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Aandeel Genfit PSE:GNFT.FR, FR0004163111

  • 3,160 19 apr 2024 17:35
  • -0,025 (-0,78%) Dagrange 3,130 - 3,190
  • 60.592 Gem. (3M) 154K

Het jaar van de waarheid

1.555 Posts
Pagina: «« 1 ... 27 28 29 30 31 ... 78 »» | Laatste | Omlaag ↓
  3. [verwijderd] 6 maart 2015 16:14
    quote:

    @ out of the blue schreef op 6 maart 2015 16:06:

    Het lijkt hier net als op de beurs! Gisteren gingen we omhoog en vandaag gaan we omlaag! Nee serieus, natuurlijk is een dag als deze zwaar balen maar begin deze week stonden we nog net iets lager, zo erg is het dus ook weer niet.
    het gaat om de trend die gezet wordt.. Met deze onstabiliteit duiken we de 50-52 range in en dan kan het enorm volatiel gaan worden. Zo dicht bij de resultaten is om extra chaos vragen..
  4. [verwijderd] 6 maart 2015 19:02
    quote:

    Genfitnew schreef op 6 maart 2015 15:07:

    [...]

    Echt een k*t actie van ODDO. Geen probleem met zijn rapport enkel de timing. Meer votaliteit in een volatieler aandeel.;

    Hij beweert trouwens dat het eindpunt van de studie; NASh reversal; betekend dat lever geen NASH meer vertoont. Heb dit zelf nooit zo geinterpreteerd. Dacht enekel een significant verschil met placebo
    Ik acht het heel goed mogelijk dat ze bewust wat verwarring aan het zaaien zijn om zelf nog wat goedkoop te kunnen inslaan (en anderen) en kijken hoe de markt reageert immers ze hebben zichzelf al ingedekt als het verhaal niet klopt
  5. [verwijderd] 7 maart 2015 09:15
    Ik blijf het een vreemde move van oddo vinden om vlak voor de bekend making van de resultaten om nog allerlei berichten de wereld in te slingeren en hun visie aantepassen Ik mag ervan uitgaan dat ze over de zelfde informatie beschikken als iedere andere buitenstaander en dat die voor iedereen toegankelijk is (of ze beschikken over voorkennis) volgens mij zetten ze hiermee hun eigen reputatie op het spel en hebben ze wel wat uitteleggen tzt

    Ik zie het steeds vaker bij zogenaamde deskundigen (analisten) dat ze steeds meer reageren op de waan van de dag (politici hebben daar ook een handje van) zonder een gedegen onderbouwing en een visie voor de toekomst
  7. Stif 7 maart 2015 16:04
    Genfit: Pivotal Phase IIb Data On NASH Offers High Risk/Reward Trade
    Mar. 6, 2015 7:37 AM ET | 4 comments | About: Genfit (GNFTF), Includes: GILD, ICPT, SAN, SNY
    Subscribers to SA PRO had an early look at this article. Learn more about PRO »
    Disclosure: The author is long GNFTF. (More...)
    Summary

    This ICPT competitor is developing a potential best-in-class drug for treatment of NASH.
    Key Phase II results due by end of March could cause the stock to double.
    GNFTF could become leader in growing, unserved NASH market.
    (Editor's Note: Investors should be mindful of the risks of transacting in securities with limited liquidity, such as GNFTF. Genfit S.A. trades with more liquidity on the Paris exchange as GNFT.PA.)

    Useful links:

    Company website

    Company presentation (all pictures, except when specified otherwise, come from this presentation and belong solely to Genfit S.A)

    Deutsche Bank Small/Midcap Biotech Report

    (click to enlarge)

    INTRODUCTION

    Genfit (OTCPK:GNFTF) is a French biopharmaceutical company focused on the development of therapeutic and diagnostic solutions for unmet patient needs in metabolic and inflammatory diseases such as Non-Alcoholic Steato-Hepatitis . The company is "focused on contributing to bringing new medicines to market for patients with serious diseases whose treatment options are limited or non-existent." (Genfit.com).

    In order to achieve this goal, the company has developed a pipeline of several drug candidates, which it believes could become leaders in major markets that currently have no viable treatment options. The most advanced of these candidates, GFT505, is positioning itself as a potential best-in-class treatment for NASH, a growing, unmet condition that affects approximately 12 percent of American adults.

    GFT505 just completed a pivotal Phase IIb study on 275 patients worldwide, and the company will receive the statistical analysis of the results on March 10th. The results will then be made public by the end of the month, or in the first weeks of April at the latest. These results are critical because if they meet or exceed expectations, GFT505 would become the most clinically advanced NASH treatment and could quickly move into Phase III with Subpart-H designation for accelerated commercialization.

