Generikahersteller in USA mit Wachstumsstory - 500 Beiträge pro Seite

[dottore]

Alpha Seeking hat eine neue Studie veröffentlicht. Daraus geht hervor dass der Wert ungebrochenes Wachstum zeigt. Ein KGV von 2(!) derzeit eine deutliche Unterbewertung dastellt und die Umsatzeinschätzungen auch für 2010 und 2011 unvermindert auf Wachstum stehen.
Nicht erwähnt wird, dass es Trouble mit der FDA gibt, weil trotz Abmahnung im Dez 2008 immer noch keine Qualitätssicherungsmaßnahmen ergriffen worden seien. Sollte da ein Rechtsstreit bevorstehen, könnte das zu Belastungen führen, die aber allemal mehr als eingepreist sind.

Hier nun die Analystenstudie:

Caraco (CPD) has annual $350M in sales and $32M in net income. The company has almost no CapEx, and over $45 in net cash. The company sells for a market cap of $116M and an EV of $70M, an EV-to-earnings multiple of 2x. The management has publicly stated a 25% sales growth for FY 2009 and should be growing revenue in high double-digits after that. At current prices, you are getting a dollar for 15 cents (we think the company should sell for 12x net income).
The main drag on the stock price is a recent FDA drug seizure at its facilities. This puts a hold on any manufacturing from their facilities, although the company can still distribute drugs produced by different companies. The company has a distribution deal with Sun Pharma, the largest pharma company in India and 76% owner of Caraco, to distribute and market drugs manufactured at Sun Pharma's facilities. The company has stated that while it works out the FDA issues, the company's distribution revenue will create enough cash flow to cover its expenses.
The Business
Caraco Pharmaceuticals is a generic drug producer in a highly competitive market. Once a branded drug comes off patent, a generic drug producer can sell its product in direct competition with the branded drug. A generic drug product is one that is comparable to a branded drug in dosage form, strength, performance characteristics, among other criteria. The generic drugs are not required to include preclinical (animal) and clinical (human) data, since the branded drugs have already passed the testing. This makes it a huge cost advantage for the generic drug and also expedites the process from R&D to distribution.
The 1984 Hatch-Waxman Act (also known as Drug Price Competition and Patent Restoration Act) was a major turning point for the generic drug industry. Hatch-Waxman established the criteria which has become the foundation of generic product approval. The process to produce a generic drug is: generic drug producer files an Abbreviated New Drug Application [ANDA] with the FDA. FDA reviews the application for many criterias including whether the drug meets the bioequivalence and patent violation. Once the FDA approves the application the generic company can begin to produce the medication. The entire process usually takes around 12 to 18 months, although with the current backlog it can take longer than 18 months.
If the generic producer is the first company to file a generic drug application for a branded product, the company receives a Para IV status. The Para IV status allows the generic drug maker a 180 days exclusive distribution of the generic. This allows the generic drug maker to gain from high margins before other generic drug manufacturers enter the market and lower prices.
The generic drug industry is expected to grow at a healthy rate going forward. With a number of blockbuster drugs losing patent in the next 3 yrs, the generic market is expected to grow at double-digit rates from 2008-2011. The generic market is expected to generate over $69 B in revenues by 2011.
The Company
Caraco Pharmaceutical Laboratories is a Detroit based generic drug manufacturer. It has its manufacturing and distribution facilities located in Detroit but has a major backing from a big international pharma company. Although it is a small cap company, it low-cost manufacturing coupled with the backing from a big pharma company, Sun Pharma, provides it with R&D and manufacturing capabilities that allow it to complete with much bigger companies.
The company has been growing at a torrid pace. In FY 2008 the management predicted 35% sales growth. The company delivered almost 200% growth. For FY 2009 the management predicts 25% sales growth. In the first six months of the FY, it has produced over 78% growth.
The company has a strong pipeline of drugs awaiting FDA approval. The company currently has 23 generic drugs awaiting approval. The company has received 4 approvals this FY. Also, it has a distribution agreement with Sun Pharma, which allows Caraco to market and distribute Sun Pharma’s generics. The Sun Pharma and Caraco pipeline includes 88 filings awaiting approval, with Sun Pharma providing guidance for filing 30 new drugs for approval in FY 2009. The company has a strong future and growth.
