News Detail
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2021
August 9, 2021
Reports Net Revenues of
Second Quarter Highlights
- Net revenues of
$101.7 million for the second quarter - GAAP net income of
$7.8 million , or$0.16 per share, for the second quarter - Adjusted non-GAAP net income of
$10.6 million , or$0.21 per share, for the second quarter
Dr.
Three Months Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Net revenues | $ | 101,663 | $ | 85,806 | $ | 204,683 | $ | 170,494 | ||||||||
GAAP net income (loss) attributable to Amphastar | $ | 7,767 | $ | (192 | ) | $ | 12,808 | $ | 3,757 | |||||||
Adjusted non-GAAP net income attributable to Amphastar* | $ | 10,615 | $ | 7,610 | $ | 24,168 | $ | 15,993 | ||||||||
GAAP diluted EPS attributable to Amphastar stockholders | $ | 0.16 | $ | (0.00 | ) | $ | 0.26 | $ | 0.08 | |||||||
Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders* | $ | 0.21 | $ | 0.16 | $ | 0.49 | $ | 0.33 |
* Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders 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.
Second Quarter Results
Three Months Ended | Change | |||||||||||||||
2021 | 2020 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net revenues: | ||||||||||||||||
Primatene Mist® | $ | 16,680 | $ | 12,468 | $ | 4,212 | 34 | % | ||||||||
Glucagon | 12,131 | - | 12,131 | N/A | ||||||||||||
Lidocaine | 11,594 | 7,608 | 3,986 | 52 | % | |||||||||||
Phytonadione | 10,421 | 10,689 | (268 | ) | (3 | )% | ||||||||||
Enoxaparin | 9,328 | 10,218 | (890 | ) | (9 | )% | ||||||||||
Epinephrine | 9,192 | 6,957 | 2,235 | 32 | % | |||||||||||
Naloxone | 6,625 | 8,723 | (2,098 | ) | (24 | )% | ||||||||||
Other finished pharmaceutical products | 18,751 | 24,272 | (5,521 | ) | (23 | )% | ||||||||||
Total finished pharmaceutical products net revenues | $ | 94,722 | $ | 80,935 | $ | 13,787 | 17 | % | ||||||||
API | 6,941 | 4,871 | 2,070 | 42 | % | |||||||||||
Total net revenues | $ | 101,663 | $ | 85,806 | $ | 15,857 | 18 | % |
Changes in net revenues were primarily driven by:
- Primatene Mist ® increased volumes resulting from:
- The continued success of our nationwide television, radio, and digital marketing campaign
- An increase in our distribution channels throughout 2020 and 2021
- Glucagon for injection emergency kit which was launched in the first quarter of 2021
- Lidocaine and epinephrine sales increased due to higher demand as a result of a market shortage
- Naloxone sales decreased due to lower average selling price resulting from increased competition
- Other finished pharmaceutical product sales decreased due to lower demand, largely due to competitors returning to their normal distribution levels
Three Months Ended | Change | |||||||||||||||
2021 | 2020 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net revenues | $ | 101,663 | $ | 85,806 | $ | 15,857 | 18 | % | ||||||||
Cost of revenues | 54,287 | 52,629 | 1,658 | 3 | % | |||||||||||
Gross profit | $ | 47,376 | $ | 33,177 | $ | 14,199 | 43 | % | ||||||||
as % of net revenues | 47 | % | 39 | % | ||||||||||||
Changes in the cost of revenues and the resulting increase in gross margin were primarily driven by:
- Increased sales of higher margin products such as Primatene Mist ® , epinephrine injection multi-dose vials, and glucagon
- Partially offset by increased cost for heparin, which is used as the starting material for enoxaparin
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2021 | 2020 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Selling, distribution, and marketing | $ | 4,129 | $ | 4,026 | $ | 103 | 3 | % | ||||||||
General and administrative | 14,565 | 15,924 | (1,359 | ) | (9 | )% | ||||||||||
Research and development | 18,122 | 16,149 | 1,973 | 12 | % | |||||||||||
Non-operating income, net | 3,657 | 1,418 | 2,239 | 158 | % |
- Selling, distribution, and marketing expenses increased due to the marketing and distribution expenses for Primatene Mist ®
- General and administrative expenses decreased primarily due to cash compensation and share-based compensation expense relating to the separation agreement that we entered into with a former executive during the second quarter of 2020, which was partially offset by an increase in legal expenses in the second quarter of 2021
- Research and development expenses increased due to an increase in salaries and personnel-related expenses as well as an increase in depreciation expense
- Non-operating income, net, increased as a result of a reduction in the accrual for the settlement of the Aventis litigation during the quarter by
$2.7 million based on the settlement agreement with Aventis during the quarter
Cash flow provided by operating activities for the six months ended
Share Buyback Program
On
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
The timing and actual number of shares repurchased will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions.
