Arrowhead Pharmaceuticals US04280A1007

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1. [verwijderd] 23 januari 2020 09:52

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   We staan nu op het niveau van voor de grote stijging midden/eind november 2019.
   
   Zijn er hier ook TA’ers? Is dit dan nu het afronden van de kop en moeten we nog door de schouder heen?
   
   Gisteren stabiliseerde de koers mooi, geen grote uitschieters en nagenoeg neutraal gesloten. Nu is het de vraag volgens mij wat er omtrent de cijfers gaat gebeuren.
   
   JnJ nam toch een belang van iets van 5% (+/- 5mln stuks) a $58 = +/- 290mln. Wat is de cash burn eigenlijk van Arrowhead?
   
   Ben heel benieuwd naar de koers de komende 2 weken. Ik heb het gevoel dat deze rond dit niveau onder spanning komt te staan, en dan bij het volgende nieuwsfeit (cijfers of eerder nog een PB omtrent het een of het ander) een grote reactie geeft, naar beneden of naar boven, afhankelijk van wat er medegedeeld wordt....
2. kwekkel 23 januari 2020 09:58

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   quote:

   mvdln schreef op 23 januari 2020 08:58:

   [...]
   Ik ga een poging doen, maar Tom3 zal waarschijnlijk een inzichtelijker antwoord kunnen plaatsen. Overigens is Holden zijn reactie juist op het "rapport" van Leerink. De twijfels over safety hebben denk ik vooral te maken met het feit dat RNAi juist komt kijken. Intussen is voor een select groepje wel duidelijk dat RNAi zeer efficiënt is en weinig bijwerkingen heeft. Dat kan gestaafd worden door alle onderzoeksresultaten die ARWR tot op heden gepresenteerd heeft en ook door data van andere RNAi bedrijven zoals Dicerna, Arbutus, ProQr, Alnylam.
   
   Leerink heeft zijn huiswerk volgens mij niet goed gemaakt of heeft andere belangen. Dat laatste is natuurlijk speculatief. De vraag is of Leerink zich verdiept in het RNAi verhaal.
   
   Laten vooral niet vergeten dat er nog 11% short positie uitstaat en die nog gesloten zal moeten worden. De ontwikkelingen van de laatste weken zijn stof tot nadenken op dat vlak.
   
   Kijk bijvoorbeeld even naar de data die gisteren gepresenteerd werden door IONS / AKCEA hun APOCIII. Er is een verwijzing geplaatst naar een vergelijking gisteren. Dat toont aan dat ARWR superieur is t.o.v. (ook) deze concurrent.
   
   Het draait allemaal om het TRiM platform. Daarmee heeft het goud in handen en is de success rate bovengemiddeld.
   

   Bedankt voor de reactie, Avita heb ik trouwens ook
3. [verwijderd] 23 januari 2020 09:58

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   Interessante vragen hier.
4. Tom3 23 januari 2020 10:27

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   Voor degenen die twijfels hebben bij de veiligheid en werkzaamheid van rna-i dmv de galnac delivery methode heb ik hier een goede en betrouwbare informatiebron:
   
   www.ncbi.nlm.nih.gov/pubmed/29792572
   
   
5. mvdln 23 januari 2020 10:40

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   @ FV: de cashburn van ARWR is heel laag in vergelijking met andere biotech bedrijven. Dat heeft te maken met hun manier van bepalen van targets. Op dat vlak bespaart het heel veel R&D kosten t.o.v. concurrenten. Daarnaast is de tijd tussen selecteren target en commercialiseren ook veel korter, ik geloof pakweg 5 jaar.
   
   In 2018 gaf ARWR 72 miljoen $ uit aan R&D. In 2019 was dat 100 miljoen $. Als je kijkt hoeveel targets er in hun pijplijn zitten is dat indrukwekkend weinig.
   
   Cash positie was op 30 september 2019 nog 302 miljoen $ en daar kwam 266 miljoen $ bij na de emissie begin december. Dat brengt de totale cash positie op 568 miljoen $. Cash burn naar schatting 30 miljoen $ afgelopen kwartaal? Zou er 538 miljoen $ in kassa moeten zitten per 31/12/2019.
   
