Wed, Jul. 20, 8:14 AM
- Abbott Laboratories (NYSE:ABT) Q2 results ($M): Total Revenues: 5,333 (+3.2%); Nutrition: 1,740 (+1.3%); Diagnostics: 1,226 (+4.2%); Est. Pharmaceuticals: 980 (+0.3%); Medical Devices: 1,372 (+6.4%).
- Top Performers: Point-of-Care (POC) Diagnostics International: 25 (+25.0%); Vascular U.S.: 346 (+16.1%); Diabetes Care International: 210 (+13.5%); Total POC: 129 (+13.2%); POC U.S.: 104 (+10.6%).
- Net Income: 615 (-21.6%); EPS: 0.41 (-21.2%); Non-GAAP EPS: 0.55 (+5.8%).
- 2016 Guidance: EPS: $1.26 - 1.36 from $1.36 - 1.46; Non-GAAP EPS: $2.14 - 2.24 (unch).
Wed, Jul. 20, 7:47 AM
Wed, Jul. 20, 7:24 AM
- Boston Scientific (NYSE:BSX) is poised to ink a settlement agreement with the IRS related to a disputed tax liability related to transfer pricing issues for Guidant for the years 2001 - 2006 and BSX's tax years 2006 and 2007. If the settlement is finalized, BSX will pay $275M plus accrued interest.
- The IRS asserted that the company owed $1.162B plus interest related to transfer pricing between domestic and foreign subsidiaries of Guidant. The IRS also proposed adjustments related to the financial terms of BSX's deal with Abbott Laboratories (NYSE:ABT) pertaining to the sale of Guidant's vascular intervention business to Abbott in April 2006 (details are on page 99 of BSX's 2015 10-K).
- Boston Scientific acquired Guidant for $27B in early 2006.
Tue, Jul. 19, 5:30 PM
Fri, Jul. 15, 3:39 PM
- The FDA approves Abbott Medical Optics' (ABT -0.4%) Tecnis Symfony Extended Range of Vision Intraocular Lens (IOL), the first IOL that provides cataract patients with an extended depth-of-focus, enhancing visual acuity over a range of distances. The FDA approval includes the Tecnis Symfony Toric IOL for patients with astigmatism (misshapen cornea).
- By age 80, over 50% of Americans have a cataract or have had cataract surgery. About 4M cataract surgeries are performed each year in the U.S. with ~25% being performed on people younger than 65. During the procedure, the natural lens of the eye is removed and the IOL is inserted. Typically, IOLs are monofocal (clear vision at a distance), but the Symfony enables clear near and intermediate vision as well.
Fri, Jul. 15, 12:25 PM
- In a statement, point-of-care diagnostics firm Alere (ALR +7.6%) confirms that will restate its annual financial statements for 2013, 2014 and 2015 and interim statements for the periods ended March 31, 2015 and September 30, 2015 after identifying the specific revenue recognition issues that have delayed the filing of its 2015 reports.
- The specific areas pertaining to the timing of revenue recognition were mainly confined to Africa, where revenue was recorded when product was shipped to the distributor but the title did not transfer until the distributor paid for the products in full or the distributor was not obligated to pay the bill until the products were sold to end users.
- Another problem was "bill and hold" transactions (an invoice is generated but the product remains in inventory), principally in China (any legitimate accounting firm will consider this a significant "no-no").
- There were other unspecified transactions where Alere recognized revenue prior to satisfying all the contractual criteria for the transfer of title and risk to the customer.
- The company says the revisions will not be material since they do not impact the total amount of recorded revenue other than the change brought about by establishing a returns allowance for its Indian subsidiary. It plans to file its 2015 financials as soon as feasible, followed by its Q1 2016 10-Q. It admits that it expects to report one or more material weaknesses in its disclosure controls and procedures and internal control over financial reporting.
- On a preliminary basis, revenue ($M) for 2015 and Q1 2016 will be $2,447 - 2477 and $573 - 593, respectively. Net income will be $10 - 25 and $(8) - 2, respectively, and non-GAAP EBITDA $505 - 520 and $106 - 116.
