Reports Net Revenues of
Fourth Quarter Highlights
Full Year Highlights
Dr.
Three Months Ended | Year Ended | |||||||||||||
December 31, | December 31, | |||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||
(in thousands, except per share data) | ||||||||||||||
Net revenues | $ | 89,690 | $ | 60,402 | $ | 294,666 | $ | 240,175 | ||||||
GAAP net income (loss) attributable to Amphastar | $ | 1,867 | $ | 787 | $ | (5,738 | ) | $ | 3,647 | |||||
Adjusted non-GAAP net income attributable to Amphastar* | $ | 6,231 | $ | 4,115 | $ | 10,399 | $ | 17,334 | ||||||
GAAP diluted EPS attributable to Amphastar shareholders | $ | 0.04 | $ | 0.02 | $ | (0.12 | ) | $ | 0.08 | |||||
Adjusted non-GAAP diluted EPS attributable to Amphastar shareholders* |
$ | 0.13 | $ | 0.08 | $ | 0.21 | $ | 0.36 |
___________________________________
* Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar shareholders 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.
Fourth Quarter Results
Three Months Ended | |||||||||||||
December 31, | Change | ||||||||||||
2018 | 2017 | Dollars | % | ||||||||||
(in thousands) | |||||||||||||
Net revenues: | |||||||||||||
Enoxaparin | $ | 19,085 | $ | 11,347 | $ | 7,738 | 68 | % | |||||
Lidocaine | 13,661 | 10,384 | 3,277 | 32 | % | ||||||||
Phytonadione | 12,942 | 10,703 | 2,239 | 21 | % | ||||||||
Naloxone | 7,703 | 8,434 | (731 | ) | (9 | )% | |||||||
Medroxyprogesterone | 7,448 | — | 7,448 | N/A | |||||||||
Epinephrine | 1,264 | 3,665 | (2,401 | ) | (66 | )% | |||||||
Primatene® Mist | 3,574 | — | 3,574 | N/A | |||||||||
Other finished pharmaceutical products | 17,257 | 11,452 | 5,805 | 51 | % | ||||||||
Total finished pharmaceutical products net revenues | $ | 82,934 | $ | 55,985 | $ | 26,949 | 48 | % | |||||
API | 6,756 | 4,417 | 2,339 | 53 | % | ||||||||
Total net revenues | $ | 89,690 | $ | 60,402 | $ | 29,288 | 48 | % |
Changes in net revenues were primarily driven by:
Three Months Ended | ||||||||||||||
December 31, | Change | |||||||||||||
2018 | 2017 | Dollars | % | |||||||||||
(in thousands) | ||||||||||||||
Net revenues | $ | 89,690 | $ | 60,402 | $ | 29,288 | 48 | % | ||||||
Cost of revenues | 55,001 | 39,912 | 15,089 | 38 | % | |||||||||
Gross profit | $ | 34,689 | $ | 20,490 | $ | 14,199 | 69 | % | ||||||
as % of net revenues | 39 | % | 34 | % |
Changes in cost of revenues and the resulting increase to gross margin were primarily driven by:
Three Months Ended | ||||||||||||
December 31, | Change | |||||||||||
2018 | 2017 | Dollars | % | |||||||||
(in thousands) | ||||||||||||
Selling, distribution and marketing | $ | 2,596 | $ | 1,629 | $ | 967 | 59 | % | ||||
General and administrative | 13,814 | 9,221 | 4,593 | 50 | % | |||||||
Research and development | 16,734 | 11,386 | 5,348 | 47 | % |
Year-End Results
Year Ended December 31, | Change | ||||||||||||
2018 | 2017 | Dollars | % | ||||||||||
(in thousands) | |||||||||||||
Net revenues: | |||||||||||||
Enoxaparin | $ | 53,371 | $ | 36,593 | $ | 16,778 | 46 | % | |||||
Lidocaine | 43,328 | 37,602 | 5,726 | 15 | % | ||||||||
Phytonadione | 41,897 | 37,946 | 3,951 | 10 | % | ||||||||
Naloxone | 37,195 | 42,342 | (5,147 | ) | (12 | )% | |||||||
Medroxyprogesterone | 24,071 | — | 24,071 | N/A | |||||||||
Epinephrine | 10,055 | 25,914 | (15,859 | ) | (61 | )% | |||||||
Primatene® Mist | 3,574 | — | 3,574 | N/A | |||||||||
Other finished pharmaceutical products | 57,568 | 49,742 | 7,826 | 16 | % | ||||||||
Total finished pharmaceutical products net revenues | $ | 271,059 | $ | 230,139 | $ | 40,920 | 18 | % | |||||
API | 23,607 | 10,036 | 13,571 | 135 | % | ||||||||
Total net revenues | $ | 294,666 | $ | 240,175 | $ | 54,491 | 23 | % |
Changes in net revenues were primarily driven by:
Year Ended December 31, | Change | |||||||||||||
2018 | 2017 | Dollars | % | |||||||||||
