Sector Update | 8 May 2018
Healthcare
Healthcare
Healthcare: P/E Relative to Sensex
PE (%)
Decoding profitability in complex generics
It’s the lead time post final approval that matters
Pharma companies focusing on US generics have been moving towards complex
generics (CG) on expectation of better and more durable profitability compared to
simple generics.
However, instances of considerable price erosion in CG despite low competition raise
concerns on this strategy.
We find that since the approval process for CG is relatively longer, the lead time
compared to competition is critical for success.
In addition to timing of filing, the quality of data and manufacturing robustness are
key to shortening the time for approval.
We remain selectively positive on stocks progressing well on CG like Aurobindo, Cadila
Healthcare, Biocon and Cipla.
Complex generics business presumed to be better than simple generics…
To limit competition and prolong high profitability business, pharma companies
focusing on US generics are building complex/specialty generics pipelines. The
complexity would be in API/formulation/routes of delivery/drug-device
combinations or where approval pathway has changed.
…but instances of considerable price erosion raise a question mark
Recent instances like g-Renvela, g-Concerta and g-Urocit-K, where there has been
significant price erosion within 3-6 months of approval despite relatively low
competition, have raised a question mark on this strategy.
An interesting space, subject to lead time before competition kicks in
The challenges in meeting regulatory requirements and higher sensitivity to
manufacturing conditions can provide considerable business opportunity depending
on the pace of advances made by a company compared to peers on the basis of
channel checks with industry experts. We continue to believe that CG remains one
of the key growth drivers in regulated markets.
Drug-specific attributes, regulatory pathway, and quality of ANDA – key
aspects in faster approval process
We have looked at key regulatory factors in different complex generics that may
considerably impact the competitive landscape. Besides regulatory hurdle, the
quality of ANDA submitted is critical for a lead over peers. The constantly-evolving
regulatory pathway can delay the approval for generics.
Research Analyst
Tushar Manudhane
Tushar.Manudhane@motilaloswal.com
+91 22 6129 1536
Kumar Saurabh
(Kumar.Saurabh@motilaloswal.com)
+91 22 6129 1519
Rajat Srivastava
Rajat.Srivastava@motilaloswal.com
+91 22 6129 1557
Ankeet Pandya
Ankeet.Pandya@motilaloswal.com
+91 22 6129 1552
Work in progress on CG pipeline by companies under our coverage
Within complex generics, (1) Aurobindo has one ANDA pending for approval and has
filed four DMFs in the peptide space, (2) Cadila Healthcare has five ANDAs pending
for approval in the transdermal space, (3) Biocon has two biosimilar filings pending
for approval each for US and EU market / filed one glatriamoid, (4) Cipla has good
mix of products pending and under development in complex generics, and (5) Lupin
has filed ~2 ANDAs in inhalation segment, ~8 ANDAs in ophthalmics, ~31 ANDAs in
topical, and has a good number of products under development in injectables.
Investors are advised to refer through important disclosures made at the last page of the Research Report.
8 May 2018
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Motilal Oswal research is available on
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