Download US FDA PDUFA action date for oral rolapitant is September 5, 2015

TESARO, INC.
FORM
8-K
(Current report filing)
Filed 02/19/15 for the Period Ending 02/19/15
Address
Telephone
CIK
Symbol
SIC Code
Industry
Sector
Fiscal Year
1000 WINTER STREET, SUITE 3300
WALTHAM, MA 02451
(339) 970-0900
0001491576
TSRO
2834 - Pharmaceutical Preparations
Biotechnology & Drugs
Healthcare
12/31
http://www.edgar-online.com
© Copyright 2015, EDGAR Online, Inc. All Rights Reserved.
Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 19, 2015
TESARO, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(state or other jurisdiction of
incorporation)
001-35587
(Commission
File Number)
1000 Winter Street
Suite 3300
Waltham, Massachusetts
(Address of principal executive offices)
27-2249687
(I.R.S. Employer
Identification No.)
02451
(Zip Code)
Registrant’s telephone number, including area code: (339) 970-0900
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Section 2 — Financial Information
Item 2.02
Results of Operations and Financial Condition .
On February 19, 2015, TESARO, Inc. issued a press release announcing its operating results for the quarter and year ended December 31, 2014.
A copy of the press release is attached to this current report as Exhibit 99.1 and is incorporated herein by reference. TESARO, Inc. has scheduled a
conference call and webcast for 4:15 p.m. Eastern time on February 19, 2015 to discuss its operating results for the quarter and year ended December 31,
2014, and slides for that call are attached to this report as Exhibit 99.2 and are incorporated herein by reference.
The information contained in this report, including Exhibit 99.1 and Exhibit 99.2, is being furnished to the Securities and Exchange Commission
and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise
subject to liabilities under that section. Furthermore, such information shall not be deemed to be incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Section 9 — Financial Statements and Exhibits
Item 9.01
(d)
Financial Statements and Exhibits.
Exhibits.
Exhibit No.
Description
99.1
TESARO, Inc. press release dated February 19, 2015 announcing operating results for the quarter and year ended December 31, 2014.
99.2
TESARO, Inc. slides for February 19, 2015 conference call and webcast for the quarter and year ended December 31, 2014.
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
TESARO, Inc.
By: /s/ Timothy R. Pearson
Timothy R. Pearson
Executive Vice President and Chief Financial Officer
Dated: February 19, 2015
3
EXHIBIT INDEX
Exhibit No.
Description
99.1
TESARO, Inc. press release dated February 19, 2015 announcing operating results for the quarter and year ended December 31, 2014.
99.2
TESARO, Inc. slides for February 19, 2015 conference call and webcast for the quarter and year ended December 31, 2014.
4
Exhibit 99.1
FOR RELEASE ON FEBRUARY 19, 2015 AT 4:01 PM ET
TESARO ANNOUNCES FOURTH-QUARTER 2014 OPERATING RESULTS
•
•
•
•
Enrollment in niraparib NOVA non-gBRCA cohort on track to complete during Q1 2015
New QUADRA trial of niraparib for the treatment of ovarian cancer to begin in Q1 2015
U.S. FDA PDUFA action date for oral rolapitant is September 5, 2015
Cash and cash equivalents totaled approximately $257 Million as of December 31, 2014
WALTHAM, MA, February 19, 2015 — TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today reported financial
results for fourth-quarter and full-year 2014 and provided an update on the Company’s pipeline programs.
“TESARO continues to make significant progress in advancing its pipeline of product candidates and in preparing for a commercial launch of rolapitant in
the U.S. during the fourth quarter of 2015,” said Lonnie Moulder, CEO of TESARO. “We are committed to improving the treatment options for women
with ovarian cancer and, as such, we are executing a comprehensive development program that includes patients, regardless of germline-BRCA mutation
status, in both the treatment and maintenance settings. We continue to receive positive feedback from investigators regarding the breadth and potential of
the niraparib program, and we look forward to initiating our QUADRA study for the treatment of patients with recurrent ovarian cancer this quarter. We
also remain on track to complete enrollment of the non-germline BRCA cohort of patients within our Phase 3 NOVA trial during this quarter, and we
expect the first data from NOVA to become available in 2015.”