   Dit jaar kan ARWR tevens enkele mijlpaalbetalingen tegemoet zien (AMGEN, JNJ).
   
   Uit het earnings call transcript:
   
   Total operating expenses for the year ended September 30, 2019 were $107.6 million, compared to $72.1 million for the year ended September 30, 2018. This increase is primarily due to increased drug manufacturing, toxicology, and clinical trial costs as our pipeline of clinical candidates has increased.
   
   Turning to our balance sheet. Our cash and investments of cash balances totaled $302.9 million at September 30, 2019, compared to $76.5 million at September 30, 2018. Increase in our cash and investments balances was driven by the payment received from Janssen. Next year we anticipate a $25 million to $30 million quarterly burn.
6. Tom3 23 januari 2020 11:01

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   quote:

   Tom3 schreef op 23 januari 2020 10:27:

   Voor degenen die twijfels hebben bij de veiligheid en werkzaamheid van rna-i dmv de galnac delivery methode heb ik hier een goede en betrouwbare informatiebron:
   
   www.ncbi.nlm.nih.gov/pubmed/29792572
   
   

   Citaat:
   
   "The following three biotech companies are currently performing clinical trials using GalNAc-siRNA conjugates: Alnylam Pharmaceuticals, Arrowhead Pharmaceuticals, and Dicerna Pharmaceuticals. While there were several significant bumps early along the road, overall data from the next generation RNAi triggers look nothing short of spectacular."
7. [verwijderd] 23 januari 2020 11:10

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   @mvdln: veel dank voor de verduidelijking!
   
   Solide basis dus inderdaad.
   
   We gaan het meemaken het komende jaar! Staat veel te gebeuren.....
8. Tom3 23 januari 2020 11:12

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   @mvdln, ik sluit niet uit dat ik later nog eens terug keer naar AMG. Ik heb belangen in een aantal andere A`s: Affimed en Arbutus. Leuke rit gemaakt met Avita (Australië?)?
9. mvdln 23 januari 2020 11:25

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   quote:

   Tom3 schreef op 23 januari 2020 11:12:

   @mvdln, ik sluit niet uit dat ik later nog eens terug keer naar AMG. Ik heb belangen in een aantal andere A`s: Affimed en Arbutus. Leuke rit gemaakt met Avita (Australië?)?
   

   Ik heb een groot deel gemist, ingestapt rond de 6$ (ik heb ze gekocht op de Amerikaanse beurs, RCEL. Tussentijds al verschillende malen bijgekocht, momenteel toch al een mooi winstpercentage en daar staat veel te gebeuren de komende tijd.
   
   Ik heb overigens ook Affimed en Arbutus (mede door jouw aanbeveling en uiteenzetting). ProQr en Dicerna heb ik ook. Maar mijn positie in deze bedrijven is klein in vergelijking met de 3 A's.
10. mvdln 23 januari 2020 11:25

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    Nog even ON TOPIC voor de genen die nog niet 100% weten waarom investeren in ARWR. Uit het earnings call transcript van Q3/2019:
    
    There are now five TRiM-enabled candidates in the clinic, three of which are wholly owned and two are partnered. Over the next month, we plan to submit regulatory filings for two additional clinical candidates, and by the end of 2020, we intend to have 10 TRiM-enabled candidates in clinical studies targeting four different cell types. Further, we expect to be in three pivotal studies by the end of 2020. Let that all sink in for a moment. We believe this is a strikingly unique position for a company our size.
    
    We feel confident about our ability to achieve these aggressive targets and we have good reason to believe in the ultimate success of these clinical programs for a number of reasons. First, we have an increasingly validated technology in the TRiM platform. Keep in mind that over 250 people have been treated with over 450 doses of TRiM-enabled candidates. We continued to see very good activity and a benign safety profile in all programs.
    
    Second, we focused on well-validated targets. We tend to select gene targets where there is a widely accepted belief in the scientific community that if you can knock the target down, there will be clinical benefits without no negative phenotypes. In other words, we leverage prior genetic studies to minimize our target and biology risk. With the expanding body of knowledge on genetics, an ever-expanding published [indiscernible] data sets, we believe new and interesting targets will continue to emerge.
    
