Coherus概述了1.5亿-2亿美元的LOQTORZI NPC目标，同时通过合作伙伴关系推进管道

Earnings Call Insights: Coherus BioSciences (CHRS) Q1 2025

Management View

• CEO Denny Lanfear stated the company has completed its biosimilar divestitures and is now “fully focused on innovative oncology,” positioning itself as a commercial-stage oncology company with the FDA-approved PD-1 inhibitor LOQTORZI and two proprietary pipeline products showing “positive data for large markets.” Lanfear emphasized, “Our strategy is anchored around three core pillars that drive both our near-term revenue growth as well as our long-term innovation.”
• Lanfear projected LOQTORZI “in just the NPC indication alone will grow to about $150 million to $200 million annually over the next three years,” providing non-dilutive funding for the development pipeline, with plans to expand indications and non-NPC sales. He noted, “Once we exceed about $15 million per quarter, we will cover our commercial costs and begin to contribute to corporate expenses progressively moving to cover R&D costs with revenues.”
• The company has established multiple partnerships to expand LOQTORZI indications, including pivotal trials with INOVIO and a pivotal study with Junshi in small cell lung cancer.
• Lanfear highlighted clinical progress with the anti-IL-27 antibody casdozokitug and CCR8 cytolytic antibody CHS-114. He stated, “We recently presented the first US clinical data with a CCR8 at AACR last week, showing visually compelling biomarker data illustrating the elimination of T-regs, infiltration and inflammation of the TME by CD8+ T cells.”
• CFO Bryan McMichael reported, “The proceeds from the UDENYCA divestiture and the use of a portion of those proceeds will not be reflected in our financial reporting until we report our Q2 results.” He added, “We received $483 million of upfront cash in April… The net cash from these transactions is almost $200 million after deducting transaction fees and taxes and is in addition to the $82 million in cash Coherus had on its balance sheet at March 31, 2025.”

Outlook

• Management reiterated the LOQTORZI NPC market share opportunity valued at $150 million to $200 million annually, driven by current and future indication expansion and increased market penetration. Lanfear said, “Clinical data readouts that are occurring in 2025 support these product candidates with safety, initial efficacy and proof of mechanism data that builds momentum as we look forward to initial key data readouts for these studies projected in the first half 2026.”
• SG&A incurred solely for Coherus programs and expenses for full year 2025 is projected to be between $90 million and $100 million.
• R&D expense outlook will depend on data readouts and portfolio prioritization, with further detail expected later in the year.

Financial Results

• Revenue for LOQTORZI was reported as $7.3 million, which was stated as “flat…due to a seasonal inventory drawdown despite strong demand growth.”
• Patient demand for LOQTORZI grew 15% in Q1, driven by an increase in new patient starts and duration of treatment, according to Executive Vice President, Commercial Sameer Goregaoker.
• COGS from continuing operations was $2.7 million, up from $1.4 million in Q1 last year, attributed to increased LOQTORZI sales.
• R&D from continuing operations was $24.4 million, a decrease of just over $4 million or 14% from Q1 last year, reflecting savings from reduced co-development with Junshi, partially offset by increased investment in CHS-114 and casdozokitug.
• SG&A from continuing operations was $26 million, down $14.2 million or 35% from Q1 last year, largely due to lower headcount and nonrecurring charges.

Q&A

• Kripa Devarakonda, Truist Securities, asked about drivers for a significant LOQTORZI inflection point and FDA changes. CEO Lanfear and Chief Scientific & Development Officer Theresa LaVallee indicated that “having well thought through high-quality packages with strength of development really is an advantage,” and that the sales team’s renewed focus following restructuring will drive growth. Goregaoker noted, “In Q2 and onwards, our sales force will be firing on all cylinders, and we expect to see an acceleration in the growth.”
• Brian Cheng, JPMorgan, questioned the definition of LOQTORZI patient demand and the sales force restructure impact. Goregaoker explained, “End-user demand is actually through patient demand,” and Lanfear said the restructuring impact was primarily in Q1, with Q2–Q3 expected to be periods of growth.
• Mike Nedelcovych, TD Cowen, asked about market share and competition from KEYTRUDA and OPDIVO. Goregaoker stated, “The Keytruda and chemo only use is real…But when we talk to physicians, it’s a very clear story…we are the only brand, only IO with an OS survival benefit.”
• Colleen Kusy, Baird, inquired about the FDA Type D meeting for CHS-114 and sales force leverage. LaVallee reported, “It was…very exciting that they found it acceptable,” with Lanfear noting potential future additions to the commercial portfolio.
• Douglas Tsao, H.C. Wainwright, asked about physician education and LOQTORZI differentiation. Chief Medical Officer Rosh Dias emphasized, “Whenever a doctor hears this data, they’re very impressed to date. It is impressive data.”

Sentiment Analysis

• Analysts expressed cautious optimism, probing for inflection points, market share growth, and competitive positioning, while raising concerns over headwinds and transitions. Some questions reflected skepticism about the pace of adoption and the impact of recent restructuring.
• Management maintained a confident tone, emphasizing strategic focus, recent clinical data, and future growth: “We are well positioned to execute on our mission to bring innovative therapies that extend the survival of the cancer patients while building a sustainable oncology franchise that delivers long-term value for our shareholders.”
• Compared to the previous quarter, analyst tone shifted from procedural and transaction-focused to more growth- and execution-oriented, while management demonstrated increased confidence and clarity following the completion of the divestiture.

Quarter-over-Quarter Comparison

• The current quarter marked a strategic shift to a pure-play oncology company, with biosimilar divestitures completed and an intensified focus on LOQTORZI and proprietary pipeline assets.
• LOQTORZI revenue was flat compared to Q4’s $7.5 million, but patient demand rose 15%, a metric not emphasized in the previous quarter.
• Management’s tone shifted from transitional and procedural in Q4 to assertive and forward-looking, with more detailed disclosure of pipeline progress and commercial execution.
• Guidance language became more explicit regarding anticipated market opportunity and growth targets for LOQTORZI, compared to broader strategic language used previously.
• Analysts’ questions shifted from transaction closure and cash runway concerns in Q4 to LOQTORZI’s market share, inflection points, and pipeline progress in Q1 2025.

Risks and Concerns

• Management acknowledged recent sales force restructuring and a supply interruption in Q4 as temporary headwinds, with expectations of resumed momentum in Q2 and beyond.
• Physician adoption of LOQTORZI is challenged by ingrained prescribing habits and delayed uptake in rare cancers, requiring ongoing education and engagement.
• Competition from off-label use of other PD-1 inhibitors persists, especially in community settings.
• Regulatory changes at the FDA and staff turnover were noted, with management emphasizing strong development packages and prior success in navigating regulatory challenges.

Final Takeaway

Coherus BioSciences signaled a pivotal quarter, emerging as a focused oncology company following divestitures and restructuring. Management underscored confidence in LOQTORZI’s market growth, projecting $150 million to $200 million annually in the NPC segment, and highlighted robust pipeline progress—particularly with CHS-114 and casdozokitug—supported by recent clinical data and expanding partnerships. The company expects renewed commercial momentum after resolving short-term operational headwinds, with strategic clarity and upcoming data readouts poised to drive long-term value creation.

Read the full Earnings Call Transcript