Recent Business Highlights
•
•
•
•
•
The New Drug Application (NDA) for oral rolapitant is under review by the U.S. Food and Drug Administration (FDA), with a PDUFA goal date of
September 5, 2015.
A clinical trial is ongoing to compare the plasma exposure of the intravenous (IV) and oral formulations of rolapitant.
Preparations are ongoing to initiate a new trial of niraparib (QUADRA) in patients with ovarian cancer who have received three or more prior lines
of prior chemotherapy. Endpoints will include objective response rate (ORR) and duration of response for the entire population, as well as platinum
sensitive, platinum resistant, germline BRCA and homologous recombination deficiency (HRD) patient subsets. This trial is anticipated to initiate
during the first quarter of 2015.
A strategy to incorporate a prospectively-defined biomarker (HRD) into the ongoing NOVA trial has been defined with FDA, and an HRD assay will
be used to analyze tumor samples from patients who enroll in the niraparib ovarian clinical program.
Patient enrollment continues in the Phase 3 BRAVO trial of niraparib, and planning continues to support initiation of additional clinical trials of
niraparib in the small cell lung cancer and ovarian cancer settings.
1
•
•
•
Patient enrollment continues in the Phase 1 study of niraparib plus temozolomide in patients with Ewing’s sarcoma.
The clinical activity of a fractionated dose of TSR-011 continues to be evaluated in ALK-positive and TRK-positive patients, and a controlled release
formulation is now available for evaluation in the ongoing Phase 1 study.
Preclinical studies of TSR-042 (our anti-PD-1 antibody candidate) and our clinical antibody candidates targeting TIM-3 and LAG-3 are underway in
collaboration with AnaptysBio.
Fourth-Quarter 2014 Financial Results
•
•
•
•
•
•
•
TESARO reported a net loss of $47.9 million, or $1.33 per share, for the fourth quarter of 2014, compared to a net loss of $23.3 million, or $0.72 per
share, for the fourth quarter of 2013.
Research and development expenses increased to $29.8 million for the fourth quarter of 2014, compared to $18.9 million for the fourth quarter of
2013, driven primarily by higher costs related to expanded development activities and increased headcount.
General and administrative expenses increased to $7.4 million for the fourth quarter of 2014, compared to $4.5 million for the fourth quarter of 2013,
primarily related to increased headcount, higher professional service fees and pre-launch commercial activities in support of oral rolapitant.
Acquired in-process research and development expenses totaled $7.0 million for the fourth quarter of 2014 and included a milestone payment related
to rolapitant and an upfront payment related to our immuno-oncology portfolio.
Operating expenses as described above include total non-cash stock-based compensation expense of $3.1 million for the fourth quarter of 2014,
compared to $2.7 million for the fourth quarter of 2013.
Net interest expense increased to $3.7 million for the fourth quarter of 2014, primarily due to the accrual of interest payable and the amortization of
the debt discount associated with the convertible notes issued in September 2014.
As of December 31, 2014, TESARO had approximately $256.9 million in cash and cash equivalents and approximately 36.1 million outstanding
shares of common stock. TESARO continues to expect average cash utilization to be in the low-$40 million range per quarter during the first half of
2015.
Full-Year 2014 Financial Results
•
•
•
TESARO reported a net loss of $171.0 million, or $4.79 per share, for 2014, compared to a net loss of $92.4 million, or $2.93 per share, for 2013.
Research and development expenses increased to $118.4 million for 2014, compared to $75.7 million for 2013, driven primarily by higher costs
related to our expanded development activities.
Acquired in-process research and development expenses totaled $24.9 million for 2014 and included milestone and upfront payments related to
rolapitant, niraparib, and our immuno-oncology portfolio, compared to $1.9 million for 2013, which included a milestone payment related to
niraparib.
2
•
•
•
General and administrative expenses increased to $23.9 million for 2014, compared to $14.8 million for 2013, primarily related to increased
headcount, higher professional service fees and pre-launch commercial activities in support of oral rolapitant.
Operating expenses as described above include total non-cash stock-based compensation expense of $11.7 million for 2014, compared to $7.8
million in 2013.
