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Lupin (LUPN.BO) Rs482.60
Equity Research
FDA approval of generic NOR-QD tablet marks OC foray
News
Lupin Pharma today announced the approval for its ANDA to market
generic version of .35 mg NOR-QD (norethindrone) tablet by the USFDA.
The company stated that it would begin shipping the product shortly. The
combined annual sales of NOR-QD and its generic equivalents is about
$52mn per the company’s press release. Today’s ANDA approval is first in
Lupin’s Oral Contraceptive segment.
Analysis
We believe Lupin is the best-positioned company (among Indian HCs) to
penetrate the Oral Contraceptive market with a portfolio of around 25-30
ANDAs awaiting approval from the USFDA (Jan 25, 2010 note; Identifying
value picks for 2010; add Piramal to C-Buy; Lupin to Buy). The company
plans to launch around 2-3 OC in 2H FY2012 with a full 15 plus product
offering by second half of FY13, as indicated on the 1Q FY 2012 conference
call.
The US oral contraceptive market is a US$3.7 bn opportunity. Branded
generics constituting around 65% (about US$2.4 bn) where Bayer and
Watson have a good portion of the market share (refer our note Apr 29,
2009, Fresh Focus on generic OC’s supports our growth thesis; Buy). The
generic oral contraceptive segment has relatively high barriers to entry and
as a result offers higher-than-average margins. Despite the limited market
size of this product, we view this approval positively, as oral contraceptives
could help improve Lupin’s product mix and growth profile.
Apart from it, Lupin’s ANDA portfolio has been gaining traction with a slew
of approvals by FDA (about 8) in the last 6 months with combined branded
sales of $5.3 bn going generic.
Implications
We maintain our Buy rating on Lupin with a 12-month Director’s Cut price
target of Rs518. Key risks include delayed product launches in the US.
INVESTMENT LIST MEMBERSHIP
Asia Pacific Buy List
Coverage View: Neutral
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Lupin (LUPN.BO) Rs482.60
Equity Research
FDA approval of generic NOR-QD tablet marks OC foray
News
Lupin Pharma today announced the approval for its ANDA to market
generic version of .35 mg NOR-QD (norethindrone) tablet by the USFDA.
The company stated that it would begin shipping the product shortly. The
combined annual sales of NOR-QD and its generic equivalents is about
$52mn per the company’s press release. Today’s ANDA approval is first in
Lupin’s Oral Contraceptive segment.
Analysis
We believe Lupin is the best-positioned company (among Indian HCs) to
penetrate the Oral Contraceptive market with a portfolio of around 25-30
ANDAs awaiting approval from the USFDA (Jan 25, 2010 note; Identifying
value picks for 2010; add Piramal to C-Buy; Lupin to Buy). The company
plans to launch around 2-3 OC in 2H FY2012 with a full 15 plus product
offering by second half of FY13, as indicated on the 1Q FY 2012 conference
call.
The US oral contraceptive market is a US$3.7 bn opportunity. Branded
generics constituting around 65% (about US$2.4 bn) where Bayer and
Watson have a good portion of the market share (refer our note Apr 29,
2009, Fresh Focus on generic OC’s supports our growth thesis; Buy). The
generic oral contraceptive segment has relatively high barriers to entry and
as a result offers higher-than-average margins. Despite the limited market
size of this product, we view this approval positively, as oral contraceptives
could help improve Lupin’s product mix and growth profile.
Apart from it, Lupin’s ANDA portfolio has been gaining traction with a slew
of approvals by FDA (about 8) in the last 6 months with combined branded
sales of $5.3 bn going generic.
Implications
We maintain our Buy rating on Lupin with a 12-month Director’s Cut price
target of Rs518. Key risks include delayed product launches in the US.
INVESTMENT LIST MEMBERSHIP
Asia Pacific Buy List
Coverage View: Neutral
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