Humira: Will AbbVie's Patents Keep Out Biosimilars For Its TNF-Blocker Blockbuster?
Markman Advisors • 21 Comments
Markman Advisors • 21 Comments
Amgen: Equity Report And Stock Valuation
Jan. 28, 2014, 4:46 PM
- Amgen (AMGN) reported its Q4 earnings rose 30% Y/Y on broad sales growth, but FY 2014 forecasts of $7.90-$8.20 EPS and $19.2B-$19.6B in revenues are at the low end of analyst estimates.
- Sales rose across the board for AMGN's product lines, with double-digit quarterly increases for all but a handful of its drugs; AMGN also says it was helped by lower tax rates.
- Among AMGN's largest franchises, global sales of Neulasta/Neupogen rose 10% Y/Y and sales of arthritis drug Enbrel gained 3%.
- Separately, AMGN announces positive top-line results from the Phase 3 LAPLACE-2 trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol.
- Shares -0.8% AH.
Jan. 28, 2014, 4:06 PM
- Amgen Inc. (AMGN): Q4 EPS of $1.82 beats by $0.14.
- Revenue of $5.01B (+13.3% Y/Y) beats by $200M.
Jan. 28, 2014, 12:10 AM
Jan. 27, 2014, 5:35 PM
Jan. 23, 2014, 9:40 AM
- Amgen's (AMGN -1.8%) Evolocumab treatment met its main goal of cutting "bad" or LDL cholesterol in the GAUSS-2 Phase III trial of patients with who cannot tolerate statins.
- "The positive GAUSS-2 results suggest that Evolocumab may offer a new lipid-lowering treatment to meet an important medical need for high-risk patients who cannot tolerate effective doses of statins," Amgen says.
Jan. 22, 2014, 6:45 PM
- Better late than never, Cowen analysts seem to say as they recommend their top biotech names even after four straight years of sector outperformance against the S&P 500.
- Amgen (AMGN) is one of the big-cap biotechs Cowen thinks will handily beat this year’s earnings estimates.
- Biogen (BIIB) remains the top name in class, and the firm thinks the stock is not overvalued at 20x 2015 earnings; Cowen also believes BIIB can beat this year’s earnings expectations.
- Nektar Therapeutics (NKTR) is a top name to buy due to its impressive clinical pipeline and list of big pharma partners; despite having eight late-stage candidates, NKTR’s market cap is just $1.3B.
- Also named: ACOR, BMRN, CELG, CMRX, DVAX, IMGN, PTLA, VVUS.
Jan. 22, 2014, 2:51 PM
- Good things could be ahead for Amgen (AMGN +3.8%), RBC analyst Michael Yee writes, believing the company has been laying the groundwork for growth through pipeline renewal, the effects of which should become evident in mid-2014.
- In the near term, the firm says shares could be range-bound as investors await the ASPIRE interim analysis in mid-2014; removal of this overhang should allow AMGN to embark on a ‘new product story” supported by Phase III PCSK-9 data and eventual approval; Phase III readout for AMG-416 (hyperparathyroidism) and Brodalumab (psorasis) and Phase II proof-of-concept data in migraine prevention (AMG-334); and Phase III anti-sclerostin data in 2015.
- AMGN has climbed 48% during the past 12 months, a fine showing but lagging Biogen’s 116% rise, Gilead Sciences' 111% gain, and even the SPDR S&P Biotech ETF’s 67% advance.
Jan. 16, 2014, 8:39 AM
- Illumina (ILMN) +4.8% premarket after reaching an agreement with Amgen (AMGN) to develop an oncology companion diagnostic test.
- The companies will develop and commercialize a multigene, NGS-based test as a companion diagnostic for Vectibix (panitumumab) in the treatment of metastatic colorectal cancer approved in the U.S. and EU.
- The test will be developed for use with ILMN's MiSeqDx instrument, which has received premarket clearance from the FDA and CE-marked for the European Union.
Jan. 15, 2014, 10:05 AM
- Amgen (AMGN) is partnering with Massachusetts General Hospital and the Broad Institute to develop treatments for inflammatory bowel disease (IBD), a chronic disorder that affects millions worldwide.
- "IBD treatment options are limited," says Amgen VP of R&D Sean Harper. "We believe this collaboration...will help identify improved treatment options for these patients." (PR)
Jan. 13, 2014, 2:03 PM
- Cytokinetics (CYTK -7.9%) is lower on the day after giving an update on the development of omecamtiv mecarbil.
- CYTK says that it and partner Amgen (AMGN) have "agreed to amend the protocol to evaluate a dose titration strategy in the expansion phase of COSMIC-HF [and up] the size of the expansion phase ... with the objective to provide greater statistical power for the planned evaluation of several pharmacodynamic parameters during oral dosing." (PR)
- Here's The Street's Adam Feuerstein, commenting: "Sounds like data release will be pushed back."