Net interest expense increased to $3.8 million for 2014, primarily due to the accrual of interest payable and the amortization of the debt discount
associated with the convertible notes issued in September 2014.
Corporate Objectives
TESARO anticipates achieving the following key objectives:
•
•
•
•
•
•
•
•
•
•
•
•
Continue commercial preparations in support of the potential U.S. launch of rolapitant in Q4 2015, pending regulatory approval;
Initiate an additional supportive safety study of IV rolapitant during Q1 2015;
Complete the study comparing the bioequivalence of oral rolapitant to IV rolapitant in mid-2015;
Submit the NDA for IV rolapitant following regulatory approval of oral rolapitant;
Finish enrollment of the expanded non-germline BRCA cohort within the Phase 3 NOVA trial of niraparib during Q1 2015;
Initiate the QUADRA trial of niraparib as a treatment for patients with ovarian cancer who have received three or more prior lines of therapy during
Q1 2015;
Report initial data from the Phase 3 NOVA trial of niraparib during 2015;
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations throughout 2015;
Initiate trials of niraparib in first line ovarian cancer maintenance (PRIMA) and small cell lung cancer in 2H 2015;
Evaluate the clinical activity of a controlled release formulation of TSR-011 within the ongoing Phase 1 study;
Advance the development of TSR-042 (anti-PD-1 antibody) to support submission of an Investigational New Drug (IND) application to the U.S.
FDA in late 2015; and
Advance the IND enabling studies for the anti-TIM-3 and anti-LAG-3 clinical candidates.
Today’s Conference Call and Webcast
TESARO will host a conference call to discuss the Company’s fourth quarter operating results today at 4:15 p.m. Eastern time. The accompanying slide
presentation and live webcast of the conference call can be accessed by visiting the TESARO website at www.tesarobio.com. The call can be accessed by
dialing (877) 853-5334 (U.S. and Canada) or (970) 315-0307 (international). A replay of the webcast will be archived on the Company’s website for 30
days following the call.
3
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and
commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or [email protected]
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking
statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Words such as “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or
expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward looking
statements contained in this press release include, among others, statements regarding our plans regarding future clinical trials with niraparib, the
estimated time periods when we expect clinical trials to commence or be completed and statements regarding our expectations about the timing of both
the selection of clinical candidates from our immune-oncology programs and the commencement of clinical testing for those candidates. Forward-looking
statements in this release involve substantial risks and uncertainties that could cause our research and pre-clinical development programs, clinical
development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from
ongoing clinical trials, expectations for regulatory approvals, patient accrual rates for clinical trials, certain expenditures and other matters that could
affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking
statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking
statements, as well as risks relating to the business of the Company in general, see TESARO’s Annual Report on Form 10-K for the year ended
December 31, 2013, and Quarterly Report on Form 10-Q for the quarter ended September 30, 2014.
4
TESARO, Inc.
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
Three Months Ended
December 31,
2013
2014
Expenses:
Research and development (1)
General and administrative (1)
Acquired in-process research and development
Total expenses
Loss from operations
Interest income (expense), net
Net loss
$
Net loss per share applicable to common stockholders - basic and
diluted
Twelve Months Ended
December 31,
2013
2014
$
18,882 $
4,465
—
23,347
(23,347)
7
(23,340) $
29,814 $
7,397
7,000
44,211
(44,211)
(3,724)
(47,935) $
75,725 $
14,780
1,940
92,445
(92,445)
83
(92,362) $
118,425
23,935
24,900
167,260
(167,260)
(3,752)
(171,012)
$
(0.72) $
(1.33) $
(2.93) $
(4.79)
Weighted-average number of common shares used in net loss per
share applicable to common stockholders - basic and diluted
32,597
36,071
31,559
35,739
(1) Expenses include the following amounts of non-cash stock-based compensation expense:
Research and development
General and administrative
$
655
2,026
5
$
1,403
1,742
$
2,034
5,725
$
4,954
6,729
TESARO, Inc.
