NEW YORK – Blueprint Medicines on Wednesday reported fourth quarter revenues of $107.0 million, including $20.0 million from sales of Ayvakit (avapritinib) and $87.0 million in collaboration revenues.
The Cambridge, Massachusetts-based company more than tripled its revenues in Q4 2021 compared to Q4 2020, when it reported $34.1 million in revenue. Blueprint's Q4 performance beat analysts' consensus revenue estimate of $102.7 million.
During the quarter, the firm recorded a threefold increase in Ayvakit sales compared to revenues of $6.7 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, or SM, a blood disorder driven by the KIT D816V mutation that can become cancerous.
The US Food and Drug Administration approved Ayvakit for SM last June. Christina Rossi, Blueprint's chief commercial officer, said Ayvakit's revenue from the advanced SM indication grew 55 percent sequentially between Q3 and Q4 in 2021, making this market the primary revenue driver for the drug.
In 2022, the company expects Ayvakit revenues of $115 to $130 million, more than doubling Ayvakit revenues in 2021. "Key drivers of our performance will be growth in new patient starts and increasing treatment duration, which we anticipate will drive acceleration in revenue, particularly as we approach the second half of the year," Rossi said.
She also noted that the "improving COVID landscape" will allow patients to return to regular visits with hematologists in the US and aid the company's efforts to identify patients eligible for Ayvakit.
In Q4 2021, Blueprint's collaboration revenue increased more than threefold to $87.0 million from $27.4 million in the prior year. This segment comprises revenues and income from several licensing deals, including Blueprint's outlicensing of its RET inhibitor Gavreto (pralsetinib) to Roche and a more recent deal with Zai Lab to license Blueprint's EGFR inhibitors, BLU-945 and BLU-701, in greater China.
In Q4, Blueprint acquired Lengo Therapeutics in a $465 million deal. The acquisition will add Lengo's lead candidate, an EGFR inhibitor to Blueprint's pipeline, along with the company's undisclosed preclinical precision oncology programs and other assets.
The company also announced several executive changes in January. Kate Haviland, Blueprint's chief operating officer, will succeed current CEO Jeff Albers in April, as Albers transitions to the role of executive chairman. Rossi will take over the role of COO, and Philina Lee, head of portfolio strategy and program management, will be promoted to chief commercial officer. Helen Ho, senior VP for corporate development, will be promoted to chief business officer.
In Q4 2021, the firm recorded a net loss of $318.7 million, or $5.40 per share, compared to a net loss of $85.7 million, or $1.53 per share, in Q4 2020. On average, analysts had expected a loss per share of $1.65.
The company's R&D spending in Q4 2021 went up more than fourfold to $356.9 million from $77.4 million in Q4 2020. Selling, general, and administrative expenses also increased 27 percent to $54.2 million from $42.5 million a year ago.
Blueprint's full year 2021 revenues were $180.1 million compared to $793.7 million in 2020, during which the company benefited from a $775 million licensing deal with Roche for Gavreto. The FDA approved Gavreto in 2020 for advanced RET fusion-positive non-small cell lung and thyroid cancer and RET-mutant medullary thyroid cancer.
Sales of Blueprint's lead product, Ayvakit, were $53.0 million in FY 2021, compared to $21.3 million in FY 2020. Blueprint recorded $4.7 million in Gavreto sales in the first half of the year before Roche began booking sales of the drug in the US in Q3. In FY 2020, Blueprint earned $900,000 from sales of Gavreto.
The company's reported net loss in FY 2021 was $644.1 million, or $11.01 per share, compared to a net income of $313.9 million, or $5.59 per share, in FY 2020. On average, analysts had estimated a loss of $6.93 per share.
For the full year in 2021, Blueprint's R&D spending jumped 84 percent to $601.0 million in 2021, compared to $326.9 million in 2020. The company spent $195.3 million on selling, general, and administrative expenses in FY 2021 compared to $157.7 million in 2020, marking a 24 percent increase.
As of Dec. 31, Blueprint had $1.03 billion in cash, cash equivalents, and marketable securities.
In 2022, Blueprint is expecting total revenues in the range of $180 million to $200 million, and Ayvakit sales in the range of $115 million to $130 million.
After the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the drug in advanced SM last month, Blueprint is optimistic it will launch the drug in Europe, under the brand name Ayvakit, in Q2 2022. Blueprint will also report results from a Phase II study of Ayvakit in non-advanced indolent SM in the first half of year, and is expecting to file a new drug application with the FDA before the end of 2022.
Blueprint will continue developing several investigational EGFR inhibitors throughout the year. The company plans to initiate a Phase I/II trial of BLU-451 in EGFR exon 20 insertion-positive NSCLC in the first quarter of 2022, and will present preclinical data from its other EGFR inhibitors this year. The company will also begin a Phase I/II trial of the CDK2 inhibitor BLU-222 in cyclin E-CDK2-aberrant cancers in Q1.