Thursday, May 5, 2016

China Cord May Hurt Minority Share Holders

Summary
CSRC passed the inquiry regarding low bid price for China Cord's minority share holders.
HKEX lacks track-records to interfere similar issues.
Watch out for SEC interventions for the last straw.
This is article is published on Seeking Alpha now. Please go to
http://seekingalpha.com/article/3972227-china-cord-may-hurt-minority-share-holders

Thanks
 

Valuation Analysis On Clinical-Stage Biotech

Executive Summary
Aduro Biotech Inc. (NASDAQ:ADRO) is a clinical-stage immunotherapy company and focuses on the discovery, development, and commercialization of treatments for challenging diseases. We analyzed the firm on the assumption of it producing only a single drug, CRS-207, and only applying to pancreatic treatment. We concluded a risk-adjusted price target of $6.70 for this business line.
This is article is published on Seeking Alpha now. Please go to http://seekingalpha.com/article/3971097-valuation-analysis-clinical-stage-biotech

Thanks

Saturday, April 30, 2016

Section 338(h)(10) Election on Lannett

In this article, I will discuss the tax benefit Lannett ("LCI") will receive from the Kremer Urban ("KUPI") acquisition.

Key Takeaways:
- Section 338(h)(10) can help LCI save tax by stepping up assets
- The NPV calculation shows $87 million cash tax savings
- The "election" may not happen yet

Let's begin.

#1) What is Section 338(h)(10) Election?
First of all, there's an awesome article on this topic from Tony Nitti.

Simply put, here is Section 388(h)(10) magic:
When a corporation purchases the stock of another corporation,  for tax purposes only the buyer is treated as acquiring the target’s assets.  

Or in other words:
A buyer could acquire a target’s stock for legal purposes - thereby keeping the target alive and preserving its non-transferable assets - but acquire the target’s assets for tax purposes, giving the buyer the stepped-up basis in the asset it seeks.
So in LCI's acquisition: LCI acquired KU's stocks -thereby keeping KUPI's contracts and patents - but acquired KU's assets for tax purposes, giving LCI the stepped-up basis in asset.

#2) How to calculate the tax benefit for LCI?
For the LCI-KUPI case, the bulkpart of asset step-up is in the form of  KUPI's intangible assets. There is $659 million net pro forma adjustment in intangible assets, $432 million of which will be amortized in 15 years.
(Source: LCI's 8K on Nov. '15)

So this amortization will hit LCI's bottom line in income statement, but in reality increase it's cash generating capacity.
We can do a simple calculation that discounts this 15-year amortization @8% discount rate, the NPV of tax saving is $87 million.
This number is lower than the management guidance, which expects at least $100 million tax benefit from Section 388(h)(10) election.

#3) Timeline for realization
It's worth mentioning that Buyer and Seller must jointly make the Section 338(h)(10) election no later than the 15th day of the 9th month beginning after the month in which the acquisition date occurs.

The acquisition completed on Nov. 2015, but I haven’t heard about the 388 (h)(10) election result yet.
Furthermore, Lannett has agreed to a 50/50 split of the additional tax liabilities UCB will incur associated with the section 338(h)(10) election, up to $35.0 million, and this $35 million has been recorded as liability.

I'm not sure that the $100 million management mentioned is the net number or not.

Related articles:

Friday, April 29, 2016

Some thoughts on Lannett

Previously, I have talked about Lannett (NYSE: LCI) from following perspectives:
1. Industry overviewThe generic pharmaceutical market overview
2. Previous growth strategyLannett, a mini-version of Valeant?
3. Future projections:Will Lannett lose another customer?Lannett's C-topical storyThe Lannett and JSP story, Controlled substance - Lannett's hidden growth engine
4. ValuationThe valuation on Lannett 

After so many moving parts, we currently conclude that LCI is undervalued (bear case valuation at $20 per share).

Investment theses:
- LCI is currently undervalued due to market sentiment
- High-margin, high-barrier controlled substance business has been overlooked by the market
- LCI can generate sufficient cash flow to deleverage, even in severe pricing environment

#1) The big picture
Personally, I don't really like generic pharmaceutical industry. No offense to hardworking and smart management in the industry, but I purely think this industry is a malformation of market inefficiencies and regulation constrains.

