Regeneron Pharmaceuticals (REGN -2.25%), Vertex Pharmaceuticals (VRTX -1.73%) and Biogen (BIIB -1.11%) are developing remarkable therapies that, instead of merely treating disorders, have the potential to cure them or at least make an impact that no other drug has to date.
At the same time, all three companies are profitable, and their successes in the lab have been paying off in the market, with their shares up nearly 10% this year. Let's see why.
1. Regeneron is looking past COVID
Regeneron's shares are up about 10% this year, despite a second quarter that saw its revenue fall 44% year over year. The reason that's not a big cause for alarm is that the company's second-quarter revenue of $2.86 billion would be up 20% over the same period in 2021 if its COVID-19 therapy, REGEN-COV, was excluded from total revenue. The company's sales of the treatment ended late last year when government contracts for the therapy ended. Even without REGEN-COV, the company had earnings per share (EPS) of $7.47 in the quarter.
The biotech company's revolutionary concept is its process of using genetic research to develop specific antibodies that bind to two different antigen proteins. The company has medicines that treat atopic dermatitis, high cholesterol, retinal disease, prostate cancer, Ebola, rheumatoid arthritis, certain skin cancers, and non-small cell lung cancer. That doesn't include the 35 therapies it has in its pipeline.
It just reported positive data for its phase 1 study on ALN-HSD, which it is developing with Alnylam Pharmaceuticals to treat non-alcoholic steatohepatitis (NASH), a form of fatty liver disease which can lead to liver failure, cancer, and death.
Its current blockbuster drug, Dupixent, is approved alone or paired with other drugs to treat atopic dermatitis, asthma, eosinophilic esophagitis (a chronic immune system disorder), and chronic rhinosinusitis with nasal polyps. In the second quarter, it brought in $2.09 billion, up 40% year over year. Overall, the company reported $2.86 billion in revenue and earnings per share of $7.47.
Regeneron is well on its way to developing another blockbuster drug. Eylea (aflibercept), an anti-blindness treatment the company is developing with Bayer, showed effectiveness and safety at high dosages in late-stage trials. The potential label expansion would help a drug that brought in $1.6 million in the second quarter, up 14% over the same period last year.
2. Vertex's gene therapies are paying off
Vertex Pharmaceuticals' shares are up more than 33% this year. That may be due to several late-stage-trial successes that have investors excited. Most prominent is Exa-cel (CTX001), which the company is developing with CRISPR Therapeutics and is seen as a revolutionary potential cure for two genetic blood disorders -- transfusion-dependent thalassemia and severe sickle cell disease.
It's also expecting big things this year from VX-880, a stem-cell treatment to cure type 1 diabetes that is in Phase 1/2 trials.
Vertex is already profitable, thanks to cystic fibrosis drug Trikafta. In the second quarter, the company reported product revenue of $2.2 billion, up 22% year over year. The company reported EPS of $3.13 compared to $0.26 in the same period a year ago.
Trikafta alone was responsible for $1.89 billion in sales in the quarter, up 50.7%, year over year. The company raised its full-year revenue guidance to be between $8.6 billion to $8.8 billion, compared to $7.5 billion last year.
3. Biogen may be on the edge of a breakthrough
Biogen, founded in 1978, is one of the older biotech companies. It focuses on fighting neurological disorders and has a diverse portfolio. The company's stock is up some 36% over the past month, due to a promising Phase 3 trial for Lecanemab, an Alzheimer's drug that Biogen is developing with Japanese pharmaceutical company Eisai. Biogen said that the drug, after 18 months, slowed cognitive decline in Alzheimer's patients by 27%, compared to a placebo, based on the Clinical Dementia Rating Sum of Boxes scale (CDR-SB).
It's the second bite of the apple for Biogen, as another Alzheimer's drug it developed with Eisai, Aduhelm, had mixed clinical trials. Though Aduhelm was approved by the FDA, The Centers for Medicare and Medicaid Services said it would allow Medicare to pay for Aduhelm treatment only for Alzheimer's patients enrolled in qualifying clinical trials. As a consequence, Biogen hasn't been able to profit much from the drug.
Finding therapies that help slow the progression of Alzheimer's has been difficult because many drugs are rendered ineffective by the blood-brain barrier. Unlike Aduhelm and other Alzheimer's therapies, Lecanemab is the first to show a strong connection between reducing amyloid-related plaque in the brain associated with Alzheimer's and slowing the progression of the disease.
Biogen is already on solid financial ground to market Lecanemab. While revenue in the second quarter was a reported $2.589 billion, down 6% year over year, the company had EPS of $7.24, compared to EPS of $2.99 in the same period in 2021. Biogen also released improved guidance based on better top-line performance and cost-cutting measures. It now expects annual revenue of between $9.9 billion to $10.1 billion, up from an earlier range of between $9.7 billion to $10 billion. It also raised non-GAAP (adjusted) EPS from a range of $14.25 to $16.00 up to an estimate $15.25 to $16.75.