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
December 31,
2013
Assets
Current assets:
Cash and cash equivalents
Other current assets
Total current assets
$
Property and equipment, net
Other assets
Total assets
$
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable
Accrued expenses
Other current liabilities
Total current liabilities
$
Convertible notes, net
Other non-current liabilities
Total liabilities
130,310
4,029
134,339
440
799
135,578
1,869
10,541
13
12,423
December 31,
2014
$
$
$
—
3
12,426
256,861
1,735
258,596
1,022
4,284
263,902
6,089
16,750
1,526
24,365
115,481
—
139,846
Commitments and contingencies
Total stockholders’ equity
Total liabilities and stockholders’ equity
$
###
6
123,152
135,578
$
124,056
263,902
Exhibit 99.2
Fourth-Quarter and Full-Year
2014 Results February 19,
2015
Safe Harbor Statement
Statements made in this
presentation about TESARO,
Inc. that are not descriptions of
historical facts are forwardlooking statements reflecting
the current beliefs and
expectations of management.
Forward-looking statements are
sometimes identified by words
such as “plan,” “may,” “will,”
“expect,” and similar
expressions referencing future
events, conditions or
circumstances. These forwardlooking statements involve
substantial risks and
uncertainties that could cause
our clinical development
programs, future results,
performance or achievements
to differ significantly from
those expressed or implied by
the forward-looking statements,
as a result of various factors,
including, without limitation,
the risks described in our
Annual Report on Form 10-K
for the year ended December
31, 2013 and our subsequent
filings with the SEC. TESARO,
Inc. undertakes no obligation to
update or revise any forwardlooking statement for any
reason.
Lonnie Moulder Chief
Executive Officer
CINV: chemotherapy-induced
nausea & vomiting Market
opportunity projections are
based upon Company estimates
IND: Investigational new drug
application KOL: Key opinion
leader TESARO Is Positioned
for Success Cash and
equivalents of ~$257M as of
12/31/2014 Approximately
36.1 million shares outstanding
as of 12/31/2014 Well
Capitalized Commercial,
development and regulatory
experience in oncology
Commercial leadership team
now in place Relationships
with KOLs and national
oncology networks
Experienced Team
Differentiated Pipeline
Rolapitant: Unmet market need
that can be addressed via
education and adherence to
existing guidelines Niraparib:
Broad development program
underway with initial Phase 3
data expected in 2015 TSR011: Phase 1 activity and
favorable tolerability in ALKpositive NSCLC patients TSR042: IND filing planned for late
2015 Anti-TIM-3, anti-LAG-3
and other mAb programs
advancing Large Peak Target
Market Opportunities
Rolapitant: $1.5B U.S. CINV
market Niraparib: $6B WW
initial indications
Tim Pearson Chief Financial
Officer
Q4 2014 Financial Results
Three Months Ended December
31, 2013 Three Months Ended
December 31, 2014 Expenses:
Research & Development
$18,882 $29,814 General &
Administrative 4,465 7,397
Acquired In-process R&D -7,000 Total Expenses 23,347
44,211 Loss from Operations
(23,347) (44,211) Interest
Income/(Expense) 7 (3,724)
Net Loss ($23,340) ($47,935)
Loss per Share ($0.72) ($1.33)
$7.0M of IPR&D in Q4 2014
includes a milestone payment
related to rolapitant ($5.0M)
and an upfront license payment
related to expansion of our
immuno-oncology programs
($2.0M) Unless otherwise
noted, figures are in thousands,
except for per-share data.
FY 2014 Financial Results
Year Ended December 31,
2013 Year Ended December
31, 2014 Expenses: Research
& Development $75,725
$118,425 General &
Administrative 14,780 23,935
Acquired In-process R&D
1,940 24,900 Total Expenses
92,445 167,260 Loss from
Operations (92,445)
(167,260) Interest Income/
(Expense) 83 (3,752) Net
Loss ($92,362) ($171,012)
Loss per Share ($2.93)
($4.79) As of December 31,
2014: Cash & equivalents
balance totaled approximately
$257 million Approximately
36.1 million shares
outstanding of common stock
Unless otherwise noted,
figures are in thousands,
except for per-share data.
Mary Lynne Hedley, Ph.D.
