Attached files
| file | filename |
|---|---|
| 8-K - 8-K - Amphastar Pharmaceuticals, Inc. | amph-20180509x8k.htm |
EXHIBIT 99.1
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2018
Reports Net Revenues of $58.4 Million for the Three Months Ended March 31, 2018
RANCHO CUCAMONGA, CA – May 9, 2018 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended March 31, 2018.
First Quarter Highlights
|
· |
Net revenues of $58.4 million for the first quarter |
|
· |
GAAP net loss of $7.2 million, or $0.16 per share, for the first quarter |
|
· |
Adjusted non-GAAP net loss of $2.5 million, or $0.05 per share, for the first quarter |
Dr. Jack Zhang, Amphastar’s CEO, commented: “We are pleased to announce that we have resubmitted our NDA for Primatene® Mist after receiving good results from our recent human factors study. While we don’t have a PDUFA date yet, we plan to begin producing inventory in preparation for a launch.”
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Three Months Ended |
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March 31, |
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2018 |
|
2017 |
||
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|
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(in thousands, except per share data) |
||||
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Net revenues |
|
$ |
58,393 |
|
$ |
56,670 |
|
GAAP net income (loss) |
|
$ |
(7,246) |
|
$ |
893 |
|
Adjusted non-GAAP net income (loss)* |
|
$ |
(2,452) |
|
$ |
4,475 |
|
GAAP diluted EPS |
|
$ |
(0.16) |
|
$ |
0.02 |
|
Adjusted non-GAAP diluted EPS* |
|
$ |
(0.05) |
|
$ |
0.09 |
* Adjusted non-GAAP net income (loss) and Adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.
First Quarter Results
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Three Months Ended |
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March 31, |
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Change |
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|||||||
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2018 |
|
2017 |
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Dollars |
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% |
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|||
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(in thousands) |
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||||
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Net revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
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Lidocaine |
|
$ |
9,782 |
|
$ |
8,289 |
|
$ |
1,493 |
|
18 |
% |
|
Phytonadione |
|
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9,181 |
|
|
7,886 |
|
|
1,295 |
|
16 |
% |
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Naloxone |
|
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8,927 |
|
|
10,939 |
|
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(2,012) |
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(18) |
% |
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Enoxaparin |
|
|
7,007 |
|
|
10,410 |
|
|
(3,403) |
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(33) |
% |
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Epinephrine |
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3,223 |
|
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9,574 |
|
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(6,351) |
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(66) |
% |
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Medroxyprogesterone |
|
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2,706 |
|
|
— |
|
|
2,706 |
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N/A |
|
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Other finished pharmaceutical products |
|
|
12,291 |
|
|
8,836 |
|
|
3,455 |
|
39 |
% |
|
Total finished pharmaceutical products net revenues |
|
$ |
53,117 |
|
$ |
55,934 |
|
$ |
(2,817) |
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(5) |
% |
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API |
|
|
5,276 |
|
|
736 |
|
|
4,540 |
|
617 |
% |
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Total net revenues |
|
$ |
58,393 |
|
$ |
56,670 |
|
$ |
1,723 |
|
3 |
% |
Changes in net revenues were primarily driven by:
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· |
Launch of medroxyprogesterone acetate in a vial form in January 2018 and a pre-filled syringe form in February 2018 |
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· |
Discontinuation of epinephrine injection vial product in the second quarter of 2017 |
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· |
Decline of enoxaparin sales due to lower unit sales at lower net average selling prices |
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· |
Increase in sales of insulin active pharmaceutical ingredient, or API, products due to the timing of customer purchases |
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Three Months Ended |
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March 31, |
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Change |
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2018 |
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2017 |
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Dollars |
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% |
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(in thousands) |
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Cost of Revenues |
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$ |
41,332 |
|
$ |
33,842 |
|
$ |
7,490 |
|
22 |
% |
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% of net revenues |
|
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71% |
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60% |
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|
Changes in cost of revenues and the resulting gross margin were primarily due to:
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· |
Increased labor costs due to implementing new quality standards and increased hourly rates |
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· |
Lower productivity at the Company’s U.S. facilities as the Company is in the process of increasing production of newly launched products |
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· |
Increased inventory write-down, partially due to increased cost of heparin |
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· |
Discontinuation of epinephrine injection vial product in the second quarter of 2017 |
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· |
Launch of medroxyprogesterone acetate, which partially offset the changes noted above |
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Three Months Ended |
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March 31, |
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Change |
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2018 |
|
2017 |
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Dollars |
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% |
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|||
|
|
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(in thousands) |
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|
|
|
|
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||||
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Selling, distribution and marketing |
|
$ |
1,721 |
|
$ |
1,479 |
|
$ |
242 |
|
16 |
% |
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General and administrative |
|
|
10,998 |
|
|
11,338 |
|
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(340) |
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(3) |
% |
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Research and development |
|
|
14,260 |
|
|
11,250 |
|
|
3,010 |
|
27 |
% |
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Gain on sale of intangible assets |
|
|
— |
|
|
(2,643) |
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|
2,643 |
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(100) |
% |
|
· |
Selling, distribution and marketing expenses increased primarily due to increased expenses at the Company’s Amphastar Nanjing Pharmaceuticals subsidiary as well as increased freight costs. |
|
· |
General and administrative expenses decreased primarily due to lower legal fees |
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· |
Research and development expenses increased primarily due to an NDA filing fee for a product that the Company currently markets under the grandfather exception as well as increased expenditures on materials for the Company’s pipeline products |
Cash flow provided by operating activities for the three months ended March 31, 2018, was $8.4 million.
