Reports Net Revenues of $75.5 Million for the Three Months Ended September 30, 2018
RANCHO CUCAMONGA, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) — Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended September 30, 2018.
Third Quarter Highlights
- Net revenues of $75.5 million for the third quarter
- GAAP net income attributable to Amphastar of $2.4 million, or $0.05 per diluted share, for the third quarter
- Adjusted non-GAAP net income attributable to Amphastar of $5.7 million, or $0.12 per diluted share, for the third quarter
Dr. Jack Zhang, Amphastar’s CEO, commented: “This is a very exciting time for Amphastar with our recent approval of Primatene® Mist, our strong sales growth in the quarter and our return to profitability.”
| Three Months Ended | Nine Months Ended | |||||||||||||
| September 30, | September 30, | |||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||
| (in thousands, except per share data) | ||||||||||||||
| Net revenues | $ | 75,543 | $ | 57,916 | $ | 204,976 | $ | 179,773 | ||||||
| GAAP net income (loss) attributable to Amphastar | $ | 2,389 | $ | 99 | $ | (7,605 | ) | $ | 2,860 | |||||
| Adjusted non-GAAP net income attributable to Amphastar* | $ | 5,721 | $ | 3,419 | $ | 4,168 | $ | 13,219 | ||||||
| GAAP diluted EPS attributable to Amphastar shareholders | $ | 0.05 | $ | 0.00 | $ | (0.16 | ) | $ | 0.06 | |||||
| Adjusted non-GAAP diluted EPS attributable to Amphastar shareholders* | $ | 0.12 | $ | 0.07 | $ | 0.09 | $ | 0.28 | ||||||
____________________________
* 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.
Third Quarter Results
| Three Months Ended | ||||||||||||||
| September 30, | Change | |||||||||||||
| 2018 | 2017 | Dollars | % | |||||||||||
| (in thousands) | ||||||||||||||
| Net revenues: | ||||||||||||||
| Enoxaparin | $ | 18,564 | $ | 6,549 | $ | 12,015 | 183 | % | ||||||
| Lidocaine | 9,875 | 9,596 | 279 | 3 | % | |||||||||
| Naloxone | 9,432 | 12,709 | (3,277 | ) | (26 | ) | % | |||||||
| Phytonadione | 8,968 | 9,352 | (384 | ) | (4 | ) | % | |||||||
| Medroxyprogesterone | 7,552 | — | 7,552 | N/A | ||||||||||
| Epinephrine | 1,881 | 2,027 | (146 | ) | (7 | ) | % | |||||||
| Other finished pharmaceutical products | 15,495 | 14,222 | 1,273 | 9 | % | |||||||||
| Total finished pharmaceutical products net revenues | $ | 71,767 | $ | 54,455 | $ | 17,312 | 32 | % | ||||||
| API | 3,776 | 3,461 | 315 | 9 | % | |||||||||
| Total net revenues | $ | 75,543 | $ | 57,916 | $ | 17,627 | 30 | % | ||||||
Changes in net revenues were primarily driven by:
- Increased sales of enoxaparin, primarily driven by higher average selling prices, as well as an increase in unit volumes
- Sales of medroxyprogesterone acetate which launched in the first quarter of 2018 so was not included in third quarter of 2017 results
- Decreased sales of naloxone primarily due to lower unit volumes
| Three Months Ended | ||||||||||||||
| September 30, | Change | |||||||||||||
| 2018 | 2017 | Dollars | % | |||||||||||
| (in thousands) | ||||||||||||||
| Net Revenues | $ | 75,543 | $ | 57,916 | $ | 17,627 | 30 | % | ||||||
| Cost of Revenues | 46,283 | 37,363 | 8,920 | 24 | % | |||||||||
| Gross Profit | $ | 29,260 | $ | 20,553 | $ | 8,707 | 42 | % | ||||||
| as % of net revenues | 39 | % | 35 | % | ||||||||||
Changes in cost of revenues and the resulting increase to gross margin were primarily due to:
- The launch of medroxyprogesterone acetate and isoproterenol hydrochloride, which both have higher margins
- Higher average selling prices of enoxaparin
| Three Months Ended | ||||||||||||
| September 30, | Change | |||||||||||
| 2018 | 2017 | Dollars | % | |||||||||
| (in thousands) | ||||||||||||
| Selling, distribution and marketing | $ | 1,963 | $ | 1,756 | $ | 207 | 12 | % | ||||
| General and administrative | 13,407 | 11,665 | 1,742 | 15 | % | |||||||
| Research and development | 11,340 | 10,075 | 1,265 | 13 | % | |||||||
- Selling, distribution and marketing expenses increased primarily due to increased freight costs
- General and administrative expenses increased primarily due to higher legal fees
- Research and development expenses increased primarily due to expenditures related to the expansion of our ANP facility as well as an increase in FDA, or Food and Drug Administration filing fees
Cash flow provided by operating activities for the nine months ended September 30, 2018 was $28.7 million.