    These results offer the potential for a very high risk/reward trade, which could lead to a double or a halving of the share value. Per comparison, when Intercept Pharmaceuticals (NASDAQ:ICPT) announced fairly good Phase IIb results for its NASH drug candidate OCA, its share price skyrocketed from $72 to $445 over two days.

    In this article, I will try to demonstrate the superior profile of GFT505 against competing drug candidates, and why I think Genfit's Phase IIb results will exceed expectations. The imminent release of those results offers risk-tolerant investors the potential for a phenomenal trade, and could be played with a reasonable amount of one's portfolio. Beyond this event-driven trade, I am strongly convinced Genfit of the potential that lies in GFT505, and I believe the company will experience stupendous growth in the coming years. I am personally long the stock in anticipation of the results, as well as for the longer-term, with a twelve-month price target of €146.

    COMPANY OVERVIEW

    MM. Jean-François Mouney (CEO) and Bart Staels founded Genfit in 1999 in Lille, France. It is located at the heart of the Eurasanté Bio Business Park, an innovation center home to 134 companies and their 17,000 employees, as well as over 12,000 students. The company also has a subsidiary in Cambridge, MA in order to be close to the FDA and the American NASH market.

    Genfit is currently running six development programs for metabolic and inflammatory diseases. In this article, I will focus on GFT505, which is the main driver of the stock's value and offers the biggest catalyst in the coming weeks, and only cover the other programs briefly.

    The company was introduced to the Alternext market in December 2006, and more recently to the Euronext market, and has experienced a sizeable appreciation in 2014 after vegetating for a few years. In 2014, the stock rose from €9 to €37.68 (+318.6%). The year-to-date return so far has also been astonishing, with a 59 percent increase to €60 after hitting a high over €70 in February. This performance shows investors' appetite for companies developing NASH treatments, and gives an idea of the stock's upside and downside potential when the pivotal results become known in a few weeks.

    I believe the stock should trade between €70-€80 before the results are published, and depending on their quality, could be good for a 100%+ increase or a 50%+ decrease. This compares with a closing price of €60 as of February 27th. I am personally long the stock, and I will lay my bull case for Genfit after a quick explanation of what NASH is.

    NON-ALCOHOLIC STEATO-HEPATITIS

    Non-Alcoholic Steato-Hepatitis (NASH) is a fairly common disease with fast-growing prevalence around the world. Because it is a "silent" disease, many people who are in the disease's early stage are not aware that they are ill and are not diagnosed soon enough. It currently affects about 12 percent of the American adult population, and this number is bound to increase in the future as the disease is linked with obesity and diabetes.

    The only viable means of diagnosing NASH is via a liver biopsy, which is a very unpleasant procedure in which a doctor uses a needle to sample a small part of the liver and analyze it. This means that the market for NASH not only needs a viable treatment; it could also use easier diagnosis techniques that don't require a biopsy.

    (click to enlarge)

    NASH causes accumulation of fat in the liver, liver inflammation, degeneration of hepatocytes, and fibrosis. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) "The progression of NASH can take years, even decades. The process can stop and, in some cases, reverse on its own without specific therapy. Or NASH can slowly worsen, causing scarring or "fibrosis" to appear and accumulate in the liver. As fibrosis worsens, cirrhosis develops; the liver becomes seriously scarred, hardened, and unable to function normally." (niddk.nih.gov)

    This makes NASH a very preoccupying condition, and explains why the FDA has given GFT505 fast-track designation. This will make clinical development faster and easier, and when Genfit manages to bring to market a safe, effective treatment for this pathology, selling it should not be the hardest part. I will now examine the clinical profile of GFT505 and explain why I think it is superior to ICPT's Obethicolic Acid (OCA) on both effectiveness and safety.

    GFT505

    GFT505 is a PPARa/d agonist, a drug that acts on the Peroxisome Proliferator-Activated Receptors (PPARs). PPARs "are a group of nuclear receptor proteins that function as transcription factors regulating the expression of genes." (Wikipedia.org). By controlling gene expression, PPAR agonists can be used for the treatment of metabolic diseases such as NASH.

    According to the company's annual report, "GFT505 is the most advanced component of a group of proprietary drug candidates historically developed by GENFIT so as to take charge of cardiovascular and metabolic diseases in groups of people suffering from a metabolic syndrome, among them, obese people, pre-diabetics and diabetics." The product, patented until 2035, should be ready to enter Phase III in the third quarter of this year if the results of the pivotal Phase IIb meet or exceed expectations.

