Blueprint Medicines(US:BPMC)2020-02-13 21:39Financial Performance - Collaboration revenue for 2019 was $66,512,000, an increase from $44,521,000 in 2018, representing a growth of 49%[639] - Total operating expenses for 2019 were $427,838,000, up from $291,549,000 in 2018, indicating a rise of 47%[639] - Net loss applicable to common stockholders for 2019 was $(347,694,000), compared to $(236,642,000) in 2018, reflecting an increase in losses of 47%[639] - Cash and cash equivalents as of December 31, 2019, were $113,938,000, compared to $68,064,000 in 2018, showing a growth of 67%[639] - Total assets as of December 31, 2019, were $707,694,000, an increase from $540,124,000 in 2018, representing a growth of 31%[639] - The company reported net losses of $347.6 million, $236.6 million, and $148.1 million for the years ended December 31, 2019, 2018, and 2017, respectively, with an accumulated deficit of $945.2 million as of December 31, 2019[670] - Net loss for the year ended December 31, 2019, was $347.7 million, an increase of $111.1 million or 47% from a net loss of $236.6 million in 2018[725] - Total operating expenses increased by $136.3 million from $291.5 million in 2018 to $427.8 million in 2019, reflecting a 47% increase[725] Research and Development - The company is advancing multiple investigational medicines in clinical development, including avapritinib for systemic mastocytosis and pralsetinib for RET-altered cancers[644] - The FDA granted breakthrough therapy designation to avapritinib for the treatment of advanced systemic mastocytosis, indicating significant potential for the drug[647] - The company plans to submit a supplemental new drug application for avapritinib in the second half of 2020, focusing on data from ongoing clinical trials[647] - Pralsetinib is currently in a Phase 1/2 clinical trial for RET-altered non-small cell lung cancer, with top-line data expected to be reported in 2020[651] - The FDA has granted orphan drug designation to pralsetinib for RET-rearranged non-small cell lung cancer, highlighting its importance in treating rare cancers[653] - Avapritinib is being developed for third-line and later GIST, with a Phase 3 VOYAGER trial currently ongoing, and top-line data expected to be submitted to the FDA by early Q2 2020[657] - The FDA has granted breakthrough therapy designation and orphan drug designation to avapritinib for treating unresectable or metastatic GIST with the PDGFRA D842V mutation[659] - Fisogatinib is under development for advanced hepatocellular carcinoma (HCC) and is currently in a Phase 1 clinical trial, with collaboration ongoing with CStone Pharmaceuticals[660] - The company plans to nominate up to two additional development candidates by the end of 2020, expanding its pipeline of drug candidates targeting resistant EGFR-positive NSCLC[661] - Research and development expenses are anticipated to increase significantly as the company advances its clinical development activities for avapritinib, pralsetinib, fisogatinib, and BLU-263[670] Expenses and Costs - Total research and development expenses increased to $331,450,000 in 2019 from $243,621,000 in 2018, representing a 36% increase[684] - Avapritinib external expenses were $98,146,000 in 2019, up from $83,417,000 in 2018, a 17% increase[684] - Pralsetinib external expenses rose to $78,689,000 in 2019, compared to $44,099,000 in 2018, marking a 78% increase[684] - Internal research and development expenses increased to $75,406,000 in 2019 from $49,230,000 in 2018, a 53% increase[684] - General and administrative expenses are expected to rise to support additional research and commercialization activities, including hiring and compliance costs[686] - Future research and development expenses are anticipated to increase due to expanded clinical trials and regulatory filings[684] - The company is expanding its operations in the U.S. and internationally, which will contribute to increased general and administrative expenses[686] - The company has incurred additional costs associated with operating as a public company and expanding its operational scope[686] - The company expects to incur costs related to collaborations with Roche and CStone, as well as for companion diagnostic tests[684] Revenue and Financing - Revenue generation is expected from the sales of AYVAKIT, which was approved by the FDA in January 2020 for treating adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation[674] - As of December 31, 2019, the company has raised an aggregate of $1.5 billion through various financing methods, including $1.2 billion from public offerings[669] - Collaboration revenue increased by $22.0 million from $44.5 million in 2018 to $66.5 million in 2019, primarily due to agreements with CStone, Roche, and Clementia[726] - The company recorded $46.2 million in revenue under the Clementia license agreement in 2019, including a $25.0 million upfront payment[726] - Interest income increased by $3.2 million from $10.6 million in 2018 to $13.7 million in 2019, attributed to higher average investment balances and returns[731] - Net cash provided by financing activities increased by $336.2 million in 2019, primarily due to a $327.5 million increase in net proceeds from the April 2019 follow-on public offering[752] Cash and Investments - As of December 31, 2019, the company had cash, cash equivalents, and investments totaling $548.0 million, with an additional $308.2 million in estimated net proceeds from a January 2020 follow-on public offering[744][757] - Net cash used in operating activities for the year ended December 31, 2019, was $(278.0) million, an increase of $103.0 million compared to $(175.0) million in 2018[748] - The company has no outstanding principal and interest under its loan and security agreement as of December 31, 2019[754] - As of December 31, 2019, the company had cash, cash equivalents, and investments totaling $548.0 million, an increase from $494.0 million in 2018[769] Market Risks - The company’s primary market risk exposure is interest rate sensitivity, with a belief that a 10% change in interest rates would not materially affect the fair market value of its investment portfolio[770] - The company is exposed to foreign currency exchange rate risk due to contracts with vendors in Asia and Europe, but currently does not hedge these risks[771] - As of December 31, 2019, the company had total operating lease obligations of $137.6 million, with $11.9 million due within one year[771] - Inflation has generally increased costs related to labor, clinical trials, and manufacturing, but it did not have a material effect on the company’s financial condition or results of operations in 2019 and 2018[773]