TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today reported operating results for second-quarter 2017
and provided an update on the Company's commercial products and
development programs.
“The U.S. launch of ZEJULA, the first and only
PARP inhibitor to be approved for the maintenance treatment of
women with recurrent ovarian cancer, regardless of BRCA mutation or
biomarker status, is off to an excellent start, and we are
gratified by the positive feedback that we have received from
patients and prescribers,” said Lonnie Moulder, CEO of TESARO.
“Following its introduction in late April, ZEJULA quickly became
the most frequently prescribed PARP inhibitor in the U.S. The MAA
for ZEJULA is under review in Europe, and we are pleased that
interest in our expanded access program (EAP) has been high, as we
anticipate the European launch of ZEJULA by year end. We continue
to globalize our mission with the recently announced Takeda
licensing agreement for ZEJULA in Japan, and the launches of VARUBY
oral in several EU countries. We are advancing the registration
program for TSR-042, our anti-PD-1 antibody, and have initiated a
combination clinical study of our anti-TIM-3 antibody, TSR-022,
plus TSR-042. We are also pleased with the progress of our earlier
stage immuno-oncology antibody and small molecule programs and the
potential for this pipeline to establish TESARO as a leading player
in the field.”
Recent Business Highlights
- TESARO launched ZEJULA™ in the U.S. in April 2017, following
U.S. Food and Drug Administration (FDA) approval for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in a
complete or partial response (CR or PR) to platinum-based
chemotherapy. ZEJULA is the most prescribed PARP inhibitor in the
U.S., with more than 1,500 new patients treated in the second
quarter and prescriptions written by over 1,000 physicians since
launch.
- Pre-launch preparations continue in support of a European
launch of ZEJULA by year-end 2017, pending European Commission
approval, and the niraparib expanded access program (EAP) has
enrolled more than 200 patients across nine European
countries.
- VARUBY® (oral formulation) was approved by the European
Commission in April and has been launched in Germany, the U.K.,
Denmark, Finland and Austria. Preparations are ongoing in support
of launches in additional European countries.
- VARUBI® (oral formulation) was the most prescribed oral NK-1
receptor antagonist in the U.S. for the second quarter of 2017. The
NDA re-submission for the intravenous (IV) formulation of
rolapitant is under review by the FDA, with a Prescription Drug
User Fee Act (PDUFA) action date of October 25, 2017.
- Enrollment continues in the PRIMA trial of niraparib for
patients with first-line ovarian cancer and the QUADRA trial of
niraparib for the treatment of patients with ovarian cancer who
have received three or more prior lines of chemotherapy.
- In July, TESARO and Takeda Pharmaceutical Company Limited
announced an exclusive licensing agreement for the
commercialization and clinical development of niraparib in Japan
and certain other countries.
- Enrollment continues in the TOPACIO trial of niraparib plus
KEYTRUDA® (pembrolizumab) in patients with platinum resistant
ovarian cancer or with triple negative breast cancer, and in the
AVANOVA trial of niraparib plus bevacizumab in patients with
recurrent ovarian cancer. Data from the TOPACIO and AVANOVA trials
are expected to be presented during the European Society for
Medical Oncology (ESMO) Congress in September.
- The registration strategy for TSR-042 (anti-PD-1) has been
finalized with the FDA for patients with metastatic microsatellite
instability-high (MSI-H) cancers. Additional data from the Phase 1
study of TSR-042 are planned for presentation during ESMO.
- Dose-escalation of TSR-022 (anti-TIM-3) as a monotherapy is
complete and a combination study of TSR-022 with TSR-042 is
ongoing.
- In August, the Phase 1 dose-escalation trial for TSR-033
(anti-LAG-3) was initiated.
- IND-enabling studies are underway for bi-specific antibody
candidate targeting PD-1/LAG-3.
Second Quarter 2017 Financial
Results
TESARO reported net product revenue of $28.8
million for the second quarter of 2017, which included ZEJULA sales
of $25.9 million and VARUBI/VARUBY sales of $2.9 million. This
compares to net product revenue of $1.2 million for the second
quarter of 2016.
