Innoviva Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress
Received GSK royalties of
Repurchased
- Gross royalty revenue from
Glaxo Group Limited (GSK) for the first quarter 2023 was$60.3 million , which included royalties of$50.9 million from global net sales of RELVAR®/BREO® ELLIPTA® and royalties of$9.4 million from global net sales of ANORO® ELLIPTA®, compared to$93.5 million for the first quarter of 2022. The decrease was primarily due to the sale of our subsidiary,Theravance Respiratory Company , with its TRELEGY® royalty stream inJuly 2022 .
- Net product sales and license revenue for the first quarter of 2023 was
$19.5 million , which included$9.0 million from GIAPREZA® net sales,$2.5 million from XERAVA® net sales and an$8.0 million milestone payment from our partner for the approval of XERAVA® in mainlandChina .
- Net income was
$34.9 million , or$0.51 basic per share, for the first quarter of 2023, compared to net income of$15.8 million , or$0.23 basic per share, for the first quarter of 2022.
- Cash and cash equivalents totaled
$144.0 million . Royalty, product sales and milestone receivables totaled$75.8 million as ofMarch 31, 2023 .
"The first quarter of 2023 was marked by strong revenues stemming from both our royalty portfolio and our internal product portfolio along with continued execution against key corporate objectives,” said
First Quarter 2023 and Recent Highlights
GSK Net Sales
- First quarter 2023 net sales of RELVAR®/BREO® ELLIPTA® by GSK were
$339.2 million with$122.4 million in net sales from the U.S. market and$216.8 million from non-U.S. markets.
- First quarter 2023 net sales of ANORO® ELLIPTA® by GSK were
$145.1 million with$62.2 million net sales from the U.S. market and$82.9 million from non-U.S. markets.
Corporate Updates
- Innoviva’s recently established subsidiary, Innoviva Specialty Therapeutics, which integrated
Entasis Therapeutics Holding Inc (“Entasis”) andLa Jolla Pharmaceutical Company and, in conjunction with its affiliates, markets GIAPREZA® and XERAVA® as well as advances the development and commercialization of sulbactam-durlobactam and zoliflodacin.
- On
January 10, 2023 , the Company’s wholly owned subsidiary,Innoviva Strategic Opportunities LLC , invested$30.0 million in a convertible promissory note of Armata Pharmaceuticals, Inc. to support the clinical development of its multiple innovative bacteriophage assets as well as advanced biologics cGMP manufacturing capabilities.
- On
February 2, 2023 , the Company’s wholly owned subsidiary,Innoviva TRC Holding LLC , invested$5.0 million in a convertible promissory note ofGate Neurosciences Inc. to support the clinical development of its differentiated pipeline of neuropsychiatric therapeutics.
- During the first quarter of 2023,
Innoviva repurchased approximately 3.4 million shares of its outstanding common stock for$40.3 million .
- In
January 2023 ,Innoviva paid off the remaining principal balance of$96.2 million of its convertible subordinated notes, due 2023.
Clinical Updates
- On
April 17, 2023 , the FDA’sAntimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in support of approval of sulbactam-durlobactam based on a favorable benefit-risk assessment for the treatment of adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The sulbactam-durlobactam New Drug Application (NDA), filed by Entasis, was accepted and granted Priority Review by the FDA inNovember 2022 , with a Prescription Drug User Fee Act (PDUFA) target action date ofMay 29, 2023 .
- Phase 3 Zoliflodacin study on track to complete enrollment in second half of 2023. Zoliflodacin is a novel, first-in-class oral antibiotic in development for the treatment of uncomplicated gonorrhea.
About
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.
