Shilpa Medicare -Racing away on the Oncology API highway!

The framework was from John Kay, inspiration was from the Ambit Report - which did a good job of capturing some of these Intangibles - have quoted that report in the thread :slight_smile: Haven’t read the book myself !!

Copy-Paste-Improve - I found the framework so positive and energising - I just knew it would work - for capturing the Intangibles - that I had been struggling to attempt for over 2 years (again on Mr D’s nudging as the next level of improvement for VP). We just went ahead and adapted it our needs - using native intelligence/brainstorming within Team VP and many seniors - to come up with our own BQ Template - and then it took me 3 months of struggle to capture these for 6 businesses - I thought I knew well:) It takes time, but now I am able to help others fill - by asking intelligent questions - even for a business I know nothing about - Think it was Anant Jain who has written about it . Some patterns do get established - and thats very important for Business Quality dissection - it has helped me tremendously in thinking about businesses at a much deeper level - now I am able to articulate crisply the most important things I want to see in a business I am looking to allocate capital to.

Recently a Senior Management executive lobbed the ball back to me suddenly - so what do you think drives valuations for an emerging business like ours - I was surprised at how cogent an answer I provided - very crisp - just 4-5 points - the matter was closed (no long-winded discussions) - he nodded and agreed - Yes!

That’s how powerful these patterns are - and I can see the power when sharing very crisply about what’s extra special in a business we like - with very senior practitioners, senior fund managers, gurus and the like …you can convey the things that really matter in your business - and that are worth noticing - crisply and catch their attention quickly; they perk up immediately; thats how dramatic an experience it has been for me - after the first 3 months struggle.

All of us can do it. I am confident it will speed up learning/investment maturity curve for most folks. I wanted to drive the BQ discussion and encourage/help more folks to put up their BQ sheets. Tasty Bites BQ sheet was put up by Anant Jain and Anindya I think…its a pity I haven’t managed to look at the final version again.

Time to pull up socks - and prioritise a few things that really matter!

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How does Shilpa Medicare compare with Natco Pharma. They are in more or less the same field

I also want to understand the comparison between Shilpa and Natco like business prospects, execution efficiency.

@vnktshb, @Rajesh1975
So, why don’t you take a lead and put up the comparison that you can find between the 2? You may want to start with their product portfolio, margins, return ratios, focus on R&D etc.

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VCCircle.com ‏@vccircle 4h4 hours ago
Shilpa Medicare’s Vishnukant Bhutada to speak @ Bengaluru Investment Summit 2015; http://bit.ly/1B0wr70 #vccblr15

Registration fees of 6400(for early birds)…

Hello @Donald,

I am putting my hands up for this excercise. (Please bear with me)
Taking inspiration from @ankitgupta work on Alembic Pharma, i am planning to reuse his framework to create a semi-automated template which can be reused for other pharma companies.

It is still WIP, and i hope to complete it over the weekend.

I have basically used the Pharma Compass site as primary source of information.

Other sources of information:

  1. http://vsez.gov.in/app_doc/HYD%20UAC%20SEZ%2007.05.2015.pdf
  2. Phillip Capital Report shared in previous posts.
  3. Karvy Report - https://www.karvyonline.com/viewdocument.aspx?DocumentID=10637
  4. Reference Type II DMFs for APIs for Generic Drug Applications

Any feedback would be helpful.

Meanwhile i would like to highlight the key points from the above referenced sources:


Something to chew on in the mean time :smile:

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Great initiative Vishnu!
If you can automate the data filing, it would be really helpful for everyone :slight_smile:
Also, I have been trying to get hold of the source for products pipeline where DMF is not filed (like in case of Karvy report - products in pipeline). If you come across any such source, pls let us know.
For any clarification, @ananth or I can offer our help.

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Superb work @crazymama

Here is my list I compiled from US DMF Data during last AGM

Some notes I made:

These are approximate revenues for formulations from different websites. May not be latest.

