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    All Signs Pointing To anguish At Cambrex - What Happened In Korea Is A Precursor | killexams.com true questions and Pass4sure dumps

    Cambrex (CBM) is a supplier of lively pharmaceutical ingredients (APIs) to the pharmaceutical industries. Based on its 2017 figures, ~66% of revenues are from supplying APIs for innovator drugs (i.e. non-generic), ~20% of revenues are from supplying APIs for generic drugs, and the ease from supplying APIs for controlled substance. As disclosed in CBM's 2017 10-K, 32.8% of revenues is from supplying sofosbuvir API for Gilead's (GILD) hepatitis C (HCV) drugs (Sovaldi, Harvoni, Epclusa, and Vosevi). Gilead's hepatitis C franchise became the largest drug in history when it sold over $19 billion worldwide in 2015. However, it has since experienced rapid decline as a result of competition and shrinking addressable market (the drug cures the disease, so each person that was treated shrinks the market size by 1).

    Given the rapid decline in the franchise, Cambrex has been subject to frequent short-selling discussions over the past several years. The short thesis was very simple. As Gilead's hepatitis C drugs declined, CBM's profit would decline significantly given its outsized contribution margin. However, the thesis hasn't really played out yet as sofosbuvir API sales continue strong into 2017. However, the downtrend is starting, as CBM itself expects a significant decline in revenue from sofosbuvir in 2018 and 2019 (repeatedly discussed on multiple earnings convoke since Q4 2017 earnings convoke but no further details provided beyond that) based on the minimum volume commitment from Gilead.

    In my opinion, the short thesis is delayed, rather than being wrong, due to minimum volume commitment in the agreement between GILD and CBM. However, the actual terminate market exact will eventually dictate the flush of CBM's sales to GILD over time. If GILD's inventory of the HCV API is indeed as extreme as I believe it to be, orders from GILD will Fall off the cliff when there is no longer a minimum volume commitment in 2020, especially when terminate market exact continues to decline and pricing of the API gets reset.

    I believe the short break exists today because

  • despite CBM trading volume of over $20M a day, its sellside coverage (Craig-Hallum, First Analysis, Jefferies, Stephens, William Blair) is quite limited with All being cheerleaders of the stock;
  • much of the work presented herein require primary research, including but is not limited to analyzing a foreign company and its financials only available in foreign language;
  • consensus figures are All over the space with some including the recent acquisition while others enact not;
  • some may not gain factored-in the $425M paid for a sizable recent acquisition (most recent poise sheet does not reflect that) while consensus figures embrace some of the earnings / EBITDA from such acquisition, thus making the stock issue cheaper than it really is; and
  • management's overly optimistic guidance that is reflected in the sellside's projections.
  • When CBM's enterprise value is properly calculated by including expense paid for its recent acquisition, CBM is trading at over 15x 2019 EBITDA and at a premium to its closest peer Catalent (CTLT). Given the valuation premium despite the GILD HCV headwind, I believe any upside potential for the stock is quite limited. Excluding my estimated substantial over-earnings from GILD's HCV business, which can be completely reset as early as in 2020, CBM is actually trading at over ~22-27x 2019 EBITDA (see the Valuation table at the terminate of the article). If the stock were to trade inline with CTLT at ~14x 2019 EBITDA, CBM's share expense should be at ~$33-42, 38-52% below where it is today. As people recognize the decline in GILD's traffic and realize its associated profit drop is more severe than they expect, the stock will be significantly derated.

    Lastly, short interest of the stock is only at less than 13% of float, so this is not yet a consensus short with plenty of borrow availability.

    ST Pharm, the other major supplier of sofosbuvir API to Gilead foreshadows what will happen to Cambrex

    Based on regulatory and company's filings (exhibits 1 & 2), ST Pharm, a Korean API manufacturer, is the other primary sofosbuvir API supplier to Gilead (we already know CBM is a significant supplier based on CBM's filings and earnings calls). Given ST Pharm's filings are only in Korean, it took some endeavor dig up and translate the figures to understand what has been going on. Without these figures, it was difficult to piece together the sofosbuvir API supply picture. In addition, I believe many CBM's bulls are not cognizant of what has been happening at ST Pharm lately.

