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Long time investor focusing on long term investments that provide substantial growth opportunities.
  • Why Investors Should Be Careful Approaching IntelGenx's PDUFA Date 9 comments
    Jan 29, 2014 3:49 PM | about stocks: BDSI, IGXT

    IntelGenx Technologies(OTCQX:IGXT) has risen 100% since December 12th on prospects of its Anti-Migraine Versafilm product being approved by February 3rd's PDUFA date, and it's clear why investors are excited. IGXT has already proven that it can bring a drug through approval to market (Forfivo XL) and by all accounts it's Versafilm product has a great chance at approval. First, let's ignore that has received enough press on internet message boards that people should become wary of whether it's obtained a "pump and dump" status(For instance, this user appears to be a proponent of "dumping", while this user appears to be a "pumper"), and that since January 17th, 38% of all volume on it's trades are investors shorting the stock. It appears a large sell off is occurring today, with the stock briefly hitting 90 cents at one point.
    But we're not here to put the merits of IGXT's price movement on trial, so let's continue on.

    The the Anti-Migraine Versafilm drug is an oral-film product that delivers the drug Rizatriptan, which is marketed by Merck Pharmaceuticals under the trade name Maxalt-MLT. That is, it is a generic product of an already approved drug. Contrary to popular believe, if we read between the lines, what is being approved here is not the drug, but the delivery method itself. Results indicate that the product is safe, and that the 90% confidence intervals of the three relevant parameters Cmax, AUC(0-t) and AUC(0-infinity) are well within the 80 - 125 acceptance range for bio-equivalency. Nobody can know for sure if the drug will be approved, so let's look at both scenario's

    The FDA Rules No

    This result is simple, IGXT heads to the bottom of the ocean. I don't say this lightly, but it's clear that the entire company portfolio is essentially built upon Versafilm's delivery method. If the FDA does not approve the product, a drug that has already been approved and has a satisfactory bioavailabilty compared to Maxalt-MLT, then they are essentially saying that something is flawed in the delivery method itself. This will call into question not only potential revenue achieved from the migraine drug(a market of $2.5 Billion dollars), but the upcoming ED drug, as well as the Buprenorphine/Nalaxone drug as well that is currently under development by Par Pharmaceuticals (a $1.5 Billion market). Some investors may also be excited about their erectile dysfunction product in development, but we can't be ensured that it'll ever get to market. Nothing is ever a sure thing in the biotechnology world. The only thing IGXT would have to go on after being told no by the FDA is existing revenue. It brought in only 804k through 9 months, compared to 2012 where it made $1.198 million for the calendar year. Let's assume IntelGenx continues it's pace, and reports 2013 revenue of 1.072 million. I thought companies were supposed to increase revenue, not decrease it. Anyway, industry wide, biotechnology firms average a 10.27 ratio for price to sales.
    With 56 million outstanding shares divided by 11,009,440, IGXT has a fair value of 19.65 cents a share. Right now, it is clear that approval has already been more than priced into the market value of the company's shares, closing at 1.04 as of January 27.

    The FDA Rules Yes

    Let's face it, if the FDA approves IntelGenx's migraine drug on February 3, it's positive for the company and it may be positive or negative for investors. As I explained earlier, I believe approval has already been priced into IGXT's shares, and would expect a sell off to occur prior to or right after approval. As of right now, the company's shares are worth roughly 20 cents.

    First, let's look at IntelGenx's track record. When Fortivo XT was approved, the company said that they were forecasting income from the drug in 2012 of $2-million, climbing to more than $7-million in 2014, when Forfivo XL sales are estimated to reach $30-million. 30 Million? They're only on track to barely crack $1 million in 2013 revenue. That's a gross error in estimating future revenue for investors. In 2012, the CEO said of Fortivo XT's approval: "2012 is a breakthrough year for the company, because we believe this launch will make us cash flow positive this year, and it is sustainable".

    Is it Mr Zerbe? Is it? Considering IGXT has a negative EPS in 2013, it's clear that the drug was not all it was cracked up to be prior to commercial launch.

    I think we can safely say that the company would overestimate future revenues obtained through sales of its migraine VersaFilm product as well. It lists on its website that as of 2012, the drug Rizatriptan film is based on achieved sales of $638 million. Raghuram Selvaraju, managing director at Aegis Capital Corp recently released an independent analysis on IGXT and in 2006, was ranked the top-ranked (#1) biotech analyst in The Wall Street Journal's "Best on the Street". In his analysis, he said "In our view, while sales of the IntelGenx drug are unlikely to ever approach the peak levels achieved by Maxalt, they could exceed $100mm annually by the 2020 / 2021 time frame.

    Ok, so not only is 2021 7 years from now, and by then the market will grow for Maxalt to a lot more than $638 million, IGXT will only be able to bring in a small percentage of that market at best, and that's if more competitors don't evolve in that time to take more market share from them. Remember, the company also only receives a percentage of sales in the form of royalties, not the entire $100 million.

