TEVA -- Zukunft mit Generika
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14051948Kibbuzim : TEVA -- Zukunft mit Generika
Über das israelische Pharmaunternehmen TEVA muß man nicht viel sagen,der auf Generika spezialisierte Pharmakonzern gehört zu den bekanntesten Unternehmen Israels.
Neue Studienergebnisse zu Parkinson Medikament
ADAGIO Trial Results Show Teva´s AZILECT(R) 1 mg Tablets Slow Progression of Parkinson´s Disease
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA videos nachrichten) announces that results of the phase III ADAGIO trial were presented today during the 12th Congress of European Federation of Neurological Societies (EFNS) in Madrid, Spain as part of a "Late Breaking News" session.
The ADAGIO study showed that Parkinson´s disease (PD) patients who took AZILECT(R) (rasagiline) 1mg tablets once-daily upon entry into the trial, demonstrated a significant improvement compared to those who initiated the drug 9 months later.
The 1mg dose met all three primary endpoints, as well as the secondary endpoint, with statistical significance. The primary analysis included three hierarchical endpoints based on Total-UPDRS (Unified Parkinson´s Disease Rating Scale) scores:
A) superiority of slopes in weeks 12-36 (-0.05; p=0.013, 95%CI -0.08,-0.01),
B) change from baseline to week 72 (-1.7 units; p=0.025, 95%CI -3.15,-0.21), and
C) non-inferiority of slopes (0.15 margin) in weeks 48-72 (0.0; 90%CI -0.04,0.04).
The safety profile of AZILECT(R) seen in the ADAGIO study was similar to previous experience with AZILECT(R).
Main results were presented at the congress by Professor Olivier Rascol, M.D., Ph.D., Department of Clinical Pharmacology, University Hospital, Toulouse, France, one of two principal investigators of the trial.
"The rigorous trial design and the fact that all three primary endpoints were met with statistical significance reinforce the quality of the data, supporting the potential for AZILECT(R) to have an effect on disease progression," said Prof. Rascol.
"The successful outcome of the study provides further rationale for the early use of AZILECT(R) among Parkinson´s disease patients," he added. "Delaying disease progression is the most important unmet need in the management of Parkinson´s disease," stated Prof. C. Warren Olanow, professor and chairman of the Department of Neurology at the Mount Sinai School of Medicine, New York, NY, and ADAGIO co-principal investigator.
"The ADAGIO study, the first of its kind, was prospectively designed to demonstrate if AZILECT(R) can slow down the progression of Parkinson´s disease. Results of the study show that early treatment with once-daily rasagiline 1mg tablets provided significant clinical benefits that were not obtained by those patients where initiation of AZILECT(R) therapy was delayed by nine months."
The ADAGIO study, one of the largest conducted in PD, included 1,176 patients with very early Parkinson´s disease in 14 countries and 129 medical centers who were randomized to receive rasagiline 1 or 2 mg/day for 72 weeks (early start) or placebo for 36 weeks followed by rasagiline 1 or 2 mg/day for 36 weeks (delayed start).
Description of trial results can be found online (http://www.abstracts2view.com/ana) in the abstract submitted by Prof. Olanow and Prof. Rascol to the 133rd Annual Meeting of the American Neurological Association, Salt Lake City, UT, September 21-24, 2008.
Prof. Olanow will be presenting these results during the Works in Progress poster session on Tuesday, September 23, 2008. The abstract was also chosen to be presented orally by Prof. Olanow on Tuesday from 11:45am-noon.
Teva intends to submit these results to the regulatory authorities in the U.S. and Europe. Based on these results, Teva will work with the regulatory authorities to incorporate the results into the label for AZILECT(R).
For more information on AZILECT(R), please visit www.azilect.com.
About the Study
ADAGIO is a randomized, multi-center, double-blind, placebo-controlled, parallel-group study prospectively examining rasagiline´s potential disease-modifying effects in 1,176 patients with early, untreated Parkinson´s disease.
