Europe’s Big Pharma Players Begin Tricky 2022 In Style
Executive Summary
Big pharma players have embraced a tricky operating environment in 2022 so far, treading a tightrope with political and financial challenges impacting their decision making and threatening to blow them off balance. However, what is not in doubt is the healthy growth experienced by those companies based around mainland Europe and the UK.
European pharma's first quarter financials have been delivered in a challenging and volatile operating environment, where the war in Ukraine and the impact of COVID-19 continue to have an impact, where inflation is up, as are energy and raw material costs and where political tensions are high.
Nevertheless, the continent's drugmakers delivered healthy growth in Q1. In the UK, AstraZeneca PLC continued to profit from the COVID-19 vaccine Vaxzevria, which brought in $1.15bn and Evusheld (tixagevimab/cilgavimab), the first drug to be authorized for the prevention of COVID-19 infections, which had sales of $469m. However, the firm expects its pandemic sales to decline by a low-to-mid 20s percentage given the impending global shift to the endemic phase.
The highlight of AstraZeneca's quarter was the performance of Farxiga/Forxiga (dapagliflozin). Sales of the SGLT2 inhibitor, which is approved for type 2 diabetes, heart failure with reduced ejection fraction (HFrEF) and chronic kidney disease. shot up by 56% to $1bn. (Also see "AstraZeneca’s Farxiga Flies Across $1bn Barrier" - Scrip, 29 Apr, 2022.)
AstraZeneca's UK-based peer GlaxoSmithKline plc, which officially changed its name to GSK on 16 May, enjoyed a strong start to the year thanks to a rebound in orders after the pandemic for shingles vaccine Shingrix, which brought in £698m, up by 17% on the previous quarter, and double the revenues of the COVID-19-hit like, year-earlier period. GSK aims to boost sales in the US and launch Shingrix in around 35 additional countries over the next three years, with the goal of doubling last year’s revenues of £2.8bn by 2026.
The monoclonal antibody Xevudy (sotrovimab) contributed £1.3bn to the coffers of GSK which is looking to spin out its consumer business, to be called Haleon, and list it on the London Stock Exchange this summer. Once Haleon is spun out, CEO Emma Walmsley promised that GSK would deliver sales growth of more than 5% per year to 2026. (Also see "GSK Gets A Lucky Q1 Boost, But All Eyes Are On RSV Vaccine Readout" - Scrip, 27 Apr, 2022.)
Over in Switzerland, Roche Holding AG noted that while first quarter sales rose 10% thanks mainly to strong demand for its antigen tests and pandemic-related demand for Actemra/Roactemra (tocilizumab) and the antibody therapy Ronapreve (casirivimab/imdevimab), the COVID-19 tailwinds the firm's products have enjoyed will blow much less strong this year. COVID-19 revenues from therapies and diagnostics are expected to decline from CHF5bn ($5.42bn) to CHF2bn in 2022, while continuing biosimilar erosion should shave off another CHF2.5bn off total revenues. (Also see "Slowing COVID-19 Sales Will Drag On Roche In 2022" - Scrip, 3 Feb, 2022.)
On the bright side, there were strong contributions from Hemlibra (emicizumab) for hemophilia, multiple sclerosis treatment Ocrevus (ocrelizumab) and Evrysdi (risdiplam) for spinal muscular atrophy and cancer immunotherapy Tecentriq (atezolizumab). However, the figures have been overshadowed by a couple of setbacks in the oncology pipeline, with the oral selective estrogen receptor degrader (SERD) giredestrant failing to show a benefit on progression-free survival in a Phase II trial for advanced breast cancer and the surprise failure of its anti-TIGIT tiragolumab in non-small cell lung cancer. (Also see "Roche's SERD Setback Means Menarini Retains An Edge" - Scrip, 25 Apr, 2022.) (Also see "Blow To Roche Growth Prospects As TIGIT Lung Cancer Trial Fails" - Scrip, 11 May, 2022.)
Across the river Rhine in Basel, Roche's neighbour Novartis AG noted that its new MS drug Kesimpta (ofatumumab) is well on its way to achieving blockbuster status and giving Roche's Ocrevus a run for its money. Sales in the first quarter reached $195m and CEO Vas Narasimhan said that around 20,000 patients have been treated, with over 60% of them being treatment-naive or first switch.
The cholesterol drug Leqvio (inclisiran), which has just been launched in the US and was approved in Europe in December 2020, brought in just $14m. Narasimhan, who has previously said that the therapy could become the biggest seller in Novartis's history, insisted that it was still early days, particularly in the US, but the foundations are being cemented to have this become a significant brand. (Also see "Novartis’s Kesimpta Already A Big Earner But Leqvio Is Slow Burner" - Scrip, 26 Apr, 2022.)
Over the border in France at Sanofi, the quarter was dominated by the continuing rise of blockbuster Dupixent (dupilumab). The dual inhibitor of IL-4 and IL-13, approved for atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis, brought in €1.61bn, a figure which will likely keep climbing, helped by new indications coming on board; it is under review for prurigo nodularis and eosinophilic esophagitis on both sides of the Atlantic. (Also see "Dupixent Drives Sanofi Growth Again Amid Pipeline Renewal" - Scrip, 28 Apr, 2022.)
CEO Paul Hudson noted that the company's research spend is now growing again "as we rebuild the pipeline following a period of lower R&D investments due to the prioritization within speciality care and discontinuation of diabetes and cardiovascular activities.” Sanofi also upped its business development activities in the quarter, placing its bets on a ‘super antibodies’ platform spanning oncology, immunology and inflammation by pairing up with IGM Biosciences, Inc. in a deal that could be worth up to $6bn and inking an agreement with Seagen Inc. to develop up to three antibody drug-conjugates. (Also see "Sanofi Bets Big On IgM ‘Super Antibodies’ In Potential $6bn Cancer and Immunology Deal" - Scrip, 29 Mar, 2022.) (Also see "Sanofi Dives Back Into ADCs With Seagen Pact" - Scrip, 17 Mar, 2022.)
In Germany, Bayer AGwas most enthusiastic about Nubeqa (darolutamide), which is selling well in the US, Europe and Japan and brought in €76m (+72.7%) in the first quarter. That figure is likely to climb considerably as the oral androgen receptor antagonist has been filed with the US Food and Drug Administration for metastatic hormone-sensitive prostate cancer (mHSPC); it is currently approved for non-metastatic castration-resistant prostate cancer.
Its top seller Xarelto (rivaroxaban) slipped due to price-related declines in China and lower license revenues from US partner Johnson & Johnson. However, Bayer trumpeted recent data on the investigational oral factor XIa inhibitor asundexian, which has been touted as a successor to Xarelto, which showed that 20mg and 50 mg doses of the drug were well-tolerated and resulted in significantly lower rates of bleeding compared with Pfizer Inc. and Bristol Myers Squibb Company's factor Xa inhibitor Eliquis (apixaban) in patients with atrial fibrillation. (Also see "D-Day Approaches For Bayer’s Asundexian Phase III Plans" - Scrip, 10 May, 2022.)
Finally in Denmark, the first-quarter figures at Novo Nordisk A/S showed that the firm has largely overcome manufacturing issues for its obesity newcomer Wegovy (semaglutide), with the once-weekly GLP-1 agonist posting sales of DKK 1.4bn ($198m). Combined with DDK2.0bn in sales for Wegovy’s weight loss predecessor Saxenda, Novo’s overall obesity care sales soared 107% to DKK3.40bn. (Also see "Novo’s Wegovy Excels But Lilly Rival Hot On Heels" - Scrip, 29 Apr, 2022.)
However, the Wegovy success story could soon be tempered by the predicted strong challenge coming from Eli Lilly and Company and its once-weekly GLP-1/GIP agonist Mounjaro (tirzepatide) which was approved for obesity earlier this month by the FDA. Lilly recently reported significant weight loss among non-diabetic adults treated with its obesity drug in the Phase III SURMOUNT-1 clinical trial, which appeared to be superior to Wegovy’s trial results. (Also see "Lilly’s Mounjaro Diabetes Approval Is First Challenge To Novo’s GLP-1 Franchise" - Scrip, 13 May, 2022.)