Cost of sales totaled $6.6 million for the
second quarter of 2017 and included $3.6 million associated with
product revenue for the second quarter of 2017 and $3.0 million
related to amortization of milestones recorded upon FDA approval of
niraparib and first commercial sales of VARUBI/VARUBY in the U.S.
and Europe. Cost of sales totaled $0.7 million for the second
quarter of 2016.
Research and development expenses increased to
$71.4 million for the second quarter of 2017, compared to $50.1
million for the second quarter of 2016, driven primarily by
increased headcount, expansion of the TSR-042 and TSR-022 programs,
and advancement of our earlier-stage immuno-oncology portfolio.
Selling, general and administrative expenses
increased to $93.0 million for the second quarter of 2017, compared
to $36.2 million for the second quarter of 2016, primarily due to
activities in support of the launches of ZEJULA and VARUBI/VARUBY
in the U.S. and Europe, increased headcount, and higher
professional service fees.
Acquired in-process research and development
expenses totaled $7.0 million for the second quarter of 2017 and
included milestone payments related to our immuno-oncology
portfolio, compared to $4.0 million for the second quarter of 2016,
which also related to a development milestone achieved within our
immuno-oncology programs.
Operating expenses as described above include
total non-cash, stock-based compensation expense of $23.5 million
for the second quarter of 2017, compared to $11.7 million for the
second quarter of 2016.
Net loss totaled $152.1 million, or ($2.82) per
share, for the second quarter of 2017, compared to a net loss of
$59.2 million, or ($1.29) per share, for the second quarter of
2016.
As of June 30, 2017, TESARO had approximately
$508 million in cash and cash equivalents and approximately 54.2
million outstanding shares of common stock. This cash and cash
equivalents balance does not include the $100 million up-front
payment received during the third quarter as part of the Takeda
license agreement.
Corporate Objectives
TESARO anticipates achieving the following key
objectives:
VARUBI / VARUBY (rolapitant):
- Launch VARUBI IV in the U.S. in Q4 2017, pending FDA approval;
and
- Continue to execute on the VARUBY oral launch in Europe.
ZEJULA (niraparib):
- Continue to execute on the ongoing U.S. launch of ZEJULA and
solidify its position as the market leading PARP inhibitor for
patients with recurrent ovarian cancer;
- Launch ZEJULA in Europe by year-end 2017, pending European
Commission approval;
- Continue to enroll the Phase 3 PRIMA trial throughout 2017;
and
- Begin to initiate expanded ovarian, breast and lung cancer
development programs in 2017.
Immuno-Oncology Portfolio:
- Continue to enroll patients with MSI-H cancer in the
registration trial of TSR-042, with the intent of supporting
accelerated FDA approval;
- Continue enrollment in the TSR-022 plus TSR-042 combination
cohort through 2017;
- Continue to enroll the Phase 1 trial of TSR-033;
- Advance IND-enabling studies for bi-specific antibody lead
clinical candidate targeting PD-1/LAG-3, in 2H 2017; and
- Identify the first clinical candidate within the MD Anderson
collaboration in Q3 2017.
Today's Conference Call and
WebcastTESARO will host a conference call to discuss the
Company's second quarter operating results and provide an update on
the Company's commercial products and development programs 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.
About ZEJULA (Niraparib)ZEJULA
(niraparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor
indicated for the maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to platinum-based
chemotherapy. In preclinical studies, ZEJULA concentrates in
the tumor relative to plasma, delivering greater than 90% durable
inhibition of PARP 1/2 and a persistent antitumor effect.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML),
including some fatal cases, was reported in patients treated with
ZEJULA. Discontinue ZEJULA if MDS/AML is confirmed.
Hematologic adverse reactions (thrombocytopenia, anemia and
neutropenia), as well as cardiovascular effects (hypertension and
hypertensive crisis) have been reported in patients treated with
ZEJULA. Monitor complete blood counts to detect hematologic adverse
reactions, as well as to detect cardiovascular disorders, during
treatment. ZEJULA can cause fetal harm and females of
reproductive potential should use effective contraception. Please
see full prescribing information, including additional important
safety information, available at www.zejula.com.
