months ended December 31, 2024, down from $2,356,000 in the prior year[13] Strategic Initiatives - The company licensed U.S. commercialization and distribution rights to ZEVTERA, anticipating its launch in mid-2025[1][5] - Innoviva plans to submit an NDA for zoliflodacin in early 2025, following positive Phase 3 data[1][5] - The strategic asset portfolio was valued at $501.5 million as of December 31, 2024, with a $10.9 million investment in Gate Neurosciences[1][6] - Innoviva's royalty portfolio includes respiratory assets partnered with GSK, contributing to its revenue growth strategy[1][7] - The company reported a license revenue of $0.4 million for Q4 2024 and $19.5 million for the full year, including an $8.0 million milestone payment[1][5]

Core Insights - Innoviva (NASDAQ: INVA) focuses on a robust portfolio of revenue-generating assets rather than solely on high-growth biotech and pharma stocks [1] Company Overview - Innoviva is primarily recognized for its royalty stream from GSK, indicating a stable income source [1] Investment Strategy - The company emphasizes understanding and investing in disruptive technologies and forward-thinking enterprises, suggesting a strategic approach towards innovation and future trends [1]

Revenue and Sales Performance - Third quarter 2024 gross royalty revenue from GSK was $60.5 million, a 6% increase from $57.0 million in the third quarter of 2023[193]. - Third quarter 2024 net product sales were $27.8 million, including U.S. net product sales of $19.7 million and ex-U.S. product sales of $8.1 million, representing a 68% increase compared to $11.8 million in the third quarter of 2023[194]. - Total net royalty revenue increased to $57.1 million for the three months ended September 30, 2024, compared to $53.6 million for the same period a year ago, primarily due to sales growth in RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®[201]. - Royalty revenue from RELVAR®/BREO® ELLIPTA® was $48.2 million for the third quarter of 2024, up 6% from $45.6 million in the same quarter of 2023[201]. - Royalty revenue from ANORO® ELLIPTA® was $12.3 million for the third quarter of 2024, an 8% increase from $11.4 million in the same quarter of 2023[201]. - Net product sales for the three months ended September 30, 2024, were $27.8 million, an increase from $13.7 million in the same period of 2023, representing a growth of 102.9%[202][203]. Expenses and Financial Performance - Cost of products sold for the three months ended September 30, 2024, was $9.99 million, a slight decrease of 1.9% from $10.18 million in the same period of 2023[207]. - Research and development expenses for the three months ended September 30, 2024, were $3.55 million, down 11% from $3.99 million in the same period of 2023[208]. - Selling, general and administrative expenses for the three months ended September 30, 2024, were $26.22 million, an 8.4% decrease from $28.64 million in the same period of 2023[210]. - Interest expense for the three months ended September 30, 2024, was $5.81 million, a 32% increase from $4.40 million in the same period of 2023[214]. - The company recorded an income tax expense of $5.6 million for the three months ended September 30, 2024, compared to $3.9 million in the same period of 2023, with an effective tax rate of 40.5%[217]. Cash Flow and Financial Position - Net cash and cash equivalents totaled $260.6 million as of September 30, 2024, with royalties receivable from GSK amounting to $60.5 million[218]. - Net cash provided by operating activities for the nine months ended September 30, 2024, was $129.5 million, an increase of 20.1% from $107.8 million in the same period of 2023[220][221]. - Net cash used in investing activities decreased to $48.3 million in 2024 from $61.6 million in 2023, reflecting a reduction of 21.5%[223][224]. - Net cash used in financing activities significantly decreased to $14.0 million in 2024 from $157.3 million in 2023, a reduction of 91.1%[225][226]. - Cash and cash equivalents are expected to be sufficient to meet anticipated debt service and operating needs for at least the next 12 months[219]. Development and Strategic Initiatives - The company commenced commercial sales of XACDURO® in the third quarter of 2023, which was approved by the FDA on May 23, 2023[190]. - The development pipeline includes zoliflodacin, which reported positive data in a pivotal Phase 3 clinical trial on November 1, 2023, with an NDA submission expected in early 2025[196]. - The company expanded its portfolio through the acquisition of Entasis Therapeutics and La Jolla Pharmaceutical Company in 2022, enhancing its hospital and infectious disease platform[190]. - The company aims to maximize the potential value of its respiratory assets and diversify its royalty management business through opportunistic acquisitions[192]. - XACDURO® was nominated for the 2024 Prix Galien USA Award for Best Biotechnology Product, recognizing its innovation in improving human health[195]. Market and Economic Factors - The changes in fair values of equity method investments resulted in an unrealized loss of $18.2 million for the three months ended September 30, 2024, compared to an unrealized gain of $72.0 million in the same period of 2023[215]. - Research and development expenses for the nine months ended September 30, 2024, were $9.99 million, a significant decrease of 68% from $31.57 million in the same period of 2023[209]. - The maximum royalty rate under the La Jolla Royalty Agreement increased to 18% starting January 1, 2024, with maximum aggregate royalty payments capped at $225.0 million[229]. - The company has approximately $9.1 million in outstanding purchase commitments under the Commercial Supply Agreement with Corden Pharma through the remainder of 2024[231]. - The company is exposed to changes in the fair value of certain investments in equity and debt securities, which could result in material gains or losses[234]. - Inflationary factors may adversely affect operating results, although no material impact has been observed to date[235]. - The company does not believe that foreign exchange risk will significantly impact operating income, as the majority of cash and investments are denominated in U.S. dollars[236].