    Third, the RNAi field is just beginning, what we believe to be a golden age. This modality is increasingly accepted as it reliable and powerful way to treat a variety of diseases after two decades of intensive study and development. While the potential and value of direct conjugation delivery and unlocking the potential of RNAi was clear to us by 2016, broader confidence took longer. Interestingly, the increasing validation of RNAi is growing amid a backdrop of scarcity related to Company's capable of leveraging it therapeutically and near-absolute scarcity of bringing RNAi outside the liver. We think we are probably years ahead of anyone else in this regard.
    
    Lastly, and as we discussed at our R&D Day last month, Arrowhead is constantly finding innovative ways to shave days, weeks and even months off of the traditional development cycle. We effectively tried to take all the waste of time out of the R&D process without ever sacrificing quality or cutting regulatory corners, and we think we have demonstrated a level of speed and efficiency that has not been seen before. So at once we are expanding the potential uses and upside of our technology, while squeezing more and more risk and development time out of the programs. This is a powerful idea, indeed. During our R&D Day last month, we went into some detail about several of our development programs.
    
12. Tom3 23 januari 2020 11:31

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    Leuke coproductie van Arrowhead en Arbutus op het gebied van hepatitis B:
    
    www.ncbi.nlm.nih.gov/pubmed/31828894
    
    
13. [verwijderd] 23 januari 2020 11:33

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    Veel dank nogmaals @mvdln! Mooi om weer te lezen, dit was voor mij ook een passage die veel deed om mijn eerste stap in Arrowhead te zetten.
14. [verwijderd] 23 januari 2020 12:29

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    Van het Yahoo-forum:
    
    SpideySense6 hours ago
    Why I continue to invest in ARWR? In addition to the RNAi science magic behind ARWR that makes it such a game changer in the biopharma space here are some business financial analysis stats to assess and justify further investing in ARWR. (taken from etrade.com)
    
    Price/earnings: ARWR's P/E Ratio at 81.16 is greater than 83% of other companies in the Biotechnology & Medical Research industry. This typically means that investors are willing to pay more for its level of earnings relative to future growth.
    
    Return on equity: The 39.94% Return on Equity for ARWR shows that it is able to reinvest its earnings more efficiently than 97% of its competitors in the Biotechnology & Medical Research industry. Typically, companies that have higher return on equity values are more attractive to investors.
    
    Operating margin 36.25%: As indicated by the Operating Margin, ARWR controls its costs and expenses better than 96% of its peers.
    
    Earnings per share at .695: ARWR's EPS Growth Rate is greater than 99% of its peers in the Biotechnology & Medical Research industry.
    
    ARWR is clearly an amazingly well managed company and I’m very excited to hear the upcoming Q1 conference call in a couple weeks to hear even more great news. NBU $120 just wait for it. GLTAL's
    
    *****
    
    Weet niet hoe kredietwaardig deze poster is, maar is wel een post met wat onderbouwing.
    
    Hoe kijkt men hier op het forum aan tegen het management?
15. Tom3 23 januari 2020 12:54

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    Ik heb een hoge pet op van het management. Het heeft de DPC platform crash van november 2016 wonderwel goed doorstaan door 30% van het personeel te ontslaan en trials die gebaseerd waren op dit DPC platform te schrappen. Kennelijk heeft men de meest waardevolle mensen binnenboord kunnen houden. Dat alleen al is een prestatie te noemen. Sedertdien heb ik het management niet op enige fout kunnen betrappen, tenminste als je (zoals recent) omroept dat je niet te koop bent beschouwt als ok.
16. [verwijderd] 23 januari 2020 14:44

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    En nog even een post van het Yahoo-forum welke mogelijk interessant is, kredietwaardigheid van de schrijver kan ik niet beoordelen:
    
    BioBoyScout13 minutes ago
    1 of 3
    Here's my write-up on my meeting with Arrowhead in San Francisco during the JP Morgan Healthcare Conference at the Sir Francis Drake Hotel on Tuesday, January 14th. The meeting was with Bruce Given, the COO, and Vince Anzalone, VP Head of Investor Relations.
    