About TESARO TESARO is an
oncology-focused biopharmaceutical company devoted to providing
transformative therapies to people bravely facing cancer. For more
information, visit www.tesarobio.com, and follow us on Twitter and
LinkedIn.
TESARO Contacts:Jennifer
DavisVice President, Corporate Communications & Investor
Relations+1.781.325.1116 or jdavis@tesarobio.com
Kate RauschAssociate Director, Investor
Relations+1.781.257.2505 or krausch@tesarobio.com
Forward Looking Statements 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 the expected
timing of the launch of VARUBI IV in the U.S., the expected timing
of our planned commercial launches of ZEJULA and VARUBY in Europe,
the expected approval of the rolapitant IV NDA and the timing
thereof, the design and expected timing of initiation and data from
our various ongoing and planned niraparib, TSR-042, TSR-033,
TSR-022, combination, and other clinical trials, and our
expectation to achieve our various key corporate objectives.
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 risks related to competition, the uncertainties
inherent in the execution and completion of clinical trials,
uncertainties surrounding the timing of availability of data from
clinical trials, uncertainties surrounding our ongoing discussions
with and potential actions by regulatory authorities, uncertainties
regarding regulatory approvals, including with respect to the
ultimate approval and indication for niraparib in Europe,
uncertainties regarding certain expenditures, risks related to
manufacturing and supply, risks related to intellectual property,
and other matters that could affect the availability or commercial
potential of our products and 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, 2016, and Quarterly
Report on Form 10-Q for the quarter ended March 31, 2017.
TESARO, Inc. |
|
|
Unaudited Condensed Consolidated Statements of
Operations |
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
(as revised)(1) |
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(as revised)(1) |
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|
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Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
ZEJULATM |
|
$ |
- |
|
|
$ |
25,945 |
|
|
$ |
- |
|
|
$ |
25,945 |
|
|
|
|
|
|
VARUBI®/VARUBY® |
|
|
1,242 |
|
|
|
2,884 |
|
|
|
1,518 |
|
|
|
5,023 |
|
|
|
|
|
Total product revenue, net |
|
|
1,242 |
|
|
|
28,829 |
|
|
|
1,518 |
|
|
|
30,968 |
|
|
|
|
|
License, collaboration and other revenues |
|
|
34,568 |
|
|
|
635 |
|
|
|
34,592 |
|
|
|
1,569 |
|
|
|
|
Total
revenues |
|
|
35,810 |
|
|
|
29,464 |
|
|
|
36,110 |
|
|
|
32,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales - product |
|
|
234 |
|
|
|
3,620 |
|
|
|
313 |
|
|
|
4,064 |
|
|
|
|
|
Cost of sales - intangible asset amortization |
|
|
463 |
|
|
|
2,979 |
|
|
|
927 |
|
|
|
3,469 |
|
|
|
|
|
Research and development (2) |
|
|
50,138 |
|
|
|
71,400 |
|
|
|
102,847 |
|
|
|
137,522 |
|
|
|
|
|
Selling, general and administrative (2) |
|
|
36,218 |
|
|
|
92,979 |
|
|
|
66,367 |
|
|
|
162,241 |
|
|
|
|
|
Acquired in-process research and development |
|
|
4,000 |
|
|
|
7,000 |
|
|
|
8,000 |
|
|
|
7,000 |
|
|
|
|
Total
expenses |
|
|
91,053 |
|
|
|
177,978 |
|
|
|
178,454 |
|
|
|
314,296 |
|
|
|
|
Loss from
operations |
|
|
(55,243 |
) |
|
|
(148,514 |
) |
|
|
(142,344 |
) |
|
|
(281,759 |
) |
|
|
