Press Release
Press Release
Exelixis Announces Second Quarter 2020 Financial Results and Provides Corporate Update
- Total Revenues of
- GAAP Diluted EPS of
- Conference Call and Webcast Today at
“Exelixis continued to execute on our key priorities and milestones in the second quarter of 2020,” said
Second Quarter 2020 Financial Results
Total revenues for the quarter ended
Total revenues for the quarter ended
Collaboration revenues, composed of license revenues and collaboration services revenues, were
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 were
Non-GAAP Financial Measures
To supplement Exelixis’ financial results presented in accordance with
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.
2020 Financial Guidance
Total revenues (1) |
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Net product revenues |
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Cost of goods sold |
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4% - 5% of net product revenues |
Research and development expenses (1)(2) |
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Selling, general and administrative expenses (1)(3) |
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Effective tax rate (1) |
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17% - 19% |
Cash and investments (4) |
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(1) |
Guidance updated on |
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(2) |
Includes |
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(3) |
Includes |
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(4) |
This cash guidance does not include any potential new business development activity, which remains a key priority for |
Cabozantinib Highlights
Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the
Positive Top-line Results from Pivotal Phase 3 CheckMate -9ER Trial Evaluating Nivolumab in Combination with Cabozantinib in Previously Untreated Advanced Renal Cell Carcinoma (RCC). In
Cabozantinib Data Presentations at the
Initiation of Three Phase 3 Pivotal Trials of Cabozantinib in Combination with Atezolizumab in Previously Treated Metastatic Non-Small Cell
- CONTACT-01 is evaluating the combination of cabozantinib and atezolizumab in patients with metastatic NSCLC who have been previously treated with an immune checkpoint inhibitor (ICI) and platinum-containing chemotherapy.
- CONTACT-02 is evaluating the combination of cabozantinib and atezolizumab in patients with metastatic CRPC who have been previously treated with one novel hormonal therapy.
- CONTACT-03 is evaluating the combination of cabozantinib and atezolizumab in patients with metastatic RCC who progressed during or following treatment with an ICI as the immediate preceding therapy.
Completion of Patient Enrollment for COSMIC-312 Phase 3 Pivotal Trial in Previously Untreated Hepatocellular Carcinoma (HCC). Today,
Announcement of Results from Phase 1b COSMIC-021 Trial of Cabozantinib in Combination with Atezolizumab in Multiple Advanced Solid Tumor Types. In
Completion of Patient Enrollment for EXAMINER Phase 4 Trial of Cabozantinib in Metastatic Medullary Thyroid Cancer. In
Corporate Updates
Takeda Pharmaceutical Company Limited (
Exelixis Files Second Complaint in Patent Infringement Lawsuit against
FDA Approves Tecentriq® (Atezolizumab) Plus COTELLIC® (Cobimetinib) and Zelboraf® (Vemurafenib) for Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma. In
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 6548897 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’ plans to present data from CheckMate -9ER and the clear cell RCC and non-clear cell RCC cohorts of COSMIC-021 at ESMO 2020; Exelixis’ regulatory filing plans and launch readiness preparations with respect to the combination of nivolumab and cabozantinib as a treatment for patients with RCC; the potential utility of cabozantinib in additional disease settings; Exelixis’ plans to file up to three new Investigational New Drug applications by the end of 2020; Exelixis’ updated 2020 financial guidance; Exelixis’ anticipated timelines for top-line results from COSMIC-312 and EXAMINER; 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 continuing COVID-19 pandemic and its impact on Exelixis’ clinical trial, drug discovery and commercial activities; the degree of market acceptance of CABOMETYX and other
MINNEBRO is a registered Japanese trademark.
