Teva Pharmaceutical: Bold Markets, Bold Moves
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Jenks Jumps • 22 Comments
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Wed, Mar. 2, 10:06 AM| Wed, Mar. 2, 10:06 AM | 2 Comments
- February monthly performance was: +1.02%
- 52-week performance vs. the S&P 500 is: -2%
- No dividends were paid in February
- Top 10 Holdings as of 12/31/2015: Teva Pharmaceutical Industries Ltd ADR (TEVA): 2.13%, Sky PLC (OTCQX:BSYBF): 1.98%, Gilead Sciences Inc (GILD): 1.8%, Apple Inc (AAPL): 1.78%, Newell Rubbermaid Inc (NWL): 1.54%, Amcor Ltd (OTC:AMCRF): 1.48%, CGI Group Inc Class A (GIB): 1.47%, Avago Technologies Ltd (AVGO): 1.46%, CK Hutchison Holdings Ltd (OTCPK:CKHUF): 1.43%, RELX PLC (OTC:RLXXF): 1.43%
Tue, Mar. 1, 10:38 AM
- Citing major deficiencies, the FDA's rejects Teva Pharmaceutical Industries' (TEVA +0.1%) marketing application for a generic version of Mylan's (MYL +1.7%) EpiPen (epinephrine injection) for the treatment of allergic reactions. The time required for Teva to address the deficiencies and a new review cycle could boost Mylan's 2017 EPS by 20 cents says Evercore ISI analyst Umer Raffat.
- Analysts were projecting an erosion of $200M in EpiPen sales for next year for Mylan's specialty division. EpiPen is the unit's top seller.
- Teva now expects to launch its generic version in 2017 at the earliest.
Fri, Feb. 26, 1:53 PM
- GlaxoSmithKline (GSK -0.9%) initiated with Hold rating and 1400p price target (-0.7% downside risk) by Cantor Fitzgerald.
- Shire plc (SHPG -0.6%) initiated with Buy rating by Cantor Fitzgerald.
- Insulet (PODD +8.7%) initiated with Sell rating and $15 (53% downside risk) price target by Empire Asset Management.
- MacroGenics (MGNX +2.2%) initiated with Equal Weight rating and $20 (29% upside) price target by Morgan Stanley.
- Biogen (BIIB +0.8%) initiated with Buy rating and $345 (30% upside) price target by Citigroup.
- Boston Scientific (BSX -0.3%) initiated with Buy rating and $21 (22% upside) price target by SunTrust Robinson Humphrey.
- Other initiations by Citigroup: Amgen (AMGN +1.1%) Neutral rating and $165 (11% upside) price target; Celgene (CELG +1.4%) Buy rating and $130 (25% upside) price target; Regeneron Pharmaceuticals (REGN) Buy rating and $480 (22% upside) price target; Alexion Pharmaceuticals (ALXN +0.1%) Neutral rating and $165 (18% upside) price target.
- IMS Health Holdings (IMS +0.2%) initiated with Outperform rating and $31 (19% upside) price target by Leerink Swann.
- Ocera Therapeutics (OCRX +5.7%) initiated with Buy rating and $10 (229% upside) price target by Brean Capital.
- Repligen (RGEN +3.8%) initiated with Buy rating and $36 (35% upside) price target by Craig-Hallum.
- Mesoblast (MESO -2.2%) initiated with Neutral rating and $5.50 (12% downside risk) price target by Chardan Capital.
- Ultragenyx Pharmaceutical (RARE +1.2%) initiated with Buy rating and $80 (29% upside) price target by Leerink Swann.
- Teva Pharmaceutical Industries (TEVA -0.2%) initiated with Outperform rating with $68-71 (21% upside from midpoint) price target by Wells Fargo.
- Medivation (MDVN +9.8%) initiated with Buy rating and $46 (28% upside) price target by Bank of America.
- Collegium Pharmaceutical (COLL -0.1%) initiated with Outperform rating and $35 (83% upside) price target by William Blair.
