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Claris Lifesciences Limited

Claris Lifesciences Limited Audited Financial Results for the Quarter and Financial Year (Fifteen Months) Ended 31st March 2015

May 22, 2015   18:44 IST 
Ahmedabad, Gujarat, India

Claris Lifesciences Ltd. (CLL) today announced its Audited Financial Results for the quarter and financial year (fifteen months] ended 31st March 2015 at its board meeting held at its registered office in Ahmedabad.

 

Management Representation of the Financial of the Speciality Injectable Business:

                                 (Values in Rupees Mn)

 

Key financial highlights or the specialty injectable Business;

- Net Sales for Q1CY15 stood at Rs. 1117 mn, which has grown by approximately 54% as compared to the management estimates of the same quarter in the previous year.

- EBITDA has grown by 81% over the same quarter previous year.

- EBITDA margins for the quarter stood at 36%, higher by 500 bps compared to the same quarter previous year.

 

Region wise Net Sales

       (Values in Rupees Mn)

 

- United States continues to be the key growth driver, with sales having grown by 441% as compared to the same quarter previous year.

- Further, the company is building its team with experience professionals in the US in line with the expected requirements of the growing sales.

 

Key financial highlights of the consolidated financials of Claris Lifesciences Ltd.:

The Infusion business for Emerging Markets was transferred to Claris Otsuka art August 2013, the consolidated numbers of CY2013 include the revenues and profits of the Infusion business, further as the company now moves to a Financial Year reporting, this year's results includes a 15 month period, hence the previous year and this year results are not comparable.

 

         (Values in Rupees Mn)

 *Includes pass through sales of Claris Otsuka

**Includes the infusion Business transferred to Claris Otsuka

#PAT of Q4CY 14 includes a onetime reversal of differed tax liability or Rs. 510 mn clue to the slump sale to CIL

@EBITDA and PAT have fallen as compared to the same quarter previous year due to drop in other income of treasury funds,

 

REVENUE

- The Total Revenue for the quarter grew by 15% over the same quarter last year.

As the pass through sales of Claris Otsuka reduces the revenue will continue to go down, but this would positively affect the margins of the business going forward.

 

EBITDA

- The EBITDA for the quarter fell by 2% over the same quarter last year, due to reduce other income of around S Cr from the treasury operation. In Q1CY14 the funds generating income were higher by Rs. 300 Cr as the company as the company had the funds allocated for buyback in the treasury.

- The EBITDA margin for the 15 months of this year financials was in line with the CY2013 at 30% against 31%,

- The EBITDA margins for Q1CY15 stood at 24% as compared to 28% in the same quarter previous year

 

PAT

- The PAT fell by 22% over the same quarter last year, due to reduced income of around 5 Cr from the treasury operation. In Q1CY14 the funds generating income were higher by Rs, 300 Cr as the company had the funds allocated for buyback in the treasury.

- Year on Year pat is not comparable due to the 15 month financial year, the PAT margins of this financial year (15 months) were higher at 19% than the 13% margins of CY2013.

- The PAT margins for Q1CY15 stood at 7%

 

Other Updates

Para IV Settlement with Fresenius:

On 2th of April 2015, the Company had reached a settlement and license agreement, ending all pending litigation with Fresenius Kabi USA, Inc. with reference to the alleged infringement of a patent relating to Propofol for Injection, 10 mg/ml, which is a generic version of DIPRIVAN.

- Under the terms of the Settlement and License Agreement, Claris and Claris Lifesciences Inc. (USA) has been granted approval to sell its generic version of Propofol for Injection beginning 15th October 2016, prior to the1st June 2025 expiry of the patent that formed the basis of the litigation.

- According to IMS health data as of June 2014, Propofol Injection had an annual market size of approximately US$ 251 million in the USA.

 

Regulatory updates:

- The US is the most important region and the Company has filed at total of 39 ANDAs in the US, out of which 13 ANDAs have been approved and another 26 are under approval. The total addressable market size of the 39 ANDAs Is approximately US$ 2,000 million, out of which the market size of approved ANDAs and under approval ANDAs stood at approximately USA 200 million and USS 1,800 million respectively.

- During the quarter, the company received approval of a supplementary ANDA, for Fluconazole in 100 and 200 ml Non PVC Bags, in the USA.

- The company has filed for 1 ANDA during this quarter, and plans to file 18 ANDAs in the US during FY2016; this is in line with the company's target to have a total of 100 ANDAs in the US by 2018-19.

 

Capacity Expansion & Technology Up-gradation:

- The company invested in a new plant Clarion 2 with terminally sterile, aseptic and lyophilized capabilities.

The second line has been installed and has commenced sales in EMs from this second line.

- The packaging automation at the Plant I. is underway for the SVP and Propofol Iines this will result into an online packaging process as well with limited human Intervention as preferred by regulatory authorities and also strive towards higher levels of quality and compliance.

- In line with the Good Manufacturing Practices (GMP), the company is investing in new and revamping the existing software, Chromeleon, LIMS, Trackwise and Training Management Systems will be incorporated at the manufacturing facilities that will again strive towards higher levels of quality and compliance.


 
 
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