erus BioSciences(US:CHRS)2023-03-07 03:22Financial Data and Key Metrics Changes - The company ended the year with $192 million in cash, cash equivalents, and marketable securities [1] - For Q4 2022, the company reported a net loss of $58.9 million and a full-year net loss of $291.8 million on a GAAP basis [25] - Net revenue for Q4 was $45.4 million, with CIMERLI generating $6.9 million in sales [27][25] - Projected total combined SG&A and R&D GAAP operating expenses for 2023 are estimated to be between $315 million and $335 million, a reduction of nearly $100 million compared to previous guidance [30][77] Business Line Data and Key Metrics Changes - CIMERLI, the first interchangeable biosimilar to Lucentis, achieved a market share of 2.4% by the end of Q4 2022, with sales of $7 million [81] - UDENYCA net sales for Q4 were $38.3 million, reflecting an 8% decline in demand and a 14% decline in net selling price [84][85] - The company anticipates CIMERLI revenues to exceed $100 million in 2023 [81] Market Data and Key Metrics Changes - The pegfilgrastim market has become increasingly competitive, with significant price discounts from market participants [75] - The company confirmed coverage on 100% of Medicare fee-for-service lives for CIMERLI, enhancing reimbursement pathways [82] Company Strategy and Development Direction - The company aims to create long-term shareholder value through immuno-oncology products while funding development with biosimilar sales [45] - The strategy includes launching multiple products in 2023, such as CIMERLI, UDENYCA, and Toripalimab, while managing expenses to achieve profitability by 2024 [31][73] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the approval of Toripalimab for nasopharyngeal carcinoma, highlighting the unmet need in the market [65] - The company is focused on expense management without jeopardizing product launches, aiming for profitability in 2024 [73][115] Other Important Information - The FDA granted Toripalimab Breakthrough Therapy designation, recognizing the unmet need for patients with MPC [65] - The company has streamlined the U.S. development plan for Toripalimab, significantly reducing clinical trial expenses [66][3] Q&A Session Summary Question: What is the visibility on YUSIMRY's positioning with payers? - Management indicated that clarity on YUSIMRY's formulary positioning will be available post-launch in July [10][38] Question: Can you elaborate on the cost savings and where they are coming from? - Cost savings are derived from reductions in headcount, development expenses, and manufacturing expenses, with a focus on operational efficiency [109][133] Question: How will the Q-code impact CIMERLI's sales? - The Q-code is expected to enhance electronic billing processes and accelerate reimbursement, serving as a catalyst for growth starting in Q2 2023 [81][125] Question: What are the expectations for Humira biosimilar revenues in 2023? - Management stated that clarity on Humira biosimilar revenues will not be available until after the July launch, as the market dynamics are still evolving [40][127] Question: How does the company plan to address the NCCN coverage for Toripalimab? - The company plans to submit additional data sets for NCCN coverage after receiving NPC approval [104][134]