Blog Big Molecule Watch May 17, 2022

Q1 2022 Earnings Roundup: Biologics and Biosimilars Update

Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies:

Biogen:  Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar revenue of $194 million decreased 5% versus the prior year.  As reflected by the assumption in the Company’s Full Year 2022 Financial Guidance, “[t]his decline in revenue reflects increased competition in the biosimilar space – continued decline in RITUXAN revenue and erosion of TECFIDERA revenue due to generic entry.”  Biogen states that “[t]he Company aims to drive potential return to growth in the biosimilar business as one of the near-term operational priorities” and “[w]hile the Company’s current commercial portfolio of anti-TNF products is likely past the peak of its lifecycle, it currently has four more programs in development and is preparing to launch BYOOVIZ, referencing LUCENTIS®, in the U.S. in the upcoming months.”

Biogen reported that it completed the sale of the company’s equity stake in the Samsung Bioepis joint venture to Samsung Biologics last month, for a total consideration of up to $2.3 billion.  Biogen states that together with Samsung Bioepis, it will continue with their exclusive agreements, including the commercialization of the current biosimilar portfolio including BENEPALI (etanercept), FLIXABI (infliximab), IMRALDI (adalimumab) and the potential filings for SB15 (aflibercerpt) in markets.  In addition, Biogen and Xbrane Biopharma AB announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize XCIMZANE, a proposed biosimilar referencing CIMZIA® (certolizumab pegol).  Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to XCIMZANE and will be the Marketing Authorization Holder.

Coherus:  At the beginning of May, Coherus Biosciences reported that quarterly revenues, consisting of net sales of UDENYCA® (pegfilgrastim-cbqv), a biosimilar to NEULASTA®, was $60.1 million and $83.0 million during the three months ended March 31, 2022 and 2021, respectively.  Despite the decline, which the Company states was primarily due to a decrease in the number of units of UDENYCA® sold as well as a lower net realized price due to increased competition, Denny Lanfear, Coherus’ CEO, stated that the Company continues to “[m]ake strong progress transforming into an innovative immune-oncology company supported by revenues generated by the diversified commercial portfolio of FDA-approved products, as it prepares for new product launches in 2022 and 2023.”

Coherus said it expects to launch the FDA-approved YUSIMRY (adaliumumab-aqvh), biosimilar to HUMIRA®, in the United States in 2023, and has discontinued development of CHS-305 (“IBI-305”), an AVASTIN® (bevacizumab) biosimilar candidate, and is returning IBI-305 rights to Innovent Biologics (Suzhou) Co., Ltd.  Coherus also reports that it is currently finalizing the preparations to launch CIMERLI (ranibizumab-ranq), a LUCENTIS® biosimilar, later this year, if approved, into the $7 billion anti-VEGF ophthalmology market in the United States.

Coherus also reported receiving a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for Toripalimab.  Coherus says that, together with partner Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”), it “plan[s] to resubmit the Toripalimab BLA by mid-summer with an expected six month review” by the FDA and is “preparing for the commercial launch directly upon approval.” Toripalimab is an anti-PD-1 monoclonal antibody designed to block PD-1 interactions with its ligands, PD-L1 and PD-L2.

Teva:  Also at the beginning of May, Teva reported total quarterly revenue of $3.7 billion, and the generic products revenues in North America segment (including biosimilars) were $899 million, a decrease of 15% compared to the first quarter of 2021.  As reported by Teva, this decrease reflects increased competition on key products and lower volumes, partially offset by higher revenues from lenalidomide capsules (the generic version of REVLIMID®) and TRUXIMA® (rituximab-abbs).  Mr. Kåre Schultz, Teva’s President and CEO, stated that “[t]he Company has a broad biosimilar portfolio with 13 biosimilars in development now, and Teva now has a settled entry date of July 2023 for biosimilar HUMIRA®.”  And longer term, the Company is aiming for addressing some roughly 80% of the value in biologic products going off patent, both in America and Europe.

Amneal:  Amneal announced its first quarter revenue of $498 million, an increase of 1% as compared to $493 million in the first quarter of 2021.  The company reports that its 2022 Q1 net loss “was $2 million … compared to a net income of $7 million in the first quarter of 2021.”  The company noted that “[b]eginning in the first quarter of 2022, we will no longer exclude research and development milestone expenses from non-GAAP financial measures.  In the first quarter of 2022 and 2021, R&D milestone expenses were $5 million and $11 million, respectively.”

This quarter, Amneal’s first U.S. biosimilars were approved: RELEUKO® (filgrastim-ayow) and ALYMSYS® (bevacizumab-maly).  The company is reportedly currently awaiting the additional approval of its pegfilgrastim biosimilar.  As reported on the earnings call, Amneal expects to launch 3 biosimilars in 2022.

Pfizer:  Pfizer’s first quarter revenue were reportedly up 82% operationally compared with the first quarter of 2021.  The company identified its oncology biosimilars portfolio as a “key growth driver for the quarter.”  Angela Hwang, Group President of the Biopharmaceuticals Group, predicted that the company would “be able to gain a fair market share” of the biosimilar market in the U.S. in the future, noting the company’s 6 recently launched biosimilars in oncology.

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