Fri, Feb. 19, 6:20 AM
- According to EU regulators, Teva Pharmaceutical (NYSE:TEVA) has offered concessions to allay antitrust concerns over its $40.5B bid for Allergan's (NYSE:AGN) generics unit.
- "Commitments have been submitted and the new legal deadline is set on 10 March," European Commission spokesman Ricardo Cardoso said in an email.
- Acquiring the Actavis generic business would strengthen Teva's position as the world's largest generics drugmaker.
Thu, Feb. 11, 7:57 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) Q4 results ($M): Total Revenues: 4,881 (-5.6%); Generic Medicines: 2,257 (-8.6%); Specialty Medicines: 2,114 (-5.8%); MS Specialty: 960 (-14.4%); Other Specialty: 1,154 (+2.9%).
- Key Product Sales: Copaxone: 960 (-14.4%); Treanda: 198 (-12.4%); ProAir: 148 (+23.3%).
- Net Income: 485 (-30.9%); EPS: 0.55 (-31.3%); Non-GAAP EPS: 1.28 (-3.8%); CF Ops: 1,615 (-7.8%).
- Q1 Guidance: Revenues: $4.7B - 4.9B; Non-GAAP EPS: $1.16 - 1.20; CF Ops: $1.2B - 1.3B. Full-year guidance will be released after the close of the Actavis Generics transaction.
- Shares are down 3% premarket on light volume.
Thu, Feb. 11, 7:10 AM
Wed, Feb. 10, 5:30 PM
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Wed, Feb. 10, 1:05 PM
- Teva Pharmaceutical Industries (TEVA +0.3%) will release Q4 and full-year 2015 results tomorrow before the open. Consensus views for the quarter and year are EPS of $1.29 on revenues of $4.8B and EPS of $5.44 on revenues of $19.6B, respectively.
Tue, Feb. 2, 10:15 AM
- Teva Pharmaceutical Industries (TEVA -1.4%) inks a collaborative research agreement with privately held Vancouver, BC-based AbCellera to discover rare monoclonal antibodies via its high-throughput single cell antibody platform.
- Under the terms of the partnership, AbCellera will receive an upfront payment, research funding and antibody development-related milestones. Specific financial terms are not disclosed.
Tue, Feb. 2, 8:49 AM
- Based on an independent third party analysis of the results from a failed Phase 2 clinical trial assessing Trimesta (oral estradiol) and Teva's (NYSE:TEVA) COPAXONE (glatiramer acetate injection) in women with relapsing-remitting multiple sclerosis (RRMS), Synthetic Biologics (NYSEMKT:SYN) decides to terminate its license and clinical trial agreements related to the drug.
- Analyses from two clinical research organizations confirmed that Trimesta failed to demonstrate a statistically valid treatment effect over and above COPAXONE.
- CEO Jeff Riley says, "We are disappointed with the outcome of the data analyses which did not demonstrate statistically significant treatment effects in this study. We intend to focus the Company's resources on its other programs, including our two Phase 2 gut microbiome programs which have both demonstrated top-line clinical results."
- Shares are down 17% premarket on increased volume.
Thu, Jan. 28, 12:35 PM
- Teva Pharmaceutical Industries (TEVA -2.9%) announces the commercial availability of BENDEKA (bendamustine hydrochloride), a liquid, low-volume (50 mL), short-time 10-minute infusion formulation of the chemo drug bendamustine.
- BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab (Roche's Rituxan) or a rituximab-containing regimen. Teva intends to replace TREANDA (bendamustine HCl) Injection, which is infused over 30 minutes for CLL and 60 minutes for NHL, with BENDEKA.
- Teva owns exclusive commercial rights to BENDEKA in the U.S. under a February 2015 license agreement with Eagle Pharmaceuticals (EGRX +11.2%). The FDA approved it last month.
- Previously: FDA clears Eagle's BENDEKA for CLL and NHL (Dec. 8, 2015)
Tue, Jan. 26, 9:42 AM
- Ness Ziona, Israel-based Mapi-Pharma (MAPI) is set for its IPO of 3.125M ordinary shares at $15 - 17.
