Monday, April 25, 2016

Lannett's C-topical story

C-topical represents the LCI's first foray into the brand market. LCI started a promotional launch with 10 in-house reps in Jan. '16.

Key Takeaways:
- C-topical has been currently sold as un-approved drug
- The downside will be FDA requires LCI to stop marketing this product
- LCI expect Phase III trial wrap up in mid-2016, which potentially solve this problem

#1) What is C-topical? 

C-topical is a cocaine hydrochloride solution. This product is an analgesic topical solution for use primarily by ear, nose and throat physicians during surgical procedures. 

#2) What's the problem? What's the current situation?

C-topical has currently been sold as an un-approved drug despite FDA's denial of grandfathered status, which management reiterated was the expected outcome of the citizen petition.

The Company strongly believes that C- Topical, once clinical trials are completed and the FDA has granted approval, will be an important contributor to total revenue, with higher than average profit margins as a result of vertical integration.

However, the risk would be that FDA stops exercising enforcement discretion (e.g., if it determined LCI wasn't following its commitment to complete the trial or if it perceived a public health risk) and requires LCI to stop marketing the product (~$30 million of FY16 revenue).


(Source: IMS)
From the above graph, we found C-topical's total prescription volume has deceased since mid-2014 and recently see a rally in late-2015.

#3) Timeline for resolution
LCI expects its clinical trial to wrap up around the middle of the year 2016 and is looking to update FDA's enforcement division near-term on its progress.

For now, I will use zero for C-topical's revenue projection to keep margin of safety.

Related articles:


Sunday, April 24, 2016

Will Lannett lose another customer?


In my previous articles, I've talked about the generic pharmaceutical market and Lannett's (NYSE: LCI) growth strategy.
Let's move on to Kremers Urban's story.

A major selling pressure on LCI came from the bad new that Kremers Urban Pharmaceuticals Inc ("KUPI"), LCI's newly acquired subsidiary, had lost a key customer. Up to now, LCI's recovered 30% of this loss by multiple clients. However, will LCI lose another customer? Is the other shoe gonna drop? Let's look closely.

Key Takeaways:
- LCI faces strong and consolidated wholesaler clients
- KUPI lost its key customer because of product downgrade
- LCI is unlikely to lose another customer for another product downgrade


#1) Who are Kremers Urban's customers?



As discussed in the generic pharmaceutical market article, the downstream of the generic pharmaceutical industry is quite consolidated. In other words, every generic pharmaceutical company probably has the same top five clients... Let's double check about KUPI.

Unfortunately, we didn't find KUPI's top client list from LCI's SEC filing. However we did find following descriptions from LCI's 8K on Oct. '15:

"For the years ended December 31, 2014, 2013 and 2012, the Company's (KUPI's) four largest customers accounted for approximately 65%, 54% and 44% of its net revenues, respectively."

(Source: LCI's 8K on Oct.'15)

For now, let's assume KUPI has the typical client profile as other generic pharmaceutical companies.

#2) Who is the lost customer? Why did it leave?
This is a difficult question. LCI's Investor Relationship guy won't tell you the answer.

From my educated guess, KUPI has lost its key customer because of the rating change of its methylphenidate hydrochloride extended-release (“Methylphenidate ER”, also called Concerta) tablets.

In Nov. 2014, FDA raised concern on KUPI’s generic Methylphenidate ER may note produce the same therapeutic benefices for some patients as the brand-name product. Until additional data is provided, FDA has changed the therapeutic rating of KUPI’s Methylphenidate ER products from AB to BX, which means the product is still approved and can be prescribed, but is not recommended as automatically substitutable at the pharmacy for the brand-name drugs.

From the 8K of LCI, it mentioned that “There is a possibility that in May 2015, or subsequently, KUPI's Methylphenidate ER product will be withdrawn from the market, depending on the results of the requested additional BE study, FDA actions and/or other factors. ”

Let's check with the almighty sell-side research analysts.
It seems the the case. According to the Dec. '15 research report from Susquehanna Financial Group, the key lost customer is Red Oak. Red Oak is the largest buying group in the US.

To put it simple, KUPI lost its key customer because of product downgrade.

#3) What's the possibility that LCI lose another customer? 
How often does FDA downgrade a drug? We didn't have the statistics, but it seems a one-in-one-hundred chance.
One interesting phenomena is that long before the downgrade, lots of patients had been complaining about Concerta in online forums.

How about LCI's other drugs? Let's search for the negative voices.

It's interesting to find that although every drug has some side effects, for instance, Levo made some people gain weight, there are not many complaints targeting LCI's other generic drugs.

As a result, it's unlikely that LCI will get another drug downgrade. Or in other words, it's unlikely that LCI will lose another customer, similar to what happened to KUPI.

That being said, LCI have some other troubles, such as it's C-Topical specialty drugJSP partnership for LCI's top two products and etc. Let's keep digging.