  8. Stif 7 maart 2015 16:06
    The study was conducted on 275 patients over 52 weeks, with a daily administration of two concentrations of GFT505 (80 and 120 mg). The primary endpoint is a reversal of histological NASH without worsening of fibrosis, as well as no safety concern. In addition, if GFT505 demonstrates an improvement in fibrosis, it would be a groundbreaking achievement and a significant advantage over OCA.

    Only 12 percent of patients opted out of the study compared to expectations of 25 percent, which is a very good sign, especially since the treatment involves two liver biopsies, at the beginning and end of the trial, which are very cumbersome processes.

    Furthermore, in October 2013, "The members of the DSMB unanimously concluded that, after more than 6 months of treatment at the dose of 80 mg/day, GFT505 shows no safety issue that compromises the continuation of the Phase IIb study." This unanimous recommendation to continue the study shows that the experts were confident on the safety profile of GFT505, and that there should not be any bad surprise on this concern when the full results are made available.

    (click to enlarge)

    This picture from the company's latest presentation gives a nice snapshot of the properties of GFT505 and how they apply to the treatment of NASH. The molecule also demonstrates very strong antifibrotic activity, which represents a great potential for the treatment of non-hepatic fibrotic diseases, in addition to the beneficial effects on NASH patients.

    Before this pivotal trial, several other trials have been performed on GFT505 on mice, monkeys, as well as humans and showed very promising results. Genfit's molecule has consistently showed improvements in markers of inflammation and liver dysfunction, as we can see on this slide from the GFT505 presentation:

    (click to enlarge)

    In an April 14, 2014 press release, Genfit released additional data that supported the strong anti-fibrotic properties of GFT505, and its ability to reverse established fibrosis therefore enabling liver regeneration. Dr Dean Hum, Genfit's CSO stated that "this data on the anti-fibrotic effects of GFT505 further strengthens its positioning as a first-line drug for the treatment of NASH patients, including those with the most advanced disease." So far, neither OCA nor Simtizumab have demonstrated solid anti-fibrotic properties, which gives Genfit's molecule a true advantage in the treatment of inflammatory diseases such as NASH or Crohn's disease. On Crohn's, M. Hum added "GENFIT is considering the possibility of launching a Phase 2 proof-of-concept study in Crohn's disease."

    In a December 16, 2014 press release, the results of a trial on rats showed that GFT505 fully prevented advanced fibrosis (stage 3) and cirrhosis (stage 4), whereas 90% of the placebo group developed such pathologies.
  9. Stif 7 maart 2015 16:07
    Furthermore, 91% of the control group developed NASH while only 25% of the GFT505 group did at the end of the period. Based on these results, Genfit's CSO declared that "This study alone meets all the criteria for an efficient NASH treatment in man, the ultimate aim being to protect patients from severe hepatic complications that can lead to liver transplantation or death."

    The absence of safety concerns is a major plus, and was recently confirmed again after a safety study on 168 healthy volunteers was performed with daily doses between 120 mg and 300 mg (2.5 times the therapeutic dose). The results, published on January 6th, 2015, showed that GFT505 had no effect on cardiac electric activity, even at the highest doses. What is important in these results is that Genfit considers the therapeutic doses at 120 mg, whereas it used to view it as 80 mg. This could mean that GFT505 is proving effective, and that its proven safety allows for a more concentrated dosage.

    Deutsche Bank Securities issued an update on the stock in December 2014, and they have laid down several scenarios for the results, which are as follows (price basis: €44)

    As we can see, the probability of success attributed to this trial is much higher that the average 45% rate at 70%. Furthermore, I believe the "BEAR1" case is irrelevant, as GFT505 has consistently proven its safety profile, even at more than two times the therapeutic dose. Therefore, the "BEAR2" case would be my worst-case scenario and if the product were to miss the study's primary endpoint, the stock would be worth less than €30/share, which translates into a 50% decline.

    I also believe there are higher chances to witness a statistically significant improvement in fibrosis: whereas DBS believes it has only a 10% of occurring, I would assign odds of 20% to the super bull case, which could propel the stock to a valuation closer to that of ICPT. I believe €150 is a reasonable objective for the super bull case.

    I stand with DBS on the 70% probability for the base case, and I believe these results could cause a 100% increase to the €120 level. This leaves a 10% probability for the BEAR2 case, and on this basis, trading the results offers an attractive risk/reward ratio.

