On February 25, 2016 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for fourth-quarter 2015 and provided an update on the Company’s development programs (Press release, TESARO, FEB 25, 2016, View Source [SID:1234509222]).
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"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.
Enrollment continues in the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy, and data from this trial is anticipated to become available in the second quarter.
Antibody drug candidates targeting PD-1, TIM-3, and LAG-3 continue to advance, and the Investigational New Drug (IND) application for TSR-042, our anti-PD-1 antibody candidate, has been cleared by the FDA.
Fourth Quarter 2015 Financial Results
TESARO reported a net loss of $75.8 million, or ($1.89) per share, for the fourth quarter of 2015, compared to a net loss of $47.9 million, or ($1.33) per share, for the fourth quarter of 2014.
Research and development expenses increased to $42.9 million for the fourth quarter of 2015, compared to $29.8 million for the fourth quarter of 2014, driven primarily by higher costs related to the ongoing registration trials of niraparib, development activities related to the rolapitant IV NDA submission, and advancement of our immuno-oncology portfolio, in addition to increased headcount.
Selling, general and administrative expenses increased to $27.9 million for the fourth quarter of 2015, compared to $7.4 million for the fourth quarter of 2014, primarily due to commercial activities in support of the launch of VARUBI, increased commercial headcount, and higher professional service fees.
Acquired in-process research and development expenses totaled $1.0 million for the fourth quarter of 2015 and included a milestone payment related to our immuno-oncology portfolio, compared to $7.0 million for the fourth quarter of 2014, which included development milestones for rolapitant and the immuno-oncology portfolio.
Operating expenses, as described above, include total non-cash, stock-based compensation expense of $8.4 million for the fourth quarter of 2015, compared to $3.1 million for the fourth quarter of 2014.
As of December 31, 2015, TESARO had approximately $230.1 million in cash and cash equivalents and approximately 40.3 million outstanding shares of common stock.
Today TESARO announced a definitive agreement for a private placement that would result in proceeds of $155 million. TESARO expects its cash utilization to be approximately $70 million on average, per quarter, during the first half of 2016.
Full-Year 2015 Financial Results
TESARO reported a net loss of $251.4 million, or ($6.38) per share, for 2015, compared to a net loss of $171.0 million, or ($4.79) per share, for 2014.
Research and development expenses increased to $155.4 million for 2015, compared to $118.4 million for 2014, driven primarily by three ongoing registration trials of niraparib, development activities related to the rolapitant IV NDA submission, and advancement of our immuno-oncology portfolio, in addition to increased headcount.
Acquired in-process research and development expenses totaled $2.0 million for 2015 and included milestone payments related our immuno-oncology portfolio, compared to $24.9 million for 2014, which was primarily due to up-front immuno-oncology license payments.
Selling, general and administrative expenses increased to $78.7 million for 2015, compared to $23.9 million for 2014, primarily due to commercial activities in support of the launch of VARUBI, increased commercial headcount, and higher professional service fees.
Operating expenses, as described above, include total non-cash, stock-based compensation expense of $25.9 million for 2015, compared to $11.7 million for 2014.
2016 Corporate Objectives
TESARO anticipates achieving the following key objectives:
Continue to execute on the VARUBI commercial launch in the United States;
Submit the NDA for IV rolapitant in Q1 2016;
Submit the oral rolapitant Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q2 2016;
Initiate patient enrollment in the Phase 3 clinical trial of niraparib in first-line ovarian cancer (PRIMA) in Q1 2016;
Initiate enrollment in the niraparib/KEYTRUDA (pembrolizumab) combination trial in Q1 2016;
Report data from the Phase 3 NOVA trial and from the QUADRA trial of niraparib in Q2 2016;
Submit the niraparib NDA and MAA in 2H 2016;
Continue to enroll the Phase 3 BRAVO trial of niraparib in breast cancer patients with germline BRCA mutations through 2016;
Initiate a Phase 1 clinical trial of TSR-042 (anti-PD-1 antibody) in Q1 2016;
Submit the IND for TSR-022 (anti-TIM-3 antibody) in Q2 2016;
Select a clinical antibody candidate targeting LAG-3 in 1H 2016;
Identify a dose and schedule for TSR-042 by the end of 2016; and
Select bispecific clinical candidates targeting PD-1/TIM-3 and PD-1/LAG-3 in 2016.