    Exhibit 1. One of Sovaldi's European Medicines Agency filings

    Exhibit 2. Sofosbuvir API sales to GILD from CBM and ST Pharm

    If one looks at the trajectory of CBM's and ST Pharm's income statements (exhibit 3), it is not difficult to find similarities. Both companies gain experienced tremendous margin expansion as a result of the growth in its traffic to Gilead.

    Exhibit 3. Historical Financials of CBM and ST Pharm

    While bulls believe CBM's margins can be sustained at a relatively high flush because management has guided to high 30%'s to 40% grievous margin long term since Q2 2017 earnings call, one should select a watch what has happened to ST Pharm 2018 results so far (exhibit 4). ST Pharm's operating margin has dropped from over 30% to single digit in 2018 (with a degradation margin on lost revenues of ~65%)!

    Exhibit 4. ST Pharm's Historical Financials and 2018 Degradation Margin

    While initially it looks surprising for ST Pharm's margin to travel below its 2013 level, it actually shouldn't be. The API manufacturing traffic profitability depends as much on pricing and profitability of each individual products as much as overall capacity utilization of the business. To accommodate the original traffic from GILD, ST Pharm has expanded capacity over the past 4 years. Without traffic to backfill the drop in revenues from GILD, ST Pharm is essentially generating a similar amount of revenues as it did in 2014/2015 but at substantially lower capacity utilization, driving margins meaningfully lower. This may give us a glimpse of what could happen to CBM's margin over the next few years as GILD's traffic drop off.

    Continuing on the volume decline theme, the fact that exact for Gilead's HCV drugs is on a sharp decline is no stealthy to anyone. After a sharp drop in 2017, patient starts continued to decline at a rapid clip year to date. I gain made some simple reasonable assumptions that illustrate how exact for sofosbuvir API will likely trend over time (exhibit 4). As I will betray in the next section, while volume is obviously important, the bigger issue here is pricing.

    Exhibit 5. Historical & Projected GILD's sofosbuvir-based HCV patient Starts

    Gilead may besides be sitting on a lot of excess sofosbuvir API. I made such conclusion because CBM disclosed a $6.2M take-or-pay payment from a customer in Q4 2017. Given the size of this payment and knowing the want of any customer concentration outside of GILD at CBM, it is highly likely it is related to the minimum volume commitment on sofosbuvir. One should deliberate why the customer would rather gain the take-or-pay payment instead of taking delivery of the product. Looking at the other side of the world, GILD besides didn't fully live up to its contracted order with ST Pharm. In September 2016, GILD signed a shrink for KRW152 billion worth of sofosbuvir API supply with ST Pharm to be delivered in 2017. However, in its full year 2017 report, ST Pharm only booked KRW138 billion of sales from GILD (note that KRW has strengthened relative to USD by ~1% from September 2016 to 2017). This is consistent with my diligence in speaking with industry experts; it is well known GILD is sitting on huge excess amount of the inventories for its HCV drugs. Investors should deem what would happen if GILD continues to build up excess inventory from its volume commitment with CBM and ST Pharm, and then when there is no more minimum volume commitment (i.e. 2020 for CBM), GILD stops ordering supply for the much smaller market at that point.

    Pricing will be the second leg down, with plenty of FDA / EMA-approved or ready suppliers likely selling sofosbuvir API at 1/20th the price

    CBM ultimate renewed its agreement with Gilead in Q3 2015 as announced on the earnings convoke for that quarter. Recall the outlook for the Gilead's HCV franchise could not be any brighter in 2015 when it became the largest drug in history and with GILD stock at its All time high. Given how profitable the drug was, GILD's goal at the time was to sell as much as practicable and as quickly as practicable while cost was likely an afterthought. They were besides in a race against time to cure as many patients as practicable before competition shows up. As such, it seems likely that as suppliers, CBM and ST Pharm were getting extremely honorable expense for supplying the API (see the expense from the US supplier (most likely CBM) below). I enact not believe the expense CBM receives has changed materially, or at least not to where the market expense is, or else CBM's revenues from Gilead would gain dropped precipitously.

