Alnylam Pharmaceuticals(US:ALNY)2021-08-03 19:31Financial Data and Key Metrics Changes - In Q2 2021, Alnylam Pharmaceuticals reported $160.8 million in total combined product sales, representing a 107% increase compared to Q2 2020 [32] - ONPATTRO generated $113.8 million in net revenue, marking a 12% growth from Q1 2021 and a 71% increase from Q2 2020 [29] - GIVLAARI achieved $30.6 million in net revenue, reflecting a 24% growth compared to Q1 2021 [31] - OXLUMO generated $16.3 million in net revenue, up from $9.1 million in Q1 2021 [31] - The company increased its full-year 2021 combined net product revenue guidance from $610 million to a range of $640 million to $665 million [34] Business Line Data and Key Metrics Changes - ONPATTRO saw a 12% quarter-on-quarter growth in demand, with over 1,725 patients on treatment [10] - GIVLAARI experienced a 24% quarter-on-quarter growth, with over 270 patients on therapy [12] - OXLUMO's performance showed continued demand strength, with approximately 100 patients on treatment as of June 30 [14] Market Data and Key Metrics Changes - International markets for ONPATTRO grew by 17% quarter-on-quarter, with strong performance in Europe and Canada [11] - GIVLAARI's market access in the US confirmed coverage for over 98% of lives, with no significant headwinds [12] - OXLUMO achieved market access with confirmed medical policy inclusions for over 80% of covered US lives [14] Company Strategy and Development Direction - Alnylam aims to build a top five biotech company by executing its P5x25 goals, focusing on sustainable innovation and organic product development [42] - The company is expanding its pipeline into prevalent diseases, including hypertension, with a commitment to maintaining profitability [44][45] - A partnership with PeptiDream aims to develop peptide-siRNA conjugates for extrahepatic delivery of RNAi therapeutics [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing recovery of the healthcare system and its positive impact on patient diagnosis and treatment compliance [10][11] - The company is optimistic about the potential of its pipeline, particularly in addressing prevalent diseases and expanding its therapeutic offerings [22][24] - Management acknowledged the challenges posed by the Delta variant but indicated that the company has built capabilities to adapt to changing healthcare environments [67] Other Important Information - Alnylam discontinued its ALN-COV program for COVID-19 treatment due to the availability of effective vaccines [28] - The company plans to submit supplemental regulatory filings for Lumasiran based on recent positive trial results [20] Q&A Session Summary Question: Future company structure and growth ambitions - Management emphasized the commitment to remain a standalone company focused on achieving top five biotech status through organic growth and innovation [42] Question: Balancing investment in larger programs with profitability - Management highlighted the excitement around RNAi therapeutics for prevalent diseases and the ability to advance these assets independently while ensuring a sustainable business model [44][45] Question: Parallels between zilebesiran and inclisiran - Management noted the similarities in addressing prevalent diseases and the strategic advantages of having de-risked primary endpoints for both programs [52] Question: Enrollment rates in HELIOS-B study - Management indicated that the faster enrollment in HELIOS-B is due to high interest among physicians and patients, with expectations for interim analysis to be considered [64] Question: Impact of Delta variant on Q3 performance - Management expressed confidence in the company's ability to navigate challenges posed by the Delta variant, citing successful adaptations made during the pandemic [67]