As far as I know, no new triggers. In fact, similar drug from Axovant
recently failed Phase 3 trials. Enrollment of Phase 2a of Suven is going on.
-Jiten Parmar
3 Likes
Q3 Results update -
Financial Highlights for the Q3 Decemberā 2017 (QoQ):
Growth in income INR 1669 Mn vs 1120 Mn - up by 49.07%
Growth in PAT INR 346 Mn vs 317 Mn - up by 8.99%
Growth in EBIDTA INR 547 Mn vs 501 Mn - up by 9.08%
Financial Highlights for the 9 monthsā period ended Decemberā 2017 (YoY):
Growth in income INR 4256 Mn vs 3805 Mn - up by 11.85%
Growth in PAT INR 958 Mn vs. 831 Mn - up by 15.38%
Growth in EBIDTA INR 1557 Mn vs 1333 Mn - up by 16.79%
Suvenās expenses on innovative R&D in Drug Discovery stood at INR 416 Mn (9.76% on
revenue) for the 9 monthsā period ended Decā 2017.
The Board has declared an Interim Dividend of Re. 1.50 per share
http://www.bseindia.com/xml-data/corpfiling/AttachLive/95a66a26-154f-4ae0-a6ba-60460984e9ac.pdf
Status of the current drug being developed by Suven Life Sciences.
3 Likes
HELLO EVERYONEā¦I have read the excellent discussion on this forum with respect to Suven and got interested into the company. After reading few previous year reports and going through literature from other resources , i have made a bear case (list of risk factors) for the stock. Im putting it here to initiate the further discussions and consumption of other members -
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The business model is over dependent upon CRAMSā¦This has been highlighted in the AR too.
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A break in the cashflow will be detrimental for the on going NCE project. NCE projects require a sustained inflow of money, time and people.
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Failure of SUVN 502 in phase II will be heart breaking as this will mean a further long waiting period for the processing of next NCE.
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A decrease in R&D and disinclination towards drug discovery by the innovators and big players will reduce the CRAMS revenues for Suven.
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Any kind of dent on the reputation of company due to deterioration in product quality or breach of the stipulated time frame for the product delivery will damage the hard work put in for the years by Suven.
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No solid plan for succession is visible. Daughters of the CEO are in USA looking after the progress of NCE molecules.
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A drop in margins due to inability to continue cost saving measures or poor management or competition.
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Undertaking debt route for the funding of SUVN 502 project. This may occur due to unsustainable increase in capex which will reduce the free cash flows of the company.
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Poor sale of Anti Rheumatic and anti Diabetic products at the innovatorās end.
10 An unsustainable diversification in pursual of mitigating over dependence upon CRAMS segment.
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In case of a chemical accident taking place in the manufacturing facilities, govt may impose environmental regulations .
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I couldn not find the remuneration policy on the website. The issue is that the remuneration is increasing on an yearly basis. It would have been better to see a profit linked commission.
12 Dr. C Rajendiran He was shown as vice president (R&D) till 2015-16 AR but there is no mention of his name in 2016-17 ARā¦Does any member has any info on thisā¦
Overall, a price of 150-160 would have been most suitable for entering the stock with a good margin of safety. The current stock price gives a margin of safety of 10% only. However, the suven is a unique story where investors are sharing the dream of Mr Jasti.
The critical time will be around june 2019 when the data for phase 2 for SUVN 502 is likely to be revealed.
Dislosure- I have entered at 195 with it as 3% of my portfolio. Plan to increase it to 10-12% at a price below 200.
7 Likes
Very informative,thanks a lot.
Disc: invested
Suven informs exchanges that "We would like to inform our shareholders through exchanges about the information appeared in media about FDA inspection in our Pashamylaram, Medak unit during Feb 2018.
US FDA during the inspection observed that there are procedures that followed on certain aspects are deficient in nature. Since these observations are procedural in nature, we have already revised our standard operating procedures (SOPs) as a corrective action and trained employees in the new SOPs thus creating new policies for the companies quality systems and operating systems and submitted documented proofs of all these remedial measures to FDA well in time."
