Madam – I must say, that I find it extraordinary that you would consider me so unintelligent and/or inexperienced to not understand Financials and/or even think of reading the relevant sections/notes ect of the SEC Filings lodged by TEVA (including the Annual reports) over the years.
Whether HC posters are interested in understanding how US Statutory Reports are prepared in compliance with the relevant GAAP policies and/or disclosure requirements that need to be made (particularly post Sarbenes-Oxley Act), is a matter for the respective poster to determine.
Regarding TEVA , the following is an extract of Ladenberg Thalmanns analyst report (following detailed review of R&D pipeline by TEVA)
“Ladenberg thalmann analyst update (12 Dec 2014)
Mesoblast Ltd. TEVA R&D Disclosures Remove Overhang; 1Q15 Catalyst in Diabetic Nephropathy
On 12/11/14, Mesoblast's partner for development of MPCs for cardiovascular disease, Teva Pharmaceuticals (TEVA, $56.91, Not Rated), held an analyst meeting to provide an outlook for 2015, including an overview of R&D priorities. We believe the presentation significantly de-risks development of Mesoblast's cardiovascular franchise and removes a potential overhang from Mesoblast shares. Teva's meeting was the first opportunity to update investors on R&D priorities since announcing in October that 14 programs would be eliminated and projected R&D spending would be cut by $150M in 2015 and $200M in 2016. Additionally, in the restructuring announcement Teva highlighted women's health, respiratory disease, CNS and certain other opportunistic programs as the primary areas for future investment. Some investors were concerned Teva might curtail spending on Mesoblast's Phase III heart failure program and Phase II acute myocardial infarction (AMI) program as part of this broader restructuring, in our view. As such, we were pleased to see Teva specifically highlight Mesoblast's chronic heart failure program as 1 of 7 Phase III programs to receive continued funding (only program outside of respiratory disease and CNS) and AMI as 1 of 8 Phase II programs to receive funding (1 of only 2 outside of respiratory disease and CNS). We believe the disclosures should put to rest lingering concern among some investors regarding Teva's commitment to continued funding of the Mesoblast partnership. Separately, we expect significant near-term news flow from multiple programs to provide potential catalysts for Mesoblast shares including release of top-line results from a Phase II study in diabetic nephropathy in 1Q15. Lastly, the company’s Japanese MSC partner, JCR Pharmaceuticals, filed for regulatory approval in Japan for GvHD in October. JCR anticipates a potential launch in 2015. Reiterate Buy rating and US $52.00 PT.
What’s New? Teva provided its outlook for 2015, including a review of R&D priorities. This was the first disclosure of R&D priorities since Teva announced plans to stop development of 14 programs and trim projected 2015 R&D spending by $150M. Both Mesoblast's Phase III program for chronic heart failure and Phase II program for AMI were highlighted as areas for continued investment. We believe this disclosure removes a potential overhang from Mesoblast shares”
End of Extract.
Ladenberg are not the only credible analysts to recently confirm TEVA’s active and firm support of Revascor.
On 12 Feb 2015, during the Q & A session, this is what our CEO had to say about the Heart Trials ( in response to a question from Kevin DeGeeter – Ladenberg Thalmann):
..“More information will be provided on the conduct of the trials , patient population of the trials and expected outcomes over the next couple of months , well in advance of the interim results themselves. What you are getting a sense of is that we are very comfortable in the Trial Design, the Target Patient population, where we see the cells having an optimal therapeutic benefit and the dose that has been chosen and the patient enrichment criteria. We will update the market significantly over the next couple of months on the overall programmatic design”..
For HC posters information, based on my understanding , the 1st cohort of P3 patients are expected to be completed in July 15 with 6 months results there after ( say Feb 16)
Maxim Group ( in their 12/2/15 research note) positively commented on the trial been enriched for inclusion of high NT-proBNP levels and heart failure-related hospitalizations in the past 9 months.
So whilst Cardiac is not a core business of TEVA + given that Teva in 2014 commenced a significant cost reduction program – these circumstances make it even more astonishing as to why (?) they are retaining REVASCOR.
Well from my perspective and view , it’s not that difficult to understand.
With Copaxone ($4bn Sales blockbuster ) coming of patent protection and subject to competition, TEVA has a number of Pipeline applications which it aims to progress and help offset any loss of the Copaxone franchise.
By 2019, TEVA are aiming to replenish any income reduction due to generic competition against Copaxone.
Eddison Research (in an analyst note dated 27 May 2014 ) have estimated peak TEVA Sales for REVASOR as follows:
CEP-41750 in CHF $4.062bn (US) - currently in P3
CEP- 41750 in AMI $1.073bn (US) - currently in P2
Based on my research, REVASCOR (subject to commercialization) can on a stand-alone basis supplement the anticipated Copaxone Sales losses . It was by no chance that EvaluatePharma valued REVASOR as number 11 in the Top 20 Most Valuable R&D Projects (Ranked by Net Present Value) for CL2014. REVASCOR was assigned a “todays NPV value of $4.332bn”
Madam – you are entitled to your view but do not assume that we are inferior to any research techniques or inquiries made in relation to MSB
In my opinion only, MSB has multiple shots on goal and fully understanding that risks remain - I do not share your clamorous exchange on MSB .. but in fact my study , research and inquiries tell me the opposite.
GLTAH - 2015
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