    These price targets rest on a valuation between €3 and 4 billion in the bull case and €600-800M for the bear case, based on the valuation of Genfit's closest competitor Intercept Pharmaceuticals. Even though its valuation currently hovers around $6B, it would not be reasonable to assume a similar valuation for Genfit as European biotech valuation metrics are not as high as their American counterparts. This is why I believe a valuation between €3 and 4 billion is more likely in case of good results that would put Genfit ahead of ICPT.

    The company also used this trial to establish biomarkers in order to diagnose NASH in an easier way, which is necessary to replace the mandatory liver biopsy. Thanks to blind blood samples collected during the study, Genfit has tried to establish benchmarks of the disease's evolution, in order to find other ways to diagnose it. It would not be possible to determine valid biomarkers if there was no evolution in the patients' condition, because one cannot measure something when there is nothing to measure. Therefore, if Genfit managed to establish new biomarkers for NASH, the treatment must have proven effective.

    If the results are better than expected, Genfit will suddenly be at the forefront of NASH players and will attract interest from all the large pharmaceutical companies. The company would probably use its strong position to sign a partnership in order to finance the Phase III program and ensure it can market its drug as fast as possible.

    In an extraordinary shareholder meeting held on February 24th, 2015, the CEO talked about several Phase III trials that would require approximately €200M. He could have been referring to an additional Phase III trial in Crohn's disease, an inflammatory pathology that could be addressed by GFT505 if it is effective enough. He also talked about the plans for a NASDAQ IPO, which is underway and should take place in the next twelve months. One can wonder if M. Mouney would make such plans if he knew that his molecule was not effective or safe enough.
  10. Stif 7 maart 2015 16:07
    OTHER NASH CANDIDATES

    (click to enlarge)

    This picture from Genfit's presentation sums up the drug candidates for the treatment of NASH. As we can see, ICPT is slightly more advanced than Genfit, having completed its Phase IIb trial recently. The trial was performed on 283 NASH patients, using a 25 mg daily dose of OCA versus placebo. The primary endpoint was met on 45% of the OCA patients versus 21% for placebo. Around 23% of OCA patients suffered from pruritus and as many were opted out of the study by the DSMB. The DSMB also noted that OCA significantly worsened cholesterol levels, but it would appear that this trend tends to reverse after the end of the treatment.

    Another candidate for NASH therapy is Gilead Science's (NASDAQ:GILD) Simtizumab, currently being evaluated in a Phase IIb study on 259 patients. However, this drug is more aimed at the treatment of NASH-induced cirrhosis, rather than curing NASH at an earlier stage.

    Currently, Intercept is clearly leading the race, but the situation is bound to evolve in the coming weeks. If GFT505 can show significant improvement on fibrosis, and more satisfying results on histological NASH, Genfit would clearly take the leader's spot.

    TGFTX AND SAN/GFT-2

    The TGFTX program is composed of 4 molecules currently in development for the treatment of metabolic, autoimmune, fibrotic or inflammatory diseases. These various programs are not as advanced as GFT505, and even though their current value is not significant, they are a proof that Genfit is not a one-trick pony and that the company is permanently innovating. More information about these programs is available on the company's website.

    The SAN/GFT-2 program is part of a collaboration agreement with Sanofi (NYSE:SNY), which was originally signed in 2011 and regularly renewed since then. Its aim is to develop molecules to correct the mitochondrial dysfunction resulting from pathologies such as Type 2 diabetes and kidney diseases. Genfit can benefit from the expertise and knowledge of a large group such as Sanofi, and the cost and risk-sharing agreement means that the company will not sink all of its resources in this project.

    FINANCIAL SITUATION AS OF DECEMBER 31st, 2014

    At the end of FY14, the company had €76.3M in cash, up from €21M the year before, and no long-term debt. The company recorded revenues of €1.6M in 2014, which mostly came from the collaboration agreement with Sanofi . Net Loss for the year has not been published, but it should be greater than the €12.6M net loss in 2013.

    The large increase in cash came in part from a €49.7M private equity placement that took place in the second quarter, and was funded mostly by US institutional investors. The company also raised €5M in the first quarter and €21M in the fourth quarter. It is hard to imagine that Genfit would be able to raise that kind of capital if they were not convinced of the groundbreaking potential of GFT505.

    Even though this level of cash is comfortable to run the company for at least two years, it cannot cover the costs of an eventual Phase III trial of GFT505, which would have to be financed through a major partnership or a capital raise such as a secondary offering or a NASDAQ IPO. Of course, financing should not be an issue when the time comes to start a Phase III, as it would imply a much higher probability of success.

    INVESTMENT RISKS

    Investing in Genfit, like any company and especially biotech ones, is inherently very risky. The company does not have significant revenue and generate consequent net losses every year. Genfit could experience failure or delays in critical clinical trials, and end up being worth little more than the cash value of the company. The company could also run out of cash if it does not manage its expenses properly and fails to raise additional cash.

