Needham & Company Maintains a 'Hold' on Impax Laboratories (IPXL); Clearing Q1 Hurdle; Regulatory Clouds Remain
Tweet
Share
E-mailGet Alerts IPXL Hot Sheet
Price: $18.30 --0%
Rating Summary:
8 Buy, 15 Hold, 3 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
8 Buy, 15 Hold, 3 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Join SI Premium – FREE
Needham & Company maintains a 'Hold' on Impax Laboratories (NASDAQ: IPXL).
Analyst, Elliot Wilbur, said, "1Q12 adjusted financials outpaced expectations though numbers upside was quickly overshadowed by disclosure of another FDA Form 483, involving a different set of issues, resulting from reinspection of IPXL’s Hayward, CA facility, an inspection resulting from efforts to rid IPXL of outstanding FDA issues first appearing in January 2011. While this additional FDA setback mars perceptions, management’s overall command of its manufacturing network is where it needs to be from a practical standpoint, in our view; absence of key approvals anticipated this year and no real at-risk first-to-file products requiring approval until May 2013 suggest IPXL shares can emerge relatively unscathed from what could prove to be a multi-year regulatory overhang. That said, we have seen clear erosion of value in terms of loss of exclusivity on generic Welchol and TriLipix, and we find it difficult to argue that shares’ risk profile hasn’t increased at least marginally as IPXL gears up
for FDA pre-approval inspection at its Taiwan facility ahead of IPX-066 approval."
FY12 EPS estimate raised from $1.61 to $1.74 and FY13 from $1.95 to $2.05.
For an analyst ratings summary and ratings history on Impax Laboratories click here. For more ratings news on Impax Laboratories click here.
Shares of Impax Laboratories closed at $22.62 yesterday.
Analyst, Elliot Wilbur, said, "1Q12 adjusted financials outpaced expectations though numbers upside was quickly overshadowed by disclosure of another FDA Form 483, involving a different set of issues, resulting from reinspection of IPXL’s Hayward, CA facility, an inspection resulting from efforts to rid IPXL of outstanding FDA issues first appearing in January 2011. While this additional FDA setback mars perceptions, management’s overall command of its manufacturing network is where it needs to be from a practical standpoint, in our view; absence of key approvals anticipated this year and no real at-risk first-to-file products requiring approval until May 2013 suggest IPXL shares can emerge relatively unscathed from what could prove to be a multi-year regulatory overhang. That said, we have seen clear erosion of value in terms of loss of exclusivity on generic Welchol and TriLipix, and we find it difficult to argue that shares’ risk profile hasn’t increased at least marginally as IPXL gears up
for FDA pre-approval inspection at its Taiwan facility ahead of IPX-066 approval."
FY12 EPS estimate raised from $1.61 to $1.74 and FY13 from $1.95 to $2.05.
For an analyst ratings summary and ratings history on Impax Laboratories click here. For more ratings news on Impax Laboratories click here.
Shares of Impax Laboratories closed at $22.62 yesterday.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Piper Sandler Reiterates Overweight Rating on Estee Lauder (EL), 'F4Q26 Preview'
- UBS Reiterates Buy Rating on NVIDIA (NVDA), Expects Q2 Revenue Beat
- Cantor Fitzgerald Reiterates Overweight Rating on Applied Materials (AMAT)
Create E-mail Alert Related Categories
Analyst Comments, Analyst EPS Change, Analyst EPS ViewRelated Entities
Needham & CompanySign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
