Securities Exchange Act of 1934
| DE | 0-32259 | 94-3267295 | ||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification Number) |
| 2560 Orchard Parkway, San Jose, CA | 95131 | |
| (Address of principal executive offices) | (Zip Code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
|
|
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
This information shall not be deemed "filed" for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Align is making reference to non-GAAP financial information in both the press release and the conference call. A reconciliation of non-GAAP financial measures contained in the attached press release to the comparable GAAP financial measures is contained in the attached press release and a reconciliation of these and certain other non-GAAP financial information provided on the conference call (to the extent not reconciled on such call) is contained on the Investor Relations section of our website at investor.aligntech.com.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: April 28, 2016 |
Align Technology, Inc. By: /s/ Roger E. George Roger E. George Vice President, Legal and Corporate Affairs and General Counsel |
| Exhibit No. | Description | |
| 99.1 | Press Release of Align Technology, Inc. dated April 28, 2016 |
SAN JOSE, CA -- (Marketwired - April 28, 2016) - Align Technology, Inc. (NASDAQ: ALGN)
-- Q1 revenues were up 20.5% year-over-year to $238.7 million, and diluted
EPS of $0.50
-- Q1 Clear Aligner shipments were up 25.2% year-over-year to 163.7
thousand cases, international shipments up 34.1% year-over-year
-- Q1 Scanner and Services revenues were up 72.0% year-over-year to $19.0
million
Align Technology, Inc. (NASDAQ: ALGN) today reported financial results for the first quarter ended March 31, 2016. Clear Aligner case shipments in the first quarter of 2016 (Q1'16) were 163.7 thousand, a 25.2% increase year-over-year. For Q1'16, revenues were $238.7 million, a 20.5% increase year-over-year, and net profit was $40.5 million, or $0.50 per diluted share, up $0.06 over the prior year.
"Q1 was a solid start to 2016 with better than expected revenues and earnings, driven by continued strong year-over-year Invisalign volume growth across our customer base, with North American shipments up 21% and international shipments up 34%. Demand for our new iTero Element scanner remains strong driving a 72% year-over-year growth in scanner and services revenues," said Joe Hogan, Align Technology President and CEO.
GAAP Summary Financial Comparisons
First Quarter Fiscal 2016
----------------------------------------------------------------------------
Q/Q Y/Y
Q1'16 Q4'15 Q1'15 Change Change
----------------------------------------------------------------------------
Clear Aligner Shipments 163,695 160,400 130,780 +2.1% +25.2%
Net Revenues $ 238.7M $ 230.3M $ 198.1 +3.7% +20.5%
Clear Aligner $ 219.7M $ 214.0M $ 187.0 +2.6% +17.5%
Scanner & Services $ 19.0M $ 16.2M $ 11.1 +17.2% +72.0%
Net Profit $ 40.5M $ 48.9M $ 36.2 (17.0)% +12.1%
EPS $ 0.50 $ 0.60 $ 0.44 $ (0.10) +$0.06
----------------------------------------------------------------------------
Note: Changes and percentages are based on actual values and may effect totals due to rounding
As of March 31, 2016, Align had $680.8 million in cash, cash equivalents and marketable securities compared to $678.7 million as of December 31, 2015.
Additional Aligners at No Charge Effective July 18, 2015
Align implemented its new Additional Aligners policy on July 18, 2015 in which the Company no longer distinguishes between mid-course corrections and case refinements providing doctors the ability to order additional aligners to address either treatment need at no charge, subject to certain requirements. These changes were effective for all new Invisalign Full, Teen, and Assist treatments shipped worldwide after July 18, 2015, as well as any cases that were open as of this date. While this policy change was largely immaterial to the Company's cash flows, it did impact the timing at which the Company recognizes revenue. The Company estimates Q1'16 revenues and pre tax income were lower by approximately $7.5 million due to this change.
Q2 2016 Business Outlook
For the second quarter of 2016 (Q2'16), Align provides the following guidance:
-- Clear Aligner case shipments in the range of 174.5 thousand to 177.0
thousand, up approximately 20.7% to 22.4% over the same period a year
ago.
-- Net revenues in the range of $253.3 million to $258.3 million.
-- Diluted EPS in the range of $0.46 to $0.49.
Align Web Cast and Conference Call
Align will host a conference call today, April 28, 2016 at 4:30 p.m. ET, 1:30 p.m. PT, to review its first quarter 2016 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 13634117 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 May 12, 2016.