Related articles:

Saturday, April 23, 2016

Lannett, a mini-version of Valeant?

In this article, I will discuss why Lannett (NYSE: LCI) has grown revenues from $106 million in 2011 to $800+ million in 2016, after the acquisition of Kremers Urban.

Key Takeaway:
- LCI has been a mini Valeant
- LCI's drug prescription volume didn't increase for last 3 years
- The management has made sensible price projections

#1) Is LCI a mini-version of Valeant?
Many investors has accused LCI for jacking up prices for its most popular drugs - Levothyroxine ("Levo") and Digoxin ("Digo"). Is this the real case? let's pull data from Medicaid.


From the Medicaid data, we found LCI has increase the price of Levo by 22% annually and Digo 27% since end of 2013.  20%+ is not a small number.

How about the industry average? Let's pull data from AARP's Rx Price Watch Report.

"The average cost for a year's supply of a prescription drug doubled in just seven years to more than $11,000 — about three-quarters of the average annual Social Security benefit."

It's equivalent to a 10% annual price increase (I know I should take the enormous data from Medicaid to get a better number, but I think the number is good enough for now.)

20+% vs. 10% - We conclude that LCI has been increasing price aggressively, well above industry average.

Do you see a mini-version of Valeant here? Oh yes.

However, LCI has grow from $151 million revenue in 2013 to $407 million in 2016. Is there something more than price jacking?

Let's dig deeper.

#2) The TRx numbers
The Total Number of Prescriptions (TRx) can demonstrate the volume of drug sales.
(Source: IMS and SFG Research)

From the above date ranging from May '13 to Nov. '15, we can find:
- Per the two most popular drugs, Levo is on an upward trend while Digo is on a downward one
- The FDA downgrade had hurt Concerta greatly, similar to Morphine Products.
- The total generic TRx suffered mild dip in 2015, which I will explain in another article

To sum up, we can extrapolate that volume haven't help LCI much to grow its revenues.

#3) Is LCI's growth sustainable?
Let's put ethics aside (You know I'm a very ethical person. Look at my eyes), and talk about whether LCI's price increase is sustainable.
 (Gif source: the Internet)

This is a big topic, and regulation is probably the biggest factor.
Nobody can really predict the government (If you could, tell me when Yellen will increase the interest rate;)).

Fortunately, the management seems prudent in this tough business. On one hand, they increased drug prices to offset ramping regulation fees (e.g. GDUFA adjusted base figure was $1.5 million in 2012, but $3.2 million in 2016), and the management clearly stated that "price increase are opportunistic things"

GDUFA2016Excel

(Source: FDALawBlog)

On the other hand, the management is aware of new competitions in the market and projected high single digit price decline for their generic products.

That being said, we need the most conservative product pricing projection for LCI, in order to keep sufficient margin of safety. For instance, at inflation rate, or no increase for LCI's drug prices in the future.

OK. enough said. Let's look into LCI's products now.


Related articles:

The generic pharmaceutical market – what’s the competition landscape for a middle-sized player?




In this article, I will analyze the Porter’s Five Forces affecting smaller generic pharmaceutical companies, using the example of Lannett (NYSE: LCI), which have annual revenues of $400mm ~ $1,000mm.



(Photo Source: Internet)

Key Takeaways:
- Small/middle- sized generic pharmaceuticals face strong bargaining power from buyers, potentially squeezing their margins
- Current regulation regime keeps generic pharmaceutical players in an upward trends; it’s safe to project 5-year cash flows
- Sustainable and decent margin, as least in the short-run

OK, let's begin.
First, get some big picture from IBIS world:
“The $61.0 billion Generic Pharmaceutical Manufacturing industry is expanding rapidly, with annualized revenue growth of 4.5% expected in the five years to 2015. An aging population with more chronic illnesses is driving demand for industry products, while regulatory provisions of the Patient Protection and Affordable Care Act expand consumer access to prescription insurance and provide increased opportunities for product development. Industry revenue is expected to grow 3.7% in 2015.”
Sounds good.  From this 10,000 feet view, we can place LCI as a middle-size player that has grown from $106.8 million revenue in 2011, to $800+ million revenue in 2016 after the Kremers Urban acquisition.
What’re the forces driving LCI’s growth? Let’s start with Porter’s Five Forces.

#1) Threat of new entrants
Although generic companies manufactures lack patent protections like brand-name drug companies, they still enjoy decent ~10% Net Margins. Logically, there should be some barriers, such as followed:
- Regulation: The production of generics is strictly regulated and companies must adhere to stringent goods manufacturing practices and quality-control standards from FDA.
- Cost of production facilities: in US, there’s an interesting “frame of tenders”. It obliges pharmacists to dispense a discounted generic product if one is available. Under this scheme, health insurers are able to pressure prices and request a high quality. This requires companies to be able to quickly produce high volumes and at a low manufacturing cost, and high quality. So small players are difficult to get foot in the door.

