ALAMEDA, Calif.–(BUSINESS WIRE)–Nov 2, 2021–
Exelixis, Inc. (Nasdaq: EXEL) right this moment reported monetary outcomes for the third quarter of 2021 and supplied an replace on progress towards reaching key company aims, in addition to business, scientific and pipeline growth milestones.
“Exelixis continued to execute throughout all aspects of our enterprise within the third quarter of 2021 with important progress throughout our business, scientific growth and pipeline actions,” mentioned Michael M. Morrissey, Ph.D., President and Chief Government Officer, Exelixis. “We’re happy with the expansion of CABOMETYX ® prescriptions within the third quarter within the face of accelerating competitors, pushed by the continued broad adoption of the CABOMETYX and OPDIVO ® mixture routine in first-line renal cell carcinoma. Moreover, in September, CABOMETYX was authorised by the U.S. Meals and Drug Administration for a differentiated thyroid most cancers indication, additional increasing the CABOMETYX label so as to add an necessary new remedy possibility for a affected person inhabitants with important unmet want. We additionally made necessary strides throughout our scientific pipeline in the course of the quarter, together with increasing our XL092 growth program and progressing enrollment for our XB002 and XL102 section 1 research. Extra just lately, following the FDA’s acceptance of the Investigational New Drug utility for XL114, we in-licensed the compound from Aurigene. Moreover, we signed a brand new collaboration settlement with STORM Therapeutics for a novel therapeutic method to deal with most cancers. I’d wish to thank the Exelixis workforce for his or her collective exhausting work and execution within the third quarter and sit up for offering additional updates on our enterprise within the the rest of the 12 months.”
Third Quarter 2021 Monetary Outcomes
Whole revenues for the quarter ended September 30, 2021 have been $328.4 million, in comparison with $231.1 million for the comparable interval in 2020.
Whole revenues for the quarter ended September 30, 2021 included web product revenues of $263.1 million, in comparison with $168.6 million for the comparable interval in 2020. The rise in web product revenues was primarily associated to a rise in gross sales quantity that was pushed by sturdy uptake for the mix remedy of CABOMETYX (cabozantinib) and OPDIVO (nivolumab) following approval by the U.S. Meals and Drug Administration (FDA) in January 2021.
Collaboration revenues, composed of license revenues and collaboration companies revenues, have been $65.3 million for the quarter ended September 30, 2021, in comparison with $62.5 million for the comparable interval in 2020. The rise in collaboration revenues was primarily associated to a rise in recognition of milestone-related revenues and better royalty revenues for the gross sales of cabozantinib outdoors of the U.S. generated by Exelixis’ collaboration companions, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Firm Restricted (Takeda), which was partially offset by a lower in growth prices reimbursements earned.
Analysis and growth bills for the quarter ended September 30, 2021 have been $163.4 million, in comparison with $176.8 million for the comparable interval in 2020. The lower in analysis and growth bills was primarily associated to decreases in scientific trial prices, license and different collaboration prices and stock-based compensation expense, which was partially offset by a rise in personnel bills.
Promoting, normal and administrative bills for the quarter ended September 30, 2021 have been $101.6 million, in comparison with $88.2 million for the comparable interval in 2020. The rise in promoting, normal and administrative bills was primarily associated to will increase in personnel bills, advertising prices and company giving, which was partially offset by a lower in stock-based compensation expense.
Provision for (profit from) revenue taxes for the quarter ended September 30, 2021 was $15.1 million, in comparison with $(6.0) million for the comparable interval in 2020, primarily because of the change in pre-tax revenue (loss).
GAAP web revenue (loss) for the quarter ended September 30, 2021 was $38.2 million, or $0.12 per share, fundamental and diluted, in comparison with GAAP web lack of $(32.0) million, or $(0.10) per share, fundamental and diluted, for the comparable interval in 2020.
Non-GAAP web revenue for the quarter ended September 30, 2021 was $64.5 million, or $0.20 per share, fundamental and diluted, in comparison with non-GAAP web revenue of $11.2 million, or $0.04 per share, fundamental and diluted, for the comparable interval in 2020. Non-GAAP web revenue excludes stock-based compensation, adjusted for the associated revenue tax impact.
