On May 3, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported operating results for first-quarter 2018, and provided an update on the Company’s commercial products and development programs (Press release, TESARO, MAY 3, 2018, View Source [SID1234526093]).
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"2018 is off to an excellent start for TESARO, as ZEJULA continues to penetrate the recurrent ovarian cancer market," said Lonnie Moulder, CEO of TESARO. "We expect to expand the market for ZEJULA to the front-line setting with PRIMA, our Phase 3 trial for patients with first-line ovarian cancer regardless of biomarker status, with data expected late next year. In March, data presented from our TOPACIO trial of ZEJULA in combination with an anti-PD-1 antibody surpassed historical monotherapy benchmarks in difficult-to-treat platinum-resistant and refractory ovarian cancer patients, and we look forward to presentations from both the ovarian and triple-negative breast cancer cohorts of TOPACIO at ASCO (Free ASCO Whitepaper). Our immuno-oncology pipeline is advancing quickly and we are on track to submit a biologic license application for TSR-042, our anti-PD-1 antibody, for patients with MSI-high tumors in 2019. Enrollment continues in our AMBER trial of TSR-022, our anti-TIM-3 antibody, in combination with TSR-042, and data from this trial in tumor-specific expansion cohorts are expected to be presented at a medical meeting later this year."
Recent Business Highlights
ZEJULA is the most utilized PARP inhibitor among ovarian cancer patients in the U.S., with more than 5,000 patients treated since launch in April 2017. The European launch of ZEJULA continues in Germany.
Enrollment was completed in the Phase 3 PRIMA trial for patients with first-line ovarian cancer regardless of biomarker status. Data from this study are anticipated in late 2019.
Data were presented from the ovarian cancer cohort of the TOPACIO trial of ZEJULA in combination with an anti-PD-1 monoclonal antibody at the Society for Gynecologic Oncology (SGO) Annual Meeting in March. Data demonstrated activity of ZEJULA in combination with an anti-PD-1 antibody in difficult-to-treat types of ovarian cancer.
Results from a retrospective analysis of the NOVA trial were presented at the SGO Annual Meeting, which identified two characteristics, patient body weight and platelet counts, to be predictors of dose modification.
In April, preliminary Phase 1 data from expansion cohorts of the GARNET trial of TSR-042 were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Activity of TSR-042 monotherapy was demonstrated in patients with MSI-high endometrial cancer and non-small cell lung cancer (NSCLC), with a well-tolerated safety profile comparable to other anti-PD-1 antibodies.
Top-line results from the QUADRA study of ZEJULA monotherapy in fourth-line plus treatment of ovarian cancer were announced in April. This trial successfully achieved its pre-specified primary endpoint and demonstrated activity in patients with fourth or fifth-line HRD-positive ovarian cancer who were PARP inhibitor naïve and platinum sensitive. Additional QUADRA data will be presented at ASCO (Free ASCO Whitepaper) in June.
Phase 2 data from the TOPACIO trial of ZEJULA with an anti-PD-1 for patients with platinum-resistant ovarian cancer or triple-negative breast cancer were accepted for two separate oral presentations at ASCO (Free ASCO Whitepaper).
TSR-042 is in a registration trial (GARNET) for MSI-high tumors. Data are being generated to demonstrate the activity of TSR-042 in multiple tumor types, including lung, breast and ovarian cancer.
Clinical trials are ongoing to evaluate TSR-022 (anti-TIM-3 antibody) and TSR-033 (anti-LAG-3 antibody) in combination with TSR-042.
AMBER: Phase 1 trial of TSR-022 in combination with TSR-042 is enrolling three tumor specific cohorts.
CITRINO: Phase 1 dose-escalation trial of TSR-033 is ongoing to determine dose and schedule for combination with TSR-042.
First Quarter 2018 Financial Results
TESARO reported net product revenue of $50.2 million for the first quarter of 2018, including ZEJULA sales of $48.9 million, compared to $2.1 million for the first quarter of 2017.
Research and development expenses increased to $96.8 million for the first quarter of 2018, compared to $66.1 million for the first quarter of 2017, primarily due to higher manufacturing and clinical development costs associated with ZEJULA, TSR-042, and TSR-022, increased headcount, and research collaborations.
Selling, general and administrative expenses increased to $93.6 million for the first quarter of 2018, compared to $69.3 million for the first quarter of 2017, primarily due to increased sales and marketing headcount and activities to support sales of ZEJULA in the U.S. and launches in Europe.
Operating expenses as described above include total non-cash, stock-based compensation expense of $26.1 million for the first quarter of 2018, compared to $18.4 million for the first quarter of 2017.
Net loss totaled $162.8 million, or ($2.98) per share, for the first quarter of 2018, compared to a net loss of $136.7 million, or ($2.55) per share, for the first quarter of 2017.
As of March 31, 2018, TESARO had approximately $499.0 million in cash and cash equivalents and approximately 54.8 million outstanding shares of common stock.
In the first quarter, TESARO’s cash and cash equivalents balance declined by approximately $144 million. The Company plans to draw $200 million in the second half of 2018 from its available term loan facility, and quarterly declines in cash and cash equivalents are expected to moderate over the course of 2018. TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million.
Key Development Milestones
TESARO intends to achieve the following development milestones:
Ovarian Cancer Franchise:
Report TOPACIO platinum-resistant ovarian cancer data at ASCO (Free ASCO Whitepaper) and confirm with FDA the intended strategy for registering ZEJULA in combination with TSR-042 in platinum-resistant/refractory ovarian cancer in mid-2018
Initiate FIRST, a Phase 3 clinical trial of ZEJULA in combination with TSR-042 in first-line ovarian cancer, in Q2 2018
Report QUADRA data at ASCO (Free ASCO Whitepaper) and define biomarker-focused regulatory strategy in 2H 2018
Report PRIMA data in first-line ovarian cancer maintenance in late 2019
Breast Cancer:
Report TOPACIO triple-negative breast cancer data at ASCO (Free ASCO Whitepaper)
Publish BRAVO data in 2H 2018
Confirm intended registration path for ZEJULA in breast cancer with FDA in mid-2018
Lung Cancer:
Report additional data from lung cancer cohort of the GARNET trial of TSR-042 in NSCLC in 2H 2018
Initial data from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor to be available in 2H 2018
Prostate Cancer:
Janssen anticipates advancing trials of ZEJULA in prostate cancer to support U.S. and EU regulatory filings in 2019
Immuno-oncology Portfolio:
Complete enrollment in the MSI-high cohort of the GARNET trial of TSR-042 to support a biologics license application (BLA) submission to FDA in 2019
Report initial data for the AMBER trial of TSR-022 in combination with TSR-042 in 2H 2018
Initiate assessment of the combination of TSR-033 plus TSR-042 in the CITRINO trial in Q2 2018 and report Phase 1 monotherapy dose-escalation data for TSR-033 in 2H 2018
Advance IND-enabling studies of PD-1/LAG-3 bi-specific antibody (TSR-075)
Today’s Conference Call and Webcast
TESARO will host a conference call to discuss first quarter operating results and provide an update on its 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