Boston Scientific Corporation (NYSE: BSX) generated sales of $2.493 billion during the first quarter of 2019. This represents growth of 4.8 percent on a reported basis, 7.8 percent on an operational1 basis and 6.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $424 million or $0.30 per share (EPS), compared to GAAP earnings of $298 million or $0.21 per share a year ago, and achieved adjusted earnings per share of $0.35 for the period, compared to $0.33 a year ago.

"Our global team and differentiated portfolio enabled us to deliver good sales and earnings growth this quarter, despite some revenue softness compared to our estimates," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "With our strong pipeline and category leadership strategy, we are confident in our top tier 2019 outlook and how we can help improve outcomes for patients around the world for years to come."

First quarter financial results and recent developments:

• Reported first quarter sales of $2.493 billion, representing an increase of 4.8 percent on a reported basis, compared to the company's guidance range of 6 to 7 percent; 7.8 percent on an operational basis; and 6.3 percent on an organic basis, compared to the company's guidance range of 7 to 8 percent, all compared to the prior year period.

• Reported GAAP earnings of $0.30 per share compared to the company's guidance range of $0.32 to $0.33 per share. Achieved adjusted earnings per share of $0.35 compared to the guidance range of $0.35 to $0.36 per share.

• Achieved first quarter revenue growth in all segments, compared to the prior year period:
  • MedSurg: 7.7 percent reported, 10.4 percent operational and 6.7 percent organic
  • Rhythm and Neuro: 2.8 percent reported, 5.6 percent operational and organic
  • Cardiovascular: 4.2 percent reported, 7.8 percent operational and 6.8 percent organic

• Reported the following regional revenue changes, compared to the prior year period:
  • U.S.: 7.1 percent reported and operational
  • EMEA (Europe, Middle East and Africa): (0.3) percent reported and 7.9 percent operational
  • APAC (Asia-Pacific): 5.3 percent reported and 10.1 percent operational
  • Emerging Markets3: 13.3 percent reported and 22.0 percent operational

• Received U.S. Food and Drug Administration (FDA) approval for, and commenced controlled launch in Europe of, the LOTUS Edge™ Aortic Valve System, a minimally invasive transcatheter aortic valve replacement (TAVR) technology for patients with severe aortic stenosis who are considered at high risk for surgical valve replacement via open heart surgery.

• Announced results from the VIRTUS study demonstrating the VICI VENOUS STENT™ System exhibited a primary patency rate of 84% at 12 months and a 98.5% rate of freedom from major adverse events at 30 days, with both measures surpassing the predefined efficacy and safety performance goals in patients with ilieofemoral venous tract obstructions.

• Commenced enrollment of the global CLEAR-DVT study which will evaluate whether thrombectomy with the AngioJet™ ZelanteDVT™ Thrombectomy Catheter significantly reduces the two-year occurrence of post-thrombotic syndrome in patients with iliofemoral deep vein thrombosis.

• Announced results from the AF-FICIENT I study highlighting positive safety and efficacy data for the LUMINIZE™ Radiofrequency (RF) Balloon Catheter for isolation of pulmonary veins (PV) when treating patients with atrial fibrillation (AF).

• Received approval of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device from the Pharmaceuticals and Medical Devices Agency in Japan, and obtained CE Mark and initiated a limited market release for the next generation WATCHMAN FLX™ LAAC Device in Europe. Both devices are intended to reduce the risk of stroke in patients with non-valvular AF.

• Received insurance coverage from United Healthcare, the largest commercial insurer in the U.S., for the SpaceOAR™ Hydrogel, a therapy used to reduce common and debilitating side effects that men may experience after receiving prostate cancer radiotherapy.

• Commenced global commercial launch of the ORISE™ Submucosal Lifting Agent, designed for use in endoluminal surgery to lift polyps, adenomas, early-stage cancers and other gastrointestinal mucosal lesions prior to resection.

• Launched the Jagwire™ Revolution High Performance Guidewire, a low-profile guidewire offering enhanced steerability in the pancreaticobiliary system, enhancing the company's leadership in the biliary space.

• Commenced the full commercial launch of the Spectra WaveWriter™ Spinal Cord Stimulator (SCS) System in Europe.

• Completed a public offering of $4.3 billion aggregate principal amount of senior notes, a portion of which is intended to finance the proposed acquisition of BTG plc. In late February, BTG plc announced its requisite shareholder approval for the proposed acquisition, which is expected to close mid-year.

• Following an FDA device reclassification and subsequent order for manufacturers to stop U.S. sales, the company ceased global sales and distribution of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse. As a result, the company now anticipates an approximate $30 million negative impact globally to 2019 full year revenue, including an approximate $5 million sales return reserve recorded in the first quarter. In addition, the company recorded an approximate $18 million charge to net income in the first quarter. Adjusted net income was negatively impacted by $11 million in the first quarter of 2019.

• Announced plans to host and webcast investor events featuring presentations and question-and-answer sessions with members of senior management on the following dates:
  • May 9, 2019, 12:00 p.m. to 1:00 p.m. EDT, focused on the company's Cardiac Rhythm Management and Electrophysiology portfolio in connection with attendance at the 40th Annual Heart Rhythm Society Scientific Sessions in San Francisco;
  • May 20, 2019, 10:30 a.m. to 11:30 a.m. EDT, focused on the company's Endoscopy portfolio in connection with attendance at Digestive Disease Week 2019 in San Diego;
  • June 26, 2019, 7:30 a.m. to 1:00 p.m. EDT, Investor Day business review meeting in New York.

Guidance for Full Year and Second Quarter 2019

The company now estimates revenue growth for the full year 2019, versus the prior year period, to be in a range of approximately 7 to 8 percent on a reported basis (compared to prior guidance of 7 to 9 percent), and a growth range of approximately 7 to 8 percent on an organic basis (compared to prior guidance of 7 to 8.5 percent). Full year organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 110 basis points from the acquisitions of NxThera, Claret and Augmenix, each with no prior period related net sales. The company now estimates income on a GAAP basis in a range of $1.09 to $1.13 per share (compared to prior guidance of $1.13 to $1.18 per share) and estimates adjusted earnings, excluding certain charges (credits), in a range of $1.54 to $1.58 per share (compared to prior guidance of $1.53 to $1.58 per share).

The company estimates revenue growth for the second quarter of 2019, versus the prior year period, to be in a range of approximately 5 to 7 percent on a reported basis and a growth range of approximately 6 to 7 percent on an organic basis. Second quarter organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 140 basis points from the acquisitions of NxThera, Claret and Augmenix, each with no prior period related net sales. The company estimates earnings on a GAAP basis in a range of $0.23 to $0.25 per share and adjusted earnings, excluding certain charges (credits), in a range of $0.37 to $0.39 per share.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.