(Business Wire India); Biocon Ltd, Asia's premier biopharmaceuticals company, announced today that it has delivered a strong consolidated financial performance for Q1 FY16.
Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated:
“The strong performance this quarter reflects the overall growth of our business backed by a combination of product sales and monetization of R&D assets through licensing. Our Biosimilars strategy is playing out well with five programs in phase 3 clinical development. During the quarter we successfully licensed biosimilar Trastuzumab in key emerging markets. Our Insulins business was boosted with the launch of insulin Glargine in Mexico and Colombia. Our focus on key brands in Branded Formulations has begun to translate into a better quality of earnings.”
Highlights:
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Dr Narendra Chirmule, appointed as Head of Biocon’s R&D.
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Two new biosimilar molecules, Pegfilgrastim (PEG-G-CSF) and Adalimumab have entered Global Phase 3 clinical trials, taking the tally to five partnered programs in Phase III clinical development, others being; Trastuzumab, insulin Glargine and Bevacizumab.
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The Insulins Drug Products facility in Malaysia successfully completed a cGMP audit by Malaysia's National Pharmaceutical Control Bureau (NPCB).
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INSUPen® and INSUPen® EZ received GDPMD (Good Distribution Practice for Medical Device) Certification in Malaysia.
Financial Highlights: Q1 FY16
In Rs Crore, except growth numbers
|
|
Q1 FY16 |
Q1 FY15 |
Growth (%)
|
|
Revenue |
857 |
742 |
15
|
|
EBITDA |
236 |
191 |
24
|
|
Net Profit |
126 |
103 |
23
|
|
R&D Expenses in P&L |
50 |
31 |
60
|
|
Total R&D Spends |
93 |
63 |
47
|
|
EBITDA Margin |
28 |
26 |
N/A
|
|
Net Profit Margin |
15 |
14 |
N/A
|
Business Performance
Biopharmaceuticals
The Biopharmaceuticals segment benefitted from a strong contribution from our Insulins and Biosimilars business in the emerging markets.
Our partner, Denmark headquartered Veloxis, received USFDA approval for its proprietary Envarus XR formulation (tacrolimus extended release tablets) for prophylactic use in kidney transplant patients.
We have established a new entity Biocon Pharma Ltd, to support our finished dosage generics business. We see this as an important future growth driver.Two licensing deals were signed in key emerging markets for Trastuzumab. Significant inroads were made in Mexico and Colombia with the launch of insulin Glargine.
We received GDPMD (Good Distribution Practice for Medical Device) Certification for INSUPen® and INSUPen® EZ in Malaysia this quarter.
Our Insulins drug product facility in Malaysia, underwent a cGMP audit by the National Pharmaceutical Control Bureau (NPCB), Malaysia. We expect to receive the formal certification in a few weeks. This will be followed by the initiation of the validation batches for the drug product.
Biocon’s partnered programs in generic insulin analogs and biosimilars, continue to advance in the clinic. While the global phase III clinical trials for Trastuzumab and Pegfilgrastim are progressing towards completion, the patient recruitment for the global phase III trials of insulin Glargine for both type 1 and type 2 diabetes studies have been completed this quarter.
Branded Formulations
Our strategy of optimizing our product offering with a focus on key brands has begun to bear fruit as reflected in the 14% sequential growth (QoQ) with sales of Rs. 112 Crore in Q1FY16. This performance was led by the Metabolics, Nephrology and Market Access divisions.
We continue to grow well in the addressable Insulins market, with a growth of 20%, against the market growth of 14% (Source: IMS, TSA May MAT 2015). CANMAb™, our affordable biosimilar Trastuzumab continues to gain traction as a life-saving therapy for HER2-positive metastatic breast cancer patients.
Novel Molecules
A scientific paper titled ‘Long-term Efficacy and Safety of Itolizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis,’ authored by Dr Sunil Dogra, Additional Professor from PGI Chandigarh with other Key Opinion Leaders in Dermatology and Biocon’s R&D team, has been published in the prestigious Journal of American Academy of Dermatology, which profiles the unique attributes of our novel anti-CD6 monoclonal antibody leading to positive patient outcomes.
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