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Blueprint Medicines Reports $24.2M in Q3 Revenues Driven by Ayvakit Sales

NEW YORK – Blueprint Medicines on Thursday reported third quarter revenues of $24.2 million, including $17.3 million in revenue from avapritinib (Ayvakit) and $6.9 million in collaboration revenue.

The company's revenues came in significantly below analysts' consensus estimates of $42.5 million. Although Blueprint's Q3 revenues dropped nearly 97 percent compared to revenues of $745.1 million in Q3 2020, its financial performance in the prior-year quarter was bolstered by a $675 million cash payment from Roche to license pralsetinib (Gavreto), which treats RET-altered metastatic non-small cell lung and thyroid cancers. In that deal in 2020, Roche also purchased $100 million of Blueprint's common stock for the rights to comarket pralsetinib in the US and gain exclusive commercialization rights outside the US, except in greater China.

Blueprint's Q3 revenues largely comprised avapritinib sales. The three months ended Sept. 30 represented the first full quarter of sales for avapritinib after its latest approval in the US for advanced systemic mastocytosis, a blood disorder driven by the KIT D816V mutation. The drug is also approved in the US to treat patients with gastrointestinal tumors harboring PDGFRA exon 18 mutations.

"The positive early trends we've been seeing [for avapritinib] reinforce our view that SM, across advanced and non-advanced forms of the disease, is the most significant near-term opportunity that we are pursuing at Blueprint Medicines," Christina Rossi, chief commercial officer at Blueprint, said on an earnings call.

In Q3, Blueprint's collaboration revenue was $6.9 million, driven by commercial supply shipments of pralsetinib to Roche and CStone Pharmaceuticals, which holds rights to market the drug in greater China, as well as royalties from sales of the drug.

Q3 was also the first quarter that Roche began booking sales of pralsetinib in the US, and Roche previously reported $5.5 million revenues.

Based on the increased revenues from these collaborations and the potential for milestone achievements in Q4, Blueprint's annual revenues may be higher than expected. The company is estimating annual revenues of between $170 million and $180 million, said CFO Mike Landsittel on the call. Blueprint had previously estimated annual revenues of $150 million.

"Early in the year, we guided to the fact that we might have $80 million in potential milestone payments," Landsittel said. While the company has recognized some of those payments in Q3, much of it is likely to come through in Q4.

"That also includes the acceleration of potential milestones that were originally forecast for 2022," he added. "As those come to fruition in Q4, the bulk of the revenue guidance raise is driven by milestone revenue that we anticipate, as well as other collaboration payments."

Rossi noted that Blueprint is focusing on expanding pralsetinib's use in the US by encouraging comprehensive and actionable biomarker profiling at diagnosis.

During the call, Blueprint executives also provided updates on how the company's pipeline of precision oncology drugs are progressing. Enrollment is accelerating in the Phase I/II dose-escalation study of BLU-945 in EGFR-positive NSCLC, Fouad Namouni, president of R&D at Blueprint, noted during the call.

According to Namouni, the company is exploring BLU-945 in combination with third-generation EGFR inhibitors. Blueprint also has studies planned for the drug in Japan. "This represents an important milestone towards building a robust trial footprint for our EGFR therapies in Asia," Namouni said.

The company previously filed an investigational new drug application with the US Food and Drug Administration for a second EGFR inhibitor, BLU-701, and expects to begin a Phase I/II trial in EGFR-positive NSCLC next quarter. Namouni said the company will also explore combination strategies with BLU-701, including pairing it with BLU-945.

Blueprint reported a net loss in the third quarter of $117.2 million, or $2.00 per share, compared to net profit of $634.0 million, or $11.16 per share, in Q3 2020, due to the Roche deal. On average, analysts expected a loss of $1.63 per share.

Blueprint increased its Q3 R&D spending by 14 percent to $84.4 million from $74.2 million in Q3 2020. Its SG&A expenses grew 33 percent to $49.8 million from $37.4 million a year ago. The company had $1.29 billion in cash, cash equivalents, and investments as of Sept. 30.