Blueprint Medicines Reports First Quarter 2023 Results
-- Achieved
-- Raising 2023 AYVAKIT net product revenue guidance to
-- FDA target action date for AYVAKIT supplemental new drug application for indolent SM is
"Our first quarter was marked by executional progress across the multiple growth opportunities that
First Quarter 2023 Highlights and Recent Progress
Systemic mastocytosis (SM)
- Presented full registrational PIONEER trial data for AYVAKIT in patients with indolent systemic mastocytosis (ISM) at the 2023
American Academy of Asthma , Allergy, and Immunology (AAAAI) Annual Conference. These data included a statistically significant and clinically meaningful improvement in total symptom score that deepened over time, with improvements shown across all individual symptoms and in quality-of-life measures. AYVAKIT showed a favorable safety profile compared to placebo, supporting potential for chronic treatment. Read the press release here. U.S. Food and Drug Administration (FDA) target action date for AYVAKIT supplemental new drug application for ISM isMay 22, 2023 .
EGFR-driven non-small cell lung cancer (NSCLC)
- Announced plans to present results from the ongoing dose escalation of the Phase 1/2 CONCERTO trial of BLU-451 in EGFR exon 20 insertion-positive NSCLC, showing early safety and clinical activity, at the 2023
American Society of Clinical Oncology (ASCO) Annual Meeting. - Announced plans to present updated results from the dose escalation of the Phase 1/2 SYMPHONY trial showing safety and tolerability of BLU-945 both as a monotherapy and in combination with osimertinib in late-line EGFR-driven NSCLC at the 2023 ASCO Annual Meeting.
- Presented real-world data showing that NSCLC patients with an EGFR L858R mutation have worse outcomes compared to patients with an EGFR exon 19 deletion mutation when treated with first-line osimertinib, and new preclinical data showing the combination of BLU-945 and osimertinib enhanced tumor regression and survival compared to osimertinib alone in a treatment-naïve EGFR L858R-mutant cell-derived model at the 2023
American Association for Cancer Research (AACR) Annual Meeting. Read the poster presentation here. - Today announced acceptance of an investigational new drug (IND) application to the FDA for BLU-525.
CDK2-vulnerable breast and other cancers
- Announced the FDA lifted the partial clinical hold on patient enrollment in the VELA trial of BLU-222. Patients already enrolled in the trial have continued on the study and trial sites are working to resume patient enrollment.
- Announced plans to present results from the ongoing dose escalation of the Phase 1/2 VELA trial of BLU-222 in breast cancer and other cancers vulnerable to CDK2 inhibition, showing evidence of monotherapy safety and pathway modulation, at the 2023 ASCO Annual Meeting.
Key Upcoming Milestones
The company plans to achieve the following milestones by mid-2023:
- Obtain FDA approval and initiate launch of AYVAKIT in ISM in mid-2023.
- Present initial CONCERTO trial dose escalation data in EGFR exon 20 NSCLC at ASCO 2023.
- Present initial VELA trial dose escalation data at ASCO 2023.
- Nominate a development candidate targeting wild-type KIT for chronic urticaria by mid-2023.
First Quarter 2023 Results
- Revenues: Revenues were
$63.3 million for the first quarter of 2023, including$39.1 million of net product revenues from sales of AYVAKIT/AYVAKYT and$24.2 million in collaboration revenues.Blueprint Medicines recorded revenues of$62.7 million in the first quarter of 2022, including$23.8 million of net product revenues from sales of AYVAKIT/AYVAKIT and$38.9 million in collaboration revenues. - Cost of Sales: Cost of sales was
$3.2 million for the first quarter of 2023, as compared to$5.1 million for the first quarter of 2022. - R&D Expenses: Research and development expenses were
$112.1 million for the first quarter of 2023, as compared to$103.1 million for the first quarter of 2022. This increase was primarily due to increased compensation related costs driven by increased headcount, along with increased costs related to early discovery efforts. Research and development expenses included$10.1 million in stock-based compensation expenses for the first quarter of 2023. - SG&A Expenses: Selling, general and administrative expenses were
$71.0 million for the first quarter of 2023, as compared to$57.1 million for the first quarter of 2022. This increase was primarily due to increased compensation related costs driven by increased headcount, along with increased costs associated with expanding our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT. Selling, general, and administrative expenses included$13.1 million in stock-based compensation expenses for the first quarter of 2023. - Net Loss: Net loss was
$129.6 million for the first quarter of 2023, or a net loss per share of$2.15 , as compared to a net loss of$106.0 million for the first quarter of 2022, or a net loss per share of$1.79 . - Cash Position: As of
March 31, 2023 , cash, cash equivalents and investments were$961.3 million , as compared to$1,078.5 million as ofDecember 31, 2022 .
2023 Financial Guidance
Conference Call Information
Upcoming Investor Conferences
- Goldman Sachs 44th Annual Global Healthcare Conference on
Wednesday, June 14, 2023 at12:20 pm ET .
A live webcast of each presentation will be available by visiting the Investors & Media section of
About
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
Trademarks
Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) |
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|
|
||||
2023 |
2022 |
||||
Cash, cash equivalents and marketable securities |
$ |
961,311 |
$ |
1,078,472 |
|
Working capital (1) |
727,660 |
863,417 |
|||
Total assets |
1,220,370 |
1,349,902 |
|||
Liability related to the sale of future royalties and revenues (2) |
434,593 |
430,330 |
|||
Term loan (2) |
139,512 |
139,083 |
|||
Deferred revenue |
8,740 |
18,291 |
|||
Total liabilities |
806,072 |
835,225 |
|||
Total stockholders' equity |
414,298 |
514,677 |
|||
(1) |
|||||
(2) Amount includes both current and non-current portions of the balances. |
Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) |
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Three Months Ended |
|||||||||||||||
|
|||||||||||||||
2023 |
2022 |
||||||||||||||
Revenues: |
|||||||||||||||
Product revenue, net |
$ |
39,069 |
$ |
23,841 |
|||||||||||
Collaboration revenue |
24,218 |
38,890 |
|||||||||||||
Total revenues |
63,287 |
62,731 |
|||||||||||||
Cost and operating expenses: |
|||||||||||||||
Cost of sales |
3,175 |
5,079 |
|||||||||||||
Collaboration loss sharing |
1,296 |
3,265 |
|||||||||||||
Research and development |
112,073 |
103,133 |
|||||||||||||
Selling, general and administrative |
70,950 |
57,058 |
|||||||||||||
Total cost and operating expenses |
187,494 |
168,535 |
|||||||||||||
Other income (expense): |
|||||||||||||||
Interest income (expense), net |
(5,819) |
442 |
|||||||||||||
Other income (expense), net |
986 |
(453) |
|||||||||||||
Total other expense, net |
(4,833) |
(11) |
|||||||||||||
Loss before income taxes |
(129,040) |
(105,815) |
|||||||||||||
Income tax expense |
520 |
184 |
|||||||||||||
Net loss |
$ |
(129,560) |
$ |
(105,999) |
|||||||||||
Net loss per share — basic and diluted |
$ |
(2.15) |
$ |
(1.79) |
|||||||||||
Weighted-average number of common shares used in net |
60,126 |
59,312 |
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SOURCE
Media Contact: Sarah Mena Guerrero, 617-714-6684, media@blueprintmedicines.com; Investor Contact: Jenna Cohen, 857-209-3147, ir@blueprintmedicines.com