TAKE SOLUTIONS LTD- will you take it?

@rohitbalakrish_

Here are few questions from my side.

Questions to Management:

1. Market Size : Total Market Size: ~16 B, out of which ~8B is in data collection stage (That is the work of CRO, TAKE doesn't participate in that area), out of the other 8B, 80% (6.4B) is addressed in house by Pharma companies (FIPCO - Fully Integrated Pharma Companies). From the rest 1.6B : Take's FY15 revenue - 77.3 mn dollar (64% of 120.8mn), Medidata FY15 revenue - 300 mn. Which means TAKE has a 5% of current market share and 1% of potential market share where as medidata, as one of the largest company has ~20% market share. Q: Is this understanding correct ? Can we infer that, there are lot of small niche companies out there doing lot of cutting edge work for a section of pharma companies? Try to get a sense of developments in technology space which can disrupt this space. In which area are the innovations happening, and how TAKE is planning for times ahead.
2. Ecron Acunova Acquisition: Our understanding is, Ecron is a Clinical Research Organization (CRO) player in the field of Biosimilars, stem cell therapy and developing medical devices in the area of diagnostics imaging. Also Ecron has been doing some work in Risk Based Monitoring which seems to be a very logical thing to do and USFDA too has been pushing for it and recently Medidata also launched a complete offering in this space and it's been said to be one of the highest potential growth area. After acquisition of Ecron, TAKE mentioned that the addressable market size has now increased from 16B to 30B. Q: Please take us through the kind of work ecron does. If Ecron is a player in CRO field, is TAKE aiming to become a more end to end player in clinical trials space with this acquisition. What kind of opportunities/risks does CRO business bring along. What was thought process behind the announcement of increased addressable market size ? Because TAKE had earlier said data collection (CRO ?) market size is 8B (refer Q:1). How does Ecron help TAKE in what it was already doing.
3. Regulatory Filings: TAKE has done over 2,00,000 regulatory filings so far. Our understanding is, TAKE does most of the regulatory filing work for innovator companies and does filing of clinical research data. Generic companies do chemical equivalence tests instead of clinical data trials but they too do regulatory filings for ANDA & DMF's. Q: What is TAKE's role in these kind of ANDA/DMF kind of regulatory filings. What is the level of engagement for TAKE with generic companies like Sun, Auro,Alembic,Cadila which TAKE lists as it's customers.
4. Consulting & Industry Network: We understand industry networks (along with consulting) practice came with the acquisition of WCI in 2011. Looking back, this seems to be like one of the best acquisition done by TAKE. Top Margins, sticky business (?) , getting the attention of top thought leaders & decision maker's in the filed. Jim Tizzard (ex WCI CEO is leading Navitas) Q: Take us through, what keeps the industry professionals hooked on to TAKe's industry networks (it's a paid service). Are there competing networks existing as of today. How do we complete with them ? We understand Delloitte had tried to build such networks in the past and it didn't work. How does these network contribute to the building of overall business for TAKE.
5. Audited/Audit Ready Data Infrastructure : TAKE has now 3 audited/audit ready data centers. Q: Take us through what role they play in the business. How easy/difficult it is to build these audit ready facilities. Do players like CTS/TCS/Infy and other clinical data mgmt. players also have them. How often are they audited by regulators (FDA etc..) . Do the audit's have same rigor as audit of pharma mfg. facility. Did TAKE acquire the first 2 facilities as part of some acquisition ?
6. Recent USFDA 483's/Import Alerts and TAKE's role: If one goes through the details of USFDA observations on Indian generic Pharma manufacturing facilities on cGMP violations/483 observation/import alerts etc...a good proportion of violations are regarding the data integrity, data audit violations, unauthorized access to data etc...etc... Q: Does TAKE provides any solution in this space ? If yes, please help to provide us more details. If not, is this a lucrative area ? who are current players ?
7. Competitors: We learn the Medidata has been spending heavily (R&D spend at 21% of sales) to build cutting edge technologies in mobile (mHealth ), big data , analytics and cloud. Q: What are take's thought on the same. How do we see TAKE's technology (R&D) spend evolving going forward. Players like Quintiles have their own CRO and Clinical Data management teams - Q: Is this correct ? In what kind of project do they seek TAKE's services.
8. Impact of GDUFA : Does the accelerated approval program of USFDA have any impact on the rate of technology adoption for Pharma companies.