Coherus Banks on 2022 Approvals After Net Losses for Q4, 2021

In its newly released earnings report for Q4 and fiscal year 2021, Coherus announced Udenyca—one of 4 pegfilgrastim biosimilars on the US market—delivered net sales of $73 million and $327 million, respectively.

But totals were down from those reported in 2020, with Udenyca earning a net $110.4 million in Q4 of 2020 and $475.8 million throughout the year. Decreases were mainly due to a reduction in the number of units sold and a decline in net realized price resulting from increased competition and COVID-19 impacts, the company said in a statement.

Udenyca is a colony stimulating factor that promotes white blood cell growth and is used to treat neutropenia resulting from cancer medications.

Coherus reported net losses for 2021 Q4 of $45.7 million, or $0.60 per share on a diluted basis compared with totals recorded in the same period in 2020; net losses were also recorded for 2021 as a whole ($287.1 million, or $3.81 per share on a diluted basis, compared with net income of $132.2 million, or $1.62 per share, on a diluted basis for 2020).

From 2020 to 2021, research and development (R&D) costs increased from $142.8 million to $363.1 million, due in large part to an upfront license fee paid to Junshi Biosciences. Costs incurred from the development of Yusimry, toripalimab and additional presentations of Udenyca also contributed to the $220.3 million rise.

Selling, general, and administrative (SG&A) costs increased year over year from $139.2 million in 2020 to $169.7 million in 2021.

In 2022, Coherus expects to launch 2 new products and initiate a clinical trial evaluating toripalimab in combination with JS006, company CEO Denny Lanfear said.

“Looking ahead to 2023, we project accelerating revenue growth with the planned launch of FDA-approved Yusimry into the $17 billion Humira market and the introduction of the Udenyca on-body injector, if approved, a new presentation that would enable us to address the remaining $1.2 billion Neulasta Onpro segment of the pegfilgrastim market where there is currently no biosimilar competition,” Lanfear added.

The company also projects combined R&D and SG&A expenses in 2022 will be in the range of $415 million to $450 million as a result of the anticipated new product launches and the additional presentation of Udenyca.

In its report, Coherus touted the FDA approval of Yusimry (adalimumab-aqvh), a Humira biosimilar in December 2021 and a biologics license application (BLA) for Cimerli (ranibizumab-ranq), a Lucentis biosimilar which has an assigned a target action date of August 2022.

An April 2022 target action date has been set for toripalimab’s BLA for the treatment of metastatic or recurrent nasopharyngeal carcinoma. It is currently under priority review by the FDA for this indication and is being studied for treatment of lung, breast, liver, skin, kidney, stomach, esophagus, and bladder cancers.