If we use some imagination, we can see this whole industry wiped off, if the government mandates brand drug companies lower the drug price after their patent cliff. Then there will be no hassles, no ANDA, no trials in court between brand drug companies and generic ones...

Furthermore, the growth and prosper of personalized drug will reshape current pharmaceutical industry, and I don't see generic pharma with limited R&D investment can survive this reshaping.

What's a future of generic pharmaceutical industry?

If we look at the most regulated industries in the US, like in the photo below:

What patterns do you see?
I see consolidation. Only big players can survive the costly compliance procedures and argue with the government.

We also joked that FDA should a great investment, since the compounded annual growth rate of Prescription Drug application free has been 14.11% for 24 years. In FY 2016, the fee is $2,374,200 for an application with “clinical data” requirement.

LCI is a small and beautiful company, but it will probably get into the consolidation swirl in the near future.

As a result, although LCI is mispriced, I am looking for a trade, instead of a long-term investment.

#2) Time-frame
In the valuation part, I have focused on the bear case valuation. Potential upside catalysts are as followed:
(This graph is outdated after 3Q16 earning call. Need to update)

(Source: complied by the author)

If we look for tools with the most skewed pay-off curve (an instrument that can provide significant upside reward), Long-Term Equity Anticipation Securities ("LEAPs") seem to be good options.

#3) More questions
It's worth mentioning that there has been strong short interest hovering LCI since 2015. The current percentage of share shorted is ~30%.

So far I have considered following reasons for this strong short selling bet:
1. LCI can't handle its transformational acquisition and go bankrupt
2. LCI's business has fraud - e.g. channel stuffing to wholesale distributors and retail drug chains
3. Potential legal issues and product downgrade
4. CEO's health condition (currently age 70)

For (1), I see minimal chance of LCI going bankrupt, since its leverage ratio is 3.8x Net Debt/EBITDA, in line with the pharma industry average.

For (2), while we can cross check with Total Number of Prescriptions (TRx) from IMS, some field researches are still needed.

For (3) and (4), I haven't found material disclosures so far.

More importantly, I still don't understand why LCI didn't walk away from the KUPI deal when there was no break-up fee. It's potentially a fatal red flag.

Wednesday, April 27, 2016

Controlled substance - Lannett's hidden growth engine


According to management, the controlled substance business is key to the growth of Lannett ("LCI").

In July 2008, the Drug Enforcement Administration ("DEA") granted Cody Labs, a subsidiary that LCI acquired in 2007, a license to directly import concentrated poppy straw for conversion into opioid- based APIs for use in various dosage forms for pain management.

From LCI's 10Q, we read:
"The value of this license comes from the successful development of patentable processes. Cody Labs' expertise in API development and manufacture, allows the Company to perform in a market with high barriers to entry and limited foreign and domestic competition."

Key Takeaways:
- Controlled substances are highly regulated
- LCI's poppy straw importing license and development expertise could be an edge 
- Revenue growth for last 4 years has been decent, but not enough


#1) what are controlled substances?
(Morphine, an example of controlled substances, can be extracted from Opium. Source: The Internet)

Controlled substances have a high potential for abuse which may lead to severe psychological or physical dependence. Thus this market is highly regulated by FDA and DEA. Manufactures/Distributors have to register with DEA on an annual basis.

Furthermore, the controlled substance drugs are protected from foreign competition as long as a source is available in the United States.


#2) What's the prospective in controlled substance business?
Sub-questions: 
a) What's market size of this business?
b) what's the barrier of entry in this business?


From the data above, we found the controlled substance market is $10+ billion in size, with limited players.

If we cross check with other data source, some data suggest the market size for Schedule II APIs is $500~$600 million, while there are five schedules in total. The sales for Hydrocodone/Acetaminophen Combo Market was ~$1.2 billion in 2015.


I haven't got good data on penetration rate yet, but this market has been growing quickly, from only ~$5 billion market size in 2005.


#3) Does LCI have an edge in this industry?

From what we get so far, the controlled instance industry seems a growing playground that haven't been crowded yet.
- Cody Labs has a license to directly import concentrated poppy straw, while only 7 producers has that license
- The management of Cody Labs sounds capable: the president, Mr. Opitz, worked for 20 years with the Bayer group in Germany and Italy in Engineering, Manufacturing, and Product Development, and in the US as SVP Engineering
- The management of LCI has ambitiously expected Controlled Substances will constitute 50% of LCI's revenue in 2019, which will be a great growth booster.




