OREANDA-NEWS. Boston Scientific Corporation (NYSE: BSX) generated sales of $1.964 billion during the first quarter ended March 31, 2016, compared to the company's guidance range for the quarter of $1.890 to $1.940 billion. This represents 13 percent operational revenue growth (calculated on a constant currency basis) and an increase of 11 percent on a reported basis, all compared to the prior year period. The company achieved adjusted earnings per share of $0.28 for the period, compared to $0.21 a year ago, and reported GAAP earnings of $202 million, or $0.15 per share, compared to earnings of $(0.00) a year ago.

"Four of our seven businesses achieved double-digit organic revenue growth this quarter, as the high performance of our global team has accelerated our growth profile as a company," said Mike Mahoney, president and chief executive officer, Boston Scientific. "This strong start enables us to raise our outlook for the year. We continue to execute on our product launches, expand into faster growth markets and deliver solutions that address unmet clinical needs."

First quarter financial results and recent developments:

  • Reported first quarter sales of $1.964 billion, representing an increase of 11 percent on a reported basis and 13 percent operational revenue growth, all compared to the prior year period.
  • Grew organic revenue 8 percent in the first 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 the American Medical Systems (AMS) male urology portfolio.
  • Delivered adjusted earnings per share of $0.28 compared to the company's guidance range of $0.23 to $0.25 per share, and reported GAAP earnings of $0.15 per share compared to the company's guidance range of $0.11 to $0.13 per share.
  • Achieved first quarter operational revenue growth of 28 percent in MedSurg (11 percent organic), 14 percent in Cardiovascular and a decline of 2 percent in Rhythm Management, all over the prior year period.
  • Delivered strong operational revenue growth across all three major regions: 14 percent growth (7 percent organic) in the U.S., 11 percent growth (6 percent organic) in Europe and 15 percent growth (14 percent organic) in AMEA (Asia, Middle East and Africa), all over the prior year period. Achieved 23 percent operational revenue growth (21 percent organic) in Emerging Markets.
  • Received a national coverage decision from the Centers for Medicare and Medicaid Services that is consistent with the U.S. Food and Drug Administration (FDA) label and will cover the WATCHMAN™ Left Atrial Appendage Closure Device as a non-pharmacological treatment option for stroke risk reduction in patients with non-valvular atrial fibrillation.
  • Received approvals for several products deemed safe for use in a magnetic resonance imaging (MRI) environment when conditions of use are met, including FDA approval for the ImageReady™ MR-Conditional Pacing System, CE Mark for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System and MR-conditional labeling for all previously implanted EMBLEM S-ICD Systems. The ImageReady System includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers and the new INGEVITY™ MRI pacing leads. The company also initiated a global trial called ENABLE MRI to evaluate the safety of currently approved implanted cardiac defibrillation (ICD) and cardiac resynchronization therapy (CRT) systems for patients in an MRI environment.
  • Received FDA approval for the ACUITY™ X4 Quadripolar Left Ventricular Leads. The addition of the quadripolar leads to the Rhythm Management portfolio enables the company to now offer a full X4 CRT system, consisting of both the device and the leads, to the U.S. market.
  • Launched the AXIOS™ Stent and Electrocautery Enhanced Delivery System to help physicians manage two serious complications from pancreatitis (pancreatic pseudosysts and certain types of walled-off pancreatic necrosis) using a minimally invasive, endoscopic approach.
  • Received CE Mark for, and began European commercialization of, the Eluvia™ Drug-Eluting Vascular Stent System,* the first polymer-based drug-eluting stent designed to treat peripheral lesions above the knee. Initiated the IMPERIAL trial to support regulatory approvals of the Eluvia System in the U.S. and Asia.
  • Received FDA approval for the Blazer™ Open-Irrigated Radiofrequency Ablation Catheter, designed for use in ablation procedures to restore a normal heart rhythm for patients with Type I atrial flutter, marking the first time that the company will offer an open-irrigated catheter to the U.S. market. The company also received CE Mark for the IntellaTip MiFi™ Open-Irrigated Catheter** for use in all cardiac ablation procedures.
  • Presented compelling data at the American College of Cardiology's 65th annual Scientific Sessions across the company's Cardiovascular and Rhythm Management franchises, including the WATCHMAN Device, the SYNERGY™ Bioabsorbable Polymer Drug-Eluting Stent System, the Lotus™ Transcatheter Aortic Valve Replacement (TAVR) System* and the communications capabilities between the company's leadless pacemaker*** and the EMBLEM S-ICD System.

