On October 28, 2021 Blueprint Medicines Corporation (NASDAQ:BPMC) reported financial results and provided a business update for the third quarter ended September 30, 2021 (Press release, Blueprint Medicines, OCT 28, 2021, View Source [SID1234592092]).
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"We successfully executed across our entire portfolio in the third quarter, expanding the commercial adoption of AYVAKIT and GAVRETO and further advancing our next wave of therapeutic candidates toward potentially transformative proof-of-concept datasets," said Jeff Albers, Chief Executive Officer of Blueprint Medicines. "We are particularly encouraged by the launch momentum for AYVAKIT in advanced systemic mastocytosis, where we see broad prescriber demand across both academic and community centers and in patients regardless of prior therapy. In addition, we are pleased by the progress across our clinical portfolio, with topline data from the PIONEER trial of AYVAKIT in non-advanced systemic mastocytosis expected in mid-2022, strong patient interest fueling enrollment in the ongoing SYMPHONY trial of our EGFR inhibitor BLU-945, and multiple trial initiations on-track for the months ahead. Overall, this commercial and clinical progress across our portfolio, combined with the strength of our financial position and diversity of revenue, provides a robust foundation for growth and continuous innovation."
Third Quarter 2021 Highlights and Recent Progress
AYVAKIT/AYVAKYT (avapritinib): systemic mastocytosis (SM) and gastrointestinal stromal tumor (GIST)
Recorded $17.3 million in net product revenue during the third quarter of 2021, an increase of 104 percent over the second quarter, for AYVAKIT/AYVAKYT.
GAVRETO (pralsetinib): RET-altered cancers
Transferred responsibilities associated with the booking of U.S. product sales of GAVRETO to our collaboration partner Roche on July 1, 2021 and began to recognize the company’s share of U.S. revenue in the GAVRETO profit and loss. As previously reported by Roche, net end user product revenues for GAVRETO were $5.5 million.
Received, via our collaboration with Roche, a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for GAVRETO for the treatment of adults with RET fusion-positive advanced non-small cell lung cancer (NSCLC). If approved, GAVRETO will be the first and only targeted treatment approved by the EMA that includes first-line treatment of people with RET fusion-positive advanced NSCLC.
Key Upcoming Milestones
The company expects to achieve the following near-term milestones:
Initiate a Phase 1 trial of BLU-701 in patients with EGFR-driven NSCLC in the fourth quarter of 2021.
Present preclinical data supporting combination of BLU-945 and BLU-701 in EGFR-driven NSCLC at a medical conference in early 2022.
Initiate a Phase 1 trial of BLU-222, a CDK2 inhibitor targeting cyclin-E aberrant cancers, in the first quarter 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.
Initiate a Phase 1 trial of BLU-852, a MAP4K1 inhibitor for the treatment of advanced cancers, in 2022. BLU-852 is the first development candidate nominated under Blueprint Medicines’ cancer immunotherapy collaboration with Roche.
Third Quarter 2021 Financial Results
Revenues: Revenues were $24.2 million for the third quarter of 2021, including $17.3 million of net product revenues from sales of AYVAKIT/AYVAKYT and $6.9 million in collaboration revenues. Blueprint recorded revenues of $745.1 million in 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.
Cost of Sales: Cost of sales was $3.8 million for the third quarter of 2021, as compared to $0.1 million for the third quarter of 2020. Cost of sales included manufacturing costs associated with our product sales as well as costs associated with the sale of drug product to our collaboration partners. The increase in cost of product sales was primarily driven by lower margin product sales to our collaboration partners during the third quarter of 2021.
Collaboration Loss Sharing: Collaboration loss sharing was $3.3 million for the third quarter of 2021 under our collaboration with Roche for GAVRETO.
R&D Expenses: Research and development expenses were $84.4 million for the third quarter of 2021, as compared to $74.2 million for the third quarter of 2020. This increase was primarily due to a decrease in reimbursement from the global development cost sharing arrangement under our collaboration with Roche for GAVRETO and increased costs related to early discovery efforts. Research and development expenses included $10.3 million in stock-based compensation expenses for the third quarter of 2021.
SG&A Expenses: Selling, general and administrative expenses were $49.8 million for the third quarter of 2021, as compared to $37.4 million for the third quarter of 2020. This increase was primarily due to increased costs associated with expanding our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT and GAVRETO, partially offset by reimbursement under our collaboration with Roche for GAVRETO. General and administrative expenses included $13.7 million in stock-based compensation expenses for the third quarter of 2021.
Net Income (Loss): Net loss was $117.2 million for the third quarter of 2021, or a net loss per share of $2.00, as compared to a net income of $634.0 million for the third quarter of 2020, or a diluted net income per share of $11.16.
Cash Position: As of September 30, 2021, cash, cash equivalents and investments were $1,293.8 million, as compared to $1,549.7 million as of December 31, 2020.
Financial Guidance
Based on product revenue growth and strong collaboration execution with multiple milestone payments anticipated during the fourth quarter of 2021, the company expects to report full year 2021 total revenues in the range of $170-$180 million.
Conference Call Information
Blueprint Medicines will host a live conference call and webcast at 8:30 a.m. ET today to discuss third quarter 2021 financial results and recent business activities. The conference call may be accessed by dialing 844-200-6205 (domestic) or 929-526-1599 (international) and referring to conference ID 963004. A webcast of the call will 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.