    Exhibit 6. Recent Sofobuvir API Transaction Prices from PharmaCompass

    While the datapoint from PharmaCompass is interesting, validating it with additional diligence and analysis is important. Based on reported sales from CBM and ST Pharm, and patient starts from Gilead, I was able to come by to an implied expense per kg of $18,000+ (exhibit 7). In order to minimize the limitation of matching terminate market exact to timing of product manufacturing (i.e. drugs necessity to be made before they come by sold and actual exact could differ from anticipated exact during manufacturing), I gain used the cumulative sales and volume from 2013-2016 to evaluate the expense of the API. To be clear, this exercise is meant to corroborate the magnitude of over-earning from the expense picked up in PharmaCompass rather than getting to a precise number. Moreover, they know there is probably at least one more API supplier to GILD based on regulatory filings, so once the sales from the additional supplier / suppliers are included in the numerator, it should propel the expense per kg easily over $20,000.

    Exhibit 7. Estimated Sofosbuvir Selling expense by CBM and ST Pharm to GILD

    The problem for CBM and ST Pharm is that the market expense for sofosbuvir has gone to ~$1,000 based on PharmaCompass data shown above as well as data presented by Dr. Andrew Hill from University of Liverpool at the IAS 2017 conference (exhibit 8). These prices are derived from import / export of sofosbuvir API in India. Given GILD has outlicensed its HCV drugs to a number of generic companies for sales in 100 low income countries (more on this later), these lower expense transactions likely depict supplies to these generic manufacturers. Thus, CBM and ST Pharm are over-earning on sofosbuvir API by a magnitude of ~20-25x! What happens when the current contracted agreement rolls off or at least when there is no more minimum volume commitment, shifting negotiating leverage back to GILD?

    Exhibit 8. Cost per Kg of Sofosbuvir API as Presented by Dr. Hill

    We besides know the HCV drugs are no longer as profitable for GILD as they were back in 2015. Based on reported patient starts and HCV sales figures from GILD, the mediocre revenue per HCV patient start in the US has gone from ~$53,000 in 2015 to ~$20,000 in 2018. In Europe, it went from ~$33,000 revenue per HCV patient start in 2015 to ~$12,000 in 2018. Given this trend, it seems natural for GILD to try to lower its costs to recapture some of the economics.

    Exhibit 9. Estimated mediocre Revenue per Patient Start

    Fortunately for GILD and perhaps unfortunately for CBM and ST Pharm, there are plenty of sofosbuvir API suppliers ready to select on this traffic at a much lower price. According to PharmaCompass, there are 25 sofosbuvir API suppliers, many of which already gain lively DMF with the FDA and manufacturing sites already inspected by the FDA and/or EMA. The readily available sofosbuvir API suppliers are perhaps the result of Gilead's licensing agreement with generic companies in 2014 to allow low cost HCV drugs to be sold in 100 countries. As these generic manufacturers sourced the essential API to supply the HCV drugs in these 100 countries, they worked with a number of API manufacturers who developed the know-hows and scale to yield commercial grade (quality and quantity) products. These API suppliers necessity to invest only a minimal amount of money to be ready to select on the traffic from Gilead, given they gain already locked down the manufacturing process. enact you believe these API manufacturers will sit idle? At a minimum, Gilead will likely spend this as leverage to negotiate a significantly reduced expense from CBM and ST Pharm.

    Using ~6,000 kg of sofosbuvir in 2020 / 2021 as projected earlier, the entire sofosbuvir API market to be shared among All the suppliers to GILD would be ~$6M if priced at $1,000 / kg. At $5,000 / kg, the market is only ~$30M. If CBM were to retain its majority share, the top line would probably be no more than $20M at a expense point that is 5x of current market price, when the market expense will likely continue to decline (see Dr. Hill's presentation earlier showing expense usually goes down over time). This is quite different from what the bulls and the sellside analysts expect, as they seem unaware of the fact that CBM is over earning by ~20x vs. current market expense of sofosbuvir API. bethink sofosbuvir API is a commodity and a commodity producer over time will earn market price. This is just economics 101 which has played out in so many stocks that crashed once the over-earning age is over.

