Crams & Cdmo
Crams & Cdmo
- By MJK Investments
Analyst: Aman .M
What is CRO, CDMO, CMO & CRAMS?
•Innovator company outsources some of their key functions to a third party for either research of a
molecule, developing the drug or manufacturing API/Formulation. Players providing outsourcing services to
Innovator companies are referred to as CRO, CDMO, CMO or CRAMS Player.
For developing a Drug/molecule, a Pharma company needs to go through multiple steps, starting from
discovery to final commercialization.
Companies spend millions of dollar to develop a drug, despite this there is no surety of success of the
molecule.
63%
58%
31%
10%
Phase 1 to Phase 2 Phase 2 to Phase 3 Phase 3 to NDA/BLA NDA/BLA to Approval Phase 1 to Approval Source: Company
Phase 1: These trials are the first tests of the drugs involving human participants. In this, the drug is usually tested on 80-100
healthy volunteers to determine the safety of the drug.
Phase 2: Here 100-250 people who are suffering from the disease are given the drug. But, the transition rate from Phase 2 to
phase 3 is 30.7%, which is the lowest of all the 4 phases of the process.
Phase 3: Here 1000-5000 volunteers who are not in a good condition are given the drug. It is done to confirm the
effectiveness of od the drug in the human body.
After the molecule has passed the third stage. A new drug application (NDA) or a Biological License Application (BLA) is
submitted to the regulator and here the chances of success are at 85.3%.
Why there is a need for a CRO or CRAMS?
For example: Currently Pfizer is working on some molecule which is in Phase 3 of clinical trials.
What will Pfizer do with the manufacturing So, to avoid such events, innovators are
facility which it has set up to manufacture the increasingly outsourcing their
drug? discovery, development and manufacturing
It will be of no use now and the company having process to developing countries like India, China
built it by raising debt will incur significant etc.
interest burden.
Scientist = moat?
Initially Pfizer will start with outsourcing of research/drug discovery under a Fee for service (FFS) model, where
R&D is outsourced and CRO takes a fee for specified service.
Now, after some years of outsourcing research and gaining confidence on Syngene capability, Pfizer would enter
into a Full Time Equivalent contract which is typically a long term contract.
Slowly and steadily as time passes, the relationship b/w Pfizer gets stronger and finally Pfizer would outsource
the whole range of activity from discovery to manufacturing.
Biologic drug (Large molecule): It is more like a vaccine. In biologic, a living organism is inserted in your body in the form of a virus
which will remind your immune system how to fight with the disease. For example insulin is the oldest biologic drug.
Anti Body Drug Conjugates: For e.g. A challenge of cancer treatment is to doing the best to ensure that benefits the medicine brings
outweighs the burden of side effects. Consider chemotherapy, it’s a powerful treatment that kills cancer cells but there are side-effect
too, like hair loss as it does not differentiates b/w cancer cells and healthy ones.
Now ADC, work more in a targeted manner and attack only the infected cancer cells and not healthy ones.
Where is Syngene Placed?
Integrated Business Model
CRO
CRO CMO
CDMO
Syngene is the only company in India which is vertically integrated from CRO to CRAMS all under one roof.
Syngene - History
2001 2016
< 50 clients
Clients
Revenue breakup
20%
4% 12%
73% 76%
In 2018, Baxter
Baxter tied up with
extended contract till
Syngene in 2013
2024.
100 Scientists & 70,000 sq.ft. 200 Scientists & 70,000 sq.ft.
laboratory laboratory
100 Scientists & 25,000 sq.ft. 170 Scientists & 60,000 sq.ft.
laboratory laboratory
300 0.2
14%
200 0.1
2%
100 -4% 0
0 -0.1
2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
Under this arrangement client is buying the whole thing infrastructure, management, people and the capability.
The arrangement under Dedicated R&D is majorly Full Time Equivalent (FTE).
The contracts are majorly for a period of 5 years or more.
Tie-ups with global Pharma leaders gives a sense of consistency in revenue at least till 2023.
2. Discovery Services- From target to a Drug Candidate
Discovery covers the process from target identification to target validation to lead generation and lead optimization. The
focus at this stage is to narrow down thousands of compounds to a few hundred, promising possibilities for further R&D.