Jan. 8, 2014, 10:46 AM
- Nomura's Ian Somaiya (formerly at Piper) is out with a number of healthcare initiations.
- Gilead (GILD +1.7%) is the firm's top biotech pick for 2014 as the company is "set to dominate the HCV market." GILD started at Buy. Price target is $118.
- Neurocrine Biosciences (NBIX -3.2%) started at Buy. Somaiya sees peak sales of $700M for NBI-98854. Price target is $23.
- Celgene (CELG +1.2%) started at Buy. "Revlimid for multiple myeloma, is less than a third of the way to realizing its peak sales potential," Somaiya says. Price target is $236.
- Biogen (BIIB +4.1%) initiated at Buy. Tecfidera, is "a blockbuster ... treatment for MS, with estimated peak sales of $9B," Somaiya notes. Price target is $368.
- Alexion (ALXN +1.5%) initiated at Buy. Price target $150.
- Pharmacyclics (PCYC +1.9%) will "transform the treatment paradigm and disease course of CLL and mantle cell lymphoma MCL." Shares started at Buy. Price target is $137.
- Other initiations: Incyte (INCY +5.9%) started at Buy. Synageva BioPharma (GEVA +3.7%) started at Buy. BioMarin (BMRN +1.2%), Amgen (AMGN), and Infinity Pharmaceuticals (INFI +2.8%) started at Neutral.
Jan. 2, 2014, 7:23 AM
- Amgen (AMGN +0.4%) says its Romosozumab drug for treating osteoporosis in postmenopausal women, which the company is developing with Belgium's UCB, significantly increased bone mineral density when compared with other treatments in a Phase II trial.
- The improvements occurred in the the lumbar spine, hip and neck bones. (PR)
Dec. 17, 2013, 2:46 PM
- Amgen's (AMGN -1%) evolocumab meets its primary endpoints in MENDEL-2 (Phase 3 PCSK9 inhibitor for elevated LDL-C).
- Outcome: The company says mean reductions in LDL-C (week 12) compared to placebo "were consistent with results observed in the MENDEL Phase 2 study."
- In the Phase 2 study, evolocumab "as a monotherapy showed robust reductions in serum LDL-C." More specifically, the "mean decrease in LDL-C from baseline for evolocumab dosed Q2W was 41% in the 70mg group, 44% in the 105mg group, and 51% in the 140mg group" (4% decrease for placebo), while the mean decrease for evolocumab "dosed Q4W was 39% in the 280mg group, 43% in the 350mg group, and 48% in the 420mg group" (5% increase in placebo). For more on the Phase 2 study, see here.
- Details of the AMGN study "will be submitted to a future medical conference and for publication," the company says. (PR)
Dec. 13, 2013, 5:07 PM
- Amgen Inc. (AMGN) declares $0.61/share quarterly dividend,29.8% increase from the prior dividend of $0.47
- Forward yield 2.18%
- Payable March 7; for shareholders of record Feb. 13; ex-div Feb. 11.
Nov. 29, 2013, 11:27 AM
- Goldman is out with an update on IMS data for some of Amgen's (AMGN) key drugs.
- "Sales are tracking slightly ahead of our estimates," analyst Terence Flynn says, adding that "Kyprolis, Epogen and Prolia are particularly strong, while Enbrel and Neulasta are tracking in-line and Aranesp is slightly below."
- Flynn sees Q4 Kyprolis sales coming in at $76M versus consensus of $71M.
- AMGN reiterated at Buy.
- Price target is $130.
Nov. 27, 2013, 10:54 AM
- New guidance from the AHA on how doctors should go about facilitating a reduction in their patients' risk of heart attack and stroke "marks the biggest shift in cardiovascular-disease prevention in 30 years," Johanna Bennett writes.
- In short, the new guidelines could dramatically increase the number of patients eligible for statin therapy.
- This is potentially big news for AstraZeneca (AZN +0.6%) as it's "the only drug maker that still has patent protection on a statin." Crestor is protected until 2016.
- Count Amgen (AMGN -0.3%) and Regeneron (REGN -1.8%) among those who may suffer from the new regime. The FDA has indicated that the companies can gain approval for their PCSK-9 inhibitors without proving they prevent heart attacks and although this means faster approval, it could also limit their uptake among physicians, according to some commentators.
- Also affected by the news: Merck (MRK +0.2%) (think Zetia, Vytorin).
Amgen, Inc. is a biotechnology medicines company, which discovers, develops, manufactures and markets medicines for grievous illnesses. The company focuses on human therapeutics and concentrates on innovating novel medicines based on advances in cellular and molecular biology. It markets... More
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