- The clinical stage firm develops improved extended-release formulations of existing drugs which it refers to as product life cycle management or LCM. Its LCM products offer advantages over currently marketed versions such as improved patient compliance and reduced side effects while allowing for extended patent and regulatory exclusivity.
- Lead product candidates include a once-monthly injection formulation (glatiramer acetate depot) of Teva Pharmaceutical Industries' (TEVA -0.3%) COPAXONE (glatiramer acetate) which is dosed 3x/week; an extended-release formulation (pregabalin ER) of Pfizer's (PFE +0.1%) LYRICA (pregabalin)(dosed 2-3 times per day) and a once-monthly depot formulation of J&J's (JNJ +1.8%) RISPERDAL CONSTA (risperidone) which is administered once every two weeks.
- 2015 Financials (9 mo.)($M): Collaboration revenue: 0.6 (+999%); Operating Expenses: 4.5 (-16.6%); Net Loss: (6.3) (-120.0%); Cash Burn: (0.6) (+86.6%).
Tue, Jan. 12, 1:00 PM
- Based on discussions between development partner Teva Pharmaceutical Industries (TEVA +1.2%) and the FDA, the size of a Phase 3 clinical trial assessing Mesoblast Limited's (MESO -0.8%) cell therapy candidate, MPC-150-IM, in patients with chronic heart failure (CHF) will be cut from 1,165 to ~600. The reduction was enabled by a change in the primary endpoint brought about by positive follow-up data in a Phase 2 study that showed the successful prevention of recurrent heart failure-related major adverse cardiovascular events (HF-MACE) for three years from a single injection of MPC-150-IM.
- In the Phase 2, no MPC-150-IM-treated patients experienced HF-MACE over 36 months compared to 11 in the control group (p<0.001), In patients with advanced heart failure, 71% of the control arm experienced at least one HF-MACE versus zero for the MPC-150-IM cohort (p<0.001).
- The revised endpoint will be a comparison of recurrent HF-MACE in patients treated with MPC-150-IM and control.
- The size reduction will significantly shorten the time to completion. A second confirmatory study will be run in parallel using the same endpoint also in ~600 subjects.
- MPC-150-IM is an "off the shelf" cell therapy based on mesenchymal lineage adult stem cells.
Thu, Jan. 7, 4:24 PM
- In a regulatory filing, OncoGenex Pharmaceuticals (NASDAQ:OGXI) discloses that Ionis Pharmaceuticals (NASDAQ:IONS) has filed a lawsuit against its subsidiary OncoGenex Technologies seeking a portion of $23.2M it received from Teva Pharmaceutical Industries (NYSE:TEVA) for advance reimbursement of R&D expenses related to the termination of collaboration agreement.
- Ionis asserts that OncoGenex is in breach of a July 2008 license agreement that entitled it to a share of certain forms of non-royalty revenue received by OncoGenex. OncoGenex says Ionis is not entitled to a share of monies received for R&D reimbursement, however. Ionis seeks damages and a declaratory judgement.
- As expected, OncoGenex intends to vigorously defend itself in the matter.
Tue, Jan. 5, 11:31 AM
- Joining (TEVA -0.3%), Mylan (MYL +1.4%) launches its generic equivalent to Janssen's (JNJ +0.6%) contraceptive Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) Tablets in the U.S. The branded product generates ~$490M in annual sales.
- Previously: Teva launches generic Ortho Tri-Cyclen Lo in U.S. (Jan. 5)
Tue, Jan. 5, 9:37 AM
- Teva Pharmaceutical Industries (TEVA -0.9%) launches its generic equivalent of the oral contraceptive Ortho Tri-Cyclen Lo (norgestimate/ethinyl estradiol) tablets in the U.S. The company's offering will be sold under the brand name Tri-Lo-Sprintec (norgestimate and ethinyl estradiol tablets, USP).
- Ortho Tri-Cyclen Lo, marketed by Janssen Pharmaceuticals (JNJ +0.4%), generates ~$490M in annual sales in the U.S.
Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC). The Generic division involves the manufacture and sale of generic products such as tablets,... More
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