Biocon Limited : Biocon’s nine-month revenues driven by growth...
January 25, 2012 at 12:26 am
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Biocon's nine-month revenues driven by
growth in Branded Formulations, Emerging
Markets and Research Services
January 24, 2012
Revenues at Rs 1,511 Crores; EBITDA at Rs 425
Crores; PAT at Rs 241 Crores
Commenting on the results, Chairman and Managing
Director Kiran Mazumdar-Shaw stated, "Our
performance in the first 3 quarters of FY12 has
been good on the manufacturing and services
fronts where profits were up nearly 29%
(excluding licensing income). Licensing income,
however, was sharply down from the exceptional
levels recorded last fiscal which resulted in
flat earnings overall. As I have frequently
stated, licensing income is a timing issue and
subject to periodic variability.
We have seen exceptional growth in our Research
Services business, an outcome of the strategic
investments we have made in enhancing our
integrated service offerings. Moving up the value
chain is integral to our growth strategy which is
reflected in the strong growth delivered by our
Branded Formulations vertical. Our focus on
Emerging Markets is also enabling us to realize a
greater potential for our APIs and Insulins
portfolios.
Our Research and Development pipeline is
advancing satisfactorily with 2 late-stage
candidates and several early stage programs with
enormous value creation potential through
licensing. We have shaped our broad-based
business into key growth verticals, which we
believe will enable us to deliver sustainable,
long-term value to our shareholders."
Highlights:
- 9 months FY12 Financials reflect a robust
performance by:
- Branded Formulations vertical which grew by 40%
YoY.
- Emerging Markets which now contribute tilt50%
of Biocon's revenues.
- Research services: 28% YoY growth in revenues,
reflecting the growing traction in our integrated
offering for accelerating innovation for our
global customers.
- Announced Positive Efficacy Data on Novel
Monoclonal Antibody, Itolizumab in Pivotal Phase
3 Psoriasis Study in India.
- Successful launch of INSUPen(R), an innovative
delivery device for Insulin and analogs enabling
us to comprehensively expand the market through
vials and cartridges.
- EBITDA and PAT margins at 28% and 16%
respectively.
Biocon Group (consolidated; excluding
Axicorp)
Business Performance and Outlook
(Vertical-wise)
Small Molecules and Biosimilars
A comprehensive portfolio of over 100 products
spread across 70 nations has helped the Biopharma
business (excluding licensing income) post 11%
YoY increase in revenues in the first nine months
of this fiscal. The growth in the third quarter
was driven by robust performances in
Immunosuppressants and the branded formulations
segments.
Immunosuppressants have grown over 40% in Q3FY12
vs. Q3FY11 on the back of strong Tacrolimus and
MMF sales.
Statins have remained buoyant with improved
margin realization.
Biocon's Fidaxomicin commercialization
partner, Optimer, has received marketing approval
for DIFICLIR(TM) tablets in the European Union in
December 2011. In its press release, Optimer has
indicated plans to launch in EU by the fourth
quarter of FY12 with their marketing partner
Astellas Pharma. Biocon is the sole supplier of
the drug substance for the global markets.
Fidaxomicin is used for the treatment of adults
with CDI (Clostridium difficile Infections) and
CDAD (Clostridium difficile-associated
diarrhea).
Dr. Arun Chandavarkar, Chief Operating Officer,
Biocon Ltd, said: "We believe that our
strategy of investing in technology platforms to
create a differentiated API portfolio has begun
to yield results as seen by the ramp up in
immunosuppressant sales. Whilst we continue to
expand our portfolio of APIs, we will explore
select opportunities to add value through
developing formulations to support our domestic
branded formulations business as well as
exports."
Branded Formulations
The Indian pharmaceutical market is expected to
grow at a CAGR of 15% over the next 10 years and
quadruple to a size of $55 billion by 2020 from a
2010 market size of $12.6 billion (IMS). The
chronic therapy segment, that represents only 25%
of the market, is outpacing the acute segment
growth by 5 percentage points. Biocon is present
in the chronic segment with over 70 brands spread
across six verticals namely, Diabetology,
Oncotherapeutics, Nephrology, Cardiology,
Immunotherapy and Comprehensive Care. Outpacing
the market, this vertical has posted a combined
YoY growth of 40% for the 9MFY12.
