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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014
`Financial Results and Provides Business Updates
` Reaffirms 2015 U.S. Product Revenue Guidance
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`SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/ Pharmacyclics, Inc. (the "Company") (NASDAQ: PCYC
`(http://studio5.financialcontent.com/prnews?Page=Quote&Ticker=PCYC)) today reported financial results for
`the quarter and year ended December 31, 2014, as well as commercial, regulatory and clinical updates.
`Key Highlights
`
`In the first full year of IMBRUVICA (ibrutinib) sales, the Company recorded total revenue of $730 million,
`®
`driven by U.S. net product revenue of $492 million for the year ended December 31, 2014, compared to
`U.S. net product revenue of $14 million for the prior year.
`Worldwide IMBRUVICA net product revenue of $548 million was recorded for the year ended December
`31, 2014, including net product revenue of $56 million from outside of the U.S. as reported by our
`collaboration partner Janssen Biotech, Inc. and its affiliates (Janssen).
`Strong fourth quarter U.S. net product revenue of $185 million was reported, representing 31% quarter
`over quarter growth.
`The fourth quarter represents the second profitable quarter under the worldwide collaboration and license
`agreement (Agreement) with Janssen.
`IMBRUVICA received regular (full) U.S. Food and Drug Administration (FDA) approval on January 29,
`2015, as the first and only treatment for patients with Waldenstrom's Macroglobulinemia (WM), and it is
`approved in all lines of therapy. This is the fourth indication for IMBRUVICA in less than 15 months. In the
`United States, approximately 1,500 people are diagnosed each year with WM, the prevalence is
`approximately 12,000 (G7 incidence estimated at 6,000 and prevalence at 23,000).
`25 IMBRUVICA trials commenced in 2014 across a variety of hematologic histologies.
`Research expansion with trials in several solid tumor types will begin in the first half of 2015.
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 1/19
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`Exhibit 2017 Page 001
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`Pharmacyclics LLC - Ex. 2017
`Coalition for Affordable Drugs IV LLC v. Pharmacyclics LLC
`Case IPR2015-01076
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`"2014 was a year of significant progress across many fronts for IMBRUVICA and for Pharmacyclics. The high
`clinical adoption rate by prescribers, steady regulatory advancement inside and outside of the U.S. generation
`of important clinical data, and quarteroverquarter increase in product revenue and demand have been
`important elements in our success to date," commented Bob Duggan, Chairman & CEO of Pharmacyclics.
`"With the elevation of IMBRUVICA to Category 1 status within NCCN guidelines, continued growing demand
`within our approved indications, and market expansion in support of our new FDA label/fourth indication, we
`anticipate IMBRUVICA 2015 U.S. net product revenue of approximately $1 billion. Simultaneous with robust
`commercial expansion in 2015, we will continue to advance our understanding of the use of IMBRUVICA as a
`single agent and in combination with other therapies of high drug value. We will not pause in our purpose to
`make a difference for the betterment of patients until they achieve a cure and we return them to normal living."
`Financial Results for the Quarter and Year Ended December 31, 2014
`Total Revenue
`
`For the year ended December 31, 2014, total revenue increased to $730 million, compared to $260 million for
`the prior year, primarily due to $479 million increase in IMBRUVICA net product revenue, as the year ended
`December 31, 2014 was our first full year of IMBRUVICA product sales.
`
`Total revenue for the quarter ended December 31, 2014 increased to $290 million from $124 million in the
`same period in the prior year, primarily due to a $172 million increase in IMBRUVICA net product revenue year
`over year.
`Milestone Revenue
`
`In connection with the Agreement, we recognized $100 million of milestone revenue during the quarter ended
`December 31, 2014, compared to $110 million for the same period a year ago.
`
`Milestone revenue for the quarter ended December 31, 2014 of $100 million was based on two events: 1) the
`EC's approval of IMBRUVICA for mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) on
`October 17, 2014 which triggered milestone payments to us of $80 million under the Agreement and 2) the
`EMA's acceptance of a Type II variation application for IMBRUVICA for the treatment of adult patients with WM
`on December 1, 2014 which triggered a milestone payment to us of $20 million under the Agreement.
