WALTHAM, Mass., May 03, 2018 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for first-quarter 2018, and provided an update on the Company's commercial products and development programs.
“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. 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
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.
(in thousands, except per share amounts) | Three Months Ended March 31, | |||||
2017 | 2018 | |||||
Product revenue, net | ||||||
ZEJULA® | - | $ | 48,869 | |||
VARUBI®/VARUBY® | $ | 2,139 | $ | 1,303 | ||
Total product revenue, net | $ | 2,139 | $ | 50,172 | ||
License, collaboration, and other revenue | $ | 934 | $ | (430 | ) | |
Total revenues | $ | 3,073 | $ | 49,742 | ||
Net loss | $ | (136,725 | ) | $ | (162,816 | ) |
Net loss per share, basic and diluted | $ | (2.55 | ) | $ | (2.98 | ) |
Operating Expenses
(in thousands) | Three Months Ended March 31, | |||
2017 | 2018 | |||
Cost of sales - product | $ | 444 | $ | 9,997 |
Cost of sales - intangible asset amortization | $ | 490 | $ | 1,437 |
Research and development (R&D) | $ | 66,122 | $ | 96,755 |
Selling, general and administrative (SG&A) | $ | 69,262 | $ | 93,607 |
Acquired in-process R&D | $ | - | $ | - |
Cash and Cash Equivalents
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.
2018 Financial Guidance
In 2018, TESARO expects:
Total Revenue, net, worldwide (FY) | $310 to $345 million | |
ZEJULA (FY) | $255 to $275 million | |
ZEJULA (Q2) | $50 to $55 million | |
Other revenue, including licensing and VARUBI/Y oral (FY) | $55 to $70 million | |
Interest expense (FY) | $50 to $60 million, including non-cash interest expense of $14 million | |
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:
Breast Cancer:
Lung Cancer:
Prostate Cancer:
Immuno-oncology Portfolio:
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.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com, and follow us on Twitter and LinkedIn.
TESARO Contacts:
Jennifer Davis
Vice President, Corporate Communications & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
Kate Rausch
Associate 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: our 2018 revenue, interest expense, and cash balance guidance; the expected decline in our cash and cash equivalents balance; the design and expected timing of initiation, enrollment, and data readouts and publications from our various ongoing and planned ZEJULA, TSR-042, TSR-033, TSR-022, combination, and other clinical trials; the expected timing of our various BLA and other regulatory filings; and our expectation to achieve our various development milestones; and our intent to draw the remaining amount available under our term loan facility. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our research and development programs, future financial and other 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 the acceptance of our products in the marketplace, 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 potential actions by regulatory authorities, uncertainties regarding the expected timing and magnitude of certain expenditures, risks related to manufacturing and supply, risks related to intellectual property, the terms of our term loan facility, other matters that could affect our financial results, the results of our ongoing and planned development programs, and/or 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, 2017.
TESARO, Inc. | ||||||||
Unaudited Condensed Consolidated Statements of Operations | ||||||||
(in thousands, except per share amounts) | ||||||||
Three Months Ended March 31, | ||||||||
2017 | 2018 | |||||||
Revenues: | ||||||||
Product revenue, net: | ||||||||
ZEJULA® | $ | - | $ | 48,869 | ||||
VARUBI®/VARUBY® | 2,139 | 1,303 | ||||||
Total product revenue, net | 2,139 | 50,172 | ||||||
License, collaboration and other revenues | 934 | (430 | ) | |||||
Total revenues | 3,073 | 49,742 | ||||||
Expenses: | ||||||||
Cost of sales - product | 444 | 9,997 | ||||||
Cost of sales - intangible asset amortization | 490 | 1,437 | ||||||
Research and development (1) | 66,122 | 96,755 | ||||||
Selling, general and administrative (1) | 69,262 | 93,607 | ||||||
Acquired in-process research and development | - | - | ||||||
Total expenses | 136,318 | 201,796 | ||||||
Loss from operations | (133,245 | ) | (152,054 | ) | ||||
Interest and other income (expense), net | (3,426 | ) | (10,346 | ) | ||||
Loss before income taxes | (136,671 | ) | (162,400 | ) | ||||
Provision for income taxes | 54 | 416 | ||||||
Net loss | $ | (136,725 | ) | $ | (162,816 | ) | ||
Net loss per share applicable to common stockholders - basic and diluted | $ | (2.55 | ) | $ | (2.98 | ) | ||
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted | 53,685 | 54,615 | ||||||
(1) Expenses include the following amounts of non-cash stock-based compensation expense: | ||||||||
Research and development | $ | 7,125 | $ | 7,814 | ||||
Selling, general and administrative | 11,276 | 18,314 | ||||||
TESARO, Inc. | ||||||
Unaudited Condensed Consolidated Balance Sheets | ||||||
(in thousands) | ||||||
December 31, | March 31, | |||||
2017 | 2018 | |||||
Assets | ||||||
Current assets: | ||||||
Cash and cash equivalents | $ | 643,095 | $ | 498,980 | ||
Accounts receivable | 53,416 | 44,182 | ||||
Inventories | 57,939 | 74,444 | ||||
Other current assets | 33,511 | 38,184 | ||||
Total current assets | 787,961 | 655,790 | ||||
Intangible assets, net | 56,384 | 54,947 | ||||
Property and equipment, net | 9,652 | 10,272 | ||||
Restricted cash | 2,552 | 2,556 | ||||
Other assets | 5,636 | 6,127 | ||||
Total assets | $ | 862,185 | $ | 729,692 | ||
Liabilities and stockholders' equity | ||||||
Current liabilities: | ||||||
Accounts payable | $ | 4,172 | $ | 5,079 | ||
Accrued expenses | 154,808 | 150,589 | ||||
Deferred revenue, current | 324 | 117 | ||||
Other current liabilities | 6,902 | 7,451 | ||||
Total current liabilities | 166,206 | 163,236 | ||||
Convertible notes, net | 143,446 | 146,529 | ||||
Long-term debt, net | 293,659 | 293,888 | ||||
Deferred revenue, non-current | 211 | 188 | ||||
Other non-current liabilities | 9,577 | 8,123 | ||||
Total liabilities | 613,099 | 611,964 | ||||
Total stockholders' equity | 249,086 | 117,728 | ||||
Total liabilities and stockholders' equity | $ | 862,185 | $ | 729,692 | ||