News Detail
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2023
November 8, 2023
Reports Net Revenues of
Third Quarter Highlights
- Net revenues of
$180.6 million for the third quarter - GAAP net income of
$49.2 million , or$0.91 per share, for the third quarter - Adjusted non-GAAP net income of
$61.9 million , or$1.15 per share, for the third quarter
Dr.
Three Months Ended | Nine Months Ended | |||||||||||||||
2023 | 2022 | 2023 | 2022 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Net revenues | $ | 180,556 | $ | 120,129 | $ | 466,290 | $ | 363,964 | ||||||||
GAAP net income | $ | 49,222 | $ | 15,874 | $ | 101,378 | $ | 57,473 | ||||||||
Adjusted non-GAAP net income* | $ | 61,898 | $ | 20,232 | $ | 128,823 | $ | 65,548 | ||||||||
GAAP diluted EPS | $ | 0.91 | $ | 0.30 | $ | 1.91 | $ | 1.09 | ||||||||
Adjusted non-GAAP diluted EPS* | $ | 1.15 | $ | 0.38 | $ | 2.43 | $ | 1.24 |
______________________________
* Adjusted non-GAAP net income 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.
Third Quarter Results
Three Months Ended | |||||||||||||||
Change | |||||||||||||||
2023 | 2022 | Dollars | % | ||||||||||||
(in thousands) | |||||||||||||||
Product revenues: | |||||||||||||||
Glucagon | $ | 29,514 | $ | 14,224 | $ | 15,290 | 107 | % | |||||||
Primatene MIST® | 24,834 | 18,359 | 6,475 | 35 | % | ||||||||||
Epinephrine | 20,199 | 19,502 | 697 | 4 | % | ||||||||||
Lidocaine | 15,522 | 12,621 | 2,901 | 23 | % | ||||||||||
Enoxaparin | 7,702 | 7,983 | (281 | ) | (4 | )% | |||||||||
Phytonadione | 7,449 | 13,978 | (6,529 | ) | (47 | )% | |||||||||
Naloxone | 4,715 | 6,818 | (2,103 | ) | (31 | )% | |||||||||
Other finished pharmaceutical products | 37,730 | 23,635 | 14,095 | 60 | % | ||||||||||
Total finished pharmaceutical products net revenues | $ | 147,665 | $ | 117,120 | $ | 30,545 | 26 | % | |||||||
API | 4,190 | 3,009 | 1,181 | 39 | % | ||||||||||
Other revenues | 28,701 | - | 28,701 | N/A | |||||||||||
Total product revenues, net | $ | 180,556 | $ | 120,129 | $ | 60,427 | 50 | % |
Changes in product revenues as compared to the third quarter of the prior year were primarily driven by:
- Glucagon sales increased primarily due to an increase in unit volumes, as a result of two suppliers discontinuing their glucagon injection products at the end of 2022
- Primatene MIST® sales increased due to an increase in unit volumes
- Lidocaine sales increased primarily due to an increase in unit volumes, as a result of supplier shortages
- Phytonadione sales decreased due to lower unit volumes, as a result of increased competition
- Sales of naloxone decreased due to lower unit volumes, as a result of increased competition
- Other finished pharmaceutical product sales increased primarily due to:
- Higher unit volumes of dextrose, atropine, calcium chloride, and sodium bicarbonate, due to increased demand caused by supplier shortages during the quarter
- A full quarter of sales for vasopressin, which was launched in
August 2022 - Launch of regadenoson in
April 2023
- Active Pharmaceutical ingredient ("API") sales increased primarily due to the timing of customer purchases
Other revenues are comprised of net revenues from the sales of BAQSIMI® of
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2023 | 2022 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net revenues | $ | 180,556 | $ | 120,129 | $ | 60,427 | 50% | |||||||||
Cost of revenues | 72,153 | 61,619 | 10,534 | 17% | ||||||||||||
Gross profit | $ | 108,403 | $ | 58,510 | $ | 49,893 | 85% | |||||||||
as % of net revenues | 60% | 49% |
Changes in the cost of revenues and gross margin were primarily driven by:
- Increased sales of higher-margin products such as glucagon and Primatene MIST®, the sales of ganirelix and vasopressin that were launched in 2022, as well as the sales of regadenoson, which we launched in
April 2023 - As a result of the
TSA , the revenue relating to BAQSIMI® is recognized on a net basis within net revenues.