    The person that was supposed to meet with Arrowhead just before me was a no show, so I started 10 minutes early and this gave me a full 40 minutes instead of just a half hour. The discussion initially began on my thoughts of Dicerna and Ionis possibly merging with each other because Dicerna is incredibly backlogged with all of its partnerships, and Ionis has potential problems in the future with its ASO (antisense oligonucleotide) modality being inferior to RNAi.
    
    Vince pointed out that Dicerna basically made the decision to become a CRO (contract research organization), therefore IT IS OBLIGATED to develop drugs for its partners, and that leaves very little bandwidth for its own development for wholly-owned drugs. He said that Ionis is also in the same boat, and as a result, both companies are missing out on developing more of their own wholly-owned drugs.
    
    Vince thinks that it's tough for anyone to acquire these companies due to the fact that much of the valuation of its drugs is partnered out, and that leaves much less additional revenue for a potential acquiring company. Vince pointed out that Arrowhead has a different business model by holding on to the global product rights for its drugs for as long as it can. This allows Arrowhead to build the MOST value for its shareholders, as well as having the added benefit of getting its drugs to patients much faster. In my opinion, I believe that one can come to the conclusion, and even reasonably assume from Vince's arguments that IF a big pharma company wanted to acquire an RNAi or gene silencing company, then Arrowhead would clearly be a much more attractive candidate than Dicerna and Ionis because of the full revenue potential that is available on its wholly-owned drug candidates. IMO, I still believe that a merger between Dicerna and Ionis still makes a lot of sense and would be in the best interests of both companies. Additionally, Dicerna may be somewhat of an attractive suitor to one of their partners, particularly Eli Lilly, as they already have some skin in the game.
    
    With that said, Arrowhead believes that it executes in the drug developing process better than any of its competitors. By keeping its drugs wholly-owned, Arrowhead can then keep for itself most of the value of its drugs. In addition, the best way to get drugs to the patients that need it most in the quickest possible time is to keep the drug development process in-house and wholly-owned, as that is the clearly the fastest path to approval. Arrowhead further believes that its clinical operations and program management operations are very fast and very good, and that its able to do this without cutting any corners along the way. Contrasting this to Dicerna, its drugs are licensed out and this slows down the entire process; because of this Dicerna can't be as motivated for data readouts as Arrowhead is.
    
    In Arrowhead's partnership with Amgen, Vince pointed out that the path for getting the data was significantly slower than if Arrowhead were to do it itself. For example, the IND-ready drug that Arrowhead gave to Amgen in the fall of 2016 would have been in the clinic in early-to-mid 2017 if Arrowhead was handling it. Amgen, however, didn't get the drug into the clinic until the summer of 2018, as Amgen wanted to be extra sure of what it had. Additionally, since the summer of 2018, Amgen has been slower with its data readouts than the way Arrowhead would handle it.
    
    Vince and Bruce pointed out that with the second target that Amgen asked for (which Bruce personally never really liked), Arrowhead delivered to Amgen exactly what it wanted, that it was a good drug, and that the drug did what it was supposed to do. In the end, Bruce wasn't surprised that Amgen didn't take the second target.
    
    At the present time Arrowhead believes that it has a good mix of partnered drugs and wholly-owned drugs. It would like to keep that particular mix the way it is, but it will partner some indications when the time is right. Presently, the main goal is to grow the wholly-owned pipeline, as it doesn't see any present need to partner. Vince said that the goal when partnering is to only partner when the partner can do something for you that you can't do yourself, such as provide capital, development, commercialization, marketing, etc., and Arrowhead doesn't need any of this at this present time.
17. [verwijderd] 23 januari 2020 14:45

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    BioBoyScout15 minutes ago
    2 of 3
    Arrowhead doesn't want to waste its time and man hours on programs of other companies, however, if companies like Amgen and JNJ come to them, then it is willing to partner novel targets that are not part of Arrowhead's pipeline and not part of what Arrowhead is already working on. By partnering NOVEL targets (including new tissue types), this allows Arrowhead to get into areas of technology that it wouldn't be otherwise working on, and that helps them learn more and expand its expertise. With that said, Bruce pointed out that Arrowhead is still guiding to have 10 drugs in, or submitted to the clinic by the end of this year; and a few years after that it should be 20 drugs. No doubt some of them will be licensed or partnered in co-development/co-marketing partnerships. This is the first time I've heard Arrowhead mention co-development and co-marketing - I consider this to be a positive as it means that Arrowhead intends to keep growing and that it is looking to keep a bigger piece of the pie in its partnered, wholly-developed drugs.
    
