On August 2, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported financial results and provided a business update for the second quarter ended June 30, 2023 (Press release, Blueprint Medicines, AUG 2, 2023, View Source [SID1234633640]).
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"We have entered a new era at Blueprint with the launch of AYVAKIT in indolent systemic mastocytosis. In the second quarter, we delivered strong growth in AYVAKIT revenue and patients on therapy, reinforcing our belief in the blockbuster potential for AYVAKIT in systemic mastocytosis," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "We also achieved important regulatory and operational milestones, including multiple readouts from our pipeline at ASCO (Free ASCO Whitepaper) and the nomination of a selective and potent inhibitor of wild-type KIT which leverages our expertise and infrastructure as we build a franchise in mast cell driven diseases. Our year-to-date achievements fortify our strong foundation for near- and long-term growth."
Second Quarter 2023 Highlights and Recent Progress
Systemic mastocytosis (SM) and other mast cell disorders
● Announced that the U.S. Food and Drug Administration (FDA) approved AYVAKIT (avapritinib), the first and only medicine approved for the treatment of adults with indolent systemic mastocytosis (ISM) and the only treatment approved across the spectrum of indolent and advanced SM. Read the press release here.
● Published detailed results from the PIONEER study in New England Journal of Medicine (NEJM) Evidence. Key results demonstrate that AYVAKIT achieved statistically significant and clinically meaningful benefits in overall symptoms and objective measures of mast cell burden compared to placebo at 24 weeks, with improvements deepening through 48 weeks. Data also show meaningful improvements in quality-of-life measurements. AYVAKIT showed a favorable safety profile compared to placebo. Read the press release here.
● Announced nomination of BLU-808, an oral, highly potent and selective wild-type KIT inhibitor with first- and best-in-class potential, as a development candidate for the treatment of mast cell disorders, including chronic urticaria.
Cancers vulnerable to CDK2 inhibition
● Presented monotherapy dose escalation data from the Phase 1/2 VELA trial of BLU-222 in patients with cancers vulnerable to CDK2 inhibition at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results showed evidence of favorable safety, cell cycle modulation and clinical response, supporting initiation of combination dose escalation of BLU-222 with ribociclib and fulvestrant in patients with hormone receptor-positive/HER2-negative breast cancer. Find the poster here.
EGFR-driven non-small cell lung cancer (NSCLC)
BLU-945
● Presented dose escalation data from the Phase 1/2 SYMPHONY study of BLU-945 in patients with late-line EGFR-driven NSCLC at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. BLU-945 monotherapy and in combination with osimertinib showed evidence of clinical activity and was generally well tolerated, with infrequent adverse events associated with wild-type EGFR inhibition, supporting continued combination dose escalation. Find the poster here.
BLU-451
● Presented dose escalation data from the Phase 1/2 CONCERTO study of BLU-451 in patients with NSCLC driven by EGFR exon 20 insertions and atypical mutations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. Results showed evidence of safety and clinical benefit, including central nervous system activity, supporting continued dose escalation. Find the poster here.
Key Upcoming Milestones
Blueprint Medicines plans to achieve the following milestones by the end of 2023:
● Present data from Part 1 of the HARBOR trial of elenestinib in indolent SM.
● Continue AYVAKIT commercial launch execution in SM.
Second Quarter 2023 Results
● Revenues: Revenues were $57.6 million for the second quarter of 2023, including $39.9 million of net product revenues from sales of AYVAKIT/AYVAKYT and $17.7 million in collaboration revenues. Blueprint Medicines recorded revenues of $36.5 million in the second quarter of 2022, including $28.5 million of net product revenues from sales of AYVAKIT/AYVAKYT and $8.0 million in collaboration revenues.
● Cost of Sales: Cost of sales was $2.3 million for the second quarter of 2023, as compared to $4.9 million for the second quarter of 2022. The decrease was primarily due to a decrease in the cost of collaboration-related sales.
● R&D Expenses: Research and development expenses were $110.1 million for the second quarter of 2023, as compared to $128.5 million for the second quarter of 2022. This decrease was primarily due to continued operational efficiency gains across our portfolio as we execute across our top priority programs and the timing of manufacturing of clinical trial materials. Research and development expenses included $10.2 million in stock-based compensation expenses for the second quarter of 2023.
● SG&A Expenses: Selling, general and administrative expenses were $71.9 million for the second quarter of 2023, as compared to $58.7 million for the second quarter of 2022. This increase was primarily due to an increase in compensation and personnel related costs driven by our first quarter field force expansion to support the AYVAKIT launch in ISM. Selling, general, and administrative expenses included $13.6 million in stock-based compensation expenses for the second quarter of 2023.
● Net Loss: Net loss was $132.8 million for the second quarter of 2023, or a net loss per share of $2.19, as compared to a net loss of $159.7 million for the second quarter of 2022, or a net loss per share of $2.68.
● Cash Position: As of June 30, 2023, cash, cash equivalents and investments were $836.6 million, as compared to $1,078.5 million as of December 31, 2022.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss second quarter 2023 financial results and recent business activities. The conference call may be accessed by dialing 833-470-1428 (domestic) or 929-526-1599 (international), and referring to conference ID 669158. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source 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 one upcoming investor conference:
● Morgan Stanley 21st Annual Global Healthcare Conference on Monday, September 11, 2023 at 11:20 a.m. ET.
A live webcast of each presentation will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcasts will be archived on Blueprint Medicines’ website for 30 days following each presentation.