Natco Pharma
BSE: 524816 | NSE: NATCOPHARM | ISIN: INE987B01018 | Pharmaceuticals
- Directors Report
- Chairman's Speech
- Auditors Report
- Notes To Accounts
- Accounting Policy
- Finished Products
- Raw Materials
| Directors Report | Year End : Mar '08 |
To the Members
At the outset, your Directors are pleased to inform you of the company
having completed twenty five years of operations. The Directors take
this opportunity to thank all the shareholders, bankers, financial
institutions and employees for the continued support extended to the
company throughout this period.
Your Directors have pleasure in presenting the 25th Annual Report
together with the audited accounts of the Company for the year ended on
31st March, 2008.
Operating Results:
The pressure on margins on APIs has slightly eased during the year,
notwithstanding the absence of any noticeable spurt. The oncology
business (finished dosage pharmaceutical formulations) has grown and
has enabled the Company to record decent levels of over- all growth.
The US retail operations also contributed to the increase in sales and
profits.
The following table summarizes the companys performance during the
financial year 2007- 2008 :
Rs. in lakhs
Particulars of Revenues 2007-2008 2006-2007
API Division 9,337 8,021
Finished Dosage Formulations Division 23,365 16,665
Job Work 822 991
Other Income 2,858 2,317
TOTAL 36,382 27,994
consolidated revenues.
The companys operations for the year resulted in a surplus of Rs.
5,532 lakhs as compared to Rs. 4,008 lakhs for the financial year
2006-2007.
Your Directors have decided to make the following adjustments from out
of the surplus :
Rs. in lakhs
Particulars of write offs etc 2007-2008 2006-2007
Surplus after operational expenditure 5,532 4,008
Write offs - bad debts / bad advances etc. - 28
Gross Surplus available 5,532 3,980
Provision for taxes 1,244 630
Provision for deferred tax 236 303
Net surplus carried to Balance Sheet 4,052 3,047
Dividend:
Your Directors had recommended and paid an interim dividend of Rs. 1,25
per equity share during October / November, 2007. Your Directors
recommend that this may be treated as the final dividend and the
recommendation / payment ratified.
Fiscal 2008 in retrospect:
API Division:
The year witnessed a slight ease of the pressure on the margins for
products from the Active Pharmaceutical Ingredients segment. However,
in spite of the strengthening of the rupee during a major part of the
year, the division was able to garner a revenue base of Rs. 9,337
lakhs, an increase of around 12% over that recorded during the fiscal
2007, Exports from this division amounted to Rs. 8,118 lakhs as against
Rs. 7,548 lakhs during the last year.
The first quarter of the fiscal 2009 has witnessed a weakness in the
Indian rupee visi-a-vis the US Dollar and this development, if
continued, is likely to shore up the revenues from this division during
the fiscal 2009.
The manufacturing facilities of the Division, of course, continues to
enjoy US FDA (renewed during the year) Australian TGA and ISO:14001
certification. Efforts to develop niche products and capture niche
markets are continuing and your Company expects to achieve a reasonable
penetration into new markets during the years to come. However, high
value, low volume specialty drugs continue to be the main foray of this
Division.
The Division is slated to focus on products from cyto-toxic, peptide
and steroid based platforms. Infrastructural facilities relating to the
sterioids and peptides block are now complete and ready. Construction
of the cyto-toxic facility being established by NATCO Organics Limited
at Chennai is in progress.
In a major development that can testify the strategy of the Company,
the Company has entered into an exclusive supply and distribution
agreement with Mylan Inc. for the generic version of Copaxone-®
(Glatirmer Acetate), a drug used in the treatment of multiple
sclerosis, The Company has been able to develop this drug on a peptide
platform. Your Company believes that this agreement would be a turning
point for the Company.
Efforts are continuing to implement the definitive supply agreement
signed with Akorn, Inc., The agreement envisages supply of two APIs (an
anti-emetic and hyper calcemia) to Akorn on a margin sharing basis.
Supplies under this agreement are expected to commence by the end of
fiscal 2009. In accordance with the terms of this agreement, Akorn has
initiated the process of regulatory submissions.
During the year, satisfactory progress has been achieved in the filing
of Drug Master Files. The table given in Annexure A to this report
indicates the latest status of these filings.
Projects :
The specialty peptide API Plant and hormone block for finished dosage
formulations plant have been commissioned. The establishment of
cyto-toxic production block by NATCO Organics is progressing
satisfactorily and is expected to commence commercial production by the
end of fiscal 2009.
The Company continues to focus on introducing niche products and
capturing niche markets.
