Dear Members,
The Board of Directors of your company hereby present the 21 Annual
Report on the business & operations of the company and Audited
Statement of Accounts for the year ended 31st March, 2011 along with
the Auditor''s Report thereon.
FINANCIAL RESULTS
Rs. in Lakhs
Particulars 2010- 2011 2009- 2010
Net Sales/Income 1001.21 398.46
Total Expenditure 761.74 234.42
Gross Operating Profit 239.47 164.04
Interest and 71.47 84.98
Finance Charges
Forex Loss 116.05 -
Depreciation 35.16 33.49
Profit before Tax 16.79 45.57
Provision for Tax 3.11 7.42
Net Profit 13.68 38.15
OPERATIONS
The Directors'' report that during the year under review the total
income was Rs.1001.21 Lakhs as against Rs.398.46 Lakhs in the previous
year and the Net Profit for the year was Rs.13.69 Lakhs as against
Rs.38.15 Lakhs for the previous year. There was a forex loss of
Rs.116.05 lakhs due to which the profit had come down,During the year,
the company has incurred an amount of Rs.286.01 lakhs on ongoing
product development and Rs.64.33 Lakhs on Fixed Assets as against
Rs.455.77 lakhs and Rs.10.05 Lakhs respectively in 2009-10.
It has been a year of some satisfaction with your company raising the
much needed funds through GDRs, the funds to enhance your company''s
ability in reaching the desired objectives on different projects.
With the funds in place, the management has initiated plans to
restructure its operations in order to realize the inherent values of
various projects much faster. The newly structured operations fall
under:
API division
Tacrolimus
- DHA
- Orlistat R&D division
RNAi based drugs
- Breast cancer
- Liver cancer
- Ovarian cancer
- Pancreatic cancer
- Monoclonal antibodies (mAbs)
- Colon cancer
- Multiple myeloma
- Non-Hodgkin''s lymphoma
- Esophageal cancer
- BeeCell technology (Auto-immune disease model)
- AIDS therapeutic vaccine
- Multiple Sclerosis
- NDDS
- Oral Insulin
- Oral AIDS vaccine
- Oral mAb based drugs
- Transdermal delivery of AIDs vaccine
APIs and commercial production:
As informed earlier, this division has achieved breakthrough on two
other APIs. Unfortunately, because of the hurdles faced by the company
in getting the approvals for expanding the manufacturing facilities at
the current location of your company, the management is looking at
alternative proposals for and during land with special emphasis on
getting environment and pollution control approvals. Realising the
poosible delays on that front, the management has opted to start the
commercial operations from a third party facility. We have already
entered into a Memorandum of Understanding with a company to start the
production using initially 64 kl fermentation facility with a capacity
to expand it to much larger capacities. Work is progressing with
installation of additional production and supporting equipment.
We are scheduled to start commercial production of DHA, one of the APIs
at the chosen 64 kl facility during Q3 of 2011-12. DHA, an Omega-3
fatty acid, is a product of great demand all over the world for its
inclusion as part of a healthy diet that helps lower risk of heart
disease and for the development of our nervous system and visual
abilities during the first 6 months of life.
Likewise, our second API, Tacrolimus is due to start regular commercial
production soon after DHA production is optimized at Transgene''s
current 4 kl facility and transferred to 64 kl plant at the new
location.
With both APIs coming into commercial production during the Q3 of
2011-12, the management is looking at expanding its marketing horizons
beyond the shores of India.
R&D
RNAi drugs
We have added two more oncology drugs to the existing Breast and Liver
cancer drug development program - Pancreatic and Ovarian cancer drugs
with the signing of MoLI with a USA based company last month. We are
scheduled to complete highly complex pre-clinical studies conducted
outside India in North America on specially bred and genetically
modified mice on all these four drugs before the end of Q3 - 2011-12.
This will be followed by animal toxicology and human clinical studies.
mAb drugs
As informed earlier, we have engaged the services of two companies
outside India for humanizing our monoclonal antibody drugs. First step
in the process of humanization has been completed by both companies.
The chimerized antibodies are delivered for conducting in-house
in-vitro cytotoxicity assays prior to advancing and completing the
process of humanization. The antibodies are directed towards Colon
cancer, Multiple myeloma, NHL and Esophageal cancer.
BeeCell technology
The BeeCell technology platform developed by Transgene has been
improved further with the acquisition of another technology. This is to
enable Transgene to accelerate and widen the auto-immune disease drug
development program. It is reported that the drugs against auto-immune
diseases generated in excess of US billion in 2008 and growing
further rapidly.