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2023 | 2022 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Selling, distribution, and marketing | $ | 6,407 | $ | 4,785 | $ | 1,623 | 34 | % | ||||||||
General and administrative | 12,654 | 11,984 | 670 | 6% | % | |||||||||||
Research and development | 16,664 | 18,514 | (1,850 | ) | (10) | % | ||||||||||
Non-operating income (expense), net | (9,041 | ) | (632 | ) | (8,409 | ) | NM |
- Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales force related to BAQSIMI®, as well as an increase in advertising spending for Primatene MIST®
- General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI®, which was partially offset by a decrease in legal fees
- Research and development expenses decreased due to:
- Decrease in clinical trials expense
- Decreases in materials and supply expense, as a result of a ramp-up of expenses in 2022 for AMP-018 and our insulin pipeline products
- This decrease was partially offset by an increase in salary and personnel-related expenses
- The change in non-operating expenses, net is primarily a result of:
- Foreign currency fluctuations
- Costs incurred in connection with the syndicated credit agreement we entered into with
Wells Fargo Bank , as syndication agent, to finance the acquisition of BAQSIMI® - Mark-to-market adjustments relating to our interest rate swap contracts
Cash flow provided by operating activities for the nine months ended
Pipeline Information
The Company currently has three ANDAs on file with the FDA targeting products with a market size of over
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®, BAQSIMI®, Primatene MIST®, REXTOVY®, 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, ten 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 and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, 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, the timing and results of clinical trials, the prospective benefits of the acquisition of BAQSIMI®, and other future events, including potential contingent consideration amounts and terms related to the acquisition of BAQSIMI®, the anticipated benefits of BAQSIMI® to our product portfolio, Amphastar's commitment to strategically maximizing the commercial potential of BAQSIMI®, and other future events. 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) 476-3416
Table I
Condensed Consolidated Statement of Operations
(Unaudited; in thousands, except per share data)
Three Months Ended | Nine Months Ended | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
Net revenues: | |||||||||||
Product revenues, net | $ | 151,855 | $ | 120,129 | $ | 437,589 | $ | 363,964 | |||
Other revenues | 28,701 | - | 28,701 | - | |||||||
Net revenues | 180,556 | 120,129 | 466,290 | 363,964 | |||||||
Cost of revenues | 72,153 | 61,619 | 211,309 | 186,272 | |||||||
Gross profit | 108,403 | 58,510 | 254,981 | 177,692 | |||||||
Operating expenses: | |||||||||||
Selling, distribution, and marketing | 6,407 | 4,784 | 20,234 | 16,059 | |||||||
General and administrative | 12,654 | 11,984 | 38,418 | 34,433 | |||||||
Research and development | 16,664 | 18,514 | 53,322 | 57,535 | |||||||
Total operating expenses | 35,725 | 35,282 | 111,974 | 108,027 | |||||||
Income from operations | 72,678 | 23,228 | 143,007 | 69,665 | |||||||
Non-operating income (expenses), net | (9,041) | (632) | (12,993) | 5,115 | |||||||
Income before income taxes | 63,637 | 22,596 | 130,014 | 74,780 | |||||||
