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MannKind Corporation (MNKD) declared recently the launch of a new Titration Pack containing 60 – 4 unit cartridges, 60 – 8 unit cartridges and 60 – 12 unit cartridges of Afrezza (insulin human) Inhalation Powder.

This new package is intended to simplify physician prescribing of Afrezza and allow patients greater dose flexibility in managing their diabetes, while potentially reducing the cost burden of multiple copays.

Michael Castagna, Chief Commercial Officer of MannKind Corporation, stated, “We are excited to see our new Titration Packs entering the supply chain this week.  This new titration box together with our new sample program will facilitate higher dose mealtime insulin patients to dose Afrezza appropriately and manage their disease in as few inhalations as possible.”

The new titration package compliments a similar Titration Pack with 90 – 4 unit and 90 – 8 unit cartridges that launched in July 2016  and now makes up almost 25% of weekly Afrezza units dispensed.

In Addition To, the Company is transitioning its sales force from a contract sales organization to an expanded team fully staffed by MannKind employees.  The new team is expected to be trained and in the field over the next two weeks. The expanded sales force will be able to reach about 75% of the total Rapid Acting Insulin Market. The Company is also changing its diabetes nurse educator model, going from a small dedicated team to a much larger nurse team operating on a per diem basis.  These efforts are expected to enhance the education and training of patients initiating Afrezza therapy, thereby increasing compliance and persistence.

“The new package, together with our new sales force expansion and nurse educator model, will facilitate us to make a stronger impact in how we market Afrezza without dramatically increasing our cost structure. In Addition To, our Commercial organization has several direct-to-consumer and digital media programs deploying in the next few months that will further expand our promotional efforts,” said Matthew Pfeffer, Chief Executive Officer.

Boston Scientific Corporation (BSX) generated sales of $2.191 billion during the fourth quarter ended December 31, 2016. This represents growth of 11 percent contrast to the prior year period on a stated and operational basis (calculated on constant currency basis). The company stated GAAP earnings of $124 million or $0.09 per share (EPS), contrast to a GAAP loss of $142 million or $(0.11) per share a year ago, and achieved adjusted earnings per share of $0.30 for the period, contrast to $0.26 a year ago.

For the year ended December 31, 2016, the company achieved full year sales of $8.386 billion, representing 12 percent revenue growth on a stated and operational basis. The company stated GAAP earnings of $0.25 per share, contrast to a GAAP loss of $(0.18) in the prior year period and delivered full year adjusted earnings per share of $1.11, contrast to $0.93 in 2015.

“Boston Scientific delivered excellent financial results in 2016, with accelerated revenue growth, improved profitability, and strong double digit adjusted EPS growth,” said Mike Mahoney, chairman and chief executive officer, Boston Scientific. “Our strategy of category leadership in key markets and diversification into high growth adjacencies is working, and enabling continued investment in innovative medical technologies. I want to thank our employees for their commitment to advancing science and improving the lives of patients around the world.”

Fourth quarter financial results and recent developments:

  • Achieved fourth quarter sales of $2.191 billion, contrast to the company’s guidance range of $2.140 to $2.190 billion, representing a boost of 11 percent on a stated and operational basis, all contrast to the prior year period.
  • Grew organic revenue 10 percent in the fourth quarter over the prior year period. Organic revenue growth excludes the impact of changes in foreign currency exchange rates and sales from the acquisition of EndoChoice Holdings, Inc. (EndoChoice).
  • Stated fourth quarter GAAP earnings of $0.09 per share contrast to the company’s guidance range of $0.15 to $0.17 per share, mainly because of litigation-related charges and delivered adjusted earnings per share of $0.30, contrast to the guidance range of $0.27 to $0.29 per share.
  • Achieved excellent fourth quarter revenue growth in all segments, all contrast to the prior year period:
    • Medsurg: 13 percent (12 percent operational and 11 percent organic)
    • Cardiovascular: 11 percent stated, operational and organic
    • Rhythm Administration: 7 percent stated, operational and organic
  • Medsurg: 13 percent (12 percent operational and 11 percent organic)
  • Cardiovascular: 11 percent stated, operational and organic
  • Rhythm Administration: 7 percent stated, operational and organic
  • Delivered revenue growth in all regions, all contrast to the prior year period:
    • U.S.: 11 percent stated, operational and organic
    • Europe: 3 percent (7 percent operational and organic)
    • AMEA (Asia-Pacific, Middle East and Africa): 17 percent (13 percent operational and organic)
    • Emerging Markets:* 9 percent (17 percent operational and organic)
  • U.S.: 11 percent stated, operational and organic
  • Europe: 3 percent (7 percent operational and organic)
  • AMEA (Asia-Pacific, Middle East and Africa): 17 percent (13 percent operational and organic)
  • Emerging Markets:* 9 percent (17 percent operational and organic)
  • Declared initial U.S. commercial performance results of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device collected during 3,822 successive LAAC procedures, demonstrating a nearly 96 percent implant success rate. The overall rate of complications evaluated within these data, presented at the Transcatheter Cardiovascular Therapeutics (TCT) Scientific Sessions, was 1.63%, and contrast favorably to the clinical trial data leading to device approval, validating the rigorous process for selecting and training new operators.
  • Declared positive results from the 900-patient MultiSENSE study evaluating the performance of the HeartLogic™ Heart Failure Diagnostic Service** to predict impending heart failure (HF) decompensation in a late-breaking clinical trial session at the American Heart Association Scientific Sessions 2016. The trial data demonstrated the HeartLogic alert could successfully notify clinicians of an associated HF event*** with a 34-day median alert window.
  • Closed the acquisition of EndoChoice, enabling Boston Scientific to offer its infection control products, pathology services and single-use devices to specialists treating a wide range of gastrointestinal (GI) conditions.
  • Closed the acquisition of certain manufacturing assets and capabilities of Neovasc, Inc. (Neovasc), which will be integrated into the Boston Scientific structural heart business, and attained a 15 percent equity stake in Neovasc, which is developing a novel mitral valve replacement device.
  • Expanded the portfolio of its Urology and Pelvic Health business with the acquisition of the Resectr™ Tissue Resection Device, a single-use solution designed to remove uterine polyps, and added the LumenR™ Tissue Retractor System, which is presently in development for use during endoscopic resection of lesions in the colon, esophagus or colon, to its Endoscopy business.
  • Launched the Dakota™ Nitinol Stone Retrieval Device with Opensure™ Handle, designed to allow physicians to release and capture kidney stones of multiple sizes.

 

 

 

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