Patients from 129 centers in 14 countries were randomized to early-start treatment (72 weeks rasagiline 1 or 2 mg once daily) or delayed-start treatment (36 weeks placebo followed by 36 weeks rasagiline 1 or 2 mg once daily (active treatment phase)).
The primary analyses of the trial were based on change in total UPDRS (Unified Parkinson´s Disease Rating Scale) and included slope superiority of rasagiline over placebo in the placebo-controlled phase, change from baseline to week 72, and non-inferiority of early-start vs. delayed-start slopes during weeks 48-72 of the active phase. UPDRS is the most commonly used rating scale to assess disease status.
About AZILECT (R)
AZILECT(R) 1mg tablets (rasagiline tablets) are indicated for the treatment of the signs and symptoms of Parkinson´s disease both as initial therapy alone and to be added to levodopa later in the disease. AZILECT(R) 1mg tablets are currently available in 30 countries, including the US, Canada, Israel, Mexico, and most of the EU countries.
About Parkinson´s Disease
Parkinson´s disease is an age-related degenerative disorder of the brain.
Symptoms can include: tremor, stiffness, slowness of movement, and impaired balance. An estimated four million people worldwide suffer from the disease, which usually affects people over the age of 60.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the world´s leading generic pharmaceutical company.
The Company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.
Over 80 percent of Teva´s sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements. Such statements are based on management´s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva´s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements, including statements relating to the results of the ADAGIO phase III trial and the potential efficacy or future market or marketability of AZILECT(R).
Following further analysis, Teva´s interpretation of the results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release as there can be no guarantee that the results from the phase III trial discussed in this press release will be confirmed upon full analysis of the results of the trial and additional information relating to the safety, efficacy or tolerability of AZILECT(R) may be discovered upon further analysis of data from the phase III trial.
Even if the results described in this release are confirmed upon full analysis of the ADAGIO study, we cannot guarantee that AZILECT(R) will be approved for marketing in a timely manner, if at all, by regulatory authorities in the EU or in the U.S. Additional risks relating to Teva and its business are discussed in Teva´s Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
"Ein Deutscher ist ein Mensch,der keine Lüge aussprechen kann, ohne sie selbst zu glauben"(Theodor W. Adorno)
amorphis : @Sylar Was soll das denn bitte heißen?
"aber bei israelischen Firmen weiß man nie..." ?
Was genau weiß man hier denn nie? Weiß ich bei chinesischen Firmen, welche per ADR an der nasdaq notiert sind (TCEHY, NIO, IQIYI, BIDU, BABA,...) etwa mehr? Weiß ich bei DAX Werten mehr? Kommt es hier nicht zu Einbrüchen?
Eigentlich ist der Vergleich ziemlich schwachsinnig, da völlig branchenfremd....aber egal. Weder Tencent, Baidu noch Alibaba haben ne bessere Performance seit Jahresbeginn (siehe Chart).
Und mal weiter vergleichen...völlig branchenfremd:
War Daimler besser? Nein - deutlich schlechter.
Waren Fresenius bzw. Fresenius Medical Care besser? Nein, deutlich schlechter. (Und hätte man nicht gerade bei Fresenius von einer "sicheren" Aktie gesprochen?)
Siemens? Minimal besser.
Bayer? BASF? Deutlich schlechter.
Der DAX? Kaum unterschiedlich zu Teva seit Jahresbeginn.
Was ich damit sagen will...
Verluste und Kurseinbrüche sind nicht lediglich bei Teva zu beobachten. Der breite Markt gibt nach. Teva ist auch betroffen, aber andere Firmen deutlich mehr.
Glänzt alles bei Teva? Nö...sicherlich nicht. Der Markt betrachtet die Verschuldung von Unternehmen derzeit ziemlich stark. Hier kann Teva aktuell nun wirklich nicht punkten. An dem Punkt muss jeder für sich selbst entscheiden, ob er dem Unternehmen zutraut die Schulden zu bedienen und auch abzubauen. Ich persönlich denke, dass genau dies in den kommenden Jahren passieren wird - und dann sprechen wir über ganz andere Kurse.
