- Niraparib rolling NDA submission to FDA complete, MAA accepted for review by EMA
- Pre-launch planning ongoing to support four potential product launches in 2017 across U.S. and Europe
- Positive Phase 3 NOVA trial results presented during Presidential Symposium at ESMO 2016 and simultaneously published in New England Journal of Medicine
- Cash and cash equivalents totaled approximately $647 million as of September 30, 2016
- The U.S. launch of VARUBI continues, and unit volume increased by 14% for the third quarter compared to the second quarter. For the month of September, VARUBI achieved a 28% market share in the oral NK-1 market in the U.S.
- TESARO officially opened its international commercial headquarters in Zug, Switzerland on October 11.
- Earlier this week, the rolling submission of a New Drug Application (NDA) for niraparib to the U.S. Food and Drug Administration (FDA) was completed for the maintenance treatment of patients with recurrent, platinum-sensitive ovarian cancer who are in response to platinum-based chemotherapy. The indication proposed in the niraparib NDA provides for the use of niraparib regardless of tumor biomarker status, and it is anticipated that the BRACAnalysis ® CDx and myChoice ® HRD tests would be available to physicians as complementary diagnostics.
- The Marketing Authorisation Application (MAA) for niraparib has been submitted to and accepted for review by the European Medicines Agency (EMA) for the maintenance treatment of patients with recurrent, platinum-sensitive ovarian cancer who are in response to platinum-based chemotherapy.
- The niraparib Phase 3 ENGOT-OV16/NOVA clinical trial results were presented at the Presidential Symposium at the ESMO 2016 Congress by Dr. Mansoor Raza Mirza, M.D., Medical Director of the Nordic Society of Gynecologic Oncology (NSGO) and principal investigator. These data were simultaneously published in the New England Journal of Medicine.
- Planning is underway to support initiation of an Early Access Program (EAP) for niraparib in the United States and Europe.
- Janssen initiated a Phase 2 clinical trial with niraparib in monotherapy in men with metastatic castration resistant prostate cancer (mCRPC) and recently began a Phase 1 safety and pharmacokinetics study of niraparib plus apalutamide (ARN-509).
- Enrollment continues in the PRIMA trial for patients with first-line ovarian cancer, the QUADRA trial of niraparib for the treatment of patients with ovarian cancer who have received three or more prior lines of chemotherapy, and in the BRAVO trial for patients with germline BRCA-mutated, metastatic breast cancer.
- Enrollment continues in the TOPACIO trial of niraparib plus KEYTRUDA ® (pembrolizumab) in patients with ovarian cancer or with triple negative breast cancer and in the AVANOVA trial of niraparib plus bevacizumab in patients with ovarian cancer.
- TESARO and Zai Lab (Shanghai) Co., Ltd. announced a collaboration to support the development and commercialization of niraparib for patients in China and the potential to advance two immuno-oncology programs outside of China.
- The Phase 1 dose escalation study of TSR-022, an anti-TIM-3 antibody candidate, was initiated in July, and the Phase 1 trial of TSR-042, an anti-PD-1 antibody candidate, continues to enroll.
Net product revenue for the third quarter of 2016 totaled $2.8 million and included sales of VARUBI from specialty pharmacy customers to patients and from specialty distributors to providers that were made during the third quarter, as well as sales from specialty distributors to providers that occurred in the second quarter of 2016. License, collaboration and other revenue for the third quarter of 2016 totaled $0.9 million and included amortization of milestone payments and shipments of clinical materials under our license agreements with Hengrui and Janssen.Research and development expenses increased to $60.8 million for the third quarter of 2016, compared to $40.1 million for the third quarter of 2015, driven primarily by higher costs related to the ongoing registration trials of niraparib, manufacturing costs associated with niraparib, and the initiation of clinical studies for our immuno-oncology portfolio, in addition to increased headcount. Selling, general and administrative expenses increased to $37.7 million for the third quarter of 2016, compared to $22.8 million for the third quarter of 2015, primarily due to higher commercial headcount, including the establishment of a U.S. field sales organization in August 2015, commercial activities in support of the launch of VARUBI, costs associated with the establishment of our international headquarters, and higher professional service fees. Operating expenses, as described above, include total non-cash, stock-based compensation expense of $12.9 million for the third quarter of 2016, compared to $8.1 million for the third quarter of 2015. As of September 30, 2016, TESARO had approximately $647 million in cash and cash equivalents, which includes the $409 million in net proceeds from a follow-on offering of 5.3 million shares of common stock that was completed in July 2016. For the quarter ended September 30, 2016, TESARO had approximately 51.2 million shares outstanding on a weighted average basis. In anticipation of four product launches in 2017, TESARO will continue to invest in pre-launch inventory manufacturing, development of supply chain capabilities and capacity, and expansion of European and targeted U.S. commercial operations, in addition to making milestone payments for regulatory submissions. As a result of these investments, the Company expects its cash and cash equivalents balance to decline by approximately $100 million during the fourth quarter of 2016.
