To the Members
The Directors have pleasure in presenting the 28th Annual Report
together with the audited accounts of the Company for the year ended on
31st March, 2011.
Operating Results:
During the year under review, the API division performed well,
recording a growth of 19%. The revenues from this division jumped from
Rs.89 Crores (2009-10) to Rs.106 Crores (2010-11). The exports of finished
dosage pharmaceutical formulations also exhibited a robust growth of
113%, recording a revenue base of Rs.51 Crores (2010-11) as against Rs.24
Crores (2009-10). The domestic oncology (finished dosage pharmaceutical
formulations) business, however, remained stable, owing to lack of new
launches and severe competition, which saw price erosions in respect of
a couple of brands.
The following is a summary of the company''s performance during the
financial year 2010-2011 :
In Rs. Lakhs
Particulars of Revenues* 2010-2011 2009-2010
API Division 10,631 8,894
Finished Dosage Formulations Division 34,312 35,134
Job Work 1,098 1,032
Other Income 2,401 2,703
TOTAL 48,442 47,763
*consolidated revenues.
The company''s operations for the year resulted in a surplus of Rs.6673
lakhs (as compared to Rs.6,238lakhs for the financial year 2009-2010).
Your Directors have decided to make the following adjustments from out
of the surplus :
In Rs. Lakhs
Particulars 2010-2011 2009-2010
Surplus after operational expenditure 6,673 6,238
Provision for taxes 1,496 1,092
Provision for deferred tax -174 274
Net surplus carried to Balance Sheet 5,351 4,872
Interim Dividend declared / paid 563 563
Tax on distribution of income 94 96
Transfer to General Reserves 400 400
Surplus carried to Balance Sheet 4,294 3,813
Dividend:
Your Directors had recommended and paid an interim dividend of Rs.2.00
per equity share (previous year - Rs.2.00 per equity share) during
February, 2011. Your Directors recommend that this may be treated as
the final dividend and the recommendation / payment ratified.
Review of 2011 performance:
API Division:
A robust growth of 19% was exhibited by the API business during the
year under review in spite of continued pressure on realizations as
well margins, together with some amount of volatility in the exchange
rate of US $ vis-à-vis Indian Rupee, which continued during a part of
the year 2011. Domestic sales as well as exports from this segment
recorded growth - domestic sales at Rs.23 Crores (as against Rs.13 Crores
last year) and API exports at Rs.83 Crores (as against Rs.75 Crores last
year). This segment could record a revenue base of Rs.106 Crores (as
against Rs.89 Croreslast year).The depreciation in the value of the
Indian Rupee against the US Dollar and other foreign currencies has
been helpful in sustaining this division''s performance.
Efforts would be made to enhance the efficiency, productivity and
profitability of this segment during the fiscal 2011-12 as well.
Despite its foray into new products, the Revenues and margins on
products from this division continue to experience pressure. The new
cyto-toxic API facility being established by the Company''s associate -
NATCO Organics Limited - has commenced operations and is likely to
throw up new avenues of growth, coupled with new products and new
markets for this division.
However, your Directors are optimistic about the performance of this
Division, with the expected Marketing Authorization approvals from US
FDA which would result in large volume supplies to the company''s
marketing partners. The first mile-stone in this direction - the
establishment of dedicated blocks for the manufacture of Glatiramer
Acetate is expected to result in increased revenues from this segment
and consequently, the performance is likely to record significant
growth during the year 2012-13 onwards.
The business strategy for this segment continues to focus on
concentrating on high value, low value specialty drugs. The API segment
forms the life-line for the company''s finished dosage pharmaceutical
formulations business as well - as it supplies the raw material for
almost all oncology drugs that the company manufactures and markets.
This results in substantial cost savings and value addition.
The manufacturing facilities of the Division continue to enjoy US FDA,
Australian TGA and ISO:14001 certification. Efforts continue to develop
niche products and capture niche markets.
The Company continues to record satisfactory progress in the matter of
regulatory filings. The table given in Annexure A to this report
indicates the updated status relating to filing of Drug Master Files.
Capital Investments & Projects:
Mylan Inc., with whom the Company has a tie-up for the manufacture and
supply of Glatiramer Acetate had asked the Company to set-up exclusive
dedicated facilities for the product. Accordingly, the Company has
initiated the establishment of a multi-production block for Mylan. The
cost of this facility is estimated to be around Rs.9030 lakhs. While the
validations and approvals for this block are expected to take some
time, Mylan has asked the Company to make available an existing block
for the manufacture of this product, with certain modifications. These
modifications are expected to cost around Rs.2825 lakhs. Mylan has agreed
to extend financial assistance to part-fund these projects. Work on
these two blocks is progressing at a rapid pace, so as to be ready by
the calendar year end 2011.
Finished Dosage Formulations Division :
The revenues from this division could not sustain the continued growth
rates that it exhibited during the last several years. The aggregate
revenues from this Division recorded Rs.232 Crores (as against Rs.202
Crores last year) - recording an increase of about 15%. These figures,
however, do not include the revenues from the US retail business, which
had dwindled owing to their sale during the year under review. The
revenues from the oncology segment remained more or less flat, while
the formulations exports have recorded a significant growth of around
113% from Rs.24 Crores during 2009-10 to Rs.51 Crores during the year under
review.
