SAN JOSE, Calif., July 24, 2014 /PRNewswire/ -- Align Technology, Inc. (Nasdaq: ALGN) today reported financial results for the second quarter ended June 30, 2014.

Total revenues for the second quarter of 2014 (Q2'14) were a record $192.5 million, a 17.5% increase year-over-year. Clear aligner case shipments in Q2'14 were 119.3 thousand, a 12.4% increase year-over-year. Net profit for Q2'14 was $35.6 million, or $0.43 per diluted share, an increase of 21.4% year-over-year from $29.3 million, or $0.36 per diluted share for Q2'13.

"Our second quarter results were good and we're pleased to get the important summer Teen season off to a solid start," said Thomas M. Prescott, Align president and CEO.  "Record revenues, which increased 17.5% year-over-year, were driven by increased Invisalign volume across North America, EMEA and the Asia Pacific regions, as well as higher Invisalign ASPs. We also had a record quarter for scanner and services revenues with unit volume up over 50% year-over-year."

As of June 30, 2014, Align had $502.7 million in cash, cash equivalents and short-term and long-term marketable securities compared to $472.0 million as of December 31, 2013. During Q2'14, we paid $70 million under an accelerated stock repurchase plan ("ASR") in which we received an initial delivery of approximately 997,000 shares of its common stock. The final number of shares repurchased will be determined at completion of the ASR based on Align's volume-weighted average stock price during the term of the ASR, less an agreed upon discount. The ASR is expected to be completed by July 29, 2014.  There remains approximately $230 million available for repurchases under the existing stock repurchase authorization, of which $30 million is expected to be used for repurchases over the next nine months.

We also announced today the appointment of Simon Beard as vice president and managing director of Europe, Middle East and Africa (EMEA) effective November 3, 2014 reporting directly to Raphael Pascaud, vice president, international. Mr. Beard assumes the position vacated by Mr. Pascaud in January, 2014.  He is currently regional director for Smith & Nephew's South East Asia business.  Mr. Beard has an extensive background in the medical industry where he has held multiple commercial, strategic, and general management positions in companies such as DePuy, Johnson & Johnson, Sankyo and Sanofi Aventis.

In addition, we announced further expansion in the EMEA region with 14 additional European countries moving from distributor coverage to our direct sales organization beginning in Q3 14.  These new countries include; Faroe Islands, Albania, Kosovo, Poland, Czech Republic, Slovakia, Hungary, Slovenia, Croatia, Bosnia & Herzegovina, Serbia, Romania, Bulgaria, and Macedonia. As with the Q1'14 integration of 11 countries, we do not expect a material impact from these countries for some time. In the near term we will leverage our existing infrastructure in adjacent country markets as we build local sales organizations to drive long-term market penetration.

Q3 Fiscal 2014 Business Outlook

For the third quarter of 2014 (Q3'14), Align provides the following guidance:

• Clear aligner case shipments in a range of 118.1 thousand to 120.5 thousand.
• Net revenues in a range of $186.3 million to $190.2 million, which reflects a year-over-year increase of 13.2% to 15.6%.
• EPS in a range of $0.41 to $0.44.

Align Web Cast and Conference Call

Align Technology will host a conference call today, July 24, 2014 at 4:30 p.m. ET, 1:30 p.m. PT, to review its second quarter 2014 results, discuss future operating trends and the business outlook. The conference call will also be web cast live via the Internet.  To access the web cast, go to the "Events & Presentations" section under Company Information on Align's Investor Relations web site at http://investor.aligntech.com.  To access the conference call, please dial 201-689-8261 approximately fifteen minutes prior to the start of the call. An archived audio web cast will be available beginning approximately one hour after the call's conclusion and will remain available for approximately 12 months. Additionally, a telephonic replay of the call can be accessed by dialing 877-660-6853 with conference number 13585899 followed by #. For international callers, please dial 201-612-7415 and use the same conference number referenced above. The telephonic replay will be available through 5:30 p.m. ET on July 31, 2014.

About Align Technology, Inc.

Align Technology is the leader in modern clear aligner orthodontics that designs, manufactures and markets the Invisalign system, which provides dental professionals with a range of treatment options for adults and teenagers. Align also offers the iTero 3D digital scanning system and services for orthodontic and restorative dentistry. Align was founded in March 1997 and received FDA clearance to market Invisalign in 1998. Visit www.aligntech.com for more information.

For additional information about Invisalign or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about iTero, please visit www.itero.com.