-see attached financial tables-
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended |
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Six Months Ended |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenues: |
|
|
|
|
|
|
|
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Net product revenues |
$ |
178,730 |
|
|
$ |
193,675 |
|
|
$ |
372,610 |
|
|
$ |
373,256 |
|
License revenues |
59,234 |
|
|
37,742 |
|
|
80,113 |
|
|
63,306 |
|
||||
Collaboration services revenues |
21,515 |
|
|
8,858 |
|
|
33,671 |
|
|
19,200 |
|
||||
Total revenues |
259,479 |
|
|
240,275 |
|
|
486,394 |
|
|
455,762 |
|
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Operating expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
9,221 |
|
|
7,539 |
|
|
18,510 |
|
|
15,040 |
|
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Research and development |
114,933 |
|
|
81,932 |
|
|
216,810 |
|
|
145,221 |
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Selling, general and administrative |
59,791 |
|
|
58,815 |
|
|
122,731 |
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|
118,953 |
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Total operating expenses |
183,945 |
|
|
148,286 |
|
|
358,051 |
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|
279,214 |
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Income from operations |
75,534 |
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|
91,989 |
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128,343 |
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176,548 |
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Interest income |
5,162 |
|
|
6,975 |
|
|
12,382 |
|
|
13,062 |
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Other income, net |
— |
|
|
803 |
|
|
6 |
|
|
828 |
|
||||
Income before income taxes |
80,696 |
|
|
99,767 |
|
|
140,731 |
|
|
190,438 |
|
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Provision for income taxes |
13,875 |
|
|
20,725 |
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|
25,298 |
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|
35,621 |
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Net income |
$ |
66,821 |
|
|
$ |
79,042 |
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$ |
115,433 |
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|
$ |
154,817 |
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Net income per share: |
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|
|
|
|
|
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Basic |
$ |
0.22 |
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|
$ |
0.26 |
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|
$ |
0.38 |
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$ |
0.51 |
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Diluted |
$ |
0.21 |
|
|
$ |
0.25 |
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|
$ |
0.36 |
|
|
$ |
0.49 |
|
Weighted-average common shares outstanding: |
|
|
|
|
|
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Basic |
307,807 |
|
|
302,188 |
|
|
306,598 |
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301,365 |
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Diluted |
318,144 |
|
|
314,911 |
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|
316,992 |
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|
314,786 |
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CONDENSED CONSOLIDATED BALANCE SHEET DATA |
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(in thousands) |
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(unaudited) |
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Cash and investments |
$ |
1,540,179 |
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$ |
1,388,628 |
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Working capital |
$ |
1,251,982 |
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$ |
868,444 |
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Total assets |
$ |
2,046,548 |
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$ |
1,885,670 |
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Total stockholders’ equity |
$ |
1,833,324 |
|
|
$ |
1,685,970 |
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RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended |
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Six Months Ended |
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2020 |
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2019 |
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2020 |
|
2019 |
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GAAP net income |
$ |
66,821 |
|
|
$ |
79,042 |
|
|
$ |
115,433 |
|
|
$ |
154,817 |
|
Adjustments: |
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Stock-based compensation - research and development expenses (1) |
6,112 |
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5,138 |
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11,198 |
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|
9,444 |
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Stock-based compensation - selling, general and administrative expenses (1) |
10,042 |
|
|
9,941 |
|
|
18,938 |
|
|
18,164 |
|
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Income tax effect of the above adjustments |
(3,609 |
) |
|
(3,385 |
) |
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(6,789 |
) |
|
(6,194 |
) |
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Non-GAAP net income |
$ |
79,366 |
|
|
$ |
90,736 |
|
|
$ |
138,780 |
|
|
$ |
176,231 |
|
GAAP net income per share: |
|
|
|
|
|
|
|
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Basic |
$ |
0.22 |
|
|
$ |
0.26 |
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$ |
0.38 |
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|
$ |
0.51 |
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Diluted |
$ |
0.21 |
|
|
$ |
0.25 |
|
|
$ |
0.36 |
|
|
$ |
0.49 |
|
Non-GAAP net income per share: |
|
|
|
|
|
|
|
||||||||
Basic |
$ |
0.26 |
|
|
$ |
0.30 |
|
|
$ |
0.45 |
|
|
$ |
0.58 |
|
Diluted |
$ |
0.25 |
|
|
$ |
0.29 |
|
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$ |
0.44 |
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|
$ |
0.56 |
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Weighted-average common shares outstanding: |
|
|
|
|
|
|
|
||||||||
Basic |
307,807 |
|
|
302,188 |
|
|
306,598 |
|
|
301,365 |
|
||||
Diluted |
318,144 |
|
|
314,911 |
|
|
316,992 |
|
|
314,786 |
|
____________________ |
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(1) |
Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Standards Codification Topic 718, Compensation—Stock Compensation. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200806005975/en/
Chief Financial Officer
650-837-7240
csenner@exelixis.com
EVP, Public Affairs & Investor Relations
650-837-8194
shubbard@exelixis.com
Source: