Pharmaceutical Market Europe • November 2021 • 8-9

NEWS

Pfizer’s 2021 revenue predictions soar to $82bn

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Pfizer’s third-quarter sales figures show that the company expects to bring in up to $82bn in the full year, up from $41.9bn in 2020, powered by $36bn from 2.3 million doses of COVID-19 vaccine Comirnaty.

From July to September, Pfizer’s revenues were $24.1bn, representing operational growth of 130%, although revenues from Pfizer’s other drugs also grew to $11.1bn, up by 7% from the same period last year.

Pfizer chairman and CEO Albert Bourla said the company was on track to achieve its goal of delivering “at least two billion doses” to low- and middle-income countries by the end of 2022, with at least one billion being delivered this year. Pfizer will supply one billion doses to the US government on a not-for-profit basis to be donated to the world’s poorest nations free of charge, he added.

In addition to $13bn in sales from Comirnaty, anticoagulant Eliquis (apixaban) grew by 19% to $1.3bn, amyloidosis therapy Vyndaqel/Vyndamax (tafamidis) was up by 42% to $502m and Inlyta increased its sales by 30%, driven by first-line use in advanced renal cell carcinoma.

Pfizer’s biosimilars business grew by 34% to $575m, driven by the launches of Ruxience (rituximab), Zirabev (bevacizumab) and Trazimera (trastuzumab), as well as continued growth from Retacrit (epoetin) in the US. The company now has the largest portfolio in the industry with six biosimilars approved in the US for patients living with cancer.


Sanofi sees double-digit growth driven by ‘megabrand’ Dupixent

Strong growth from its new asthma/allergy antibody blockbuster Dupixent (dupilumab) sees Paris-based Sanofi reach double-digit sales growth in July to September.

Dupixent sales were €1.4bn in the third quarter, up by 54.6% from earlier in the year, driving Sanofi’s entire specialty care business to a 20% growth.

The company’s vaccine portfolio was also up by 16% to €2.4bn – driven by its flu shots – and its consumer health business saw an 11% rise in sales, although general medicine sales were down by nearly 2%.

The weight Sanofi is putting behind Dupixent seems to be paying off, with specialty care head, Bill Sibold, predicting annual sales of €6bn, although Sanofi CEO Paul Hudson has a strategy to push the megabrand to peak sales of €10bn.

Dupixent’s growth is due to market dominance in atopic dermatitis, plus ‘continued uptake’ in asthma and chronic rhinosinusitis with nasal polyps, said Sanofi. The brand recently replaced AbbVie goliath, Humira, as the top spender on TV advertising.

In spite of the good news, Sanofi has experienced some setbacks this quarter. After delays to its phase 3 trials in haemophilia drug, fitusiran, due to blood clots last year, regulatory approval is not now expected until 2024. Other drugs that were delayed include tusamitamab in lung cancer and BTK inhibitor rilzabrutinib (which the company acquired from the $3.7bn Principia Biopharma deal).


Gilead Q3 sales buoyed by anti-COVID-19 drug Veklury

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Gilead has reported third-quarter sales of $7.4bn, an increase of 13% compared to the same period last year, due to increased demand for its COVID-19 antiviral Veklury (remdesivir).

Without the Veklury bump, total product sales decreased by 3% to $5.4bn for the third quarter, primarily due to the loss of exclusivity of HIV combination therapies Truvada and Atripla in the US. The drop was also partially offset by a 20% increase to $2.3bn from Biktarvy and Trodelvy, said Gilead.

Veklury saw sales of $1.9bn, more than double that of the second quarter of the year ($829m), as more than two million people received the drug or generic remdesivir.

Its cell therapy product sales increased by 51% to $222m in the third quarter. Yescarta reached $175m in relapsed/refractory large B-cell lymphoma and relapsed/refractory indolent follicular lymphoma in both the US and Europe.

Sales of Tecartus saw $47m in mantle cell lymphoma and Trodelvy hit $101m, reflecting increased use for the second-line treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer in the US.

Gilead has updated its full-year guidance and now expects total product sales of up to $26.3bn in 2021, up from $24.4bn in 2020.