Finished Dosage Formulations Division :
The Finished Dosage Formulations division continued to exhibit good
performance. The credit for this good performance goes to the Oncology
segment and US retail business.
The company could maintain its numero-uno position in the oncology
segment (in terms of revenues^ amongst the Indian companies). This
division now clocks revenues in excess of Rs. 7 Crore per month, and
for the fiscal 2008, as a whole, the division recorded a revenue base
of Rs. 79 Crores as compared to Rs. 56 Crores during the last fiscal -
a commendable increase of 40%. Other segments in the division have
turned out equally good performance.
The Company continued to launch new brands in various therapeutic
segments which have been well received in the market. Tarana, the state
of the art, world class oral contraceptive for women, launched last
year, has been well received in the market and is doing well.
In its efforts to develop new products, your Company aims to target
products which are first ever launches in India. Due prominence is
given to life-saving drugs as compared to life-style drugs. It must be
mentioned that the basic drugs for most of these medicines are made at
the Companys API division, resulting in significant cost savings.
Development of the nano-technology based oncological drug - Paclitaxel
- has been completed and is expected to be launched during the second
half of 2008.
During the year under review, the company had launched the following
brands:
Brand Name Drug
Lenalid capsules in different strengths Lenalidomide
Bortenat injection Bortezomib
Docenat injection in different strengths Docetaxel
Iminat - C injection Imipenem and Cilastatin
Planoset injection Palanosetron
X-tane tablets Exemestane
Glatimer Glatiramer Acetate
Tarana Drospirenone & Ethinyl
Estradiol
Primanat injection Impenem & Cilastatin
Rimnat Rimonabant
Western Markets :
In order to ensure a quick and effective entry into the Western
markets, your Company is aiming at :
a) quick commercialization of tie-up agreements entered into with
multi-national companies;
b) completion of registration process for products in new markets
c) dedicated US FDA approved manufacturing facility at Kothur
exclusively for US / European markets.
Work on the up-gradation of the Kothur facility is continuing. A
cyto-toxic injectable facility and a cyto-toxic orals manufacturing
facility, conforming to US FDA standards are being established at
Kothur. The cyto-toxic orals manufacturing facility is expected to be
commissioned by October, 2008
During the year, the companys application for abbreviated new drug
application (ANDA) in respect of Citalopram - an anti-depressant has
been approved by the US FDA authorities. The company has commenced
supplies of Ondansetron tablets to the US markets. The companys
constituents have since obtained approval from the Canadian Health
Authorities for Citalopram and Ondansetron tablets and these tablets
have since been launched in Canada.
US Pharmacy Business:
During the year under review, K & C Pharmacy - a general partnership
firm in which the Company is a major partner - has acquired Newark
Drugs, a retail pharmacy store in Newark, New Jersey, USA. This is the
third pharmacy store that the company owns and manages in the USA.
Nicks Drugs, which was acquired by K & C Pharmacy during the year 2006
is doing well. The companys share of profit from this store for the
year ended on 31st March, 2008 amounted to Rs. 322.58 lakhs. Till 31st
March, 2008, the companys share of profits from this store amounted to
Rs. 825.09 lakhs.
Save Mart Pharmacy, Lancaster, Pennsylvania, USA, which was acquired
through the companys wholly owned subsidiary, NATCO Pharma Inc. also
continues to do well and for the year ended on 31st March, 2008, the
subsidiary has recorded a net profit, after tax, of Rs. 46 lakhs, after
accounting for interest of Rs. 129 lakhs paid to the Company on the
loans advanced by the parent company. The subsidiary has also repaid a
part of the loan amounting to Rs. 151 lakhs.
Efforts are on to acquire more such stores (with a target of a total
revenue base of US $ 100 Million from the retail segment) in the USA.
It is the intention of the Company to examine the various options
available to it to enhance the value of this business and would
evaluate the possibility of launching its own private generic brands
through these stores, while developing and utilizing locally available
manufacturing facilities.
The operation of these pharmacy stores is helping the company in
establishing a suitable channel for the companys products in USA, and
in gaining firsthand knowledge about the US markets.
Branded Generics & Institutional Sales :
Business from this segment Is satisfactory, though the margins are
meager.
With a view to expand this business into newer markets, the Company is
exploring ways and means of entering the neighbouring markets such as
Sri Lanka, Myanmar, Nepal and Bangladesh. As a step in this direction,
the Company has filed an application before the Controller General of
Patents, Government of India, for compulsory licensing of certain
life-saving drugs for marketing in Nepal. These applications are yet to
be disposed off.
The Institutional sales segment continues to be highly competitive.
