SEC Filings

MEDTRONIC PLC filed this Form 10-Q on 12/04/2017
Entire Document

Continued growth from Neurosurgery StealthStation and O-Arm Imaging Systems, Midas and ENT power systems.
Continued successful placement of robotic units and associated market adoption of robot-assisted spine procedures, under an exclusive worldwide distributor agreement with Mazor Robotics.
Continued market acceptance of our new integrated solutions through the Surgical Synergy strategy, which integrates our spinal implants with enabling technologies such as imaging, navigation, power instruments, nerve monitoring and Mazor robotics.
Continued success of our "Speed-to-Scale" program launches, which involves faster innovation cycles and launching a steady cadence of new products at scale with sets immediately available for the entire market.
Market acceptance and continued global adoption of innovative new Spine products, such as our CD Horizon Solera Voyager system, our ELEVATE expandable interbody cages, and our OLIF25 and OLIF51 procedural solutions.
Growth in the broader vertebral compression fracture (VCF) and adjacent markets, as we continue to pursue the development of other therapies to treat more patients with VCF, including continued success of both the Kyphon V vertebroplasty system and the Osteocool RF Spinal Tumor ablation system.
Acceptance of Kanghui's broad portfolio of trauma, spine, and large-joint reconstruction products focused on the growing global value segment.
Continued acceptance and adoption rates of stimulators and leads approved to treat chronic pain in major markets around the world. Our Intellis spinal cord stimulator recently received U.S. FDA approval and CE Mark.
Ongoing obligations under the U.S. FDA consent decree entered in April 2015 relating to the SynchroMed drug infusion system and the Neuromodulation quality system. The U.S. FDA recently lifted its distributor requirements on our implantable drug pump in October and its warning letter in November 2017.
Continued and future acceptance of our current indications for Medtronic DBS Therapy for the treatment of movement disorders and epilepsy (approved in Europe). We anticipate continued competitive pressures in Europe and the U.S.
Continued acceptance and growth of our Specialty Therapies, including InterStim therapy for the treatment of the symptoms of overactive bladder, urinary retention, and bowel incontinence, and Transformative Solutions products and strategies to focus on its four core markets of orthopedic, spine, breast surgery, and Cardiac Rhythm Disease Management device replacements.
Diabetes Group
The Diabetes Group's products include insulin pumps, continuous glucose monitoring (CGM) systems, insulin pump consumables, and therapy management software. The Diabetes Group’s net sales for the three and six months ended October 27, 2017 were $462 million and $911 million, respectively, and were flat compared to the corresponding periods in the prior fiscal year. The Diabetes Group's net sales were flat for the three and six months ended October 27, 2017, primarily as a result of a decline in sales in the U.S. due to ongoing sensor supply constraints, offset by growth in international markets due to strong sales in Europe and Asia Pacific of the MiniMed 640G system. In the U.S., we continue to experience strong consumer demand and acceptance of our revolutionary 670G hybrid closed loop system.
Looking ahead, we expect our Diabetes Group could be affected by the following:
Competitive and pricing pressure, reimbursement challenges, impacts from changes in the mix of our product offerings, the timing of product registration approvals, and fluctuations in currency exchange rates.
Continued sensor supply constraints, along with higher than expected demand, will impact net sales as we prioritize fulfillment against our installed base of patients first. We continue to ramp manufacturing and expect new and expanded sensor manufacturing lines to be ready for commercial production by the fourth quarter of fiscal year 2018, at which time we expect to have the unconstrained capacity needed to meet the rapidly growing sensor demand.
Future growth associated with the transition of Animas insulin pump customers to our insulin pump technology.