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`To date, in addition to the upfront payment of $150 million, milestone payments of $605 million have been
`earned under the Agreement and the Company maintains the potential to receive up to an additional $220
`million in development ($50 million), regulatory ($50 million) and approval ($120 million) milestone payments
`from Janssen, assuming specific targets are achieved.
`GAAP and NonGAAP net income
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`NonGAAP net income for the quarter ended December 31, 2014 was $75 million, or $0.96 per diluted share,
`compared to nonGAAP net income of $24 million, or $0.30 per diluted share for the quarter ended December
`31, 2013.
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`NonGAAP net income for the year ended December 31, 2014 was $140 million, or $1.80 per diluted share,
`compared to nonGAAP net income of $1 million or $0.01 per diluted share for the year ended December 31,
`2013. See "Use of NonGAAP Financial Measures" below for a description of the Company's NonGAAP
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 2/19
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`Exhibit 2017 Page 002
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`Financial Measures. Reconciliation between certain GAAP and NonGAAP measures is provided at the end of
`this press release.
`
`GAAP net income for the quarter ended December 31, 2014 was $63 million, or $0.81 per diluted share,
`compared to GAAP net income of $64 million or $0.82 per diluted share for the quarter ended December 31,
`2013.
`
`GAAP net income for the year ended December 31, 2014 was $86 million, or $1.10 per diluted share,
`compared to GAAP net income of $67 million or $0.87 per diluted share for the year ended December 31,
`2013.
`Worldwide Collaboration and License Agreement with Janssen
`
`Under the Agreement, the repayment of Excess Amounts is contingent and would become payable, with
`interest, to Janssen from the Company's quarterly share of pretax commercial profits, commencing after the
`third profitable quarter for the collaboration until the total Excess Amounts have been repaid from the
`Company's earned pretax collaboration net profit in subsequent quarters. As of December 31, 2014, total
`Excess Amounts were $138 million which was comprised of the cumulative amount funded by Janssen todate
`of $134 million and interest of $4 million.
`
`The quarter ended December 31, 2014 represented the second profitable quarter for the collaboration,
`calculated as follows (in thousands):
`
`
`
`Three Months Ended
`Dec. 31,
`2014
`
`50% of Pharmacyclics' U.S. product revenue, net
`Less: 50% of Pharmacyclics' U.S. cost of goods sold
`Pharmacyclics' 50% share of U.S. net product revenue, less cost of goods sold
`Less: Pharmacyclics' share of U.S. commercial expenses under the Agreement
`Pharmacyclics' share of U.S. pretax profits from the commercialization of IMBRUVICA under the Agreement
`Less: Pharmacyclics' share of outsideU.S. pretax commercial loss under the Agreement
`Pharmacyclics' share of worldwide pretax profits from the commercialization of IMBRUVICA under the Agreement
`Less: Pharmacyclics' share of worldwide research and development expenses under the Agreement
`Pharmacyclics' share of IMBRUVICA related pretax net profit under the Agreement
`
`$ 92,568
`(6,687)
`85,881
`(20,695)
`65,186
`(7,741)
`57,445
`(31,748)
`$ 25,697
`
`As of December 31, 2014, the Company has achieved two profitable quarters for the collaboration and expects
`that the three months ending March 31, 2015 will represent the third profitable quarter for the collaboration.
`Accordingly, the Company will begin to pay Excess Amounts from its quarterly share of pretax commercial
`profits to Janssen beginning in the fourth profitable quarter for the collaboration and until Excess Amounts
`have been fully paid.
`GAAP and NonGAAP costs and expenses
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 3/19
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`Exhibit 2017 Page 003
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`NonGAAP R&D expenses of $44 million for the quarter ended December 31, 2014 increased by $3 million,
`compared to $41 million for the quarter ended December 31, 2013. NonGAAP SG&A expenses of $43 million
`for the quarter ended December 31, 2014 increased by $8 million, compared to $35 million for the quarter
`ended December 31, 2013. Reconciliation between certain GAAP and NonGAAP measures is provided at the
`end of this press release.
`
`GAAP R&D expenses of $48 million for the quarter ended December 31, 2014 increased by $37 million,
`compared to $11 million for the quarter ended December 31, 2013. GAAP SG&A expenses of $50 million
`increased by $26 million, compared to $24 million for the quarter ended December 31, 2013.
