Innoviva Reports First Quarter 2024 Financial Results; Highlights Recent Company Progress
Innoviva, Inc. (NASDAQ: INVA) reported strong first quarter financial results with $61.9 million in GSK royalties, $19.1 million in net product revenues, and a successful pipeline. The company highlighted positive Phase 3 zoliflodacin clinical trial results and key appointments.
Strong first quarter financial results with $61.9 million in GSK royalties and $19.1 million in net product revenues.
Positive Phase 3 zoliflodacin clinical trial results in uncomplicated gonorrhea with a 90.9% microbiological cure rate.
Appointment of Derek Small to the Company's Board of Directors.
- None.
Insights
Innoviva's first quarter results show a positive growth trend, with a 66% increase in net product sales and a steady royalty income from GSK. Their strategic investments, particularly in Armata Pharmaceuticals, have contributed to a notable net change in equity and long-term investments. The company's commitment to their share buyback program, with 0.6 million shares repurchased, further affirms their confidence in ongoing financial health.
From a net income perspective, the growth to
The progress of Innoviva's pipeline, especially with zoliflodacin's positive Phase 3 clinical trial results, could position the company as a front-runner in the antibiotic space. With an efficacy rate of
The anticipated submission of a New Drug Application to the FDA in early 2025 could mark a pivotal point for Innoviva, potentially leading to revenue diversification and strengthening their infectious disease portfolio. This foresight into R&D could translate into substantial long-term rewards for investors willing to wait for regulatory approvals and market penetration.
Core royalty platform on track; receiving GSK royalties of
Achieved net product revenues of
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
Derek Small appointed to the Company’s Board of Directors
“Our first quarter financial results continue to demonstrate the successful transformation for Innoviva. We had a strong performance driven by resilient cash flows from our core GSK royalties portfolio and robust revenue growth across our commercial products marketed by IST, a leader in critical care medicine and infectious disease,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “We also remain laser focused on utilizing our strong financials to drive shareholder value by continuing to exercise cost discipline, investing prudently in our strategic healthcare assets, and completing our share buyback plan.”
Matt Ronsheim, Ph.D., President of IST, noted: “Our IST platform is a powerful engine for growth anchored by a robust portfolio of differentiated life saving therapies. We are pleased with our first quarter performance, led by the strong launch of our novel therapeutic XACDURO®. Our core products GIAPREZA® and XERAVA® continue to grow, propelled by increasing awareness of our strong data underscoring the value of our products. We are also excited about our lead pipeline product, zoliflodacin, a potential first in class well tolerated oral drug for uncomplicated gonorrhea, whose Phase 3 data was highlighted in an oral presentation by our non-profit partner GARDP at ESCMID Global 2024, the largest global infectious disease congress. We remain on track to submit our New Drug Application for zoliflodacin in early 2025.”
Financial Highlights
-
Royalty revenue: First quarter 2024 gross royalty revenue from Glaxo Group Limited (“GSK”) was
$61.9 million $60.3 million -
Net Product Sales: First quarter 2024 net product sales and license revenue were
$19.1 million $12.1 million $4.8 million $2.2 million 66% increase compared to$11.5 million -
Equity and long-term investments: First quarter 2024 net change in fair values of equity and long-term investments of
$22.0 million -
Net income: First quarter 2024 net income was
$36.5 million $0.58 $34.9 million $0.51 -
Share repurchases: During the first quarter 2024, Innoviva repurchased 0.6 million shares of its outstanding common stock for
$9.7 million $5.3 million -
Cash and cash equivalents: Totaled
$178.4 million $76.0 million
Key Business and R&D Highlights
-
XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use: targeted antibacterial for patients with HABP/VABP caused by Acinetobacter
- Following the launch in September 2023, commercial efforts continue to deliver strong performance with growing number of health systems integrating XACDURO® into their protocols.