    After its migraine drug is approved, investors can look forward to an ongoing lawsuit for patent infringement regarding IntelGenx's Buprenorphine/Nalaxone pain product that is currently under development by Par Pharmaceuticals. This patent does not expire until 2022, and should the lawsuit hold up, the company would have to virtually stop development. If it somehow found a way to bring the product to the FDA for potential approval, they would have to wait 30 months before a decision anyway according to the Hatch-Waxman Act. This market also faces stiff competition from BioDelivery Sciences International (BDSI), and its pain drug BUNAVAIL.

    Some would tout the ED drug as a blockbuster as well, but IntelGenx estimated its sales to only reach $120 million 6 years after release
    And we know how far off their estimates can be if Vortivo XT is any indication.

    In conclusion, short term investors could face huge upside and downside potential with the upcoming decision on February 3rd, so I would be careful with your investment decisions in the near term. Long term, I don't believe the company will be as successful as some hope, so err on the side of caution when investing in IntelGenx Technologies, as approval already seems to be priced in to the share price.

    Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.

    Additional disclosure: I saw the recent buzz on IGXT and thought that I ought to do more research into the company before buying shares. I decided not to puchase any shares, as my portfolio is composed of long term investment opportunities, and I don't think that IntelGenx warrents that classification.

    Themes: short-ideas Stocks: BDSI, IGXT
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Comments (9)
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  • Chad Jackson
    , contributor
    Comment (1) | Send Message
     
    Author’s reply » It's a shame SA didn't post this when it was submitted for review on Monday, as had investors of IGXT been able to see it, they might have saved themselves double digit losses today!
    29 Jan, 04:28 PM Reply Like
  • garypalys
    , contributor
    Comments (94) | Send Message
     
    It's nice to finally find some intelligent life on this subject! Thank you Chad... The pumpers just don't understand what happens during a PDUFA catalyst, or what happens after the decision is announced. Unfortunately, they are about to experience something that will leave them shaking in their boots! With all the pumping going on there are going to be some serious bag holders here. Even the nutty crew, Viral Network News that runs the Intelgenx Twitter site was thanking a penny stock list today on Twitter for including them in their list. How stupid is that? Or as Mark over at BioRunUp said, how desperate is that? Horst Zerbe should kick them to the curb! I just truly feel sorry for what the pumpers have done to the unknowledgeable traders! There are even people saying that they got back in today, sad, very sad!
    29 Jan, 07:38 PM Reply Like
  • kidkodak
    , contributor
    Comments (17) | Send Message
     
    if your article was submitted Monday then how does it have comments about todays trading??
    29 Jan, 07:52 PM Reply Like
  • garypalys
    , contributor
    Comments (94) | Send Message
     
    Because Seeking Alpha rejected it on Monday... Seems they only wanted to pump it Monday. So he added to it and posted it today as a insta-blog!
    29 Jan, 08:04 PM Reply Like
  • villagorgona
    , contributor
    Comments (3) | Send Message
     
    is just the opinion of this guy, nobody knows for sure what will happen next week, this guys wait until the stock reach some price or show some weakness to jump, I've seen it before, many times!
    29 Jan, 08:04 PM Reply Like
  • garypalys
    , contributor
    Comments (94) | Send Message
     
    Yes, and the same can be said about the 2 pumping posts the past 2 days as well villagorgona, but you don't want to see that, do you?
    29 Jan, 08:08 PM Reply Like
  • evanevans
    , contributor
    Comments (4) | Send Message
     
    Look, it's a delivery method company, not a drug company. They're not even going to manufacturer it. They hold a TradeMark and they wrap a previously approved drug in generic form in their TradeMarked delivery process, do some safety tests to pass FDA Marketing approval, and then hand the sales off to a distributor who pays them back royalties on the sales. I think you are over-estimating their impact on the market, and the market on them. They've been worth 60 cents with their current product in sales flow which is a Wellbutrin knockoff and takes from a $600M market share, and with the approval of this RizaTriptan based product which is a $640M market, we should see about the same results in the end, thereby increasing their product portfolio to TWO, and thereby doubling price valuation from 60 cents, to $1.20. With Opioid Therapy, a $1.5B market coming 4-6 months after that, we should see a similarly proportioned pop in valuation, revenue, sales, et al, basically adding another $1.80 to the price, bringing the late 2014 price valuation of the stock to $3.00. After that, it's Erectile Dysfunction. Shortly after that in 2015 they will be expanding into pet drug delivery, and their adhesive dissolving technology will surely be a success with those pet owners who are sick of frustratingly shooting pills into their pet's mouth, and will opt for the sticky dissolving version instead. A method that will likely gain viral marketing ground as pet owners talk with each other about the greatest new and easy way to give their pet's their medicine.

     

    Each new launch brings with it, further partnerships, and increased brand exposure.
    30 Jan, 02:27 AM Reply Like
  • garypalys
    , contributor
    Comments (94) | Send Message
     
    You're living in a fantasy world... Goodluck!
    30 Jan, 05:37 AM Reply Like
  • RhodeNav
    , contributor
    Comments (40) | Send Message
     
    Illusion is that the company with FDA approved decision cost below 1...;) but nice article to make you good gap and catch the fish on 3/02. Smart...
    30 Jan, 10:17 AM Reply Like
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