Blueprint Medicines Reports Third Quarter 2020 Financial Results
"Following our tremendous progress in the third quarter,
Third Quarter 2020 Highlights and Recent Updates
AYVAKIT (avapritinib): systemic mastocytosis (SM)
- Announced positive top-line results from the Phase 1 EXPLORER and Phase 2 PATHFINDER clinical trials of AYVAKIT in patients with advanced SM. Consistent with previously reported EXPLORER trial results, the data showed profound reductions in mast cell burden, high overall response and complete remission rates, and durable clinical benefit, including prolonged median overall survival. AYVAKIT was generally well-tolerated, with an improved safety profile at the 200 mg once daily dose. Read the press release here.
AYVAKIT/AYVAKYT (avapritinib): gastrointestinal stromal tumor (GIST)
- Recorded
$6.1 million in net product revenue during the third quarter of 2020 for AYVAKIT, which was approved by theU.S. Food and Drug Administration (FDA) inJanuary 2020 for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. Received European Commission (EC) conditional marketing authorization for avapritinib under the brand name AYVAKYT as a monotherapy for the treatment of adult patients with unresectable or metastatic GIST harboring the PDGFRA D842V mutation and initiated the first commercial launch following EC approval inGermany . Read the press release here.
GAVRETO (pralsetinib): RET-altered cancers
- Received FDA approval of GAVRETO for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test and launched GAVRETO together with
Genentech , a member of the Roche Group, in theU.S. in September. Read the press release here. 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 ongoing ARROW clinical trial of GAVRETO in advanced RET-mutant medullary thyroid cancer (MTC) at the
European Society for Medical Oncology (ESMO) Virtual Congress 2020. The data showed durable responses and a well-tolerated safety profile for GAVRETO in patients with advanced RET-mutant MTC, with consistent clinical activity in patients across lines of therapy and regardless of RET mutation genotypes. Read the press release here. - Announced acceptance of
U.S. marketing application for GAVRETO for the treatment of patients with advanced or metastatic RET-mutant MTC and RET fusion-positive thyroid cancer. The FDA accepted the new drug application (NDA) for priority review under its Real-Time Oncology Review (RTOR) pilot program, and set an action date ofFebruary 28, 2021 under the Prescription Drug User Fee Act.
BLU-945: EGFR-mutated NSCLC
- Reported preclinical proof-of-concept data for BLU-945 at the
ESMO Virtual Congress 2020. The data showed BLU-945 potently and selectively inhibited triple-mutant epidermal growth factor receptor (EGFR) harboring the most common on-target resistance mutations to standard treatments for EGFR-mutated NSCLC, resulting in robust anti-tumor activity in multiple lung cancer models. Read the press release here. - Announced plans to develop BLU-945 as a monotherapy and in combination with other agents for the treatment of patients with treatment-resistant EGFR NSCLC.
Corporate:
- Strengthened the company's leadership team with the appointment of Fouad Namouni, M.D., as President, Research & Development. In this new role, Dr. Namouni leads a joint research and development organization, overseeing all phases of product development from discovery through global registration under a unified portfolio vision.
Key Upcoming Milestones
The company expects to achieve the following near-term milestones:
- Submit a supplemental new drug application to the FDA for avapritinib for the treatment of patients with advanced SM in the fourth quarter of 2020.
- Obtain
U.S. approval of GAVRETO for RET-altered thyroid cancers in the first quarter of 2021. - Initiate a global Phase 1 dose-escalation trial for BLU-945 in EGFR-mutated NSCLC in the first half of 2021.
Third Quarter 2020 Financial Results
- Revenues: Revenues were $745.1 million for the third quarter of 2020, including $6.1 million of net product revenues from sales of AYVAKIT,
$0.2 million of net product revenues from sales of GAVRETO and $738.8 million in collaboration revenues under the collaboration agreements with Roche and CStone. Blueprint Medicines recorded $9.1 million in collaboration revenues for the third quarter of 2019. - Cost of Sales: Cost of sales was
$0.1 million for the third quarter of 2020. Blueprint Medicines did not incur cost of sales in the third quarter of 2019, as no product sales were generated during that period. - R&D Expenses: Research and development expenses were $74.2 million for the third quarter of 2020, as compared to $81.5 million for the third quarter of 2019. This decrease was primarily due to reimbursement from the global development cost sharing arrangement under the collaboration agreement with Roche for pralsetinib. Research and development expenses included $8.6 million in stock-based compensation expenses for the third quarter of 2020.
