Full Press Release Details
"Our progress in recent months is a testament to the agility of the Blueprint Medicines team and the strength of our fully-integrated business," said Jeff Albers , Chief Executive Officer of Blueprint Medicines. "Despite challenges related to the COVID-19 pandemic and top-line results from the VOYAGER trial, we broadly executed against our planned milestones, including the submission of marketing applications for pralsetinib for RET fusion-positive non-small cell lung cancer in the U.S. and Europe and the reporting of transformative datasets for avapritinib in systemic mastocytosis and pralsetinib in RET-altered cancers, paving the way for multiple planned launches through 2021."
First Quarter 2020 Highlights and Recent Updates
Avapritinib: systemic mastocytosis (SM)
Avapritinib: gastrointestinal stromal tumors (GIST)
Pralsetinib: RET-altered cancers
Key Upcoming Milestones
The company expects to achieve the following near-term milestones:
Response to the COVID-19 Pandemic and Potential Business Impacts
Due to the evolving and uncertain global impacts of the COVID-19 pandemic, Blueprint Medicines cannot precisely determine or quantify the impact this pandemic will have on its business, operations (including clinical trials) and financial performance for the remainder of our fiscal year ending December 31, 2020 and beyond.
Blueprint Medicines will continue to assess potential impacts of the COVID-19 pandemic and seek to advance the company's pipeline of targeted therapies as quickly as possible, while making the health and safety of the company's employees and their families, healthcare providers, patients and communities a top priority.
First Quarter 2020 Financial Results
Financial Guidance
Based on its current operating plans, Blueprint Medicines expects that its existing cash, cash equivalents and investments, together with anticipated product revenues but excluding any potential option fees, milestone payments or other payments under its collaboration or license agreements, will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2022.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss first quarter 2020 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 7980947. A webcast of the call will be available under "Events and Presentations" in the Investors & Media 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 AYVAKIT (avapritinib), pralsetinib, fisogatinib, and BLU-263, including the timing, designs, implementation, enrollment, plans and announcement of results regarding Blueprint Medicines' ongoing and planned clinical trials; plans and timelines for submitting marketing applications for avapritinib and pralsetinib and, if approved, commercializing avapritinib for additional indications or pralsetinib; the impact of the COVID-19 pandemic on Blueprint Medicines' business, operations and financial performance; the potential benefits of the FDA's RTOR program or the FDA's Project Orbis initiative; the potential benefits of Blueprint Medicines' current and future approved drugs or drug candidates in treating patients; expectations regarding Blueprint Medicines' existing cash, cash equivalents and investments; and Blueprint Medicines' strategy, goals and anticipated milestones, business plans and focus. The words "aim," "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 impact of the COVID-19 pandemic to Blueprint Medicines' business, operations, strategy, goals and anticipated milestones, including Blueprint Medicines' ongoing and planned research and discovery activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products; Blueprint Medicines' ability and plan in establishing a commercial infrastructure, and successfully launching, marketing and selling its approved product; Blueprint Medicines' ability to successfully expand the approved indications for AYVAKIT or obtain marketing approval for AYVAKIT in additional geographies in the future; the delay of any current or planned clinical trials or the development of Blueprint Medicines' drug candidates or licensed product candidate; Blueprint Medicines' advancement of multiple early-stage efforts; Blueprint Medicines' ability to successfully demonstrate the safety and efficacy of its drug candidates and gain approval of its drug candidates on a timely basis, if at all; 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; and the success of Blueprint Medicines' current and future collaborations or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Blueprint Medicines' filings with the Securities and Exchange Commission (SEC), including Blueprint Medicines' most recent Annual Report on Form 10-K, as supplemented by its most recent Quarterly Report on Form 10-Q 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) | |||||
| March 31, | December 31, | ||||
| 2020 | 2019 | ||||
| Cash, cash equivalents and investments | $ | 750,430 | $ | 547,960 | |
| Working capital (1) | 606,395 | 410,304 | |||
| Total assets | 913,623 | 707,694 | |||
| Deferred revenue | 45,499 | 46,073 | |||
| Total liabilities | 230,692 | 243,335 | |||
| Total stockholders' equity | 682,931 | 464,359 | |||
| (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 | ||||||
| March 31, | ||||||
| 2020 | 2019 | |||||
| Revenues: | ||||||
| Product revenue, net | $ | 3,458 | $ | - | ||
| Collaboration revenue | 2,709 | 730 | ||||
| Total revenues | 6,167 | 730 | ||||
| Cost and operating expenses: | ||||||
| Cost of sales | 24 | - | ||||
| Research and development | 84,146 | 74,250 | ||||
| Selling, general and administrative | 35,655 | 16,553 | ||||
| Total cost and operating expenses | 119,825 | 90,803 | ||||
| Other income (expense): | ||||||
| Interest income (expense), net | 2,904 | 2,710 | ||||
| Other income (expense), net | (201) | (44) | ||||
| Total other income (expense) | 2,703 | 2,666 | ||||
| Net loss | $ | (110,955) | $ | (87,407) | ||
| Net loss per share — basic and diluted | $ | (2.11) | $ | (1.98) | ||
| Weighted-average number of common shares used in net loss per share — basic and diluted | 52,655 | 44,097 |
SOURCE Blueprint Medicines Corporation