- Diabetology - Biocon ranks #3 in the 4O IU
insulin space, with a growth rate of 43% that
outpaces the market growth of 17% (ORG IMS Nov
2011 MAT). This growth has come on the back of
our presence in the vials segment. INSUPen(R),
our foray into insulin delivery devices in
November'11, will enable us to compete
effectively in the cartridges segment thereby
revving up growth. INSUPen(R) has garnered strong
support from doctors and patients alike. It has
also received accolades for its high quality and
ease of use features, unique packaging of insulin
Refills and a comprehensive IT- based
patient-care model that also offers on-call and
on-field support through 120 diabetes care
advisors.
The existing product portfolio's growth as of
ORG IMS MAT November 2011 was led by Basalog(R),
the largest brand in the Glargine vials
market.
Insugen(R) 100 IU, a FY 10-11 launch, has made
steady in-roads into the 100 IU insulin market
and has garnered 8% of market share in the first
year of its launch.
- Comprehensive Care - In the third quarter of
FY12, the comprehensive care business unit
delivered a strong performance driven by
Albubet(R), Penmer(R) and Biopiper(R). The
current portfolio was strengthened with the
launch of Suprava(R), Cegava(R) and Albubet
Safe(R). Within a year of the division's
launch, three of its brands now feature among the
top 10 brands in their respective categories.
- Nephrology - The third quarter of FY12 saw the
Nephrology business unit deliver a strong growth
driven by commendable performances in both the
renal transplant and dialysis portfolios. This
quarter was marked by the launch of Tacrograf(R)
0.25mg, the lowest strength of Tacrolimus to be
launched globally for the management of
post-transplant recipients on Tacrolimus.
- Oncotherapeutics - Abraxane(R) completed three
years of launch in the last quarter, and is the
fastest growing brand in the highly competitive
taxane market. In its fifth year since launch,
BIOMAb EGFR(R) continues to be developed via a
robust clinical development program in multiple
difficult-to-treat-tumors such as glioblastoma
multiforme, esophageal cancer, cervical and lung
cancer. BIOMAb EGFR(R) has gained the trust of
over 250 Indian oncologists who have extended the
benefit of this molecule to over 3500 Indian
patients. BIOMAb EGFR(R) features in the 2011 Top
20 most successful New Drug Launches in India
(IMS Market Intelligence).
- Immunotherapy - The division has grown robustly
over the last quarter driven by the three
flagship brands: TBIS(R) (Tacrolimus) PICON(R)
(Pimecrolimus) and PSORID(R) (Cyclosporin).
According to ORG IMS Nov 2011 MAT, TBIS(R) has
now moved from 4th to the 3rd place value-wise
over the last quarter. PICON is now ranked 2nd in
volume terms as per ORG IMS November MAT 2011.
The business unit also launched Calpsor(R)
(Calcipotriol) and Calpsor C(R) (Calcipotriol +
steroid) in the last quarter. Both these products
have been well received by dermatologists.
- Cardiology - The Injectible portfolio has
demonstrated strong growth of 55%. STATIX(R)
(Atorvastatin) is now a visible brand in the
market.
Research Services
The research services business has built on the
momentum of the first half and delivered a robust
28% growth in top line for 9MFY12 vs. 9MFY11.
Syngene - This quarter saw Syngene tying up with
Cellectis Bioresearch, a specialist in genome
customization and a subsidiary of Cellectis for
the development of novel, genetically customized
cell lines by employing Syngene's biology
platform.
Clinigene - In December 2011, Clinigene partnered
with Pacific Biomarkers Inc. (PBI), a premier
biomarker and specialty efficacy testing services
provider to the American drug development
industry, for addressing specialty biomarker and
high-end clinical lab needs of the global pharma
and biotech industry.
Commenting on this performance Peter Bains,
Director, Syngene International, said, "This
has been a very encouraging quarter for Syngene.
We are retaining and growing our customer base
and we are seeing clear traction against our
strategy to broaden our range of discovery and
development capabilities to provide a more
integrated service capability to support our
customers changing Research and Development
models and goals. Growth has been anchored in our
small molecule discovery and development services
which has been supported by encouraging
acceleration in our Biologics, Discovery Biology
and Custom manufacturing services".
Novel Molecules
Biocon continues to advance its novel portfolio,
including the Anti-CD20 and fusion MAb
programs.