(in thousands) |
||||||||||||||
Net revenues | $ | 294,666 | $ | 240,175 | $ | 54,491 | 23 | % | ||||||
Cost of revenues | 187,681 | 149,666 | 38,015 | 25 | % | |||||||||
Gross profit | $ | 106,985 | $ | 90,509 | $ | 16,476 | 18 | % | ||||||
as % of net revenues | 36 | % | 38 | % |
Changes in cost of revenues and the resulting increase to gross margin were primarily driven by:
Year Ended December 31, | Change | ||||||||||||
2018 | 2017 | Dollars | % | ||||||||||
(in thousands) | |||||||||||||
Selling, distribution and marketing | $ | 8,156 | $ | 6,460 | $ | 1,696 | 26 | % | |||||
General and administrative | 49,888 | 44,458 | 5,430 | 12 | % | ||||||||
Research and development | 57,564 | 43,503 | 14,061 | 32 | % | ||||||||
Gain on sale of intangible assets | — | (2,643 | ) | 2,643 | (100 | )% |
Cash flow provided by operating activities for the year ended
Certain GAAP and non-GAAP measures for comparative periods in 2017 were revised for immaterial errors.
Pipeline Information
The Company currently has five abbreviated new drug applications, or ANDAs, filed with the
Amphastar’s Chinese subsidiary, ANP, currently has nine Drug Master Files, or DMFs, on file with the
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, including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar.
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) attributed to Amphastar and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar’s shareholders, which 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,
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 4878419.
The call can also be accessed on the Investors page on the Company’s website at 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
Contact Information:
Chief Financial Officer
(909) 980-9484
Table I
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)
Three Months Ended | Year Ended | ||||||||||||||||
December 31, | December 31, | ||||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||||
Net revenues | $ | 89,690 | $ | 60,402 | $ | 294,666 | $ | 240,175 | |||||||||
Cost of revenues | 55,001 | 39,912 | 187,681 | 149,666 | |||||||||||||
Gross profit | 34,689 | 20,490 | 106,985 | 90,509 | |||||||||||||
Operating (income) expenses: | |||||||||||||||||
Selling, distribution, and marketing | 2,596 | 1,629 | 8,156 | 6,460 | |||||||||||||
General and administrative | 13,814 | 9,221 | 49,888 | 44,458 | |||||||||||||
Research and development | 16,734 | 11,386 | 57,564 | 43,503 | |||||||||||||
Gain on sale of intangible assets | — | — | — | (2,643 | ) | ||||||||||||
Total operating expenses | 33,144 | 22,236 | 115,608 | 91,778 | |||||||||||||
Income (loss) from operations | 1,545 | (1,746 | ) | (8,623 | ) | (1,269 | ) | ||||||||||
Non-operating income (expense), net | (956 | ) | 601 | (1,303 | ) | 2,518 | |||||||||||
Income (loss) before income taxes | 589 | (1,145 | ) | (9,926 | ) | 1,249 | |||||||||||
Income tax expense (benefit) | (1,129 | ) | (1,932 | ) | (3,266 | ) | (2,398 | ) | |||||||||
Net income (loss) | $ | 1,718 | $ | 787 | $ | (6,660 | ) | $ | 3,647 | ||||||||
Net loss attributable to non-controlling interests | $ | (149 | ) | $ | — | $ | (922 | ) | $ | — | |||||||
Net income (loss) attributable to Amphastar | $ | 1,867 | $ | 787 | $ | (5,738 | ) | $ | 3,647 | ||||||||
Net income (loss) per share attributable to Amphastar shareholders: | |||||||||||||||||
Basic | $ | 0.04 | $ | 0.02 | $ | (0.12 | ) | $ | 0.08 | ||||||||
Diluted | $ | 0.04 | $ | 0.02 | $ | (0.12 | ) | $ | 0.08 | ||||||||
Weighted-average shares used to compute net income (loss) per share attributable to Amphastar shareholders: |
|||||||||||||||||
Basic | 46,268 | 46,233 | 46,395 | 46,107 | |||||||||||||
Diluted | 49,181 | 49,330 | 46,395 | 48,367 |
The comparative periods in 2017 were revised for immaterial errors.
