Full Press Release Details
-- Achieved $204.0 million in total revenues in 2022, including $111.0 million in AYVAKIT®/AYVAKYT® (avapritinib) net product revenues --
-- Continued progress toward regulatory approvals of AYVAKIT/AYVAKYT for indolent systemic mastocytosis, with FDA granting priority review of a supplemental new drug application and EMA validating a type II variation marketing authorization application --
-- Positive data from PIONEER trial of AYVAKIT in indolent systemic mastocytosis to be presented at the AAAAI Annual Meeting --
CAMBRIDGE, Mass. , Feb. 16, 2023 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC ) today reported financial results and provided a business update for the fourth quarter and full year ended December 31, 2022 .
Fourth Quarter 2022 Highlights and Recent Progress
Systemic mastocytosis
EGFR-driven non-small cell lung cancer (NSCLC)
CDK2-vulnerable breast and other cancers
Key Upcoming Milestones
The company plans to achieve the following milestones by mid-2023:
Fourth Quarter and Year End 2022 Results
2023 Financial Guidance
Blueprint Medicines today announced it anticipates approximately $130 million to $140 million in AYVAKIT net product revenues for advanced SM and GIST in 2023, and $40 million to $50 million in collaboration revenues from existing collaborations. This guidance excludes revenue from the anticipated AYVAKIT indication expansion in ISM in mid-2023. 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 fourth quarter and full year 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 286085. 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.
Upcoming Investor Conferences
Blueprint Medicines will participate in two upcoming investor conferences:
A live webcast of each presentation will be available by visiting the Investors & Media section of Blueprint Medicines' website at http://ir.blueprintmedicines.com . A replay of the webcasts will be archived on Blueprint Medicines' website for 30 days following each presentation.
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, strategies, timelines and expectations for Blueprint Medicines' current or future approved drugs and drug candidates, including approvals and launches, the initiation of clinical trials or the results of ongoing and planned clinical trial; Blueprint Medicines' plans, strategies and timelines to nominate development candidates; timelines and expectations for interactions with the FDA and other regulatory authorities; statements regarding the plans and potential benefits of AYVAKIT in treating patients with indolent SM; statements regarding plans and expectations for Blueprint Medicines' current or future approved drugs and drug candidates; the potential benefits of any of Blueprint Medicines' current or future approved drugs or drug candidates in treating patients; 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: the risk the partial clinical hold may or may not be resolved in a timely manner; there may be additional adverse events observed that could impact the extent of the partial clinical hold or Blueprint Medicines' resolution of the partial clinical hold; there may be amendments to the trial protocol that impact the timing of the trial or evaluation of the data; preliminary activity and safety data may not be representative of more mature data; the COVID-19 pandemic may impact Blueprint Medicines' business, operations, strategy, goals and anticipated milestones, including ongoing and planned research and discovery activities, Blueprint Medicines' ability to conduct ongoing and planned clinical trials; the risk of delay of any current or planned clinical trials or the development of Blueprint Medicines' current or future drug candidates; risks related to 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; preclinical and clinical results for Blueprint Medicines' drug candidates 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 may be delayed or slower than anticipated; actions of regulatory agencies may affect the initiation, timing and progress of clinical trials; risks related to Blueprint Medicines' ability to obtain, maintain and enforce patent and other intellectual property protection for its products and current or future drug candidates it is developing; and the success of Blueprint Medicines' current and future collaborations, financing arrangements, partnerships or licensing arrangements. 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, AYVAKIT, AYVAKYT and associated logos are trademarks of Blueprint Medicines Corporation.
| Blueprint Medicines Corporation Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) | |||||
| (1) Blueprint Medicines defines working capital as current assets less current liabilities. | |||||
| December 31, | December 31, | ||||
| 2022 | 2021 | ||||
| Cash, cash equivalents and investments | $ | 1,078,472 | $ | 1,034,643 | |
| Working capital (1) | 863,417 | 404,260 | |||
| Total assets | 1,349,902 | 1,252,225 | |||
| Deferred revenue (2) | 18,291 | 36,576 | |||
| Liability related to the sale of future royalties and revenues (2) | 430,330 | - | |||
| Term loan (2) | 139,083 | - | |||
| Total liabilities | 835,225 | 281,490 | |||
| Total stockholders' equity | 514,677 | 970,735 |
| (1) | Blueprint Medicines 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 | Years Ended | |||||||||||
| December 31, | December 31, | |||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||
| Revenues: | ||||||||||||
| Product revenue, net | $ | 30,064 | $ | 20,029 | $ | 110,993 | $ | 57,687 | ||||
| Collaboration and License Revenue | 8,717 | 86,993 | 65,543 | 122,393 | ||||||||
| License Revenue – Related Party | -- | -- | 27,500 | -- | ||||||||
| Total revenues | $ | 38,781 | $ | 107,022 | $ | 204,036 | $ | 180,080 | ||||
| Cost and operating expenses: | ||||||||||||
| Cost of sales | 4,848 | 7,549 | 17,813 | 17,934 | ||||||||
| Collaboration loss sharing | 1,872 | 4,531 | 8,948 | 7,801 | ||||||||
| Research and development | 117,840 | 356,877 | 477,419 | 601,033 | ||||||||
| Selling, general and administrative | 64,019 | 54,199 | 237,374 | 195,293 | ||||||||
| Total cost and operating expenses | $ | 188,579 | $ | 423,156 | $ | 741,554 | $ | 822,061 | ||||
| Other income (expense): | ||||||||||||
| Interest income (expense), net | (9,240) | 463 | (16,767) | 2,386 | ||||||||
| Other income (expense), net | 1,435 | (381) | 2,004 | (1,489) | ||||||||
| Total other income (expense) | $ | (7,805) | $ | 82 | $ | (14,763) | $ | 897 | ||||
| Loss before income taxes | $ | (157,603) | $ | (316,052) | $ | (552,281) | $ | (641,084) | ||||
| Income tax expense | 1,036 | 2,635 | 5,236 | 3,001 | ||||||||
| Net loss | $ | (158,639) | $ | (318,687) | $ | (557,517) | $ | (644,085) | ||||
| Net loss per share applicable to common stockholders — basic | $ | (2.65) | $ | (5.40) | $ | (9.35) | $ | (11.01) | ||||
| Net loss per share applicable to common stockholders —diluted | $ | (2.65) | $ | (5.40) | $ | (9.35) | $ | (11.01) | ||||
| Weighted-average number of common shares used in net loss per share applicable to common stockholders — basic | 59,873 | 58,985 | 59,642 | 58,518 | ||||||||
| Weighted-average number of common shares used in net loss per share applicable to common stockholders —diluted | 59,873 | 58,985 | 59,642 | 58,518 |
SOURCE Blueprint Medicines Corporation