Press Release
Press Release
Exelixis Announces Second Quarter 2019 Financial Results and Provides Corporate Update
- Total Revenue of
- GAAP Diluted EPS of
- Conference Call and Webcast Today at
“The second quarter of 2019 was highlighted by the strong and sustained momentum of our business,” said
Dr. Morrissey continued: “Our clinical development efforts continue to accelerate with the initiation of COSMIC-313, a new phase 3 pivotal trial of the cabozantinib triplet combination with nivolumab and ipilimumab in renal cell carcinoma, as well as the recent expansion of COSMIC-021, our phase 1b trial of cabozantinib and atezolizumab across multiple tumor types. Through the rest of our 25th anniversary year, we’re working to advance our business with a focus on sustainable long-term growth through commercial execution, thoughtful research and development investments, and financial discipline.”
Second Quarter 2019 Financial Results
Total revenues for the quarter ended
Total revenues included net product revenues of
Total revenues for the quarter ended
Research and development expenses for the quarter ended
Selling, general and administrative expenses for the quarter ended
Provision for income taxes for the quarter ended
GAAP net income for the quarter ended
Non-GAAP net income for the quarter ended
Cash and investments totaled
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with GAAP,
These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.
2019 Financial Guidance
Cabozantinib Highlights
Strong Growth in Cabozantinib Franchise Net Revenues and Royalties. Net product revenues generated by the cabozantinib franchise were
Takeda Submits Marketing Application to the
Completion of Enrollment in CheckMate 9ER. In May, CheckMate 9ER, the phase 3 pivotal study evaluating the combination of cabozantinib and nivolumab versus sunitinib in patients with previously untreated advanced or metastatic RCC, completed enrollment. The trial randomized approximately 650 patients globally. CheckMate 9ER is sponsored by
Initiation of COSMIC-313, a Phase 3 Pivotal Trial Evaluating the Triplet Combination of Cabozantinib, Nivolumab and Ipilimumab Versus the Combination of Nivolumab and Ipilimumab in Patients with Previously Untreated Advanced Intermediate- or Poor-Risk RCC. In May,
Expansion to Clinical Research Protocol for Phase 1b COSMIC-021 Trial. In July,
Corporate Highlights
Daiichi Sankyo Launches MINNEBRO Tablets for the Treatment of Hypertension in
Presence at the
Basis of Presentation
Conference Call and Webcast
To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6687332 to join by phone.
A telephone replay will be available until
About
Founded in 1994,
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ intention to advance the business with a focus on sustainable long-term growth through commercial execution, thoughtful research and development investments, and financial discipline; Exelixis’ updated guidance for 2019 cost of goods sold, research and development expenses (including non-cash expenses related to stock-based compensation), selling, general and administrative expenses (including non-cash expenses related to stock-based compensation), and effective tax rate; Exelixis’ eligibility for additional development, regulatory and first-sale milestone payments, as well as royalties on sales under its collaboration with Takeda; Exelixis’ expectation of results in early 2020 from CheckMate 9ER; Exelixis’ eligibility for additional commercialization milestone payments, as well as low double-digit royalties on sales of MINNEBRO; Exelixis’ financial and other obligations under each of its option and license agreements with Iconic and Aurigene; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the degree of market acceptance of CABOMETYX, COMETRIQ, COTELLIC and MINNEBRO in the territories where they are approved, and Exelixis’ ability to obtain or maintain coverage and reimbursement for these products; the effectiveness of CABOMETYX, COMETRIQ, COTELLIC and MINNEBRO in comparison to competing products; the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; the potential failure of cabozantinib, cobimetinib, esaxerenone and other
MINNEBRO is a registered Japanese trademark.
