Soliris’s revenue performance
In its 2Q17 earnings conference call, Alexion Pharmaceuticals (ALXN) raised its 2017 revenue projections for Soliris from the previously estimated range of $3.025 billion–$3.1 billion to $3.075 billion–$3.125 billion. These projections are based on the expectation of a gradual improvement in identifying patients suffering from paroxysmal nocturnal hemoglobinuria (or PNH) or atypical hemolytic uremic syndrome (or aHUS). However, the company has also assumed a pricing headwind of around 1.0% for Soliris for 2017.
In 2Q17, Soliris reported revenues of $814.0 million due to a solid 18.0% year-over-year (or YoY) growth in sales volumes. Since many of the PNH patients starting on Soliris therapy are newly diagnosed and treatment-naïve, Alexion Pharmaceuticals is confident that many PNH patients have not been identified yet. The company also believes that the growth opportunity for the drug in the aHUS indication is even larger than that for PNH.
If Soliris continues to witness a rapid uptake in PNH and aHUS indications, it may have a favorable impact on Alexion Pharmaceuticals stock as well as the stock of the iShares Core S&P 500 (IVV). Alexion Pharmaceuticals makes up about 0.14% of IVV’s total portfolio holdings.
Soliris in refractory gMG indication
The above diagram explains that 5.0%–10.0% of the 60,000–80,000 myasthenia gravis (or MG) patient population is the target market for Soliris. This label expansion will enable the company to compete effectively for shareholder value with other rare disease players such as Bioverativ (BIVV), Vertex Pharmaceuticals (VRTX), and United Therapeutics (UTHR).
Alexion Pharmaceuticals expects the European Commission’s decision in 3Q17 on the company’s application seeking approval for Soliris for refractory generalized myasthenia gravis (or gMG) patients who are also anti-acetylcholine receptor antibody-positive. The FDA (U.S. Food & Drug Administration) has set up the prescription drug user fee act (or PDUFA) date for this supplemental biologics license application for Soliris as October 23, 2017. The supplemental New Drug Application for Soliris in this indication has already been accepted in Japan, and a decision is expected in 2018.
In the next part, we’ll look at Alexion Pharmaceuticals’ metabolic franchise.