Money, money equivalents, restricted money equivalents and investments have been $1.8 billion at September 30, 2021, in comparison with $1.5 billion at December 31, 2020.
Non-GAAP Monetary Measures
To complement Exelixis’ monetary outcomes offered in accordance with U.S. Typically Accepted Accounting Rules (GAAP), Exelixis presents non-GAAP web revenue (and the associated per share measures), which excludes from GAAP web revenue (loss) (and the associated per share measures) stock-based compensation expense, adjusted for the associated revenue tax impact for all intervals offered.
Exelixis believes that the presentation of those non-GAAP monetary measures supplies helpful supplementary info to, and facilitates extra evaluation by, buyers. Particularly, Exelixis believes that these non-GAAP monetary measures, when thought-about along with its monetary info ready in accordance with GAAP, can improve buyers’ and analysts’ means to meaningfully evaluate Exelixis’ outcomes from interval to interval, and to determine working tendencies in Exelixis’ enterprise. Exelixis has excluded stock-based compensation expense, adjusted for the associated revenue tax impact, as a result of it’s a non-cash merchandise which will range considerably from interval to interval because of modifications circuitously or instantly associated to the operational efficiency for the intervals offered. Exelixis additionally repeatedly makes use of these non-GAAP monetary measures internally to grasp, handle and consider its enterprise and to make working choices.
These non-GAAP monetary measures are along with, not an alternative choice to, or superior to, measures of monetary efficiency ready in accordance with GAAP. Exelixis encourages buyers to fastidiously contemplate its outcomes beneath GAAP, in addition to its supplemental non-GAAP monetary info and the reconciliation between these displays, to extra totally perceive Exelixis’ enterprise. Reconciliations between GAAP and non-GAAP outcomes are offered within the tables of this launch.
2021 Monetary Steerage
Exelixis is offering the next up to date monetary steering for fiscal 12 months 2021:
Whole revenues (1) |
$1,300 million – $1,350 million |
|
Web product revenues (1) |
$1,050 million – $1,100 million |
|
Price of products bought |
Roughly 5% – 6% of web product revenues |
|
Analysis and growth bills (1)(2) |
$650 million – $675 million |
|
Promoting, normal and administrative bills (1)(3) |
$400 million – $425 million |
|
Efficient tax charge |
20% – 22% |
|
Money and investments (1)(4)(5) |
Roughly $1.8 billion |
———————————————————— |
||
(1) |
Steerage up to date on November 2, 2021 from beforehand supplied steering on August 5, 2021. |
|
(2) |
Contains $50 million of non-cash stock-based compensation expense. |
|
(3) |
Contains $70 million of non-cash stock-based compensation expense. |
|
(4) |
This money and investments steering doesn’t embrace any potential new enterprise growth exercise. |
|
(5) |
Money and investments consists of money, money equivalents, restricted money equivalents and investments. |
Cabozantinib Highlights
Cabozantinib Franchise Web Product Revenues and Royalties. Web product revenues generated by the cabozantinib franchise within the U.S. have been $263.1 million in the course of the third quarter of 2021, with web product revenues of $259.8 million from CABOMETYX and $3.3 million from COMETRIQ ® (cabozantinib). Exelixis earned $27.1 million in royalty revenues in the course of the quarter ended September 30, 2021, pursuant to collaboration agreements with our companions, Ipsen and Takeda.
