Yesterday, 10:22 AM
- As expected, the European Commission approves privately-held Boehringer Ingelheim's single-pill Synjardy (empagliflozin/metformin hydrochloride) for glycemic control in adult type 2 diabetics. The product was developed under its alliance with Eli Lilly (LLY +0.3%).
- Diabetes-related tickers: (SNY -0.5%)(JNJ +0.1%)(OTCQB:ISLT)(OTCQB:BTHE)(VTAE -2.4%)(MRK +0.4%)(NVO -1.5%)(ABT +0.2%)(VKTX +1.4%)(HPTX)(OTCPK:TKPYY +0.3%)(ALR -0.4%)(MNKD -0.8%)(TNDM -1.6%)
- Previously: European Ad Comm recommends approval of combo pill for type 2 diabetes (March 30)
Thu, May 7, 5:30 PM
- In a setback for branded drug makers, the California Supreme Court rules that financial payments from makers of patented drugs to competitor firms to delay the commercialization of cheaper generic versions of their branded medicines, called pay-to-delay deals, illegally restrain trade and violate the Cartwright Act, the state's primary antitrust law.
- The court reversed a summary judgement to Bayer (OTCPK:BAYRY) and Barr, whose $398.1M deal blocked the launch of generic versions of the antibiotic Cipro (ciprofoxacin) for almost seven years. It found it was immaterial that the companies' agreement settled patent litigation since antitrust principles prohibit a patentee's purchase of a potential competitor's consent to stay out of the market, even when the patent is likely valid.
- The Court's rule also applies to collusive non-cash settlements. An excerpt from its opinion reads: "courts considering Cartwright Act claims should not let creative variations in the form of consideration result in the purchase of freedom from competition escaping detection."
- The U.S. Federal Trade Commission filed a lawsuit last year against AbbVie (NYSE:ABBV), Abbott Laboratories (NYSE:ABT) and Teva Pharmaceutical Industries (NYSE:TEVA) charging the firms with violating antitrust laws and harming consumers with their pay-to-delay transactions related to AndroGel testosterone replacement therapy.
Thu, May 7, 11:13 AM
- Spurred by the progress of a bill moving through Congress that will speed new drugs to market for conditions lacking cures, called The 21st Century Cures Act, the FDA has scheduled a public meeting this summer to address concerns by the drugs industry that regulatory restrictions on what they can say about the off-label use of their products violates their First Amendment right to free speech. Language in the bill is ratcheting up the pressure on the agency to relax its guidelines.
- Drug makers were emboldened on its prospects of changing the rules after an appeals court overturned the conviction of a pharmaceutical sales representative in 2012 who was convicted of promoting off-label uses of the narcolepsy drug Xyrem. The court ruling was based on First Amendment protection for truthful and non-misleading off-label speech.
- The American Medical Association supports the need for physicians to have access to accurate and unbiased information about off-label uses of drugs since it already accounts for as much as 20% of prescribing, with higher levels in oncology and pediatric rare diseases.
- Giving drug firms more leeway in this arena has its detractors, however. Rita Redberg, M.D., Professor of Medicine at the UC-San Francisco says, "At my own medical center we have banned pharmaceutical reps from coming because we don't think they are a good source of information. You don't ask the barber if you need a haircut."
- Pharma companies have a dubious history of breaking the rules governing off-label promotion. Over the past 10 years, 17 firms have paid more than $16B in settlements related to inappropriate off-label selling.
- Further complicating matters is the fact that up to 75% of published pre-clinical trial results cannot be reproduced in later studies.
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Related tickers: (MRK +0.4%)(LLY -0.1%)(PFE +0.3%)(BMY +0.7%)(GSK -4.1%)(OTCQX:RHHBY -1.1%)(SNY -0.6%)(OTCPK:BAYRY -0.5%)(NVS +0.1%)(AZN -0.3%)(JNJ +0.2%)(ABT -0.1%)(ABBV +0.1%)
Wed, Apr. 22, 3:33 PM
- According to Bloomberg, Omnicare (OCR +7.4%) is reportedly working with financial advisors seeking a buyer. Company representatives have declined to comment. Trading halted.
- Consensus Q1 view is EPS of $1.01 on revenues of $1.6B.
- The company is currently embroiled in a lawsuit filed by the U.S. Department of Justice over alleged kickbacks from Abbott Labs (ABT +2.4%) in exchange for purchasing the dementia drug Depakote.
- Previously: DOJ sues Omnicare over alleged dementia drug kickbacks (Dec. 22, 2014)
Wed, Apr. 22, 8:31 AM
- Abbott Laboratories (NYSE:ABT) Q1 results ($M): Total Revenues: 4,897 (-6.6%); Nutrition: 1,669 (+2.3%); Diagnostics: 1,093 (-2.1%); Est. Pharmaceuticals: 897 (-22.1%); Medical Devices: 1,226 (-6.6%).
- Net Income: 2,292 (+511.2%); GAAP EPS: 1.51 (+529.2%); Operating Earnings: 766 (+22.6%); Operating Earnings Yield: 15.6% (+31.2%).
- 2015 Guidance: GAAP EPS: $1.33 - 1.43 (unch); Non-GAAP EPS: $2.10 - 2.20 (unch).
Wed, Apr. 22, 7:50 AM| Comment!
Tue, Apr. 21, 5:30 PM
Wed, Apr. 1, 7:45 AM
- Abbott Laboratories (NYSE:ABT) prices its public offering of 35M shares of Mylan at $58.35 per share. Underwriters over-allotment is an additional 5.25M shares. The sale represents 31.8% (36.6% if the over-allotment is sold) of Abbott's 110M-share stake.