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`The Company recorded no Excess Amounts for the quarter ended December 31, 2014.
`Company Update
`
`During the fourth quarter, Pharmacyclics was the recipient of two prestigious awards. The 2014 Society for
`Medicines (SMR) Research Award for Drug Discovery was awarded to the Company at the U.K.based
`organization's biannual award lecture in London for the Company's discovery of ibrutinib. This prestigious
`independent research award recognizes outstanding development in the multidisciplinary field of drug
`discovery and is bestowed upon compounds which demonstrate a novel mechanism of action, a novel
`molecular interaction principle, a high degree of clinical benefit, and a significant ability to address an unmet
`medical need. In addition to accepting the award, Betty Y. Chang, Ph.D., Vice President of Research at
`Pharmacyclics who has studied the Bruton's tyrosine kinase (BTK) pathway and leads the Company's research
`of BTK inhibitors, presented the SMR Award Guest Lecture entitled, "Bench to Bedside: From PCI32765 to
`ibrutinib to IMBRUVICA.Dav" Past recipients of this award include Vertex Pharmaceuticals for its work in
`hepatitis C, Genentech on behalf of Avastin, and Novartis for its development of Glivec, among others.
`
`In addition, the Company received BayBio's 2014 Pantheon DiNA™ Award for Outstanding Company for its
`rapid development and commercialization of IMBRUVICA. BayBio, the Northern California affiliate of the
`Biotechnology Industry Association (BIO), represents 1,000 life sciences companies and institutions in
`Northern California. The Outstanding Company Award is given through an independent nomination and
`selection process to one company each year that has made the greatest advancement in and/or the greatest
`overall contribution to the Northern California life sciences industry in the prior year. Past recipients of this
`award include BioMarin Pharmaceuticals, Medivation, and Onyx Pharmaceuticals, among other companies.
`Commercial and Medical Affairs Update
`
`In January 2015, the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN
`Guidelines NonHodgkin's Lymphomas, Version 1.2014) for relapsed/refractory (R/R) CLL updated its
`®
`guidelines to elevate use of IMBRUVICA to a Category 1 designation.
`
`In the fourth quarter of 2014, the Company announced the launch of informCLL™, a large, observational,
`prospective registry that will explore the natural history of CLL, examine how IMBRUVICA and other approved
`targeted therapies are being used to treat patients with CLL, and provide a comparison to treatments using
`conventional chemoimmunotherapy. The CLL registry will enroll more than 1,000 patients with CLL or small
`lymphocytic lymphoma (SLL) from community and academic institutions across the U.S. Registry enrollment is
`planned to begin in the first half of 2015.
`Regulatory Update
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 4/19
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`Exhibit 2017 Page 004
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`On January 29, 2015, the U.S. FDA granted full approval for the use of IMBRUVICA (across all lines of
`treatment) for patients with WM, a rare, indolent form of blood cancer. This is the fourth FDA label approval for
`IMBRUVICA in less than 15 months and represents a significant milestone for WM patients as it now is the first
`and only drug approved for this rare blood cancer. IMBRUVICA received FDA Breakthrough Therapy
`Designation for this indication in February 2013. The FDA application was filed on October 20, 2014 and was
`approved more than two months ahead of the April 17, 2015 Prescription Drug User Fee Act (PDUFA) target
`date.
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`Previously, the Company announced that the EMA accepted a Type II variation application for IMBRUVICA to
`be used as a treatment for patients with WM. This triggered a milestone payment to the Company of $20
`million.
`Clinical Update
`
`In November 2014, the Company announced a clinical trial collaboration agreement with AstraZeneca to
`evaluate the efficacy and safety of its investigational antiPDL1 immune checkpoint inhibitor, MEDI4736, in
`combination with IMBRUVICA as a treatment for hematologic cancers including diffuse large Bcell lymphoma
`(DLBCL) and follicular lymphoma (FL). A separate agreement will also study this investigational combination in
`solid tumors. In addition, a clinical trial collaboration agreement was also signed to explore separate
`combinations of two different AstraZeneca investigational products including a PI3 kinase pathway inhibitor and
`an mTOR inhibitor in combination with IMBRUVICA for the treatment of R/R DLBCL.