Income tax provision | 14,025 | 6,559 | 27,160 | 16,187 | |||||||
Net income before equity in losses of unconsolidated affiliate | 49,612 | 16,037 | 102,854 | 58,593 | |||||||
Equity in losses of unconsolidated affiliate | (390) | (163) | (1,476) | (1,120) | |||||||
Net income | $ | 49,222 | $ | 15,874 | $ | 101,378 | $ | 57,473 | |||
Net income per share: | |||||||||||
Basic | $ | 1.01 | $ | 0.32 | $ | 2.10 | $ | 1.18 | |||
Diluted | $ | 0.91 | $ | 0.30 | $ | 1.91 | $ | 1.09 | |||
Weighted-average shares used to compute net income per share: | |||||||||||
Basic | 48,701 | 48,904 | 48,368 | 48,635 | |||||||
Diluted | 53,921 | 52,788 | 52,997 | 52,665 |
Table II
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share data)
2023 | 2022 | ||||
(unaudited) | |||||
ASSETS | |||||
Current assets: | |||||
Cash and cash equivalents | $ | 266,778 | $ | 156,098 | |
Restricted cash | 4,259 | 235 | |||
Short-term investments | 33,098 | 19,664 | |||
Restricted short-term investments | 2,200 | 2,200 | |||
Accounts receivable, net | 118,990 | 88,804 | |||
Inventories | 109,978 | 103,584 | |||
Income tax refunds and deposits | 1,506 | 171 | |||
Prepaid expenses and other assets | 6,196 | 7,563 | |||
Total current assets | 543,005 | 378,319 | |||
Property, plant, and equipment, net | 280,836 | 238,266 | |||
Finance lease right-of-use assets | 610 | 753 | |||
Operating lease right-of-use assets | 32,666 | 25,554 | |||
Investment in unconsolidated affiliate | 1,026 | 2,414 | |||
619,351 | 37,298 | ||||
Long-term investments | 972 | - | |||
Other assets | 25,299 | 20,856 | |||
Deferred tax assets | 40,868 | 38,527 | |||
Total assets | $ | 1,544,633 | $ | 741,987 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
Current liabilities: | |||||
Accounts payable and accrued liabilities | $ | 222,719 | $ | 84,242 | |
Income taxes payable | 31,092 | 4,571 | |||
Current portion of long-term debt | 433 | 3,046 | |||
Current portion of operating lease liabilities | 3,719 | 3,003 | |||
Total current liabilities | 257,963 | 94,862 | |||
Long-term reserve for income tax liabilities | 7,225 | 7,225 | |||
Long-term debt, net of current portion and unamortized debt issuance costs | 638,206 | 72,839 | |||
Long-term operating lease liabilities, net of current portion | 30,199 | 23,694 | |||
Deferred tax liabilities | 201 | 144 | |||
Other long-term liabilities | 15,699 | 14,565 | |||
Total liabilities | 949,493 | 213,329 | |||
Commitments and contingencies | |||||
Stockholders' equity: | |||||
Preferred stock: par value | - | - | |||
Common stock: par value | 6 | 6 | |||
Additional paid-in capital | 477,880 | 455,077 | |||
Retained earnings | 373,102 | 271,723 | |||
Accumulated other comprehensive loss | (8,411) | (8,624) | |||
(247,437) | (189,524) | ||||
Total equity | 595,140 | 528,658 | |||
Total liabilities and stockholders' equity | $ | 1,544,633 | $ | 741,987 |
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
Three Months Ended | Nine Months Ended | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
GAAP net income | $ | 49,222 | $ | 15,874 | $ | 101,378 | $ | 57,473 | |||
Adjusted for: | |||||||||||
Intangible amortization | 6,168 | 392 | 6,651 | 1,088 | |||||||
Share-based compensation | 4,644 | 4,299 | 15,620 | 13,556 | |||||||
Impairment of long-lived assets | 474 | - | 3,174 | - | |||||||
Expenses related to BAQSIMI?? acquisition | 2,182 | - | 3,682 | - | |||||||
Debt issuance costs | 3,019 | - | 6,043 | - | |||||||