Nothing to panic. No regulatory action required.
4 Likes
Lets see how market reacts tomorrowā¦We can buy more at the current priceā¦
Company says the observations were procedural in nature and remedial action has already been taken. Market apparently overreacted on incorrect media coverage.
Suven came up with strong numbers.
Good jump in yoy numbers: Revenue - 18.6%, PAT - 56%, EBITDA - 89%, also the R&D expense has reduced (hope the last yearās huge R&D expense reflect on the products and sales 
).
Invester presentation:
From their presentation:
ā¢ SUVN-502 Phase 2A clinical trial, indicated for patients with
moderate Alzheimerās initiated in 76 investigator sites in USA and so
far enrolled 443 patients against target of 537 patients in the study.
ā¢ Suvenās Pashamylaram unit successfully completes US FDA
inspection.
ā¢ During the period Suven secures 9 product patents in Australia,
Canada, Eurasia, Europe, India, Norway, Singapore and South
Korea.
Disc: Invested and planning to add more on dips.
3 Likes
Jiten bhaiā¦i went through the last concall where you asked how this nce molecule is different than others that failed. Jastiās response that this is performing better on safety (which led to the downfall of others in phase 3) is an edge. But again, its performance on efficacy is a complete wild card. Any other insights on the same?
As these guys are expensing out every dime spent on NCE pipeline (i.e. not capitalizing), failures here on this front wonāt impact the financials. It would just have a big sentimental impact on the company and the stock.
The base business is doing very well producing superb cash flows enabling the company to remain debt free while supporting huge r&d. It is projected to do well for next few years. Not many crams companies have this kind of BS!
Superb chart formation portraying increasing bullishness.
2 Likes
We may know something on Suvn-502 in 2019, I think. That is an option value in the stock. Chances of success in these kinds of molecules are quiet low. Suven is in phase 2A. CRAMS and services business is doing quiet well, so that can support valuations to a certain extent.
2 Likes
This study is scheduled to be completed this month. I went on to the drug control site to check on results. None yet. Overall there is increasing disillusionment with the drugs being developed to control Alzheimerās. Was trending for a few years but as mentioned in various posts - results are not worth considering.
care rating
http://www.careratings.com/upload/CompanyFiles/PR/Suven%20Life%20Sciences%20Ltd-09-28-2018.pdf
SUVN-502 is a promising pure, 5-HT6 receptor antagonist in development for the treatment
of moderate Alzheimerās disease, a novel triple combination treatment approach.
This trial evaluates the efficacy and safety of SUVN-502 added to background stable
donepezil and memantine, a triple therapy in subjects with moderate AD dementia.
At CTAD, Suven is presenting the baseline patient demographics and scales from the
ongoing phase-2a proof-of-concept trial of SUVN-502 for moderate Alzheimerās disease.
Top-line efficacy results from this study are expected during August/September of 2019
from exchange notificationā¦
Actually, 5HT6 has seen multiple failures in treatment of Alzheimerās.
https://www.alzforum.org/news/research-news/rip-serotonin-receptor-5-ht6-antagonist
Any success in Suvn502 would be against the grain of all current outcomes. An investor would be prudent to assume failure.
6 Likes
Last Patient enrolled for SUVN 502 phase 2 trials. Total patients enrolled is 563 against target of 537. Final result expected in July/Aug 2019.
4 Likes
What is the margin of safety for an investor at current valuations if SUVN 502 fails ? I feel the experience gained ( even through SUVN 502 failure) by the company help them in their sucessive compounds.Also their CRAMS coupled with the strong bs will help them to recover earlier than the market sentiments.
Iām hearing many positive thing about this drug. It might be one of those attempts that could potentially catapult these guys into the big league, like how Natco had done with Sofosbbuvir and Glatiramer.