On May 2, 2018 Blueprint Medicines Corporation (Nasdaq: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported financial results and provided a business update for the quarter ended March 31, 2018 (Press release, Blueprint Medicines, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346251 [SID1234525940]).

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"In the first quarter, we continued to make significant progress across our portfolio toward our vision of rapidly delivering potentially transformative kinase medicines to patients with genomically defined diseases," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "In particular, we were excited to present initial clinical proof-of-concept data for our highly selective RET inhibitor BLU-667, which showed consistent clinical activity in patients with multiple tumor types, RET alterations and prior therapies, along with a favorable safety and tolerability profile. In addition, we received positive feedback from the FDA supporting our registration plan in systemic mastocytosis, including support for a single-arm registration-enabling Phase 2 trial in patients with advanced systemic mastocytosis representing a potential expedited path to registration."

Clinical Programs:

Avapritinib: Gastrointestinal Stromal Tumors (GIST)

In March 2018, Blueprint Medicines completed enrollment of the PDGFRα D842V expansion cohort of its ongoing Phase 1 NAVIGATOR clinical trial. Based on feedback from the U.S. Food and Drug Administration (FDA) at an End-of-Phase 1 meeting in 2017, Blueprint Medicines believes that data from the PDGFRα D842V expansion cohort may be sufficient to support a New Drug Application (NDA) for avapritinib for the treatment of patients with PDGFRα D842V-driven GIST. Based on the expected timeline for the collection of data, Blueprint Medicines now anticipates it will submit an initial NDA to the FDA for avapritinib in the first half of 2019. In the first quarter, Blueprint Medicines announced it had completed enrollment of the third-line or later (KIT-driven) GIST cohort and initiated enrollment of the second-line GIST cohort in the Phase 1 NAVIGATOR trial. Blueprint Medicines anticipates presenting updated data from the NAVIGATOR trial in the second half of 2018.
Avapritinib: Advanced Systemic Mastocytosis (SM)

Blueprint Medicines recently received positive feedback from the FDA supporting its proposed registration plan for avapritinib in patients with advanced, smoldering and indolent SM. Consistent with feedback from the FDA, Blueprint Medicines plans to initiate a registration-enabling open-label, single-arm Phase 2 clinical trial in patients with advanced SM, called the PATHFINDER trial, by the middle of 2018. In addition, Blueprint Medicines plans to initiate a registration-enabling Phase 2 clinical trial in patients with indolent SM and smoldering SM, called the PIONEER trial, by the end of 2018.
Enrollment in the expansion portion of the Phase 1 EXPLORER clinical trial for advanced SM is ongoing, and Blueprint Medicines anticipates presenting updated data from this trial in the second half of 2018.
BLU-667: RET-Altered Solid Tumors

In April 2018, Blueprint Medicines presented proof-of-concept data from its ongoing Phase 1 ARROW clinical trial of BLU-667 in patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data showed broad and robust clinical activity across multiple tumor types and RET genotypes, including in patients whose disease had progressed on prior multi-kinase therapy. Radiographic tumor reductions were observed in 84 percent of patients with RET-altered solid tumors and measurable target lesions, and preliminary overall response rates were 50 percent and 40 percent in patients with NSCLC and MTC, respectively. The data also showed that BLU-667 was generally well-tolerated, and most adverse events reported by investigators were Grade 1. Read the full data here. The maximum tolerated dose (MTD) was determined to be 400 mg once daily, and global enrollment in the dose expansion portion of the Phase 1 ARROW clinical trial is ongoing.
In April 2018, Blueprint Medicines announced the publication of foundational preclinical data and clinical proof-of-concept results for BLU-667. The publication outlined preclinical data characterizing the potency and selectivity of BLU-667 against multiple oncogenic RET variants and resistant mutants and anti-tumor activity in multiple solid tumor models. It also included four patient vignettes from the ongoing Phase 1 ARROW clinical trial, showing clinical responses in patients with RET-KIF5B-altered NSCLC and MTC harboring multiple RET mutations. The paper, titled "Precision targeted therapy with BLU-667 for RET-driven cancers," was published online in Cancer Discovery.
Research Programs:

In the first quarter of 2018, Blueprint Medicines initiated investigational new drug application-enabling studies for BLU-782, its development candidate for the treatment of patients with fibrodysplasia ossificans progressiva. Blueprint Medicines plans to report preclinical data for the program in 2018.
Blueprint Medicines also recently nominated a new wholly-owned discovery program for an undisclosed kinase target.
First Quarter Financial Results:

Cash Position: As of March 31, 2018, cash, cash equivalents and investments were $621.1 million, as compared to $673.4 million as of December 31, 2017. This decrease was primarily related to cash used in operating activities.
Collaboration Revenues: Collaboration revenues were $0.9 million for the first quarter of 2018, as compared to $5.8 million for the first quarter of 2017. This decrease was primarily due to the termination of the Alexion agreement in 2017, which resulted in no revenue recognized under this agreement in the first quarter 2018, as well as the impact on revenue recognized under the Roche agreement as a result of the adoption of Accounting Standards Codification 606 effective January 1, 2018.
R&D Expenses: Research and development expenses were $50.0 million for the first quarter of 2018, as compared to $28.5 million for the first quarter of 2017. This increase was primarily attributable to increased clinical and manufacturing expenses associated with advancing avapritinib, BLU-554, and BLU-667 further through clinical trials and increased personnel-related expenses. Research and development expenses included $3.0 million in stock-based compensation expenses for the first quarter of 2018.
G&A Expenses: General and administrative expenses were $9.9 million for the first quarter of 2018, as compared to $5.7 million for the first quarter of 2017. This increase was primarily attributable to increased personnel-related expenses and increased professional fees, including pre-commercial planning activities. General and administrative expenses included $2.5 million in stock-based compensation expenses for the first quarter of 2018.
Net Loss: Net loss was $56.5 million for the first quarter of 2018, or a net loss per share of $1.29, as compared to a net loss of $28.0 million for the first quarter of 2017, or a net loss per share of $0.84.
Financial Guidance:

Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaboration with Roche, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the middle of 2020.

Conference Call Information:

Blueprint Medicines will host a live conference call and webcast today at 8:30 a.m. ET. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 7572918. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines’ website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the conference call.

On May 2, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) reported that it will report its financial results for the first quarter of 2018 on Wednesday, 09 May 2018 (Press release, Evotec, MAY 2, 2018, View Source;announcements/press-releases/p/evotec-ag-to-report-first-quarter-2018-results-on-09-may-2018-5676 [SID1234525960]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. Furthermore, the Management Board will present an outlook for the fiscal year 2018. The conference call will be held in English.

Conference call details

Date: Wednesday, 09 May 2018
Time: 02.00 pm CEST (01.00 pm BST/08.00 am EDT)
From Germany: +49 69 22 22 29 043
From France: +33 170 750 705
From Italy: +39 023 601 3806
From UK: +44 20 3009 2452
From USA: +1 855 402 7766
Access Code: 37969784#
A simultaneous slide presentation for participants dialling in via phone is available at
http://www.audio-webcast.com/, password: evotec0518

On May 2, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration, reported that it will report its first quarter 2018 financial and operating results after the close of U.S. financial markets on Wednesday, May 9, 2018 (Press release, Tracon Pharmaceuticals, MAY 2, 2018, View Source [SID1234525977]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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Conference call and webcast:
Date: May 9, 2018
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 3189378
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section

A replay of the webcast will be available for 60 days on the website.

On May 2,2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that Dan Shoemaker, Chief Scientific Officer, will present at the Deutsche Bank 43rd Annual Health Care Conference in Boston on Wednesday, May 9, 2018 at 10:40 a.m. ET (Press release, Fate Therapeutics, MAY 2, 2018, View Source [SID1234525941]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com. Following the live webcast, an archived replay will be available on the Company’s website.