Exelixis Companion Takeda and Ono Pharmaceutical Co., Ltd. (Ono) Obtain Approval in Japan for CABOMETYX in Mixture with OPDIVO for the Remedy of Unresectable or Metastatic Renal Cell Carcinoma (RCC). In August, Exelixis introduced that Takeda, its accomplice liable for the scientific growth and commercialization of CABOMETYX in Japan, and Ono, Bristol Myers Squibb’s accomplice liable for the scientific growth and commercialization of OPDIVO in Japan, acquired approval from the Japanese Ministry of Well being, Labour and Welfare to fabricate and market CABOMETYX together with OPDIVO as a remedy for unresectable or metastatic RCC. The approval was based mostly on the outcomes of CheckMate -9ER, a section 3 pivotal trial evaluating CABOMETYX together with OPDIVO in beforehand untreated sufferers with superior or metastatic RCC in contrast with sunitinib. Upon the primary business sale of the mix in Japan, Exelixis acquired a milestone cost of $20.0 million from Takeda within the third quarter of 2021.
FDA Approval of CABOMETYX for Sufferers with Beforehand Handled Radioactive Iodine (RAI)-Refractory Differentiated Thyroid Most cancers (DTC). In September, Exelixis introduced that the FDA authorised CABOMETYX for the remedy of grownup and pediatric sufferers 12 years of age and older with domestically superior or metastatic DTC that has progressed following prior vascular endothelial progress issue receptor-targeted remedy and who’re RAI-refractory or ineligible. The FDA granted Breakthrough Remedy designation and Precedence Evaluate to CABOMETYX for this indication, and its approval got here greater than two months forward of the Prescription Drug Consumer Payment Act goal motion date of December 4, 2021.
Cabozantinib Displays on the 2021 European Society of Medical Oncology (ESMO) Congress. In September, cabozantinib was the topic of a number of scientific knowledge displays on the 2021 ESMO Congress, together with: a post-hoc exploratory evaluation of the section 3 CheckMate -9ER pivotal trial demonstrating efficacy advantages of the mix of CABOMETYX and OPDIVO in contrast with sunitinib as a first-line remedy in superior RCC sufferers no matter prior nephrectomy standing; detailed outcomes from the expanded cohort 6 of the section 1b COSMIC-021 trial of cabozantinib together with atezolizumab in sufferers with metastatic castration-resistant prostate most cancers; and ultimate outcomes from the section 3 COSMIC-311 pivotal trial of CABOMETYX in sufferers with beforehand handled RAI-refractory DTC.
Pipeline Highlights
Exelixis and Invenra, Inc. (Invenra)Increase Collaboration to Uncover and Develop Novel Biologics in Oncology. In August, Exelixis and Invenra introduced an enlargement to their discovery and licensing collaboration to incorporate a further 20 oncology targets. The augmented partnership builds on the 2 corporations’ ongoing collaboration and license settlement to find and develop mono-specific and multi-specific antibodies for incorporation into novel biologics to deal with most cancers, which was initially introduced in Could 2018 and expanded in October 2019.
Exelixis In-Licenses Second Anti-Most cancers Compound from Aurigene Discovery Applied sciences Restricted (Aurigene)Following FDA Acceptance of Investigational New Drug (IND) Software. In October, Exelixis and Aurigene introduced that Exelixis exercised its unique choice to in-license XL114 (previously AUR104) beneath the businesses’ July 2019 collaboration, possibility and license settlement. In consequence, Exelixis assumed duty for all subsequent scientific growth, manufacturing and commercialization of the compound, which inhibits the CARD11-BCL10-MALT1 signaling pathway that promotes lymphocyte survival and proliferation. Following the FDA’s latest acceptance of Exelixis’ IND, the corporate plans to provoke a section 1 trial of XL114 as a monotherapy in sufferers with non-Hodgkin’s lymphoma.
Company Updates
Exelixis and STORM Therapeutics (STORM) Enter Unique Collaboration and License Settlement to Uncover and Develop Inhibitors of Novel RNA Modifying Enzymes. In October, Exelixis and STORM entered into an unique collaboration and license settlement beneath which the businesses will uncover and advance novel drug leads meant for the remedy of most cancers. The collaboration will focus initially on ADAR1, advancing early work by STORM making use of its proprietary RNA epigenetic platform, in addition to discover a further undisclosed goal.
Foundation of Presentation
Exelixis has adopted a 52- or 53-week fiscal 12 months that usually ends on the Friday closest to December 31 st. For comfort, references on this press launch as of and for the fiscal intervals ended October 1, 2021, January 1, 2021 and October 2, 2020 are indicated as being as of and for the intervals ended September 30, 2021, December 31, 2020, and September 30, 2020, respectively.