One important point to check if Shilpa has patent for a particular molecule. If shilpa medicare, has patent for a molecule/API, there is high chance that generic manufacturer will choose shilpa’s API when the molecule goes off exclusivity. This will be good for generic manufacturer (formulation) as he will be saved from litigations from innovator.

The DMFs for molecules for which ANDA is pending exclusivity expiration, shilpa has patent for ALL OF THEM. Bortezomib, PEMETREXED, BENDAMUSTIN, IMATINIB MESYLATE and FINGOLIMOD HYDROCHLORIDE.

This will give some edge to shilpa, as when the generic manufacturer launches the generic, it high chance that they may choose Shilpa’s API. However, there are other 4-5 players who filed DMFs for these molecules who also have patents for those.
I have seen the patents from patents.google.com

I have seen/used exclusivity expiration dates from USFDA site instead of patent expiration dates. This is because para IV are launched on exclusivity expiration and not on patent expiration. Pricing/margins is higher during para IV launch and it is the time where significant market shares may be taken.

However, thing I’am not sure is with pending 483s, will generic manufacturers come to shilpa ?

Your capacity info is very interesting.

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Shilpa Medicare

•Shilpa has converted its CRAMS alliance into a 50:50 JV and set up a greenfield facility with an investment of Rs 1.5bn. The commissioning of the plant is expected in Q3FY16 and has a peak sales potential of Rs 5bn.

•Looking at the CRAMS opportunity in oncology formulations, and to leverage its strong association with domestic and global formulators for oncology APIs, Shilpa has set up a greenfield onco‐formulation facility with an investment of Rs 1.5bn in Jadcherla, Andhra Pradesh. The facility is currently producing exhibit batches for dossier development on behalf of partners and paid for this. Onco‐formulation is mainly on cost‐plus contract manufacturing basis.

• Shilpa has signed a technology transfer agreement with global innovator Gilead for manufacturing HIV/AIDS drug APIs and supplying to over 100 countries. Supply of tenofovir is likely Q3FY16 onwards and the management expects full‐fledged ARVs operation by FY18. It expects potential revenue of Rs 2.5‐3.0bn from ARVs by FY18.

source:phillipcapital

Good long read for me. Did a good job sir :smile:

Hello @ananth,

Thanks for sharing your analysis.

With respect to the Patents, i think it is misleading to depend on the results from patents.google.com
Though i could not navigate to the Patent List in Shilpa’s website, i got the link from google search.

http://www.vbshilpa.com/listofour_patents.html

From the above API’s you had highlighted, i could not find Bortezomib and IMATINIB MESYLATE among the US or the global PCT Patents list in Shilpa’s site.

Re: the capacity info, it turns out i was lucky to find that info. There is similar info. for other companies like Divi’s, but like Shilpa it is an exception.

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@crazymama

I could find patents for these molecules from patents.google.com for the molecules which you are mentioning.

https://www.google.co.in/patents/WO2014199244A3?cl=en&dq=imatinib+mesylate+%2B+shilpa&hl=en&sa=X&ei=npmOVd2CA47buQTt44AY&ved=0CBwQ6AEwAA

https://www.google.co.in/patents/WO2014199244A3?cl=en&dq=imatinib+shilpa&hl=en&sa=X&ei=S5qOVZbPBYq1uASO9IDwDA&ved=0CBwQ6AEwAA

I think that capacity information is crucial, We may get insights into molecules that shilpa is working on and planning to file DMF/ANDA

I have relied on patents.google.com before.