`
`This follows two earlier collaborations that were announced in October 2014. One was for a clinical trial
`collaboration to evaluate the safety, tolerability and preliminary efficacy of BristolMyers Squibb's
`investigational PD1 immune checkpoint inhibitor, nivolumab, in combination with IMBRUVICA as a potential
`treatment option for patients with nonHodgkin Lymphoma (NHL), including DLBCL, FL and CLL. The other
`one was for a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and
`preliminary efficacy of IMBRUVICA in combination with obinutuzumab, in patients with NHL and CLL/SLL.
`
`During the fourth quarter, 52 clinical, nonclinical and preclinical abstracts on IMBRUVICA data were
`presented at the 56th Annual American Society of Hematology (ASH) Meeting in San Francisco from
`December 59, 2014. Of these abstracts, nine were oral presentations. Key data from select studies evaluating
`IMBRUVICA's use as a single agent and in combination included:
`
`New longer term data from the Phase III RESONATE™ (PCYC1112) in IMBRUVICA patients with
`relapsed/refractory CLL, including highrisk CLL patients with del 17p demonstrated at 12 months an 84%
`progressionfree survival rate (PFS) in all patients with previously treated CLL or SLL who received
`IMBRUVICA and at 12 months a 94% PFS rate in patients who received only one prior therapy. One
`hundred twentytwo patients (62%) randomized to ofatumumab crossed over to IMBRUVICA; the best
`ORR for singleagent IMBRUVICA was 90% versus 25% for ofatumumab, with 74% of IMBRUVICA patients
`achieving a partial response (PR), 8% partial responses with lymphocytosis (PRL) and 4% complete
`responses (CR). The most frequent Grade 3 or 4 adverse events (AEs) in the RESONATE trial analysis
`occurring in IMBRUVICA patients were: neutropenia (18%); pneumonia (9%); thrombocytopenia (6%);
`anemia (6%); and, hypertension (6%).
`Results were presented from Phase II RESONATE™17 (PCYC1117), the largest prospective trial
`dedicated to studying CLL or SLL patients with del 17p (n=114) showing that IMBRUVICA was associated
`with an 83% overall response rate (ORR). Seventynine percent of patients were alive and had not
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`Exhibit 2017 Page 005
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`progressed at 11.5 months, with an OS rate of 84%. The most common Grade 3 or 4 AEs in the
`RESONATE17 trial (occurring in > 5% of IMBRUVICA patients) were neutropenia (14%), anemia (8%),
`and hypertension (8%).
`IMBRUVICA's impact on patient wellbeing also was presented from a subanalysis of the Phase III
`RESONATE trial showing that IMBRUVICA was associated with improvements in hematologic function and
`disease burden in previously treated CLL/SLL patients versus those treated with ofatumumab. The data
`suggest the survival benefit afforded by IMBRUVICA, combined with sustained improvements in key
`endpoints of the trial including patientreported outcomes, may enhance patient quality of life while also
`prolonging survival.
`New Phase II data reported IMBRUVICA's potential utility as a combination therapy when used with
`rituximab. The data suggested that the overall efficacy and safety profile of IMBRUVICA is well tolerated
`when combined with rituximab in patients with relapsed or refractory mantle cell lymphoma (MCL).
`IMBRUVICA was combined with rituximab in a singlecenter, Phase II trial in 50 relapsed/refractory MCL
`patients. After a median followup of 11 months (range 416 months), the ORR for all 50 patients was 88%
`(56% CRs and 48% PRs) patients and for the 34 patients with lower levels (< 50) of the Ki67 protein, a
`known marker associated with cell growth, the ORR was 100% (56% CRs and 44% PRs). The median
`duration of response (DOR) and median PFS have not yet been reached. There were no deaths due to
`toxicity. Grade 1 hematologic toxicity events included anemia (30%) and thrombocytopenia (25%). The
`most common treatmentemergent, nonhematologic adverse events (occurring in > 15% of patients
`treated with IMBRUVICA plus rituximab) included fatigue; diarrhea; myalgia and dyspnea. This combination
`has been well tolerated.
`Phase II data also reported during the meeting showed that IMBRUVICA demonstrates antitumor activity
`both as a singleagent and as combination therapy in heavily pretreated patients with relapsed or
`relapsed/refractory multiple myeloma (MM).