Litigation settlements | - | 800 | - | (4,929) | |||||||
Income tax provision on pre-tax adjustments | (3,811) | (1,133) | (7,725) | (1,640) | |||||||
Non-GAAP net income | $ | 61,898 | $ | 20,232 | $ | 128,823 | $ | 65,548 | |||
Non-GAAP net income per share: | |||||||||||
Basic | $ | 1.27 | $ | 0.41 | $ | 2.66 | $ | 1.35 | |||
Diluted | $ | 1.15 | $ | 0.38 | $ | 2.43 | $ | 1.24 | |||
Weighted-average shares used to compute non-GAAP net income per share: | |||||||||||
Basic | 48,701 | 48,904 | 48,368 | 48,635 | |||||||
Diluted | 53,921 | 52,788 | 52,997 | 52,665 |
Three Months Ended | |||||||||||||||||
Cost of | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net | Income tax provision | ||||||||||||
GAAP | $ | 72,153 | $ | 6,407 | $ | 12,654 | $ | 16,664 | $ | (9,041) | $ | 14,025 | |||||
Intangible amortization | (6,149) | - | 34 | (53) | - | - | |||||||||||
Share-based compensation | (1,004) | (213) | (2,975) | (452) | - | - | |||||||||||
Impairment of long-lived assets | (470) | - | (4) | - | - | - | |||||||||||
Expenses related to BAQSIMI® acquisition | - | - | (357) | - | 1,825 | - | |||||||||||
Debt issuance costs | - | - | - | - | 3,019 | - | |||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 3,811 | |||||||||||
Non-GAAP | $ | 64,530 | $ | 6,194 | $ | 9,352 | $ | 16,159 | $ | (4,197) | $ | 17,836 | |||||
Three Months Ended | |||||||||||||||||
Cost of | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net |
Income | ||||||||||||
GAAP | $ | 61,619 | $ | 4,784 | $ | 11,984 | $ | 18,514 | $ | (632) | $ | 6,559 | |||||
Intangible amortization | (206) | - | (186) | - | - | - | |||||||||||
Share-based compensation | (915) | (178) | (2,810) | (396) | - | - | |||||||||||
Litigation settlements | - | - | (800) | - | - | - | |||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 1,133 | |||||||||||
Non-GAAP | $ | 60,498 | $ | 4,606 | $ | 8,188 | $ | 18,118 | $ | (632) | $ | 7,692 | |||||
Nine Months Ended | |||||||||||||||||
Cost of | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net |
Income | ||||||||||||
GAAP | $ | 211,309 | $ | 20,234 | $ | 38,418 | $ | 53,322 | $ | (12,993) | $ | 27,160 | |||||
Intangible amortization | (6,582) | - | (16) | (53) | - | - | |||||||||||
Share-based compensation | (3,868) | (649) | (9,323) | (1,780) | - | - | |||||||||||
Impairment of long-lived assets | (3,170) | - | (4) | - | - | - | |||||||||||
Expenses related to BAQSIMI® acquisition | - | - | (1,857) | - | 1,825 | - | |||||||||||
Debt issuance costs | - | - | - | - | 6,043 | - | |||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 7,725 | |||||||||||
Non-GAAP | $ | 197,689 | $ | 19,585 | $ | 27,218 | $ | 51,489 | $ | (5,125) | $ | 34,885 | |||||
Nine Months Ended | |||||||||||||||||
Cost of | Selling, distribution and marketing | General and administrative | Research and development | Non-operating income (expense), net |
Income | ||||||||||||
GAAP | $ | 186,272 | $ | 16,059 | $ | 34,433 | $ | 57,535 | $ | 5,115 | $ | 16,187 | |||||
Intangible amortization | (660) | - | (428) | - | - | - | |||||||||||
Share-based compensation | (3,238) | (540) | (8,389) | (1,389) | - | - | |||||||||||
Litigation settlements | - | - | (800) | - | (5,729) | - | |||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 1,640 | |||||||||||
Non-GAAP | $ | 182,374 | $ | 15,519 | $ | 24,816 | $ | 56,146 | $ | (614) | $ | 17,827 |
SOURCE:
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