“Discovery services offers a class of ‘value added biological services’ which work to extract more client dollars per small
molecule.” Source: Syngene Annual Report
Discovery Services
How is Syngene undertaking Discovering Process:
Solution Provided: Conducts
early-stage research, from • Discovery Chemistry.
target identification to
delivery of drug candidates • Discovery Biology.
for further development
• Bio-Informatics.
Collaboration Model:
Primarily FTE engagements.
Discovery Services- “A CRO function”
Syngene has been continuously adding capacities and bringing new technologies to strengthen its discovery
process, thereby making it more reliable and go to partner for global MNC.
New Processes like Anti Body Drug The investment in new platforms like Anti Body Drug Conjugates and
conjugates, Oligonucleotide Oligonucleotide, brings Syngene at par with global CRO’s.
Collaboration with Deerfield Management In 2020, Syngene tied up Deerfield Management company. Deerfield plays
company for 5 years a critical role in early stage therapeutics. This collaboration would further
enhance the discovery capabilities of Syngene.
Discovery Services Revenue
700 644 0.6
602 Discovery Services Revenue Contribution
600 50% 0.5
500 470
0.4 33% 33% 32%
400
312 28%
0.3 26%
300 255 23%
23%
0.2
200
100 7% 0.1
0 0
2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
The company has been continuously focusing on Discovery services and this is visible in the contribution which has
increased from 23% to 32%.
With the recent developments, the scope of services in the Discovery space has increased which has made Syngene
more capable of delivering solutions to clients.
Development Services
Development Services
Solution: Encompasses
activities from pre-clinical to
clinical trials including drug
substance development and
associated services to
demonstrate the
safety, tolerability and efficacy
of the selected drug candidate
Solution: Manufacturing
Services for small and
Large molecules, including
clinical supplies and
registration batches as well
as commercial volumes
through a new, state of the
art API manufacturing
facility.
Collaboration Model:
Customized engagement
models.
Development and Manufacturing Services
800 744 0.4
35% 675
700
0.3
600 569
476 19% 0.2 Development and Manufacturing Revenue Contribution
500
420
400 0.1
10%
300 43% 40%
0 37% 37%
35%
200
-12% -0.1
100
0 -0.2
2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
With the expansion into the following spaces Syngene is well placed to provide the full range of services right
from discovery to manufacturing:
1. Viral Testing Facility.
2. Biologics Manufacturing Facility.
3. Mangalore API Plant.
Lets try to Understand Managements Strategy
Manufacturing Plant
Company established Viral testing facility in 2016 and was the first company in India to do so.
2. Viral Testing Facility Viral testing is an integral part of submissions (safety assurance) to regulatory authorities. This comprises the
conduct of clinical trials and marketing authorizations. The testing is mandatory for all biopharmaceutical
products.
3. Tie-ups • Amgen is recognized as one of the leaders in Biotechnology. Company tied up with Amgen in 2017.
• Tie up with Canadian Biotech company to develop few antibodies, again shows how these collaborations is
helping Syngene to strengthen its Biologic Journey.
4. Personnel's • Jonathan Hunt, current CEO has over 25 years experience in Bio pharma. He was designated as CEO in 2016
• Dr Jayshree Aiyar was hired in 2016 as a Head of Biology.
Q2 2020 Concall
Solid Client Base
Year Collaborations
400 90%
360
350 79% 71%
69% 72% 70% 316
331 80% 2017 Tie up with Canadian Biotech firm
293 70%
300
256 65%
250 221
69% 68% 67% 60% 2018 Discovery Project with GSK
183 186 50%
200
40% 2018 Development & Manufacturing project with
150 115 30% Zoetis
100 20%
50 10% 2018 Multi year contract with Japanese spec Chem
0 0% company
2012 2013 2014 2015 2016 2017 2018 2019 2020
2018 French Biotech company
Clients Top 10 Customers Revenue concentration
2019 R&D partner for Artelo Biosciences
2019 Zumutor Biologics
2020 Extended Collaboration with Merck
22% 23%
1500 1423
20%
1201 19%
1107
15%
1000 860
700
550 10% 10%
417 8%
500
264 322 6% 5%
0 0%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 TTM
• The dip in revenue growth in 2017, was due to the fire that broke out at one of the company’s facility which
represented 20% of total revenues.