    Now I feel quite snug with the conclusion drawn above. But hypothetically, if the expense is indeed much lower than $20,000, there is another problem (if not a bigger problem) for CBM. Since they know the actual sales from CBM and ST Pharm to GILD, if the expense was actually $2,000 per kg instead of $20,000+ as suggested in the analysis above, that would imply the amount of sofosbuvir API Gilead is sitting on is substantially greater than I expected (67 years of inventory, as modeled in Exhibit 10). Thus either way you lop it, it's titanic anguish for CBM.

    Exhibit 10. Implied Excess Sofosbuvir Inventories at Much Lower Price

    CBM's 2018 full year guidance appears to be more 2H weighted then it was historically (exhibit 11).

    Exhibit 11. CBM's Historical and Guided First Half to full Year EBITDA Contribution.

    Assuming for a minute that the company can hit its net revenue guidance of currency adjusted -2% to +2% (excluding repercussion from ASC-606), the company still needs to ramp grievous margin up significantly from Q1 and Q2 flush to achieve the full year EBITDA guidance of $150-160M. Note that Q2 results included a $3.2M shrink termination fee. Excluding that, normalized grievous margin would gain been 35.9% instead of 37.4% reported. What could drive such extend in grievous margin in 2H to hit full year guidance? (exhibit 12). How about another sizable take-or-pay payment from its largest customer in Q4 fancy ultimate year? While it will provide Great benefit to grievous margin (no costs associated with such payment) and allows the company to meet the guidance, it would clearly be a negative sign in terms of where sofosbuvir revenues will trend going forward, as it indicates weak terminate market demand.

    Exhibit 12. Projected 2018 Summary Income Statement Based on Management's Guidance.

    On medium term guidance, while CBM besides said it expects grievous margin to be under pressure as capacity utilization suffers from declining sofosbuvir revenues, it still expects grievous margin to trend to high 30%'s to 40% over the next few years. But with grievous margin already at ~mid 30s thus far in 2018 while still generating meaningful revenue from sofosbuvir (a product with outsized contributing margin), how would CBM come by to high 30s to 40% grievous margin as sofosbuvir revenues continue to decline sharply over next few years? bethink that sofosbuvir revenues carry such high margins as a result of its own profitability, as well as allowing CBM to fill up its capacity. To generate high 30%s to 40% grievous margin, CBM would necessity to replace the sofosbuvir volume with a collection of exceptionally high margin products. As they observe in the financials of CBM and ST Pharm prior to the ramp-up in sofosbuvir revenues, this will be an smooth task.

    Perhaps the margin compression trend ST Pharm experienced this year is a more likely outcome to CBM's margins over next few years.

    CBM besides expects innovator API excluding its largest product to grow double digit over next few years. However, as one can observe below (exhibit 13), CBM has never grown innovator API revenues excluding HCV consistently in the double digits. Even the 8% CAGR is heavily driven by the occasional single product, where one product from Gilead drove the majority of growth that year but besides the decline in 2017, while the majority of growth in 2018 is expected to be driven by one original product contributing $20m+ in revenues (from a minuscule amount in 2017) as guided by management. Based on the company's pipeline disclosure, there isn't any one product in the pipeline that can provide $20M in first year of market. This begs the question how likely it is for CBM to grow this revenue line double digit in the next few years as guided by management.

    Exhibit 13. CBM's Historical Organic Growth for Innovator API Segment Excluding Sofosbuvir.

    Recent sellside bullishness is completely misguided.

    On 9/25/2018, Jefferies initiated coverage on CBM with a Buy rating and $75.50 expense target, driving the stock up over 9% since the report. One of the key differentiated views expressed in the report is that revenue from GILD will outperform investors' expectations.

    "CBM’s Gilead related revenue seems to gain a disproportionate weighting to Gilead in Europe, where patient starts gain been roughly flat for the past 24 months, and government controlled budgets signify a more protracted treatment/cure curve"

    The analyst drew such conclusion because ((i)) CBM is shipping the product overseas; ((ii)) starting 2013, CBM recorded great upticks in domestic exports roughly equaling the size of the growth in its sales to GILD; and ((iii)) Gilead owns a facility in Ireland that serves both EU and other international markets and it uses two manufacturing plants in California to manufacture, package, and label its HCV drugs to Americas and the Pacific Rim. If this were correct, it could be a meaningful pushback to the short thesis. However, based on the actual wording in GILD's 10-K and FDA regulatory filings, it appears the analyst's interpretation here is wrong.