Ist es derzeit so schlecht, wie vom Markt eingepreist? Nein, sicherlich auch nicht. Wir reden hier immer noch vom größten Generika Hersteller. Ein Unternehmen das zuletzte sehr gute Fortschritte gemacht hat, welches sehr hohe Cash Flows generiert und diese auch in den Schuldenabbau steckt. Gleichzeitig wird auf der Kostenseite eingespart.
Aktuell wird Teva mit einem historisch günstigen KGV bewertet, siehe:
Forward P/E 5.13
Ich denke es gibt wesentlich schlechtere Werte, in die man aktuell sein Geld stecken kann. Haben wir aktuell den Tiefpunkt bei der Aktie erreicht? Ehrlich - keinen Plan. Interessiert mich aber auch nicht, da ich hier langfristig orientiert bin und ich mich in mehreren Tranchen einkaufen wollte. Ich freue mich bei vielen Aktien sogar, dass ich diese mit deutlichem Abschlag kaufen kann im Vergleich zu den letzten Monaten. Vielleicht geht es noch unter 10$. Ja...wahrscheinlich ist das sogar so. Werde ich persönlich jetzt deshalb die positive Entwicklung der letzten Monate ignorieren? Nein, definitiv nicht. Teva gehört definitiv zu den auserwählten Werten, welche ich in dieser Marktschwäche verstärkt kaufen werden (immer vorausgesetzt fundamental ändert sich nichts). Und dann sprechen wir uns mal in ein paar Jahren erneut. Ich persönlich handel Aktien seit 23 Jahren...und in diesen 23 Jahren waren mehrere Einbrüche wie auch Höhenflüge dabei. Was sich in den 23 Jahren aber immer gelohnt hat, war in Schwäche hinein zu kaufen (und nicht zu verkaufen!).
amorphis : Sylar...
beulermaennlein881 : Teva
amorphis : patent settlement with Neos
amorphis : seeking alpha
The stock's recovery has almost entirely reversed as the price per share returns nearer to all-time lows.
Management anticipates over $3.5B free cash flow for 2018.
A big challenge for the business is paying off another $29B in long-term debt. The target looks achievable now that we're seeing stabilization across product segments.
kbvler : Schultz
amorphis : @kbvler
Natürlich kann man das nicht, im Beitrag steht auch das der Vergleich eigentlich schwachsinnig ist. Wie in diesem Beitrag bereits erwähnt sollte lediglich klar gemacht werden, dass andere Werte auf Sicht von einem Jahr ebenfalls mit dem Abgabedruck am Markt zu kämpfen haben. Hier wurde von manchem User argumentiert "der Kursverlauf war zuletzt so schlecht, deshalb habe ich nun kein Vertrauen mehr in den von Teva gefahrenen Kurs, da kommt noch was negatives...!"
So könnte man derzeit dann bei vielen Aktien argumentieren, was natürlich nicht haltbar ist.
amorphis : US Launch of a Generic Version of Elidel
amorphis : short ratio weiter angestiegen
Short Interest (Shares Short)
Short Interest Ratio (Days To Cover)
Short Percent of Float
Short % Increase / Decrease
Short Interest (Shares Short) - Prior
amorphis : My Top Portfolio Holdings for 2019
No. 3: Teva Pharmaceutical Industries
Generally speaking, I live by the "you hate it, I love it" rule. There aren't too many investors who will willingly admit to owning troubled generic- and branded-drug maker Teva Pharmaceutical Industries (NYSE:TEVA), but I'm one of them. I've owned a stake in Teva for more than a year now.