#2) Bargaining power of buyers
Let’s first look at a simplified supply chain of pharmaceutical industry:



- Strong counterparties: As a manufacture, LCI’s clients are strong and consolidated wholesalers. Today, the top three wholesalers own 90% of the market share. Their revenue model has evolved into a low margin business that makes money by maximizing economies of scale, creating physical distribution efficiencies and financial efficiencies (Kaiser Family Foundation, 2005).
That’s bad, if you have strong counter-parties. That being said, in an environment that retail price is increasing, will wholesalers keep a fixed markup, or ask for a high margin? I will write about this in another article.
- Brand recognition: for generic products, brand seems useless. The pharmacist can provide any generic drug, as long as it has the effective content.

#3) Bargaining power of suppliers
- Low bargaining power from suppliers – the upstream is commoditized, reflected by low COGS (~20% of revenues)

However, we should keep in mind generic pharmaceutical companies can be manufactures, as well as distributors.
For instance, LCI's over 50% revenue comes from one single supplier, JSP. It is because that LCI is acting as a distributor, not a manufacture in this case. 

#4) Threat of substitute of products or services
That’s a tricky question, and Game Theory is in play
- There’s a certain cost to produce a generic drug, such as FDA and facility cost
- However, the revenue side is uncertain, depending on numbers of players in the market



  

 For instance, assuming a drug demand is $100 million, and the brand drug is priced at $100; fixed cost to launch this drug is $10million and COGS is 20%. We can play following scenarios:
(In $ Millions)









We can find that the third player will not enter the market, leaving existing two players enjoying higher drug price and margins.  In another words, after a certain threshold, new competitors don’t have an incentive to launch a drug and existing players can enjoy less rivalry.

#5) Rivalry among existing competitors
It’s also a product by product question. Similar dynamics as described in the Threat of substitute of products or services are also in play.

#6) Landscape migration
It’s a big question, which needs another 10,000+ words to explain. From the bird view, we should bear in mind that prospers of the generic pharmaceutical market has come from one act: Hatch-Waxman Act in 1984.
Since this Act, the industry has seen an increase in the percent of branded drugs that have a generic competitor on the market. In 1999, nearly 100% of the top-selling drugs with expired patents had generic versions available, versus only 36% in 1983.

Is there a possibility that a new act will be in place and completely destroy the generic pharmaceutical market? The short answer is definitely YES.
Pulling data from Congress.gov, we found it takes average 267.57 days to pass a bill into law. But how long it takes to introducing a bill? The timeframe varies from 2 weeks to forever.

For now, we can safely say (99% confident interval:)) that generic pharmaceutical companies will keep flat/slight upward pricing in 5 years.

Friday, April 22, 2016

Generic insulin and Chinese partner - another turnaround story of Lannett?


Today Lannett (NYSE: LCI) announced plans to co-develop a generic insulin pharmaceutical product for the U.S. market with its strategic partner in China. Is this news a fabricated stimulation to LCI's stock price, or a real growth opportunity? Every value investor wants to know. 

Key Takeaway:
- The Chinese partner is relative young with limited track record
- Potential revenue stream from generic insulin will be after minimum 36 months
- Generic insulin market already exists and seems crowded

More detailed discussions are as followed:

# 1) How reliable is the Chinese partner?

YiChang HEC ChangJiang Pharmaceutical ("HEC", HK:1558) is a pharmaceutical manufacturing company, focusing on areas of anti-virus, endocrine, metabolic, and cardiovascular diseases.

 - Company structure: A subsidiary of layers of parent companies
 - Management: Relative young management, with ~40 average age
 - 60%+ revenue (RMB 453.8 million) comes from "Kewei", an anti-influenza medicine
 - R&D: interestingly, only 3.8% of HEC's employees (36 out of 946) have "Master or Above" education level

# 2) What's the timeline to monetize the investment?

- LCI will facilitate the U.S. FDA approval and have market exclusivity in the U.S. Market. 

- HEC are currently developing three types of insulin APIs, which will be produced into six form of insulin products. In 2015, the Group has applied for clinical trials for insulin aspart, insulin aspart injection and insulin aspart 30 injection. Recombinant human insulin is now in the phase III clinical trial.

- If we take the data from 2013, it takes 36 months to get ANDA approval from date of receipt. So we can project the revenue will come after year 2019.

# 3) What's the potential revenue stream?
- According to IMS, global spending on diabetes in 2015 was 43~48 $billion, enjoying a 11.9% CAGR in last 5 years
- Per American Diabetes Association, U.S. insulin sales in 2011 totaled $8.3 billion, a 14.9% increase compared to 2010
- The generic Insulin is manufactured by 25 companies and in 101 brands
- 6 million people currently take insulin in the United States

Without further research, the generic insulin market seems already crowded.

More research will come. In another article I will talk about the Kremers Urban Story. Stay tuned:)