Compared with other generic drug producers, Caraco is one of the smaller companies in the industry. Caraco currently has a market cap of 145M, compared with the leaders in the industry: Teva (TEVA) (34B), Mylan (MYL) (2B), Watson (WPI) (2B), Perrigo (PRGO) (3B). Caraco’s sales are much smaller than competition. Caraco had $350M in sales in FY 2008, compared to Teva ($9B), Watson ($2.5B), Mylan ($2B), Perrigo ($1.8B).
By market cap, the company looks small compared to its peers. Although, the company’s partnership with Sun Pharma gives it access to R&D facilities that its peers enjoy. This is at the core of the value proposition of Caraco, for some reason the market hasn’t realized this yet. Sun Pharma has publicly stated that it expected huge growth in the US market and Caraco has been the major driver for this growth. Also, with Sun Pharma’s recent acquisitions, Caraco is positioned to benefit enormously.
The Caraco and Sun Pharma Relationship
Sun Pharma is one of the largest pharmaceutical companies, the largest via market cap, in India. It owns about 76 percent of Caraco, including both common and preferred stock. Sun is the largest drug company in India, valued by market size, at over $5 billion.
In 1997 Caraco was struggling to survive. The company had $28M in accumulated losses and practically no ANDAs awaiting approval. The company had a FDA approved manufacturing site in Detroit but with no ANDAs awaiting approval, it was like a zombie.
During that time, Sun Pharma was looking to enter the US generic market. In 1997, Sun Pharma made a purchase of 5.3 million shares for $7.5 million. Sun Pharma also provided over $9.7M in debt. Sun Pharma’s investment in Caraco was the turnaround point for the company. Not only was capital provided to Caraco, Sun Pharma put in place its own management team to lead the company back to growth and profitability.
In August of 1997, Caraco entered into a technology transfer agreement with Sun Pharma. Under the terms of the pact Sun Pharma was to transfer 25 generic products in exchange for 544,000 shares apiece over a five year period. The technology transfer for each medication took place once a bioequivalency test was completed on the generic drug. Sun Pharma transferred 13 drugs under this agreement.
In 2002, Caraco and Sun entered into a new technology transfer agreement. Similarly to the previous arrangement, Sun Pharma agreed to supply Caraco with 25 generics over a five year period in exchange for 544,000 preferred shares apiece. These preferred shares are not convertible for three years. As of the most recent quarterly filing all 25 products have been selected for transfer and have passed bioequivalency tests.
Under both of these agreements Caraco had the right to sell products in only the United States and Puerto Rico. Also, Caraco expenses all technology transfers as R&D expenditure on its income statement. In Caraco’s quarterly and annual SEC filings they expense the technology transfers as non-cash R&D expenditure at the current market value of Caraco’s shares.
In FY 2007 Sun Pharma and Caraco entered into a marketing agreement where Caraco will market and distribute Sun Pharma’s products. The margins on these marketing and distribution products is capped at 10% for Caraco. Although the margins are much lower than the manufactured products (with are around 46%), Caraco gains an additional source of revenue stream.
In FY 2008, Sun Pharma and Caraco entered into an agreement where Caraco will market and distribute Sun Pharma’s Para IV products. Caraco’s margins are capped at 8% for these Para IV products. Although the margins are low, Sun Pharma’s Para IV are usually for multi-billion dollar branded drugs. The agreement provides another additional source of revenue stream for Caraco.
In 2005, Sun Pharma purchased a manufacturing facility, out of bankruptcy, in Ohio. Although Sun Pharma hasn’t done much with that facility, recently Sun Pharma took one of its top executives from Caraco and placed him in charge of the Ohio plant. Also, Caraco has signed multiple agreements with a third-party for distribution and marketing of products. Caraco currently had agreements to produce 4 different products with unaffiliated third party firms. It is very likely that Sun Pharma sees Caraco as a distribution and marketing arm to get the Ohio manufacturing facility into profitability.
Although the technology transfer agreement between Sun Pharma and Caraco has ended, Sun Pharma has a strong vested interest, 76% equity interest, in Caraco. Also the recent agreements between Sun Pharma and Caraco show that Caraco has plenty to gain from the relationship with Sun Pharma. Sun Pharma’s founder and CEO, Dilip Sanghvi, serves on the Board of Caraco, along with 3 other Sun Pharma executives on the Board.
Caraco’s Business