Convention Name and Webcast
Exelixis administration will talk about the corporate’s monetary outcomes for the third quarter of 2021 and supply a normal enterprise replace throughout a convention name starting at 5:00 p.m. EDT / 2:00 p.m. PDT right this moment, Tuesday, November 2, 2021.
To entry the webcast hyperlink, log onto www.exelixis.com and proceed to the Information & Occasions / Occasion Calendar web page beneath the Buyers & Media heading. Please hook up with the corporate’s web site a minimum of quarter-hour previous to the convention name to make sure sufficient time for any software program obtain that could be required to hearken to the webcast. Alternatively, please name 855-793-2457 (home) or 631-485-4921 (worldwide) and supply the convention name passcode 9563879 to affix by cellphone.
A phone replay can be obtainable till 8:00 p.m. EDT on November 4, 2021. Entry numbers for the phone replay are: 855-859-2056 (home) and 404-537-3406 (worldwide); the passcode is 9563879. A webcast replay can even be archived on www.exelixis.com for one 12 months.
About Exelixis
Based in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially profitable, oncology-focused biotechnology firm that strives to speed up the invention, growth and commercialization of latest medicines for difficult-to-treat cancers. Following early work in mannequin system genetics, we established a broad drug discovery and growth platform that has served as the inspiration for our continued efforts to deliver new most cancers therapies to sufferers in want. Our discovery efforts have resulted in 4 commercially obtainable merchandise, CABOMETYX ® (cabozantinib), COMETRIQ ® (cabozantinib), COTELLIC ® (cobimetinib) and MINNEBRO ® (esaxerenone), and we’ve entered into partnerships with main pharmaceutical corporations to deliver these necessary medicines to sufferers worldwide. Supported by revenues from our marketed merchandise and collaborations, we’re dedicated to prudently reinvesting in our enterprise to maximise the potential of our pipeline. We’re supplementing our current therapeutic property with focused enterprise growth actions and inner drug discovery – all to ship the following era of Exelixis medicines and assist sufferers get well stronger and dwell longer. Exelixis is a member of the Normal & Poor’s (S&P) MidCap 400 index, which measures the efficiency of worthwhile mid-sized corporations. For extra details about Exelixis, please go to www.exelixis.com, observe @ExelixisInc on Twitter or like Exelixis, Inc. on Fb.
Ahead-Trying Statements
This press launch incorporates forward-looking statements, together with, with out limitation, statements associated to: Exelixis’ up to date 2021 monetary steering; Exelixis’ plans to provoke a section 1 trial of XL114 as a monotherapy in sufferers with non-Hodgkin’s lymphoma; and Exelixis’ plans to reinvest in its enterprise to maximise the potential of the corporate’s pipeline, together with by focused enterprise growth actions and inner drug discovery. Any statements that consult with expectations, projections or different characterizations of future occasions or circumstances are forward-looking statements and are based mostly upon Exelixis’ present plans, assumptions, beliefs, expectations, estimates and projections. Ahead-looking statements contain dangers and uncertainties. Precise outcomes and the timing of occasions may differ materially from these anticipated within the forward-looking statements because of these dangers and uncertainties, which embrace, with out limitation: the persevering with COVID-19 pandemic and its affect on Exelixis’ scientific trial, drug discovery and business actions; the diploma of market acceptance of CABOMETYX and different Exelixis merchandise within the indications for which they’re authorised