With the latest batch of quarterly operating results behind most companies and rising economic anxiety across the globe, it's likely that most stocks will be driven by macro and sector-specific forces in the near term. But that may not be true for biodiesel producer Renewable Energy Group (NASDAQ:REGI) and pharma giant Novo Nordisk (NYSE:NVO).
Events taking place this September have the potential to leave a lasting mark on the two businesses. Renewable Energy Group's long-term future -- and a pending $370 million windfall -- could be heavily influenced by Congress returning to session after its summer recess. Meanwhile, U.S. regulators will hand down a decision on Novo Nordisk's most important drug candidate, oral semaglutide, by the end of the month. Some analysts expect the drug to deliver peak annual sales of $5 billion, which would inject much-needed growth into the pharma giant.
Here's why investors looking for a little excitement should watch these two stocks this September.
Can the trade war save the biodiesel industry?
There's no end in sight for the trade war between the United States and China. While Washington is holding all the cards from a geopolitical perspective, Beijing has still managed to inflict pain on its counterpart by sharply reducing imports of agricultural products. It hurts because agricultural products were the only trade category (excluding services) in which Uncle Sam had consistently run a surplus in recent years.
The economic burden caused by diminished access to global markets has fallen on American farmers, who've also had to deal with record flooding and uncertainty in the biofuels markets. The government cannot control the weather, and it seems invested in the trade war. That leaves biofuels markets, and especially the biodiesel industry, as one obvious lever to pull in any relief package extended to farmers.
Consider that the existence of America's biodiesel industry creates a market for soy oil and incentivizes soybean crushing, both of which used to be a net cost to farmers. But Congress allowed an important biodiesel tax credit to expire at the end of 2017. That's led to curtailed biodiesel production, which has put pressure on an important domestic market for farmers just as they're losing access to China.
That's also hurt Renewable Energy Group, which is North America's largest producer of biodiesel. The business reported an operating loss of $92 million in the first half of 2019 but estimates it would receive a $370 million windfall if Congress reinstates the tax credit. The company desperately needs the cash injection to invest in renewable diesel opportunities and outgrow the uncertainty of biodiesel markets for good.
Congress will be back in session in September following a monthlong recess. If an economic relief package is extended to farmers, then there's a solid chance it'll include retroactive reinstatement of the biodiesel tax credit, which has strong bipartisan support. There's no guarantee, but investors should expect the biodiesel industry to capitalize on its limited window of opportunity. In a strange, twisted way, the trade war might actually help biodiesel producers.
Stirring up a blockbuster market opportunity
A relatively new class of drugs has emerged in recent years for individuals with type 2 diabetes: glucagon-like peptide-1 (GLP-1) receptor agonists. These GLP-1 analogs mimic the function of incretin hormones that increase insulin production, reduce glucagon production (allowing the liver to retain its energy reserves), and slow increases in blood sugar levels. Clinical evidence suggests they may also hold potential in combating obesity.
The one downside for patients is that all GLP-1 drugs approved to date have to be injected. The one downside for companies is that the market is getting a little crowded, as there are now at least seven such drugs approved in the United States. Novo Nordisk thinks it can scale both obstacles with the first oral GLP-1 drug.
The company currently leads the GLP-1 market with Victoza (injectable liraglutide) and Ozempic (injectable semaglutide). The latter commanded a dominant 35% market share in the United States and 53% market share globally, with respect to new patients, at the end of June. Ozempic also delivered $568 million in revenue in the first half of 2019, which puts it on pace to cross the $1 billion annual sales mark this year.
Investors shouldn't overlook the importance of Ozempic earning blockbuster status, but that might represent only a fraction of the drug's potential. Novo Nordisk is currently waiting for the U.S. Food and Drug Administration to approve or reject oral semaglutide as an adjuvant to diet and exercise in patients with type 2 diabetes; a decision is expected by the end of September.
If the drug is approved, Novo Nordisk would own the first oral GLP-1 on the market. Analysts expect that would be a game changer for the drug class. According to FiercePharma, pharmaceutical analyst Evaluate predicts oral semaglutide could reach $2 billion in sales by 2024, although peak annual sales could hit $5 billion. For perspective, Novo Nordisk is on pace to deliver about $18 billion in total revenue in 2019.
Meeting those sky-high projections requires oral semaglutide to earn supplementary approvals to expand its label, such as in reducing cardiovascular events in individuals with type 2 diabetes -- but it must first get the stamp of approval later this month. As is the case with investing in any pharmaceutical stock, there's a degree of uncertainty with the regulatory approval for oral semaglutide. Investors will find out what the fate is for Novo Nordisk's promising drug soon enough.