FY 08 FY 07 FY 06 FY 05
Sales $350M $117M $83M $64M
Net Income $32M $26M ($10M) ($2M)
Non Cash R&D Expense $12M $12M $35M $26M
Net Income + Non Cash R&D $44M $38M $25M $24M
Cap Ex ($5M) ($6M) ($3.6M) ($.6M)
Caraco’s turnaround has been spectacular for Sun Pharma and Caraco. From the 1997, near death status, Caraco has become a growth machine. It has gone from practically zero ANDAs awaiting approval in 1997 to 23 ANDAs awaiting approval as of October 2008. It has gone from an accumulated $28M in NOLs, to a net income of over $35M (this doesn’t include $12M in non-cash R&D expense due to the technology transfer agreement) in FY 2008. Also the company has gone from buried in debt and no cash, to a balance sheet with zero debt and over $30M in cash.
Management expects sales to grow by 25% in FY 2009. Compared to the 6-months of FY 09 to FY 08, Caraco has grown sales by over 70%.
Caraco continues to expand its product offerings and ANDAs awaiting approval. The company currently has 23 ANDAs awaiting approval for 19 products. Also, with its distribution agreement with Sun Pharma the company has access to additional products awaiting ANDA approval. Combines Caraco and Sun Pharma, there are 95 ANDA awaiting approvals. So the growth pipeline looks extremely good.
Caraco also continues to expand its manufacturing facilities. At the start of 2007, Caraco owned 114,000 sq ft and leased 67,000 sq ft of manufacturing facilities. In 2008, Caraco acquired 135,000 sq ft of distribution warehouse. Also, the company started a building an expansion facility of 140,000 sq ft in Detroit. Once the expansion facility is ready to go, the company plans to double its headcount. The cost of new facility is estimated at $14.5. Caraco secured the deal under very favorable terms with the city of Detroit and the state of Michigan where these local governments give the company $14 million of tax abatements over the next 12 years. Also, the State of Michigan will provide a comprehensive job training and retention program, which the State values at $13M. The training program will be focused on developing coursework at community colleges for pharmaceutical manufacturing. This will decrease Caraco’s operating costs and should make its employees more productive.
Competition
Caraco is like a hobbit compared to its competitors. Although it might be small in size, you will be amazed by how big its feet are.

All data is 12 month trailing Caraco Teva Perrigo Watson KV Pharma (KVA)
Sales 500M 10.6B 1.9B 2.5B 620M
SG&A Expense 15M 2.35B 288M 420M 226M
Pre-tax Profit 55M 2.193B 191M 331M 141M
Net Income 40M 1.89B 139M 220M 95M
EPS (34.74M outstanding) 1.01

SG&A as % of Sales 3% 22% 15.15% 16.8% 36.45%
Pre-tax Profit Margin 11% 20.69% 10% 13.24% 22.75%

