Cimzia Keeps Raking In The Cash As UCB Waits For New Products Impact

The Belgian group’s older products helped push 2022 revenues to the top of their guidance range as the peak sales forecast for the new epilepsy drug Fintepla is set at €800m.

Source: UCB

 

As it patiently waits to finally get US approval for potential autoimmune disease blockbuster Bimzelx, UCB S.A. has been highlighting the continued strong growth of its less high-profile drug in the space, the TNF blocker, Cimzia.

The Belgian drugmaker has issued a financial update saying that it expects to "land at the upper end of the range" of its guidance for 2022 which targeted revenues of €5.3bn-$5.4bn. Much of the total is coming from Cimzia (certolizumab pegol), which is approved for psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis, as well as for Crohn's disease and rheumatoid arthritis.

UCB noted that the drug had reached its guided peak sales target of €2bn well ahead of time as it was forecast to hit that mark by 2024. The company enjoyed a strong year "despite the macroeconomic headwinds," and group sales will come in ahead of analyst consensus forecasts thanks to the performance of Cimzia and the anti-seizure drug Vimpat (lacosamide), although the latter is now facing generic competition on both sides of the Atlantic.

Chief financial officer Sandrine Dufour said the group's solid performance was also boosted by the successful integration of Zogenix, acquired in March 2022 in a deal valued at $1.9bn, which proved less dilutive to earnings than had been expected. She also heralded UCB's "cost discipline, wise resource allocations and efficiencies." (Also see "UCB Jumps Early Onto M&A Merry-Go-Round With Zogenix Buy" - Scrip, 19 Jan, 2022.)

The Zogenix purchase was centred around the epilepsy drug Fintepla (fenfluramine), which was already approved in the US and EU for Dravet syndrome. Under UCB's ownership, it has also secured the green light from the US Food and Drug Administration and a positive opinion from the European Medicines Agency for another rare type of epilepsy, Lennox-Gastaut syndrome (LGS).

Dufour said that "we are very confident about the future of UCB," and Fintepla will play a big part. She gave expected peak sales for the first time for the drug, guiding for €800m by 2027, which is well above consensus of around €580m; Fintepla is competing with Jazz Pharmaceuticals plc’s Epidiolex (cannabidiol), secured with the $7.2bn acquisition of GW Pharmaceuticals in 2021, which is also approved for Dravet and LGS.

Analysts at Jefferies issued a note saying they were not surprised to see UCB shares rise on the morning of 10 January, "although given the limited magnitude of beat in terms of the top of the range versus consensus expectations, we are surprised to see them up over 4%." The broker, which reiterated its buy rating on the stock, expects UCB to post a 1.7% revenue increase in 2023, although consensus models a 1.3% decline.

Much could depend on when Bimzelx (bimekizumab) finally enters the key US psoriasis market. Having comfortably secured approval in the EU and the UK for the IL-17A and IL-17F inhibitor in August 2021, UCB has endured a torrid time in the US and after a series of problems relating to manufacturing issues, the company only resubmitted the drug in November.  (Also see "UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx" - Scrip, 13 May, 2022.)  (Also see "UCB Makes Another Push To Get Bimzelx Over Finishing Line In US" - Scrip, 23 Nov, 2022.)

The FDA accepted the resubmission just before Christmas but designated it as Class 2 which means a six-month review period that could include a re-inspection of UCB's fill-finish facility. A Class 1 would have meant just a two-month review cycle but UCB remains enthusiastic about the prospects for Bimzelx in hidradenitis suppurativa, psoriatic arthritis and axial spondyloarthritis, as well as psoriasis. (Also see "UCB Aims High In Hidradenitis Suppurativa After Bimzelx Success" - Scrip, 9 Dec, 2022.)

Rozanolixizumab Filed For gMG

UCB will be hoping for a less bumpy ride from regulators for another potential big earner, rozanolixizumab. In the last couple of weeks, the subcutaneous monoclonal antibody targeting the neonatal Fc receptor (FcRn) has been filed in the US and the EU for generalized myasthenia gravis (gMG), which causes muscle weakness and fatigue.

The FDA has granted a priority review for rozanolixizumab, so a decision could come within six months, compared with 10 months under standard review. The drug has a different but potentially complementary mechanism of action to UCB’s other gMG treatment, zilucoplan, which was filed with the EMA for review in September and with the FDA in November. Zilucoplan is a subcutaneous, self-administered peptide inhibitor of complement component 5 (C5 inhibitor). (Also see "Can UCB Make Its Mark In Myasthenia Gravis?" - Scrip, 11 May, 2022.)

The gMG space is becoming a competitive one and UCB would be going up against AstraZeneca PLC's blockbuster Soliris (eculizumab) and its follow-up Ultomiris (ravulizumab), and argenx N.V.'s Vyvgart (efgartigimod).