    In GILD's 10-K, it says the following:

    "We utilize their Cork, Ireland facility for the commercial manufacture, packaging and labeling of their antiviral products. They besides accomplish quality control testing, labeling, packaging and final release of many of their products for distribution to the European Union and other international markets."

    It clearly stated that the Cork, Ireland facility manufactures, packages, and label All of its antiviral products. It besides does other functions for other products that are distributed in the EU and international markets. This indicates that while CBM is shipping its API to Ireland, hence it being booked as exports revenues in its financials, the drugs come by shipped back to countries globally for sales. This is a pretty common rehearse for pharmaceutical companies given the tax benefits from having manufacturing done in Ireland, even if the terminate market sales are in the US.

    The 10-K besides states the following. It clearly says it does NOT manufacture its antiviral / HCV products in the California plants as suggested by their analyst.

    "At their San Dimas, California and La Verne, California facilities, they manufacture AmBisome (in San Dimas), package and label the majority of their commercial products and divide their products to the Americas and Pacific Rim."

    This is very different from what the analyst wrote:

    "GILD uses its two manufacturing plants in San Dimas and La Verne, California, to manufacture, package, and label its HCV drugs to Americas and the Pacific Rim."

    Lastly, based on Sovaldi's chemistry review document from the FDA, it is very pellucid that Gilead Ireland is the facility that manufactures the drug for sales in the U.S (exhibit 14).

    Exhibit 14. Excerpt from Sovaldi's Advisory Committee Meeting Chemistry Review Document

    The analyst besides lauded the Halo Pharma acquisition. It used CBM's acquisition of PharmaCore as a precedent of a successful acquisition although no information was actually provided by the analyst on why PharmaCore was a value creating transaction. Moreover, CBM has provided very limited information on Halo, a private company, which makes it difficult to construct a proper assessment. My preparatory assessment is that other than its aptitude to manipulate controlled substance, the service provided by Halo is quite commoditized. Interestingly, it appears according to John Kreger from William Blair on the conference call, CBM has stayed away from finished dosage traffic in the past so this deal was moderately of a surprise.

    "Steve, you guys gain opted to not be in the finished dose traffic in the past. Why enact you believe this is now the birthright time to sort of lunge into a more integrated approach to the business?"

    Perhaps the judgement CBM has been gun-shy in entering the finished dose traffic is that it did try to enter the traffic through an acquisition but failed massively, something most bulls are probably not cognizant of. In November 2010, CBM acquired 51% of Zenara Pharma, a company focused on the formulation of final dosage form products, for $20M. Pursuant to the stock purchase agreement, Cambrex was expected to acquire the remaining 49% in early 2016 at a value based on a weighted combination of a multiple of 2015 earnings before interest, taxes, depreciation and amortization (“EBITDA”) and cumulative EBITDA for the years 2011 through 2015. I imagine at the time, they were expecting the traffic to grow and will pay more than $20M for the other 49%. Apparently, EBITDA in 2011-2015 did not travel so well that CBM preemptively negotiated to acquire the other 49% for $2.7M in 2014. Soon thereafter, CBM recorded ~$17M restructuring charges in 2015 and 2016 and eventually sold the entire traffic for $2.8M in 2017. Bulls should hope that CBM does much better with the $425M Halo pharma acquisition than it did with ~90% loss in Zenara.

    Insiders are Voting with their Feet

    Steven Klosk, CEO of CBM is unloading his holdings rapidly over the past few months. Soon before the announcement of the Halo Pharma acquisition, he started unloading a significant number of shares. In less than three months from June to September, he decided to exercise 220,000 options that don't expire until October 2019 to October 2021 in multiple transactions via a 10b5-1 design [Link, Link, Link, Link]. And, as if the sales under the design was not sufficient, he besides sold another 80,000 common shares he owned outright in August [Link]. All together, he sold over 70% of his holdings [Link]. The recent great sales in such a short age of time are in contrast to his selling of 136,100 shares in 2017 and 69,600 shares in 2016 (exhibit 15).