Market Cap 144M 34.8B 3B 2.6B 784M
Shares Outstanding 34.74M
Cash 33M 2.85B 250M 352M 134M
Long Term Debt 0M 5.1B 893M 825M 267M
EV (Mkt cap + LT Debt – Cash) 111M 37B 3.64B 3.07B 917M
Earnings Yield 25%
The above table has mixed results, so let’s look at it carefully.
Caraco has over 20% of market cap in cash and zero debt. Compared to its peers, it has the most amount of cash compared to market cap and its zero debt allows it to operate without needing to access the capital markets. With an EPS of $1 and a stock price of $4.15, you get an earnings yield of almost 25% for a company that is growing over 25%.
The SG&A expense shows that Caraco has the lowest SG&A expense compared to its peers. One of the strengths of Caraco, and Sun Pharma, is that their management is extremely efficient in running a low-cost operation compared to peers in the industy. Sales of the company have increased from 64M in 2005 to 350M in 2008, in the meanwhile, SG&A has increased from 5.8M in 2005 to 14.3M in 2008.
Caraco’s pre-tax profit margin is low compared to its peers. The main reason for this is the distribution and marketing agreements that state 8% margins on Sun Pharma Para IV drugs and 10% margins on Sun Pharma ANDA drugs. Since Sun Pharma is taking all the risk in R&D, filing, waiting for approval, and legal costs the margins that Caraco more than compensated for the risk it is taking, which is zero. Caraco gains from flow-thru of the additional stream of sales dropping to the bottom line.
Let’s take a look at what happened in the past two quarterly reports.

Q2 2008 Q2 2007 Q1 2008 Q1 2007
Sales 122M 41M 108M 35M
SG&A 4.23M 3M 3.8M 3.4M
Pre-tax profit 12M 4M 14.5M 9.6M

SG&A as % of Sales 3.47% 7.3% 3.5% 9.7%

Sales increase compared to prev quarter 81M 73M
Pre-tax profit increase from prev quarter 8M 5M

Estimated Gross Margin on increased sales 9% 9%
Gross Profit 7.29M 6.57M

We know that the distribution deal with Sun Pharma has a 8-10% gross margin. Based on the information above, if we assume that all the sales increase is coming from the sales via the distribution agreement we can see that most of the sales is dropping to pre-tax income. I’ve taken an average 9% gross margin to apply to the additional sales. In Q2 of 2008, the company had increased sales of 81M, compared to last year. Taking 9% of the increase we get 7.29M. The company’s Pre-tax Income increased by 8M in Q2 of 2008, so most of the gross profit dropped to the bottom line.
The company’s low-cost advantage and distribution agreement with Sun Pharma will allow the company’s bottom line to grow at a healthy pace.



The Financials
The Income Statement
Caraco’s (CPD) management has been conservative in making projections and has delivered beyond expectations.
In the 2006 annual report:
We believe that we will continue to achieve 25% to 30% revenue growth during Fiscal 2007 over Fiscal 2006.
Net Sales for 2006: 82M
Net Sales for 2007: 117M
Increase in Sales: 42%
In the press release for 2007 annual reports:
Based on current trends and future realizations, we believe we will achieve a 30% growth in sales for fiscal year 2008, compared to fiscal year 2007.
Net Sales for 2007: 117M
Net Sales for 2008: 350M
Increase in Sales: 200%
In the 2008 annual report:
Based on our own development pipeline and the current agreements we have with Sun Pharma along with other third party developers we believe we will achieve 25% growth in sales for Fiscal 2009, compared to Fiscal 2008.
Sales for first 6 months of 2008: 76M
Sales for first 6 months of 2009: 230M
Increase in Sales: 202%
The company’s sales growth has been accelerating and future product pipeline is extremely strong. Between Sun Pharma and Caraco, there are 95 ANDAs awaiting approval. Caraco currently has 23 ANDAs awaiting approval.
The Balance Sheet
Caraco’s balance sheet has been free of long-term debt since 2003. The company currently has 33M in cash. Caraco has mentioned that it plans to use its strong balance sheet to make acquisitions. Given the tightening of the credit markets, there will be opportunities for Caraco to acquire companies that are struggling due to the credit crisis.
The company’s net book value is 161M. So you are buying the company for less than book value.
The Cash Flow Statement
For the 12 months trailing, Caraco had 40M in net profit. The CapEx for the past 12 months has been 18M, but in the last 6 months it has been 8M and 6M per quarter. Caraco is currently in the process of doubling its manufacturing capacity. So the CapEx are not normally expected expenditures. The CapEx for FY08 was 5M, FY07 was 6M, FY06 was 3.6M. So a FCF for the past 12 months is 22M (40M – 18M).
The company expects the expansion development to be completed at end of 2008. I expect the CapEx to get back to normal in 2009, expecting around 1-1.5M per quarter. If we apply the normal expected CapEx to the past 12 month’s CF from Operations (Caraco has negligible depreciation/amortization), we get a FCF of 34M (40M – 6M).
Valuation
I believe that currently Caraco sells at an extreme discount compared to its peers and valuations used in recent mergers and acquisitions.
Looking at valuations you don't need to look much further than Caraco's parent Sun Pharma. Sun Pharma recently offered to buy Taro Pharma (TAROF.PK), a generic pharma company, for .9x sales. If you apply a similar multiple to Caraco, you get a $10/share valuation. Also, Taro Pharma has substantial debt and is a turn-around opportunity for Sun Pharma. Caraco is in a much healthier position and has one of the best operations in the generic pharma sector.

