On May 2, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported financial results and business progress for the quarter ended March 31, 2018 (Press release, Genomic Health, MAY 2, 2018, View Source [SID1234525966]).

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"In the first quarter of 2018, we delivered 13 percent growth in revenue and delivered a non-GAAP profit demonstrating continued operating leverage for the 11th consecutive quarter of improved profitability," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "We delivered a strong start to the year with multiple revenue drivers, including the implementation of PAMA and AJCC breast cancer staging criteria, and the recent strengthening of NCCN prostate cancer guidelines. With several additional catalysts on the near-term horizon, including ECOG’s presentation of TAILORx results at ASCO (Free ASCO Whitepaper) and the anticipated finalization of the Medicare LCD for the Oncotype DX AR-V7 Nucleus Detect test, we expect strong revenue growth in the second half of the year."

Pre-606 Adjusted Revenue

Effective January 1, 2018, the company adopted the new ASC 606 accounting standard for revenue, using the modified retrospective method, which applies the new standard prospectively and does not impact prior years’ financial statements. Since the as-reported 2017 quarterly and annual financial statements will not be restated to reflect the new accounting standard, the company has provided a supplemental financial schedule in the non-GAAP tables at the end of this release, reflecting an estimate of revenue as if the new standard had been applied as of January 1, 2017 referred to herein as "pre-606 adjusted revenue."

First Quarter Financial Results

Total revenue was $92.6 million in the first quarter of 2018, compared with pre-606 adjusted revenue of $82.3 million for the first quarter of 2017, an increase of 13 percent, and an increase of 12 percent on a non-GAAP constant currency basis. Revenue was $84.0 million in the first quarter of 2017.

U.S. product revenue was $78.9 million in the first quarter of 2018, compared with pre-606 adjusted revenue of $69.2 million for the first quarter of 2017, an increase of 14 percent. U.S. product revenue was $70.6 million in the first quarter of 2017. U.S. invasive breast revenue from Oncotype DX Breast Recurrence Score tests was $71.0 million in the first quarter of 2018, compared with U.S. invasive breast pre-606 adjusted revenue of $63.4 million for the first quarter of 2017, an increase of 12 percent. U.S. invasive breast revenue was $64.8 million in the first quarter of 2017. U.S. prostate test revenue from Oncotype DX Genomic Prostate Score (GPS) tests was $5.8 million in the first quarter of 2018, compared with $3.3 million in the first quarter of 2017, an increase of 75 percent.

International product revenue was $13.8 million in the first quarter of 2018, compared with pre-606 adjusted revenue of $13.1 million for the first quarter of 2017, an increase of 5 percent, and a 1 percent increase on a non-GAAP constant currency basis. International product revenue was $13.4 million in the first quarter of 2017.

Net loss was $3.8 million, or $0.11 per share on a basic and diluted basis, in the first quarter of 2018, compared with a net loss of $0.8 million, or $0.02 per share on a basic and diluted basis, in the first quarter of 2017. Operating loss was $4.4 million in the first quarter of 2018, compared with an operating loss of $2.8 million in the first quarter of 2017.

On a non-GAAP basis, excluding the $8.5 million one-time charge for the realignment of resources that was completed in the quarter and certain other one-time charges, net income was $4.6 million in the first quarter of 2018, compared with a $2.8 million non-GAAP net loss in the first quarter of 2017. On a non-GAAP basis, operating income was $4.2 million in the first quarter of 2018, compared with a non-GAAP operating loss of $2.8 million in the first quarter of 2017.

More than 32,440 Oncotype test results were delivered in the first quarter of 2018, an increase of 3 percent, compared with more than 31,580 test results delivered in the same period in 2017. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 4 percent in the first quarter of 2018 compared with the same period in 2017. Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 25 percent in the first quarter of 2018 compared with the same period in 2017. International tests delivered decreased by 7 percent compared with the same period in 2017 and represented approximately 22 percent of total test volume in the first quarter of 2018.

Cash and cash equivalents and short-term marketable securities at March 31, 2018 were $130.4 million, which included the fair value of the company’s investment in marketable equity securities of $3.8 million, compared with $129.6 million at December 31, 2017, which included the fair value of the company’s investment in marketable equity securities of $3.5 million.

Recent Business Highlights

Results from the landmark ECOG-ACRIN Cancer Research Group TAILORx study were accepted for presentation at the Plenary Session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) on Sunday, June 3.

Multiple private insurers established new coverage for the Oncotype DX Genomic Prostate Score test, bringing the total number of U.S. covered lives to more than 71 million.

Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, issued a draft local coverage determination (LCD) for the Oncotype DX AR-V7 Nucleus Detect test.

The National Institute for Health and Care Excellence (NICE) in the United Kingdom issued a revised Diagnostics Consultation Document (DCD) including the Oncotype DX Breast Recurrence Score test for continued use to guide adjuvant chemotherapy decisions for patients with hormone receptor-positive, HER2-negative, node-negative early-stage breast cancer.

