On August 2, 2018 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported operating results for second-quarter 2018 and provided an update on the Company’s commercial products and development programs (Press release, TESARO, AUG 2, 2018, View Source [SID1234528385]).
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"In the second quarter, we continued to execute on the ZEJULA launch in the U.S. and Europe, and we are changing the treatment paradigm for women with recurrent ovarian cancer," said Lonnie Moulder, CEO of TESARO. "Following the results from our Phase 3 PRIMA trial, which is now fully enrolled, we hope to offer ZEJULA to women with newly diagnosed ovarian cancer, regardless of BRCA mutation status. Beyond ovarian cancer, our Phase 2 JASPER trial of ZEJULA in combination with an anti-PD-1 antibody in first-line, non-small cell lung cancer is ongoing and we expect to share data at a medical meeting in the first half of 2019. Our immuno-oncology pipeline is advancing quickly, led by TSR-042, our anti-PD-1 antibody, for which we are on track to submit a biologic license application (BLA) in 2019. Initial data from AMBER, a trial of our anti-TIM-3 antibody TSR-022 in combination with TSR-042, have been submitted for inclusion in the SITC (Free SITC Whitepaper) Annual Meeting in November, and include results from lung cancer patients who have progressed on prior anti-PD-1 treatment."
Recent Business Highlights
ZEJULA is the most utilized PARP inhibitor among ovarian cancer patients in the U.S., with more than 6,000 patients treated since its launch in April 2017. ZEJULA is now approved in 32 countries and reimbursed and launched in Germany, the U.K. and several other European countries.
The National Institute for Health and Care Excellence (NICE) made ZEJULA available to women with recurrent platinum-sensitive ovarian cancer in England and Wales via the Cancer Drugs Fund (CDF) in June.
At the ASCO (Free ASCO Whitepaper) meeting in June, results of the QUADRA study of ZEJULA monotherapy for the treatment of ovarian cancer were presented and included durable responses beyond patients with BRCA mutations and overall survival in the late-line ovarian cancer treatment setting. Results of the TOPACIO trial evaluating ZEJULA in combination with an anti-PD-1 antibody were also presented and highlighted promising activity in platinum-resistant/refractory ovarian cancer and triple-negative breast cancer beyond patients with BRCA mutations.
Enrollment was completed in the Phase 3 PRIMA trial of ZEJULA monotherapy for patients with first-line ovarian cancer regardless of biomarker status, and data from this study are anticipated in late 2019. Blinded, pooled interim safety data from PRIMA associated with a 200 milligram starting dose based upon baseline weight and platelet count were accepted for poster discussion at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October.
TESARO divested the oral and intravenous formulations of VARUBI (rolapitant) in the U.S. and Canada to TerSera Therapeutics LLC for $40 million plus potential milestone payments and royalties.
Data from the GARNET registration trial for TSR-042 (anti-PD-1 antibody) in patients with MSI-high endometrial cancer were accepted for poster discussion at the ESMO (Free ESMO Whitepaper) Annual Meeting in October.
Enrollment continues in the Phase 1 AMBER trial of TSR-022 (anti-TIM-3 antibody) in combination with TSR-042 in tumor-specific cohorts, including lung cancer patients who have progressed on prior PD-1 therapy.
In the Phase 1 CITRINO trial, dosing of TSR-033 (anti-LAG-3 antibody) in combination with TSR-042 was initiated.
At the end of June, TESARO drew the $200 million second tranche under its term loan agreement with Pharmakon Advisors, LP.
Second Quarter 2018 Financial Results
TESARO reported net product revenue of $56.5 million for the second quarter of 2018, compared to a total of $28.8 million for the second quarter of 2017, primarily due to growth in ZEJULA net revenue, which increased 108% to $53.9 million for the second quarter of 2018, compared to $25.9 million for the second quarter of 2017.
Research and development expenses increased to $97.6 million for the second quarter of 2018, compared to $71.4 million for the second quarter of 2017, primarily due to higher costs associated with the development of ZEJULA, TSR-042 and TSR-022, increased headcount, and research collaborations.
Selling, general and administrative expenses increased to $100.0 million for the second quarter of 2018, compared to $93.0 million for the second quarter of 2017, primarily due to increased headcount 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 $28.4 million for the second quarter of 2018, compared to $23.5 million for the second quarter of 2017.
Net loss totaled $166.7 million, or ($3.04) per share, for the second quarter of 2018, compared to a net loss of $152.1 million, or ($2.82) per share, for the second quarter of 2017.
As of June 30, 2018, TESARO had approximately $575.1 million in cash and cash equivalents, excluding $35 million received from TerSera in the third quarter upon closing of the VARUBI divestiture, and approximately 54.9 million outstanding shares of common stock.
2018 Financial Guidance
TESARO is revising its 2018 financial guidance to reflect the divestiture of VARUBI in the U.S. and Canada, updated timing of clinical milestone payments, and updated expectations for the market penetration of PARP inhibitors for ovarian cancer maintenance treatment in the U.S.
In the second quarter, TESARO’s cash and cash equivalents balance declined by approximately $120 million, excluding the impact of the $196 million (net of lender fees) received from the term loan facility. Quarterly declines in cash and cash equivalents are expected to moderate over the remainder of 2018 and TESARO anticipates year-end 2018 cash and cash equivalents to be approximately $400 million, including the $35 million upfront payment received in the third quarter from the divestiture of VARUBI.
Key Development Milestones
Gynecologic Cancer:
Submit QUADRA sNDA for treatment of late-line ovarian cancer beyond BRCAmut patients in Q4 2018
Initiate registrational trial of ZEJULA in combination with TSR-042 in platinum-resistant/refractory ovarian cancer in Q4 2018
Initiate enrollment in FIRST, a Phase 3 clinical trial of ZEJULA in combination with TSR-042 ± bevacizumab in first-line ovarian cancer, in September 2018
AVANOVA Phase 2 data of ZEJULA in combination with bevacizumab for treatment of recurrent ovarian cancer to be submitted for presentation at a medical meeting in 1H 2019
Report Phase 2 OVARIO data of ZEJULA in combination with bevacizumab in first-line ovarian cancer maintenance in late 2019
Report Phase 3 PRIMA data of ZEJULA in first-line ovarian cancer maintenance in late 2019
Report additional data from MSI-high endometrial cohort of the GARNET trial of TSR-042 at the ESMO (Free ESMO Whitepaper) Annual Meeting in October and submit a BLA to FDA in 2H 2019
Lung Cancer:
Initiate Phase 2 registration enabling trial of TSR-042 versus standard of care in first-line NSCLC in early 2019
Report additional data from lung cancer cohort of the GARNET trial of TSR-042 in NSCLC at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November
Report initial data from the AMBER trial of TSR-022 in combination with TSR-042 at the SITC (Free SITC Whitepaper) Annual Meeting
Following availability of initial data in Q4 2018 from Phase 2 JASPER study of ZEJULA in combination with an anti-PD-1 inhibitor, submit data for presentation at a medical meeting in 1H 2019
Breast Cancer:
Submit BRAVO data for publication in Q4 2018
Complete protocol development for registration study of ZEJULA in combination with TSR-042 in breast cancer
Prostate Cancer:
Janssen is advancing trials of ZEJULA in prostate cancer to support U.S. and EU regulatory filings in 2019
Immuno-oncology Pipeline:
Continue to enroll CITRINO trial (combination of TSR-033 plus TSR-042) and report Phase 1 monotherapy dose-escalation data for TSR-033 at the SITC (Free SITC Whitepaper) Annual Meeting
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 second 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.