Caraco Teva (TEVA) Perrigo (PRGO) Watson (WPI) KV Pharma (KVA)
P/E Ratio 4 18.9 22.67 12.4 9.4
Price/Sales .41 3.28 1.58 1.04 1.26
Price/CF (adjusted removes non-cash R&D expense) 6.6
(4.25 adjusted) 14.2 13.3 6.4 6.2
Caraco is attractive given the low P/E, Price/CF, and Price/Sales multiples. A Price/CF multiple of less than 6.6x for a company that is growing at 25%. The adjusted CF removes the non-cash R&D expense that the company had accounted for as part of the technology transfer agreement (Caraco transferred 544,000 shares to Sun Pharma for each ANDA that Sun Pharma transferred to Caraco). At adjusted Price/CF, you have the company selling at 40% discount to its peers.
In FY 08, the company had earnings of 35M. If you assume normalize CapEx of 5-6M, you get a company that is selling at 4.8x CF, and at 3.6x if you remove the cash. If you assume atleast an 8x of earnings, you are getting the company for half the price.
The generics industry is expected to grow in double-digits until 2011. The company has stated a 25% growth for current year. Let’s be conservative about the FY 2010 and 2011 growth rate and expect 15% growth. We assume that all sales increase have a 9% gross margin, and that 4% (of sales increase) hits the bottom line.

FY 2008 FY 2009 FY 2010 FY 2011
Sales 350 437M 503M 578M
Net Income 35M 39M 41M 44M
CapEx 5M 22M 10M 11M
FCF 30M 17M 31M 33M
Cash 33M 50M 81M 114M

Sales Growth 25% 15% 15%
Gross Margin on additional sales 4% 4% 4%
The above projections use a fairly conservative growth of 15%. The company has been growing sales over 28% for the past 3 years, so 15% is a very conservative projection. I use the 25% growth estimate for FY2009, although the company is currently on a pace to grow much faster. Also, given the favorable conditions for the generic industry, I think the company can easily grow around 15% in 2010 and beyond.
For a terminal value, I expect the company to make a net income of 44M and growing in double-digits, I use a 12x of 44M. That gives a value of 529M and with 114M in cash, the company should be worth 643M. At the current price of 145M, it seems the market is throwing a pitch right in the middle of the plate.
Conclusion
With a large number of products in pipeline, a strong backing from a large pharma, zero debt, and solid balance sheet, Caraco is a fast growing company with large potential trading at an extremely cheap price. Caraco has the tools and the backing to compete larger firms on a large scale.
At current earnings, you are getting a high double-digit growth company, with a strong backing from a large pharma company, with over 20% of market cap in cash, and no debt for about 3x of current earnings (adjusted for cash).

[buy-out]

Katastrophale Zahlen für das erste Quartal. Bin allerdings gestern in den USA
eingestiegen. Jetzt müsste der worst case eingepreist sein.

