Volatility to Continue for Amarin (AMRN) with No NCE Decision, But Serious Upside Exists - Jefferies
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Price: $14.07 -0.57%
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
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Jefferies commented on Amarin Corporation (NASDAQ: AMRN) after this month's FDA Orange Book update contained no decision on 5-year versus 3-year exclusivity for Vascepa.
While the firm expects more volatility with no NCE decision, Amarin's 10-Q, stating - "We have been informed by FDA that the FDA has drafted a proposed response letter to our exclusivity request, that such draft response letter has been circulated internally at the FDA for comment and the FDA has been considering the issue actively" - is a modest positive.
"There may be several more opportunities for a monthly update of the Orange Book to yield a decision on Vascepa exclusivity before a potential launch in late January/early February," analyst Thomas Wei notes. "We believe AMRN's 10-Q disclosure is a modest positive in that it signals a potential decision near-term."
Wei also commented on the key strategic announcement pending in late November on whether the company will sell, seek a partnership, or launch with an AMRN salesforce:
"We continue to believe negotiations with potential pharma partners are active, where we also believe the core issue related to the FDA NCE decision remains one of valuation but that there still remains pharma interest even in the event that only 3 years of exclusivity is granted by the FDA (presumably longer exclusivity through patents helps drive this value). That being said, with no NCE decision, we acknowledge an uncertainty factor in potential pharma negotiations remains that will
likely contribute to further stock volatility. Furthermore, we continue to believe it would be prudent for investors to assume AMRN may very well announce plans to launch Vascepa on its own. In that scenario, we are encouraged that AMRN expects pharma negotiations to continue in parallel while the company also believes it could launch and gain specialty traction in the MARINE indication using a focused specialty salesforce. Additionally, even if AMRN must launch Vascepa itself in early 2013, we continue to see long-term value in the likely issuance of ANCHOR patents, which could strengthen the case for Vascepa exclusivity until 2030, with a potential decision on the ’520 patent in 1-2 months."
Wei maintained a Buy rating and $28 price target on AMRN.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
Shares of Amarin Corporation closed at $10.84 yesterday.
While the firm expects more volatility with no NCE decision, Amarin's 10-Q, stating - "We have been informed by FDA that the FDA has drafted a proposed response letter to our exclusivity request, that such draft response letter has been circulated internally at the FDA for comment and the FDA has been considering the issue actively" - is a modest positive.
"There may be several more opportunities for a monthly update of the Orange Book to yield a decision on Vascepa exclusivity before a potential launch in late January/early February," analyst Thomas Wei notes. "We believe AMRN's 10-Q disclosure is a modest positive in that it signals a potential decision near-term."
Wei also commented on the key strategic announcement pending in late November on whether the company will sell, seek a partnership, or launch with an AMRN salesforce:
"We continue to believe negotiations with potential pharma partners are active, where we also believe the core issue related to the FDA NCE decision remains one of valuation but that there still remains pharma interest even in the event that only 3 years of exclusivity is granted by the FDA (presumably longer exclusivity through patents helps drive this value). That being said, with no NCE decision, we acknowledge an uncertainty factor in potential pharma negotiations remains that will
likely contribute to further stock volatility. Furthermore, we continue to believe it would be prudent for investors to assume AMRN may very well announce plans to launch Vascepa on its own. In that scenario, we are encouraged that AMRN expects pharma negotiations to continue in parallel while the company also believes it could launch and gain specialty traction in the MARINE indication using a focused specialty salesforce. Additionally, even if AMRN must launch Vascepa itself in early 2013, we continue to see long-term value in the likely issuance of ANCHOR patents, which could strengthen the case for Vascepa exclusivity until 2030, with a potential decision on the ’520 patent in 1-2 months."
Wei maintained a Buy rating and $28 price target on AMRN.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
Shares of Amarin Corporation closed at $10.84 yesterday.
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