`
`On January 5, 2015, the Company announced that the use of IMBRUVICA in treatmentnaive and previously
`treated highrisk CLL patients resulted in a significant response rate, with 92% of highrisk CLL patients with
`del 17p or tumor protein 53 (TP53 aberrations) achieving an objective response (50% achieved a partial
`response (PR; n=24) and 42% achieved a PR with lymphocytosis (n=20)). These highrisk patients typically do
`not respond well to standard therapies. The results were published in The Lancet Oncology.
`
`The estimated PFS at 24 months for all patients on an intentiontotreat basis was 82% (95% CI, 7194). Forty
`two of the 51 patients enrolled in the study (82%) continued on IMBRUVICA treatment without disease
`progression. The most frequent Grade 3 or 4 hematologic AEs in this study were neutropenia (24%), anemia
`(14%) and thrombocytopenia (10%).
`
`IMBRUVICA clinical trials are active in all regions including the U.S., Europe, Asia Pacific, Asia, and Latin
`America. To date, over 5,600 patients have been treated in Companysponsored IMBRUVICA trials conducted
`in over 35 countries involving more than 800 investigators. Currently, 58 IMBRUVICA clinical trials are
`registered on www.clinicaltrials.gov (http://www.clinicaltrials.gov/), of which 13 are Phase III trials. As these
`trials complete enrollment, approximately 8,600 patients will have participated. In the past 12 months, the
`Company initiated one Company sponsored Phase III trial and two medical research centersponsored Phase
`III trials. Currently, there are eight Phase III trials in CLL, two Phase III trials in MCL, one Phase III trial in
`DLBCL, one Phase III trial in FL, and one Phase III trial in WM.
`IMBRUVICA – Selected Clinical Trials
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 6/19
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`Exhibit 2017 Page 006
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
`
`RESONATE™ (PCYC1112): Phase III study of IMBRUVICA versus ofatumumab in patients with
`relapsed/refractory (R/R) CLL/SLL was initiated in the first quarter of 2012. This was a randomized, multi
`center, openlabel Phase III trial of IMBRUVICA administered as monotherapy. This 391 patient study met
`its primary end point of progressionfree survival (PFS) as well as a key secondary endpoint of Overall
`Survival (OS) at the preplanned interim analysis in January 2014. This study confirmed IMBRUVICA's
`clinical benefit in CLL patients who have received one prior therapy, resulting in regular (full) FDA approval
`for this patient population on July 28, 2014.
`RESONATE™17 (PCYC1117): Openlabel, singlearm, Phase II study of IMBRUVICA as a single agent in
`patients with CLL who have deletion of chromosome 17p and who did not respond to or relapsed after at
`least one prior treatment (a high unmet need population) was initiated in the first quarter of 2013. The
`primary endpoint of the study is Overall Response Rate (ORR). This study completed enrollment of 111
`patients worldwide in the third quarter of 2013. Data was presented at the 56 Annual ASH Meeting on
`th
`December 9 , 2014.
`th
`RESONATE™2 (PCYC1115): Phase III study of IMBRUVICA versus chlorambucil in newly diagnosed
`elderly CLL/SLL patients was initiated in the first quarter of 2013. This is a randomized, multicenter, open
`label trial of IMBRUVICA as a monotherapy versus chlorambucil in patients 65 years or older with
`treatment naïve CLL/SLL. The study design was agreed upon with the FDA under a Special Protocol
`Assessment (SPA). The primary objective of the study is to demonstrate a clinically significant
`improvement in PFS when compared to chlorambucil. This study completed enrollment of 273 patients
`worldwide in the first quarter of 2014. A data read out is anticipated in the second half of 2015.
`ILLUMINATE (PCYC1130): Phase III study of IMBRUVICA in combination with GAZYVA versus
`®
`chlorambucil in combination with GAZYVA in newly diagnosed CLL/SLL patients was initiated in the fourth
`quarter of 2014. This is a randomized, multicenter, openlabel trial in patients 18 years or older with
`treatment naïve CLL/SLL. The primary objective of the study is to demonstrate a clinically significant
`improvement in PFS when compared to chlorambucil plus GAZYVA. The enrollment target of this study is
`212 patients.