DETROIT, July 28 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) recorded net sales of $48.1 million in the first quarter of Fiscal 2010, ended June 30, 2009, compared to $108.3 million during the corresponding period of Fiscal 2009. The reduction in sales was primarily due to reduced sales of Para IV products in the current period, as compared to the corresponding period of Fiscal 2009. Sales of distributed products were also lower due to price erosion on the products sold, partially offset by new product launches. Caraco's manufactured product sales in the first quarter of Fiscal 2010 were lower due to the negative impact of our voluntary recalls of certain products, and, in part, the FDA's seizure of certain of our inventory and cessation of manufacturing, as previously disclosed. We incurred a net pre-tax loss of $14.4 million during the first quarter of Fiscal 2010, as compared to net pre-tax income of $14.6 million during the corresponding period of Fiscal 2009. The net pre tax loss was primarily due to the creation of an inventory reserve relating to the inventory seized by the FDA, as well as lower sales.

Dan Movens, Caraco's Chief Executive Officer, said, "As previously disclosed, on June 25, 2009, the FDA seized drug products manufactured in our Michigan facilities. The seizure also included ingredients held at these same facilities. The FDA's most recent inspection of Caraco's Detroit facility, completed in May 2009, found observations of potential unresolved violations of cGMP requirements as previously disclosed in our last SEC filing on Form 10-K for the fiscal year ended March 31, 2009, filed on June 15, 2009. The Company believes that corrective actions have been made and continual improvements are in process. We are working with consultants to further define and correct any remaining deficiencies. Products sold and distributed by Caraco that are manufactured outside of these facilities are not materially impacted. As a result of this event, there has been a material adverse effect on our current operations and may be a material adverse effect on our near term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible."

The total value of the seized inventory is $22.9 million. Of such inventory, we have created a partial reserve in the amount of $8.4 million which consists of work in process relating to those materials which are in various stages of production within our manufacturing facilities, finished goods having a shelf life of one year or less as of June 30, 2009, and those products which will be difficult to recondition. Once we have further understanding and clarity from the FDA on the status of the entire inventory, we will make a determination of whether adjustments to the reserve need to be made.

We incurred a gross loss of $3.6 million during the first quarter of Fiscal 2010, as compared to gross profit of $23.6 million during the corresponding period of Fiscal 2009. The gross loss in the first quarter of Fiscal 2010 was primarily due to the $8.4 million inventory reserve and lower sales of manufactured and distributed products. "Although gross profit margins have decreased to a negative 7.5% for the first quarter of Fiscal 2010 as compared to 21.7% during the corresponding period of Fiscal 2009, due to the creation of the inventory reserve, lower sales, and the mix of distributed products weight over manufactured products, we believe we will remain competitive in marketing and distribution product sales and manufactured products sales that are manufactured by third parties," Mr. Movens said.

Selling, general and administrative ("SG&A") expenses during the first quarter of Fiscal 2010 were $3.7 million, as compared to $3.8 million during the corresponding period of Fiscal 2009, representing a decrease of 4%. SG&A expenses, as a percentage of net sales increased to 8% for the first three months of Fiscal 2010, as compared to 4% for the corresponding period of Fiscal 2009. The higher percentage of SG&A is primarily due to the lower sales in the current period versus the corresponding period last year.

Total R&D expenses for the first quarter of Fiscal 2010 were $7.1 million, as compared to $5.5 million during the corresponding period of Fiscal 2009. The R&D expenses during the first quarter of Fiscal 2010 were higher compared to those during the corresponding period of Fiscal 2009 as we incurred increased expenses relating to bio-equivalency studies for certain products under development and increased patent related expenses in an effort to expand our product portfolio. We did not file any Abbreviated New Drug Applications ("ANDAs") with the FDA during the first quarter of Fiscal 2010. We have not received FDA approval for any ANDAs during the first quarter of Fiscal 2010 and do not expect to receive any approvals until we resolve the FDA's concerns. The total number of ANDAs pending approval by the FDA as of June 30, 2009 was 29 (including four tentative approvals) relating to 25 products.

