EXHIBIT 99.1
Annual Meeting
September 8, 2008
Safe Harbor Statement
This presentation contains forward-looking statements made pursuant to the safe-harbor
provisions of the Private Securities Litigation Reform Act of 1995. Such statements are
based on management’s current expectations and are subject to risks and uncertainties that
could cause actual results to differ materially from those described in the forward-looking
statements. These risks and uncertainties are contained in the Corporation’s filings with
the Securities and Exchange Commission and include, but are not limited to: information
of a preliminary nature that may be subject to adjustment, potentially not obtaining or
delay in obtaining FDA approval for new products, governmental restrictions on the sale
of certain products, development by competitors of new or superior products or less
expensive products or new technology for the production of products, the entry into the
market of new competitors, market and customer acceptance and demand for new
pharmaceutical products, availability of raw materials, timing and success of product
development and launches, dependence on few products generating majority of sales,
product liability claims for which the Company may be inadequately insured, and other
risks identified in this report and from time to time in our periodic reports and registration
statements. These forward-looking statements represent our judgment as of the date of this
report. We disclaim, however, any intent or obligation to update our forward-looking
statements.
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Generic Pharmaceutical Industry Overview
The Generic Pharmaceutical Industry primarily consists of generic versions of
brand pharmaceuticals that have lost their patent exclusivity or are products that do
not infringe the innovator’s patent
U.S. brand pharmaceutical sales for 2007 were $228 billion. U.S. generic
pharmaceutical sales were $58.5 billion*
The U.S. market for unbranded generics grew by 8% in 2007*
Generic pharmaceuticals account for 67.3% of all prescriptions dispensed in the
United States*
Blockbuster products coming off patent are valued at $13 billion in Calendar 2008
*Source: IMS Health
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Company Overview
Established in 1984, based in Detroit, MI
Caraco develops, manufactures, markets and distributes generic and private-label
pharmaceuticals
In 1997, Sun Pharmaceutical Industries, Ltd. invested $7.5 million in Caraco through a stock
purchase agreement
In 2002, Caraco signed an agreement with Sun for the technology transfer of 25 products
All 25 products have been selected and passed their respective bio-studies
At the Beginning of Calendar 2007, Caraco entered into a definitive marketing agreement for
Sun ANDAs
During Fiscal 2008, Caraco entered into a distribution and sale agreement for Paragraph IV
Sun products
Total of four products are being developed under definitive agreements with unaffiliated third
party developers or formulators
Sun Pharmaceutical Industries, Ltd.
Established in 1983, Sun is an international, integrated, specialty pharmaceutical
company. It manufactures and markets a large basket of pharmaceutical
formulations as branded generics as well as generics in India, US and several other
markets across the world.
In India, Sun is a leader in niche therapy areas of Psychiatry, Neurology,
Cardiology, Diabetology, Gastroenterology, and Orthopedics. The company has
strong skills in product development, process chemistry, and manufacturing of
complex API, as well as dosage forms.
Largest drug maker in India based on a market cap value of approximately US $5
billion
Together, Caraco’s and Sun’s Research and Development represent 88 ANDAs
awaiting approval at the FDA
Our Competitive Advantages
Size of our Product Portfolio vs. the Size of Company
Ability to service our customers’ immediate needs
Management
Experienced in the industry
Disciplined
Product Portfolio
Deep pipeline through diverse paths of development
Many products vertically integrated via Sun API’s
Strong Customer Relationships
Removal of Barriers, Execution
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Fiscal 2008 Financial Overview
Sales of $350 million compared to $117 million over the same
period last year
Gross Profit of $85 million compared to $58 million over the
same period last year
Pre-tax Income of $42 million compared to $27 million in the
previous year
Cash Flow From Operations of $28 million compared to $28
million in the previous year
Fiscal 2008 in Review
7th consecutive year of growth in sales
Maintained gross profit of 49% for manufactured products
SG&A as a percentage of net sales declined to 4% for Fiscal
2007, as compared to 8% for the corresponding period of
Fiscal 2007. Peer group SG&A as a percentage of net sales is
estimated to be in the mid to upper teens as a percentage
Annual Results (in US $ millions)
*Change in Fiscal year. Covers transition period from 1/1/2005 to 3/31/2005
60
36
(0)
22
17
9
-4
5
83
41
-10
9
117
58
27
28
350
85
35
28
(25)
25
75
125
175
225
275
325
2004
F2005*
F2006
F2007
F2008
Net Sales
Gross
Profit
Net Income
Cash Flow
from
operations
Product Market Share Trends
Caraco’s current product portfolio consists
of 54 products in 118 strengths
23 of the 54 products are in the top three of
generic market share
Net Sales by Trade Class
Fiscal 2008
19%
17%
15%
16%
33%
Fiscal 2007
12%
22%
30%
16%
20%
CHAIN
DISTRIBUTOR
GOVERNMENT
MANAGED CARE/MAIL ORDER
WHOLESALER
Internal Product Development
Product Filings
Fiscal 2008: Filed 8 ANDAs (7 Products) with the FDA
Fiscal 2009 Q1: Filed one NDA
Approvals
Fiscal 2008: FDA approval of 12 ANDA’s relating to 11
products
Fiscal 2009 Q1: FDA approval of 8 ANDA’s relating to 3
products
Internal Product Development
16
19
1
7
8
11
19
10
0
5
10
15
20
25
30
Number of ANDA Filings
Products Filed
ANDAs Awaiting Approval
Products Awaiting Approval
Product Litigation
Lexapro - Forest has two U.S. patents listed with the FDA that they claim cover Lexapro, the ‘712 patent and the ‘941 patent. We filed an ANDA in which we certified to the noninfringement and/or invalidity of both patents. On July 10, 2006, Forest sued us on the ‘712 patent in federal court in Detroit, Michigan. On February 23, 2007, the court partially stayed discovery pending a decision in the U.S. Court of Appeals for the Federal Circuit in a related case in federal court in Delaware. The Delaware case involved Forest’s assertion of the ‘712 patent against Ivax Pharmaceuticals. On December 3, 2007, after the appellate court affirmed the Delaware district court’s finding that the ‘712 patent was valid and infringed by Ivax, the Detroit judge issued a ruling allowing discovery to proceed in our case. Accordingly, discovery is now ongoing.