Debt Refinancing
On
Pipeline Information
The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately
Amphastar's Chinese subsidiary, ANP, currently has 17 Drug
Company Information
Amphastar is a bio-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 and resources are available at www.amphastar.com .
Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar ® , Primatene Mist ® , 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
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) 407-0989 or (201) 389-0921 for international callers, five minutes before the conference.
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 our expectations regarding future financial performance, backlog, sales and marketing of our products, market size and growth, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, our share buyback program and other future events, such as the impact of the COVID-19 pandemic including its variants and related responses of business and governments to the pandemic on our operations and personnel, and on commercial activity and demand across our business operations and results of operations. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our 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
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 | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Net revenues | $ | 101,663 | $ | 85,806 | $ | 204,683 | $ | 170,494 | ||||||||
Cost of revenues | 54,287 | 52,629 | 112,361 | 100,494 | ||||||||||||
Gross profit | 47,376 | 33,177 | 92,322 | 70,000 | ||||||||||||
Operating expenses: | ||||||||||||||||
Selling, distribution, and marketing | 4,129 | 4,026 | 8,666 | 7,320 | ||||||||||||
General and administrative | 14,565 | 15,924 | 29,903 | 26,670 | ||||||||||||
Research and development | 18,122 | 16,149 | 32,887 | 31,452 | ||||||||||||
Total operating expenses | 36,816 | 36,099 | 71,456 | 65,442 | ||||||||||||
Income (loss) from operations | 10,560 | (2,922 | ) | 20,866 | 4,558 | |||||||||||
Non-operating income (expense), net | 3,657 | 1,418 | (1,535 | ) | (257 | ) | ||||||||||
Income (loss) before income taxes | 14,217 | (1,504 | ) | 19,331 | 4,301 | |||||||||||
Income tax provision (benefit) | 5,595 | (75 | ) | 6,750 | 2,205 | |||||||||||
Net income (loss) | $ | 8,622 | $ | (1,429 | ) | $ | 12,581 | $ | 2,096 | |||||||
Net income (loss) attributable to non-controlling interests | $ | 855 | $ | (1,237 | ) | $ | (227 | ) | $ | (1,661 | ) | |||||
Net income (loss) attributable to Amphastar | $ | 7,767 | $ | (192 | ) | $ | 12,808 | $ | 3,757 | |||||||
Net income (loss) per share attributable to Amphastar stockholders: | ||||||||||||||||
Basic | $ | 0.16 | $ | (0.00 | ) | $ | 0.27 | $ | 0.08 | |||||||
Diluted | $ | 0.16 | $ | (0.00 | ) | $ | 0.26 | $ | 0.08 | |||||||
Weighted-average shares used to compute net income (loss) per share attributable to Amphastar stockholders: | ||||||||||||||||
Basic | 47,731 | 46,753 | 47,626 | 46,581 | ||||||||||||
Diluted | 49,552 | 46,753 | 49,535 | 48,458 |
Table II
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share data)
2021 | 2020 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 105,432 | $ | 92,642 | ||||
Restricted cash | 19,159 | 1,865 | ||||||
Short-term investments | 11,745 | 12,977 | ||||||
Restricted short-term investments | 2,200 | 2,200 | ||||||
Accounts receivable, net | 67,893 | 66,005 | ||||||
Inventories | 97,931 | 96,831 | ||||||
Income tax refunds and deposits | 718 | 385 | ||||||
