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| Statement |
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| Our conviction in achieving this ambition is bolstered by the following: First, we have strong advocacy from the nation's leading opinion leaders in NPC |
| So that's a very, very compelling |
| And we expect that the margin and the qualitt of revenues, for example, with LOQTORZI and UDENYCA will lead to greater profitability as we go into the back side of the year |
| We believe this strategy creates long-term shareholder value as we develop and deliver next-generation oncology treatments for patients |
| Regarding our clinical stage pipeline, we remain excited about the potential to combine our novel agents on top of the toripalimab backbone by targeting both the T-cell with toripalimab and also the tumor microenvironment with our novel agents, the aim will be to make the tumor microenvironment more favorable to antitumor effect and therefore realize potential additive benefit |
| We are entering 2024 with strong upward momentum and a clear organizational focus on extending survival for patients with cancer |
| And I think that the significant market share increase like the 4-week trailing 25% and our look forward here for 2024 shows that our long-term strategy is paying off |
| We saw pretty impressive growth with auto-injector in the fourth quarter, driven largely in the clinic market |
| We’re pleased with our progress on all fronts to drive our sales higher, strictly control our expenses, reduce our debt and advance our pipeline |
| We are very pleased with the uptake, very pleased that P&T committees and how well we're doing there |
| This reflects our strong partnership and high level of cooperation with Junshi |
| We're particularly encouraged that the clinical activity observed with our IL-27 antagonist, casdozokitug has in addition to clinical response, demonstrated immune activation in liver and lung patients |
| Within six weeks of approval, LOQTORZI was also included in the NCCN guidelines for MPC by the NCCN head and neck panel with a very strong positioning |
| With both the UDENYCA on-body approval and approval of LOQTORZI for all lines of therapy and all patient subsets of nasopharyngeal carcinoma, the Coherus Oncology franchise is well positioned |
| In summary, we're excited to become a trusted partner within the head and neck community and to bring new hope for greater survival for MPC patients nationwide |
| With LOQTORZI, we are gaining predictable and growing high margin revenues from our innovative product and are able to realize the synergies of having two adjacent oncology products |
| With respect to the 33 NCCN designated cancer centers, 55% have already added LOQTORZI to formulary with the remaining centers in P&T review, and I'm confident we'll have successful outcomes with these centers as well |
| Customer enthusiasm for the UDENYCA auto-injector presentation led to a 129% demand growth quarter-over-quarter |
| The FDA approvals of the UDENYCA auto-injector, UDENYCA on-body injector and LOQTORZI and nasopharyngeal cancer have positioned us for further commercial success in 2024, capitalizing on synergies |
| Each of these products aligns to our vision of oncology leadership and each paves the way for the impressive slate of tumor microenvironment focused immuno-oncology assets in our development pipeline |
| So this increase in response rate together with deepening of the responses is very encouraging |
| We've locked in great payer coverage and we've been able to have a competitive ASP |
| We ended 2023 with strong momentum to the business with the divestiture of the ophthalmology franchise |
| I'm pleased to report to you today's strong fourth quarter results, rounding out an important year of transition for Coherus, as we sharpened our focus on innovative oncology, positioning the company for new levels of efficiency and growth in 2024 and beyond |
| And then lastly, we're making very good progress reducing our interest cost |
| So we're getting it in both lines, which is great, and the launch is going very well |
| This strengthens our competitive position and allows us to compete on factors other than price |
| Now that both UDENYCA auto-injector and on-body presentations are launched, our strategy moving forward is to deliver profitable revenue and market share growth fueled by three drivers |
| We want to drive the top line, but we also really -- the quality of the revenues, especially with the product like LOQTORZI, it is going to be far better, more stable and more sustainable than your typical biosimilar |
| We are the only Category 1 listed agent for first-line in terms of immunotherapy, and I think that really does reflect the strength of the data and the confident in the data in this area of unmet need |
| Statement |
|---|
| We continue to expect slower growth for Humira biosimilars through 2024 till the implementation of the Inflation Reduction Act 2025 |
| Specifically, in Q4 2023, we recorded a $47 million charge for the write-down of slow-moving CIMERLI inventory and related firm purchase commitments |
| R&D expense for Q4 2023 was $26.4 million, a decrease of $2.7 million from the same period in the prior year |
| SG&A expense for the year was $192 million, down from $198.5 million in the prior year |
| For the fourth quarter of 2023, we reported a net loss of $79.7 million or $0.71 per share compared to a net loss of $58.9 million or $0.76 per share for the same period in 2022 |
| In the interim, others have exited the market with aggressive pricing, we're still there |
| We ended the year with R&D expense totaling $109.4 million, down $89.9 million from the prior year |
| For the quarter, SG&A expense was $49.5 million, down $4.1 million and 8% compared to a year ago, decreases primarily reflected savings from lower headcount, partially offset by other costs |
| Rosh Dias And maybe one last thing I'll add, safety is always important |
| I think the primary issue is that we have freshly launched the UDENYCA on-body |
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