EXELIXIS, INC. |
|||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
|||||||||||||||
(in thousands, except per share amounts) |
|||||||||||||||
(unaudited) |
|||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
193,675 |
|
|
$ |
145,836 |
|
|
$ |
373,256 |
|
|
$ |
280,108 |
|
Collaboration revenues |
46,600 |
|
|
40,272 |
|
|
82,506 |
|
|
119,719 |
|
||||
Total revenues |
240,275 |
|
|
186,108 |
|
|
455,762 |
|
|
399,827 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
7,539 |
|
|
5,997 |
|
|
15,040 |
|
|
11,636 |
|
||||
Research and development |
81,932 |
|
|
42,488 |
|
|
145,221 |
|
|
80,245 |
|
||||
Selling, general and administrative |
58,815 |
|
|
51,853 |
|
|
118,953 |
|
|
105,869 |
|
||||
Total operating expenses |
148,286 |
|
|
100,338 |
|
|
279,214 |
|
|
197,750 |
|
||||
Income from operations |
91,989 |
|
|
85,770 |
|
|
176,548 |
|
|
202,077 |
|
||||
Other income (expense), net: |
|
|
|
|
|
|
|
||||||||
Interest income |
6,975 |
|
|
2,697 |
|
|
13,062 |
|
|
4,592 |
|
||||
Other, net |
803 |
|
|
(72 |
) |
|
828 |
|
|
97 |
|
||||
Total other income (expense), net |
7,778 |
|
|
2,625 |
|
|
13,890 |
|
|
4,689 |
|
||||
Income before income taxes |
99,767 |
|
|
88,395 |
|
|
190,438 |
|
|
206,766 |
|
||||
Provision for income taxes |
(20,725 |
) |
|
(901 |
) |
|
(35,621 |
) |
|
(3,415 |
) |
||||
Net income |
$ |
79,042 |
|
|
$ |
87,494 |
|
|
$ |
154,817 |
|
|
$ |
203,351 |
|
Net income per share, basic |
$ |
0.26 |
|
|
$ |
0.29 |
|
|
$ |
0.51 |
|
|
$ |
0.68 |
|
Net income per share, diluted |
$ |
0.25 |
|
|
$ |
0.28 |
|
|
$ |
0.49 |
|
|
$ |
0.65 |
|
Shares used in computing net income per share, basic |
302,188 |
|
|
297,336 |
|
|
301,365 |
|
|
296,874 |
|
||||
Shares used in computing net income per share, diluted |
314,911 |
|
|
312,241 |
|
|
314,786 |
|
|
313,024 |
|
EXELIXIS, INC. |
|||||||||
CONDENSED CONSOLIDATED BALANCE SHEET DATA |
|||||||||
(in thousands) |
|||||||||
(unaudited) |
|||||||||
|
June 30,
|
|
December 31,
|
||||||
Cash and investments (2) |
$ |
1,161,002 |
|
|
$ |
851,621 |
|
||
Working capital |
$ |
846,451 |
|
|
$ |
791,544 |
|
||
Total assets |
$ |
1,643,098 |
|
|
$ |
1,422,286 |
|
||
Total stockholders’ equity |
$ |
1,488,632 |
|
|
$ |
1,287,453 |
|
___________________ |
|
(1) |
Derived from the audited consolidated financial statements. |
(2)
|
Cash and investments include cash and cash equivalents, short- and long-term investments and long-term restricted cash and investments. Long-term restricted cash and investments totaled $1.1 million as of June 30, 2019 and December 31, 2018. |
EXELIXIS, INC. |
|||||||||||||||
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME |
|||||||||||||||
(in thousands, except per share amounts) |
|||||||||||||||
(unaudited) |
|||||||||||||||
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
GAAP net income |
$ |
79,042 |
|
|
$ |
87,494 |
|
|
$ |
154,817 |
|
|
$ |
203,351 |
|
Adjustments: |
|
|
|
|
|
|
|
||||||||
Stock-based compensation - research and development expenses |
5,138 |
|
|
2,900 |
|
|
9,444 |
|
|
5,933 |
|
||||
Stock-based compensation - selling, general and administrative expenses |
9,941 |
|
|
6,383 |
|
|
18,164 |
|
|
12,655 |
|
||||
Income tax effect of the above adjustments |
(3,385 |
) |
|
(180 |
) |
|
(6,194 |
) |
|
(380 |
) |
||||
Non-GAAP net income |
$ |
90,736 |
|
|
$ |
96,597 |
|
|
$ |
176,231 |
|
|
$ |
221,559 |
|
GAAP net income per share, basic |
$ |
0.26 |
|
|
$ |
0.29 |
|
|
$ |
0.51 |
|
|
$ |
0.68 |
|
GAAP net income per share, diluted |
$ |
0.25 |
|
|
$ |
0.28 |
|
|
$ |
0.49 |
|
|
$ |
0.65 |
|
Non-GAAP net income per share, basic |
$ |
0.30 |
|
|
$ |
0.32 |
|
|
$ |
0.58 |
|
|
$ |
0.75 |
|
Non-GAAP net income per share, diluted |
$ |
0.29 |
|
|
$ |
0.31 |
|
|
$ |
0.56 |
|
|
$ |
0.71 |
|
Shares used in computing net income per share, basic |
302,188 |
|
|
297,336 |
|
|
301,365 |
|
|
296,874 |
|
||||
Shares used in computing net income per share, diluted |
314,911 |
|
|
312,241 |
|
|
314,786 |
|
|
313,024 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190731005811/en/
Source:
Chris Senner
Chief Financial Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.com
Susan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
650-837-8194
shubbard@exelixis.com