It's safe to say that the bulk of healthcare investors' attention has settled on players in the coronavirus vaccine race. But biotech and pharmaceutical companies are also working to develop drugs that can treat patients already diagnosed with COVID-19, the virus that has led to economic shutdowns worldwide and over 190,000 deaths in the U.S. alone. Over 1,900 clinical studies are currently recruiting trial participants or are in active pre-trial stages, according to the National Institutes of Health (NIH). That count includes vaccine trials, but also potential treatments ranging from hydroxychloroquine, to plasma-based therapies, and even traditional Chinese medicines.
It's impossible to guess which -- if any -- of the studied treatments will be successful until they earn regulatory approvals. But at this stage, one particular company's efforts have already caught my eye: Regeneron Pharmaceuticals (REGN 0.91%) is developing its investigational antibody therapy to treat and prevent COVID-19. That's two markets, and two major opportunities. If the treatment is safe and effective for both types of use, Regeneron could hit the jackpot. And if you buy the stock, you might too. Let's take a closer look at this biotech company's program.
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An antibody cocktail
Regeneron used its fleet of genetically engineered mice to test its investigational product. Researchers studied thousands of human antibodies produced by the mice and concurrently isolated antibodies from recovered COVID-19 patients. Then, researchers chose the two antibodies from either study that were best able to neutralize the virus and combined them, creating the candidate REGN-COV2, an "antibody cocktail."
Regeneron planned for its clinical studies to overlap in order to speed up the development timeline. On June 11, the company announced the start of human trials. After a positive safety review in 30 hospitalized and non-hospitalized COVID-19 patients, the company launched a phase 2/3 trial to test the drug candidate's efficacy.
On July 6, Regeneron reported that a phase 3 trial had begun, which aimed to enroll 2,000 participants. This trial is currently evaluating the cocktail's ability to prevent infection in individuals who are in contact with COVID-19 patients. This may include a person living with a COVID-19 patient or medical professionals, for example. Regeneron expects to report initial results from the trials this month. This week, the company announced the start of a separate phase 3 trial in the U.K. to evaluate REGN-COV2 in addition to standard-of-care treatment versus standard-of-care alone. If trials show that the antibody cocktail candidate can appropriately treat currently-ill patients and prevent future illness, Regeneron could find its product in high demand by two different patient groups.
Funding and partnerships
The company is also moving forward thanks to support from outside funding and new partnerships. In July, Operation Warp Speed (OWS), the government program created to accelerate the development of COVID-19 vaccines and treatments, penned a $450 million contract with Regeneron in order to scale the development and manufacturing of REGN-COV2. While the company's current trials aim to pinpoint the necessary number of treatment doses per patient, Regeron estimates that it will produce between 70,000 and 300,000 treatment doses for the U.S. government.
Regeneron has joined forces with Switzerland-based Roche (RHHBY 1.10%) in order to prepare for the distribution of REGN-COV2 internationally. The partnership with the drug giant will increase production capacity by three and a half times. Under the agreement, both companies will jointly fund the ongoing clinical trials. This partnership spells gains for Regeneron in terms of both manufacturing potential and financial benefits from Roche's investment. Regeneron will market REGN-COV2 in the U.S. -- if the treatment is approved -- and Roche will market it outside of the U.S.
Will buying Regeneron today will make you rich?
If the past is any indicator, gains in Regeneron have come over longer periods of time. For instance, if you invested $10,000 in Regeneron at the start of 2011, you would have over $170,000 today. But if you invested the same amount at the start of 2016, your investment would be worth just over $10,700 today. Between 2011 and today, five of Regeneron's six drugs won regulatory approval. Some of Regeneron's best-selling drugs include Eylea, a treatment for wet age-related macular degeneration, and Dupixent, a treatment for atopic dermatitis. While approvals and growing revenue have powered massive share gains over the decade, the share price has fluctuated between $300 and $600 over the past four years. If that roller coaster ride continues, a new investor may not reap rewards right off the bat.
Still, this year, Regeneron shares are on a roll. They've gained 50% and positive REGN-COV2 news would only push them higher, especially if the cocktail candidate meets its goal of addressing both the treatment and prevention markets. That said, anything can happen in clinical trials -- including failure. And that could hurt Regeneron in the near term.
Considering all of this, if you buy Regeneron shares, plan to buy and hold for the long term. And do so only if you're confident in this biotech company's pipeline and already marketed products. It's possible that investing in Regeneron today will make you rich years down the road, if product sales continue to rise and the pipeline produces successful drug candidates. And if regulators approve REGN-COV2, you may be on your way to getting rich a little sooner than expected.