Secured tender with the UNICANCER hospital group in France for the Oncotype DX Breast Recurrence Score test increasing access to approximately 20 percent of the French market.

Established new public coverage for the Oncotype DX Breast Recurrence Score test in Germany, bringing the total number of German covered lives to more than 17 million.

Secured public coverage with the province of Manitoba for the use of the Oncotype DX Breast Recurrence Score test in early-stage breast cancer patients with node-negative disease, increasing the total number of covered lives in Canada to 35 million.

The Oncologist published positive results from a study conducted by Sunnybrook Health Sciences Centre in Canada, demonstrating a 37 percent reduction in chemotherapy among breast cancer patients with up to three positive nodes, as well as an increase in physicians’ and patients’ confidence (49 and 54 percent, respectively) when Oncotype DX was used to make adjuvant treatment decisions.

Presented results from three studies at the 11th European Breast Cancer Conference (EBCC-11) in March.

Received acceptance to present two studies utilizing the Oncotype DX Genomic Prostate Score test at the American Urological Association Annual Meeting in May.

Non-GAAP Disclosure

The company makes reference in this press release to "non-GAAP operating income (loss)" which excludes 2018 expenses resulting from the restructuring charges for the cessation of Oncotype SEQ, including the Oncotype SEQ Liquid Select test, and Oncotype SEQ product development and commercialization activities (restructuring charges). Additionally, the company references "non-GAAP net income (loss)" which excludes the Q1 2018 restructuring charges as well as fair value adjustments related to its collaborations with Biocartis and Cleveland Diagnostics in the first quarter of 2018 and the gain on sale of marketable equity securities in the first quarter of 2017. The company believes that excluding these items and their related tax effects from its financial results reflects operating results that are more indicative of the company’s ongoing operating performance while improving comparability to prior periods, and, as such may provide investors with an enhanced understanding of the company’s past financial performance and prospects for the future. The company also considers the impact of foreign currency exchange rates on its global business as described in the constant currency table accompanying this press release. The company’s management uses such non-GAAP measures internally to evaluate and assess its core operations and to make ongoing operating decisions. This information is not intended to be considered in isolation or as a substitute for income (loss) from operations or net income (loss) information prepared in accordance with GAAP. An explanation and reconciliation of the non-GAAP financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this press release.

Conference Call Details
To access the live conference call today, May 2, at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 2186716. Please dial in approximately ten minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

On May 2, 2018 Bristol-Myers Squibb (NYSE:BMY) and Flatiron Health, reported that a market leader in oncology-specific electronic health record software and the curation of regulatory-grade real-world data for cancer research and real-world evidence (RWE) generation, expanded their relationship a three-year collaboration agreement (Press release, Bristol-Myers Squibb, MAY 2, 2018, View Source [SID1234525965]).

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Bristol-Myers Squibb will use Flatiron’s real-world data to accelerate its research and development efforts, as well as improve its ability to generate additional evidence on the use of its cancer medicines outside of clinical trials. With the expanded collaboration, the two companies intend to form a joint Scientific Advisory Board to advance the use of RWE for regulatory decision making.

"Our continued collaboration with Flatiron further strengthens our comprehensive RWE capabilities, an important component of our oncology drug development program, giving us greater insight into the use and impact of our cancer therapies," said Thomas J. Lynch, M.D., executive vice president and chief scientific officer, Bristol-Myers Squibb. "We will work with Flatiron to contribute to RWE industry guidance and standards, and advance new regulatory-focused RWE use cases. Ultimately, this work will enable us to accelerate our ability to help patients."

Bristol-Myers Squibb will use Flatiron data to generate RWE across a substantial range of tumors and will collaborate, along with other stakeholders, on the development and validation of real-world endpoints within Flatiron’s longitudinal datasets. Additionally, the partnership includes broadened access to Flatiron and Foundation Medicine’s jointly established Clinico-Genomic Database.

"Bristol-Myers Squibb has been an important partner since 2014 when we first began working together on the development of our initial real-world datasets," said Amy Abernethy, M.D., chief scientific officer, chief medical officer and SVP, oncology, Flatiron Health. "This collaboration, key legislation like the 21st Century Cures Act and an increasing focus by the Food & Drug Administration, signal a turning point where RWE is not just a promising tool, but one that is substantive and credible enough to be able to make real, outcomes-based decisions to advance medical research."

About Flatiron Health

Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and care providers to learn from the experience of every patient. Currently, Flatiron partners with over 265 community cancer clinics, six major academic research centers and the top 15 therapeutic oncology companies. Additionally, Flatiron’s regulatory-grade real-world data is currently used by the Food & Drug Administration, National Cancer Institute, and other cancer researchers across the oncology community. These research initiatives include supporting post-marketing commitments, accelerating label expansions, informing health technology assessments, designing clinical trials, implementing external control arms, and, importantly, supporting quality monitoring and quality improvement at the point of care. For more information, visit www.flatiron.com.