About Non-GAAP Financial Measures

While there are no non-GAAP adjustments to the three months ended June 30, 2014 we may use from time to time the following non-GAAP financial measures to supplement our consolidated financial statements: non-GAAP net profit and non-GAAP earnings per share, which exclude, as applicable, impairment of goodwill, impairment of long-lived assets, and any related income tax adjustments. The presentation of this financial information is not intended to be considered in isolation, or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP.

We use these non-GAAP financial measures for financial and operational decision making and as a means to evaluate period-to-period comparisons. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our "core operating performance." Management believes that "core operating performance" represents Align's performance in the ordinary, on-going and customary course of its operations. Accordingly, management excludes from "core operating performance" certain expenditures and other items that may not be indicative of our operating performance including discrete cash and non-cash charges that are infrequent, or one-time in nature. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting and analyzing future periods. These non-GAAP financial measures also facilitate management's internal evaluation of period-to-period comparisons. We believe these non-GAAP financial measures are useful to investors both because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making, and (2) they are provided to and used by our institutional investors and the analyst community to facilitate comparisons with prior and subsequent reporting periods. A reconciliation of the GAAP and non-GAAP financial measures for the six months ended June 30, 2013 and a more detailed explanation of each non-GAAP financial measure and its uses are provided in the footnotes to the table captioned "Reconciliation of GAAP to non-GAAP Key Financial Metrics" included at the end of this release.

Forward-Looking Statement

This news release, including the tables below, contains forward-looking statements, including statements regarding certain business metrics for the third quarter of 2014, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, case shipments, additional common stock repurchases and cash, cash equivalents and short-term and long-term investments.  Forward-looking statements contained in this news release and the tables below relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement. Factors that might cause such a difference include, but are not limited to, difficulties predicting customer and consumer purchasing behavior, the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers, the possibility that the development and release of new products does not proceed in accordance with the anticipated timeline, the possibility that the market for the sale of these new products may not develop as expected, the risks relating to Align's ability to sustain or increase profitability or revenue growth in future periods while controlling expenses, growth related risks, including capacity constraints and pressure on our internal systems and personnel, our ability to successfully achieve the anticipated benefits from the scanner and services business, continued customer demand for our existing and new products, changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages and consumer confidence, the timing of case submissions from our doctors within a quarter, acceptance of our products by consumers and dental professionals, foreign operational, political and other risks relating to Align's international manufacturing operations, Align's ability to protect its intellectual property rights, continued compliance with regulatory requirements, competition from existing and new competitors, Align's ability to develop and successfully introduce new products and product enhancements and the loss of key personnel. These and other risks are detailed from time to time in Align's periodic reports filed with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K for the fiscal year ended December 31, 2013, which was filed with the Securities and Exchange Commission on February 28, 2014.  Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Notes:

There were no Non-GAAP adjustments for the three months ended June 30, 2014 or 2013.

(1) Impairment of goodwill. These costs represent non-cash write-downs of our goodwill generally related to negative trends in market and economic conditions, termination of relationships with distributors, or the increase in competitive environment related to our Scanner and Services reporting unit. We remove the impact of these charges to our operating performance to assist in assessing our ability to generate cash from operations. We believe this may be useful information to users of our financial statements; therefore, we have excluded these charges for purposes of calculating these non-GAAP measures to facilitate an evaluation of our current operating performance, particularly in terms of liquidity.

(2) Impairment of long-lived assets. These costs represent non-cash write-downs of our long-lived assets generally related to the increase in competitive environment related to our Scanner and Services reporting unit. As a result of these conditions, we have assessed that our asset group within the reporting unit was not recoverable and, therefore, recorded an impairment charge. We remove the impact of these charges to our operating performance to assist in assessing our ability to generate cash from operations. We believe this may be useful information to users of our financial statements; therefore, we have excluded these charges for purposes of calculating these non-GAAP measures to facilitate an evaluation of our current operating performance, particularly in terms of liquidity.

(3) Income tax-related adjustments. Non-GAAP financial information for the quarter is adjusted for a tax rate equal to our annual estimated tax rate on non-GAAP income. This rate is based on our estimated annual GAAP income tax rate forecast, adjusted to account for discrete tax items and items excluded from GAAP income in calculating the non-GAAP financial measures presented above. Our estimated tax rate on non-GAAP income is determined annually and may be re-calculated during the year to take into account events or trends that we believe materially impact the estimated annual rate.

(4) Shares used in computing diluted Non-GAAP Net profit per share. As we had a net loss for the six months ended June 30, 2013 but have a net profit on a Non-GAAP basis, the shares used in computing diluted Non-GAAP Net profit per share has been adjusted from GAAP to include the dilutive effect of potential common stock.

SOURCE Align Technology, Inc.