`HELIOS (CLL3001): Phase III study of IMBRUVICA in combination with bendamustine and rituximab in
`patients with R/R CLL/SLL was initiated in the third quarter of 2012. This is a randomized, multicenter,
`doubleblinded, placebocontrolled trial of IMBRUVICA in combination with bendamustine and rituximab
`versus placebo in combination with bendamustine and rituximab (BR) in R/R CLL/SLL patients who have
`received at least one line of prior therapy. The primary objective of the study is to demonstrate a clinically
`significant improvement in PFS when compared to bendamustine and rituximab. This study completed
`enrollment of 578 patients worldwide in the first quarter of 2014. An interim analysis is anticipated in the
`first half of 2015.
`BRILLIANCE (CLL3002): Phase III study of IMBRUVICA versus rituximab in patients with R/R CLL/SLL was
`initiated in the fourth quarter of 2013. This is a randomized, openlabel, multicenter study to evaluate the
`efficacy and safety of IMBRUVICA versus rituximab in adult Asia Pacific region patients with R/R CLL or
`SLL with active disease requiring treatment, who have failed at least one prior line of therapy and are not
`considered appropriate candidates for treatment or retreatment with purine analogbased therapy or
`combination chemoimmunotherapy. The primary objective of the study is to demonstrate a clinically
`significant improvement in PFS. The enrollment target of this study is 150 patients.
`Thirdparty sponsored: Phase III study of IMBRUVICA versus IMBRUVICA + rituximab versus
`bendamustine + rituximab in frontline newly diagnosed elderly (≥ 65 Years of Age) CLL/SLL patients
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`http://www.prnewswire.com/newsreleases/pharmacyclicsreportsfourthquarterandfullyear2014financialresultsandprovidesbusinessupdates30003… 7/19
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`Exhibit 2017 Page 007
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`(Alliance A041202) was initiated by the National Cancer Institute in the fourth quarter of 2013. This is a
`randomized, multicenter study designed to evaluate the improvement in PFS of IMBRUVICA with or
`without rituximab vs bendamustine and rituximab. Secondary outcome measures include OS and duration
`of response. The enrollment target of this multicenter study is 523 patients.
`Thirdparty sponsored: Phase III study in treatmentnaive, young fit patients with CLL, comparing the
`combination of IMBRUVICA and Rituxan to chemo immunotherapy of FCR (fludarabine,
`cyclophosphamide, and rituximab), (ECOG1912), was initiated by the Eastern Cooperative Oncology
`Group in the first quarter of 2014. This is a randomized study designed to evaluate the improvement in
`PFS of IMBRUVICA with rituximab vs FCR. Secondary outcome measures include OS and adverse events.
`The enrollment target of this multicenter study is 519 patients.
`Thirdparty sponsored: Phase III study in untreated, intermediate and highrisk patients with CLL,
`comparing monotherapy IMBRUVICA to placebo or no therapy, (CLL12), was initiated by the German
`Study Group in the first quarter of 2014. This is a randomized study designed to evaluate the improvement
`in eventfree survival (EFS) of IMBRUVICA vs. watch and waiting. Secondary outcome measures include
`ORR and PFS. The enrollment target of this multicenter study is 302 patients.
`
`Mantle Cell Lymphoma (MCL)
`
`RAY (MCL3001): Phase III study of IMBRUVICA versus temsirolimus in R/R MCL patients was initiated in
`the fourth quarter of 2012. This is a randomized, multicenter, openlabel trial of IMBRUVICA as a
`monotherapy versus temsirolimus in R/R MCL patients who received at least one prior rituximabcontaining
`chemotherapy regimen. The primary endpoint of the study is PFS. This exU.S. study completed
`enrollment of 280 patients in the fourth quarter of 2013. A data readout is anticipated in the second half of
`2015.
`SHINE (MCL3002): Phase III study of IMBRUVICA in combination with BR in elderly patients with newly
`diagnosed MCL was initiated in the second quarter of 2013. This is a randomized, multicenter, double
`blinded, placebocontrolled trial of IMBRUVICA plus BR versus placebo plus BR in patients 65 years or
`older with newly diagnosed MCL. The primary endpoint of the study is PFS. The enrollment target of this
`global study is 520 patients.
