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 Havenât 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 Dâs 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!
Thatâs how powerful these patterns are - and I can see the power when sharing very crisply about whatâs extra special in a business we like - with very senior practitioners, senior fund managers, gurus and the like âŚyou 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 thinkâŚits a pity I havenât managed to look at the final version again.
Time to pull up socks - and prioritise a few things that really matter!
@vnktshb, @Rajesh1975
So, why donât 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.
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.
Great initiative Vishnu!
If you can automate the data filing, it would be really helpful for everyone
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.
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 shilpaâs 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 Shilpaâs 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 Iâam not sure is with pending 483s, will generic manufacturers come to shilpa ?
â˘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.
â˘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 oncoâformulation 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. Oncoâformulation is mainly on costâplus 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 fullâfledged ARVs operation by FY18. It expects potential revenue of Rs 2.5â3.0bn from ARVs by FY18.
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 Shilpaâs website, i got the link from google search.
From the above APIâs you had highlighted, i could not find Bortezomib and IMATINIB MESYLATE among the US or the global PCT Patents list in Shilpaâs site.
Re: the capacity info, it turns out i was lucky to find that info. There is similar info. for other companies like Diviâs, but like Shilpa it is an exception.
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 Shilpaâs site.
8 out of 14 were disclosed on the site and available for public domain as either âUnder developmentâ or listed as âTech Pack/Open Partâ
Abiraterone Acetate
Bosutinib
Enzalutamide
Lapatinib Ditosylate
Regorafenib
Vemurafenib
Crizotinib
Nilotinib
In my first attempt to search for any PDF with the terms âPralatrexateâ + âShilpa Medicareâ as inline text, i hit the jackpot with the Capacity PDF.
Google Search Terms:
intext:âPralatrexateâ + 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.
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.
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 âEXISTING DMFâ - 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 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 ?
Please find my observations as below:
a) Exclusivity - I have taken the earliest date. I have taken âCAPECITABINEâ as an example, and the dates seem to tally.
b) There is actually Column P in âExisting DMFâsâ 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 âWishlistâ
(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
Great job. I think many of the ANDAâs 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 Iâm not understanding all of it but Iâm sure you guys @crazymama@ankitgupta@ananth are doing something amazing here Do let me know if I can be of some help.
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!
Havenât read the book myself !!