- SG&A Expenses: Selling, general and administrative expenses were $37.4 million for the third quarter of 2020, as compared to $25.6 million for the third quarter of 2019. This increase was primarily due to an increase in costs and personnel expenses associated with building
Blueprint Medicines' commercial infrastructure for commercialization of AYKAKIT and GAVRETO, partially offset by reimbursement for Roche's share of the loss generated from the commercialization of GAVRETO in theU.S. under the collaboration for pralsetinib. Selling, general and administrative expenses included $11.0 million in stock-based compensation expenses for the third quarter of 2020. - Net Income (Loss): Net income was $634.0 million for the third quarter of 2020, or a diluted net income per share of $11.16, as compared to a net loss of $94.3 million for the third quarter of 2019, or a diluted net loss per share of $1.93.
- Cash Position: As of
September 30, 2020 , cash, cash equivalents and investments were$1,355 .9 million, as compared to$548.0 million as ofDecember 31, 2019 . This increase was primarily related to upfront payments of$775.0 million received in the third quarter of 2020 underBlueprint Medicines' collaboration with Roche and$308.4 million in net proceeds received fromBlueprint Medicines' January 2020 follow-on underwritten public offering, partially offset by cash used in operating activities.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2020 financial results and recent business activities. The conference call may be accessed by dialing (855) 728-4793 (domestic) or (503) 343-6666 (international), and referring to conference ID 2995408. A webcast of the call will 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.
Blueprint Medicines will participate in the
About Blueprint Medicines
Blueprint Medicines is a precision therapy company striving to improve human health. With a focus on genomically defined cancers, rare diseases and cancer immunotherapy, we are developing transformational medicines rooted in our leading expertise in protein kinases, which are proven drivers of disease. Our uniquely targeted, scalable approach empowers the rapid design and development of new treatments and increases the likelihood of clinical success. We have two approved precision therapies and are currently advancing multiple investigational medicines in clinical and pre-clinical development, along with a number of earlier-stage research programs. 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 the plans, strategies, timelines and expectations of
Trademarks
Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) |
|||||
|
|
||||
2020 |
2019 |
||||
Cash, cash equivalents and investments |
$ |
1,355,900 |
$ |
547,960 |
|
Working capital (1) |
731,547 |
410,304 |
|||
Total assets |
1,558,178 |
707,694 |
|||
Deferred revenue |
45,408 |
46,073 |
|||
Total liabilities |
238,178 |
243,335 |
|||
Total stockholders' equity |
1,320,000 |
464,359 |
|||
(1) Blueprint Medicines 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 |
|||||||
|
|||||||
2020 |
2019 |
||||||
Revenues: |
|||||||
Product revenue, net |
$ |
6,308 |
$ |
— |
|||
Collaboration revenue |
738,810 |
9,139 |
|||||
Total revenues |
745,118 |
9,139 |
|||||
Cost and operating expenses: |
|||||||
Cost of sales |
146 |
— |
|||||
Research and development |
74,230 |
81,453 |
|||||
Selling, general and administrative |
37,375 |
25,647 |
|||||
Total cost and operating expenses |
111,751 |
107,100 |
|||||
Other income (expense): |
|||||||
Interest income, net |
1,173 |
3,758 |
|||||
Other income (expense), net |
(192) |
(72) |
|||||
Total other income |
981 |
3,686 |
|||||
Income (loss) before income taxes |
634,348 |
(94,275) |
|||||
Income tax expense |
370 |
— |
|||||
Net income (loss) |
$ |
633,978 |
$ |
(94,275) |
|||
Net income (loss) per share — basic |
$ |
11.49 |
$ |
(1.93) |
|||
Net income (loss) per share – diluted |
$ |
11.16 |
$ |
(1.93) |
|||
Weighted-average number of common shares used in |
55,169 |
48,921 |
|||||
Weighted-average number of common shares used in |
56,786 |
48,921 |
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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