Biotech investing is not for the weak-hearted. While the clinical and regulatory success of a drug can mean huge gains, any failure in the development and commercialization process can literally decimate a biotech investor's portfolio.
Many investors consider Moderna (NASDAQ:MRNA) to be one such risky biotechnology company, with fortunes largely dependent on the success or failure of its experimental COVID-19 vaccine, mRNA-1273. But although Moderna may be riskier than other prominent COVID-19 vaccine players such as Pfizer (NYSE:PFE) and AstraZeneca (NASDAQ:AZN), that doesn't mean it's purely a speculative play. mRNA-1273 is definitely the biggest short-term growth driver for the company -- but Moderna also has much more to offer in the field of mRNA therapeutics.
Here are three reasons why healthcare investors can consider starting a small position in this high-growth stock on any pullback in 2020.
Its COVID-19 vaccine could be a game-changer
With traditional vaccines, a small and/or inactive amount of a virus or disease is injected to provoke the body into mounting an immune response to the proteins the intruder produces. mRNA vaccines are different, using messenger RNA -- a molecule in cells that translates DNA into proteins -- to fool the body into producing some of the virus's proteins itself, then mounting the immune response. No mRNA vaccines have ever been approved for human use, but Pfizer and BioNTech (NASDAQ:BNTX) recently reported 95% overall efficacy for their mRNA-based COVID-19 vaccine candidate, BNT162b2, based on an ongoing phase 3 study. The companies did not report any serious safety concerns.
The positive news from these competitors bodes well for Moderna. The mRNA technology that is Moderna's focus, and that Pfizer and BioNTech used to make their vaccine candidate, is not yet commercialized, so the latter's success should boost confidence in Moderna's approach.
Also, vaccine development is generally more time-consuming than drug development, requiring a wide array of safety studies to ensure that the vaccine does not cause serious adverse events in various populations. But to speed up the process, this protocol has not been followed for potential COVID-19 vaccines, meaning the safety of any vaccine development platform must now be assessed based on the totality of data available from all companies. Because of this, Pfizer and BioNTech's positive safety data is good news for Moderna, too.
On Nov. 16, Moderna reported efficacy of 94.5% for mRNA-1273 in a phase 3 study that involved more than 30,000 participants. This is important especially considering that many participants were from the populations most affected by the pandemic, including people over 65 years of age, people of color, and people with comorbidities such as diabetes, obesity, and cardiac diseases. Moderna has also not reported any severe side effects for its vaccine in the interim analysis; two-month safety follow-up data should be released at the end of November.
In the end, it may be logistics that prove to be the winning stroke for Moderna. mRNA-1273 can remain stable at -20 degrees Celsius (about -4 Fahrenheit) for six months, at temperatures of 2 to 8 degrees Celsius (about 35 to 46 degrees Fahrenheit) for 30 days, and at room temperature for 12 hours. Hence, this vaccine can be easily distributed using existing transportation and storage infrastructure. Pfizer's BNT162b2 vaccine candidate, however, has to be stored at -70 degrees Celsius (-94 degrees Fahrenheit), making it pretty difficult to transport and store even in developed countries.
mRNA therapeutics are a big opportunity
Moderna is a key player in the mRNA vaccines and therapeutics landscape, a global market expected to be worth $9.4 billion by the end of 2021. Investors are showing increasing confidence in Moderna's other clinical programs, such as vaccines for cytomegalovirus (CMV) and Zika, personalized cancer vaccines for solid tumors and melanoma, and other vaccines and treatments for a range of rare diseases.
In September, Moderna announced positive interim results for its CMV vaccine candidate, mRNA-1647. The company estimates the vaccine's peak sales in the range of $2 billion to $5 billion per year , considering that CMV is the leading cause of birth defects in developed countries and there is no approved vaccine against this infection.
An increase in cash will boost R&D
Moderna plans to produce 20 million doses of the coronavirus vaccine by the end of 2020 in the U.S. and 500 million to 1 billion doses worldwide in 2021. The company plans to price mRNA-1273 in the range of $25 to $37 per dose, depending on purchase quantity. Moderna has already secured a $1.5 billion contract from the U.S. government to supply 100 million doses, with an option for an additional 400 million. The company has also received $1.1 billion in cash payments from governments around the world.
Moderna currently has cash and investments worth $4 billion and zero debt on its balance sheet. A significant sales ramp-up in 2021 will add to the company's cash reserve, which in turn can fuel the research and development (R&D) pipeline.
There are risks to be considered
Moderna is trading at a forward price-to-earnings (P/E) multiple (calculated by dividing share price by forecasted earnings per share for the next fiscal year) of 22.4. Other far more diversified and less risky COVID-19 vaccine players -- such as Pfizer, AstraZeneca, and Johnson & Johnson (NYSE:JNJ) -- are trading at forward P/E multiples of 12.9, 21.9, and 16.3, respectively. Moderna is definitely a more expensive pick than any other coronavirus vaccine player.
Moderna's share price depends heavily on the potential success of mRNA-1273. The company has not disclosed information about the time period for which the vaccine protects individuals after dosage and whether it prevents transmission from one person to another. Moderna also did not include children in its phase 3 trial, which may limit use of the vaccine in this population. Investors are concerned about the insider trading activity of some high-ranking Moderna executives, and excessive stock selling by insiders is a potent threat to the company's share prices.
Despite all of these uncertainties, Moderna is essentially a play on the future of mRNA technology. Taking on a big position in this stock right now may prove risky. However, interested healthcare investors with above-average risk appetite can find enough reason to start a small holding in Moderna -- especially on any pullback in stock price.