Don't get me wrong: The depths of Teva's issues caught me by surprise. Aside from substantially reducing its earnings guidance in 2017, the company also halted its previously top-notch dividend, settled with U.S. regulators over bribery charges, replaced its CEO, saw its lead brand-name drug (Copaxone, for multiple sclerosis) face its first generic competition, and contended with generic-drug price weakness throughout the industry. It was a year to forget, for sure.
However, Teva has made more progress than Wall Street likely gives the company credit for. Namely, it's been diligently selling off noncore assets and utilizing its operating cash flow to reduce its debt. At one time, Teva held more than $34 billion in net debt following its acquisition of generic-drug arm Actavis from Allergan. Today, that net debt load is down to about $27.6 billion. Sure, it has more work to do, but the company has consistently been generating $4 billion in annual operating cash flow, leaving little doubt that it can manage (and reduce) its debt. When combined with an expected $3 billion in annual cost cuts by the end of 2019, Teva has done an excellent job of "trimming the fat," so to speak.
On the other end of the spectrum, Teva's generic business is beginning to see less pricing pressure. Over the longer run, this is a portion of its business that should thrive as physicians, insurers, and consumers push for less-pricey generic options rather than brand-name medications. Although generic margins are much lower than brand-name products, Teva, being the largest generic drugmaker in the world, can more than make up for that with volume.
Even taking into account the likelihood of a small revenue decline in 2019, Teva appears far too inexpensive at five times next year's profit projections.
Körnig : Ihr Fragt euch warum steigt die Teva wieder?
Körnig : Habe heute nochmals 120 Stk.
tazmaraz : News von der Konferenz und dem CEO
Padawan : market-stabilizing top News
shuntifumi : Teva
Padawan : Ausbruch über 18$
Körnig : Padawan
Padawan : Moin Körnig viel Glück
amorphis : Körnig...
...gib der Aktie einfach ein paar Jahre Zeit ;-)
Ob derzeit 16€ oder bald 19€....das sind ganz bestimmt nicht die Regionen in denen Teva steht, wenn:
1.)Konsequent die Schulden weiter abgebaut werden.
(letztes Quartal wurden 27,6 Mrd $ gemeldet: https://s22.q4cdn.com/366566841/files/.../Teva-Factsheet-Q3-2018.pdf)
=> Teva hat die Schulden bereits von über 35 Mrd $ auf den derzeitigen Wert abgebaut.
Schafft es Teva wieder zu wachsen wird der Schuldenabbau sicher nicht langsamer voran gehen ;-)
=> sobald die Schulden deutlich zurückgefahren wurden, werden von dieser Seite auch weniger Risiken eingepreist. Das lässt dann deutlich höhere Bewertungen zu (und das bedeutet ganz sicher nicht, dass Teva die Schulden auf Null senken muss. Weitere 10-15 Mrd $ würden sicherlich ausreichen, um deutlich weniger risikobehaftet bewertet zu werden!)
2.)Der Generika Markt sich weiter stabilisiert => Teva wird nicht von einer bereits spürbaren Stabilisierung sprechen, wenn sie nicht klare Anzeichen dafür hätten.
3.)Teva wieder Wachstum generiert.
Teva braucht Wachstum: die Zulassungen der letzten Monate werden meiner Meinung nach vom Markt derzeit überhaupt nicht berücksichtigt. Es ist nur ein paar Monate her, da wurde ein potenzieller neuer Blockbuster zugelassen. Es hat seitdem auch weitere positive News gegeben. Hat sich das im Kurs bereits bemerkbar gemacht? Teva hat von Quartal zu Quartal die Zahlen übertroffen und jeweils den Ausblick auf den Rest des Jahres erhöht. Hat sich das irgendwie nachhaltig im Kurs niedergeschlagen? Nein! Stattdessen haben wir zum Jahresende einen Abverkauf sondergleichen gesehen auf nicht für möglich gehaltene Kursniveaus.
