erus BioSciences(US:CHRS)2021-02-25 03:44Financial Data and Key Metrics Changes - Coherus reported net sales of UDENYCA at $110 million for Q4 2020, a decrease from $124 million in Q4 2019, primarily due to a decrease in net selling price amid increased competition [28] - For the full year 2020, UDENYCA net sales were $476 million, down from $356 million in 2019, reflecting an increase in units sold but offset by a decrease in net selling price [29][14] - R&D expenses rose to $45 million in Q4 2020 from $35 million in Q4 2019, with a full-year total of $143 million, an increase of $49 million compared to 2019 [30][31] - The company reported a net income of $10 million, or $0.12 per share, for Q4 2020, and $132 million, or $1.62 per share, for the full year 2020 [33] Business Line Data and Key Metrics Changes - UDENYCA's performance was impacted by COVID-19, which hindered market share growth against new competitors, but the company expects to regain market share as COVID recedes [8][24] - The company is advancing its biosimilar pipeline, with the FDA accepting the BLA for CHS-1420 (Humira biosimilar) for review, with an action date set for December 2021 [15] - The Lucentis biosimilar BLA is on track for submission in mid-2021, following a supportive pre-BLA meeting with the FDA [17] Market Data and Key Metrics Changes - The overall pegfilgrastim market grew 4% quarter-over-quarter in volume, while UDENYCA's market share remained stable [21] - The company anticipates significant growth opportunities in the PD-1 market, projected to be a $25 billion opportunity [20] Company Strategy and Development Direction - Coherus is expanding its late-stage pipeline to include immuno-oncology, with a collaboration announced with Junshi Biosciences for the PD-1 inhibitor toripalimab [9] - The company plans to leverage its existing infrastructure and commercial capabilities to capture a significant share of the $6 billion anti-VEGF ophthalmology market [18] - The strategy includes investing cash flows from the biosimilar business to build a robust immuno-oncology franchise [20] Management's Comments on Operating Environment and Future Outlook - Management views 2021 as a year of fundamental transition and an inflection point for the company, expecting to regain market share as COVID-19 impacts lessen [9][24] - The management expressed confidence in the upcoming BLA submissions and the potential for significant revenue growth from the expanded product portfolio [38][39] Other Important Information - The company plans to host an Analyst Day event later in the year to provide a comprehensive overview of its business and strategies [13] - Coherus has a strong balance sheet with $541 million in cash and cash equivalents at year-end [33] Q&A Session Summary Question: Context on UDENYCA sales and Q1 expectations - Management indicated that Q1 will see a dip in sales due to COVID-19 but expects recovery in Q2 as vaccination rates increase and market dynamics shift [45][49] Question: Growth share and competition with Neulasta Onpro - Management expressed confidence in regaining market share from Neulasta Onpro as COVID-19 impacts recede and emphasized the value proposition of UDENYCA [54][59] Question: Confidence in upcoming BLA submissions - Management provided assurance regarding the BLA for toripalimab, citing strong data and prior discussions with the FDA, while also expressing optimism for the Lucentis and Humira biosimilars [72][75] Question: Impact of new PD-1 entrants on the market - Management highlighted their competitive strategy focused on understanding customer needs and delivering value, indicating confidence in capturing market share despite new entrants [78][81]