On May 2, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the first quarter of 2018 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones (Press release, Exelixis, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346470 [SID1234525961]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"In the first quarter of 2018, Exelixis continued to make significant progress in the ongoing commercialization of CABOMETYX (cabozantinib) for advanced renal cell carcinoma. Following FDA approval for its expanded indication in advanced first-line renal cell carcinoma, our team immediately began promoting CABOMETYX across all lines of therapy for this patient population, resulting in further uptake from prescribers at both major academic institutions and in the community setting," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. "The resulting growth in U.S. sales, as well as the increasing collaboration revenues from our various partners, were important contributors to our strong financial performance during the quarter, leading to net income of $115.9 million or $0.37 per share on a fully diluted basis."

Dr. Morrissey continued: "From its initial approval for a rare disease indication five years ago, cabozantinib has grown to become an oncology franchise with the potential for global impact. We and our collaboration partners are committed to maximizing its opportunity to help patients across multiple tumor types. This now includes our recent regulatory submissions for previously treated advanced hepatocellular carcinoma, an aggressive cancer with worldwide relevance. Our efforts in liver cancer, as well as our plans to start additional phase 3 trials in other forms of cancer later this year, are each reflective of the Exelixis corporate mission to help patients with cancer recover stronger and live longer."

First Quarter 2018 Financial Results

Total revenues for the quarter ended March 31, 2018 were $212.3 million, compared to $80.9 million for the comparable period in 2017.

Total revenues include net product revenues of $134.3 million for the quarter ended March 31, 2018, compared to $68.9 million for the comparable period in 2017. The increase in net product revenues reflects the growth of our second and later-line advanced renal cell carcinoma (RCC) business and the impact of additional sales following the U.S. Food and Drug Administration’s (FDA) approval in December 2017 of the expanded indication for CABOMETYX, which now encompass all patients with advanced RCC.

Total revenues also include collaboration revenues of $78.1 million for the quarter ended March 31, 2018 compared to $12.0 million for the comparable period in 2017. The increase in collaboration revenues for the quarter ended March 31, 2018 was primarily the result of recording $45.8 million in revenue for a $50.0 million milestone from Ipsen Pharma SAS (Ipsen) we expect to earn in the second quarter of 2018 for the approval of cabozantinib for the first-line treatment of advanced RCC by the European Commission (EC). The determination to recognize the $45.8 million in revenue was made following the Committee for Medicinal Products for Human Use’s (CHMP) positive opinion of cabozantinib for the first-line treatment of advanced RCC. The increase in collaboration revenues was also a result of a $20.0 million milestone from our collaboration partner Daiichi Sankyo Company, Limited (Daiichi Sankyo), which was earned as a result of Daiichi Sankyo’s submission of a regulatory application to the Japanese Pharmaceutical and Medical Devices Agency for esaxerenone (CS-3150) as a treatment for patients with essential hypertension. These increases were partially offset by a decrease in the recognition of deferred revenue due to our adoption of Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606) on January 1, 2018. As a result, $258.5 million was recorded in stockholders’ equity relating primarily to a reduction in the remaining unrecognized upfront and non-substantive milestone payments that had been received from our collaboration partners and was included in deferred revenue at December 31, 2017. For more information on our adoption of the new revenue standard, see "Note 1. Organization and Summary of Significant Accounting Policies – Revenue" contained in Part I, Item 1 of Exelixis’ Quarterly Report on Form 10-Q expected to be filed with the Securities and Exchange Commission (SEC) on May 2, 2018.

Research and development expenses for the quarter ended March 31, 2018 were $37.8 million, compared to $23.2 million for the comparable period in 2017. The increase in research and development expenses was primarily related to an increase in personnel-related expenses resulting from an increase in headcount in support of our development and discovery efforts and an increase in clinical trial costs. Clinical trial costs increased primarily due to start-up costs associated with CheckMate 9ER, an ongoing phase 3 pivotal trial of cabozantinib plus immunotherapy in patients with previously untreated RCC that is being conducted with Bristol-Myers Squibb Company, and start-up costs associated with our phase 1b trial of cabozantinib and atezolizumab in locally advanced or metastatic solid tumors; those increases were partially offset by decreases in costs related to METEOR, our completed phase 3 pivotal trial comparing CABOMETYX to everolimus in patients with advanced RCC. Research and development expenses for the quarter ended March 31, 2018 also included a $3.0 million upfront payment for our exclusive collaboration and license agreement with StemSynergy Therapeutics, Inc. (StemSynergy).

