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Exhibit 99.1
TESARO ANNOUNCES FOURTH-QUARTER 2015 OPERATING RESULTS
· U.S. commercial launch of VARUBI® (oral rolapitant) well underway
· Niraparib Phase 3 NOVA results expected in Q2 2016 are positioned to be the first data from a randomized, prospective Phase 3 trial of a PARP inhibitor
· New Drug Application (NDA) submission for niraparib planned for 2H 2016
· Investigational New Drug (IND) application for TSR-042 cleared by FDA
· IND submission for TSR-022 (anti-TIM-3 antibody) planned for Q2 2016
· Cash and cash equivalents totaled $230.1 million as of December 31, 2015
· Private placement financing will add an additional $155 million upon closing
WALTHAM, Mass., Feb. 25, 2016 — TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for fourth-quarter 2015 and provided an update on the Company’s development programs.
“2016 is poised to be another exciting year for TESARO as we continue to drive awareness of CINV and work to make VARUBI® available to all eligible patients,” said Lonnie Moulder, CEO of TESARO. “We have implemented a comprehensive, global development program for niraparib in ovarian cancer that spans the treatment and maintenance settings, several patient subgroups and multiple lines of therapy, and we are also exploring combination and monotherapy approaches for additional tumor types. We continue to anticipate that data from our NOVA and QUADRA registration trials of niraparib will become available during the second quarter. Our NOVA study results will be the first data from a prospectively designed, randomized Phase 3 trial for a PARP inhibitor, and the full data from this global trial are intended to support regulatory applications and submissions to payors and pricing authorities as part of our commercialization strategy for the U.S. and European markets. We are enthusiastic about the potential for our pipeline candidates to create significant value for shareholders, particularly by expanding our niraparib development program into additional tumor types and advancing our portfolio of immuno-oncology candidates into the clinic.”
Recent Business Highlights
· TESARO launched VARUBI® (oral rolapitant) in November of 2015, following U.S. Food and Drug Administration (FDA) approval for use in combination with other antiemetic agents in adults, for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.
· The intravenous (IV) rolapitant development program is complete, and a New Drug Application (NDA) will be submitted to the FDA in the first quarter of 2016.
· Patient treatment continues in the Phase 3 NOVA trial of niraparib in patients with ovarian cancer, and based upon the observed event rate, TESARO continues to expect data in the second quarter of 2016.
The following information was filed by Tesaro, Inc. (TSRO) on Thursday, February 25, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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Financial - Expense Highlight
development activities under our collaboration with AnaptysBio, costs related to commercial activities associated with VARUBI, costs related to the advancement of clinical trial and other development activities under our current development programs, such as niraparib and the immuno-oncology activities under our collaboration with AnaptysBio, costs related to ongoing commercial activities, including our commercial sales force, executing marketing and promotional programs, and other commercialization costs associated with VARUBI, costs related to expanding our international operations, and costs related to potential future collaborative or in-licensed development programs.
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Financial - Expense Highlight
an increase of $14.3 million in costs associated with niraparib development activities, primarily related to increased costs of our ovarian cancer clinical trials, partially offset by lower costs relating to drug process development and manufacturing
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Financial - Expense Highlight
a decrease of $7.2 million in costs associated with rolapitant development activities, primarily due to lower costs related to the oral rolapitant Phase 3 clinical trials, which were completed in 2014, partially offset by increased costs relating to drug process development and manufacturing and costs relating to IV rolapitant development activities.
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Financial - Expense Highlight
for the year ended December 31, 2014, net cash proceeds of $194.7 million net of underwriting discounts and commissions and offering expenses from the issuance of the Convertible Notes, partly offset by the use of $20.8 million in cash associated with the Capped Calls, as well as net cash proceeds of $94.2 million from a follow-on offering of common stock and
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Financial - Expense Highlight
the initiation, progress, timing, costs and results of clinical trials for our product candidates and any future product candidates we may in-license, including our current and potential future Phase 2 and 3 clinical trials for niraparib
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Other - Other
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for the year ended December...Read more
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Financial - Expense
employee-related expenses, including salaries, bonuses,...Read more
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Financial - Shares
In March 2015, we completed...Read more
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Ticker: TSRO
CIK: 1491576
Form Type: 10-K Annual Report
Accession Number: 0001558370-16-003631
Submitted to the SEC: Fri Feb 26 2016 6:09:27 PM EST
Accepted by the SEC: Mon Feb 29 2016
Period: Thursday, December 31, 2015
Industry: Pharmaceutical Preparations
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