President and COO
Development Programs Update
Oral rolapitant NDA under
review by FDA; PDUFA date
09/05/15 Oral rolapitant
commercial launch planned for
Q4 2015 A clinical trial has
been initiated to compare the
exposure of IV rolapitant to
oral rolapitant; results expected
in mid-2015 Rolapitant
Expanded Phase 3 NOVA trial
non-gBRCA cohort enrollment
on track to complete during Q1
2015 QUADRA trial for
treatment of patients with
recurrent ovarian cancer to
begin in Q1 2015 SCLC and 1L
ovarian trials to begin in 2H
2015 Phase 3 BRAVO trial
enrollment to continue through
2015 Niraparib Controlled
release formulation available
for use within ongoing study
ALK+, ALK-inhibitor naive
patients enrolling Goal to make
go / no go decision for
registration program by yearend 2015 TSR-011 Advancing
TSR-042 antibody (anti-PD-1)
to support IND filing with U.S.
FDA in late 2015 Advance IND
enabling studies for anti-TIM -3
and anti-LAG-3 antibody
candidates Bispecific antibody
candidate identification work
continues I-O Platform NDA:
New drug application IV:
Intravenous SCLC: Small cell
lung cancer
Development Programs Update
NDA: New drug application
IV: Intravenous SCLC: Small
cell lung cancer Oral rolapitant
NDA under review by FDA;
PDUFA date 09/05/15 Oral
rolapitant commercial launch
planned for Q4 2015 A clinical
trial has been initiated to
compare the exposure of IV
rolapitant to oral rolapitant;
results expected in mid -2015
Rolapitant Expanded Phase 3
NOVA trial non -gBRCA
cohort enrollment on track to
complete during Q1 2015
QUADRA trial for treatment of
patients with recurrent ovarian
cancer to begin in Q1 2015
SCLC and 1L ovarian trials to
begin in 2H 2015 Phase 3
BRAVO trial enrollment to
continue through 2015
Niraparib Controlled release
formulation available for use
within ongoing study ALK+,
ALK-inhibitor naive patients
enrolling Goal to make go / no
go decision for registration
program by year-end 2015
TSR-011 Advancing TSR-042
antibody (anti-PD-1) to support
IND filing with U.S. FDA in
late 2015 Advance IND
enabling studies for anti-TIM -3
and anti-LAG-3 antibody
candidates Bispecific antibody
candidate identification work
continues I-O Platform
Niraparib Value Proposition
Compelling RECIST
response rate and durability
in heavily pre-treated patients
1 Potentially differentiated
tolerability profile 2
Convenient, once per day
dosing (3 capsules) 3
Broadest PARPi program in
ovarian cancer 4 Biomarker
incorporation potentially
allows for patient selection 5
Potential for combinations
with immuno-oncology and
other targeted agents 6
Niraparib Dosing: 300 mg
(3x100 mg capsules) Once
Daily Building an Ovarian
Cancer Franchise Recurrent
Ovarian Treatment QUADRA
Trial ORR primary endpoint
Efficacy analyses in
prespecified gBRCAmut and
HRD+ subgroups Phase 2 trial
to begin Q1 2015 1st Line
Maintenance PRIMA Trial PFS
primary endpoint Will enroll
gBRCAmut and HRD+ patients
Phase 3 trial to begin 2H 2015
PFS: Progression free survival
ORR: Overall response rate
HRD: Homologous
recombination deficiency
*TCGA, Integrated genomic
analyses of ovarian carcinoma,
Nature, 2011, 474, 609.