Manufacturing facilities :
To maintain the status of the state of the art facilities, as also to
comply with several regulatory requirements, the following up gradation
programs are being planned for the fiscal 2009:
a) Construction of a new bio-technology production block along with
normal up- gradation of facilities at the US FDA approved API facility
in Mekaguda.
b) A new Unit containing a Cytotoxic liquid injectable facility,
solid-dosage manufacturing facility and novel drug delivery systems is
being planned at the US FDA approved Kothur facility.
c) An annex is being added to the existing NATCO Research Centre. The
cell biology lab, one-kg. lab for formulations and animal house would
be completed during the fiscal 2009. Five new laboratories are also
being established at the Research Centre.
d) In order to continue to avail the tax benefits, a new facility for
tablets, capsules and parenterals is being planned at Dehradoon.
The manufacturing facility at Dehradoon, Uttarakhand continues to do
well. Sales from this unit for the year under review amounted to Rs.
6,178 lakhs. Construction of a parenterals block (capable of
manufacturing cyto-toxic injectables, tablets, capsules, and small
volume parentals - ampoules, vials, catridges etc.) is proceeding
satisfactorily.
Abbreviated New Drug Applications (ANDAs) :
Annexure B to this report details the latest status on the abbreviated
new drug applications filed by your Company.
During the year under review, the companys ANDA for Citalopram tablets
has been approved by US FDA. The company has filed and received,
through its constituents, approval from the Canadian health authorities
for marketing these tablets. The company has started shipments of
Ondansetron tablets (in respect of which the companys ANDA was
approved by the US FDA authorities) to the US which have been well
received in the market.
De-risking ANDA costs:
The company has consciously followed a de-risking strategy with regard
to the costs of filing ANDAs. The companys supply agreements with
Akorn Inc and Mylan Inc are examples of this strategy. The company
continues to look forward for similar tie-up for other products as
well.
Research Efforts and Intellectual Property
Annexure C to this report details the latest status on the various
patent applications filed by the Company.
Your Company continues to lay emphasis on building and sustaining a
strong research base. To this end, several compounds are being
evaluated towards their efficacy in disease management and control. The
Companys Research Centre has several teams, each headed by competent
technical personnel, which are working on development of molecules,
processes and products.
Satisfactory progress has been recorded in the evaluation of the two
new chemical entities (NRC 19 and NRC 24) which the company is
developing. In respect of NRC 19, all the required pre-clinical studies
have been completed. The Company has since filed an Innovative New Drug
(IND) application and simultaneously applied to the Drug Controller
General of India for undertaking Phase I clinical trials in India. The
DCGI is presently scrutinizing the companys application and the
process Involves laying down the methodology for undertaking the
clinical trials, including constitution of a Monitoring Committee. The
Company has also filed a preliminary clinical trial application with
the Canadian regulatory authorities (Office of Clinical Trials -
Therapeutic Products Directorate, Health Canada), for undertaking
similar trials in Canada. This will be followed by the filing of a
Innovative New Drug application in Canada.
Satisfactory progress has been achieved in the development of new
molecules for the treatment of pancreatic and lung cancer. New
molecules - NRC 2694, NRC 1005 and NRC 1008 are undergoing toxicology
studies. Out of these, an optimal molecule would be selected for Phase
I clinical trials, probably by the end of fiscal 2009.
The developmental work on various analogues useful in the field of
anti-cancer, anti- depressant and anti-ulcer therapies, and new drug
delivery systems is continuing satisfactorily.
CRAMS and Contract Manufacturing:
The Company is carrying out contract manufacturing activity for almost
all reputed pharmaceutical companies. Efforts are being made to make a
presence in CRAMS as well.
Future developmental work :
Work on the nano-technology platform is continuing satisfactorily.
Developmental work on compounds useful in the treatment of non-small
cell lung cancer, and chronic myeloid leukemia, are also progressing
well.
Corporate Social Responsibilities (CSR):
NATCO Trust continues to actively pursue its social welfare activities.
The Trust has been instrumental in providing drinking water (by
installing reverse osmosis plants) for certain fluoride affected
villages in Nalgonda District in Andhra Pradesh. The Trust is also
supporting several schools in Hyderabad.
The Company has started an in-house quarterly magazine called
Spandana.
Financial Matters :
All the Foreign Currency Convertible Bonds issued in 2004 have been
converted into equity shares, except for 28 bonds which have been
redeemed during the fiscal 2008.
The proceeds of the issue have been used for the purposes mentioned in
the offer document and in accordance with the prevalent guidelines
issued by the Reserve Bank of India.
The Company has no derivative contracts outstanding as at 31st March,
2008.