|
||||||||
Condensed Consolidated Statements of Income |
||||||||
(in thousands, except per share data) |
||||||||
(Unaudited) |
||||||||
Three Months Ended |
||||||||
|
||||||||
2023 |
2022 |
|||||||
Revenue: | ||||||||
Royalty revenue, net (1) |
$ |
56,858 |
|
$ |
90,059 |
|
||
Net product sales |
|
11,514 |
|
|
- |
|
||
License revenue |
|
8,000 |
|
|
- |
|
||
Total revenue |
|
76,372 |
|
|
90,059 |
|
||
Expenses: | ||||||||
Cost of products sold (inclusive of amortization of inventory fair value adjustments, excluding depreciation and amortization of intangible assets) |
|
8,749 |
|
|
- |
|
||
Cost of license revenue |
|
1,600 |
|
|
- |
|
||
Selling, general and administrative |
|
19,735 |
|
|
6,492 |
|
||
Research and development |
|
12,588 |
|
|
5,838 |
|
||
Amortization of acquired intangible assets |
|
3,805 |
|
|
- |
|
||
Loss on debt extinguishment |
|
- |
|
|
20,662 |
|
||
Changes in fair values of equity method investments, net |
|
(15,817 |
) |
|
11,950 |
|
||
Changes in fair values of equity and long-term investments, net |
|
2,164 |
|
|
(2,539 |
) |
||
Interest and dividend income |
|
(3,365 |
) |
|
(322 |
) |
||
Interest expense |
|
4,427 |
|
|
3,010 |
|
||
Other expense, net |
|
1,346 |
|
|
250 |
|
||
Total expenses |
|
35,232 |
|
|
45,341 |
|
||
Income before income taxes |
|
41,140 |
|
|
44,718 |
|
||
Income tax expense |
|
6,275 |
|
|
6,860 |
|
||
Net income |
|
34,865 |
|
|
37,858 |
|
||
Net income attributable to noncontrolling interest |
|
- |
|
|
22,085 |
|
||
Net income attributable to |
$ |
34,865 |
|
$ |
15,773 |
|
||
Basic net income per share attributable to |
$ |
0.51 |
|
$ |
0.23 |
|
||
Diluted net income per share attributable to |
$ |
0.42 |
|
$ |
0.20 |
|
||
Shares used to compute basic net income per share |
|
67,786 |
|
|
69,544 |
|
||
Shares used to compute diluted net income per share |
|
89,788 |
|
|
93,730 |
|
(1) Total net revenue is comprised of the following (in thousands): | ||||||||
Three Months Ended |
||||||||
|
||||||||
2023 |
2022 |
|||||||
(unaudited) |
||||||||
Royalties |
$ |
60,314 |
|
$ |
93,515 |
|
||
Amortization of capitalized fees |
|
(3,456 |
) |
|
(3,456 |
) |
||
Royalty revenue, net |
$ |
56,858 |
|
$ |
90,059 |
|
||
|
||||||
Condensed Consolidated Balance Sheets |
||||||
(in thousands) |
||||||
(unaudited) |
||||||
|
|
|||||
2023 |
2022 |
|||||
Assets | ||||||
Cash and cash equivalents |
$ |
144,049 |
$ |
291,049 |
||
Royalty and product sale receivables |
|
75,804 |
|
64,073 |
||
Inventory, net |
|
49,653 |
|
55,897 |
||
Prepaid expense and other current assets |
|
26,940 |
|
32,492 |
||
Property and equipment, net |
|
180 |
|
170 |
||
Equity and long-term investments |
|
455,865 |
|
403,013 |
||
Capitalized fees |
|
94,151 |
|
97,607 |
||
Right-of-use assets |
|
2,973 |
|
3,265 |
||
|
27,946 |
|
26,713 |
|||
Intangible assets |
|
248,314 |
|
252,919 |
||
Other assets |
|
3,893 |
|
4,299 |
||
Total assets |
$ |
1,129,768 |
$ |
1,231,497 |
||
Liabilities and stockholders’ equity | ||||||
Other current liabilities |
$ |
35,210 |
$ |
32,322 |
||
Accrued interest payable |
|
833 |
|
4,359 |
||
Deferred revenue |
|
2,094 |
|
2,094 |
||
Convertible subordinated notes, due 2023, net |
|
- |
|
96,193 |
||
Convertible senior notes, due 2025, net |
|
190,759 |
|
190,583 |
||
Convertible senior notes, due 2028, net |
|
253,933 |
|
253,597 |
||
Other long term liabilities |
|
70,133 |
|
70,918 |
||
Deferred tax liabilities |
|
5,392 |
|
5,771 |
||
Income tax payable - long term |
|
9,921 |
|
9,872 |
||
|
561,493 |
|
565,788 |
|||
Total liabilities and stockholders’ equity |
$ |
1,129,768 |
$ |
1,231,497 |
||
Cash Flows Summary |
||||||||
(in thousands) |
||||||||
(unaudited) |
||||||||
Three Months Ended |
||||||||
2023 |
2022 |
|||||||
Net cash provided by operating activities |
$ |
25,684 |
|
$ |
98,102 |
|
||
Net cash used in investing activities |
|
(35,722 |
) |
|
(143,156 |
) |
||
Net cash (used in) provided by financing activities |
|
(136,962 |
) |
|
60,331 |
|
||
Net change |
$ |
(147,000 |
) |
$ |
15,277 |
|
||
Cash and cash equivalents at beginning of period |
|
291,049 |
|
|
201,525 |
|
||
Cash, cash equivalents and restricted cash at end of period |
$ |
144,049 |
|
$ |
216,802 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20230509006103/en/
Investors and Media:
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