We also filed a separate case challenging the ‘941 patent on the grounds of noninfringement. On April 23, 2007, Forest granted us a covenant not to sue on the ‘941 patent and, based upon that covenant, the Detroit court dismissed the case for lack of a controversy. For strategic reasons, we appealed. On April 1, 2008, the Federal Circuit reversed, finding that the covenant not to sue did not moot the controversy between the parties and that we could therefore proceed with our lawsuit. Forest subsequently filed a motion for en banc review of the decision, which was denied on June 24, 2008. The case is in the process of being returned to the district court.
Prandin – Novo Nordisk filed suit against us in Michigan for patent infringement. FDA granted tentative approval on August 13, 2007. The parties are in discovery. No trial date has been set.
Ultracet - Ortho originally filed suit in Michigan for patent infringement. We certified to noninfringement and obtained summary judgment of noninfringement. This decision was recently affirmed by the Federal Circuit. Our generic version of Ultracet is presently on the market. Ortho subsequently filed for a reissue patent, and again sued for patent infringement in New Jersey. We certified to invalidity of the reissue patent and filed another motion for summary judgment. On April 18, 2008, the United States District Court of New Jersey granted our motion for summary judgment that the claims of the reissue patent are invalid. Ortho has moved for entry of final judgment so that it can appeal the district court’s decision.
Clarinex - Schering filed suit in both New Jersey and Michigan for patent infringement against us and Sun. Sun certified to noninfringement and invalidity. We filed a motion to dismiss for lack of subject matter jurisdiction because Sun is the ANDA filer, not us. Schering also filed suit against several other ANDA filers. Each of these proceedings has been consolidated in New Jersey for pretrial proceedings. Fact discovery is ongoing. No trial date has been set.
Capacity
At the start of 2007, facilities included 114,000 sq ft owned and 67,000 sq ft
leased for total footprint of approximately 180,000 sq ft
2008 additions
Acquired and opened 135,000 sq ft distribution warehouse
Expansion of 140,000 sq ft to be occupied approximately November 1,
2008 using redevelopment incentives from the City of Detroit and State of
MI
Fiscal 2008 production was approximately 300 million tablets per month, up
from Fiscal 2007 production of approximately 270 million tablets per month.
Currently running two shifts, five days a week and partial shifts on weekends
Manual equipment being replaced by automatic equipment as we grow for better
throughput
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Initiatives Fiscal 2009
Quality
Continue to focus and improve on FDA compliance.
Increase cGMP training to accommodate growing staff
and compliance.
Management
Increase focus on succession planning.
Increase management training and development.
Initiatives Fiscal 2009
Research & Development
Increase research and development activities, with a view
to increase the number of ANDA filings.
Research possible development of brands for existing
stream of products where such potential exists.
Sales
Increased market share for certain existing products and
recently introduced products.
Enhanced customer reach and satisfaction.
Initiatives Fiscal 2009
Capacity and Efficiency
Continue to invest in equipment and facilities to
expand capacity to meet requirements of projected
short and long-term growth while improving quality.
Build or lease new facilities to meet the increased
demand for production and warehousing in short and
long term.
Achieving further operational efficiencies by attaining
economies of scale and cost reduction per unit.
Initiatives Fiscal 2009
Business Opportunities
Increase revenue and cash by marketing ANDAs
owned by Sun Pharma and other third parties.
Expand our relationships with financial institutions to
fortify our credit position and borrowings if necessary.
Look for potential acquisitions that either complement
or are synergistic to our current business model.
Research alternate product development sources and
product licenses
Drivers Fiscal 2009
FDA product approvals
Maximize market share on current portfolio
Improve operational execution
Streamline processes and reduce operational costs
Contents
I.
Industry Overview
II.
Caraco Overview
III.
Fiscal 2008 in Review
IV.
Fiscal 2009 Initiatives & Drivers
V.
Summary
Summary
We are Built to Fit the Current Competitive Environment
Size and management structure conducive to success
Large basket of products awaiting FDA approval
Vertical integration with Sun allows us to enjoy longer lifecycles and value
on products that we market
Increasing capacity
Focus on Quality