Claris Lifesciences Ltd - Stock Valuation and Financial Performance

Claris Lifesciences was originally incorporated as Oracle Laboratories Limited on July 19, 1994 under the Companies Act, 1956, as a public limited company and received the certificate for commencement of business on July 28, 1994. The Company subsequently changed the name to Core Laboratories Limited pursuant to a special resolution passed by the shareholders at a general meeting dated May 28, 1996 as the Company was acting as the marketing and distribution agent for Core Healthcare Limited at that time and wanted to align its name accordingly. Pursuant to the change of name, a fresh certificate of incorporation was granted to the Company by the Registrar of Companies, Gujarat Dadra & Nagar Haveli on June 18, 1996. The Company changed the name again to Claris Lifesciences Limited pursuant to a special resolution passed by the shareholders at a general meeting dated March 31, 1999 as the management decided to change the name as above. The new certificate of incorporation was granted to the Company by the Assistant Registrar of Companies, Gujarat, Dadra and Nagar Haveli on April 1, 1999, at Ahmedabad.

The Company commissioned its first manufacturing plant, Clarion I, in 2002 and since then has expanded its operations to four manufacturing facilities (Clarion I to IV). A fifth manufacturing facility, Clarion V, is currently under construction and is expected to be operational by the third quarter of 2011.

Business area of the Company:

Claris Lifesciences is one of the largest Indian sterile injectables pharmaceutical companies with a presence in 76 countries worldwide. Their product offering comprises of 113 products across multiple markets and therapeutic areas. All of its products are off-patent products, a significant majority of which are capable of being directly injected into the body and are predominantly used in the treatment of critical illnesses.

Company’s products ranges across various therapeutic segments, including anaesthesia, critical care, anti-infectives, renal care, infusion therapy, enteral nutrition, parenteral nutrition and oncology. The Company offers injectables in various delivery systems, such as glass and plastic bottles, vials, ampules, pre-filled syringes and non-PVC and PVC bags.

Claris has presence in certain regulated markets and one of its key growth strategies going forward is to further expand its distribution network and product offerings in markets such as the United States, Western Europe, Australia, New Zealand, Canada and South Africa, as potential sales and profit margins are higher than those in the emerging markets.

In order to achieve growth in the regulated markets, the company has also filed 257 applications for product registrations in regulated markets, including 16 applications in the United States, out of which the Company has obtained 108 product registrations, including 4 in the United States.

Out of its products offering, one of Company’s key products, propofol, represented approximately 14.84% of its total sales for the financial year ended December 31, 2009. The Company holds patents for APIs for its hydroxyl ethyl starch product. Company’s regulatory team has developed capabilities and processes to file product registrations in regulated 108 and emerging markets; as of March 31, 2010, the Company had obtained over 1,000 registrations worldwide and approximately 410 applications were pending approval.

In addition to manufacturing its own products which the Company sells under its own brands, the Company uses its facilities to manufacture products which are sold to Indian and international companies who market such products under their own brands.

Its products:

Anithesia: The Company’s expertise in lipid-based technology has made it one of the few companies in the world to manufacture propofol. Provive/Profol is an internationally accepted brand and the no. 1 brand of propofol in India as well as diverse countries across Latin America, Asia, Africa and the CIS.

Bupivacaine Injection: Bupivacaine is a long acting local anaesthetic agent that belongs to amide group & injection is sterile, non-pyrogenic, isotonic, single dose container. It contains an amide linkage between the aromatic nucleus and the amino or piperidine group.

Ketamine Injection IP: Ketamine hydrochloride is a non-barbiturate anaesthetic which blocks nerve paths without depressing respiratory and circulatory functions and, therefore, acts as a safe and reliable anaesthetic.

Propofol Intravenous anesthesia: PROVIVE / PROFOL is a white, oil in water, isotonic emulsion for intravenous injection containing 10 mg propofol in each ml along with excipients soybean oil, glycerol, egg lecithin and sodium hydroxide to adjust pH.

Midazolam Injection BP: Sedoz (Midazolam) is a short acting benzodiazepine with sedative-general anaesthetic properties. It can be used to produce sleepiness or drowsiness and to relieve anxiety before surgery or certain procedures.

Lidocaine Injection IP: Lidocaine (lignocaine) is the most important amide local anesthetic. Like other local anesthetics, it slows down the depolarization of the nerve cell membrane. This effect is based on the interaction with a specific receptor site in the sodium channel. Lidocaine reduces the automaticity in the conductive system of the heart by slowing down the diastolic depolarization.

Thiopentone Sodium for Injection IP: Thiopentone sodium is an ultra short-acting barbiturate derivative, which induces hypnosis and anesthesia, but not analgesia. It produces hypnosis within 30 to 40 seconds of intravenous injection.

Propofol Spiva: SPIVA ensures faster metabolism of lipid and thus offers less pain on site of injection and less lipid load

Subsidiaries:

The Company has four wholly owned Indian Subsidiaries. They are as follows:

It has eleven wholly owned foreign Subsidiaries, which are as follows:

Milestones:

1999- Company’s first international office was inaugurated in Brazil.

2002- Company received the WHO GMP certificate for its Clarion I facility also the Company reached Rs 1 billion mark in sales turnover during the year.

2003- Company’s manufacturing facility was approved by INVIMA, Colombia.

2004- Commercial production started at the Company’s infusion manufacturing facility.

2005- Company’s injectable manufacturing facility was approved by the MHRA, UK. The Company received its first regulated market order from the Netherlands and also received its first product registration from MHRA, UK. Further, the Company filed six ANDAs with the USFDA.

2006- First Carlyle Ventures III invested Rs 905.04 million in Equity Shares and convertible preference shares in the Company.

2007- The USFDA granted approval of the Company’s sterile injectable manufacturing facility in Clarion I.

2008- Received approval for four ANDAs in the United States. Commenced its own sales and marketing activities in the USA. Launch of a range of infusion products in non-PVC bags in India.

2009- Company’s one of the non-resident Subsidiaries entered into a business arrangement with Pfizer Asia Contract Operations Pte. Ltd. for the marketing and supply of specific sterile injectables in certain regulated markets.

2010- The Company received a letter from the USFDA in relation to the registration of its aseptic manufacturing line.

2012 -Claris Lifesciences forms JV with two Japanese companies

Recognition: