Blueprint Medicines Reports Third Quarter 2024 Results and Raises AYVAKIT®/AYVAKYT® (avapritinib) Full Year Revenue Guidance
-- Achieved
-- Raising AYVAKIT net product revenue guidance to
-- On track to initiate the registration-enabling HARBOR Part 2 study of elenestinib in ISM by year end --
"With another strong quarter of AYVAKIT revenue performance, our year-to-date results provide the foundation to drive significant growth and long-term shareholder value creation in 2025 and beyond. AYVAKIT's sales momentum has given us the confidence to raise our revenue expectations again this year, estimating that we will end the year between
Third Quarter 2024 Highlights and Recent Progress
Mast cell disorders
- Achieved AYVAKIT net product revenues of
$128.2 million for third quarter of 2024, including$113.1 million in the US and$15.1 million ex-US, representing 136 percent growth year-over-year. - Advanced the Phase 1 single ascending dose/multiple ascending dose healthy volunteer study of BLU-808, a highly selective and potent investigational oral wild-type KIT inhibitor, with best-in-class potential for chronic urticaria and other mast cell disorders. Data from the healthy volunteer study, including safety, pharmacokinetic and pharmacodynamic markers, are anticipated in early 2025.
- Presented data at the
American College of Allergy, Asthma and Immunology (ACAAI) conference demonstrating the efficacy of AYVAKIT in patients with moderate and severe indolent SM (ISM) at baseline, and showing the significant disease burden of SM, highlighting the urgency to diagnose and treat. Read the presentations here. - Hosting scientific seminar on mast cell franchise development with leading allergy and asthma expert Dr.
Paul O'Byrne onThursday, November 14, 2024 .
2024 Financial Guidance
Key Upcoming Milestones
The company plans to achieve the following remaining milestones by the end of 2024:
Mast cell disorders
- Initiate registration-enabling Part 2 of the HARBOR trial of elenestinib in ISM by the end of this year.
Cell cycle inhibition
- Continue strategic business development discussions.
- Complete Phase 1 combination dose escalation for BLU-222 by end of year to inform registration plans.
Third Quarter 2024 Results
-
Revenues: Revenues were
$128.2 million for the third quarter of 2024 generated from the net product sales of AYVAKIT/AYVAKYT. Revenues were$56.6 million in the third quarter of 2023, including$54.2 million of net product revenues from sales of AYVAKIT/AYVAKYT and$2.4 million in collaboration, license and other revenues. -
Cost of Sales: Cost of sales was
$1.9 million for the third quarter of 2024, as compared to$2.8 million for the third quarter of 2023. The decrease was primarily due to lower sales to our collaboration partner in greaterChina . -
R&D Expenses: Research and development expenses were
$85.3 million for the third quarter of 2024, as compared to$110.3 million for the third quarter of 2023. This decrease was primarily due to operational efficiency 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$12.6 million in stock-based compensation expenses for the third quarter of 2024. -
SG&A Expenses: Selling, general and administrative expenses were
$89.9 million for the third quarter of 2024, as compared to$70.7 million for the third quarter of 2023. This increase was primarily due to an increase in activities supporting the commercialization of AYVAKIT/AYVAKYT. Selling, general, and administrative expenses included$15.7 million in stock-based compensation expenses for the third quarter of 2024. -
Net Loss: Net loss was
$56.3 million for the third quarter of 2024, as compared to a net loss of$133.7 million for the third quarter of 2023. -
Cash Position: As of
September 30, 2024 , cash, cash equivalents and investments were$882.4 million , as compared to$767.2 million as ofDecember 31, 2023 .Blueprint Medicines' cash and investments provide a durable capital position which, together with anticipated product revenues, the company believes will enable it to reach a self-sustainable financial profile.
Conference Call Information
Upcoming Investor Conferences
-
Guggenheim Inaugural Healthcare Innovation Conference onTuesday, November 12, 2024 at3:30 p.m. ET . -
Stifel 2024 Healthcare Conference on
Monday, November 18, 2024 at10:20 a.m. ET . -
Jefferies London Healthcare Conference onThursday, November 21, 2024 at 12:00noon GMT .
Scientific Webinar Series
-
Blueprint Medicines will host the second event in its scientific seminar series, focused on mast cell diseases, onThursday, November 14 th at10:00 a.m. ET .
A live webcast of the above presentations and any related slides will be available under "Events and Presentations" in the Investors & Media section of the
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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2024 |
|
2023 |
|
Cash, cash equivalents and investments |
$ |
882,353 |
|
$ |
767,171 |
Working capital (1) |
|
597,187 |
|
|
593,470 |
Total assets |
|
1,199,649 |
|
|
1,049,250 |
Deferred revenue (2) |
|
12,034 |
|
|
5,604 |
Liability related to the sale of future royalties and revenues (2) |
|
261,207 |
|
|
441,625 |
Term loan (2) |
|
386,569 |
|
|
238,813 |
Total liabilities |
|
886,501 |
|
|
918,641 |
Total stockholders' equity |
|
313,148 |
|
|
130,609 |
|
(1) Blueprint Medicines defines working capital as current assets less current liabilities. |
(2) Includes both current and long-term portions of the balance. |
Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) |
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Three Months Ended |
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Nine Months Ended |
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2024 |
|
2023 |
|
2024 |
|
2023 |
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Revenues: |
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|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
128,184 |
|
$ |
54,228 |
|
$ |
334,825 |
|
$ |
133,173 |
Collaboration, license and other revenue |
|
|
— |
|
|
2,338 |
|
|
27,633 |
|
|
44,250 |
Total revenues |
|
|
128,184 |
|
|
56,566 |
|
|
362,458 |
|
|
177,423 |
Cost and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
|
1,932 |
|
|
2,782 |
|
|
12,716 |
|
|
8,280 |
Collaboration loss sharing |
|
|
— |
|
|
1,771 |
|
|
— |
|
|
4,301 |
Research and development |
|
|
85,300 |
|
|
110,252 |
|
|
257,761 |
|
|
330,184 |
Selling, general and administrative |
|
|
89,926 |
|
|
70,741 |
|
|
262,822 |
|
|
215,826 |
Total cost and operating expenses |
|
|
177,158 |
|
|
185,546 |
|
|
533,299 |
|
|
558,591 |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(7,616) |
|
|
(3,808) |
|
|
(20,376) |
|
|
(13,624) |
Other income (expense), net |
|
|
587 |
|
|
(728) |
|
|
962 |
|
|
(369) |
Debt extinguishment gain |
|
|
— |
|
|
— |
|
|
173,676 |
|
|
— |
Total other income (expense), net |
|
|
(7,029) |
|
|
(4,536) |
|
|
154,262 |
|
|
(13,993) |
Loss before income taxes |
|
|
(56,003) |
|
|
(133,516) |
|
|
(16,579) |
|
|
(395,161) |
Income tax expense |
|
|
273 |
|
|
197 |
|
|
554 |
|
|
907 |
Net Loss |
|
$ |
(56,276) |
|
$ |
(133,713) |
|
$ |
(17,133) |
|
$ |
(396,068) |
Net Loss per share — basic and diluted |
|
$ |
(0.89) |
|
$ |
(2.20) |
|
$ |
(0.27) |
|
$ |
(6.55) |
Weighted-average number of common |
|
|
63,381 |
|
|
60,688 |
|
|
62,608 |
|
|
60,445 |
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