`
`Waldenstrom's Macroglobulinemia (WM)
`
`INNOVATE (PCYC1127): Phase III study of IMBRUVICA or placebo in combination with rituximab in
`patients with previously treated WM was initiated in the second quarter of 2014. This is a randomized,
`multicenter, doubleblinded, placebocontrolled trial of IMBRUVICA. The primary outcome measure of this
`study is PFS. The secondary outcome measures include ORR, time to next treatment, OS and the number
`of participants with AEs as a measure of safety and tolerability within each treatment arm. The enrollment
`target of this study is 180 patients.
`
`Diffuse Large Bcell Lymphoma (DLBCL)
`
`PHOENIX (DBL3001): Phase III study of IMBRUVICA in combination with RCHOP (rituximab,
`cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with newly diagnosed nonGCB
`subtype of DLBCL was initiated in the third quarter of 2013. This is a randomized, multicenter, double
`blinded, controlled trial of IMBRUVICA plus rituximab, cyclophosphamide, doxorubicin, vincristine, and
`prednisone (RCHOP) versus RCHOP in patients with newly diagnosed nonGCB subtype DLBCL. The
`primary endpoint of the study is to demonstrate a clinically significant improvement in EFS when compared
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`Exhibit 2017 Page 008
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`7/30/2015
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`Pharmacyclics Reports Fourth Quarter and Full Year 2014 Financial Results and Provides... SUNNYVALE, Calif., Feb. 18, 2015 /PRNewswire/
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`to RCHOP. The enrollment target of this global study is 800 patients.
`PCYC1123: Phase Ib/II randomized, multicenter, openlabel, study of IMBRUVICA, in combination with
`lenalidomide with or without rituximab in relapsed or refractory patients with diffuse large bcell lymphoma
`was initiated in the first quarter of 2014. The primary endpoint of the Phase IIb portion of this study is
`maximum tolerated dose of the investigational combination regimen and the primary endpoint of the Phase
`II portion is ORR. The enrollment target of this study is 130 patients.
`PCYC1124: Phase Ib/II randomized, multicenter, openlabel, study of IMBRUVICA, in combination with
`dose adjusted EPOCHR in relapsed or refractory patients with diffuse large bcell lymphoma was initiated
`in the second quarter of 2014. The primary endpoint of the Phase IIb portion of this study is maximum
`tolerated dose of the investigational combination regimen and the primary endpoint of the Phase II portion
`is ORR. The enrollment target of this study is 56 patients.
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`Follicular Lymphoma (FL)
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`PCYC1125: Phase II multicenter, openlabel, study of IMBRUVICA, in combination with rituximab in
`previously untreated patients with follicular lymphoma was initiated in the fourth quarter of 2013. The
`primary endpoint of this study is ORR. The enrollment target of this study is 80 patients.
`DAWN (FLR2002): Phase II study of IMBRUVICA in patients with R/R FL was initiated in the second
`quarter of 2013. This is a multicenter, openlabel, singlearm, global trial of IMBRUVICA in patients with
`chemoimmunotherapyresistant FL, whose disease has relapsed from at least two prior lines of therapy,
`including at least one rituximab combination chemotherapy regimen. The primary endpoint of this study is
`ORR. This study completed enrollment of 111 patients worldwide in the second quarter of 2014. A data
`read out is anticipated in the second half of 2015.
`SELENE (FLR3001): Phase III study of IMBRUVICA in patients with R/R FL and marginal zone lymphoma
`was initiated in the first quarter of 2014. This is a randomized, multicenter, placebocontrolled trial in
`combination with either BR or RCHOP in patients with previously treated indolent NonHodgkin Lymphoma
`(iNHL). The primary endpoint of this study is PFS. The enrollment target of this global study is 400
`patients.
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`Marginal Zone Lymphoma (MZL)
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`PCYC1121: Phase II study of IMBRUVICA in patients with R/R marginal zone lymphoma was initiated in
`the fourth quarter of 2013. This is a multicenter, openlabel, monotherapy study to evaluate the safety and
`efficacy of IMBRUVICA in patients with R/R marginal zone lymphoma. The primary endpoint of this study is
`ORR and the enrollment target of this study is 60 patients.
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`Multiple Myeloma (MM)
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`PCYC1111: Phase II study of IMBRUVICA in patients with R/R multiple myeloma was initiated in the first
`quarter of 2