Dec. 23, 2014, 2:23 PM
Dec. 8, 2014, 5:53 PM
- Former OtisMed Corp. (NYSE:SYK) CEO Charlie Chi admitted to intentionally distributing knee replacement surgery cutting guides after the company's application for marketing clearance had been rejected by the FDA. Mr. Chi and OtisMed entered their guilty pleas in Newark federal court.
- To settle the criminal charges, OtisMed was fined $34.4M plus $5.16M in criminal forfeiture. In a separate civil settlement, the company agreed to pay $40M plus interest.
- The cutting guides were used by surgeons during total knee arthroplasty or knee replacement surgery. OtisMed marketing the guide as a tool to help surgeons in making accurate bone cuts specific to the patient's anatomy based on magnetic resonance imaging performed prior to surgery. None of the claims regarding the OtisKnee device were evaluated by the FDA before the company included them in advertisements and promotional material.
- On each of three counts, Mr. Chi faces a maximum penalty of one year in prison and a $100K fine, or twice the gain or loss from the offense.
- Previously: Stryker settles with DOJ on OtisKnee promotion (Dec. 8, 2014)
Dec. 8, 2014, 3:08 PM
- Stryker Corp. (SYK) enters into a settlement with the U.S. Department of Justice in connection with the DOJ's civil and criminal investigations into the sales and marketing of the OtisKnee device prior to Stryker's acquisition of OtisMed in November 2009. The companies have agreed to pay the government $79,560,400 plus interest.
- The DOJ acknowledged that OtisMed's criminal conduct occurred prior to Stryker's transaction and without Styker's knowledge or acquiescence.
- The DOJ's allegations pertained to the promotion of a medical device that was not approved by the FDA.
Nov. 24, 2014, 5:19 PM
- Stryker (NYSE:SYK) is considering making a bid for medical device manufacturer Smith & Nephew (NYSE:SNN) as a standstill period that prevents it from making an offer nears its end, according to reports out earlier.
- SYK is examining structuring the deal as a tax inversion, allowing it to move its legal address to the lower-tax U.K., but SYK is said to see strong strategic reasons to pursue a combination aside from tax advantages, and an inversion would not be essential to make the deal work.
- J.P. Morgan analysts think an acquisition could be at least 7%-8% accretive to SYK's 2016 EPS, rising to 11% in 2017 and 13% in 2018, assuming a 30%-35% premium relative to the unaffected price and that the acquisition is not an inversion; however, the firm thinks SNN is not looking to sell, and a combination would not gain easy U.S. or EU anti-trust approval.
- SNN gained 4.3% and SYK rose 1.4% in today's trading.
Nov. 4, 2014, 4:10 AM
- Stryker (NYSE:SYK) has settled a lawsuit over thousands of hip implants it recalled in 2012 after patients complained of adverse reactions, including pain and swelling.
- Stryker will pay a base amount of $300K per case to patients who had the devices surgically removed, resulting in more than $1B in costs to resolve the 4,000 suits.
- The orthopedics company does not expect the settlement to hurt its profit.
Oct. 16, 2014, 4:35 PM
Oct. 16, 2014, 4:15 PM
- Stryker (SYK -0.4%) Q3 results ($M): Total Revenues: 2,389 (+11.1%); Gross Profit: 1,567 (+6.7%); Operating Expenses: 1,063 (-16.4%); Operating Income: 450 (+300.0%); Net Income: 57 (-44.7%); EPS: 0.16 (-40.7%); Quick Assets: 4,677 (+17.5%); CF Ops: 535 (-14.0%).
- Revenue by geography: U.S.: 1,628 (+12.4%); International: 761 (+8.4%).
- Revenue by business: Reconstructive: 1,016 (+8.5%); MedSurg: 936 (+16.3%); Neurotech and Spine: 437 (+6.7%).
- 2014 Guidance: Organic sales growth: 5 - 6% (unch); non-GAAP EPS: at the low end of $4.75 - 4.80.
Oct. 16, 2014, 10:52 AM
Oct. 15, 2014, 5:35 PM
Sep. 23, 2014, 7:45 AM
- U.S. Treasury Secretary Jack Lew says that the Obama Administration is prepared to institute rules to stop tax inversion deals. If so, it will do so without a sliver of Republican support. Barclays analyst Michael Leuchten says, "Washington is playing for time. It makes them look good and it allows Congress to maybe get its act together and maybe do something on the legislative side."
- Mr. Lew's comments have spooked the market a bit. European companies already involved in deals or rumored to be targets are all under pressure due to the perception that some of the deals already announced may be at risk.
- The U.S. firm in the best position is Horizon Pharma (NASDAQ:HZNP). It completed its tax inversion transaction with Ireland-based Vidara Therapeutics last week.
- Related tickers: (MDT -0.4%)(COV -0.5%)(ABBV -0.6%)(SHPG -0.7%)(OTCQB:SHPGF -1.5%)(PFE -0.7%)(AZN -0.1%)(SNN +0.1%)(SYK -0.8%)
Jul. 21, 2014, 7:15 AM
- Bloomberg reports that, according to analysts, there are three ex-U.S. medical firms that should be high on the target acquisition list for tax inversion deals. Ireland-based Perrigo (NYSE:PRGO), Switzerland-based Actelion and U.K.-based Smith & Nephew Plc (NYSE:SNN) (OTCQB:SNNUF) are all attractive targets. Observers believe there will be more acquisitions consummated before Congress puts limits on the maneuvers.
- Stryker (NYSE:SYK) has been mentioned as a potential suitor for Smith& Nephew. Pfizer (NYSE:PFE) may make another run at AstraZeneca (NYSE:AZN) after the end of the cool-off period.
Jul. 17, 2014, 4:28 PM
- Stryker (SYK -0.7%) Q2 results: Net Sales: $2,363M (+6.8%); COGS: $808M (+10.7%); R&D Expense: $158M (+19.7%); SG&A Expense: $1,038M (+2.3%); Operating Income: $307M (+5.9%): Net Income: $215M (+0.9%); EPS: $0.56 (unch); Quick Assets: $4,745M (+19.2%); CF Ops: $366M (+2.8%).
- 2014 Guidance: Organic sales growth: 5.0 - 6.0%; adjusted diluted EPS: $4.75 - 4.80.
Jul. 17, 2014, 4:27 PM
Jul. 16, 2014, 5:35 PM
Jul. 7, 2014, 3:53 PM
- Mariel Therapeutics enters into a definitive agreement with Stryker (SYK -0.1%) to acquire its Bone Morphogenetic Protein-7 (BMP-7) assets for the potential treatment of osteoarthritis, chronic kidney disease and other organ fibrosis conditions, lupus and obesity. Under the terms of the agreement, Mariel secures the rights to over 450 issued and pending patents, Stryker's BMP-7-related clinical and research data and associated biologic materials. Stryker will have the right of first negotiation for commercial rights in osteoarthritis. Terms of the deal are not disclosed.
- Muriel plans to pursue a Phase 2b/3 clinical trial for osteoarthritis and a Phase 1 for chronic kidney disease and Alport's disease.
Jun. 30, 2014, 10:34 AM
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