• Over the last 10 years revenue has grown at a Cagr of 23% and 14% over the last 5 years.
Gross Profitability
1200 0.4
1008 0.35
1000 34% 33% 920
31% 829 0.3
800 28%
665 25% 0.25
547 571
600 0.2
19%
419 16%
353 0.15
400
276 11%
207 10% 0.1
200 154
4% 0.05
0 0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 TTM
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 TTM
0 81%
2015 2016 2017 2018 2019 2020
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 TTM
Net Profitability
450 412 50%
400 CAGR 10 yr: 28% 363 40%
CAGR 5 yr: 9% 37% 38% 331
350 34% 305
31% 287 30%
300 24%
241 20%
250 19%
200 0% 0% 175 10%
150 -8% 134
98 8% 0%
100 73 6%
50 31 28 -12% -10%
0 -20%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 TTM
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 9M 2021
630 677
540
446
398
300 308 226 323 306
286
231 230 220
139 129 134 113 168 137
104 81 95 111 109 77
13 19
Q1 2020 concall
Working Capital Management
2.4 2.2
2.3 2.6 2.0 3.6 4.3 3.6
2.8 2.3
8.0 7.6 8.1 11.6 15.1
9.4 8.3 9.2
6.7 7.8
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Debtors Turnover Inventory Turnover Payable Turnover
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Particulars 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Working Capital as a % of Sales 2% -6% -4% -23% -8% -8% -8% -6% -6% -5%
Cash Conversion Cycle (Days) -73 -56 -96 -78 -4 20 -4 -14 -52 -72
Prudent Capital Sourcing
4%
20%
24%
3%
43% 2%
42%
7%
15%
22%
11% 6%
Others Others
Return Ratios
Depressed due
to capex and
unutilized
capacity
32%
31%
25% 27%
25% 23%
28% 26%
24% 23% 24% 24%
20% 18% 20%
17%
13%
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
ROE ROCE
Valuation Ratios
66
52
38
36 35 35
32
29 29
27 27
24
18
13 13 14
12 11
9 8 9
7 6 5
Both these giants uses Anti Body Drug Syngene, first company in India to develop Viral
Discovery Capabilities
Conjugates (ADC), Viral Test Facility, CAR-T testing facility. It also formed ADC and CAR-Ttherapy.
therapy for its operations.
Talent Pool More than 80% of the employees are scientists More than 85% of the employees are scientists in
in Wuxi Apptec. Syngene.
Lonza is also establishing API facility for further Syngene has also established its API facility in
Future Plans
integrating its services. Mangalore for integrating its services.
Although Wuxii and Lonza are very large as compared to Syngene, but Syngene is also doing the same things which these
companies have done. So, therefore we can say that Syngene is on the right track with capacity and technology in place.
Peer Comparison
Revenue (USD mn) EBITDA Margins
5638 36%
5092 34%
32% 32%
4667 29% 29%
4347 26%27% 27%28%
4057 26% 25% 26%
22% 24%
2529
1845
1186 1395
871
167 185 219 263 267
2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
Prior to joining Syngene in January 2015, he worked with Astrazeneca. He has more than 25 years
Jonathan Hunt MD & CEO of extensive experience in the global biopharmaceuticals industry.
Held various positions across companies like Pfizer, Amgen and has experience of more than 20
Mahesh Bhalgat COO years.
SVP-Disovery Joined Syngene in 2019, prior to that he has worked with Merck, Abbott and has experience of
Dr. Kenetth Brar services more than 30 years.
SVP-Developmental
Dr. Jan-Olav Henck Services Prior to joining Syngene he has worked with Bayer and has experience of more than 13 years.
What makes Syngene special?
Only Integrated Player in India right from CRO to CDMO all under one head.
Continuous innovation in the processes and the early mover advantage (one of the early mover to enter
Biologics space in India).
Business built on strong relationships with top pharma companies associated for a long period of time.
Low: Threat of New entrants is very Moderate: As, the company has proved
niche space, and has established strong companies can outsource their research
When we look at the likes of Wuxi Apptec, it is around 10 times the size of Syngene and is still growing at high double digit
continuously. On the other hand Syngene is also on the right track as compared to global peers and the growth journey has just
started. Looking at the huge opportunity in the CRO segment, Syngene could be a major beneficiary of the growth in Biologics
industry.