Since 2012, we see a decent growth of this segment in LCI's revenue stream, in spite that the branded drug had some issues with FDA since 2015. However,  the growth was not enough to meet management's ambitions (See Figure above).

To sum up, I believe that controlled substance could be a booster of LCI's top-lines, but we need more information of this niche market. 

Tuesday, April 26, 2016

The Lannett and JSP story

One risk related to Lannett (NYSE: LCI) is that over 50% of its revenue (before the Kremers Urban acquisition) comes from one single supplier, Jerome Stevens Pharmaceutical, Inc ("JSP"). In this article I will discuss this partnership and analyze potential risks related to it.

Key Takeaways:
- The banding between JSP and LCI are relatively strong
- Two parties will renegotiate contract in 2019
- We can't rule out the case that JSP will ask a bigger piece of the pie, but the possibility is limited

#1) Why did it begin? 

Levothyroxine ("Levo") Sodium Tablets are used to treat hypothyroidism and other thyroid disorders. It is one of the most prescribed drugs in the United States with over 13 million patients. 

JSP’s Unithroid® was the first FDA approved (August 2000) Levothyroxine Sodium Tablet formulation. Both Synthroid® from Abbott Laboratories’ and Levoxyl® from Monarch Pharmaceutical were approved by the FDA in the following years. 

However, the sales of JSP's Levo products didn't take off. Subsequently JSP filed supplementary application for generic version of Levo .

Since 2002, LCI has been distributing a number of JSP products. And in 2004, LCI and JSP executed a contract that provides LCI with exclusive distribution rights in the United States for the current line of JSP products. The agreement was for a period of ten years.

As a compensation, Lannett granted JSP four million shares of Lannett’s authorized, unissued common stock.

In 2014, these two parties extended a 5-year contract, for which LCI issued 1.5 million shared to JSP and $20.1 non-recurring contract extension cost . LCI also announced If the parties agree to a second five year extension from March 23, 2019 to March 23, 2024, LCI is required to issue to JSP or its designees an additional 1.5 million shares of LCI's common stock.

Furthermore, LCI is required to purchase, in the aggregate, $31 million of products from JSP each year. If LCI does not meet the minimum purchase requirements, JSP’s sole remedy is to terminate the agreement. This translates into ~$150 million annual sales, reasonable at current stage.


#2) How strong is the partnership?
From JSP's website, we found LCI has been distributing most of JSP's products. Moreover, JSP's 5.5 million shares represent ~15% of LCI's outstanding shares.

#3) Is there a possibility that JSP will impact LCI's profit margin in the long-run?
The sub-questions will be:
#a) when they renegotiate the contract in 2019, will JSP eat up the profit margin that LCI is enjoying now?
#b) What's the chance that JSP would abandon LCI and let another distributor to sell its products, or sell its products by itself?

The answer really depends on the negotiation power of management. Since JSP is a family-owned business and they had chosen to get equity from LCI from the beginning, I lean towards a sustainable partnership between these two parties.

Monday, April 25, 2016

The valuation on Lannett

Base on previous discussion, let's focus on the bear case valuation first.

Key Takeaways:
- Stronger financial performance from the cash flow perspective 
- Bear case valuation at $20 per share

My bear case counts in all the negative scenarios that could happen to LCI. Assumptions include:

1. FDA requires LCI to stop marketing C-topical in 2016
2. After JSP renew contract with LCI in 2019, the gross profit margin of related products will drop to 50%
3. Generic segment sales decrease at 9.2% run rate for year 2016-2020
4. Conservative product launches for ANDAs





This projection is ~10% discount of management guidance on $555 million - $565 million revenues in FY2016; projected 50%-55% gross margin is well below 60.5%-61.5% gross margin in the guidance.

Furthermore, due to the step-up in asset from 338(h)(10) tax benefit, amortization of KUPI's product rights and deferred financing cost, we see stronger performance in terms of Free Cash Flow per share.
(KUPI's product rights amortization schedule. Source: LCI's 8K on Nov. '15)


(LCI's deferred financing costs. Source: LCI management presentation on Mar. '16)

I believe a 7x FCF forward multiple (based on 12.8x median P/ LTM FCF for its peers) is appropriate to value LCI in the bear case, which concludes a risk-adjusted valuation of $20 per share.

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:)