    Exhibit 15. Steven Klosk's Open Market Activities in 2016 and 2017

    (Source: Bloomberg)

    Shawn Cavanagh, COO of CBM, decided to unload 86,250 shares (similarly a combination of early exercise of options and common shares) from May to August [Link, Link]. This is the largest sale he has done over the past 13 years with the exception of the sale of 113,749 shares in November 2015 (exhibit 16), before the share dropped ~40% within three months.

    Exhibit 16. Shawn Cavanagh's Open Market Activities since 2006

    (Source: Bloomberg)

    Samantha Hanley, CBM's universal counsel, sold All her holdings in August 2018 [Link]. Ms. Hanley has two other open market trades, both of which cleaned out her entire holdings. She exited her entire holding in November 2015, the identical time Shawn Cavanagh did prior to a 40% expense decline [Link]. In June 2017, she besides exited her entire holding [Link] before stock dropped 27% within five months. Overall, Ms. Hanley clearly has killer instinct when it comes to getting ahead of stock drawdown.

    Tom Vadaketh, now ex-CFO of CBM, resigned from the company abruptly on August 8, 2018 with less than one month of transition age [Link]. The collective actions of the senior management team clearly enact not paint a promising picture for the stock.

    Valuation

    With sofosbuvir revenue expected to decline significantly in 2018 as guided by management on the Q4 2017 earnings call, EBITDA is expected to be down ~$20M or 12% at midpoint of guidance given amalgamate shift (CBM guided overall net revenue to be -2% to +2%). As CBM has already guided sofosbuvir revenue to be down significantly (but what's the magnitude?!) again in 2019, it would not be surprising for EBITDA to decline again. For a moment, let's assume CBM hits its EBITDA midpoint guidance of $155M of EBITDA but that it declines 12% again in 2019 (I believe there is the potential for an grisly surprise on what the sofosbuvir revenues will be in 2019, given excess inventory sitting at GILD and the fact that CBM has not quantified the magnitude of decline in the minimum volume commitment that year), then they are looking at ~$136M in EBITDA for CBM before including Halo in 2019. The company disclosed that Halo generated $27M of EBITDA in 12 months ended 6/30/18. So let's assume it grows a miniature over 10% to $30M in 2019, then CBM should gain a 2019 EBITDA of ~$166M, lower than what it was in 2017 without Halo ($175M) after spending $425m on the acquisition. At the current enterprise value (remember to add the amount paid for Halo as the 6/30/18 poise sheet does not embrace that), this translates into a 15.3x 2019 EBITDA multiple. While most people spend Catalent as the closest comp to CBM, it only trades at 14.3x CY2019 EBITDA without the issue CBM has with the HCV revenues. (exhibit 17)

    In fact, given CBM is over-earning at such a degree with its sofosbuvir API and the fact that there is no minimum volume for 2020, one probably shouldn't apply a multiple on that profit stream. If one removes the sofosbuvir revenue and profit by either assuming the EBITDA margin reverts back to 2013 flush or based on the degradation of margin experienced by ST Pharm, then CBM 2019 EBITDA including Halo would be $94M to $116M, implying the stock trading at ~22x-27x 2019 EBITDA! (exhibit 17)

    If one values CBM using 2019 EBITDA excluding HCV and CTLT's multiple, CBM should be worth $33-42, down 38-52%.

    Exhibit 17. Summary of Projected 2018 and 2019 EBITDA and Valuation

    Conclusion

    We gain All seen this movie countless times where the market takes a company's near term performance and extrapolates it into perpetuity. While CBM clearly hit jackpot and generated massive earnings and cashflow over time from GILD's HCV drugs, what created the fortune for CBM in the past is going to be the cause for its downfall now. GILD's stock expense has already gone from ~$120 in mid-2015 to <$70 in 2017 as its HCV franchise declined. Based on consensus expectations, ST Pharm's operating income is expected to decline over 90% in 2018 as sales to GILD dropped significantly. For CBM, I believe history will repeat itself, allowing for a miniature patience.

    Risks
  • CBM starts winning much larger amount of original traffic compared to its historical track record, particularly if it lands another traffic similar sized to GILD's HCV drugs.
  • CBM acquires high quality businesses at below market multiple despite a very heated M&A market in the space.
  • Disclosure: I am/we are short CBM.

    I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I gain no traffic relationship with any company whose stock is mentioned in this article.


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