Itolizumab: The phase III study for Chronic
Plaque Psoriasis (TREAT-PLAQ) was completed in
December 2011.Results from the interim, 28-week
data analysis have shown promising results,
indicating that Itolizumab has successfully met
the primary endpoint of significant improvement
in PASI-75 (Psoriasis Area and Severity Index)
score after 12 weeks of treatment in patients
with moderate to severe psoriasis compared to
placebo. The results also indicate that multiple
secondary endpoints after 12 and 28 weeks of
treatment have also been met. In this 28-week
interim analysis, the treatment regimens were
statistically significantly better than placebo.
The molecule also exhibited an excellent safety
and tolerability profile with very low rates of
infection (tilt10%) in active treatment arms
suggesting a favorable risk benefit profile
compared to currently available biologic
treatments.
IN-105: We are continuing to engage with global
pharmaceutical companies for partnering the novel
IN-105 oral insulin program.
Peptide Hybrid: A US IND has been filed by our
partner, Amylin, for AC165198.
About Biocon:
Biocon Limited (BSE code: 532523, NSE Id: BIOCON,
ISIN Id: INE376G01013) is India's premier
biotechnology company with a strategic focus on
biopharmaceuticals and research services.
Established in 1978 by Dr. Kiran Mazumdar-Shaw,
the Group is an integrated, innovation-driven
healthcare enterprise with offerings that
traverse the entire drug development value chain.
Balancing its novel molecule research pipeline
with a diversified product portfolio, Biocon
delivers affordable solutions to partners and
customers in over 70 countries across the globe.
Many of these products have USFDA and EMA
acceptance. Stellar products from Biocon's
stable include the world's first Pichia based
recombinant human Insulin, INSUGEN(R) and
glargine, BASALOG(R) coupled with a state of the
art insulin pen device, INSUPen(R) and
India's first indigenously produced
monoclonal antibody
BIOMAb-EGFR(R).www.biocon.com
Disclaimer
Certain statements in this release concerning our
future growth prospects are forward-looking
statements, which are subject to a number of
risks, uncertainties and assumptions that could
cause actual results to differ materially from
those contemplated in such forward-looking
statements. Important factors that could cause
actual results to differ materially from our
expectations include, amongst others general
economic and business conditions in India, our
ability to successfully implement our strategy,
our research and development efforts, our growth
and expansion plans and technological changes,
changes in the value of the Rupee and other
currency changes, changes in the Indian and
international interest rates, change in laws and
regulations that apply to the Indian and global
biotechnology and pharmaceuticals industries,
increasing competition in and the conditions of
the Indian biotechnology and pharmaceuticals
industries, changes in political conditions in
India and changes in the foreign exchange control
regulations in India. Neither our company, our
directors, nor any of our affiliates, have any
obligation to update or otherwise revise any
statements reflecting circumstances arising after
this date or to reflect the occurrence of
underlying events, even if the underlying
assumptions do not come to fruition.
Earnings Call
The company will conduct an hour long call at 3
pm IST on January 25, 2012 where the senior
management will discuss the company's
performance and answer questions from
participants. To participate in this conference
call, please dial the numbers provided below five
to ten minutes ahead of the scheduled start time.
The dial-in number for this call is 1800 102 1300
(India Toll Free number is accessible through all
mobiles and landline services). Other toll
numbers are listed in the conference call invite
which is posted on the company website
www.biocon.com. The operator will provide
instructions on asking questions before the start
of the call. A replay of this call will also be
available from January 25, 2012 - February 1,
2012 on the same dial-in numbers provided above.
The transcript of the conference call will be
posted on the company website.
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Biocon Limited is an India-based biopharmaceutical company, which focuses on treating diabetes, cancer and autoimmune diseases. Its segment includes Generics, Biosimilars, Novel Biologics and Research Services. It has developed and commercialized novel biologics, biosimilars, and complex small molecule active pharmaceutical ingredients (APIs) in India and several key global markets, as well as Generic Formulations in the United Sates, Europe and key emerging markets. Its API portfolio includes cardiology, anti-diabetics, immunosuppressants, multiple sclerosis, anti-cancer/oncology and other key products. Its products include Tacrolimus, Rosuvastatin, Simvastatin, Atorvastatin, Pravastatin, Fingolimod and others. It has over five facilities across Bangalore, Hyderabad and Visakhapatnam in India. Its API manufacturing facilities leverage complex technology platforms that range from microbial fermentation, chromatographic purification, chemical synthesis, peptide synthesis and HPAPIs.