Annual Report No : 3
Highlights of #Guficbiosciences Annual Report FY 21

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1. Company Overview

Gufic biosciences limited is involved in research and development, manufacturing, marketing, distribution and sale of pharmaceutical products.
The company is one of the largest manufacturers of lyophilized products in India and have a fully automated lyophilized plant.

Their lyophilized plant is involved in therapeutic areas like Antibiotic, Antifungal, Cardiac, Infertility, Antiviral and Proton-Pump Inhibitor (PPI).
Gufic is looking to diversify its geographical reach by deepening its presence in markets of India, Canada, Europe, South Africa.
Gufic is also involved in the production of active pharmaceutical ingredients in areas like Antifungals, Antibacterials, Anesthetics and also Intermediates for Antifungals.
2. Business segments
Gufic has 3 major areas of business

1) Branded Domestic Business

The branded domestic business is split into 3 categories. These three segments include Gufic Super Specialty Business, Gufic Mass Specialty Business and Gufic Specialty Business.
Gufic super specialty business further has 2 sub categories-

a)Critical care business

Criticare is further divided into primary healthcare and mycocare.
Has products like tigefic plus, caspofungin, micafungin, Rabol and cefoperazone.Gufic’s focus is going to be in building specific Acute Therapy brands in the Anti-Infective category.
Gufic claims to manufacture life saving drug products which it supplies to hospitals all over india.
Criticare has a market opportunity of around ₹4500-5000 crores
b)Ferti care business
The Ferti care business of Gufic is the division that manufactures products for infertility treatment. Most of the products in this division are supplied by in-house APIs.
Some of the products of this division are cetrocare, puregraf 75IU 3D and Luprocare 3.75mg 3D.

Infertility business has a market opportunity of around ₹3000 crores.
Gufic Mass Specialty Business has 2 sub categories-

a)Spark

It is Gufic’s thrust area. Gufic’s own representatives meet and promote the products of this division to doctors. The therapeutic areas include antibiotic, Gastrointestinal,
Enzyme & protein preparations, pain management, Anti-inflammatory drugs. Some products in this division are Aznee 100, aznee 200, Eclin and Flabone
b)Herbal
Gufic is among the leading manufacturers of specialized herbal products. The production plant is located in Belgaum, Karnataka. In-house production facilities help them stay flexible and consistent with their quality.
One of their products - Sallaki is used for the treatment of osteoarthritis and rheumatoid arthritis.
Gufic Specialty Business’ 2 sub categories

a)Gufic Stellar

The division focuses mainly on Orthopedic and Gynecological products in various segments like pain, infection, pregnancy, lactation, bone and muscle products.
This SBU will help them build specific specialty focus that have a long term prescription profile

b)Gufic Aesthaderm

Aesthaderm is involved in various dermatology products in the moisturizing agents, anti-aging, hyperpigmentation, sunscreen and pre / post procedural products.
Gufic is the first company to launch an indigenously manufactured Botulinum Toxin (for wrinkles and sagging skin) in collaboration with Prime-Bio, USA.
Most of the other differentiated products are also developed in technical collaboration with Lucas Meyer - a company that specializes in aesthetic dermatology. The major target audience for Aesthaderm is – Cosmetologists, Plastic Surgeons, Aesthetic Dermatologists and Beauticians
2)CMO – Domestic, International Business

Using lyophilization capacities and multiple approvals Gufic aims at venturing into the newer markets of Australia, Brazil, Ukraine, South Africa, Kenya for its CMO business and out-licensing business.
3)API Business

The therapeutic categories of APIs manufactured include antifungals, intermediates for antifungals, anesthetic, immunosuppressant and angiotensin receptor blocker. Gufic manufactures a varied therapeutic basket of APIs,
which are mostly utilized for their captive consumption.
3. Revenue Break-up
4. Research and development
Gufic invests in R&D in 3 key areas:
1. New molecules and innovative combinations

R&D under this segment revolves around projects which have opportunity in terms of new launches for domestic as well as international business.
The therapy areas include – anti-diabetic, cardiac, anti-infectives, hormones, neurologicals, antifungals, nutraceuticals and pain management products.
The business strategy on the molecules is to launch the products under Gufic's trademarks and offer the products to their CMO partners
2. Advanced drug delivery systems

Gufic has been working on NDDS formulations in the critical care and infertility segment. The R&D team has successfully completed in-house trials on several innovative concepts in pre-filled syringes, dual chamber bags and dual chamber syringes
(a novel concept to deliver critical care products).

3. Biologics & Peptides

Gufic would be launching several products under immunity (thymosin alpha), cosmetic dermatology (botulinum toxin), pain management (botulinum toxin), infertility (recombinant products)
and several others products in the critical care segment for the first time. They would be launched through proper Phase 2 and 3 clinical trials for obtaining market authorization in India and other countries by in-licensing these products (technology transfer) from
several countries across the globe.

As of Q3 FY22, the R&D department in Navsari works on Botulinum Toxin projects and have started now working on certain biological peptides. This was to be complemented by the Indore R&D which was going to start in the month
of February in vaccine production and new drug delivery systems.

5. Amalgamation
Gufic Lifesciences Ltd, one of the oldest pharma companies in India, had got the regulatory approval for the amalgamation of its injectables unit - Gufic LifeSciences. With the absorption
of the company Gufic Lifesciences will own a lyophilized plant in Navsari, Gujarat, for regulated as well as non-regulated markets. As a result, Gufic as a group is one of the largest manufacturers of lyophilized injectables in India.
6. Capex
Gufic is planning around ₹240 crores of capex for Indore plant. They will also be investing around ₹20 Cr in the Navsari plant. The capex will be funded by ₹150 crores of debt and the remaining will be from internal accruals.
7. New ventures
Gufic is planning to come up with a new pipeline of criticare products which are mostly targeted for primary healthcare products. There were to be 2-3 products to be launched in the month of February and 2 more in the month of March and a new drug delivery system
coming in the month of April. Gufic is also coming with a lot of nutraceuticals according to their latest conference call, mainly for kids, which are to be used on a day to day basis. Besides that they are working on massage oils for infants.
Gufic is launching Anvil, an anti diabetic drug. They believe that because of COVID lot of increase in sugar level and diabetes is being seen. Gufic has also partnered with Prime Bio,
USA for manufacturing Botulinum Toxin API and formulation under the brand name “Stunnox” under Aesthaderm division

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