Caraco Pharmaceutical: Underappreciated and Undervalued, Part 1

|
 |  Includes: AGN, CPD, KVPBQ, MYL, PRGO, TEVA
by: Pakiya

Investment Thesis

Caraco (NYSEMKT: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 (NYSE:TEVA) (34B), Mylan (NASDAQ:MYL) (2B), Watson (WPI) (2B), Perrigo (NYSE: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)

Click to enlarge

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%

Click to enlarge

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

Click to enlarge

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.

Part 2 >>

Comment on this article