-
Zoliflodacin: a potential first-in-class, single dose, oral antibiotic in development for the treatment of patients with uncomplicated gonorrhea
- Positive Phase 3 zoliflodacin clinical trial results highlighted in an oral presentation given by the Company’s non-profit partner, The Global Antibiotic Research & Development Partnership (GARDP), at the European Society of Clinical Microbiology and Infectious Disease Global Congress (ESCMID Global 2024).
-
The data showed that in the micro-intent-to-treat population (n=744), zoliflodacin achieved a microbiological cure rate of
90.9% , a5.3% difference compared to ceftriaxone and azithromycin, the current global standard of care, which achieved a96.2% cure rate (95% CI:1.4% ,8.7% ). Microbiological cure rates at extragenital sites were comparable between treatment arms (secondary endpoints). Zoliflodacin was generally well tolerated and emergent adverse events were comparable between treatment arms (46.2% vs46.4% ). No deaths or other serious adverse events were reported. -
The Company expects a New Drug Application to be submitted to the
U.S. FDA in early 2025.
Strategic Healthcare Assets
-
Our portfolio of strategic assets under the Company’s various subsidiaries was valued at
$628.4 million $561.0 million $35.0 million $5.8 million $2.7 million
Corporate Updates
- In April 2024, Derek Small, an accomplished biopharmaceutical entrepreneur and executive, joined the Company’s Board of Directors.
-
Management will participate in the upcoming Bank of America Securities Health Care Conference, taking place on May 15, 2024, in
Las Vegas . A live webcast of the Company’s corporate presentation is scheduled for 9:20 a.m. PT and can be accessed here. An archived replay will be available following the event.
About Innoviva
Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics (“IST”), and a portfolio of strategic investments in healthcare assets. Innoviva’s royalty portfolio includes respiratory assets partnered with Glaxo Group Limited (“GSK”). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva’s other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults.
ANORO®, RELVAR® and BREO® are trademarks of the GSK group of companies.
Forward Looking Statements
This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words “anticipate”, “expect”, “goal”, “intend”, “objective”, “opportunity”, “plan”, “potential”, “target” and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties, and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA®, GIAPREZA®, XERAVA® and XACDURO® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva’s growth strategy and corporate development initiatives); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus (“COVID-19”); the timing, manner and amount of capital deployment, including potential capital returns to stockholders; and risks related to the Company’s growth strategy. Other risks affecting Innoviva are described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in Innoviva’s Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission (“SEC”) and available on the SEC’s website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
| INNOVIVA, INC. | ||||||||
| Condensed Consolidated Statements of Income and Comprehensive Income | ||||||||
| (in thousands, except per share data) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
|
2024 |
|
|
2023 |
|
|||
| Revenue: | ||||||||
| Royalty revenue, net (1) | $ |
58,415 |
|
$ |
56,858 |
|
||
| Net product sales |
|
19,084 |
|
|
11,514 |
|
||
| License Revenue |
|
- |
|
|
8,000 |
|
||
| Total revenue |
|
77,499 |
|
|
76,372 |
|
||
| Expenses: | ||||||||
| Cost of products sold (inclusive of amortization of inventory fair value adjustments) |
|
10,971 |
|
|
8,749 |
|