Table II
Condensed Consolidated Balance Sheet
(Unaudited; in thousands, except per share data)
December 31, | December 31, | |||||||
2018 | 2017 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 86,337 | $ | 65,594 | ||||
Short-term investments | 2,831 | 2,635 | ||||||
Restricted cash and short-term investments | 4,155 | 4,155 | ||||||
Accounts receivable, net | 52,163 | 35,996 | ||||||
Inventories | 69,322 | 63,609 | ||||||
Income tax refunds and deposits | 49 | 6,036 | ||||||
Prepaid expenses and other assets | 5,485 | 9,753 | ||||||
Total current assets | 220,342 | 187,778 | ||||||
Property, plant, and equipment, net | 210,418 | 180,545 | ||||||
Goodwill and intangible assets, net | 42,267 | 45,140 | ||||||
Other assets | 9,918 | 8,663 | ||||||
Deferred tax assets | 30,618 | 28,946 | ||||||
Total assets | $ | 513,563 | $ | 451,072 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 87,418 | $ | 57,555 | ||||
Income taxes payable | 1,187 | 3,325 | ||||||
Current portion of long-term debt and capital leases | 18,229 | 6,312 | ||||||
Total current liabilities | 106,834 | 67,192 | ||||||
Long-term reserve for income tax liabilities | 415 | 879 | ||||||
Long-term debt and capital leases, net of current portion | 31,984 | 40,844 | ||||||
Deferred tax liabilities | 1,031 | 1,361 | ||||||
Other long-term liabilities | 8,940 | 7,060 | ||||||
Total liabilities | 149,204 | 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; 51,438,675 and 46,631,118 shares issued and outstanding as of December 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 | 344,434 | 313,891 | ||||||
Retained earnings | 67,485 | 72,642 | ||||||
Accumulated other comprehensive loss | (4,013 | ) | (2,100 | ) | ||||
Treasury stock | (75,476 | ) | (50,702 | ) | ||||
Total Amphastar stockholders’ equity | 332,435 | 333,736 | ||||||
Non-controlling interests | 31,924 | — | ||||||
Total equity | 364,359 | 333,736 | ||||||
Total liabilities and stockholders’ equity | $ | 513,563 | $ | 451,072 |
The
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
Three Months Ended | Year Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
GAAP net income (loss) | $ | 1,718 | $ | 787 | $ | (6,660 | ) | $ | 3,647 | |||||||
Adjusted for: | ||||||||||||||||
Intangible amortization | 265 | 717 | 1,987 | 2,856 | ||||||||||||
Share-based compensation | 3,910 | 4,182 | 16,680 | 17,087 | ||||||||||||
Impairment of long-lived assets | 1,257 | — | 1,647 | — | ||||||||||||
Income tax expense on pre-tax adjustments | (1,004 | ) | (1,571 | ) | (4,044 | ) | (6,256 | ) | ||||||||
Non-GAAP net income | $ | 6,146 | $ | 4,115 | $ | 9,610 | $ | 17,334 | ||||||||
Non-GAAP net loss attributable to non-controlling interests | $ | (85 | ) | $ | — | $ | (789 | ) | $ | — | ||||||
Non-GAAP net income attributable to Amphastar | $ | 6,231 | $ | 4,115 | $ | 10,399 | $ | 17,334 | ||||||||
Non-GAAP net income per share attributable to Amphastar shareholders: | ||||||||||||||||
Basic | $ | 0.13 | $ | 0.09 | $ | 0.22 | $ | 0.38 | ||||||||
Diluted | $ | 0.13 | $ | 0.08 | $ | 0.21 | $ | 0.36 | ||||||||
Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar shareholders: |
||||||||||||||||
Basic | 46,268 | 46,233 | 46,395 | 46,107 | ||||||||||||
Diluted | 49,181 | 49,330 | 48,830 | 48,367 |
Three Months Ended December 31, 2018 | ||||||||||||||||||||||||
Selling, | General | Research | Income | Non-controlling | ||||||||||||||||||||