Revenue Performance - Third quarter 2024 gross royalty revenue from GSK was $60.5 million, a 6% increase from $57.0 million in Q3 2023[3] - U.S. net product sales for Q3 2024 reached $19.7 million, reflecting a 68% year-over-year growth from $11.8 million in Q3 2023[4] - Total net product sales for Q3 2024 were $27.8 million, including $8.1 million from ex-U.S. sales[4] - Total revenue for September 2024 was $89,508,000, an increase of 33% compared to $67,259,000 in September 2023[17] - Royalty revenue, net for September 2024 was $57,056,000, up 6% from $53,558,000 in September 2023[17] - Net product sales reached $27,822,000 in September 2024, significantly higher than $13,701,000 in September 2023, representing a 103% increase[17] Income and Expenses - Net income for Q3 2024 was $1.2 million, or $0.02 per share, compared to $82.0 million, or $1.26 per share, in Q3 2023[5] - The company reported a net income of $1,213,000 for September 2024, a significant drop from $82,046,000 in September 2023[17] - Basic net income per share for September 2024 was $0.02, down from $1.26 in September 2023[17] - Research and development expenses were $3,551,000 for September 2024, a decrease from $3,989,000 in September 2023[17] Cash and Assets - Total cash and cash equivalents as of September 30, 2024, amounted to $260.6 million, with receivables totaling $91.1 million[6] - Cash and cash equivalents at the end of the period increased to $260,630,000 from $193,513,000 at the beginning of the period[20] - Net cash provided by operating activities was $129,451,000 for September 2024, compared to $107,808,000 in September 2023[20] - Total assets decreased slightly to $1,231,612,000 as of September 30, 2024, from $1,243,507,000 as of December 31, 2023[18] - Total liabilities and stockholders' equity remained stable at $1,231,612,000 as of September 30, 2024[18] Strategic Initiatives - The company plans to submit a New Drug Application for zoliflodacin to the U.S. FDA in early 2025[2] - XACDURO was nominated for the Best Biotechnology Product by The Galien Foundation USA, highlighting its innovative impact[2] - The company reported a $35.2 million unfavorable net change in fair value of equity and long-term investments, primarily due to Armata Pharmaceuticals' lower share price[5] - The company remains focused on prudent capital allocation to maximize shareholder value and sees multiple opportunities for continued value creation[2]