Selling, general and administrative expenses for the quarter ended March 31, 2018 were $52.6 million, compared to $34.3 million for the comparable period in 2017. The increase in selling, general and administrative expenses was primarily a result of increases in corporate giving, personnel expenses and marketing activities. The increase in personnel expense resulted from an increase in general and administrative headcount to support the company’s commercial and research and development organizations.

Net income for the quarter ended March 31, 2018 was $115.9 million, or $0.39 per share, basic and $0.37 per share, diluted, compared to a $16.7 million, or $0.06 per share, basic and $0.05 per share diluted, for the comparable period in 2017. The increase in net income was primarily the result of increases in net product revenues and collaboration revenues, which was partially offset by the increases in research and development and selling, general and administrative expenses.

Cash and cash equivalents, short- and long-term investments and short- and long-term restricted cash and investments totaled $525.6 million at March 31, 2018, as compared to $457.2 million at December 31, 2017.

2018 Financial Guidance

The company is maintaining its guidance that total costs and operating expenses for the full year will be between $430 million and $460 million. This guidance includes approximately $50 million of non-cash costs and expenses related primarily to stock-based compensation expense.

Cabozantinib Highlights

Strong Growth in Cabozantinib Franchise Net Revenues. Cabozantinib generated $134.3 million in net product revenues during the first quarter of 2018, an increase of 95 percent year-over-year. During the first quarter of 2018, CABOMETYX generated $128.9 million in net product revenues and COMETRIQ (cabozantinib) capsules for the treatment of patients with progressive, metastatic medullary thyroid cancer generated an additional $5.3 million in net product revenues.

Amendment to Clinical Research Protocol for Phase 1b Trial of Cabozantinib in Combination with Atezolizumab in Patients with Locally Advanced or Metastatic Solid Tumors. In January, Exelixis announced an amendment to the protocol for the phase 1b trial of cabozantinib in combination with atezolizumab in patients with locally advanced or metastatic solid tumors. The amendment added four new expansion cohorts to the trial, which now includes patients with non-small cell lung cancer and castration-resistant prostate cancer, in addition to previously included patients with RCC and urothelial carcinoma (UC). The primary objective in the expansion stage of this trial remains to determine the objective response rate in each cohort.

Cabozantinib Data at the ASCO (Free ASCO Whitepaper) 2018 Genitourinary Cancers Symposium (ASCO-GU). In February, cabozantinib was the subject of 14 presentations at the 2018 ASCO (Free ASCO Whitepaper)-GU Symposium in San Francisco. Updated results from the ongoing phase 1 trial of cabozantinib in combination with nivolumab, with or without ipilimumab, in patients with refractory genitourinary tumors were the subject of a poster presentation, with the two combination regimens demonstrating an acceptable tolerability profile, and high rates of durable responses in the previously treated metastatic UC and metastatic RCC cohorts. This phase 1 trial informed the design of CheckMate 9ER.

Cabozantinib Data at the 2018 Multidisciplinary Head and Neck Cancers Symposium. Also in February, cabozantinib was the subject of an oral presentation at this medical meeting held in Scottsdale, Arizona. Investigators presented results from the ongoing investigator-sponsored phase 2 trial of cabozantinib in patients with radioiodine-refractory differentiated thyroid carcinoma (DTC) in the first-line setting. Based on these results and data from other studies of cabozantinib in previously treated DTC, Exelixis plans to initiate a pivotal phase 3 study with cabozantinib in patients with advanced DTC later this year.

Submission of Supplemental New Drug Application (sNDA) for CABOMETYX as a Treatment for Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC). In March, Exelixis announced it had completed the submission of its sNDA to the FDA for CABOMETYX as a treatment for patients with previously treated advanced HCC. The sNDA submission is based on results from the CELESTIAL randomized pivotal phase 3 trial, data from which were presented in January at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Gastrointestinal Cancers Symposium (ASCO-GI). At ASCO (Free ASCO Whitepaper)-GI, Exelixis and Ipsen hosted a live briefing event for the financial community to discuss cabozantinib data presented at the conference. The replay of the briefing is available on the News & Events / Event Calendar page at www.exelixis.com.