and within the territories the place they’re authorised, and Exelixis’ and its companions’ means to acquire or preserve protection and reimbursement for these merchandise; the effectiveness of CABOMETYX and different Exelixis merchandise compared to competing merchandise; the extent of prices related to Exelixis’ commercialization, analysis and growth, in-licensing or acquisition of product candidates, and different actions; Exelixis’ means to keep up and scale sufficient gross sales, advertising, market entry and product distribution capabilities for its merchandise or to enter into and preserve agreements with third events to take action; the supply of knowledge on the referenced instances; the potential failure of cabozantinib and different Exelixis product candidates, each alone and together with different therapies, to exhibit security and/or efficacy in scientific testing; uncertainties inherent within the drug discovery and product growth course of; Exelixis’ dependence on its relationships with its collaboration companions, together with their pursuit of regulatory approvals for partnered compounds in new indications, their adherence to their obligations beneath related collaboration agreements and the extent of their funding within the sources vital to finish scientific trials or efficiently commercialize partnered compounds within the territories the place they’re authorised; complexities and the unpredictability of the regulatory assessment and approval processes within the U.S. and elsewhere; Exelixis’ persevering with compliance with relevant authorized and regulatory necessities; surprising considerations which will come up because of the prevalence of antagonistic security occasions or extra knowledge analyses of scientific trials evaluating cabozantinib and different Exelixis merchandise; Exelixis’ dependence on third-party distributors for the event, manufacture and provide of its merchandise and product candidates; Exelixis’ means to guard its mental property rights; market competitors, together with the potential for rivals to acquire approval for generic variations of Exelixis’ marketed merchandise; modifications in financial and enterprise circumstances; and different components mentioned beneath the caption “Threat Components” in Exelixis’ Quarterly Report on Type 10-Q submitted to the Securities and Alternate Fee (SEC) on August 5, 2021, and in Exelixis’ future filings with the SEC, together with, with out limitation, Exelixis’ Quarterly Report on Type 10-Q anticipated to be filed with the SEC on November 2, 2021. All forward-looking statements on this press launch are based mostly on info obtainable to Exelixis as of the date of this press launch, and Exelixis undertakes no obligation to replace or revise any forward-looking statements contained herein, besides as required by regulation.
Exelixis, the Exelixis emblem, CABOMETYX, COMETRIQ and COTELLIC are registered logos of Exelixis, Inc.
MINNEBRO is a registered trademark of Daiichi Sankyo Firm, Restricted.
OPDIVO is a registered trademark of Bristol-Myers Squibb Firm.
EXELIXIS, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) (in 1000’s, besides per share quantities) (unaudited) |
|||||||||||||||
Three Months Ended September 30, |
9 Months Ended September 30, |
||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
Revenues: |
|||||||||||||||
Web product revenues |
$ |
263,117 |
$ |
168,587 |
$ |
774,577 |
$ |
541,197 |
|||||||
License revenues |
49,694 |
33,205 |
116,862 |
113,318 |
|||||||||||
Collaboration companies revenues |
15,612 |
29,300 |
92,391 |
62,971 |
|||||||||||
Whole revenues |
328,423 |
231,092 |
983,830 |
717,486 |
|||||||||||
Working bills: |
|||||||||||||||
Price of products bought |
11,874 |
8,725 |
39,956 |
27,235 |
|||||||||||
Analysis and growth |