While total products sales excluding Veklury are expected to be down slightly at $21.5bn (compared to $21.7bn in 2020), sales of the anti-COVID antiviral are expected to reach $4.8bn based on expected hospitalisation rates.


BMS reports strong growth as its Q3 results beat predictions

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US-based Bristol Myers Squibb (BMS) has announced a 10% increase in revenue in the three months to September, driven by strong demand across all four of its key therapeutic areas.

Revenues topped out at $11.6bn, which included $7.3bn in US sales (up by 12% on last year) and $4.3bn in international revenues, up by 8% on the same quarter in 2020.

The drivers of growth were multiple myeloma drug Revlimid, which saw sales of $3.34bn (up by 11%), blood-thinner Eliquis with $2.41bn (up by 15%) and cancer drug Opdivo with sales of $1.9bn (up by 7%).

With generic competition for Revlimid expected next year, BMS is keen to highlight its new product sales, which more than doubled from $161m in the first quarter to $344m in Q3.

The company’s CAR-T cancer drugs posted strong growth: Abecma, which launched in May as the first cell-based gene therapy for multiple myeloma, had $71m in sales, up from $24m in Q2, while Breyanzi, launched this year in lymphoma, had $30m in sales, up from $17m earlier in the year.

The company also highlighted several pipeline achievements: a ‘compelling and differentiated’ profile for Deucrava, seen in two phase 3 studies and its potential as a treatment for psoriatic arthritis.


Novartis sales top £13bn in Q3

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Swiss-based Novartis has announced ‘solid Q3 growth’ of 5% compared to the same period last year, with innovative medicines up by 7%.

The increase was driven by the strong performance of its heart failure combination Entresto which was up by 44%, psoriasis antibody Cosentyx up by 22%, myelofibrosis drug Jakavi up by 26%, spinal muscular atrophy gene therapy Zolgensma up by 28%, and cancer medicine Kisqali, which grew by 27% in sales revenue.

Net sales topped $13bn for Q3; top earners were Entresto with $924m – which saw ‘continued strong growth’ and increased patient share – and Cosentyx, with $1bn in sales driven by ‘sustained underlying demand’ in the US and Europe as well as strong volume growth in China. Overall, Novartis operations in China grew strongly, with sales reaching $839m, which were also up by 18%.

However, generics division Sandoz reported a 2% fall in sales driven by a 20% drop in the US. Novartis has announced that it has started a strategic review of Sandoz that will ‘explore all options’, including separating the two businesses.

Key innovation milestones in Q3 include Kisqali demonstrating statistically significant survival benefit for 1L HR+/HER2- advanced breast cancer, Cosentyx meeting its primary endpoint in phase 2 giant cell arteritis study and remibrutinib meeting its primary endpoint in phase 2b for patients with chronic spontaneous urticaria.


Eli Lilly focuses on 2022 launches as revenues climb

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Four growth products have fuelled an 18% increase in revenues at Eli Lilly between July and September this year compared to the same period last year.

Diabetes medicine Trulicity, immunology blockbuster Taltz, breast cancer therapy Verzenio and migraine prevention antibody Emgality each saw revenues rise by more than 30% year on year.

US-based Lilly recorded worldwide revenue of $6.77bn in Q3, including worldwide revenue of $423.5m for COVID-19 therapies.

Excluding revenue from COVID-19 therapies, revenue growth was 11% in both third-quarter and year-to-date 2021 results.

Highlighting “numerous positive pipeline events” and the expansion of Verzenio and Jardiance through new indications, CEO David Ricks announced two pieces of regulatory news.

The first is that Lilly has started a rolling submission to the US Food and Drug Administration (FDA) for accelerated approval of donanemab in early Alzheimer’s disease. This will pit the drug against Biogen’s drug Aduhelm, which has been slow to get off the starting blocks following its controversial approval earlier this year. The phase 3 TRAILBLAZER-ALZ 4 is a head-to-head clinical trial aimed to compare the action of donanemab and Adhulem in clearing brain amyloid plaque in early symptomatic Alzheimer’s disease.

The second is a new drug application (NDA) to the FDA and a marketing authorisation application to the European Medicines Agency (EMA) for tirzepatide for the treatment of adults with type 2 diabetes. Both drugs will be important 2022 launches for Lilly, if approved.