Prepaid expenses and other assets | 5,895 | 6,777 | ||||||
Total current assets | 310,973 | 279,682 | ||||||
Property, plant, and equipment, net | 252,590 | 260,055 | ||||||
Finance lease right-of-use assets | 540 | 612 | ||||||
Operating lease right-of-use assets | 27,169 | 20,042 | ||||||
40,049 | 40,615 | |||||||
Other assets | 9,444 | 5,250 | ||||||
Deferred tax assets | 24,980 | 24,980 | ||||||
Total assets | $ | 665,745 | $ | 631,236 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 109,604 | $ | 95,504 | ||||
Income taxes payable | 3,631 | 1,077 | ||||||
Current portion of long-term debt | 8,077 | 12,263 | ||||||
Current portion of operating lease liabilities | 3,237 | 3,357 | ||||||
Total current liabilities | 124,549 | 112,201 | ||||||
Long-term reserve for income tax liabilities | 4,709 | 4,709 | ||||||
Long-term debt, net of current portion | 30,460 | 34,186 | ||||||
Long-term operating lease liabilities, net of current portion | 24,555 | 17,464 | ||||||
Deferred tax liabilities | 765 | 741 | ||||||
Other long-term liabilities | 13,484 | 13,212 | ||||||
Total liabilities | 198,522 | 182,513 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock: par value | - | - | ||||||
Common stock: par value | 6 | 5 | ||||||
Additional paid-in capital | 427,301 | 410,061 | ||||||
Retained earnings | 130,581 | 117,773 | ||||||
Accumulated other comprehensive loss | (4,931 | ) | (3,721 | ) | ||||
(130,964 | ) | (121,812 | ) | |||||
421,993 | 402,306 | |||||||
Non-controlling interests | 45,230 | 46,417 | ||||||
Total equity | 467,223 | 448,723 | ||||||
Total liabilities and stockholders' equity | $ | 665,745 | $ | 631,236 | ||||
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
Three Months Ended | Six Months Ended | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
GAAP net income (loss) | $ | 8,622 | $ | (1,429 | ) | $ | 12,581 | $ | 2,096 | |||||||
Adjusted for: | ||||||||||||||||
Intangible amortization | 277 | 251 | 553 | 509 | ||||||||||||
Share-based compensation | 6,084 | 4,194 | 10,918 | 9,476 | ||||||||||||
Impairment of long-lived assets | 308 | 16 | 314 | 30 | ||||||||||||
Expense related to executive separation agreement | - | 4,869 | - | 4,869 | ||||||||||||
Reserves for litigation and settlements | (2,704 | ) | - | 2,991 | - | |||||||||||
Income tax (benefit) provision on pre-tax adjustments | (306 | ) | (1,445 | ) | (2,535 | ) | (2,449 | ) | ||||||||
Non-GAAP net income | $ | 12,281 | $ | 6,456 | $ | 24,822 | $ | 14,531 | ||||||||
Non-GAAP net income (loss) attributable to non-controlling interests | $ | 1,666 | $ | (1,154 | ) | $ | 654 | $ | (1,462 | ) | ||||||
Non-GAAP net income attributable to Amphastar | $ | 10,615 | $ | 7,610 | $ | 24,168 | $ | 15,993 | ||||||||
Non-GAAP net income per share attributable to Amphastar stockholders: | ||||||||||||||||
Basic | $ | 0.22 | $ | 0.16 | $ | 0.51 | $ | 0.34 | ||||||||
Diluted | $ | 0.21 | $ | 0.16 | $ | 0.49 | $ | 0.33 | ||||||||
Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders: | ||||||||||||||||
Basic | 47,731 | 46,753 | 47,626 | 46,581 | ||||||||||||
Diluted | 49,552 | 48,668 | 49,535 | 48,458 | ||||||||||||
Three Months Ended | ||||||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net | Income tax provision (benefit) | Non-controlling interest adjustment | ||||||||||||||||||||||
GAAP | $ | 54,287 | $ | 4,129 | $ | 14,565 | $ | 18,122 | $ | 3,657 | $ | 5,595 | $ | 855 | ||||||||||||||