Corporate ObjectivesThe following is a summary of TESARO's key objectives: VARUBI ® (rolapitant):
- Achieve #1 market share position within the oral NK-1 receptor antagonist market by year-end 2016 in the U.S.;
- Launch VARUBI IV into the U.S. market in 1H 2017, pending FDA approval;
- Establish a European commercial organization; and
- Launch VARUBI oral in Europe in 1H 2017, pending EMA approval.
- Continue commercial preparations in support of the launches of niraparib in the U.S. in 1H 2017 and Europe in 2H 2017, pending regulatory approvals;
- Report QUADRA data in 2H 2017;
- Report Phase 3 BRAVO data in 2H 2017;
- Finalize a potential lung cancer registration strategy and initiate development program in 1H 2017; and
- Determine the potential registration strategy for niraparib plus an anti-PD-1 antibody in ovarian cancer and triple-negative breast cancer in 2H 2017.
- Identify a dose and schedule for TSR-042 (anti-PD-1 antibody) by the end of 2016;
- Select at least one bispecific antibody clinical candidate by the end of 2016;
- Identify the first clinical candidate within the MD Anderson collaboration in 1H 2017;
- Initiate a Phase 1 study of TSR-033 (anti-LAG-3 antibody) in 1H 2017;
- Finalize the TSR-042 registration strategy and initiate a registration program in 1H 2017; and
- Initiate a Phase 1 clinical trial of TSR-022 in combination with an anti-PD-1 antibody in mid-2017.
|Unaudited Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Product revenue, net||$||-||$||2,799||$||-||$||4,408|
|License, collaboration and other revenues||87||931||87||36,190|
|Cost of sales - product||-||424||-||738|
|Cost of sales - intangible asset amortization||-||464||-||1,391|
|Research and development (1)||40,063||60,783||112,538||163,630|
|Selling, general and administrative (1)||22,766||37,685||50,791||104,052|
|Acquired in-process research and development||-||1,940||1,000||9,940|
|Loss from operations||(62,742||)||(97,566||)||(164,242||)||(239,153||)|
|Interest income (expense), net||(3,844||)||(3,587||)||(11,407||)||(11,377||)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(1.66||)||$||(1.98||)||$||(4.49||)||$||(5.45||)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted||40,038||51,151||39,129||45,994|
|(1) Expenses include the following amounts of non-cash stock-based compensation expense:|
|Research and development||$||3,783||$||5,605||$||7,808||$||13,826|
|Selling, general and administrative||4,346||7,314||9,702||20,238|
|Unaudited Condensed Consolidated Balance Sheets|
|December 31, 2015||September 30, 2016|
|Cash and cash equivalents||$||230,146||$||647,315|
|Other current assets||4,560||7,409|
|Total current assets||236,491||670,101|
|Intangible assets, net||14,732||13,341|
|Property and equipment, net||2,779||3,781|
|Liabilities and stockholders' equity|
|Deferred revenue, current||500||772|
|Other current liabilities||1,534||670|
|Total current liabilities||46,681||57,841|
|Convertible notes, net||121,325||129,017|
|Deferred revenue, non-current||288||-|
|Other non-current liabilities||113||515|
|Total stockholders' equity||86,874||502,221|
|Total liabilities and stockholders' equity||$||255,281||$||689,594|
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