||
| Cost of license revenue |
|
- |
|
|
1,600 |
|
||
| Selling, general and administrative |
|
30,405 |
|
|
19,735 |
|
||
| Research and development |
|
3,878 |
|
|
12,588 |
|
||
| Amortization of acquired intangible assets |
|
6,440 |
|
|
3,805 |
|
||
| Changes in fair values of equity method investments, net |
|
(35,342 |
) |
|
(15,817 |
) |
||
| Changes in fair values of equity and long-term investments, net |
|
13,335 |
|
|
2,164 |
|
||
| Interest and dividend income |
|
(4,399 |
) |
|
(3,365 |
) |
||
| Interest expense |
|
5,851 |
|
|
4,427 |
|
||
| Other expense, net |
|
1,236 |
|
|
1,346 |
|
||
| Total expenses |
|
32,375 |
|
|
35,232 |
|
||
| Income before income taxes |
|
45,124 |
|
|
41,140 |
|
||
| Income tax expense |
|
8,592 |
|
|
6,275 |
|
||
| Net income and comprehensive income | $ |
36,532 |
|
$ |
34,865 |
|
||
| Net income per share | ||||||||
| Basic | $ |
0.58 |
|
$ |
0.51 |
|
||
| Diluted | $ |
0.46 |
|
$ |
0.42 |
|
||
| Shares used to compute net income per share | ||||||||
| Basic |
|
63,185 |
|
|
67,786 |
|
||
| Diluted |
|
84,531 |
|
|
89,788 |
|
||
| (1) Total net revenue is comprised of the following (in thousands): | ||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
|
2024 |
|
|
2023 |
|
|||
| (unaudited) | ||||||||
| Royalties | $ |
61,871 |
|
$ |
60,314 |
|
||
| Amortization of capitalized fees |
|
(3,456 |
) |
|
(3,456 |
) |
||
| Royalty revenue, net | $ |
58,415 |
|
$ |
56,858 |
|
||
| INNOVIVA, INC. | |||||
| Condensed Consolidated Balance Sheets | |||||
| (in thousands) | |||||
| (unaudited) | |||||
March 31, |
December 31, |
||||
2024 |
2023 |
||||
| Assets | |||||
| Cash and cash equivalents | $ |
178,357 |
$ |
193,513 |
|
| Royalty and product sale receivables |
|
76,010 |
|
84,075 |
|
| Inventory, net |
|
37,437 |
|
40,737 |
|
| Prepaid expense and other current assets |
|
19,538 |
|
25,894 |
|
| Property and equipment, net |
|
324 |
|
483 |
|
| Equity and long-term investments |
|
628,437 |
|
560,978 |
|
| Capitalized fees |
|
80,328 |
|
83,784 |
|
| Right-of-use assets |
|
2,269 |
|
2,536 |
|
| Goodwill |
|
17,905 |
|
17,905 |
|
| Intangible assets |
|
223,895 |
|
230,335 |
|
| Other assets |
|
3,112 |
|
3,267 |
|
| Total assets | $ |
1,267,612 |
$ |
1,243,507 |
|
| Liabilities and stockholders’ equity | |||||
| Other current liabilities | $ |
28,059 |
$ |
33,435 |
|
| Accrued interest payable |
|
833 |
|
3,422 |
|
| Deferred revenues |
|
987 |
|
1,277 |
|
| Convertible senior notes, due 2025, net |
|
191,476 |
|
191,295 |
|
| Convertible senior notes, due 2028, net |
|
255,283 |
|
254,939 |
|
| Other long term liabilities |
|
71,686 |
|
71,870 |
|
| Deferred tax liabilities |
|
3,807 |
|
563 |
|
| Income tax payable - long term |
|
11,800 |
|
11,751 |
|
| Innoviva stockholders’ equity |
|
703,681 |
|
674,955 |
|
| Total liabilities and stockholders’ equity | $ |
1,267,612 |
$ |
1,243,507 |
|
| INNOVIVA, INC. | |||||||
| Cash Flows Summary | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| Three Months Ended March 31, | |||||||
|
2024 |
|
|
2023 |
|
||
| Net cash provided by operating activities | $ |
37,047 |
|
$ |
25,684 |
|
|
| Net cash used in investing activities |
|
(43,038 |
) |
|
(35,722 |
) |
|
| Net cash used in financing activities |
|
(9,165 |
) |
|
(136,962 |
) |
|
| Net change | $ |
(15,156 |
) |
$ |
(147,000 |
) |
|
| Cash and cash equivalents at beginning of period |
|
193,513 |
|
|
291,049 |
|
|
| Cash and cash equivalents at end of period | $ |
178,357 |
|
$ |
144,049 |
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508594441/en/
Innoviva, Inc.
David Patti
Corporate Communications
(908) 421-5971
david.patti@inva.com
Investors and Media:
Argot Partners
(212) 600-1902
innoviva@argotpartners.com
Source: Innoviva, Inc.
