Blueprint Medicines Reports Second Quarter 2021 Financial Results
"In the second quarter, we achieved one of our foundational corporate goals, securing
Second Quarter 2021 Highlights and Recent Progress
AYVAKIT™/AYVAKYT® (avapritinib): systemic mastocytosis (SM) and gastrointestinal stromal tumor (GIST)
- Recorded
$8.5 million in net product revenue during the second quarter of 2021 for AYVAKIT/AYVAKYT, which was approved by theU.S. Food and Drug Administration (FDA) inJune 2021 for the treatment of adult patients with advanced systemic mastocytosis (Advanced SM), including aggressive SM (ASM), SM with an associated hematologic neoplasm (SM-AHN) and mast cell leukemia (MCL). Read the press release announcing the expansion of the FDA label for AYVAKIT into advanced SM here. AYVAKIT received its initial approval from the FDA in 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. Please click here to see the full Prescribing Information for AYVAKIT and visit www.AYVAKIT.com for more information on AYVAKIT.
GAVRETO® (pralsetinib): RET-altered cancers
- Recorded
$2.9 million in net product revenue during the second quarter of 2021 for GAVRETO, which was approved by the FDA inSeptember 2020 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test and inDecember 2020 for the treatment of patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer. Blueprint Medicines is commercializing GAVRETO in the U.S. together with Genentech, Inc., a member of the Roche Group. Please click here to see the full Prescribing Information for GAVRETO and visit www.GAVRETO.com for more information on GAVRETO. - Reported updated data from the Phase 1/2 ARROW clinical trial of GAVRETO in metastatic RET fusion-positive NSCLC and other advanced solid tumors at the 2021
American Society of Clinical Oncology (ASCO) Annual Meeting. The data showed high response rates to GAVRETO in treatment-naïve patients with RET fusion-positive NSCLC, clinical activity across a number of RET fusion-positive tumor types and a safety profile consistent with previously reported results. Read the press release here.
BLU-263: SM
- Initiated the HARBOR trial, a randomized, double-blind, placebo-controlled Phase 2/3 trial in non-advanced SM.
BLU-945: treatment-resistant EGFR-driven NSCLC
- Initiated the global Phase 1/2 trial of BLU-945 in patients with treatment-resistant EGFR-driven NSCLC.
BLU-222: Cyclin E-aberrant cancers
- Announced a strategic research collaboration with
The University of Texas MD Anderson Cancer Center focused on accelerating development of BLU-222, an investigational precision therapy designed to target cyclin-dependent kinase 2 (CDK2). Read the press release here.
Corporate:
- Announced the appointment of
Percy Carter , MBA, Ph.D., as Chief Scientific Officer. In this role,Dr. Carter oversees all research and preclinical development. Read the press release here.
Key Upcoming Milestones
The company expects to achieve the following near-term milestones:
- Present preclinical data supporting combination of BLU-945 and BLU-701 in treatment-naïve EGFR-driven NSCLC in the second half of 2021.
- Initiate a Phase 1 trial of BLU-701 in patients with treatment-resistant EGFR-driven NSCLC in the second half of 2021.
- Initiate a Phase 1 trial of BLU-222, a CDK2 inhibitor targeting cyclin-E aberrant cancers, in the first half of 2022.
- Disclose topline data for the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced systemic mastocytosis in mid-2022.
