6. GlaxoSmithKline

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GSK's vaccine portfolio, led by shingles shot Shingrix, was slowed down in 2020 by COVID-related lower vaccination rate. (Eric Sagonowsky)

GlaxoSmithKline
2020 revenue: £34.10 billion ($43.77 billion)
2019 revenue: £33.75 billion ($43.32 billion)
Headquarters: Brentford, United Kingdom

GlaxoSmithKline is one of the world’s largest vaccine makers, with a broad portfolio covering meningitis, influenza, shingles, DTaP, and more. But in the early race to develop an effective COVID-19 shot, the British pharma decided to take a supporting role, offering its adjuvant to boost the potency of other companies’ candidates rather than developing its own vaccine.

Unfortunately, both GSK's established vaccines and its COVID efforts suffered during the pandemic, contributing to flat year-over-year sales.

The most prominent adjuvant collaboration GSK signed was with Sanofi on a recombinant protein-based COVID vaccine, but that suffered a setback that pushed the pair behind many other players.

The partners were forced to rejigger their formulation in December, after the vaccine failed to trigger a strong enough immune response in people aged 50 years and older who participated in a phase 1/2 study.

A new phase 2 with the tweaked version of the COVID vaccine started a few weeks ago, with a potential phase 3 planned for the second quarter.

RELATED: After setback, Sanofi, GSK take tweaked COVID-19 vaccine into phase 2

Meanwhile, GSK’s established vaccines were hit hard, as consumers put off routine vaccinations during the pandemic. Its growth engine, shingles vaccine Shingrix, registered 10% growth to £1.99 billion sales in 2020, but that was disappointing, given that the demand for the shot had been outstripping the supply before the pandemic. And it wasn’t enough to offset the 15% decline in total sales of its established vaccines, which brought in £3.23 billion last year.

With COVID-19 vaccinations now being prioritized, GSK expects the Shingrix slowdown will continue at least through the first half of 2021, with no real uptick until 2022. Still, GSK’s pharma chief, Luke Miels, said during a conference call in February that the underlying demand for Shingrix remains strong, and sales are “deferred, not lost.”

GSK did have some bright spots in 2020, including its respiratory product line. Three-in-one inhaler Trelegy hauled in £819 million, up 58% year over year. The drug picked up a vital FDA nod in September as a maintenance therapy for asthma, on top of its original COPD indication. As a result, its U.S. new-to-brand share prescribed by allergists tripled in 2020, according to Miels.

RELATED: As GSK enters key transition year, COVID-19 immunization could hurt Shingrix uptake: exec

Pressure is gaining on Trelegy, though. AstraZeneca launched its own triplet, Breztri, in COPD in July after having suffered a previous FDA rejection, and a matching asthma nod is on the horizon.

Further complicating the competitive picture is a recent rejection of GSK’s petition to tap into the asthma market in Europe. In rejecting that label expansion in February, the European Medicines Agency took issue (PDF) with GSK's failure to show the drug produced an additional benefit in reducing sudden asthma attacks compared with its dual-drug sister, Breo, known as Relvar in Europe. The phase 3 data GSK used showed that Trelegy could further improve lung function, but the EMA said that alone wasn’t enough for approval in asthma.

The other GSK respiratory growth driver, Nucala, pulled in £994 million, up 29% year over year. Last year, Nucala added an FDA green light to treat a rare blood cell disease called hypereosinophilic syndrome. GSK has also filed for FDA approval of Nucala as a treatment for patients with chronic rhinosinusitis with nasal polyps. The phase 3 Synapse trial showed that Nucala shrank nasal polyps and reduced the level of nasal obstruction over standard care and that it could extend the time before patients had to undergo surgery.

Sanofi and Regeneron compete in the sinusitis market with their product, Dupixent, and AstraZeneca is also eying the nasal polyps field with its rival biologic drug, Fasenra. AZ announced a positive phase 3 readout in September. Both Nucala and Fasenra are IL-5 inhibitors, and Nucala currently holds a market share lead against its competitor in all major markets. GSK is also working on a long-acting IL-5 drug, GSK294, which aims to reduce the dosing frequency from once every four weeks for Nucala to once every six months. The therapy just entered phase 3.

RELATED: GSK's ViiV, touting superior long-acting data, can challenge Gilead in HIV prevention: analyst

HIV is another pillar of GSK’s pharma franchise. In 2020, HIV sales were flat at 4.88 billion, but GSK achieved several breakthroughs there. They included the approvals of the world’s first full-regimen, long-acting HIV injectable Cabenuva in Canada and the EU. The drug earned an FDA nod this January.

Injectable cabotegravir, a component of Cabenuva that’s given every two months, could give GSK a leg up on Gilead’s blockbuster PrEP monopoly. Clinical trial data showed that cabotegravir is a much better HIV prevention drug than Gilead's daily oral Truvada in both men and women. The wins came a year ahead of schedule as GSK’s ViiV Healthcare plots an early filing.

GSK has also made a major push into oncology R&D, but that effort hasn’t yielded high returns. PARP inhibitor Zejula did win an important FDA clearance as a first-line maintenance therapy for ovarian cancer patients who respond to an initial round of chemo, regardless of BRCA mutation status. It’s a wider label than a similar indication AZ and Merck got for their rival med Lynparza, used in tandem with Roche’s Avastin.

As a result, Zejula’s 2020 sales grew 48% year over year to £339 million. Though it's still way behind blockbuster Lynparza, Zejula is now ahead of AZ for the treatment of ovarian cancer without BRCA mutations, Miels said.

Despite that win, GSK’s oncology pipeline hit several setbacks heading into 2021. Its Merck KGaA-partnered bifunctional fusion protein bintrafusp alfa failed to top Merck & Co.’s Keytruda in a head-to-head non-small cell lung cancer trial, and the company’s PD-1 inhibitor dostarlimab is being stalled by a COVID-related FDA inspection delay. As a result, SVB Leerink’s Geoffrey Porges questioned GSK’s long-term business outlook.

On the consumer health front, GSK has been busy integrating its own portfolio with Pfizer’s and working on executing a separation program in preparation for the planned spinoff in 2022. In 2020, the vitamins and food supplements franchise in the consumer department saw its sales grow by the high teens, as the pandemic drove consumers to prioritize preventive care.

6. GlaxoSmithKline