Suven Life Sciences - A Zero Or One Company!

Folks,
This post is specifically about the emerged Life sciences arm of Suven. There is a separate forum for Suven Pharma which is CRAMS business that is not described here.

So here is my piece on what is possibly the only truly publically listed drug discovery company in India. The Indian Pharma market as you may know is generally considered to be composed of

  1. Branded generics - Some of the biggies do offer a branded version of the originator molecule that has lost patent
  2. Generics - This is common paracetamol kind of stuff where there are dime a dozen mnf
  3. Biologics/Biosimilars- Very similar to generics except that this is not a true copy of the originator. The Generics copy the chemical entity while Biosimilars make similar monoclonal antibodies or cells.
  4. API/ Formulation manufactures

Largely the pharma space is concentrated by companies in the Generic molecule space. Largely the money to be made in the Pharma world is the development of NME(New molecular entities) that get 20-year commercial patent protection leading to a monopoly (think Pfizer, Roche, Novartis, etc)

Stages of clinical trials

  1. Computer model
  2. Pre-clinical studies
  3. Phase-1: Safety, tolerability
  4. Phase-2: Safety, tolerability + efficacy
  5. Phase-3: All the rest but in a bigger trial population

Typically it takes 8-12 years to bring an NME to the market meaning that the product only has the remaining 12-8 years to make money before it loses exclusivity and generics come in. The same applies for Suven

Coming over to our company Suven Life sciences - This company was carved out of the recent demerger at Suven with a pinpoint focus on discovering and bringing to clinical trials innovative molecules in the Central nervous system (CNS) space such as Alzheimer’s, Cognitive disorders, Depression.

The Business model

Revenue: This is currently a cash-burning machine. The revenue model revolves around the successful development of the molecules across the stages of the clinical trials. As the company is quite a small size and can’t commercialize on its own they will make money from

  1. Out-licensing the molecule
  2. Partnering with the bigger company in Phase-3 and revenue share if successful

Risk- Clinical trials have two outcomes - If it is successful, you make a lot of money. If not, then all R&D costs are basically sunk costs and zero revenue

This is what happened to SUVN-502 which recently failed to meet end-outcome in Alzheimer’s in Phase-2 POC trial. But apparently they are now testing it in dementia

Other assets and stages of development

  1. SUVN-G3031: Narcolepsy, Phase 2 POC
  2. SUVN-911: Depressive disorders, Ready for Phase 2
  3. SUVN- D4010: Depression, Dementia, Planning for Phase 2

The success depends on how the company can get a product into Phase 3 and beyond because then it will get the attention of major players in the disease areas.

Current revenue sources
a) 136 crores loan from Suven Pharma- Enough to last them for the next 15 months
b) Contract technical services - minor

Costs - As I said, the costs of a drug discovery company are largely R&D numbers which are around 44 crores in FY20. As per the latest estimate, they are burning cash at the rate of 10-12 crores per month. A major point to note is that they get a tax deduction benefit, under Section 35(2AB) of Income-tax, of 150% of the R&D expenses. Therefore if they were able to successfully monetize the assets, they will get an additional benefit of a tax deduction on costs.

Risks or Unknowns

  1. COVID has delayed trials and this company cannot afford delays considering the tight budget they are on
  2. It’s a 0 or 1 company. If the assets fail to meet end-points in Clinical trials, it is game over for them.
  3. Currently, they can manage 12-15 months but they can’t produce a good result what happens then? They may possibly dilute equity further by raising more money either in the US or India.
  4. The main guy in this company is Dr. NVS Ramakrishna who heads drug discovery. He led Zydus previously and is an oncologist. I don’t have any further information but he is the guy to know about

Financials

  • I am not going to talk about the P&L for two reasons
    a) This got demerged from Suven and therefore nothing is comparable YoY
    b) Its a cash-burning machine. They do not have sustainable revenue sources right now because its a drug discovery.

I advise against trying to value this a generic Indian Pharma company. The payoffs are not linear and either they can score a big win or go bankrupt.

Questions (Need to ask the management)

  1. How is management dividing the span of attention between Life sciences and Pharma business
  2. Impact of COVID in patient enrollment
  3. What is the validity of the current patents of molecules in Phase 2? Remember that they have a fixed 20 year period
  4. The consolidated R&D spend was 121 crores while standalone was 43 crore so I’m trying to figure out the numbers here
  5. About 100 crores worth of land given to Suven Pharma is in the name of Suven Life sciences. This can be a hidden asset
  6. Why is the board composition made up majorly of finance people and not scientists/drug discovery folks?

IMHO this is a pretty interesting company to track as it is the only one in its space. it has a niche but that comes with its own set of risks which includes bankruptcy.

Comments/suggestions/questions are welcome

Cheers
Uzi

Discl - Going to take a tracking position.

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Please accept my ignorance but isn’t Sun Pharma Advanced Research Company (SPARC) a comparable company?

Hi Sujay,
Yes, it is. I never knew about it but it is definitely in a similar business of drug discovery. Although it has clinical assets in several therapeutic areas while Suven is more focused on CNS only.

Happy to learn more!
Cheers
Uzi

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Thanks for initating the thread @Uzair_Fahmi.

Need some clarity on the below point where you have mentioned about 136Crores loan from Suven Pharma:

My understanding so far based on demarger docs is that a loan of INR133 Cr. has been given to Suven Pharma. Even this was discussed in the Q4’20 and Q1’21 calls.

Thanks,
Tarun

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Well the answer to this lies in the demerger agreement - when they demerged, Suven life sciences was supposed to get some 300 odd crores (A lot of land and buildings were transferred to Suven Pharma so maybe this is payment for that). Now the balance remaining of that amount as of now is 115-136 crores that will be sufficient to meet expenses for up to 15 months.