    Investing in Genfit before the Phase IIb results is even riskier because in case of unsatisfying results, the sell-off would be very sharp and a decline of more than 50 percent is more than possible. Therefore, this investment is only suitable for risk-seeking investors who are aware of the very speculative nature of this investment. If you like the company's profile but are too risk-averse to play the results, it could be a wiser idea to take another look at the stock 6 to 12 months from now.

    CONCLUSION AND RECOMMENDATION

    There are several indicators that point to a superiority of GFT505, which should be confirmed by the Phase IIb results due in a few weeks. I believe GFT505 has the potential to become the first marketed treatment for NASH, and reap billions of dollars of high-margin revenue. Investors' commitment over the past year shows that Genfit is not an empty shell, and that despite the sizeable return of the stock so far, most of the growth still lies ahead.

    The obvious confidence of management over the last months, and particularly at the Feb. 24 shareholder meeting, leads to believe that Genfit is convinced of the superiority of its GFT505. Furthermore, the coming year should be very important for the company, with a planned IPO on the NASDAQ and the possible initiation of a Phase III trial on GFT505. The company could sign a partnership before initiating this trial in order to share the costs and risks with a partner. For all these reasons, I have been long the stock since the start of the year, and my current twelve-month price target is €146, which translates into a market capitalization of €3.5B, free of any dilution.
  13. forum rang 4 Opstapelen 8 maart 2015 15:15
    Heel mooi uitgebreid stuk kick. Geeft heel mooi risicos plus potentie aan
    Als het zo gaat lopen wat deze meneer schrijft dan is zijn 146 koersdoel te laag
    Helemaal met subpart h
    Dus dinsdag krijgen ze resultaten. Dan zullen ze pb gaan voorbereiden plus powerpoint
    Spannende weken zeg
    Zou dit stuk zelfde impact hebben als oddo? En dit keer up?
    Moet traden tussen 70-80 voor de cijfers Nog 15 euro omhoog dus komende weken
  15. [verwijderd] 8 maart 2015 18:26
    quote:

    Opstapelen schreef op 8 maart 2015 15:15:

    Heel mooi uitgebreid stuk kick. Geeft heel mooi risicos plus potentie aan
    Als het zo gaat lopen wat deze meneer schrijft dan is zijn 146 koersdoel te laag
    Helemaal met subpart h
    Dus dinsdag krijgen ze resultaten. Dan zullen ze pb gaan voorbereiden plus powerpoint
    Spannende weken zeg
    Zou dit stuk zelfde impact hebben als oddo? En dit keer up?
    Moet traden tussen 70-80 voor de cijfers Nog 15 euro omhoog dus komende weken


    Vond het artike oppervlakkig en heel eenzijdig (Gent bekeken door de ogen van een Bull) en bevat wat fouten over de concurrenten. Je moet weten dat deze artikels geen invloed hebben op het aandeel. Kan geschreven worden door mensen zoals jij en ik.

    Dit worden inderdaad spannende weken. Ik haal mijn stop weg op 49eur (je weet maar nooit dat die zover zakt maar hoop natuurlijk van niet). Hopen dat er genoeg kopers zijn die in genfit geloven.
  16. forum rang 4 Opstapelen 9 maart 2015 09:10
    Tuurlijk een stuk geschreven vanuit de hoek van een aandeelhouder.
    Neemt niet weg dat een mooi uitgebreid stuk is met punten waar je over kan twisten.Maar vooral de risico's versus potentie is goed weer gegeven.

    Krijg sterk de indruk dat iemand weer wat lager stukken heeft opgepikt net.
    Na een -10% dagje verwacht je toch vandaag beetje herstel.
  17. [verwijderd] 9 maart 2015 09:26
    quote:

    Genfitnew schreef op 8 maart 2015 18:26:

    [...]

    Vond het artike oppervlakkig en heel eenzijdig (Gent bekeken door de ogen van een Bull) en bevat wat fouten over de concurrenten. Je moet weten dat deze artikels geen invloed hebben op het aandeel. Kan geschreven worden door mensen zoals jij en ik.

    Dit worden inderdaad spannende weken. Ik haal mijn stop weg op 49eur (je weet maar nooit dat die zover zakt maar hoop natuurlijk van niet). Hopen dat er genoeg kopers zijn die in genfit geloven.
    Is inderdaad verstandig om over je stop na te denken. Een koers van onder de 50 sluit ik niet meer uit. Het gaat weer hard.
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