The oncology segment had to face severe competition in the market place
which was one of the reasons for the flat performance of this segment.
Added to this, the company could not launch any new products in the
segment
during the current year. As is always, the company makes a careful
evaluation before launching a brand as to its utility and market
opportunity
During the year under review, the Company launched anti-biotics -
Zubact Injection and PT-Max Injection.
Supply & Distribution Agreements :
The company aims to target the US markets, whilst several of its
applications for Marketing Authorizations are expected to be approved
in the next couple of years. The company''s applications have always
been aimed at products with significant market size.
The company has filed Abbreviated New Drug Applications - five of which
seek to challenge the existing patents. All these products have
significant market size and have exhibited good growth during the last
couple of years. Out of these five, your Company has obtained the
First-to-File status for four products - which would result in a
180-days market exclusivity after the patent expiry, if the said ANDAs
are approved. Briefly, these products are :
Molecule / Product Market Size (US $) Status Therapeutic Area
Glatiramer Acetate 2.5 Billion Second-to-file Multiple
Sclerosis
Lenalidomide 2.0 Billion First-to-file Multiple
Myeloma
Lanthanum Carbonate 100 Million First-to-file Kidney disease
Oseltamavir
Phosphate 241 Million First-to-file Swine Flu
Lapatinib
Ditosylate 115 Million First-to-file Breast cancer
The supply and distribution agreements entered into with Mylan Inc.,
Dr. Reddys'' Laboratories Limited, Actavis, Breckinridge
Pharmaceuticals, Watson Pharmaceuticals and Lupin Limited present
substantial and significant market opportunities for the Company. This
is the best way the company can explore and encash its technical
abilities while using the vast marketing net work available to the
partners. What is more important is that the company is insulated from
any kind of litigation, mitigating the legal risks.
Realizing this is the best form suitable for un-locking the hidden
value, the company is pursuing more of such opportunities. The existing
arrangements are being pursued to their logical conclusion. However,
benefits in terms of revenue growth or earnings could be expected only
after fiscal 2012.
Up-gradation of Kothur Facility :
A new manufacturing block for liquids and pellets is being planned at
Kothur. The cyto-toxic orals manufacturing facility has been
commissioned.
During the year, the company''s application for Abbreviated New Drug
Applications (ANDA) in respect of Trihexyphenidyl Hcl 2 mg / 4 mg
tablets, Chloroquine Phosphate 250/500 mg. tablets and Letrozole 2.5
mg. tablets have been approved by the US FDA authorities.
The company has launched some of these products in the USA through its
marketing partners.
The applications for Marketing Authorizations which have been applied
for would warrant significant amount of capital expenditure and
creation of capacity. In view of this sizeable expansions are planned
at various facilities as under :
In Rs. Lakhs
Particulars Estimated Cost
Lansoprazole Cap Block - Kothur 2003
New Tablet Section - Unit IV - Kothur 434
Sixty Kg. Oncology Block - Kothur 1311
Injectables Section - Kothur 250
Lenalidomide Section - Kothur 80
Powder Injection Section - Sagar 558
TOTAL 4636
Proposed issue of securities :
To part finance the capital investments required at the various
manufacturing facilities, the Company is contemplating issue of
securities not exceeding 30 lakh equity shares aggregating in value, up
to INR 100 Crores. The Members of the company had, at an Extra-ordinary
General Meeting held on 15th December, 2010, approved the issue. The
company is exploring various options available for raising these
resources.
US Pharmacy business:
On 6th December, 2010, K & C Pharmacy, a general partnership firm
registered in the USA (in which the company is a major partner) had
sold the assets and business of Nicks Drugs. With the several budgetary
cuts imposed by the New Jersey Government in respect of Medicaid
reimbursements, the business no longer remained profitable and hence
was sold. The loss incurred on the sale of this business has duly been
accounted in the books of accounts for the year ended on 31st March,
2011.
SaveMart Pharmacy, Lancaster, Pennsylvania, USA, which was acquired
through the company''s wholly owned subsidiary, NATCO Pharma Inc., USA
also continues to do well and for the year ended on 31st March, 2011,
the subsidiary has recorded a net profit, after tax, of Rs.176
lakhs(against Rs.111 lakhs previous year) after accounting for interest
of Rs.80 lakhs (previous year Rs.129 lakhs) payable to the Company on the
loans advanced by the parent company. The subsidiary has also repaid
Rs.505 lakhs (Rs.496 lakhs previous year) out of the loan advanced by the
Company.
Branded Generics & Institutional Sales :
In spite of lower margins and severe competition, business from these
segments is quite satisfactory. The company has made in-roads into new
markets in Sri Lanka, Myanmar, Nepal and Bangladesh. The Company has
made an offer to the Government of India to set up generic medicine
outlets in select government-run hospitals under the Jan Aushadi
scheme.