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 the Invisalign system in 1998. Visit www.aligntech.com for more information.
For additional information about the Invisalign system or to find an Invisalign provider in your area, please visit www.invisalign.com. For additional information about the iTero 3D digital scanning system, please visit www.itero.com.
Forward-Looking Statement
This news release, including the tables below, contains forward-looking statements, including statements regarding certain business metrics for the second quarter of 2016, including, but not limited to, anticipated net revenues, gross margin, operating expenses, operating profit, diluted earnings per share, and case shipments. 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 year ended December 31, 2015, which was filed with the Securities and Exchange Commission on February 25, 2016. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended
----------------------------
March 31, March 31,
2016 2015
------------- -------------
Net revenues $ 238,720 $ 198,086
Cost of revenues 58,093 46,996
------------- -------------
Gross profit 180,627 151,090
------------- -------------
Operating expenses:
Selling, general and adminstrative 112,210 88,281
Research and development 15,083 13,885
------------- -------------
Total operating expenses 127,293 102,166
Operating profit 53,334 48,924
Interest and other income (expense), net (427) (1,452)
------------- -------------
Profit before income taxes 52,907 47,472
Provision for income taxes 12,361 11,295
------------- -------------
Net profit $ 40,546 $ 36,177
============= =============
Net profit per share
- basic $ 0.51 $ 0.45
============= =============
- diluted $ 0.50 $ 0.44
============= =============
Shares used in computing net profit per share
- basic 79,831 80,459
============= =============
- diluted 81,320 81,824
============= =============
ALIGN TECHNOLOGY, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
March 31, December 31,
2016 2015
------------- -------------
ASSETS
Current assets:
Cash and cash equivalents $ 154,418 $ 167,714
Marketable securities, short-term 393,660 359,581
Accounts receivable, net 178,000 158,550
Inventories 22,618 19,465
Prepaid expenses and other current assets 34,307 26,700
------------- -------------
Total current assets 783,003 732,010
Marketable securities, long-term 132,690 151,370
Property, plant and equipment, net 148,029 136,473
Goodwill and intangible assets, net 78,606 79,162
Deferred tax assets 57,527 51,416
Other assets 7,705 8,202
------------- -------------
Total assets $ 1,207,560 $ 1,158,633
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 36,258 $ 34,354
Accrued liabilities 92,723 107,765
Deferred revenues 145,769 129,553
------------- -------------
Total current liabilities 274,750 271,672
Other long term liabilities 40,780 39,035
------------- -------------
Total liabilities 315,530 310,707
Total stockholders' equity 892,030 847,926
------------- -------------
Total liabilities and stockholders' equity $ 1,207,560 $ 1,158,633
============= =============
ALIGN TECHNOLOGY, INC. Q1 2016 FINANCIAL AND BUSINESS METRICS (in thousands except average selling price, utilization and doctors trained)
----------
Q1 Q2 Q3 Q4 Fiscal Q1
2015 2015 2015 2015 2015 2016
Invisalign Clear
Aligner Net
Revenues by
Geography:
North America $118,844 $126,137 $124,085 $129,663 $498,729 $135,699
International 55,920 61,896 61,265 70,980 250,061 69,850
Non-case* 12,265 12,784 12,942 13,405 51,396 14,149
-------- -------- -------- -------- -------- --------
Total Clear
Aligner Net
Revenues $187,029 $200,817 $198,292 $214,048 $800,186 $219,698
======== ======== ======== ======== ======== ========
YoY % growth 11.2 % 11.7 % 11.3 % 14.8 % 12.3 % 17.5 %
QoQ % growth 0.3 % 7.4 % -1.3 % 7.9 % 2.6 %
*includes
Invisalign
training,
ancillary
products, and
retainers
Average
Invisalign
Selling Price
(ASP):
