On March 23, Sanofi (SNY -0.47%) and Regeneron's (REGN -0.84%) Dupixent shared positive results in its phase 3 clinical trial of patients with uncontrolled, chronic obstructive pulmonary disease (COPD).
With no novel treatments approved in over 10 years for the disease, Dupixent could be on the verge of breaking that long drought. What could this mean for Sanofi's future revenue? Let's take a look at the clinical data and the global COPD market to assess the sales potential of the drug.
An effective treatment option for a serious disease
COPD is a potentially fatal respiratory condition that harms the lungs and causes progressive lung function deterioration. Common physical symptoms of the condition include a persistent cough and shortness of breath, which can interfere with daily activities when severe enough. Unsurprisingly, the physical challenges of COPD can also result in depression, anxiety, and insomnia.
Image source: Getty Images.
COPD is diagnosed using pulmonary function tests. The forced expiratory volume in one second (FEV1) to forced vital capacity or FVC (the complete amount of air that can be exhaled with effort in one breath) ratio can be used to determine the disease's severity.
As expected, the prognosis for mild COPD is better than very severe COPD: The five-year survival rate of the disease ranges from 70% on the mild end of the spectrum to 40% on the severe end. Particularly severe cases of the disease have a two-year survival rate of just 50%.
Fortunately, cutting-edge treatments like Dupixent could soon make their way to the market and help numerous patients. Recognizing the tremendous unmet medical need of COPD, Sanofi and Regeneron shaved years off the standard clinical development timeline by its direct-to-phase 3 program approach. The reason for this confidence to go straight into late-stage trials is that the companies knew the drug's mechanism of action and were confident that it could produce results for COPD patients.
Patients with uncontrolled COPD who were or are smokers with evidence of type 2 inflammation were enrolled in a randomized clinical trial to receive either Dupixent or the current standard-of-care inhaled therapy called triple therapy.
Patients taking Dupixent were 30% less likely to experience exacerbation (a rapid and acute worsening of respiratory symptoms) during the 52-week clinical trial than those in the placebo group. This suggests that the medicine is a major step up from the current standard of care, which could make a huge difference in the lives of countless COPD patients.
Significant sales potential
With 300,000 patients in the U.S. with uncontrolled COPD and type 2 inflammation, the potential market is sizable for Dupixent. With Dupixent appearing to be the best available treatment for COPD, analysts at the investment banking advisory company Evercore believe the medicine could seize 30% of the U.S. market. This would generate an estimated $2.5 billion in peak U.S. sales for Dupixent alone. Adding in another $1 billion in international sales and a fully approved drug could be a meaningful growth catalyst for Sanofi.
The pharmaceutical company's $1.7 billion share of this annual estimated revenue would be a 3.5% increase to the $49 billion in revenue that analysts expect in 2023. And with over 80 other projects in clinical development, Sanofi has an exceedingly encouraging future.
Sanofi is a cheaply valued growth stock
Analysts anticipate that Sanofi's earnings will rise by 12.3% annually over the next five years. For context, that's quite a bit stronger than the drug manufacturers' industry average earnings growth outlook of 6.8%.
Shares of the stock have edged 5% higher over the last 12 months. But that hasn't yet pushed Sanofi's valuation into unreasonable territory. In fact, the stock is still a downright bargain. Sanofi's forward price-to-earnings (P/E) ratio of 10.7 is well below the drug manufacturers' industry average forward P/E ratio of 13.2. That's why the stock is arguably a buy for growth investors seeking great value as well.