163,370 |
176,762 |
471,448 |
393,572 |
|||||||||||
Promoting, normal and administrative |
101,558 |
88,185 |
302,404 |
210,916 |
|||||||||||
Whole working bills |
276,802 |
273,672 |
813,808 |
631,723 |
|||||||||||
Revenue (loss) from operations |
51,621 |
(42,580 |
) |
170,022 |
85,763 |
||||||||||
Curiosity revenue |
1,658 |
3,994 |
6,231 |
16,376 |
|||||||||||
Different revenue (expense), web |
(19 |
) |
565 |
(120 |
) |
571 |
|||||||||
Revenue (loss) earlier than revenue taxes |
53,260 |
(38,021 |
) |
176,133 |
102,710 |
||||||||||
Provision for (profit from) revenue taxes |
15,056 |
(5,981 |
) |
40,236 |
19,317 |
||||||||||
Web revenue (loss) |
$ |
38,204 |
$ |
(32,040 |
) |
$ |
135,897 |
$ |
83,393 |
||||||
Web revenue (loss) per share: |
|||||||||||||||
Primary |
$ |
0.12 |
$ |
(0.10 |
) |
$ |
0.43 |
$ |
0.27 |
||||||
Diluted |
$ |
0.12 |
$ |
(0.10 |
) |
$ |
0.42 |
$ |
0.26 |
||||||
Weighted-average frequent shares excellent: |
|||||||||||||||
Primary |
315,380 |
309,116 |
313,990 |
307,437 |
|||||||||||
Diluted |
322,022 |
309,116 |
322,084 |
317,495 |
EXELIXIS, INC. CONDENSED CONSOLIDATED BALANCE SHEET DATA (in 1000’s) (unaudited) |
|||||||
September 30, 2021 |
December 31, 2020 |
||||||
Money and investments (1) |
$ |
1,796,112 |
$ |
1,538,842 |
|||
Working capital |
$ |
1,392,520 |
$ |
1,240,737 |
|||
Whole property |
$ |
2,447,741 |
$ |
2,137,333 |
|||
Whole stockholders’ fairness |
$ |
2,112,447 |
$ |
1,879,113 |
|||
(1) |
Money and investments consists of money, money equivalents, restricted money equivalents and investments. |
EXELIXIS, INC. RECONCILIATION OF GAAP NET INCOME (LOSS) TO NON-GAAP NET INCOME (in 1000’s, besides per share quantities) (unaudited) |
|||||||||||||||
Three Months Ended September 30, |
9 Months Ended September 30, |
||||||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||||||
GAAP web revenue (loss) |
$ |
38,204 |
$ |
(32,040 |
) |
$ |
135,897 |
$ |
83,393 |
||||||
Changes: |
|||||||||||||||
Inventory-based compensation – analysis and growth bills (1) |
11,487 |
18,936 |
37,550 |
30,134 |
|||||||||||
Inventory-based compensation – promoting, normal and administrative bills (1) |
22,479 |
36,719 |
59,104 |
55,657 |
|||||||||||
Revenue tax impact of the above changes |
(7,631 |
) |
(12,406 |
) |
(21,655 |
) |
(19,195 |
) |
|||||||
Non-GAAP web revenue |
$ |
64,539 |
$ |
11,209 |
$ |
210,896 |
$ |
149,989 |
|||||||
GAAP web revenue (loss) per share: |
|||||||||||||||
Primary |
$ |
0.12 |
$ |
(0.10 |
) |
$ |
0.43 |
$ |
0.27 |
||||||
Diluted |
$ |
0.12 |
$ |
(0.10 |
) |
$ |
0.42 |
$ |
0.26 |
||||||
Non-GAAP web revenue per share: |
|||||||||||||||
Primary |
$ |
0.20 |
$ |
0.04 |
$ |
0.67 |
$ |
0.49 |
|||||||
Diluted |
$ |
0.20 |
$ |
0.04 |
$ |
0.65 |
$ |
0.47 |
|||||||
Weighted-average frequent shares excellent: |
|||||||||||||||
Primary |
315,380 |
309,116 |
313,990 |
307,437 |
|||||||||||
Diluted (2) |
322,022 |
318,501 |
322,084 |
317,495 |
|||||||||||
(1) |
Non-cash stock-based compensation expense used for GAAP reporting in accordance with Accounting Requirements Codification Subject 718, Compensation—Inventory Compensation. |
(2) |
The dilutive impact of shares associated to worker inventory plans usually are not included within the calculation of GAAP diluted loss per share within the third quarter of 2020 because the impact can be anti-dilutive. |
View supply model on businesswire.com:https://www.businesswire.com/news/home/20211102006271/en/
CONTACT: Chris Senner
Chief Monetary Officer
Exelixis, Inc.
650-837-7240
csenner@exelixis.comSusan Hubbard
EVP, Public Affairs & Investor Relations
Exelixis, Inc.
650-837-8194
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH PHARMACEUTICAL CLINICAL TRIALS ONCOLOGY
SOURCE: Exelixis, Inc.
Copyright Enterprise Wire 2021.
PUB: 11/02/2021 04:05 PM/DISC: 11/02/2021 04:06 PM