myChoice HRDTM Selected as
Tumor Marker Classifier
myChoice HRD Applied to
HGS-OvCa Can Separate
BRCA Deficient and Other
HRD Tumors from HR
Proficient A Cut-Off Value of
42 Has Been Determined Based
on Combined Breast and
Ovarian Data Combined
Studies Ovarian Likely NonResponders Likely Responders
MyChoice HRD test is a
proprietary, algorithm-based
genomic test to define HRD
status HRD score distribution
in ovarian cancer shows clear
bimodality, demonstrating
delineation of HR deficient and
proficient tumors Myriad has
regulatory experience in
developing an FDA approved
test Number of Samples Likely
Non -Responders Likely
Responders
Prospectively defined
statistical analysis of PFS in the
HRD population >90% power
PFS: Progression free survival;
HRD: Homologous
recombination deficiency Phase
3 Trial of Niraparib in 2nd Line
(Recurrent) Ovarian Cancer
Maintenance (NOVA Trial)
gBRCAmut Endpoint
Assessment Niraparib 300 mg
Placebo Non-gBRCAmut /
HRD Endpoint Assessment
Niraparib 300 mg Placebo 2:1
Randomization 2:1
Randomization n=120 n=60
n=207 n=103 Overall survival,
PFS 2, patient reported
outcomes PFS; >90% power to
detect 4.5 month improvement
(HR 0.50 in both cohorts)
Assumption: 4.5 month PFS for
control arms High Grade
Serous Ovarian Cancer,
Platinum Sensitive, Relapsed
Response to Platinum
Treatment n=490
Endpoint Assessment Niraparib
300 mg Daily Treatment
Received > 3 Lines of
Chemotherapy N=225
Registration Trial of Niraparib
for Treatment of Ovarian
Cancer (QUADRA Trial)
Duration of Response, Disease
Control Rate, Safety Overall
RECIST Response Rate High
Grade Serous Ovarian Cancer,
Platinum Resistant or Platinum
Sensitive, gBRCAmut or HRD
Placebo N=96 2:1
Randomization *Control from
ICON 7, OVAR 16 and
erlotinib studies Phase 3 Trial
of Niraparib in 1st Line
Ovarian Cancer Maintenance
(PRIMA Trial) PFS Power
assumptions: 13* vs. 20
months, HR=0.625, 90% power
PFS2, OS, QOL, Safety
Responded to 1st Line
Platinum Chemotherapy, with
No Evidence of Progression,
No Disease >2cm and Normal
CA125 High Grade Serous
Ovarian Cancer
1L: 1st Line; 2L: 2nd Line;
Treatment: 3 or more lines of
previous therapy Dollar figures
reflect current PARP inhibitor
pricing. Source: Company
estimates. PARP Inhibitor Peak
Market Opportunity in Ovarian
Cancer Approximates $4
Billion gBRCAmut nongBRCAmut/HRD+ NongBRCAmut / HRD- United
States Europe Approximately
40,000 Eligible Patients in the
U.S. and Europe
Other/Ineligible
Breast Cancer: Phase 3
Treatment Trial Design
(BRAVO Trial) 2:1
Randomization 300 mg
Niraparib Investigator Choice:
Eribulin, Capecitabine,
Gemcitabine or Vinorelbine
PFS: Progression free survival
TNBC: Triple negative breast
cancer PFS >95% power to
detect 3 month improvement
(HR 0.50) Assumption: 3
month PFS for control:
weighted average of 2.3 months
for TNBC and 3.9 months for
others vs. 6 months for
niraparib; 60% of gBRCAmut
are TNBC Overall survival Up
to Two Prior Treatments for
Advanced/Metastatic Disease,
Including Anthracycline and
Taxane gBRCAmut,
Advanced/Metastatic Breast
Cancer (n=306)
Dollar figures reflect current
PARP inhibitor pricing.