* In the U.S., the Eluvia Stent System and Lotus Valve System are investigational devices limited under U.S. federal law to investigational use only and not available for sale.

** In the U.S., the IntellaTip Mifi Open Irrigated Catheter is not available for use or sale.

*** The leadless pacemaker is a concept device or technology. Not available for use or sale.

Net sales for the first quarter:

         

Change

  
   

Three Months Ended
March 31,

  

As
Reported
Basis

  

Less: Impact of
Foreign Currency

  

Constant
Currency
Basis

  

in millions

2016

2015

        
                             
 

   Interventional Cardiology

$

548

  

$

495

    

11

  

%

  

$

(19)

  

(2)

  

%

  

13

  

%

  
 

   Peripheral Interventions

242

  

217

    

12

  

%

  

(7)

  

(2)

  

%

  

14

  

%

  
 

Cardiovascular

790

  

712

    

11

  

%

  

(26)

  

(3)

  

%

  

14

  

%

  
 

   Cardiac Rhythm Management

433

  

456

    

(5)

  

%

  

(11)

  

(2)

  

%

  

(3)

  

%

  
 

   Electrophysiology

59

  

58

    

3

  

%

  

(2)

  

(2)

  

%

  

5

  

%

  
 

Rhythm Management

492

  

514

    

(4)

  

%

  

(13)

  

(2)

  

%

  

(2)

  

%

  
 

   Endoscopy

333

  

305

    

9

  

%

  

(9)

  

(2)

  

%

  

11

  

%

  
 

   Urology and Pelvic Health

228

  

123

    

85

  

%

  

(8)

  

(2)

  

%

  

87

  

%

*
 

   Neuromodulation

121

  

114

    

6

  

%

  

(2)

  

(2)

  

%

  

8

  

%

  
 

MedSurg

682

  

542

    

26

  

%

  

(19)

  

(2)

  

%

  

28

  

%

  
                             

Net Sales

$

1,964

  

$

1,768

    

11

  

%

  

$

(58)

  

(2)

  

%

  

13

  

%

  
                             

*Excluding the sales of acquired AMS male urology portfolio products, organic Urology and Pelvic Health grew 12%
                             

Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.
   

Sales growth rates that exclude the impact of changes in foreign currency exchange rates and/or the impact of recent acquisitions with significant sales are not prepared in accordance with U.S. GAAP. An explanation of the company's use of these non-GAAP financial measures is included in the exhibits attached to this news release.

On a consolidated GAAP basis, net income for the first quarter of 2016 was $202 million, or $0.15 per share. These results included acquisition- and divestiture-, litigation-, and restructuring and restructuring- related net charges and amortization expense, of $176 million (after-tax) or $0.13 per share. Adjusted net income for the first quarter of 2016, excluding these net charges, was $378 million, or $0.28 per share.

On a consolidated GAAP basis, net loss for the first quarter of 2015 was $1 million, or $(0.00) per share. These results included acquisition- and divestiture-, litigation-, and restructuring and restructuring-related net charges, pension termination charges and amortization expense, of $287 million (after-tax) or $0.21 per share. Adjusted net income for the first quarter of 2015, excluding these net charges, was $286 million, or $0.21 per share.

Guidance for Full Year and Second Quarter 2016

The company now estimates revenue for the full year 2016 to be in a range of $8.075 to $8.225 billion (compared to prior guidance of $7.900 to $8.100 billion), which versus the prior year period represents growth of approximately 8 to 10 percent on a reported basis, growth of approximately 9 to 11 percent on an operational basis and growth of approximately 6 to 8 percent on an organic basis. The company now estimates income on a GAAP basis in a range of $0.64 to $0.69 per share (compared to prior guidance of $0.62 to $0.67 per share), and now estimates adjusted earnings, excluding acquisition- and divestiture-, litigation-, and restructuring and restructuring-related net charges, and amortization expense, in a range of $1.06 to $1.10 per share (compared to $1.03 to $1.07 per share).

The company estimates sales for the second quarter of 2016 to be in a range of $2.010 to $2.060 billion, which versus the prior year period represents growth of approximately 9 to 12 percent on a reported basis, growth of approximately 11 to 13 percent on an operational basis and growth of approximately 6 percent to 8 percent on an organic basis. The company estimates earnings on a GAAP basis in a range of $0.14 to $0.17 per share. Adjusted earnings, excluding acquisition- and divestiture- and restructuring and restructuring-related net charges and amortization expense, are estimated in a range of $0.25 to $0.27 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 more than 35 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.