-- Achieved $36.5 million in total revenues, including $28.5 million in AYVAKIT® (avapritinib) net product revenues representing 20 percent AYVAKIT revenue growth from Q1 2022 --
-- Plan to report topline data for registration-enabling PIONEER trial of AYVAKIT in non-advanced SM in August 2022 --
-- Licensed KIT exon 13 inhibitor to IDRx in exchange for a 15 percent Series A preferred equity investment, and the potential to receive up to $217.5 million in development, regulatory, and sales-based milestones and tiered percentage royalties --
-- Investor Day planned for November 1, 2022 in New York, NY --
CAMBRIDGE, Mass., Aug. 2, 2022 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC) today reported financial results and provided a business update for the second quarter ended June 30, 2022.
"We are now one year into the AYVAKIT launch in advanced systemic mastocytosis (SM) and continue to see a significant expansion of our prescriber base as well as strong patient demand, reinforcing our conviction in the growth opportunity in SM," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "We are on track to announce topline data from our registration-enabling PIONEER trial in August, which will catalyze our ability to bring AYVAKIT's transformative potential to patients living with non-advanced SM. In addition, we continue to make significant progress across our pipeline of innovative investigational medicines in EGFR-mutant and CDK2-vulnerable cancers. We look forward to sharing more about our strategic vision, including the opportunities we see in SM, EGFR-mutant lung cancer, and CDK2-vulnerable cancers, and how our expanding research platform will continue to drive innovation at an Investor Day on November 1, 2022 in New York, NY. With our strong revenue performance, a clinical-stage pipeline of five significant assets, and well over $1 billion in cash on our balance sheet as of today, we are uniquely positioned to drive near- and long-term value for all of our stakeholders by delivering transformative precision medicines to patients around the world."
Second Quarter 2022 Highlights and Recent Progress
AYVAKIT®/AYVAKYT® (avapritinib): systemic mastocytosis (SM) and PDGFRA gastrointestinal stromal tumor (GIST)
GAVRETO® (pralsetinib): RET-altered cancers
Corporate
Key Upcoming Milestones
The company plans to achieve the following near-term milestones:
Second Quarter 2022 Results
Financial Guidance
Blueprint Medicines anticipates approximately $180M to $200M in total revenues in 2022, including approximately $115M to $130M in AYVAKIT net product revenues. The company continues to expect that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss second quarter 2022 financial results and recent business activities. The conference call may be accessed by dialing 844-200-6205 (domestic) or 929-526-1599 (international), and referring to conference ID 694684. A webcast of the call will also 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
Blueprint Medicines is a global precision therapy company that invents life-changing therapies for people with cancer and blood disorders. Applying an approach that is both precise and agile, we create medicines that selectively target genetic drivers, with the goal of staying one step ahead across stages of disease. Since 2011, we have leveraged our research platform, including expertise in molecular targeting and world-class drug design capabilities, to?rapidly and reproducibly translate science into a broad pipeline of precision therapies. Today, we are delivering approved medicines directly to patients in the United States and Europe, and we are globally advancing multiple programs for systemic mastocytosis, lung cancer and other genomically defined cancers, and cancer immunotherapy. For more information, visit www.BlueprintMedicines.com and follow us on Twitter (@BlueprintMeds) and LinkedIn.
