Pharma || Hospitals || Diagnostics : Industry perspective

Mutual Funds have started NFO in pharma space now , may be sector is heading to recovery .

Mirae Asset Healthcare Fund

Cadila Healthcare: Execution is going to be key this fiscal

RJ on Pharma Sector today’s interview CNBC

Pharma
“I am pretty sure that worst is behind for pharma sector as generic competition in the US is leveling off,” Jhunjhunwala said.
He is positive on the domestic branded pharma businesses. “Indian pharma industry is entering unknown, but exciting space.”
Healthcare majors Sun Pharma & Lupin entered into speciality generics, the next leg of growth.

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FDA Repays Industry by Rushing Risky Drugs to Market

While the FDA over the past three decades has implemented at least four major routes to faster approvals — the current commissioner, Dr. Scott Gottlieb, is easing even more drugs’ path to market. The FDA okayed 46 “novel” drugs — whose chemical structure hadn’t been previously approved — in 2017, the most in at least 15 years. At the same time, it’s rejecting fewer medications. In 2017, the FDA’s Center for Drug Evaluation and Research denied 19.7 percent of all applications for new drugs, biologics, and efficacy supplements, down from a 2010 peak of 59.2 percent, according to agency data.

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Bigger uptick for both bulk drugs and formulations at 22% and 28% respectively in USD terms for May.

Considering Rupee depreciation, its actually higher in rupee terms at 28% and 34%

Maybe this is what has got the market excited. Early days still.

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Does the launch of Pharma funds mean there will be increasing demand esp for big pharma cos like Sun and Cipla. Not looking for buy sell recommendations. Trying to understand how the launch of new funds works in terms of demand for particular stocks.

Thanks

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Revelations by Rajasthan drug regulator that brands of 4 firms substandard. Includes names of Sun Pharma, Alkem Laboratories, Cipla and Aristo :


Shocking if it’s really true…However, the manufacturers have called the samples collected by Rajasthan drug regulator as counterfeit. Which is even more shocking. Does this mean that their is a cartel which copies the popular brands / prescription drugs and manufacturers substandard products which are sold as the real ones?

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Some sweeping changes which will have structural impact on domestic business for pharma companies.

Nation Pharma Pricing Authority (NPPA) expanding its purview to prescribe a ceiling price for certain drugs:

08/13: Ceiling price revision for 92 drugs:
http://nppaindia.nic.in/ceiling/press14August18/FormulationPrices(72).pdf

07/04: Ceiling price revision for 58 drugs:
http://nppaindia.nic.in/ceiling/press04July18/FormulationPrices(50).pdf

06/12: Ceiling price revision for 22 drugs:
http://nppaindia.nic.in/ceiling/press06June18/1%20FormulationPrices(20).pdf

04/02: Ceiling price revision for 869 drugs:
http://nppaindia.nic.in/ceiling/press02April18/Formulation_Prices(841).pdf

Thanks,
Tarun

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Considering current USDINR 71 price, my opinion is good to invent more in excellent track record export oriented pharma companies.

Thanks,
Manish

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The generic drug approvals trend in the US -


Note: FDA’s fiscal year (Fy) runs from Oct 1 to Sep 30. *Fy2019 data is for 3 months from Oct to Dec 2018.

  • A record 781 ANDA approvals in the Fy18 (Oct '17 to 'Sep 18) period by the USFDA.
  • At 278, approvals remained very high in the Dec '18 quarter.
  • Fy19 may surpass Fy18, given that ANDA backlog is still over 3,500.
  • Ever-increasing approval trend is likely to continue in Fy20.

On the positive side -

  • ANDA filings have relatively slowed in recent months.
  • ANDA withdrawals have increased since last 12-15 months.

Trend indicates pricing pressure in the US market is unlikely to abate anytime soon. That said, there are pocket of opportunities arising from exit of Teva and Mylan from many drugs, Chinese API issue, some drug shortages, value erosion of base business lesser than revenues from new product launches, etc.; mainly stock specific opportunities.

Source:

  1. Raw data: FDA site
  2. The livemint article (thanks to @mrai74 for posting this on one of the thread @ VP).
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We shouldn’t generalise it but seems pharma industry is seriously lacking expected practices. These incidents will certainly delay the recovery of health of Indian Pharma industry

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Pharma sector has been going downhill all the way. Please share the way forward for this sector and preferred stocks

Pharma sector is facing lot of headwinds

  1. USA market is very price sensitive and low margin business. Infact ROW and Brazil are better bets. Things in USA may seem to have stabilized but more players will enter and competition may not allow any price increase. Specialized high end products may be the only way out and in that space sun, natco, drl are better placed it seems. But then growth will be linked to patent status and launch date of these.

  2. Domestic market : Dcgi is making things difficult by new regulations and slower than expected approvals. Many FDCs are banned and many are going under NLEM capping the price. As per March Gazette, para 13 retailer margin of many expensive formulations is capped. Plus NPPA is getting strict on pricing.

  3. Policy : generic drugs are now gaining traction and many exclusive stores are.coming up for generics. This will pose challenge to many companies engaged in ethical business. Cipla generic division is number one in India.

So I feel pharma will not see rapid growth in foreseeable future.

Things are not very rosy at present in Europe also.

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