Intangible amortization | (244 | ) | - | (33 | ) | - | - | - | 11 | |||||||||||||||||||
Share-based compensation | (932 | ) | (147 | ) | (4,568 | ) | (437 | ) | - | - | 791 | |||||||||||||||||
Impairment of long-lived assets | (84 | ) | - | (2 | ) | (222 | ) | - | - | 1 | ||||||||||||||||||
Reserves for litigation and settlements | - | - | - | - | (2,704 | ) | - | - | ||||||||||||||||||||
Income tax provision (benefit) on pre-tax adjustments | - | - | - | - | - | 306 | 8 | |||||||||||||||||||||
Non-GAAP | $ | 53,027 | $ | 3,982 | $ | 9,962 | $ | 17,463 | $ | 953 | $ | 5,901 | $ | 1,666 | ||||||||||||||
Reconciliation of Non-GAAP Measures (continued)
Three Months Ended | ||||||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non- operating income (expense), net | Income tax provision (benefit) | Non-Controlling interest adjustment | ||||||||||||||||||||||
GAAP | $ | 52,629 | $ | 4,026 | $ | 15,924 | $ | 16,149 | $ | 1,418 | $ | (75 | ) | $ | (1,237 | ) | ||||||||||||
Intangible amortization | (217 | ) | - | (34 | ) | - | - | - | 11 | |||||||||||||||||||
Share-based compensation | (970 | ) | (123 | ) | (2,733 | ) | (368 | ) | - | - | 86 | |||||||||||||||||
Impairment of long-lived assets | (3 | ) | - | (13 | ) | - | - | - | 6 | |||||||||||||||||||
Expense related to executive separation agreement | - | - | (4,869 | ) | - | - | - | - | ||||||||||||||||||||
Income tax provision (benefit) on pre-tax adjustments | - | - | - | - | - | 1,445 | (20 | ) | ||||||||||||||||||||
Non-GAAP | $ | 51,439 | $ | 3,903 | $ | 8,275 | $ | 15,781 | $ | 1,418 | $ | 1,370 | $ | (1,154 | ) | |||||||||||||
Six Months Ended | ||||||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net | Income tax provision (benefit) | Non-controlling interest adjustment | ||||||||||||||||||||||
GAAP | $ | 112,361 | $ | 8,666 | $ | 29,903 | $ | 32,887 | $ | (1,535 | ) | $ | 6,750 | $ | (227 | ) | ||||||||||||
Intangible amortization | (486 | ) | - | (67 | ) | - | - | - | 22 | |||||||||||||||||||
Share-based compensation | (2,078 | ) | (274 | ) | (7,536 | ) | (1,030 | ) | - | - | 862 | |||||||||||||||||
Impairment of long-lived assets | (84 | ) | - | (8 | ) | (222 | ) | - | - | 3 | ||||||||||||||||||
Reserves for litigation and settlements | - | - | (1,295 | ) | - | 1,696 | - | - | ||||||||||||||||||||
Income tax provision (benefit) on pre-tax adjustments | - | - | - | - | - | 2,535 | (6 | ) | ||||||||||||||||||||
Non-GAAP | $ | 109,713 | $ | 8,392 | $ | 20,997 | $ | 31,635 | $ | 161 | $ | 9,285 | $ | 654 | ||||||||||||||
Six Months Ended | ||||||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net | Income tax provision (benefit) | Non-controlling interest adjustment | ||||||||||||||||||||||
GAAP | $ | 100,494 | $ | 7,320 | $ | 26,670 | $ | 31,452 | $ | (257 | ) | $ | 2,205 | $ | (1,661 | ) | ||||||||||||
Intangible amortization | (441 | ) | - | (68 | ) | - | - | - | 22 | |||||||||||||||||||
Share-based compensation | (2,329 | ) | (230 | ) | (5,952 | ) | (965 | ) | - | - | 213 | |||||||||||||||||
Impairment of long-lived assets | (13 | ) | - | (17 | ) | - | - | - | 7 | |||||||||||||||||||
Expense related to executive separation agreement | - | - | (4,869 | ) | - | - | - | - | ||||||||||||||||||||
Income tax provision (benefit) on pre-tax adjustments | - | - | - | - | - | 2,449 | (43 | ) | ||||||||||||||||||||
Non-GAAP | $ | 97,711 | $ | 7,090 | $ | 15,764 | $ | 30,487 | $ | (257 | ) | $ | 4,654 | $ | (1,462 | ) | ||||||||||||
SOURCE:
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