Employees Stock Option Scheme :
As at 31st March, 2008, in respect of NATSOP 2004, (under which 598,300
options have been granted to some Directors and employees), 469,925
options became due for vesting and were duly vested. The aggregate
number of options exercised amounted to 419,775 and the process of
allotment has since been completed, and the relevant shares have been
listed on the Stock Exchanges. None of the options have lapsed. There
has been no variation in the terms of the options.
No fresh options have been granted during the year under review.
The options have been granted at an exercise price of Rs. 10/- per
share. Intrinsic value of these options (as on the date of grant) has
been considered for the purpose of charge to the Profit & Loss Account.
Buy-back of Equity Shares :
The Company has completed the buy-back of equity shares announced in
July, 2006. The amount of Rs. 700 lakhs set apart for the purpose of
buy-back has been fully utilized and the Company had bought back
492,881 equity shares from the open market through buying on the stock
exchanges. The paid up capital of the company as at 31st March, 2008
stood at Rs. 2,804 lakhs.
NATCO Organics Limited :
Having received all necessary approvals, NATCO Organics Limited is
implementing the bulk intermediates project at Chennai and it is
expected that production in at least one block would commence by
December, 2008. NATCO Organics Limited has been sanctioned working
capital facilities as well as a term loan from Centurion Bank of Punjab
Limited (now merged with HDFC Bank Limited).
Pending finalization of the capital structure, adequate disclosures
have been made in the financial statements regarding the amounts
advanced to NATCO Organics Limited and the interest thereon.
Directors :
Dr. B.S. Bajaj, Mr. G.S. Murthy and Dr. Jasti Sambasiva Rao would be
retiring by rotation and being eligible, offer themselves for
re-election. Notices in writing have been received from Members
proposing their names for the office of Director.
Directors Responsibility Statement :
In compliance with the provisions of Section 217(2A) of the Companies
Act, 1956, the Directors confirm that :
a) in the preparation of annual accounts, the applicable accounting
standards have been followed;
b) the Directors have selected such accounting policies as mentioned in
Schedule 18 of the Annual Accounts 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 and loss of the Company for
that year;
c) the Directors have taken proper and sufficient care for the
maintenance of adequate accounting records in accordance with the
provisions of the aforesaid Act for safeguarding the assets of the
Company and for preventing and detecting fraud and other
irregularities; and
d) the annual accounts have been prepared on a going concern basis.
Statutory Auditors :
M/s. Brahmayya & Company, Chartered Accountants, Hyderabad, the
statutory auditors of the Company hold office till the conclusion of
the ensuing Annual General Meeting, and are eligible for
re-appointment. The Board recommends their re-appointment.
Internal Auditors :
M/s. Seshachalam & Company, Chartered Accountants, Hyderabad, who have
been appointed by your Board to carry-out internal audit of the Company
will be continuing as internal auditors for this year as well.
Cost Audit :
The Government of India had prescribed maintenance of cost accounting
records and ordered cost audit under the provisions of Section 233B of
the Companies Act, 1956. in respect of your Companys operations. Your
Company is following the prescribed guidelines in maintaining the
requisite records.
Particulars of Employees :
Employees drawing remuneration in excess of prescribed amount as
specified in terms of Section 217(2A) of the Companies Act, 1956 is
annexed.
Particulars regarding Energy conservation, etc.
Information on conservation of energy, technology absorption, foreign
exchange earnings and outgo as required to be disclosed under the
provisions of Section 217(l)(e) of the Companies Act, 1956 is enclosed
and forms part of this report.
Listing Information :
The securities of the Company are listed with and are traded in,
dematerialized form at the Stock Exchanges at Mumbai and on the
National Stock Exchange. The annual listing fees were paid to each of
these exchanges for the year 2007-2008. Facilities for
dematerialization have become fully operational. The ISIN No. of the
Company is INE987B01018.
Fixed Deposits :
There are no outstanding and overdue deposits as at 31st March, 2008.
The Company had not accepted any deposits during the year.
Acknowledgements :
Your Directors place on record their deep sense of gratitude for the
support, cooperation and guidance received by the Company from various
departments / agencies of the Central and State Governments, the
consortium of banks led by Allahabad Bank as also to Yes Bank Limited,
and HDFC Bank Limited (erstwhile Centurion Bank of Punjab Limited).
The Directors also thank the shareholders, officers and staff of the
Company for their excellent cooperation and dedicated work.
for and on behalf of the Board
NATCO PHARMA LIMITED
Place : HYDERABAD V.C. NANNAPANENI
Date : 30th June, 2008 Chairman & Managing Director
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