Ich persönlich glaube, dass Teva die richtigen Maßnahmen ergriffen hat um langfristig wieder auf dem richtigen Weg zu sein und eine positive Zukunft vor sich hat. Ich glaube nach wie vor an alte Höchststände in den kommenden 3-5 Jahren ;-)
amorphis : J.P. Morgan Health Care Conference
amorphis : Highlights
Restructuring program on-track: significant spend base reduction of $1.8 billion Q3 YTD 2018
Approval and launch of AJOVY™ in the U.S.; demand continues to grow steadily over the
first three months of launch
AUSTEDO® rapid growth continues
COPAXONE® maintaining share in the U.S.
North American generic revenues stabilizing
Partner Celltrion and Teva announced FDA approval of TRUXIMA® (rituximab-abbs), a
biosimilar to RITUXAN® and HERZUMA® (trastuzumab-pkrb), a biosimilar to HERCEPTIN®
Reduction of net debt continues: $27.6 billion (Q3’18)
Was kann ich den Highlights der Teva Präsentation entnehmen? Dort werden exakt die Dinge hervorgehoben, die ich in #1531 angesprochen habe. Der Fokus liegt auf Wachstum, Schuldenabbau und Kosteneinsparungen. Der Markt für Generika stabilisiert sich in den USA. Hier stimmt die Richtung ;-)
amorphis : Zur Strategie und ein paar wichtige Aussagen:
"Now a little bit about the strategic principles, how are we going to take Teva forward. The first thing is the key element of how to make the company more efficient, more competitive."
"The next thing is organic growth. And again, here you could say organic growth, that's not really how Teva was built, and that's not maybe the best solution for everybody. But given the circumstances we have in Teva, that is for sure the only solution because, since we have a huge debt, there's no way we can do anything else but organic growth. .... And then you can say, okay yeah, but where can you grow organically? Well, we can actually grow organically in many different areas, and I'll get back to it a little later in the presentation, but we have many franchises, many business areas where we in the pipeline have strong development projects for organic growth."
"Now, long term, I believe we have three very strong growth drivers. Every single pharma market worldwide is going more generic. Japan is going more generic. China is going more generic. U.S. is going more generic. So anybody who can compete effectively in generics has a good sustainable business for many years. Biosimilars are increasing as a natural consequence of biologics having increased over the last 25 years. Biosimilars will also be increasing."
"Now all of this is of no interest to the shareholders unless it turns into value. And how do we make sure it turns into value? We do it by these three very simple mechanisms. A clear target for operating margin; we're not there right now but we'll get there in the coming years. A clear target for cash flow and cash-to-earnings because we need to pay down the debt, and a clear target for reduction of the debt getting down below three times EBITDA for the net debt. And then of course, a commitment to creating value for the current shareholders by not doing any new equity, but simply working on a long-term plan to reduce debt and thereby increase value for the currentshareholders."
"So this year, we'll be focusing on AJOVY, AUSTEDO, continuing to do nice on those. We'll be focusing on the stabilization of the U.S. generics sales. We'll be having some challenges as we've shared with everybody on COPAXONE and we might see generic competition on ProAir, on bendamustine. We'll hit the target for the restructuring. We'll do the consolidation moving from 60 to now around 70 further below 70 manufacturing sites worldwide. And then of course, we'll be committed to pay down debt and continue to do that going forward."
Siehe Q&A Transcript:
"Then there's a positive, which is, of course, the constant growth of the newly launched products, such as AUSTEDO, which is doing very well, growing very steadily, as we've also been sharing with you. It's – potentially once we see real revenue coming in from AJOVY. AJOVY is off to a real good start."
" And I would say the new thing compared to like a quarter ago, after the third quarter, I'm more confident now that we're seeing this stabilization of U.S. generics and that we also continue to see a
stable European outlook for generics. That's pretty clear to me. "
"Chris Schott Analyst, JPMorgan Securities LLC
Maybe one more for me and I'll open up. Just on AJOVY, you shared some comments of launch going well, but just a little bit more color of just 30% share, is that what you would expect at this point and what are you seeing in terms of the shake out of the three players as the market's starting to evolve here?