Share buyback program
On May 7, 2018, the Company’s Board of Directors authorized an increase of $20.0 million to the Company’s share buyback program, which is expected to continue for an indefinite period of time. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs.
Purchases may be made through the open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions, or other means, as determined by the Company’s management and in accordance with the requirements of the Securities and Exchange Commission.
The timing and actual number of shares repurchased will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions.
Pipeline Information
The Company currently has three abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of over $0.5 billion, three biosimilar products in development targeting products with a market size of over $15.0 billion, and 12 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IQVIA data for the 12 months ended March 31, 2018. The Company’s proprietary pipeline includes NDAs for Primatene® Mist and intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.
Company Information
Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information is available at the Company’s website at www.amphastar.com.
Amphastar’s logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc.
Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles, or GAAP, the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, that exclude amortization expense, share-based compensation, and impairment charges in order to supplement investors’ and other readers’ understanding and assessment of the Company’s financial performance, because the Company’s management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.
Conference Call Information
The Company will hold a conference call to discuss its financial results today, May 9, 2018, at 2:00 p.m. Pacific Time.
To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 5298899.
The call can also be accessed on the Investors page on the Company’s website www.amphastar.com.
Forward Looking Statements
All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s business, operations and other similar or related factors. Words such as “may,” “might,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar’s control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar’s filings with the Securities and Exchange Commission. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. Amphastar undertakes no obligation to revise or update information in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause Amphastar’s expectations to change.
Contact Information:
Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484
Table I
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)
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|
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Three Months Ended |
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|
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March 31, |
||||
|
|
|
2018 |
|
2017 |
||
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
58,393 |
|
$ |
56,670 |
|
Cost of revenues |
|
|
41,332 |
|
|
33,842 |
|
Gross profit |
|
|
17,061 |
|
|
22,828 |
|
|
|
|
|
|
|
|
|
Operating (income) expenses: |
|
|
|
|
|
|
|
Selling, distribution, and marketing |
|
|
1,721 |
|
|
1,479 |
|
General and administrative |
|
|
10,998 |
|
|
11,338 |
|
Research and development |
|
|
14,260 |
|
|
11,250 |
|
Gain on sale of intangible assets |
|
|
— |
|
|
(2,643) |
|
Total operating expenses |
|
|
26,979 |
|
|
21,424 |
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
(9,918) |
|
|
1,404 |
|
|
|
|
|
|
|
|
|
Non-operating income (expense), net |
|
|
888 |
|
|
100 |
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
(9,030) |
|
|
1,504 |
|
Income tax expense (benefit) |
|
|
(1,784) |
|
|
611 |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(7,246) |
|
$ |
893 |
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
Basic |
|
$ |
(0.16) |
|
$ |
0.02 |
|
Diluted |
|
$ |
(0.16) |
|
$ |
0.02 |
|
|
|
|
|
|
|
|
|
Weighted-average shares used to compute net income (loss) per share: |
|
|
|
|
|
|
|
Basic |
|
|
46,514 |
|
|
46,069 |
|
Diluted |
|
|
46,514 |
|
|
48,057 |
Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet
(Unaudited; in thousands, except per share data)
|
|
|
March 31, |
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December 31, |
||
|
|
|
2018 |
|
2017 |
||
|
ASSETS |
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
54,547 |
|
$ |
65,594 |
|
