Coherus’ Struggling Picture Prior to Udenyca On-Body Injector Approval and Yusimry Launch

On its 2022 earnings call last week, Coherus Biosciences revealed some promising tidbits but the overall impression is worrisome, just prior to its Yusimry® launch in July.

During the earnings call, Coherus executives announced that it had filed for approval of the long-awaited, first competitor to Neulasta OnPro®. Last year, the company was hoping that its Udenyca® on-body injector would reach the market in 2023. Coherus did not publicly announce when the approval was filed, but it may not be granted until later in the year; therefore, 2023 sales may not be a big contributor to revenues. In the meantime, Coherus did receive FDA approval in March for the first autoinjector version of pegfilgrastim, which the company will launch in the second quarter of 2023.

Udenyca marketshare fell to 12.4% (a decline of 1 point from the third quarter). This is down from its high of 21% in 2020, reported by IQVIA. Declining net costs and prescription units resulted in a drop in the company’s revenues to $211.0 million from $326.6 million in 2021. All but $6.9 million (Cimerli® sales) were attributed to Udenyca, and that product’s revenue fell to $38.3 million in the fourth quarter of 2022. The company also registered a $26 million write-off for drug that was nearing product expiration.

It is unknown what impact the first pegfilgrastim autoinjector may have on the market. President Denny Lanfear said that Coherus believes the Udenyca autoinjector will serve patients who tried but did not have positive experiences with OnPro (e.g., if they are very active or want more control). “We think the autoinjector will serve an unmet need,” he stated, and will compete with Amgen’s OnPro.

On the positive side of the fence, Cimerli was assigned a permanent Q-code, which may enable easier processing of reimbursements. Cimerli only launched in the second half of 2022, so revenues are anticipated to rise by at least $100 million in 2023; although the marketshare is only 2%, the company stated that it has coverage of 100% of Medicare fee-for-service lives. Cimerli’s future contribution to Coherus’ bottom line will be tempered by a royalty of over 50% on its gross Cimerli profits.

Coherus executives could not give an expectation of 2023 Yusimry sales, stating that it would only be able to provide estimates in November, after 2023’s third-quarter numbers are in. The company’s adalimumab biosimilar will be facing heavy competition, but should be able to garner some meaningful numbers by the end of the year.

The company is spending on research for innovative products in the immune-oncology area, which contributed to a net loss for 2022. It also announced a cut in its full- and part-time staff in an effort to reduce costs.

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