Revenue and Sales Performance - Gross royalty revenue from GSK for Q2 2024 was $67.2 million, a 2.3% increase from $65.7 million in Q2 2023[164]. - Net product sales for Q2 2024 reached $21.7 million, representing a 38% increase compared to $15.7 million in Q2 2023[164]. - Total net royalty revenue increased to $63.7 million for the three months ended June 30, 2024, compared to $62.3 million for the same period in 2023[171]. - Total royalty revenue from RELVAR®/BREO® ELLIPTA® was $53.98 million for the three months ended June 30, 2024, compared to $54.45 million for the same period in 2023[171]. - Net product sales for Q2 2024 reached $21.7 million, a 38.2% increase from $15.7 million in Q2 2023, driven by sales of GIAPREZA®, XERAVA®, and XACDURO®[172][174]. - License revenue for Q2 2024 was $14.5 million, including $8.0 million from a regulatory milestone with Zai Lab, compared to $3.0 million in Q2 2023[174]. Product Development and Approvals - The company commenced commercial sales of XACDURO® in Q3 2023, which was approved by the FDA on May 23, 2023[162]. - Zoliflodacin, an investigational treatment for uncomplicated gonorrhea, reported positive Phase 3 clinical trial data on November 1, 2023, with an NDA submission expected in early 2025[167]. - XACDURO® was approved in China in May 2024 and named the preferred agent for treating Carbapenem-resistant Acinetobacter baumannii infections in July 2024[165]. Financial Performance and Expenses - Cost of products sold for Q2 2024 was $8.5 million, a decrease of 6% from $9.0 million in Q2 2023[175]. - Research and development expenses significantly decreased to $2.6 million in Q2 2024, down 83% from $15.0 million in Q2 2023, primarily due to the FDA approval of XACDURO®[177][178]. - Selling, general and administrative expenses increased to $27.7 million in Q2 2024, an 18% rise from $23.5 million in Q2 2023, attributed to resource reallocation and increased marketing efforts[179]. - Interest expense for Q2 2024 was $5.8 million, a 32% increase from $4.4 million in Q2 2023, mainly due to higher effective interest rates[182]. - The company recorded an income tax benefit of $4.6 million for Q2 2024, compared to an expense of $4.5 million in Q2 2023, with an effective tax rate of 68.4%[185]. Cash Flow and Financial Position - As of June 30, 2024, the company had net cash and cash equivalents of $217.0 million and accounts receivable totaling $26.8 million[186]. - Net cash provided by operating activities for the six months ended June 30, 2024, was $80.8 million, an increase of 26.4% from $63.9 million in the same period of 2023[188][189]. - Net cash used in investing activities for the six months ended June 30, 2024, was $43.0 million, compared to $35.7 million in the same period of 2023, reflecting an increase of 20.5%[191][192]. - Net cash used in financing activities for the six months ended June 30, 2024, was $14.2 million, significantly reduced from $146.2 million in the same period of 2023[193]. - Cash and cash equivalents are expected to be sufficient for at least the next 12 months to meet debt service and operating needs[187]. Strategic Initiatives and Acquisitions - The company expanded its portfolio through the acquisitions of Entasis Therapeutics and La Jolla Pharmaceutical in July and August 2022, respectively[162]. - The company’s corporate strategy focuses on maximizing the potential value of respiratory assets and pursuing opportunistic acquisitions in the healthcare industry[163]. Risks and Obligations - The company has contractual obligations of $192.5 million related to 2025 Notes and $261.0 million related to 2028 Notes, with interest rates of 2.5% and 2.125% respectively[194]. - The maximum royalty rate under the La Jolla Royalty Agreement increased to 18% starting January 1, 2024, with maximum aggregate royalty payments capped at $225.0 million[195]. - The company has approximately $9.7 million in outstanding purchase commitments under a Commercial Supply Agreement for the remainder of 2024[196]. - The company is exposed to inflationary pressures, which may adversely affect operating results in the near future[199]. - The company faces foreign exchange risk due to transactions in currencies other than U.S. dollars, but the majority of cash and investments are in U.S. dollars, mitigating significant impact[200].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FORM 10-Q For the transition period from to (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR Commission File Number: 000-30319 INNOVIVA, INC. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation or Or ...

Exhibit 99.1 Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress Core royalty platform on track; receiving GSK royalties of $61.9 million Achieved net product revenues of $19.1 million, representing 66% year-over-year growth driven by launch of XACDURO and growth of key core product GIAPREZA Strong pipeline progress: positive Phase 3 zoliflodacin clinical trial results in uncomplicated gonorrhea highlighted at ESCMID Global 2024; on track to submit NDA in early 2025 Der ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Burlingame, CA (Address of principal executive offices) Registrant's telephone number, including area code: (650) 238-9600 | Title of Each Class | Trading Symbol(s) | Name of Each Exchange On Which Registe ...

Exhibit 99.1 Innoviva Reports Fourth Quarter and Full Year 2023 Financial Results; Highlights Recent Company Progress Core royalty platform on track; received GSK royalties of $69.6 million for fourth quarter Achieved net product revenues of $19.7 million for the fourth quarter of 2023 representing 35% year on year growth Strong pipeline progress in 2023: Approval and launch of first pathogen targeted antibacterial XACDURO for treatment of HABP/VABP caused by Acinetobacter infections; positive topline Phase ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 000-30319 INNOVIVA, INC. (Exact Name of Registrant as Specified in its Charter) (State or Other Jurisdiction of Incorporation o ...