Short-term investments |
|
|
2,826 |
|
|
2,635 |
|
Restricted cash and short-term investments |
|
|
4,155 |
|
|
4,155 |
|
Accounts receivable, net |
|
|
31,883 |
|
|
35,996 |
|
Inventories |
|
|
62,780 |
|
|
63,609 |
|
Income tax refunds and deposits |
|
|
12,194 |
|
|
6,036 |
|
Prepaid expenses and other assets |
|
|
5,661 |
|
|
9,753 |
|
Total current assets |
|
|
174,046 |
|
|
187,778 |
|
Property, plant, and equipment, net |
|
|
191,915 |
|
|
185,339 |
|
Goodwill and intangible assets, net |
|
|
44,850 |
|
|
45,140 |
|
Other assets |
|
|
10,714 |
|
|
8,663 |
|
Deferred tax assets |
|
|
28,257 |
|
|
27,745 |
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
449,782 |
|
$ |
454,665 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable and accrued liabilities |
|
$ |
58,498 |
|
$ |
57,555 |
|
Income taxes payable |
|
|
7,983 |
|
|
3,325 |
|
Current portion of long-term debt and capital leases |
|
|
6,061 |
|
|
6,312 |
|
Total current liabilities |
|
|
72,542 |
|
|
67,192 |
|
|
|
|
|
|
|
|
|
Long-term reserve for income tax liabilities |
|
|
879 |
|
|
879 |
|
Long-term debt and capital leases, net of current portion |
|
|
39,706 |
|
|
40,844 |
|
Deferred tax liabilities |
|
|
1,425 |
|
|
1,361 |
|
Other long-term liabilities |
|
|
8,126 |
|
|
7,060 |
|
Total liabilities |
|
|
122,678 |
|
|
117,336 |
|
Commitments and contingencies: |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding |
|
|
— |
|
|
— |
|
Common stock: par value $0.0001; 300,000,000 shares authorized; 50,471,687 and 46,656,793 shares issued and outstanding as of March 31, 2018 and 50,039,212 and 46,623,581 shares issued and outstanding as of December 31, 2017, respectively |
|
|
5 |
|
|
5 |
|
Additional paid-in capital |
|
|
316,665 |
|
|
313,891 |
|
Retained earnings |
|
|
69,570 |
|
|
76,235 |
|
Accumulated other comprehensive loss |
|
|
(910) |
|
|
(2,100) |
|
Treasury stock |
|
|
(58,226) |
|
|
(50,702) |
|
Total stockholders’ equity |
|
|
327,104 |
|
|
337,329 |
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders’ equity |
|
$ |
449,782 |
|
$ |
454,665 |
Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
|
|
|
Three Months Ended |
||||
|
|
|
March 31, |
||||
|
|
|
2018 |
|
2017 |
||
|
|
|
|
|
|
|
|
|
GAAP net income (loss) |
|
$ |
(7,246) |
|
$ |
893 |
|
Adjusted for: |
|
|
|
|
|
|
|
Intangible amortization |
|
|
729 |
|
|
721 |
|
Share-based compensation |
|
|
4,666 |
|
|
4,451 |
|
Impairment of long-lived assets |
|
|
598 |
|
|
— |
|
Income tax expense on pre-tax adjustments |
|
|
(1,199) |
|
|
(1,590) |
|
Non-GAAP net income (loss) |
|
$ |
(2,452) |
|
$ |
4,475 |
|
|
|
|
|
|
|
|
|
Non-GAAP net income (loss) per share: |
|
|
|
|
|
|
|
Basic |
|
$ |
(0.05) |
|
$ |
0.10 |
|
Diluted |
|
$ |
(0.05) |
|
$ |
0.09 |
|
|
|
|
|
|
|
|
|
Weighted-average shares used to compute non-GAAP net income (loss) per share: |
|
|
|
|
|
|
|
Basic |
|
|
46,514 |
|
|
46,069 |
|
Diluted |
|
|
46,514 |
|
|
48,057 |
|
|
|
Three Months Ended March 31, 2018 |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
Selling, |
|
General |
|
Research |
|
Income |
|||||
|
|
|
Cost of |
|
distribution |
|
and |
|
and |
|
tax expense |
|||||
|
|
|
revenue |
|
and marketing |
|
administrative |
|
development |
|
(benefit) |
|||||
|
GAAP |
|
$ |
41,332 |
|
$ |
1,721 |
|
$ |
10,998 |
|
$ |
14,260 |
|
$ |
(1,784) |
|
Intangible amortization |
|
|
(689) |
|
|
— |
|
|
(40) |
|
|
— |
|
|
— |
|
Share-based compensation |
|
|
(1,160) |
|
|
(107) |
|
|
(2,893) |
|
|
(506) |
|
|
— |
|
Impairment of long-lived assets |
|
|
(74) |
|
|
— |
|
|
(3) |
|
|
(521) |
|
|
— |
|
Income tax expense on pre-tax adjustments |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,199 |
|
Non-GAAP |
|
$ |
39,409 |
|
$ |
1,614 |
|
$ |
8,062 |
|
$ |
13,233 |
|
$ |
(585) |
|
|
|
Three Months Ended March 31, 2017 |
|||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||
|
|
|
|
|
Selling, |
|
General |
|
Research |
|
Income |
|||||
|
|
|
Cost of |
|
distribution |
|
and |
|
and |
|
tax expense |
|||||
|
|
|
revenue |
|
and marketing |
|
administrative |
|
development |
|
(benefit) |
|||||
|
GAAP |
|
$ |
33,842 |
|
$ |
1,479 |
|
$ |
11,338 |
|
$ |
11,250 |
|
$ |
611 |
|
Intangible amortization |
|
|
(685) |
|
|
— |
|
|
(36) |
|
|
— |
|
|
— |
|
Share-based compensation |
|
|
(1,131) |
|
|
(84) |
|
|
(2,783) |
|
|
(453) |
|
|
— |
|
Income tax expense on pre-tax adjustments |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,590 |
|
Non-GAAP |
|
$ |
32,026 |
|
$ |
1,395 |
|
$ |
8,519 |
|
$ |
10,797 |
|
$ |
2,201 |