|
Interest
income (expense), net |
|
|
(3,911 |
) |
|
|
(3,467 |
) |
|
|
(7,790 |
) |
|
|
(6,893 |
) |
|
|
|
Loss before
income taxes |
|
|
(59,154 |
) |
|
|
(151,981 |
) |
|
|
(150,134 |
) |
|
|
(288,652 |
) |
|
|
|
Provision
for income taxes |
|
|
- |
|
|
|
78 |
|
|
|
- |
|
|
|
132 |
|
|
|
|
Net
loss |
|
$ |
(59,154 |
) |
|
$ |
(152,059 |
) |
|
$ |
(150,134 |
) |
|
$ |
(288,784 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
per share applicable to |
|
|
|
|
|
|
|
|
|
|
|
|
common stockholders - basic and diluted |
|
$ |
(1.29 |
) |
|
$ |
(2.82 |
) |
|
$ |
(3.46 |
) |
|
$ |
(5.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common |
|
|
|
|
|
|
|
|
|
|
|
|
shares used in net loss per share applicable to common
stockholders - basic and diluted |
|
|
45,808 |
|
|
|
53,982 |
|
|
|
43,387 |
|
|
|
53,834 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) The
Company adopted Financial Accounting Standards Board Accounting
Standards Update No. 2014-09 effective January 1, 2017, |
|
with full
retrospective application to January 1, 2015. Results for
periods prior to January 1, 2017 have been revised
accordingly. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2)
Expenses include the following amounts of non-cash stock-based
compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,479 |
|
|
$ |
7,862 |
|
|
$ |
8,222 |
|
|
$ |
14,987 |
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
7,206 |
|
|
|
15,646 |
|
|
|
12,924 |
|
|
|
26,922 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TESARO, Inc. |
|
Unaudited Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016 |
|
June 30, 2017 |
|
|
|
|
|
|
|
|
(as revised)(1) |
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
|
|
$ |
785,877 |
|
$ |
507,941 |
|
|
Accounts receivable |
|
|
|
|
|
6,195 |
|
|
23,149 |
|
|
Inventories |
|
|
|
|
|
|
14,700 |
|
|
28,285 |
|
|
Other current assets |
|
|
|
|
|
10,515 |
|
|
23,045 |
|
Total
current assets |
|
|
|
|
|
817,287 |
|
|
582,420 |
|
|
|
|
|
|
|
|
|
|
|
|
Intangible
assets, net |
|
|
|
|
|
12,877 |
|
|
44,408 |
|
Property
and equipment, net |
|
|
|
|
6,640 |
|
|
9,958 |
|
Restricted
cash |
|
|
|
|
|
1,694 |
|
|
2,522 |
|
Other
assets |
|
|
|
|
|
|
3,795 |
|
|
6,087 |
|
|
Total assets |
|
|
|
|
$ |
842,293 |
|
$ |
645,395 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
|
|
$ |
5,236 |
|
$ |
45 |
|
|
Accrued expenses |
|
|
|
|
|
68,700 |
|
|
99,589 |
|
|
Deferred revenue, current |
|
|
|
|
95 |
|
|
95 |
|
|
Other current liabilities |
|
|
|
|
|
2,978 |
|
|
2,701 |
|
Total
current liabilities |
|
|
|
|
|
77,009 |
|
|
102,430 |
|
|
|
|
|
|
|
|
|
|
|
|
Convertible
notes, net |
|
|
|
|
|
131,775 |
|
|
137,447 |
|
Deferred
revenue, non-current |
|
|
|
|
305 |
|
|
258 |
|
Other
non-current liabilities |
|
|
|
|
5,086 |
|
|
5,346 |
|
|
Total liabilities |
|
|
|
|
|
214,175 |
|
|
245,481 |
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
|
|
|
|
628,118 |
|
|
399,914 |
|
|
Total liabilities and stockholders' equity |
|
|
$ |
842,293 |
|
$ |
645,395 |
|
|
|
|
|
|
|
|
|
|
|
|
(1) The
Company adopted Financial Accounting Standards Board Accounting
Standards |
|
|
Update No.
2014-09 effective January 1, 2017, with full retrospective
application to January 1, |
|
|
2015.
Results for periods prior to January 1, 2017 have been revised
accordingly. |
|
|
|
|
|
|
|
|
|
|
|
|
|
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