Efforts are being made to introduce branded generics in new therapeutic
areas.
Manufacturing facilities:
Finished dosage orals are being manufactured at both the manufacturing
facilities situated at Dehradoon and these units continue to be
eligible for income-tax and excise duty concessions. However, on and
from the accounting year 2011-12, the first unit at Dehradoon would be
eligible for a reduced income-tax benefit of 30%, while the profit from
the second unit would be completely exempt from the income-tax.
Sales from the manufacturing facilities at Dehradoon, Uttarakhand, for
the year ended on 31st March, 2011 amounted to Rs.10,093 lakhs as against
Rs.11,621 lakhs last year.
Abbreviated New Drug Applications (ANDAs) :
Annexure B to this report details the latest status on the Abbreviated
New Drug Applications filed by your Company.
The Company continues to sell Granisetron, Anastrazole and Ondansetron
tablets in USA and Canada and has been receiving royalties from its
constituents as per the agreements in force.
Research Efforts and Intellectual Property
Annexure C to this report details the latest status on the various
patent applications filed by the Company.
The division continuously evaluates several compounds for their
efficacy in disease management and control. Multiple teams would be
working on several compounds simultaneously. These teams are typically
engaged in the development of molecules, processes and products.
In respect of one molecule - NRC 19 - Phase I clinical trials are in
their final stage and Phase II clinical trials are expected to commence
shortly. Another compound - NRC 2694 - is being evaluated for
commissioning of Phase I clinical trials.
Other molecules are continuously being evaluated for their efficacy.
Various analogues useful in the field of anti-cancer, anti-depressant
and anti-ulcer therapies, and new drug delivery systems are
continuously evaluated for taking up for further development.
The revenues from contract manufacturing activity continue to be stable
around Rs.1100 lakhs. The company has an impressive list of clients in
this category.
Corporate Social Responsibilities (CSR):
The Company is proud to be associated with NATCO Trust, which continues
to actively pursue its social welfare activities. The Trust has
expanded its activities to cover new geographical locations, situated
near the company''s manufacturing locations.
The Company''s in-house quarterly magazine Spandana continues to
receive appreciation from all quarters - both from within and outside
the Company.
Financial Matters :
The Company has no derivative contracts outstanding as at 31st March,
2011.
Employees Stock Option Scheme :
No further options have been exercised as at 31st March, 2011 and no
fresh options have been granted during the year under review.
NATCO Organics Limited :
NATCO Organics Limited has commenced the trial runs of its cyto-toxic
API manufacturing facility near Chennai. Under an arrangement with
NATCO Organics Limited, the company would procure these APIs from NATCO
Organics Limited and would convert them into finished dosage
pharmaceutical formulations for sale in the open markets.
In line with its commitment to this project, the company has opted to
convert the advances made by it to NATCO Organics into equity shares of
NATCO Organics Limited.
NATCO Farma Do Brasil, Brazil:
The Company had acquired, during the year under review, a small
distributing business - called Uniao Distributors, later renamed as
NATCO Farma Do Brasil - in Brazil. The acquisition was undertaken by
Time Cap Overseas Limited (TCOL), an entity registered in the Republic
of Mauritius. While the Company owns 75% of TCOL, 25% is owned by
Levomed Inc., USA. TCOL owns 90% of the outstanding quotas of NATCO
Farma Do Brasil, while the rest 10% is owned by Mr. Lincoln Gomes, a
Brazilian national. Thus, NATCO Farma Do Brasil is a step- down
subsidiary of the Company. The company aims to register its products in
Brazil and distribute them through this enterprise.
The step-down subsidiary is yet to commence full-scale operations.
Directors :
Mr. Rajeev Nannapaneni, Dr. P. Bhaskara Narayana and Dr. A.K.S.
Bhujanga Rao would be retiring at the ensuing Annual General Meeting
and are eligible for re-appointment.
Directors'' Responsibility Statement :
In compliance with the provisions of Section 217(2AA) 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.
Item # 4 of Notes to the Accounts would adequately clarify the
observations made by the Statutory Auditors in their report dated 30th
May, 2011, pertaining to non-recognition of MAT credit available.
Statutory Auditors :
M/s. Walker, Chandiok & Co., 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 reappointment.
Internal Auditors :
M/s. Seshachalam & Co., Chartered Accountants, Hyderabad, who have been
appointed by your Board to carry-out internal audit of the Company last
year 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 Company''s operations. Your
Company is following the prescribed guidelines in maintaining the
requisite records.
Particulars of Employees :
The information required under Section 217(2A) of the Companies Act,
1956 and the Rules there under in respect of the employees who were in
receipt of remuneration in accordance with the specified limits is
attached to and forms part of this report.
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(1)(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 on the Bombay Stock Exchange and the National Stock
Exchange. The annual listing fees were paid to each of these exchanges
for the year 2010-2011. 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, 2011.
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 Export-Import Bank
of India, Yes Bank Limited, and Axis Bank 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
Hyderabad, V.C. Nannapaneni
12-08-2011 Chairman & Managing Director
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