Cost of | distribution | and | and | tax expense | interest | |||||||||||||||||||
revenue | and marketing | administrative | development | (benefit) | adjustment | |||||||||||||||||||
GAAP | $ | 55,001 | $ | 2,596 | $ | 13,814 | $ | 16,734 | $ | (1,129 | ) | $ | (149 | ) | ||||||||||
Intangible amortization | (224 | ) | — | (41 | ) | — | — | 11 | ||||||||||||||||
Share-based compensation | (898 | ) | (86 | ) | (2,602 | ) | (324 | ) | — | 62 | ||||||||||||||
Impairment of long-lived assets | (1,010 | ) | — | (5 | ) | (242 | ) | — | 1 | |||||||||||||||
Income tax expense on pre-tax adjustments |
— | — | — | — | 1,004 | (10 | ) | |||||||||||||||||
Non-GAAP | $ | 52,869 | $ | 2,510 | $ | 11,166 | $ | 16,168 | $ | (125 | ) | $ | (85 | ) |
Three Months Ended December 31, 2017 | |||||||||||||||||||||||
Selling, | General | Research | Income | Non-controlling | |||||||||||||||||||
Cost of | distribution | and | and | tax expense | interest | ||||||||||||||||||
revenue | and marketing | administrative | development | (benefit) | adjustment | ||||||||||||||||||
GAAP | $ | 39,912 | $ | 1,629 | $ | 9,221 | $ | 11,386 | $ | (1,932 | ) | $ | — | ||||||||||
Intangible amortization | (675 | ) | — | (42 | ) | — | — | — | |||||||||||||||
Share-based compensation | (913 | ) | (65 | ) | (2,928 | ) | (276 | ) | — | — | |||||||||||||
Income tax expense on pre-tax adjustments |
— | — | — | — | 1,571 | — | |||||||||||||||||
Non-GAAP | $ | 38,324 | $ | 1,564 | $ | 6,251 | $ | 11,110 | $ | (361 | ) | $ | — |
The comparative periods in 2017 were revised for immaterial errors.
Reconciliation of Non-GAAP Measures (continued)
Year Ended December 31, 2018 | ||||||||||||||||||||||||
Selling, | General | Research | Income | Non-controlling | ||||||||||||||||||||
Cost of | distribution | and | and | tax expense | interest | |||||||||||||||||||
revenue | and marketing | administrative | development | (benefit) | adjustment | |||||||||||||||||||
GAAP | $ | 187,681 | $ | 8,156 | $ | 49,888 | $ | 57,564 | $ | (3,266 | ) | $ | (922 | ) | ||||||||||
Intangible amortization | (1,826 | ) | — | (161 | ) | — | — | 22 | ||||||||||||||||
Share-based compensation | (3,923 | ) | (383 | ) | (10,853 | ) | (1,521 | ) | — | 130 | ||||||||||||||
Impairment of long-lived assets | (1,087 | ) | — | (9 | ) | (551 | ) | — | 2 | |||||||||||||||
Income tax expense on pre-tax adjustments |
— | — | — | — | 4,044 | (21 | ) | |||||||||||||||||
Non-GAAP | $ | 180,845 | $ | 7,773 | $ | 38,865 | $ | 55,492 | $ | 778 | $ | (789 | ) |
Year Ended December 31, 2017 | |||||||||||||||||||||||
Selling, | General | Research | Income | Non-controlling | |||||||||||||||||||
Cost of | distribution | and | and | tax expense | interest | ||||||||||||||||||
revenue | and marketing | administrative | development | (benefit) | adjustment | ||||||||||||||||||
GAAP | $ | 149,666 | $ | 6,460 | $ | 44,458 | $ | 43,503 | $ | (2,398 | ) | $ | — | ||||||||||
Intangible amortization | (2,706 | ) | — | (150 | ) | — | — | — | |||||||||||||||
Share-based compensation | (3,756 | ) | (302 | ) | (11,643 | ) | (1,386 | ) | — | — | |||||||||||||
Income tax expense on pre-tax adjustments |
— | — | — | — | 6,256 | — | |||||||||||||||||
Non-GAAP | $ | 143,204 | $ | 6,158 | $ | 32,665 | $ | 42,117 | $ | 3,858 | $ | — |
The comparative periods in 2017 were revised for immaterial errors.
Source: Amphastar Pharmaceuticals, Inc.
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