French pharmaceutical company Sanofi (SNY 2.46%) is seeing a jump in its share price following major product news on Feb. 23. The company shared that the Food and Drug Administration (FDA) had approved Altuviiio for hemophilia A, an inherited blood clotting disorder. The new drug is indicated for routine preventative care and on-demand treatment to control bleeding episodes, as well as when either child or adult patients need surgery.

Sanofi also announced promising results for tolebrutinib, in a phase 2 clinical trial for multiple sclerosis, which according to the company had a significant impact on key immune mediators to reduce the worsening over time of the disease.

Let's explore what else the company could have on the horizon for investors to consider.

Earnings results made investors wary

Investors had not taken the company's annual results well. However, the good news helped boost SNY share prices, which sagged as low as $45.42 on Feb. 6 and rebounded to $47.76 at the close on March 3.

The investor wariness is surprising at first glance. On Feb. 3 the company released 2022 figures, showing a 7% sales growth year over year, to just shy of 43 billion euros ($46.6 billion) at constant exchange rates (CER). Non-GAAP earnings per share grew 17.1% year over year to 8.26 euros ($8.78).

But investors may have been focused more on the modest fourth-quarter sales increase, up just 2.6% at CER to 10.73 billion euros ($11.37 billion), which missed analysts' expectations; growth stunted by a 16.3% drop in vaccine sales, which the company attributed to "phasing" in sales of its influenza and PPH (pertussis, polio, and Haemophilus B) shots. For the quarter, EPS was 1.71 euros, a 17.4% increase at CER.

The company attributed the annual sales growth to booming demand for its best-selling monoclonal antibody allergy treatment Dupixent, up 43.8% year over year, vaccine sales up 6.3% (despite the Q4 drop), and its consumer healthcare segment, up 8.6%. Sanofi partners with Regeneron Pharmaceuticals (REGN -0.20%) on Dupixent.

Sanofi's own outlook for 2023 also weighed on investors' minds at the beginning of February, with the company anticipating 2023 business EPS to grow at low single-digit rates, the latter factor bringing business EPS down 3.5% to 4.5%.

A boost from promising treatments

The Altuviiio approval is a boon for a company that had expected such sluggish growth. According to Allied Market Research, the global market for hemophilia treatments, including both the A and B forms of the genetic disease, was $12.8 billion in 2021 and is expected to more than double to $26.9 billion by 2031. Per the Centers for Disease Control and Prevention, a 2012-2018 study showed the A form of the disease is much more common, at 12 cases per 100,000 U.S. males, compared with 3.7 cases per 100,000 U.S. males for hemophilia B (males get the disorder much more commonly than females) -- meaning most patients would be within the drug's target market.

Analysts at the European financial group ODDO BHF cited by Fierce Pharma, state that sales of Altuviiio are expected to total 1.3 billion euros ($1.4 billion) by 2029. The drug may not have any direct competition initially, as Sanofi says it is "first in class" and that it gives patients near-normal activity levels of the clotting factor for most of a week following once-weekly dosing. The drug also "significantly reduces bleeds compared to prior factor VIII prophylaxis," the company says.

Approval from the European Medicines Agency (EMA) for Altuviiio is likely but not guaranteed, as U.S. and European approvals often follow one another, and the European Commission designated it an orphan drug in June 2019. Sanofi expects to apply for EMA approval in the second half of the year.

Other promising pipeline news from Sanofi includes encouraging results from a long-term extension of a phase 3 trial of Nexviazyme (avalglucosidase alfa) for late-onset Pompe disease. The condition is a rare genetic disorder that causes increasing weakness over time in the heart and skeletal muscles. Over roughly three years, the drug "showed sustained treatment effect" in patients who had never been treated before and those who switched from the longtime standard of care, alglucosidase alfa, Sanofi said Feb. 24. Beyond the Nexviazyme results, Sanofi reported that its monoclonal antibody treatment Beyfortus (nirsevimab) had consistently "reduced respiratory syncytial virus lower respiratory tract infections requiring medical care in infants."

However, could all this pipeline progress be threatened by the departure, announced on Feb. 13, of the global head of R&D Dr. John Reed? His interim replacement, Dr. Dietmar Berger, has been serving as Sanofi's chief medical officer and global head of development since joining the company in 2019, after stints at various other pharmaceutical companies such as Genentech, Bayer, and Amgen. Sanofi is searching for a permanent global head of R&D; this could lead to a bit of uncertainty for investors that should straighten out in the long term.

Long-term investors may well want to stick around for the positive bottom-line impact of Altuviiio, which the company will debut in April, but anyone seeking a quick high-growth stock will have to look elsewhere.