Amylin Reports

Amylin Reports

Diabetic Investor can’t wait for the day when an Amylin (NASDAQ:AMLN) earnings call is all about Bydureon sales and not it’s status at the FDA. Sadly that day is not here yet and we’re stuck with the same question; when will we actually see Bydureon on the market. That being said Amylin must deal with the situation at hand and continue to politely answer those unanswerable questions on Bydureon and the FDA.

The company must deal with the fact that Victoza® from Novo Nordisk (NYSE:NVO) continues to gain share and that Byetta sales are basically flat. The silver lining for Amylin is the GLP-1 market continues to grow as a greater share of physicians see what this therapy can do. Another plus for Amylin is Victoza also proves what Diabetic Investor has been saying for years; the less frequently a drug needs to be dosed the better. Just as once daily Victoza is seen as better than twice daily Byetta, so too will once weekly Bydureon be seen as better than once daily Victoza.

Until we reach that point the key for the company is to manage their existing business efficiently, continue to develop their pipeline and remain diligent with the FDA. Based on this afternoon’s call this is exactly what the company is doing. Most importantly the company noted that the FDA has approved the QT study design and they will submit their response to the FDA’s complete response letter in the second half of this year. The company went onto state that Bydureon approval could come in 2012.

While Bydureon should not be the only story for Amylin it is an important story and it’s understandable that investors would focus all their attention here. As we have noted in the past Bydureon has the potential to become a paradigm shifting drug. Yet the company knows that they cannot be just about Bydureon and must make sure investors see the bigger picture.

The reality is while the pipeline looks great and the company is managing the business efficiently, when it comes to Amylin Bydureon will determine the company’s future. Or put another way Bydureon will determine the multiple Lilly (NYSE:LLY) is willing to pay when they finally acquire Amylin.