We incurred a net pre-tax loss of $14.4 million during the first quarter of Fiscal 2010, as compared to net pre-tax income of $14.6 million during the corresponding period of Fiscal 2009. Net pre-tax income was lower because of the $8.4 million inventory reserve, as disclosed above, and the decreased sales. During the first quarter of Fiscal 2010, we provided for an income tax benefit of $5.0 million, as compared to an income tax expense of $5.1 million in the corresponding period of Fiscal 2009. We incurred a net loss of $9.4 million during the first quarter of Fiscal 2010, as compared to net income of $9.4 million during the corresponding period of Fiscal 2009.

As noted, the cessation of manufacturing operations will adversely affect the overall profitability of the Company in the near term. The Company has initiated a reduction in various expenses in an effort to bring its expenses in line with its current levels of sales, including the indefinite reduction in its workforce of approximately 350 employees. At June 30, 2009, the Company had $55 million in cash and $10 million in short-term investments (excluding borrowings). The Company believes that its cash flow from operations and cash balances will continue to support its ongoing business requirements, however, because of, among other things, decreased customer confidence, the uncertainty of future costs of FDA compliance and associated costs, there can be no assurance.

Mr. Movens added, "Though Fiscal 2009 and the first quarter of Fiscal 2010 have seen several challenges in manufacturing and compliance, we have hired experienced people in these areas to help us correct any deficiencies. Sun Pharma has provided assistance and guidance from its own corporate quality group. It also continues to provide improvements for our quality systems. We believe the Company's future performance in these areas will be capable of supporting our efforts in providing a quality product on time to satisfy our customers' needs once we have satisfied the FDA's remaining concerns. Though near term sales of manufactured products face significant challenges, we believe we are effecting the changes required to improve our performance on manufactured product sales on a long-term basis. We continue to market 29 products which are categorized as distributed products. We also currently have 4 products that are categorized under manufactured products that are manufactured by third party manufacturers including Sun Pharma for a total of 33 products that we currently market and distribute. We intend to continue to compete effectively in the market we serve."

This press release should be read in conjunction with our quarterly report on Form 10-Q which will provide more detailed information on the results of the first quarter of Fiscal 2010. This report will be filed shortly.

[dottore]

inzwischen wurde die Beschwerde der FDA als nicht beweisbar zurückgewiesen (wenn ich richtig übersetze) Und die "schlechten Zahlen" zum 1. Quartal sind auf geringere Margen zurück zu führen. Der Umsatz steige ungebrochen. Restrukturierungsmaßnahmen mit dem Abbau teurer Vertriebsstrukturen soll bereits im 3. Quartal für Gewinnsteigerungen sorgen.
Die Kurs haben um fast 10% angezogen. Ich persönlich rechne mit weiteren 20-30% in diesem Jahr

[dottore]

Caraco Pharmaceutical ist einer der größten Generikahersteller und Vertreiber in USA und hat die Zulassung Sumatriptan succinat zu vermarkten, nachdem das Patent für Imitrex von GSK abgelaufen ist.
Das Medikament ist für den akuten Migräneanfall zugelassen und in Deutschland "Leitsubstanz" in dieser Indikation. Dieses Medikament ist gut und ich verschreibe es gerne und oft in meiner Praxis ....

DETROIT, Aug. 11 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) has launched sumatriptan succinate tablets on behalf of Sun Pharmaceutical Industries Ltd. (Sun Pharma), immediately following Sun Pharma's recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Imitrex(R) tablets. These sumatriptan succinate tablets, 25 mg (base), 50 mg (base) and 100 mg (base) are therapeutically equivalent to Imitrex(R) tablets from GlaxoSmithKline. Sumatriptan succinate tablets are indicated for the acute treatment of migraine attacks with or without aura in adults.


Imitrex(R) is a registered trademark of GlaxoSmithKline.


Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.