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, strategies, timelines and expectations for interactions with the FDA and other regulatory authorities; plans and timelines to update the primary endpoint of the registrational PIONEER trial of AYVAKIT in patients with non-advanced SM; expectations regarding the potential benefits of AYVAKIT in treating patients with non-advanced SM; and the potential benefits of Blueprint Medicines' collaborations and strategic financing transactions; and Blueprint Medicines' financial performance, 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 plans in continuing to establish and expand a commercial infrastructure, and successfully launching, marketing and selling current or future approved products; Blueprint Medicines' ability to successfully expand the approved indications for AYVAKIT/AYVAKYT and GAVRETO or obtain marketing approval for AYVAKIT/AYVAKYT in additional geographies in the future; the delay of any current or planned clinical trials or the development of Blueprint Medicines' current or future drug candidates; 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 either as monotherapies or in combination with other agents or may impact the anticipated timing of data or regulatory submissions; the timing of the initiation of clinical trials and trial cohorts at clinical trial sites and patient enrollment rates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines' ability to obtain, maintain and enforce patent and other intellectual property protection for AYVAKIT/AYVAKYT, GAVRETO or any drug candidates it is developing; Blueprint Medicines' ability to develop and commercialize companion diagnostic tests for AYVAKIT/AYVAKYT, GAVRETO or any of its current and future drug candidates; Blueprint Medicines' ability to successfully expand its operations, research platform and portfolio of therapeutic candidates, and the timing and costs thereof; Blueprint Medicines' ability to realize the anticipated benefits of its executive leadership transition plan; and the success of Blueprint Medicines' current and future collaborations, financing arrangements, partnerships 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.
Trademarks
Blueprint Medicines, AYVAKIT, AYVAKYT, GAVRETO and associated logos are trademarks of Blueprint Medicines Corporation.
Blueprint Medicines Corporation | ||||||
Selected Condensed Consolidated Balance Sheet Data | ||||||
(in thousands) | ||||||
(unaudited) | ||||||
June 30, | December 31, | |||||
2022 | 2021 | |||||
Cash, cash equivalents and investments | $ | 947,159 | $ | 1,034,643 | ||
Working capital (1) | 793,419 | 404,260 | ||||
Total assets | 1,192,446 | 1,252,225 | ||||
Deferred revenue (2) | 22,139 | 36,576 | ||||
Liability related to the sale of future royalties (2) | 171,254 | - | ||||
Total liabilities | 444,696 | 281,490 | ||||
Total stockholders' equity | 747,750 | 970,735 |
(1) Blueprint defines working capital as current assets less current liabilities. (2) Includes both current and long-term portions of the balance |
Blueprint Medicines Corporation | ||||||||||||||||||||
Condensed Consolidated Statements of Operations Data | ||||||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
(unaudited) | ||||||||||||||||||||
Three Months Ended, June 30 | Six Months Ended, June 30 | |||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Revenues: | ||||||||||||||||||||
Product revenue, net | $ | 28,454 | $ | 11,433 | $ | 52,295 | $ | 20,388 | ||||||||||||
Collaboration revenue | 8,093 | 15,862 | 46,983 | 28,483 | ||||||||||||||||
Total revenues | 36,547 | 27,295 | 99,278 | 48,871 | ||||||||||||||||
Cost and operating expenses: | ||||||||||||||||||||
Cost of sales | 4,886 | 6,493 | 9,964 | 6,595 | ||||||||||||||||
Collaboration loss sharing | 2,145 | ---- | 5,410 | ---- | ||||||||||||||||
Research and development | 128,466 | 80,027 | 231,599 | 159,738 | ||||||||||||||||
Selling, general and administrative | 58,688 | 49,286 | 115,747 | 91,288 | ||||||||||||||||
Total cost and operating expenses | $ | 194,185 | 135,806 | 362,720 | 257,621 | |||||||||||||||
Other income (expense): | ||||||||||||||||||||
Interest income (expense), net | 427 | 633 | 869 | 1,371 | ||||||||||||||||
Other income (expense), net | 632 | (373) | 177 | (587) | ||||||||||||||||
Total other income (expense) | $ | 1,059 | 260 | 1,046 | 784 | |||||||||||||||
Loss before income taxes | $ | (156,579) | (108,251) | (262,396) | (207,966) | |||||||||||||||
Income tax expense | (3,130) | (193) | (3,313) | (193) | ||||||||||||||||
Net loss | $ | (159,709) | $ | (108,444) | $ | (265,709) | $ | (208,159) | ||||||||||||
Net loss per share ? basic and diluted | $ | (2.68) | $ | (1.86) | $ | (4.47) | $ | (3.58) | ||||||||||||
Weighted-average number of common shares used in net loss per share ? basic and diluted | 59,617 | 58,406 | 59,465 | 58,216 | ||||||||||||||||
SOURCE Blueprint Medicines Corporation
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