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Innoviva(INVA) - 2024 Q3 - Quarterly Results
2024-11-06 21:18
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]
Innoviva(INVA) - 2024 Q2 - Quarterly Report
2024-07-31 20:47
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].
Innoviva(INVA) - 2024 Q1 - Quarterly Report
2024-05-08 20:46
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 ...
Innoviva(INVA) - 2024 Q1 - Quarterly Results
2024-05-08 20:44
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 ...
Innoviva(INVA) - 2023 Q4 - Annual Report
2024-02-29 22:01
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 ...
Innoviva(INVA) - 2023 Q4 - Annual Results
2024-02-29 21:15
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 ...
Innoviva(INVA) - 2023 Q3 - Quarterly Report
2023-11-01 20:44
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 ...
Innoviva(INVA) - 2023 Q2 - Quarterly Report
2023-08-02 21:02
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 June 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) Delaware 94-3265960 (State or Other Jurisdiction of ...
Innoviva(INVA) - 2023 Q1 - Quarterly Report
2023-05-09 21:05
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 March 31, 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 or Or ...
Innoviva(INVA) - 2022 Q4 - Annual Report
2023-02-28 21:44
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K | (Mark One) ☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | --- | --- | --- | | | For the fiscal year ended December 31, 2022 | | | | 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 No. 000-30319 | | | | INNOVIVA, INC. | | | | (Exact name of re ...