Hope this answers!

An interview with the Chairman Mr. Venkat Jasti

Mention of SUVN-G3031 for narclepsy

Clinical trial candidates across several phases for Narcolepsy
https://www.centerwatch.com/clinical-trials/listings/condition/572/narcolepsy/

The potential of a innovative molecule in Nacrolepsy market

Jazz’s Xyrem raked in $1.4bn last year in sales for the treatment of narcolepsy.

New product being launched : Wakix (another H3 receptor inverse agonist)

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Mr.Jeevan Patwa’s tweets:

  1. SUVN – 502
    SUVN-502 has recently failed in phase-2 trials where it couldn’t meet the primary end points related to Alzheimer’s but sub group studies has revealed some interesting statistically significant and
    potentially beneficial effects of masupirdine on cognition,function and behavior, which can be useful for further studies in Dementia and Neuro-psychiatry. Suven is planning phase-2 studies for the treatment
    of behavioural and psychological symptoms of dementia (BPSD). Market size for this could be $2 Bn for USA.

  2. SUVN-G3031 (phase-2 to be completed by Mar-21)
    This molecule addresses a rare disease – Excessive Daytime Sleepiness (EDS) – in narcoleptic patients

  3. SUVN-D4010 (phase-1 completed)
    This molecule works for better cognition and as an anti-depressant

  4. SUVN-911 (phase-1 completed)
    It addresses the biggest limitations of current major depressive disorder (MDD) therapeutics with rapid onset of action, no sexual dysfunction, and enhancement in cognition

Some of the listed companies on NASDAQ working in CNS, (though not strictly comparable) are Denali therapeutics ($7 Bn) and AC Immune ($340 Mn)

There are two possibilities ahead. Either it can partner with any big pharma company or list itself in USA. In the first case, it can get upfront payment with milestone payments defined.
In 2018, Lilly and AC Immune announced licensing deal for few molecules where AC immune received upfront payment of CHF80 Mn and up to approximately CHF1.7 Bn in other potential development, regulatory and commercial milestones, and low double-digit royalties with Lilly

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Q4 & FY21 results are out. No surprises in there. Till the time comes for monetisation of its molecules, the company continues in red. In line with the earlier announcements, transaction related to funds raised from warrants issued to promotor appears in this quarter. Updates on outcome of clinical trial of SUVN-G3031 and update on planned trial of SUVN-502 for new indications remain the keenly watched milestones / triggers.

Disc: Holding from lower levels since a long time.

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(Suven Life Sciences To Spend $40 Mn On US Clinical Trials Of Two Molecules Targeting Alzheimer's)

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Results announced today, more or less along expected lines. Expenses have grown significantly, probably indicating some pick-up in activity of clinical trials. The more important update on clinical trials though do not report any significant new milestones achieved in the recent period, so progress seems very slow.

  1. SUVN-502 (Masupirdine) – Completed phase 2 study on Alzheimer’s in USA and to be initiated phase 3 study for new indication on Agitation and Aggression in Alzheimer’s type dementias in North America and Europe; expected completion by end of the year 2024. Expected site activation by end of March 2022 and expected patient enrolment during the quarter April – June 2022

  2. SUVN-G3031 (Samelisant) – Ongoing phase 2 study on Narcolepsy in North America; expected completion by FY2023. 109 patients randomized, 82 completed of the total expected 195 patients (including 18 replacements).

  3. SUVN-D4010 (Usmarapride) – Completed phase 1 study, ready for phase 2

  4. SUVN-911 (Ropanicant) – Completed phase 1 study, ready for phase 2

.Full details at

Disc: invested from pre-demerger days

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It’s the patent holder. Suven Pharma will manufacture the product for it,and it can sell it at whatever price it wants.

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Does anyone has any news regarding SUVN-502? as the stock is in uptrend. Phase - III results are expected on September-October or maybe end of December…
Does insiders know the news and started to nibble?

Look like heavy accumulation going on with huge volumes so there is a possibility of positive outcome of trial

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Its phase 2 results for samelisant which is used to treat narcolepsy, associated with sleep cycle. The medicine has less side effects compared to pitolisant and oxybates, which are currently the preferred method for treating narcolepsy. The question on efficacy remains, which will be disclosed post phase 2 trials. The most interesting part is, in narcolepsy, there is an opportunity for out licensing post phase 2 trials, as was seen in the case of sumitomo pharma’s drug for narcolepsy. In such arrangements, the company licensing it pays an amount upfront, for conclusion of phase 3 trials plus there is also a royalty associated. Opportunity size is huge, as narcolepsy drugs is a billion dollar market, and suven lifesciences market cap is just 1000cr. However, everything depends on phase 2 trial results, which is expected anytime between September- October.
Disclosure: Invested and biased.

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Capital will not be an issue for SLS with sale of Suven Pharma.
Some of the molecules looks to be near completion.
I owned before demerger and exited only SLS post demerger. Held on to Pharma.

Disc: Now invested again in SLS with small quantity to track.

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Actually very difficult to predict the outcome of trial. Accumulation of shared seems to be more due to expectation of capital flows from sale of Suven Pharma into Suven Life.

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Is today’s price movement riding on Suven’s novel formulation mentioned in paper below?
https://www.researchgate.net/publication/376955784_Bioequivalence_food_effect_and_comparative_pharmacokinetics_of_SUVN-1105_a_novel_granule_formulation_of_abiraterone_acetate_to_Zytiga_in_healthy_male_subjects