Approvals in past 5 years: 7
Value of recent approvals: $30.16 billion
Percent of value from recent approvals: 24.46%
If there’s one thing GlaxoSmithKline knows all too well, it’s that investors are keeping a watchful eye on its pipeline.
While the British pharma has racked up a number of regulatory wins in recent years, it’s also posted its fair share of R&D flops, particularly in oncology. That’s not to mention GSK’s questionable decision as the world’s largest vaccine company to forgo developing its own COVID-19 jab, but rather proffer its adjuvant to other candidates.
When it comes to pushing drugs over the FDA’s finish line, GSK has done fairly well, scoring seven regulatory nods for new treatments over the last five years. That places it about the middle of the pack among 11 Big Pharma peers included in this report.
GSK’s entire class of marketed drugs carries a net present value of $123 billion, ranking just above Eli Lilly on that metric. Nearly a quarter of that, or about $30 billion, comes from GSK’s new drugs, according to EvaluatePharma and Evaluate Vantage estimates. To note, GSK also shares the revenues for two of its new HIV meds through its ViiV Healthcare joint venture.
GSK’s pipeline performance, amplified by activist investor group Elliott Management in recent months, has taken center stage as CEO Emma Walmsley moves to split the company into two separate companies—one focused on consumer health and the other on pharma and its lucrative vaccine business.
Elliott has raised doubts over whether Walmsley, who’s been in the top job for four years, is the right person to oversee the "New GSK" that's focused on drugs and vaccines. For its part, GSK is standing behind its chief to drive £33 billion ($46 billion) in sales by 2031.
GSK is relying on its vaccine business, particularly its newest “crown jewel” Shingrix, to pave the way. First approved in 2017 for the prevention of shingles in adults 50 and older, the vaccine recently won the FDA’s go-ahead for younger patients who are immunocompromised and at a greater risk of developing the viral condition.
The shot carries the highest net present value of all of GSK’s latest medicines at about $18.3 billion, Evaluate says. Right now, though, GSK is trying to get Shingrix back on its blazing path after the pandemic knocked it off course.
The jab generated about £1.99 billion ($2.71 billion) in 2020, but that mere 11% year-over-year growth marked a clear slowdown compared to 2019 when sales more than doubled.
GSK also has to contend with a key patent loss coming down the pike for its HIV bellwether dolutegravir starting in 2028. That molecule is found in four of GSK’s best-selling HIV brands—Tivicay, Triumeq, Juluca and Dovato.
To offset some of that decline, GSK is placing its hopes in more convenient long-acting HIV injectables over daily pills to fill the void. One of those includes Cabenuva, which became the world’s first complete long-acting, injectable HIV treatment upon its FDA approval in January.
The treatment, which combines Viiv’s cabotegravir and Johnson & Johnson’s rilpivirine, carries a net present value of about $2.8 billion, Evaluate says. That far outpaces the $708 million value for another new HIV treatment, Rukobia, which joined GSK’s portfolio last year. The med, taken alongside other existing antiretroviral therapies, is relegated to patients who are resistant to multiple HIV drugs.
Heading into 2021, the U.K.-based drugmaker had reported notable oncology R&D fumbles. That included the failure of late-stage cancer drug bintrafusp alfa in a key clinical trial and an inspection setback for another oncology hopeful, dostarlimab, amid the pandemic.
Despite those delays, dostarlimab—sold as Jemperli—finally garnered its FDA nod in April for or previously treated patients with advanced or recurrent mismatch repair-deficient (dMMR) endometrial cancer. With that nod, Jemperli joined a crowded field of PD-1/L1 inhibitors dominated by Merck’s Keytruda. Evaluate says Jemperli’s net present value stands at $2.3 billion.
Just before Jemperli's approval, GSK clutched an FDA nod for Blenrep, a BCMA-targeted antibody-drug conjugate for multiple myeloma patients who’ve tried four other options. That drug, which Evaluate values at about $5.9 billion in net present value, was closely followed by Bristol Myers Squibb’s Abecma in March and could soon be joined by Johnson & Johnson’s cilta-cel.