- Analysts expect the $5.8B takeover by Abbott Laboratories (ABT -0.4%) to proceed.
Wed, Jul. 13, 5:12 AM
- The FTC has requested additional information from Abbott Laboratories (NYSE:ABT) and St. Jude Medical (NYSE:STJ), which are attempting to complete a $25B deal combining two of the leading makers of heart-related devices.
- The request extends the waiting period - the time frame before companies can close a transaction - by 30 days.
Tue, Jul. 12, 8:01 AM
- Following a collaborative process with the FDA, point-of-care diagnostic firm Alere (NYSE:ALR) will be initiating a voluntary withdrawal of its Alere INRatio and INRatio2 PT/INR Monitoring System.
- In December 2014, the company initiated a voluntary correction to inform users of the device that patients with certain medical conditions should not be tested with the product due to the potential misreporting of results. Over the past two years, Alere updated the software to address the issue. At the end of 2015, the FDA notified the company that it did not agree that the problem was fixed and advised the company to submit a plan for the voluntary removal of INRatio from the market.
- Alere is working with the FDA to determine the most appropriate timing for product discontinuation and will provide guidance on transitioning patients to an alternate solution to allow them to continue anti-coagulation monitoring in the least disruptive manner possible.
- Related ticker: (NYSE:ABT)
Tue, Jul. 5, 11:43 AM
- The FDA approves Abbott Vascular's (ABT -0.3%) Absorb GT1 Bioresorbable Vascular Scaffold System, the first full absorbable stent cleared for sale in the U.S. to treat coronary artery disease.
- The GT1 releases everolimus [Novartis' (NVS -1.1%) Afinitor] which limits the growth of scar tissue. It is gradually absorbed by the body in about three years.
Fri, Jun. 24, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Mon, Jun. 13, 3:37 PM
- Results from a six-month study called IMPACT showed patients using Abbott Laboratories' (ABT -1.1%) continuous glucose monitor, FreeStyle Libre, reduced the time spent in hypoglycemia (low blood sugar) 38% compared to traditional systems that rely on self-monitoring of blood glucose (SMBG) via a finger-stick blood sample. The data were presented at the 76th Scientific Sessions at the American Diabetes Association meeting in New Orleans, LA.
- IMPACT's primary endpoint was the difference in number of hours per day in hypoglycemia (<70 mg/dL) between the FreeStyle Libre cohort and the SMBG cohort from days 194 - 208. 252 adults participated in the study across 23 sites in Europe.
- Key findings included a 38% reduction in time spent in hypoglycemia, a 40% reduction in time spent in nocturnal (11 pm - 6 am) hypoglycemia and a 50% reduction in serious hypoglycemia (<55 mg/dL). In addition, there was no increase in HbA1c at month 6.
- FreeStyle Libre consists of a small round sensor worn on the back of the upper arm for up to 14 days, measuring glucose in interstitial fluid every minute through a small filament (5 mm long, 0.4 mm wide) inserted under the skin and held in place with a small adhesive pad. A smartphone-sized reader is scanned over the sensor to obtain a glucose result almost simultaneously.
- The device was approved in Europe in September 2014. Its marketing application was submitted in the U.S. in August 2015. Approval is expected later this year.
Fri, Jun. 10, 11:10 AM
Mon, May 23, 12:39 PM
- "Politics is now a topic in every client discussion," say David Kostin and team, and the nature of today's electorate nearly assures a close race, even though prediction markets currently assign a high probability of a Clinton victory.
- When uncertainty rises, consumer staples (NYSEARCA:XLP) typically outperforms, while tech (NYSEARCA:XLK) lags.
- Getting down to names, with protectionism and tax policy two key areas of debate, buy those stocks with high U.S. sales and high effective tax rates, and avoid those with high foreign sales and low tax rates.