Source: Company estimates
PARP Inhibitor Peak Market
Opportunity in gBRCAmut
Breast Cancer Exceeds $1
Billion Approximately 20,000
Eligible Patients in the U.S. and
Europe 1L Patients 2L Patients
3L Patients
Development Programs Update
NDA: New drug application
IV: Intravenous SCLC: Small
cell lung cancer IND:
Investigational New Drug Oral
rolapitant NDA under review
by FDA; PDUFA date 09/05/15
Oral rolapitant commercial
launch planned for Q4 2015 A
clinical trial has been initiated
to compare the exposure of IV
rolapitant to oral rolapitant;
results expected in mid -2015
Rolapitant Expanded Phase 3
NOVA trial non -gBRCA
cohort enrollment on track to
complete during Q1 2015
QUADRA trial for treatment of
patients with recurrent ovarian
cancer to begin in Q1 2015
SCLC and 1L ovarian trials to
begin in 2H 2015 Phase 3
BRAVO trial enrollment to
continue through 2015
Niraparib Controlled release
formulation available for use
within ongoing study ALK+,
ALK-inhibitor naive patients
enrolling Goal to make go / no
go decision for registration
program by year-end 2015
TSR-011 Advancing TSR-042
antibody (anti-PD-1) to support
IND filing with U.S. FDA in
late 2015 Advance IND
enabling studies for anti-TIM -3
and anti-LAG-3 antibody
candidates Bispecific antibody
candidate identification work
continues I-O Platform
Development Programs Update
NDA: New Drug Application
IV: Intravenous SCLC: Small
cell lung cancer IND:
Investigational New Drug Oral
rolapitant NDA under review
by FDA; PDUFA date 09/05/15
Oral rolapitant commercial
launch planned for Q4 2015 A
clinical trial has been initiated
to compare the exposure of IV
rolapitant to oral rolapitant;
results expected in mid -2015
Rolapitant Expanded Phase 3
NOVA trial non -gBRCA
cohort enrollment on track to
complete during Q1 2015
QUADRA trial for treatment of
patients with recurrent ovarian
cancer to begin in Q1 2015
SCLC and 1L ovarian trials to
begin in 2H 2015 Phase 3
BRAVO trial enrollment to
continue through 2015
Niraparib Controlled release
formulation available for use
within ongoing study ALK+,
ALK-inhibitor naive patients
enrolling Goal to make go / no
go decision for registration
program by year-end 2015
TSR-011 Advancing TSR-042
antibody (anti-PD-1) to support
IND filing with U.S. FDA in
late 2015 Advance IND
enabling studies for anti-TIM -3
and anti-LAG-3 antibody
candidates Bispecific antibody
candidate identification work
continues I-O Platform
Lonnie Moulder Chief
Executive Officer
Rolapitant Value Proposition
1 Provides 5 continuous days
of protection from CINV 2
Convenient single dose
administered just prior to
chemotherapy 3 4 5 6
Customer partnerships enable
support of CINV educational
initiatives Reduced risk of
CYP3A4-mediated drug
interactions Oral and IV
formulations in development
to address entire market May
be combined with any
approved 5-HT3 RA
Source: IMS data and
Company estimates U.S. NK-1
Market Opportunity in CINV
Cisplatin AC-based breast
cancer regimens Certain
carboplatin regimens Other
Addressable Market
Opportunity for NK-1 Receptor
Antagonists is Approximately 5
Million Doses Annually in the
U.S.
1 As reported by IMS National
Sales Perspective Dollar figures
reflect current NK-1 RA
pricing of ~$300/cycle on
average 5 Million “Day One”
Doses Annually in the U.S.
Significant Revenue Potential
from Targeted Markets
Rolapitant Potential Share:
25% 50% 75% Eligible
Chemotherapy Initiations1 1M
doses $300 M 2M doses $600
M 3M doses $900 M 0.25M
doses $75 M 0.5M doses $150
M 0.75M doses $225 M IV
Opportunity 4M Doses Oral
Opportunity 1M Doses IV Oral
Opportunity for Significant
Leverage: Anticipate
Rolapitant P&L to Break Even
at Annual Sales of ~$50–60M
[LOGO]
2015: A Transformative Year
for TESARO Initiate potential
registration trial for treatment
of patients with recurrent
ovarian cancer during Q1
(QUADRA) Complete
enrollment of the expanded
non-gBRCA cohort of NOVA
in Q1 Report the initial data
from NOVA during 2015
Initiate trials in 1L ovarian
cancer and SCLC in 2H 2015
Niraparib Establish a full-scale
oncology U.S. commercial
organization by Q3 2015 Oral
rolapitant PDUFA date
September 5, 2015 Submit
NDA for IV rolapitant
following regulatory approval
of oral rolapitant Rolapitant
Enroll additional ALK+, ALKinaïve patients to enable go/no
go decision Submit IND for
TSR-042 by year end
Selectively pursue combination
approaches for I-O candidates
Early Stage Pipeline NDA:
New Drug Application IV:
Intravenous SCLC: Small cell
lung cancer IND:
Investigational New Drug
Fourth-Quarter and Full-Year
2014 Results February 19,
2015