European Medicines Agency (EMA) Validation of the Application for a New Indication for CABOMETYX for Previously Treated Advanced HCC. Also in March, Exelixis’ partner Ipsen announced its application for variation to the CABOMETYX marketing authorization had been validated by the EMA for the addition of a new indication for patients with previously treated advanced HCC. Upon the acceptance of this filing, Exelixis will receive a $10.0 million milestone payment per the terms of the company’s collaboration agreement with Ipsen.

CABOMETYX Receives Positive CHMP Opinion for Previously Untreated Intermediate- or Poor-Risk Advanced RCC. In March, Exelixis’ partner Ipsen received a positive opinion from the CHMP, the scientific committee of the EMA, for CABOMETYX for the first-line treatment of adults with intermediate- or poor-risk advanced RCC. The positive CHMP opinion is being reviewed by the EC, which has the authority to approve medicines for the European Union.

Cobimetinib Highlights

Phase 1b Results for the Combination of Cobimetinib and Atezolizumab in Metastatic Colorectal Cancer (CRC) at ASCO (Free ASCO Whitepaper)-GI. In January, updated safety and efficacy results from the phase 1b clinical trial sponsored by Genentech, Inc. (a member of the Roche Group) (Genentech) evaluating cobimetinib in combination with atezolizumab in patients with metastatic CRC were presented at ASCO (Free ASCO Whitepaper)-GI. Initial results reported from this study presented at the 2016 ASCO (Free ASCO Whitepaper) Annual Meeting led to the initiation of IMblaze370 (formerly COTEZO), a phase 3 pivotal trial evaluating both the combination of cobimetinib and atezolizumab and atezolizumab alone versus regorafenib in patients with unresectable locally advanced or metastatic CRC, for which Genentech has guided it expects top-line results in the first half of 2018.

IMspire150 TRILOGY Trial Reaches Full Enrollment. The Roche Group recently confirmed that IMspire150 TRILOGY, its phase 3 pivotal trial evaluating the combination of cobimetinib, atezolizumab and vemurafenib in patients with first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma, completed enrollment. The trial began enrolling patients in January 2017.

Corporate Highlights

Exclusive Licensing Agreement with StemSynergy for the Discovery and Development of Novel Anticancer Therapies. In January, Exelixis announced it had entered into an exclusive collaboration and license agreement with StemSynergy for the discovery and development of novel oncology compounds targeting Casein Kinase 1 alpha, a component of the Wnt signaling pathway implicated in key oncogenic processes.

Daiichi Sankyo’s Submission of Regulatory Filing for Esaxerenone (CS-3150) in Japan. In February, Exelixis announced its partner Daiichi Sankyo submitted its regulatory application for esaxerenone as a treatment for patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency. The application was based on the results of phase 3 studies including ESAX-HTN, a randomized, double-blind, three-arm parallel group comparison study evaluating the efficacy and safety of esaxerenone versus eplerenone in patients with essential hypertension in Japan. As a result of the submission, Exelixis received a $20.0 million milestone payment in March 2018 per the collaboration agreement.

Election of Dr. Maria Freire to Exelixis’ Board of Directors. In April, Exelixis announced the election of biomedical research executive Maria C. Freire, Ph.D. to the company’s Board of Directors. Dr. Freire currently serves as President and Executive Director and as a member of the board of directors of the Foundation for the National Institutes of Health, an independent 501(c)(3) charitable organization established by Congress to support the National Institutes of Health by raising private funds for biomedical research and fostering partnerships and alliances around the world.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended March 30, 2018, December 29, 2017 and March 31, 2017 are indicated as being as of and for the periods ended March 31, 2018, December 31, 2017 and March 31, 2017, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the first quarter of 2018 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Wednesday, May 2, 2018.

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 7895176 to join by phone.

A telephone replay will be available until 8:30 p.m. EDT on May 4, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7895176. A webcast replay will also be archived on www.exelixis.com for one year.