- High U.S. sales and high tax rates (buy): Cardinal Health (NYSE:CAH), Fidelity National (NYSE:FIS), Discover (NYSE:DFS), AmerisourceBergen (NYSE:ABC), Schwab (NYSE:SCHW), ADP (NASDAQ:ADP), Chipotle (NYSE:CMG), Reynolds America (NYSE:RAI), Express Scripts (NASDAQ:ESRX), Alliance Data (NYSE:ADS), Fiserv (NASDAQ:FISV), Paychex (NASDAQ:PAYX), Whole Foods (NASDAQ:WFM), Akamai (NASDAQ:AKAM), Intuit (NASDAQ:INTU), Southwest Airlines (NYSE:LUV).
- High foreign sales and low tax rates (avoid): Abbott Labs (NYSE:ABT), Agilent (NYSE:A), Mondelez (NASDAQ:MDLZ), XL Group (NYSE:XL), Waters (NYSE:WAT), Priceline (NASDAQ:PCLN), Transocean (NYSE:RIG), PerkinElmer (NYSE:PKI), Nvidia (NASDAQ:NVDA), Lam Research (NASDAQ:LRCX), Western Digital (NASDAQ:WDC).
Thu, May 12, 6:12 PM
- Epilepsy drug Depakote (divalproex sodium) continues to be an albatross for inventor Abbott Laboratories (NYSE:ABT). Originally approved by the FDA in 1978, it was once among the company's top sellers, pulling in $1.6B in sales in 2007 before going off patent.
- The company's promotional practices came under scrutiny when four whistleblower lawsuits were filed between 2007 and 2010 accusing the Abbott Park, IL firm of promoting off-label uses of the drug and paying kickbacks to prescribers to drive sales. In 2012, the company paid $1.6B to settle claims from the Feds and 24 states over its alleged illegal marketing of the product.
- Abbott's troubles with Depakote were far from over, though. Plaintiffs began filing personal injury lawsuits in August 2011, now totaling over 800, alleging the use of the drug during pregnancy caused birth defects, including spina bifida. The first suit to go to trial, Kaleta vs. Abbott Labs, was held in St. Louis. It ended with a $38M judgement against the company ($15M compensatory damages + $23M in punitive damages). In November 2015, however, Abbott prevailed in an Ohio case.
- Unsurprisingly, Abbott denies culpability and intends to vigorously defend itself in court. A new trial, slated to begin next month in the U.S. District Court for the Southern District of Illinois, will hear two cases at once. Judge Nancy Rosenstengel appears less than enthused about her crowded docket of pending Depakote cases, now totaling 13, saying she was "more than a little disappointed" over the impasse to settlement. Nevertheless, Abbott believes it will ultimately prevail, guaranteeing a lengthy process and healthy returns for lawyers.
Thu, Apr. 28, 9:16 AM| Thu, Apr. 28, 9:16 AM
Thu, Apr. 28, 6:56 AM
- Hot off the press: Abbott Labs (NYSE:ABT) acquires St. Jude Medical (NYSE:STJ) for $25B. Developing...
- Update: Under the terms of the deal, St. Jude shareholders will receive $46.75 in cash and 0.8708 of a share of Abbott common stock representing a total per-share value of $85. Abbott intends to fund the cash portion with medium- and long-term debt.
- The deal will be accretive to Abbott's non-GAAP EPS in the first year post close, adding $0.21 in 2017 and $0.29 in 2018. Anticipated pre-tax synergies should be $500M by 2020.
- The combined annual sales of the Abbott's cardiovascular business and St. Jude is ~$8.7B, with #1 or #2 market positions across almost every area in cardiovascular devices.
- Separately, Abbott plans to issue $3B of common stock in the secondary market to rebalance its capital structure. Timing has yet to be determined.
- Abbott will host a conference call this morning at 8:00 am ET to discuss the transaction.
- In premarket trading, ABT is down 5% and STJ is up 27%, both on robust volume.
Abbott Laboratories engages in the discovery, development, manufacture and sale of a broad and diversified line of health care products. The company operates through four reportable segments: Established Pharmaceutical Products, Diagnostic Products, Nutritional Products and Vascular Products.... More
Industry: Drug Manufacturers - Major
Country: United States
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