Intellectual property and patents
The advancement of drug development programs on several fronts along
with addition of new projects, there has been a tremendous increase in
the number of patents filed during the final quarter of 2010-11 and
subsequently. So far, more than 30 patents have been filed during this
period covering India, USA and PCT countries in addition to the earlier
filed ones.
Expansion of scientific staff
In line with the expansion of manufacturing operations and with
advancing R&D milestones, several new and experienced scientists have
been added to each division headed by highly qualified and experienced
leaders.
DIVIDEND
In spite of increased revenue and profits, your Directors are unable to
recommend any dividend for the year due, keeping in mind of substantial
funds needed to support the increasing R&D activities where activities
such as pre-clinical and clinical studies are known to be highly cost
intensive.
GROWTH PLANS AND OUTLOOK
Transgene Biotek''s own comprehensive technology platforms represent a
powerful tool for the development of various therapeutic products for
treatment of several dangerous and debilitating conditions''such as
AIDS, Multiple Sclerosis etc. Recent acquisition of another technology
for auto-immune diseases has contributed to the rapid advancement of
drug development for auto-immune diseases apart from addition of two
more drugs for conditions such as Parkinson''s disease and Psoariasis.
In cancer treatment, the products being developed by Transgene are
first in-class targeting the tumour cells in a selective manner, with
release of high concentration of siRNAs be it shRNA or miRNAs into the
cancer cells and may therefore induce tumor regression or even tumor
death in a safe and effective manner. This in turn reduces or
eliminates the need for chemo-therapy. With advancing in-vivo studies
on several cancer drugs, the management hopes to enter the critical
milestone of human studies on some of these by the end of 2011- 12. We
have engaged the services of an experienced CRO company in North
America for conducting pre- clinical studies on three products to
substantiate and add value to our pipeline.
Global sales of cancer drugs will grow at a compounded annual rate of
12 to 15 percent, reaching to billion by 2012, according to a
new forecast by IMS Health (NYSE: RX), the world''s leading provider of
market intelligence to the pharmaceutical and healthcare industries.
The growth rate for oncology products will be nearly double the
forecasted growth rate of the global pharmaceutical market. Recent
innovations have improved quality of life, delayed disease progression
and helped prolong survival for patients battling different types of
cancer.
The expanding nature of new drug delivery technologies at Transgene
with the scientists gaining better insight over the last decade into
the challenges posed in delivering those drugs through routes other
than by injectable path, opened up another dimension in creating or
enhancing the value of each drug under development at Transgene. Today,
Transgene is on the cusp of achieving its objective in providing a
better alternative to the injections and in doing so, increasing the
patient compliance resulting in better or effective treatment of
conditions such as AIDs, Cancer etc.
New or novel drug delivery systems continue to be a fast-growing
market. Currently approaching billion in annual sales, it is
estimated that this industry will reach billion by 2009 - close to
20% of total global pharmaceutical sales.
The API division at Transgene, headed by a highly experienced and
committed team of scientists provides a stable and sustainable platform
for the company in moving forward with its devout objective of becoming
a globally recognized and innovative biotech company as we advance with
API manufacturing and R&D projects. The expanding manufacturing
operations and expansion of its marketing horizons beyond India shail
enhance its value even further.
The market for Omega-3 fatty acids (DHA/EHA) was estimated at over B
(2007), according to Scientia Advisors. With lot of emerging scientific
evidence demonstrating the health benefits of DHA / EPA and consumer
awareness, the market is expected to drive >60% growth in the coming
years, according to a reteni Frost & Sullivan report (2010). Demand is
projected to outstrip available supply.
Marillion Pharmaceuticals Inc
In the context of its restructuring program, the management has decided
to terminate its proposed acquisition of Marillion Pharmaceuticals Inc
of USA, following an in-depth due diligence exercise. However,
Transgene continues its quest for inorganic growth through selective
acquisition of or strategic partnerships with companies within and
outside India.
In the near and medium term, Transgene is to grow through expanding its
API manufacturing operations within and outside India generating
substantial revenues and profits. Over the longer term, the Company
continues to advance its novel drugs and achieving the critical
milestones which are protected by patents and which are of significant
value.
In summary, despite the economic and financial turbulence in the
developed markets, we now have the team and the strategy in place to
take the business forward to the next stage of its evolution. At
Transgene we will continue to consolidate what we have been building on
our solid platform and diversify where needed. This will be through a
combination of organic growth and innovation, product licensing and
acquisition, and strategic partnerships or company acquisitions.
EMPLOYEES STOCK OPTION SCHEME
The employee stock option scheme is still under implementation.