Disclosure: Shilpa is one of my top holdings so I may be biased,

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Hello @ankitgupta,

I wanted a second source of verification for the Karvy report.
First thing i did was go to the Oncology API under development section on Shilpa’s site.
8 out of 14 were disclosed on the site and available for public domain as either “Under development” or listed as "Tech Pack/Open Part"
Abiraterone Acetate
Bosutinib
Enzalutamide
Lapatinib Ditosylate
Regorafenib
Vemurafenib
Crizotinib
Nilotinib

In my first attempt to search for any PDF with the terms “Pralatrexate” + “Shilpa Medicare” as inline text, i hit the jackpot with the Capacity PDF.
Google Search Terms:

intext:“Pralatrexate” + Shilpa Medicare + pdf

In case of Hetero Drugs, the drugs in pipeline are mentioned upfront.
So, i guess the answer is dependent on the companies themselves.

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@crazymama

I think the second source of information can be patent database. If the company has found a novel way of producing a molecule and filed a patent, then there is high chance that they will file a DMF for it.

As you mentioned, we can also look at the company website to understand work in progress molecules.

In the case of alembic pharma, most of the API produced are for captive use. They use the API they produce for their formulations. API/DMFs are filed many years prior to ANDA filing. Hence we can take a guess at ANDA pipeline for alembic by looking at DMF filings. If I recall, for abilify (aripiprazole), they filed DMF in 2009. ANDA got approval in 2015.

Similarly for shilpa, in the recent interview, they said they have filed 12-14 ANDAs. My guess is that they filed it for same molecules for which they have API for.

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Quick update on the status of the Template:

It is more time-consuming than i presumed.
I have collated all the input sources, and created the template for “Existing DMF’s” sheet.

Pending Tasks:

  • DMF’s in Pipeline
  • ANDA’s in Pipeline

Pharma Companies Analysis Template

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@crazymama

This has come out really well. I have following suggestions.

a) on exclusivity expiry date - can you get it from US FDA site ? I will send you offline message about how to get it from USFDA site. The dates in your xls and from USFDA site do not match.
b) one the second page “EXISTING DMF” - can you include patent information too ? so that for a particular molecule/DMF does shilpa have patent on the same page ?
c) This may be tough :slight_smile: but can you include the names of other patent holders for same molecule ? As I said earlier, I have used patents.google.com. Not sure if it can be automated. May be use the uspto.gov site
c) every quarter when USFDA updates the DMF filings - can your excel be updated automatically :slight_smile: ?

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Thanks for the feedback.

Please find my observations as below:
a) Exclusivity - I have taken the earliest date. I have taken “CAPECITABINE” as an example, and the dates seem to tally.

b) There is actually Column P in “Existing DMF’s” which should indicate that. I have missed it. Will add it in my next update.
I am considering only listing the US Patents, or would it make better sense to include other patents as well?

Re: Listing of all patents specific to a molecule can be tricky. But will add it to the “Wishlist” :smile:
(Right now that would be a low priority as intention is to get the basic template ready. Patent Info would be a happy add-on IMHO)

c) As @ankitgupta had rightly pointed out, this is a manual task. It is a Copy+Paste job, but still manual. It could have been automated if the txt file was CSV/TSV formatted.

Welcome to more feedback!
Please bear with me as I am in mid of a hectic work schedule!
All good things come to those who wait :smile:

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Hi Vishnu,

Great job. I think many of the ANDA’s in pipeline will match with API (DMFs) to be filed since they are vertically integrated into formulations now. Also, for ANDA holders, you can use - http://www.accessdata.fda.gov/scripts/cder/ob/docs/queryai.cfm (orange book), type the name of molecule and you can get the information about ANDA holders. For market size, you can google and search for revenue for a molecule for which patent hasnt expired.

I am eager to work on product pipeline and shall complete it by next week.

Though I’m not understanding all of it but I’m sure you guys @crazymama @ankitgupta @ananth are doing something amazing here :slight_smile: Do let me know if I can be of some help.

Ayush

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Thanks @ayushmit for the compliments!

Owe a lot to you! Started my proper journey with Avanti feeds from your dalal street blog!
It has been a patient and exciting journey over the last 2 years!

Please check @vml new toys :smile:

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