Merit Medical Reports Results for Fourth Quarter and Year Ended December 31, 2015

SOUTH JORDAN, Utah, Feb. 22, 2016 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced fourth quarter revenues of $138.4 million ($141.0 million in constant currency), an increase of 4.2% over reported revenues and 6.2% on a comparable, constant currency basis over $132.8 million for the quarter ended December 31, 2014.  Fourth quarter non-GAAP earnings were $10.8 million, or $0.24 per share, down 4.4% compared to $11.3 million, or $0.26 per share, for the quarter ended December 31, 2014.  As reported, net income for the quarter ended December 31, 2015 was $6.4 million or $0.14 per diluted share. 

Revenues for the year ended December 31, 2015 were a record $542.1 million ($553.4 million in constant currency), an increase of 6.4% over reported revenues and 8.6% on a comparable, constant currency basis over $509.7 million for the year ended December 31, 2014.  Merit's non-GAAP net income and diluted earnings per share for the year ended December 31, 2015 were a record $38.5 million, or $0.87 per share, an increase of 14.1% and 11.5%, respectively, compared to $33.8 million, or $0.78 per share, for the year ended December 31, 2014.  GAAP net income for the year ended December 31, 2015 was $23.8 million, or $0.53 per diluted share, an increase of 3.6% and 0.0%, respectively, compared to $23.0 million or $0.53 per diluted share for the year ended December 31, 2014.

Revenues from Merit's core business grew 3.5% and 5.9% for the quarter and year ended December 31, 2015, respectively, compared to the corresponding periods of 2014.

For the quarter ended December 31, 2015, compared to the quarter ended December 31, 2014, Endotek sales increased 24%; stand-alone device sales rose 11%; catheter sales were up 6%; inflation device sales increased 2%; Malvern sales fell 1%; custom kit and tray sales declined 2%; and BioSphere sales decreased 4%.

For the year ended December 31, 2015, compared to the year ended December 31, 2014, Endotek sales were up 18%; catheter sales increased 11%; stand-alone device sales were up 8%; custom kit and tray sales increased 5%; BioSphere sales grew 3%; Malvern sales rose 3%; and inflation device sales rose 1%.

RECENT DEVELOPMENTS
Merit recently announced the receipt of regulatory approvals for four new products:

Merit's Centros® Dialysis Catheter has received CE Marking.  The device has been available in the United States since 2014 and can now be marketed in European territories.

Merit also received CE Marking for HepaSphere™ Microspheres with irinotecan indication, which is expected to complement the doxorubicin indication.

In the United States, Merit received FDA approval for the Elation® Wireguided Balloon Dilation Catheter with biliary indication, which is expected to complement the company's esophageal indication.

Additionally, Merit’s Prelude SNAP™ Splittable Hydrophilic Sheath gained approval from the FDA and is expected to complement Merit’s existing uncoated sheath.

Management believes these four new approvals will considerably strengthen Merit’s product portfolio and that upon successful launch of these products, Merit will be able to achieve greater market penetration, which, in turn, is expected to drive top-line growth.  Merit also boasts an encouraging product pipeline, which includes a safety centesis catheter, the PAL™ Planner and the 40 atm. BasixTouch™ Inflation Device.
           
"We are pleased we accomplished our forecasted top-line and non-GAAP results for the year," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer.  “Not every aspect of our plan was on point, but we believe the important parameters were met and will propel us into year two of our three-year plan.  Despite a slow second half of 2015, we hit our revenue expectation at the midpoint.  We believe that transitioning to direct sales from distributors in Canada and Australia; the momentum of product introductions in the second half of 2015 such as our Elation™ balloon line, the Prelude SNAP™ splittable sheath, the AEROmini® tracheobronchial stent, and our global distribution agreement for the SwiftNINJA® steerable microcatheter; and new product introductions early this year, will accelerate our growth in 2016.  We also believe that our introduction of the HeRO® Graft and the opportunities in vascular surgery will contribute to growth as well.”

MERIT NAMES NEW CHIEF LEGAL OFFICER
Management today announced that it has named Brian G. Lloyd Merit’s new Chief Legal Officer effective April 1, 2016.  Lloyd has been a member of the business transactions group at Parr Brown Gee & Loveless for more than 20 years.  His experience includes advising public and private companies, as well as investors, on corporate governance, securities regulation, mergers, acquisitions, and financing transactions, including public offering, private equity and venture capital transactions. He has represented a number of Utah’s leading publicly held companies, including Merit, counseling clients on financing transactions, corporate governance issues and regulatory matters. Lloyd has been recognized as one of the top corporate/mergers and acquisitions lawyers in Utah in the 2003-2015 editions of Chambers USA –America’s Leading Business Lawyers and has been honored by Best Lawyers in America from 2007-2016, including recognition in Utah as “Lawyer of the Year” in Corporate Compliance in 2015.  He earned a B.A. from Brigham Young University and a J.D. from Columbia University.

2016 GUIDANCE
Based upon information currently available to Merit's management, Merit estimates that for the year ending December 31, 2016, absent non-recurring transactions, Merit's revenues will be in the range of $587-$597 million, an increase of approximately 8-10%, compared to revenues of $542.1 million for the year ended December 31, 2015.  Also, based on information currently available to Merit's management, Merit estimates that, absent non-recurring transactions, Merit's GAAP earnings per share for 2016 will be in the range of $0.74-$0.80 and non-GAAP earnings per share will be in the range of $0.97-$1.03.

CONFERENCE CALL TODAY
Merit invites all interested parties to participate in its fourth quarter and year-end conference call (conference ID 42311430) today, February 22, 2016, at 5:00 p.m. Eastern (4:00 p.m. Central, 3:00 p.m. Mountain, and 2:00 p.m. Pacific).  The telephone numbers to call are (domestic) 877-313-5341; and (international) 253-336-8671.  A live webcast will also be available at merit.com.

ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 200 individuals.  Merit employs approximately 3,850 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; and Melbourne, Australia.

 

Statements contained in this release which are not purely historical, including, without limitation, statements regarding our future performance, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in our Annual Report on Form 10-K for the year ended December 31, 2014. Such risks and uncertainties include risks relating to our potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions; costs and expenses associated with our pursuit of a strategic plan to grow through acquisitions; product recalls and product liability claims; potential restrictions on our liquidity or our ability to operate our business by our current credit agreement, and the consequences of any default under that agreement; possible infringement of our technology or the assertion that our technology infringes the rights of other parties; the potential imposition of fines, penalties, or other adverse consequences if our employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; expenditures relating to research, development, testing and regulatory approval or clearance of our products and the risk that such products may not be developed successfully or approved for commercial use; greater governmental scrutiny and regulation of the medical device industry; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or our failure to comply with, governing regulations; availability and pricing of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination, modification or interruption of our relationships with our suppliers, or failure of such suppliers to perform; fluctuations in Euro and GBP exchange rates; our need to generate sufficient cash flow to fund our debt obligations, capital expenditures, and ongoing operations; concentration of our revenues among a few products and procedures; development of new products and technology that could render our existing products obsolete; market acceptance of new products; volatility in the market price of our common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; failures to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; and other factors referred to in our Annual Report on Form 10-K for the year ended December 31, 2014, and other materials filed with the Securities and Exchange Commission.  All subsequent forward-looking statements attributable to our company or persons acting on our behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and we assume no obligation to update or disclose revisions to those estimates.

This press release has been trimmed, see the original version here