- Previously: Abbott to unload portion of Mylan stake (March 30)
Mon, Mar. 30, 1:23 PM
- Certain subsidiaries of Abbott Laboratories (ABT +0.7%) commence a public offering of 35M shares of Mylan (MYL -3.6%) N.V. It will also grant underwriters a option to purchase an additional 5.25M shares. Mylan will receive no proceeds from the sale.
- The divestiture represents 31.8% (36.6% of the over-allotment is sold) of Abbott's 110M-share stake.
Tue, Mar. 10, 12:02 PM
- Abbott Laboratories (ABT -1.3%) enters into underwriting agreements for the three tranches of a $2.5B debt offering.
- $750M aggregate principal amount 2.00% Senior Notes due March 15, 2020; $750M aggregate principal amount 2.55% Senior Notes due March 15, 2022 and $1B aggregate principal amount 2.95% Senior Notes due March 15, 2025.
- Net proceeds will be used for general corporate purposes.
Mon, Feb. 23, 11:04 AM
- The FDA's Orthopedic and Rehabilitation Devices Advisory Panel votes 5 -1 (2 abstain) that VertiFlex's Superion Interspinous Spacer System is safe and 4 -2 (2 abstain) that the risk-benefit profile is adequate.
- The FDA does not have to abide by the vote in its final decision, but it usually follows the committee's recommendation.
- Related tickers: (ABT -0.2%)(MDT +0.3%)(JNJ +0.2%)
- Previously: Ad Comm review approaches for Vertiflex spinal implant (Feb. 18)
Fri, Feb. 20, 10:42 AM
Thu, Feb. 19, 10:10 AM
- Facing ever-increasing pushback from payers over the high price of new treatments, some biotech firms are working on a new payment model that rewards them for the long-term performance of their drugs. Gene therapy developers, including BioMarin Pharmaceuticals (BMRN +0.4%) and Sangamo BioSciences (SGMO -0.1%), are leading the effort.
- The industry says that a one-time cure, even if priced greater than $1M, saves money over the long term but acknowledges that payers will balk at paying the cost upfront. The general consensus is that an upfront payment over $1M will be unacceptable.
- Under a pay-for-performance scheme, the annuity-like payments would cease if medical testing showed that the therapy was not working. Much work remains to be done, though, before this approach could be implemented. For example, legislation may be required to force insurers to pick up the tab for patients that switch coverage.
- Some proponents of the new scheme say that the payment streams could be securitized and sold to investors, like consumer debt.
- Gene therapies represent the highest priced treatments. Only one has cleared the regulatory hurdle to date, UniQure's (QURE +1.5%) Glybera, which costs 850K euros ($1M) in Germany. It will be sold for a one-time payment because it is too difficult to measure how well it works (this reasoning will undoubtedly pop up again).
- Previously: UniQure sets price record with Glybera (Nov. 26, 2014)
- Related tickers: (CELG +1.3%)(AMGN -0.2%)(BIIB +0.5%)(GILD +0.1%)(MRK -0.3%)(GSK -0.2%)(AZN +0.9%)(LLY +0.3%)(NVS +0.1%)(PFE -0.5%)(JNJ -0.3%)(OTCQX:RHHBY +1.4%)(BMY -0.4%)(ABT)(BAX -1.1%)
Wed, Feb. 18, 1:54 PM
- The FDA's Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meets Friday, February 20 to discuss the Premarket Approval Application (PMA) from privately-held San Clemente, CA-based VertiFlex for its Superion InterSpinous Spacer for the treatment of moderate lumbar stenosis (narrowing of the openings for the spinal cord and nerve roots).
- The device, CE marked in Europe since 2007, alleviates back pain via insertion in the lumbar area which decompresses the spine and relieves the pressure. Its value proposition is a one-piece expandable, reversible and motion preserving implant that is easily inserted via a small incision in the back under local anesthesia in the outpatient setting.
- Executive Summary, Panel Questions
- Related tickers: (NYSE:ABT) (NYSE:MDT) (NYSE:JNJ)
Thu, Jan. 29, 8:54 AM
- Abbott Laboratories (NYSE:ABT) Q4 results ($M): Total Revenues: 5,356 (-5.3%); U.S.: 1,548 (-2.6%); Intl: 3,808 (-6.3%); Nutrition: 1,804 (+6.0%); Diagnostics: 1,234 (+3.2%); Est. Pharmaceuticals: 922 (-28.4%); Medical Devices: 1,379 (-3.8%).
- COGS: 2,337 (-1.6%); R&D Expense: 361 (-0.6%); SG&A Expense: 1,666 (+6.7%); Net Income: 905 (+53.7%); EPS: 0.59 (+59.5%).
- Gross Profit: 3,019 (-8.0%); COGS: 43.6% (+3.9%); Gross Margin: 56.4% (-2.8%); Non-GAAP Operating Earnings: 992 (-26.9%); Operating Earnings Yield: 18.5% (-22.8%); Net Earnings Yield: 16.9% (+62.2%).
- 2015 Guidance: Non-GAAP EPS: $2.10 - 2.20; GAAP EPS: $1.33 - 1.43.
- Q1 Guidance: Non-GAAP EPS: $0.41 - 0.43; GAAP EPS: $0.18 - 0.20.
Thu, Jan. 29, 8:07 AM| Comment!
ABT vs. ETF Alternatives
Abbott Laboratories discovers, develops, manufactures and sells health care products. Its products include branded generic pharmaceuticals manufactured internationally, marketed and sold outside the United States.
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