    I then asked about ARO-ANG3 and ARO-APOC3 and whether Arrowhead is looking to partner the non-orphan indications. Bruce mentioned that Arrowhead could probably get the resources to do it on its own, but that you probably wouldn't want to do that off of the base of a $6 billion company, but you might want to do it off of the base of a $12 to $20 billion market cap company, and you don't know exactly where you're going to be in the future. With $500 million in cash there is no urgency for Arrowhead to partner, as it is currently in its best ever position of strength. It is most likely that they will probably create some partnerships in the future, but it doesn't feel currently forced to do so, and this allows Arrowhead to work out the best deal possible that is most beneficial to the company, and to maximize shareholder value.
    
    Arrowhead is still guiding ARO-ENaC for its IND filing in the first half of 2020, and it is very excited about the target for a number of reasons. ARO-ENaC is currently under GLP tox studies, and once that's finished Arrowhead will immediately file an IND. At that point it then becomes plug-and-play for a number of targets that big pharma has been wanting to drug and is unable to drug. If ARO-ENaC turns out to do what it's supposed to do, Arrowhead sees a franchise rolling out very rapidly. Bruce emphasized that new classes of pulmonary drugs come out about once every decade, and that there's been very little movement in this area. He further said that if the pulmonary franchise evolves the way Arrowhead wants it to, then it could see asthma, COPD, and other indications in the future, with possible co-development and co-marketing in the mix.
    
    The dimer and muscle target are still under wraps, as it appears that they don't want the competition to find out anything about it until it's necessary. There is currently no guidance yet for these targets.
    
    I then asked Bruce about its HBV drug and if there's any possibility that the FDA might possibly approve the drug if it has good data. He said that it depends on how good the data and safety profile are, and that there are "breakthrough pathways" in both the US and Europe right now, as the trials are robust enough. So it isn't impossible, especially since the regulators are more lenient nowadays, but it is unlikely, as the patient size may not be big enough. If the regulators really like what they're seeing, then they'll probably make the pathway to approval much easier, very similarly in the way it happened with Gilead and HCV. In that instance, the data from Pharmasset was so strong that the regulators provided a quicker and easier path to approval, additionally, the regulators also eased up on the standards because they liked what they were seeing.
    
    With regards to ARO-AAT, Arrowhead probably won't be releasing any data this year, especially the blinded Sequoia study - that might happen around the 18 month mark, but not sure yet. With regards to the open label, Arrowhead will assess that at the 6 month mark to determine if it's in Arrowhead's best interest at that time or not. It is, however, unlikely, as Arrowhead may not want to give competitors an early heads-up about the data. I understand Bruce's thinking here, as the competition may be waiting to see how Arrowhead's trial is proceeding before determining what to do next with its own trials and how to best proceed next. The longer you can keep the competition at bay, the bigger advantage Arrowhead is able make on the competition.
18. [verwijderd] 23 januari 2020 14:50

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    De 3 van 3 kan ik even niet vinden
19. Hulskof 23 januari 2020 15:15

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    Ik denk dat hier iemand binnenkort al z'n Galacentjes in Arrowhead gaat stoppen. ;-) Toch, FV?
20. [verwijderd] 23 januari 2020 15:17

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    Hahahaha, nee hoor, dat dan weer niet. Maar ik lijk er nu wel naartoe te werken dat ik mijn belang in Arrowhead wat ga vergroten. Maar Gala blijft voor mij de basis, dat belang hou ik aan totdat ik het nodig heb. Tot die tijd.....
21. [verwijderd] 23 januari 2020 15:38

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    BioBoyScout10 minutes ago
    I have been trying to post part 3 of 3, but I think a bit more time needs to go by before Yahoo allows me to post another longer message