Full Press Release Details
Fourth Quarter 2018 Highlights and Recent Progress:
Avapritinib: Gastrointestinal stromal tumors (GIST):
Avapritinib: Systemic mastocytosis (SM):
BLU-667: RET-altered solid tumors:
BLU-554: Hepatocellular carcinoma (HCC):
BLU-782: Fibrodysplasia ossificans progressiva (FOP):
Key Upcoming Milestones:
The company expects to achieve the following milestones by the end of the second quarter of 2019.
Fourth Quarter and Year End 2018 Financial Results:
Financial Guidance :
Based on its current plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, excluding any potential option fees and milestone payments under its existing collaborations with Roche and CStone Pharmaceuticals, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2020.
Conference Call Information:
Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss fourth quarter and full year 2018 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international) and referring to conference ID 26735762. A webcast of the conference call will be available in the Investors section of the Blueprint Medicines' website at http://ir.blueprintmedicines.com . The archived webcast will be available on Blueprint Medicines' website approximately two hours after the conference call and will be available for 30 days following the call.
About Blueprint Medicines:
Cautionary Note Regarding Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans and timelines for the development of avapritinib, BLU-667, BLU-554 and BLU-782; the potential benefits of Blueprint Medicines' current and future drug candidates in treating patients; Blueprint Medicines' "2020 Blueprint" strategy, key goals and anticipated milestones; plans and timelines for submitting an NDA to the FDA for avapritinib; plans and timelines for presenting the registration dataset for avapritinib in PDGFRA Exon 18 mutant GIST and fourth-line GIST; plans and timelines for presenting updated data from the Phase 1 EXPLORER trial of avapritinib in advanced SM; plans and timelines for presenting updated data from the Phase 1 ARROW trial of BLU-667 in RET-altered cancers; plans and timelines for completing previously treated NSCLC and MTC patient cohorts in the Phase 1 ARROW trial of BLU-667; expectations regarding Blueprint Medicines' existing cash, cash equivalents and investments; and Blueprint Medicines' strategy, business plans and focus. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the delay of any current or planned clinical trials or the development of Blueprint Medicines' drug candidates, including avapritinib, BLU-667, BLU-554 and BLU-782; Blueprint Medicines' advancement of multiple early-stage efforts; Blueprint Medicines' ability to successfully demonstrate the safety and efficacy of its drug candidates; the preclinical and clinical results for Blueprint Medicines' drug candidates, which may not support further development of such drug candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines' ability to develop and commercialize companion diagnostic tests for its current and future drug candidates, including companion diagnostic tests for avapritinib for PDGFRα D842V-driven GIST, BLU-667 for RET-driven NSCLC and BLU-554 for FGFR4-driven HCC; the success of Blueprint Medicines' current and future collaborations, including its cancer immunotherapy collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. and its collaboration with CStone Pharmaceuticals. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Blueprint Medicines' Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 , as filed with the Securities and Exchange Commission (SEC) on October 30, 2018 , and any other filings that Blueprint Medicines has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Blueprint Medicines' views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines explicitly disclaims any obligation to update any forward-looking statements.
| Blueprint Medicines Corporation | |||||||
| Selected Condensed Consolidated Balance Sheet Data | |||||||
| (in thousands) | |||||||
| (unaudited) | |||||||
| December 31, | December 31, | ||||||
| 2018 | 2017 | ||||||
| Cash, cash equivalents and investments | $ | 494,012 | $ | 673,356 | |||
| Working capital (1) | 439,464 | 642,615 | |||||
| Total assets | 540,124 | 715,737 | |||||
| Deferred revenue | 46,167 | 35,373 | |||||
| Term loan payable | - | 1,518 | |||||
| Lease incentive obligation | 14,617 | 16,331 | |||||
| Total stockholders' equity | 419,009 | 623,970 | |||||
| (1) Blueprint Medicines defines working capital as current assets less current liabilities. |
| Blueprint Medicines Corporation | ||||||||||||
| Condensed Consolidated Statements of Operations Data | ||||||||||||
| (in thousands, except per share data) | ||||||||||||
| (unaudited) | ||||||||||||
| Three Months Ended | Year Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||
| Collaboration revenue | $ | 1,033 | $ | 1,628 | $ | 44,521 | $ | 21,426 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 70,532 | 43,629 | 243,621 | 144,687 | ||||||||
| General and administrative | 13,643 | 8,092 | 47,928 | 27,986 | ||||||||
| Total operating expenses | 84,175 | 51,721 | 291,549 | 172,673 | ||||||||
| Other income (expense): | ||||||||||||
| Other income, net | 2,825 | 1,108 | 10,459 | 3,349 | ||||||||
| Interest expense | (5) | (42) | (73) | (221) | ||||||||
| Total other income (expense) | 2,820 | 1,066 | 10,386 | 3,128 | ||||||||
| Net loss | $ | (80,322) | $ | (49,027) | $ | (236,642) | $ | (148,119) | ||||
| Net loss per share — basic and diluted | $ | (1.83) | $ | (1.23) | $ | (5.39) | $ | (3.92) | ||||
| Weighted-average number of common shares used in net loss per share — basic and diluted | 43,994 | 39,988 | 43,867 | 37,793 |
SOURCE Blueprint Medicines Corporation