The wait is almost over
It’s somewhat ironic that today, the day Amylin (NASDAQ:AMLN) reported third quarter results, marks yet another milestone for the company. The company is now just 100 days away from the learning whether the FDA has finally come to their senses and approves Bydureon. Yes, January 28th, 2012 the PUDFA date for Bydureon is now just 100 days from today.
While the countdown has begun, the company must still try and conduct business even though about the only thing anyone cares about is getting Bydureon on to the market. Judging by the tone of today’s call this task has become more difficult as the company’s current products, Byetta and Symlin, aren’t growing and are basically treading water. This fact was made clear as the company continued to stress they are managing their business to match existing cash flow, or in plain English Bydureon can’t get here soon enough and better be the hit everyone thinks it will be.
The company did receive some unexpected good news during the call as they announced that the FDA approved the use of Byetta with Lantus. To Diabetic Investor this is just one more piece of evidence of the expanding role GLP-1 therapy will play in the treatment of Type 2 diabetes. Even so, we doubt this approval will have a material impact on Byetta sales in the fourth quarter.
The reality for Amylin is their future rests squarely on the shoulders of Bydureon. Should Bydureon match expectations, the future looks great; as without a solid performance from Bydureon Amylin will be like the Indianapolis Colts without Peyton Manning. As we have seen by the Colts performance so far this year, effort alone is not enough when your superstar quarterback is watching games on the sidelines.