Certain GAAP and non-GAAP measures for comparative periods in 2017 were revised for immaterial errors.
Pipeline Information
The Company currently has four abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of approximately $0.7 billion, three biosimilar products in development targeting products with a market size of over $14 billion, and 11 generic products in development targeting products with a market size of over $12 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2018. The Company’s proprietary pipeline includes a new drug application for intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.
Amphastar’s Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, currently has nine Drug Master Files, or DMFs, on file with the FDA and is developing nine additional DMFs.
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) attributed to Amphastar Pharmaceuticals, Inc. and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar Pharmaceuticals, Inc. 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, November 8, 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 5587773.
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 FDA filings or approvals, including the DMFs of ANP, the timing of product launches, 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)
| Three Months Ended | Nine Months Ended | ||||||||||||||||
| September 30, | September 30, | ||||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||||
| Net revenues | $ | 75,543 | $ | 57,916 | $ | 204,976 | $ | 179,773 | |||||||||
| Cost of revenues | 46,283 | 37,363 | 132,680 | 109,754 | |||||||||||||
| Gross profit | 29,260 | 20,553 | 72,296 | 70,019 | |||||||||||||
| Operating (income) expenses: | |||||||||||||||||
| Selling, distribution, and marketing | 1,963 | 1,756 | 5,560 | 4,831 | |||||||||||||
| General and administrative | 13,407 | 11,665 | 36,074 | 35,237 | |||||||||||||
| Research and development | 11,340 | 10,075 | 40,830 | 32,117 | |||||||||||||
| Gain on sale of intangible assets | — | — | — | (2,643 | ) | ||||||||||||
| Total operating expenses | 26,710 | 23,496 | 82,464 | 69,542 | |||||||||||||
| Income (loss) from operations | 2,550 | (2,943 | ) | (10,168 | ) | 477 | |||||||||||
| Non-operating income (expense), net | 24 | 829 | (347 | ) | 1,917 | ||||||||||||
| Income (loss) before income taxes | 2,574 | (2,114 | ) | (10,515 | ) | 2,394 | |||||||||||
| Income tax expense (benefit) | 958 | (2,213 | ) | (2,137 | ) | (466 | ) | ||||||||||
| Net income (loss) | $ | 1,616 | $ | 99 | $ | (8,378 | ) | $ | 2,860 | ||||||||
| Net loss attributable to non-controlling interests | $ | (773 | ) | $ | — | $ | (773 | ) | $ | — | |||||||
| Net income (loss) attributable to Amphastar | $ | 2,389 | $ | 99 | $ | (7,605 | ) | $ | 2,860 | ||||||||
| Net income (loss) per share attributable to Amphastar shareholders: | |||||||||||||||||
| Basic | $ | 0.05 | $ | 0.00 | $ | (0.16 | ) | $ | 0.06 | ||||||||
| Diluted | $ | 0.05 | $ | 0.00 | $ | (0.16 | ) | $ | 0.06 | ||||||||
| Weighted-average shares used to compute net income (loss) per share attributable to Amphastar shareholders: | |||||||||||||||||
| Basic | 46,241 | 46,101 | 46,437 | 46,065 | |||||||||||||
| Diluted | 48,281 | 48,215 | 46,437 | 48,046 | |||||||||||||
The comparative periods in 2017 were revised for immaterial errors.
Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheet
(Unaudited; in thousands, except per share data)
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 68,734 | $ | 65,594 | ||||
| Short-term investments | 2,829 | 2,635 | ||||||
| Restricted cash and short-term investments | 4,155 | 4,155 | ||||||
| Accounts receivable, net | 43,816 | 35,996 | ||||||
| Inventories | 65,414 | 63,609 | ||||||
| Income tax refunds and deposits | 3,186 | 6,036 | ||||||
| Prepaid expenses and other assets | 6,670 | 9,753 | ||||||
| Total current assets | 194,804 | 187,778 | ||||||
| Property, plant, and equipment, net | 202,526 | 180,545 | ||||||
| Goodwill and intangible assets, net | 42,727 | 45,140 | ||||||
| Other assets | 11,127 | 8,663 | ||||||
| Deferred tax assets | 29,458 | 28,946 | ||||||
| Total assets | $ | 480,642 | $ | 451,072 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 76,362 | $ | 57,555 | ||||
| Income taxes payable | 1,667 | 3,325 | ||||||
| Current portion of long-term debt and capital leases | 18,592 | 6,312 | ||||||
| Total current liabilities | 96,621 | 67,192 | ||||||
| Long-term reserve for income tax liabilities | 879 | 879 | ||||||
| Long-term debt and capital leases, net of current portion | 32,606 | 40,844 | ||||||
| Deferred tax liabilities | 1,303 | 1,361 | ||||||
| Other long-term liabilities | 7,963 | 7,060 | ||||||
| Total liabilities | 139,372 | 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; 50,883,467 and 46,159,652 shares issued and outstanding as of September 30, 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 | 330,265 | 313,891 | ||||||
| Retained earnings | 65,618 | 72,642 | ||||||
| Accumulated other comprehensive loss | (3,576 | ) | (2,100 | ) | ||||
| Treasury stock | (72,896 | ) | (50,702 | ) | ||||
| Total Amphastar stockholders’ equity | 319,416 | 333,736 | ||||||
| Non-controlling interests | 21,854 | — | ||||||
| Total equity | 341,270 | 333,736 | ||||||
| Total liabilities and stockholders’ equity | $ | 480,642 | $ | 451,072 | ||||
The December 31, 2017 figures were revised for immaterial errors.
Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| GAAP net income (loss) | $ | 1,616 | $ | 99 | $ | (8,378 | ) | $ | 2,860 | |||||||
| Adjusted for: | ||||||||||||||||
| Intangible amortization | 271 | 713 | 1,722 | 2,139 | ||||||||||||
| Share-based compensation | 3,908 | 4,157 | 12,770 | 12,905 | ||||||||||||
| Impairment of long-lived assets | 10 | — | 390 | — | ||||||||||||
| Income tax expense on pre-tax adjustments | (788 | ) | (1,550 | ) | (3,040 | ) | (4,685 | ) | ||||||||
| Non-GAAP net income | $ | 5,017 | $ | 3,419 | $ | 3,464 | $ | 13,219 | ||||||||
| Non-GAAP net loss attributable to non-controlling interests | $ | (704 | ) | $ | — | $ | (704 | ) | $ | — | ||||||
| Non-GAAP net income attributable to Amphastar | $ | 5,721 | $ | 3,419 | $ | 4,168 | $ | 13,219 | ||||||||
| Non-GAAP net income per share attributable to Amphastar shareholders: | ||||||||||||||||
| Basic | $ | 0.12 | $ | 0.07 | $ | 0.09 | $ | 0.29 | ||||||||
| Diluted | $ | 0.12 | $ | 0.07 | $ | 0.09 | $ | 0.28 | ||||||||
| Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar shareholders: | ||||||||||||||||
| Basic | 46,241 | 46,101 | 46,437 | 46,065 | ||||||||||||
| Diluted | 48,281 | 48,215 | 48,713 | 48,046 | ||||||||||||
| Three Months Ended September 30, 2018 | |||||||||||||||||||
| Cost of revenue |
Selling, distribution and marketing |
General and administrative |
Research and development |
Income tax expense (benefit) |
|||||||||||||||
| GAAP | $ | 46,283 | $ | 1,963 | $ | 13,407 | $ | 11,340 | $ | 958 | |||||||||
| Intangible amortization | (230 | ) | — | (41 | ) | — | — | ||||||||||||
| Share-based compensation | (884 | ) | (86 | ) | (2,615 | ) | (323 | ) | — | ||||||||||
| Impairment of long-lived assets | — | — | — | (10 | ) | — | |||||||||||||
| Income tax expense on pre-tax adjustments | — | — | — | — | 788 | ||||||||||||||
| Non-GAAP | $ | 45,169 | $ | 1,877 | $ | 10,751 | $ | 11,007 | $ | 1,746 | |||||||||
| Three Months Ended September 30, 2017 | ||||||||||||||||||||
| Cost of revenue |
Selling, distribution and marketing |
General and administrative |
Research and development |
Income tax expense (benefit) |
||||||||||||||||
| GAAP | $ | 37,363 | $ | 1,756 | $ | 11,665 | $ | 10,075 | $ | (2,213 | ) | |||||||||
| Intangible amortization | (677 | ) | — | (36 | ) | — | — | |||||||||||||
| Share-based compensation | (815 | ) | (88 | ) | (2,948 | ) | (306 | ) | — | |||||||||||
| Income tax expense on pre-tax adjustments | — | — | — | — | 1,550 | |||||||||||||||
| Non-GAAP | $ | 35,871 | $ | 1,668 | $ | 8,681 | $ | 9,769 | $ | (663 | ) | |||||||||
The comparative periods in 2017 were revised for immaterial errors.
Reconciliation of Non-GAAP Measures (continued)
| Nine Months Ended September 30, 2018 | ||||||||||||||||||||
| Cost of revenue |
Selling, distribution and marketing |
General and administrative |
Research and development |
Income tax expense (benefit) |
||||||||||||||||
| GAAP | $ | 132,680 | $ | 5,560 | $ | 36,074 | $ | 40,830 | $ | (2,137 | ) | |||||||||
| Intangible amortization | (1,602 | ) | — | (120 | ) | — | — | |||||||||||||
| Share-based compensation | (3,025 | ) | (297 | ) | (8,251 | ) | (1,197 | ) | — | |||||||||||
| Impairment of long-lived assets | (77 | ) | — | (4 | ) | (309 | ) | — | ||||||||||||
| Income tax expense on pre-tax adjustments | — | — | — | — | 3,040 | |||||||||||||||
| Non-GAAP | $ | 127,976 | $ | 5,263 | $ | 27,699 | $ | 39,324 | $ | 903 | ||||||||||
| Nine Months Ended September 30, 2017 | ||||||||||||||||||||
| Cost of revenue |
Selling, distribution and marketing |
General and administrative |
Research and development |
Income tax expense (benefit) |
||||||||||||||||
| GAAP | $ | 109,754 | $ | 4,831 | $ | 35,237 | $ | 32,117 | $ | (466 | ) | |||||||||
| Intangible amortization | (2,031 | ) | — | (108 | ) | — | — | |||||||||||||
| Share-based compensation | (2,843 | ) | (237 | ) | (8,715 | ) | (1,110 | ) | — | |||||||||||
| Income tax expense on pre-tax adjustments | — | — | — | — | 4,685 | |||||||||||||||
| Non-GAAP | $ | 104,880 | $ | 4,594 | $ | 26,414 | $ | 31,007 | $ | 4,219 | ||||||||||
The comparative periods in 2017 were revised for immaterial errors.