Second Quarter 2021 Financial Results
- Revenues: Revenues were $27.3 million for the second quarter of 2021, including
$8.5 million of net product revenues from sales of AYVAKIT/AYVAKYT,$2.9 million of net product sales from GAVRETO and $15.9 million in collaboration revenues. Blueprint recorded revenues of$8.3 million in the second quarter of 2020, including$5.7 million of net product revenues from sales of AYVAKIT and$2.7 million in collaboration revenues. The increase in net product revenues was driven by increased sales quantity and the increase in collaboration revenues was primarily driven by the sales of drug substance and drug product to our collaboration partners. - Cost of Sales: Cost of sales was
$6.5 million for the second quarter of 2021, as compared to$0.1 million for the second quarter of 2020. Cost of sales includes manufacturing costs associated with our products sales as well as costs associated with the sale of drug product to our collaboration partners. The increase in costs of product sales was primarily driven by the lower margin product sales to our collaboration partners during the second quarter of 2021. - R&D Expenses: Research and development expenses were $80.0 million for the second quarter of 2021, as compared to
$91.1 million for the second quarter of 2020. This decrease was primarily due to decreased expenses associated with clinical supply manufacturing activities and reimbursement from the global development cost sharing arrangement under our collaboration with Roche for pralsetinib, partially offset by increased costs related to early discovery activities. Research and development expenses included $10.5 million in stock-based compensation expenses for the second quarter of 2021. - SG&A Expenses: Selling, general and administrative expenses were $49.3 million for the second quarter of 2021, as compared to
$42.2 million for the second quarter of 2020. This increase was primarily due to increased costs associated with building our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT and GAVRETO, partially offset by reimbursement under our collaboration with Roche for pralsetinib. General and administrative expenses included $13.8 million in stock-based compensation expenses for the second quarter of 2021. - Net Loss: Net loss was $108.4 million for the second quarter of 2021, or a net loss per share of $1.86, as compared to a net loss of $123.5 million for the second quarter of 2020, or a net loss per share of
$2.28 . - Cash Position: As of
June 30, 2021 , cash, cash equivalents and investments were$1,380.1 million , as compared to$1,549.7 million as ofDecember 31, 2020 .
Conference Call Information
About Blueprint Medicines
Blueprint Medicines is a global precision therapy company that invents life-changing medicines for people with cancer and hematologic disorders. Applying an approach that is both precise and agile, we create therapies 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 our approved medicines to patients in the United States and Europe, and we are globally advancing multiple programs for genomically defined cancers, systemic mastocytosis, 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
Trademarks
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|
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2021 |
2020 |
|||||
Cash, cash equivalents and investments |
$ |
1,380,051 |
$ |
1,549,722 |
||
Working capital (1) |
578,673 |
796,957 |
||||
Total assets |
1,568,795 |
1,718,393 |
||||
Deferred revenue |
38,277 |
41,158 |
||||
Total liabilities |
239,991 |
248,305 |
||||
Total stockholders' equity |
1,328,804 |
1,470,088 |
||||
(1) Blueprint defines working capital as current assets less current liabilities. |
Condensed Consolidated Statements of Operations Data (in thousands, except per share data) (unaudited) |
|||||||||||
Three Months Ended |
Six Months Ended |
||||||||||
|
|
||||||||||
2021 |
2020 |
2021 |
2020 |
||||||||
Revenues: |
|||||||||||
Product revenue, net |
$ |
11,433 |
$ |
5,680 |
$ |
20,388 |
$ |
9,138 |
|||
Collaboration revenue |
15,862 |
2,663 |
28,483 |
5,372 |
|||||||
Total revenues |
27,295 |
8,343 |
48,871 |
14,510 |
|||||||
Cost and operating expenses: |
|||||||||||
Cost of sales |
6,493 |
127 |
6,595 |
150 |
|||||||
Research and development |
80,027 |
91,079 |
159,738 |
175,225 |
|||||||
Selling, general and administrative |
49,286 |
42,174 |
91,288 |
77,829 |
|||||||
Total cost and operating expenses |
135,806 |
133,380 |
257,621 |
253,204 |
|||||||
Other income (expense): |
|||||||||||
Interest income, net |
633 |
1,586 |
1,371 |
4,490 |
|||||||
Other expense, net |
(373) |
(23) |
(587) |
(224) |
|||||||
Total other income |
260 |
1,563 |
784 |
4,266 |
|||||||
Loss before income taxes |
(108,251) |
(123,474) |
(207,966) |
(234,428) |
|||||||
Income tax expense |
(193) |
— |
(193) |
— |
|||||||
Net loss |
$ |
(108,444) |
$ |
(123,474) |
$ |
(208,159) |
$ |
(234,428) |
|||
Net loss per share — basic and diluted |
$ |
(1.86) |
$ |
(2.28) |
$ |
(3.58) |
$ |
(4.39) |
|||
Weighted-average number of common shares used in net loss per share — basic and diluted |
58,406 |
54,217 |
58,216 |
53,436 |
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SOURCE
Investor and Media Contact: Geoffrey M. Grande, CFA, 617-871-1563, media@blueprintmedicines.com; Investor Contact: Kristin Hodous, 617-714-6674, ir@blueprintmedicines.com