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Blueprint Medicines' Q1 Ayvakit Sales More Than Triple 

NEW YORK – Blueprint Medicines on Tuesday reported revenues of $62.7 million during the first quarter of 2022, including $23.8 million from sales of Ayvakit (avapritinib) and $38.9 million in collaboration revenues. 

The Cambridge, Massachusetts-based company nearly tripled its revenues in Q1 2022 compared to Q1 2021, when it reported $21.6 million in revenue. Blueprint's Q1 performance beat analysts' consensus revenue estimate of $38.7 million. 

During the quarter, Ayvakit sales more than tripled from $7.1 million in the year-ago quarter. The drug is approved in the US for unresectable or metastatic gastrointestinal stromal tumors with PDGFRA exon 18 mutations and for advanced systemic mastocytosis (SM), a blood disorder driven by the KIT D816V mutation that can become cancerous. 

The US Food and Drug Administration approved Ayvakit for advanced SM in June 2021 and during Q1, the European Commission approved the same indication. "The advanced SM indication contributed the majority of the [$23.8 million in] revenue for the quarter, and we anticipate that it will be the primary driver for Ayvakit revenue growth for the course of the year," Blueprint Chief Operating Officer Christina Rossi said during a call to discuss the company's financial performance. 

Rossi noted that the launch of Ayvakit has "fundamentally changed" the treatment of advanced SM and "is the treatment of choice for 70 percent of all advanced SM patients starting on or switching to a new therapy." Since the launch of the drug in the US, the percent of advanced SM patients on the drug has grown by around 40 percent, she estimated. In Europe, the first advanced SM patient received treatment with Ayvakit within a week of its regulatory approval, and Blueprint is planning to launch the drug in other EU countries as it works through regional reimbursement. 

In Q1 2022, Blueprint's collaboration revenue grew more than threefold from $12.6 million in the prior year. 

During the quarter, the firm's net loss swelled to $106.0 million, or $1.79 per share, from $99.7 million, or $1.72 per share, in Q1 2021. On average, analysts had expected a loss per share of $1.86. 

The company's R&D spending in Q1 2022 went up 29 percent to $103.1 million from $79.7 million in Q1 2021. During the same period, selling, general, and administrative expenses also increased 36 percent to $57.1 million from $42.0 million. 

The company is planning to share real-world data on Ayvakit's impact on overall survival in advanced SM at an upcoming medical meeting, and in the late summer will report top-line data from the second part of the PIONEER trial involving non-advanced SM patients, who currently have inadequate treatment options. In part one of PIONEER, researchers established the optimal dose of Ayvakit in this setting and explored the drug's tolerability and ability to reduce SM symptoms. Based on this data, the FDA granted breakthrough therapy designation to Ayvakit in non-advanced SM. 

In part two of PIONEER, researchers will assess non-advanced SM patients' response rate and total symptom score on Ayvakit versus placebo. The company will submit this data as part of a supplemental new drug application with the FDA by year end. 

In the second half of the year, Blueprint is expecting initial data readouts from two Phase I/II trials involving EGFR mutation-positive non-small cell lung cancer patients: the SYMPHONY trial of BLU-945 plus AstraZeneca's Tagrisso (osimertinib) and the Phase I/II trial of BLU-701. In the H1 2023, Blueprint is expecting initial data from an early-stage trial of BLU-451, which it is studying for NSCLC patients with EGFR exon 20 insertion mutations. "We will continue to initiate combination cohorts in progressively earlier lines of treatment," Blueprint Chief Medical Officer Becker Hewes said during the call. 

The development of the CDK2 inhibitor BLU-222, which Blueprint is studying for cyclin E-aberrant cancers, is also advancing quickly, Hewes said, noting that the first clinical data for this drug is slated for the first half of 2023. Blueprint is exploring BLU-222 in multiple solid tumors in the VELA trial, including in previously treated estrogen receptor-positive breast cancer and in combination with Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) and hormonal therapy.

As of March 31, Blueprint had $893.4 million in cash, cash equivalents, and marketable securities. 

Blueprint continues to expect revenues in the range of $180 million to $200 million in 2022, and Ayvakit sales in the range of $115 million to $130 million.