Worldwide ASP $ 1,335 $ 1,300 $ 1,255 $ 1,250 $ 1,285 $ 1,255
International
ASP $ 1,410 $ 1,380 $ 1,325 $ 1,315 $ 1,355 $ 1,315
Invisalign Clear
Aligner Cases
Shipped by
Geography:
North America 91,110 99,630 101,260 106,390 398,390 110,500
International 39,670 44,940 46,225 54,010 184,845 53,195
-------- -------- -------- -------- -------- --------
Total Cases
Shipped 130,780 144,570 147,485 160,400 583,235 163,695
======== ======== ======== ======== ======== ========
YoY % growth 16.6 % 28.9 % 23.6 % 26.4 % 22.0 % 25.2 %
QoQ % growth 3.1 % 10.5 % 2.0 % 8.8 % 2.1 %
Number of
Invisalign
Doctors Cases
Shipped To:
North America 20,165 21,335 21,160 21,835 31,710 22,355
International 9,050 9,790 10,150 10,865 16,460 11,280
-------- -------- -------- -------- -------- --------
Total Doctors
Cases Shipped
To 29,215 31,125 31,310 32,700 48,170 33,635
======== ======== ======== ======== ======== ========
Invisalign
Doctor
Utilization
Rates*:
North America 4.5 4.7 4.8 4.9 12.6 4.9
North American
Orthodontists 9.0 9.5 9.9 9.9 31.8 10.4
North American
GP Dentists 2.9 3.0 2.9 3.1 7.4 3.0
International 4.4 4.6 4.6 5.0 11.2 4.7
Total
Utilization
Rates 4.5 4.6 4.7 4.9 12.1 4.9
* # of cases
shipped/# of
doctors to
whom cases
were shipped
Number of
Invisalign
Doctors
Trained:
North America 870 1,120 1,060 1,270 4,320 870
International 1,540 1,335 1,200 1,400 5,475 1,600
-------- -------- -------- -------- -------- --------
Total Doctors
Trained
Worldwide 2,410 2,455 2,260 2,670 9,795 2,470
======== ======== ======== ======== ======== ========
Total to Date
Worldwide 96,405 98,860 101,120 103,790 103,790 106,260
======== ======== ======== ======== ======== ========
Total Net
Revenues:
Clear Aligner
Net Revenues $187,029 $200,817 $198,292 $214,048 $800,186 $219,698
Scanner &
Services Net
Revenues 11,057 8,671 9,344 16,228 45,300 19,022
-------- -------- -------- -------- -------- --------
Total
Worldwide Net
Revenues $198,086 $209,488 $207,636 $230,276 $845,486 $238,720
======== ======== ======== ======== ======== ========
YoY % growth 9.7 % 8.8 % 9.4 % 15.9 % 11.0 % 20.5 %
QoQ % growth -0.3 % 5.8 % -0.9 % 10.9 % 3.7 %
Stock-based
Compensation
(SBC)
SBC included in
Gross Profit $ 980 $ 970 $ 984 $ 1,008 $ 3,942 $ 961
SBC included in
Operating
Expenses 10,670 11,860 13,677 12,799 49,006 11,563
-------- -------- -------- -------- -------- --------
Total SBC
Expense $ 11,650 $ 12,830 $ 14,661 $ 13,807 $ 52,948 $ 12,524
======== ======== ======== ======== ======== ========
----------
Note: Historical public data may differ due to rounding. Additionally,
rounding may effect totals.
ALIGN TECHNOLOGY, INC. BUSINESS OUTLOOK SUMMARY (unaudited) The outlook figures provided below and elsewhere in this press release are approximate in nature since Align's business outlook is difficult to predict. Align's future performance involves numerous risks and uncertainties and the company's results could differ materially from the outlook provided. Some of the factors that could affect Align's future financial performance and business outlook are set forth under "Forward Looking Information" above in this press release.
Financial Outlook
(in millions, except per share amounts and percentages)
Q2'16 Guidance
----------------
GAAP
----------------
Net Revenues $253.3 - $258.3
Gross Margin 75.0% - 75.5%
Operating Expenses $142.7 - $144.2
Operating Margin 18.7% - 19.7%
Net Income per Diluted Share $0.46 - $0.49
Business Metrics: Q2'16
----------------
Case Shipments 174.5K - 177.0K
Capital Expenditure $20M - $25M
Depreciation & Amortization $5.0M - $5.5M
Diluted Shares Outstanding 81.4M*
Stock Based Compensation Expense $14.3M
Tax Rate 24.0%
* Excludes any stock repurchases during the quarter
Investor Relations Contact Shirley Stacy Align Technology, Inc. (408) 470-1150 sstacy@aligntech.com Press Contact Shannon Mangum Henderson Ethos Communication, Inc. (678) 261-7803 align@ethoscommunication.com