DIRECTORS
Sri S S Marthi and Dr P K Ghosh retire by rotation and being eligible
offer themselves for re-appointment.
ISSUE OF GDRs
The company was able to successfully issue 2500000 GDRs @ USD 9.2 per
GDR which were fully subscribed. The underlying shares of 25000000
Equity Shares of Rs.10/- each were listed on the Bombay Stock Exchange
Limited w.ef. May 06, 2011.
FIXED DEPOSITS
The company has not accepted any Fixed Deposits and the provisions of
section 58A of the Companies Act, 1956 are not applicable to the
Company.
AUDITORS
M/s Sarath & Associates, Chartered Accountants, the statutory Auditors
of the Company retire at the ensuing Annual General Meeting and are
eligible for reappointment.
DIRECTORS'' RESPONSIBILITY STATEMENT
As required under the Companies Act, 1956, your Directors wish to
state:
(a) That in the preparation of the Annual Accounts, the applicable
accounting standards have been followed.
(b) That the Directors had selected such accounting policies and
applied them consistently and made judgments and estimates that are
reasonable and prudent, so as to give a true and fair view of the state
of affairs of the Company at the end of the financial year and of the
profit of the Company for that period;
(c) That the Directors had taken proper and sufficient care for the
maintenance of adequate accounting records in accordance with the
provisions of the Companies Act, 1956 for safeguarding the assets of
the Company and for preventing and detecting fraud and other
irregularities.
(d) That the Directors had prepared the annual accounts for the year
ended 31st March 2011 on a going concern basis.
CORPORATE GOVERNANCE
Pursuant to clause 49 of the listing agreement, your Company has taken
adequate steps to ensure that all mandatory provisions of corporate
Governance as prescribed under the listing agreement of the Stock
Exchange with due compliance of all the applicable laws, rules and
regulations. A separate report on Corporate Governance and the
Auditor''s certificate on its compliance are annexed hereto and forms
part of this Annual report.
EMPLOYEE RELATIONS
The key to our success is to develop core values within all of our
staff which lead to an environment where they believe that what they
are doing is making a difference. The core values with which we
operate are participation, achievement, trust and respect, innovation
and enthusiasm.
Transgene recognises that in an industry based on innovation and
research and development, its employees are some of its biggest assets
and it seeks to communicate and, where appropriate, consult with them
on matters affecting them as employees, in the correct manner.
Transgene provides training and development appropriate to individual
needs and offers remuneration packages (including pensions, permanent
health and life insurance) and a working environment that are designed
to be both fair and competitive with larger companies within the
industry.
There is no employee whose particulars are to be furnished pursuant to
the provisions under Section 217 (2A) of the Companies Act, 1956 read
with the Companies (Particulars of Employees) Rules, 1975 as amended by
the Companies (Amendment) Act, 1988.
CONSERVATION OF ENERGY, ENVIRONMENT, TECHNOLOGY ABSORPTION AND FOREIGN
EXCHANGE
A. Conservation of Energy, Power and Environment :
We are committed to minimising the impact of our activities on the
environment and energy efficiency is the most important means of
climate protection currently available to the company. Efforts for
conservation of energy and fuel consumption are ongoing processes in
the Company and every effort is made in that direction.
B. Research & Development:
The Company''s R&D division continues to be recognized and certified
under DSIR guidelines. The company fosters the development of molecules
owned/co-owned byTransgene Biotek Ltd, in terms of finding right CROs
in India, US and Europe based on their capabilities, overseeing,
analysis and monitoring of information on in-vivo efficacy/ toxicology
studies being conducted within or outside India.
C. Foreign Exchange Earnings : Nil
D. Foreign Exchange Outgo : Rs. 4,55,64,518
ACKNOWLEDGEMENTS
Our employees remain crucial to the success of Transgene and it is
their skill and expertise that have enabled us to achieve our progress
to date. This has been recognised at various meetings where, over the
past twelve months, Transgene has made presentations on its drug
development pipeline.
We are committed to the development of a motivated and professional
workforce in order to build a business that is constantly looking to
innovate and evolve. On behalf of the Board, we thank all our staff for
their hard work and continued support and commitment.
Your Directors wish to place on record their gratitude to the
Government authorities, for the support and co- operation received from
M/S Union Bank of India, Bankers of the company, Shareholders,
Auditors, Customers, vendors, business associates and Staff of the
Company for their valued support during the year under review.
By order of the Board
For TRANSGENE BIOTEK LIMITED
Place: Hyderabad Dr. K. Koteswara Rao
Date: 05-09-2011 Chairman & Managing Director
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