) shares tumbled Wednesday after the FDA says the company's Lake County diagnostic manufacturing operations will be found not in conformity with Quality System Regulation.
Merrill Lynch downgraded the stock to near term neutral from buy on the news. Analyst Daniel Lemaitre says at this juncture, it's unclear what issues remain unresolved. He thinks there is further risk to sales if existing customers switch vendors. Also, a delay derails the timing of new product approvals that are key to rebound 9%-10% growth in diagnostic sales, he says.
The analyst notes the company may have to pay additional fines. While it is too early to retool EPS estimates, he downgrades the stock. However, long-term investors may be inclined to use weakness to add to or establish positions, but the stock is likely to mark time pending clarity on the impact of the delay.