On May 2, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that it will report first quarter 2018 financial results on Wednesday, May 9, 2018, after market close, and will host a conference call to discuss financial results and provide a business update at 5:00 p.m. ET (2:00 p.m. PT) (Press release, FibroGen, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346241 [SID1234525964]).

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46778299#.

Dial-In Information
Live (U.S./Canada): (888) 771-4371
Live (International): (847) 585-4405
Confirmation number: 46778299#

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 [SID1234525963]).

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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.

Exelixis Announces First Quarter 2018 Financial Results Page 2 of 8
and Provides Corporate Update May 2, 2018

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

Exelixis Announces First Quarter 2018 Financial Results Page 3 of 8
and Provides Corporate Update May 2, 2018

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

Exelixis Announces First Quarter 2018 Financial Results Page 4 of 8
and Provides Corporate Update May 2, 2018

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

Exelixis Announces First Quarter 2018 Financial Results Page 5 of 8
and Provides Corporate Update May 2, 2018

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.

On May 2, 2018 Exelixis, Inc. (Nasdaq: EXEL) reported that it has entered into a collaboration with Invenra, Inc., the Madison, Wisconsin-based biotechnology firm focused on developing next-generation biologics, to discover and develop multispecific antibodies for the treatment of cancer (Press release, Exelixis, MAY 2, 2018, View Source;p=RssLanding&cat=news&id=2346478 [SID1234525962]). The partnership pairs Exelixis’ fundamental biological insights, clinical development prowess and commercialization expertise with Invenra’s innovative platform technologies and biologics expertise to identify, optimize, and manufacture multispecific therapeutics, including immunotherapy applications. The collaboration is part of Exelixis’ ongoing strategy to build an innovative pipeline beyond its two internally discovered, commercially available compounds, cabozantinib and cobimetinib. The agreement with Invenra creates a biologics discovery capability that complements Exelixis’ in-house small molecule drug discovery efforts.

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This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, Exelixis and Invenra will collaborate to discover and develop multispecific antibodies through the use of Invenra’s B-Body technology platform, which enables high-throughput discovery, functional screening, and in vitro and in vivo preclinical characterization of promising therapeutic candidates. Invenra will be responsible for antibody lead discovery and generation. Exelixis will lead investigational new drug (IND)-enabling studies, manufacturing, clinical development in single-agent and combination therapy regimens, as well as future regulatory and commercialization activities.

"Partnering with Invenra to leverage its deep expertise in protein engineering and the discovery of multispecific antibodies is an important step toward adding proprietary biologics to the Exelixis pipeline," said Peter Lamb, Ph.D., Executive Vice President, Discovery Research and Chief Scientific Officer of Exelixis." We are excited to work with the Invenra team and have structured our collaboration to provide relatively small financial support upfront and pay for success down the road. As we rebuild our internal small molecule discovery capability, this partnership provides a complementary approach that enables us to target pathways not accessible to small molecules, increasing our ability to advance novel therapies into the clinic."

Under the collaboration agreement, Exelixis will receive an exclusive, worldwide license to one preclinical asset, and Exelixis and Invenra intend to pursue up to six additional discovery projects during the term of the collaboration, which in total are directed to three discovery programs. In consideration for the exclusive worldwide license and other rights contained in the collaboration agreement, Exelixis will pay Invenra an upfront payment of $2.0 million plus $2.0 million at initiation of each discovery project. Invenra is eligible to receive payments of up to $131.5 million based on the achievement of specific pre-clinical, clinical development and regulatory milestones for any product containing a lead preclinical asset in the first indication. Upon successful commercialization of a product, Invenra is eligible to receive global milestone payments up to $325 million, if certain sales thresholds are achieved as well as single digit tiered royalties on net sales of the approved product.

"We’re very excited to partner with Exelixis on this multi-asset collaboration as the company moves beyond its small molecule expertise to build a biologics pipeline," said Roland Green, Ph.D., Chief Executive Officer and Co-Founder of Invenra. "Invenra’s B-Body platform has been validated internally. Our innovative technologies to discover, characterize, and generate multispecific antibodies pair well with Exelixis’ demonstrated success in oncology clinical development and commercialization. We look forward to working together with the Exelixis team to bring forward potential new anti-cancer therapies."

About Invenra

Invenra, Inc., is a biotechnology company focused on the discovery and development of multispecific antibodies for immuno-oncology. Invenra’s proprietary B-Body and SNIPER technologies are used to develop novel antibodies that can bind to two or more specific therapeutic targets and mimic the natural IgG antibodies made by the human body. The B-Body platform enables the rapid identification of an optimal combination of epitope, affinity and geometry of an antibody using high throughput in-format screening for function in cell-based assays, while maintaining the biophysical characteristics needed for lead development. Importantly, the B-Body platform is designed to create advantages for candidate discovery with novel mechanisms of action and ease of manufacturing. Invenra has developed its own pipeline of lead multispecific antibodies and has partnered with several biotechnology and pharmaceutical companies who leverage Invenra’s technologies to identify molecules with biological relevance for drug development. For more information, please visit www.invenra.com.