Indoco Remedies Ltd. - Company Overview
1. Company Profile
The company
was established in 1947. Indoco is a small-sized pharma company engaged in
manufacture, marketing and distribution of pharmaceutical products and services
in the domestic & international markets. Through its nine marketing
divisions viz. Indoco, Spade, Warren NexGen, Warren ACE, Warren Excel and
Vision, Indoco Focus, Indoco CND, Spera and Institution the company serves a
range of doctor specialties. Indoco has signed supply agreements with companies
like Watson, Aspen and DSM to supply formulations to advanced and emerging
markets.
Figure:1 Graph Showing Revenue Trend & Revenue Breakup
2. India
formulations growth core to overall growth
Domestic
formulations (~63% of FY20 revenues) grew at 6.5% CAGR in FY16-20. The subdued
growth can be attributed to high concentration of acute therapies and one of
the lowest MR productivities. With a market share of ~0.7% and overall rank of
29, the company is still a marginal player with some top brands in smaller
categories like stemmatological.
3. Exports
formulations slowly - back on track
Exports formulations
(~27% of overall FY20 sales) have de-grown at 6.6% CAGR in FY16-20,
undone by regulatory hurdles in developed markets. However, recent clearance
from the UK-MHRA and lifting of warning letters from the USFDA for Goa plant II
and III (plant I is still under warning letter) is likely to improve operating
leverage for export formulations.
4. Revenue Mix – FY20
Figure:2 Pie Chart showing Revenue Mix
5. Research
and Development
Indoco’s
R&D Centre has a highly skilled team of around 400 scientists involved in
the research and development of API, FDFs as well as Analytical Services. First
time launch of Allogliptin under Aloja and Aloja-M for antidiabetic therapy in
India. On the back of this launch and a lower antidiabetic portfolio size, the
management expects double digit growth in this segment going ahead.
· One para IV launch scheduled for H2FY21for the US
market.
· The company provided for 2.25 crore of extra bad
debts in Q1FY21
· Baddi (Plant-3) utilisation level at 35% and has an Opex
of 4 crore per quarter (including depreciation)
· Q1 expenses were down to lower travel expenses and
higher US sales contribution.
· Q1FY21 gross margins (~70%) are sustainable, going
ahead. Employee cost is likely to be stable for the rest of this fiscal. Other
expenditure - Some savings in travel + promotional spend may continue, higher
productivity in India business.
· Q2FY21 domestic sales will continue to be impacted.
· Business on track as compared to last year – April: 50%,
May: 60- 65%, June: 80%, Currently: 90%
The Company
enjoys a good position in the domestic market with 27 brands ranking amongst
the top 5 positions in their respective sub-segments:
Figure:3 Table Showing Market Share%
6. Patent Application filed till date – Geographic Distribution
Out of the 68 API patent applications filed, 24
applications were accepted and granted. These include two Patents granted in
Europe and one in US for Alogliptin (Europe) and Canagliflozin (Europe and USA)
APIs, during the financial year 2019 – 20. Out of the 22 FDF patent
applications filed, 10 applications were accepted and granted. Indoco’s R&D
efforts received Indian Patents for formulation of Diclofenac and Quetiapine
tablets.
Figure:4 Table showing number of Patents filed and approved till date
7. Capex &
Debt
Capex was
Rs500m for FY20 and guided to in similar range for FY21. INDR has a gross debt
of Rs2.6bn with long and short term borrowing at Rs1.4bn and 1.3bn. CAPEX cycle
is over while its regulatory issues are behind. There could be a possibility of
next few quarters to be inflection point for earnings recovery.
It has multiple triggers like
1) Increased focus on chronic products
2) Strong order book for EU
3) Launch of new products in US
4) Underutilized API capacity.
Long term debt - 144 crore, short term debt - 125 crore, cash
- 10-12 crore. Capex over the next two to three years to be less than 50 crore.
Gross block for overall API segment is
120 crore.
8. ANDA Filing
Company
targets to file 5-6 ANDAs every year and have sizable filings in Injectables.
With number of ANDAs and Dossiers awaiting approval, the future for the
Regulated markets looks optimistic over the next two years. Regulated markets
include UK, US, New Zealand, Germany, Spain and others. In Emerging markets it
includes mainly Africa, Asia, LatAm and others. Indoco has approval of 12
ANDAs while it has pending approval for 44 ANDAs with US FDA.
The company received approval for its
ANDA for Olanzapine Tablets 2.5mg, 5mg, 7.5mg, 10mg, 15mg and 20mg.The company
is planning to launch this product in the US in the second half through a
marketing partner.
One of the
company’s US partners received approval for Palonosetron injection ANDA, which
was filed from the Goa Plant II. Launch of this product has been planned in
2QFY21. Launch quantities of Tranexamic injections (June’20) and Zolendronic
injections (July’20) have been shipped to the US from the Goa Plant II.
9. India Business
The company
launched Telmichek–CT Tablets in the cardiac category. The company has Alogliptin
combination with Metformin launch stated for later this year. Apixaban patent
litigation case is scheduled for hearing before the Delhi High Court on
September 8, 2020. The company’s legacy products accounted for 60% of the
revenue. The number of MRs in India is around 2300.
In addition to Fevindo, Indoco has two more new products for launch in Covid Care range, i.e., Povidone Iodine Gargle and Immunity booster chewable tablets with Zinc, Vitamin C and Vitamin D.Fevindo-400 (Favipiravir) is an antiviral drug, effective against the RNA‐based influenza virus. The drug has been approved by DCGI in the treatment of Covid-19.
10. US Market
Revenue were
flat QoQ at Rs. 268m. It received approval for Olanzapine tabs in 1QFY21 and
plans to launch in 2QFY21. Its US partner received approval for Palonesetron
injection, which was filed from Goa Plant II and it will be Launched in
2Q FY21 . Guided revenue of Rs1.5bn (vs. Rs560m in FY20) for FY21. It has
around 18-20 ophthalmic products among the pending ANDA’s and it is in
negotiation with three potential marketing partners and targeting for launch in
FY 22.
11. Europe
and EMS
Revenue grew
52% QoQ and declined 2% QoQ respectively. Guided for revenue of Rs2.25bn for
Europe in FY21E (46% growth Y-o-Y) as it has a strong order book for next 6-8
months. Ivory Coast, French West Africa and Kenya have been major contributors
for EM business.
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