Kåre Schultz President, Chief Executive Officer & Director, Teva Pharmaceutical Industries Ltd
Yeah. So, first of all, we should remind ourselves that it's a fantastic new therapy, where we have three
competitors which have all shown actually quite comparable, very good clinical results. So, you have three products that are basically good products in the marketplace. Now, how will this pan out when you have three professional companies competing with really good drugs for a segment with a huge unmet need? Most likely it's going to be huge in volume because you have three big players with a good drug promoting it in a professional way, then you should expect to see big volumes. And I think that's what we're seeing. We're seeing bigger volumes than what we were predicting.
Then in terms of the relative share, some would say, well, let's just use a generic order of entry model, or let's look at details on what margin parameters do one have versus another. I think we have a few parameters on ours. We have a simple way. We don't have two doses to get to the max. It's just once monthly dosing. We have the offer of quarterly dosing. And we have less constipation than one of the competitors. So, we have some hooks. I was estimating that we would get between 20% and 30% from overall assessment. Right now we're seeing we're having 30% of NBRx and the TRx is, of course, climbing slowly towards that. So, it's probably half of that right now, the TRx. And I don't see in the marketplace, and what I hear anecdotally, any enormous differentiation apart from these smaller things I just touched on. And I will be saying that I think 30% seems to me like a fair and good share, which we should be able to keep on a sustainable basis."
"Chris Schott Analyst, JPMorgan Securities LLC
So, the $3 billion cost reduction numbers for 2019, just as you gotten further along in the process, can you talk about is there opportunities to beat a number like that, whether it's 2019 or over time, or just how do we think about where we are in that process, and what you've learned as you've gone through kind of the consolidated facilities, et cetera?
Kåre Schultz President, Chief Executive Officer & Director, Teva Pharmaceutical Industries Ltd.
Yeah, I can give the first overall ends and then I'm sure Mike can give some more color, too. So, the overall plan is for two-year restructuring where we want to hit $3 billion. And I've made the plan out of the total cost pool because I think it's always frustrating when people say, we want to do this cost saving and then they have 10 explanations afterwards why they didn't do it because of currencies and this change and this change. So, I thought, okay, why don't we take the absolute number? And we say, we're just going to reduce by $3 billion then there's not so much discussion about whether we did it or not. So that's what we are driving for. And we are completely on plan or slightly ahead of plan, so I have no doubt that we'll hit that.
Then as you move into the coming years, you could say, it's maybe not so much about the absolute number, it's more about the margin because, of course, if we do well and we grow revenue then, of course, some part of the cost picture will also grow. So, the absolute number might be growing. So really what you should look at there is the 27% operating margin target we have, which is better than where we are right now and which we are fully committed to reaching that target."
"The guidance for 2019, of course, will come in February.But very clear that we want to use all of our capital allocation to pay down debt until we reach that less than 3 times longer-term target that Kåre presented in the presentation. After that, then we'll start looking at things. I think he also mentioned in his presentation that if we do have small targeted investments we can do to license projects and look at minor product things, we'll do that but nothing on a large scale until we get the leverage under control.
So, in generics, you could say our strategy is really to be the market leader. So, we go for all big products no matter whether they are simple chemicals or complex proteins or devices whatever. So, there, we basically go for everything of significant value. Where there's a link to the CNS and respiratory and neurology is more in the biopharmaceutical and biosimilar field where you need some credibility in order to penetrate in the market. So, that's where you should see the therapeutic focus, so to speak. And in our R&D pipeline, we have more than 20 biologics projects which we don't talk about because we really don't want to talk about them before they're quite late stage. But, of course, they are focused on the therapeutic categories where we know what we're talking about. So, we've done a big trimming of the pipeline and got rid of everything which we don't see as being core to what we know about it."
shuntifumi : Teva
Körnig : Mein letzter Kauf liegt im Plus:) Die ganze Posi
KalleZ : Zahlen