News Detail
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2024
May 8, 2024
Reports Net Revenues of
First Quarter Highlights
- Net revenues of
$171.8 million for the first quarter - GAAP net income of
$43.2 million , or$0.81 per share, for the first quarter - Adjusted non-GAAP net income of
$55.3 million , or$1.04 per share, for the first quarter
Dr.
Three Months Ended | ||||||||
2024 | 2023 | |||||||
(in thousands, except per share data) | ||||||||
Net revenues | $ | 171,836 | $ | 140,022 | ||||
GAAP net income | $ | 43,177 | $ | 26,032 | ||||
Adjusted non-GAAP net income* | $ | 55,296 | $ | 32,143 | ||||
GAAP diluted EPS | $ | 0.81 | $ | 0.50 | ||||
Adjusted non-GAAP diluted EPS* | $ | 1.04 | $ | 0.62 |
____________________________________
* 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.
First Quarter Results
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2024 | 2023 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Product revenues: | ||||||||||||||||
Glucagon | $ | 28,535 | $ | 25,696 | $ | 2,839 | 11 | % | ||||||||
Epinephrine | 26,110 | 20,091 | 6,019 | 30 | % | |||||||||||
Primatene MIST ® | 24,166 | 23,483 | 683 | 3 | % | |||||||||||
BAQSIMI ® | 13,843 | - | 13,843 | N/A | ||||||||||||
Lidocaine | 12,773 | 13,646 | (873 | ) | (6 | )% | ||||||||||
Phytonadione | 9,973 | 7,713 | 2,260 | 29 | % | |||||||||||
Enoxaparin | 7,096 | 9,867 | (2,771 | ) | (28 | )% | ||||||||||
Naloxone | 4,287 | 4,957 | (670 | ) | (14 | )% | ||||||||||
Other finished pharmaceutical products | 29,154 | 30,557 | (1,403 | ) | (5 | )% | ||||||||||
Total finished pharmaceutical products net revenues | $ | 155,937 | $ | 136,010 | $ | 19,927 | 15 | % | ||||||||
API | 1,692 | 4,012 | (2,320 | ) | (58 | )% | ||||||||||
Other revenues | 14,207 | - | 14,207 | N/A | ||||||||||||
Total net revenues | $ | 171,836 | $ | 140,022 | $ | 31,814 | 23 | % |
Changes in net revenues as compared to the first quarter of the prior year were primarily driven by:
- BAQSIMI ® sales consisting of
$13.8 million in sales made by the Company directly to its customers which are recorded as part of Product Revenues, net, and$24.6 million in sales made by Lilly on behalf of the Company under the Transition Services Agreement ("TSA"), which resulted in a net payment to the Company of$14.2 million after deducting cost of sales and other expenses and was recorded in Other Revenues - Glucagon sales increased due to a growth in unit volumes, impacting sales by
$1.8 million as well as a higher average selling price, impacting sales by$1.1 million as we launched glucagon inCanada - Epinephrine and Phytonadione sales increased primarily due to an increase in unit volumes, as a result of other supplier shortages
- Primatene MIST ® sales increased primarily due to an increase in unit volumes and a higher average selling price
- Lidocaine sales decreased primarily due to a decrease in unit volumes, as a result of other suppliers returning to their historical distribution levels
- Enoxaparin and Naloxone sales decreased primarily due to a decrease in unit volumes
- Other finished pharmaceutical product sales changes were primarily due to:
- Lower unit volumes of MPA, as our Active Pharmaceutical Ingredient ("API") supplier discontinued making the active ingredient
- This decrease was partially offset by higher unit volumes of dextrose and sodium bicarbonate caused by other supplier shortages during the quarter
- Launch of regadenoson in
April 2023
- API sales decreased primarily due to the timing of customer purchases
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2024 | 2023 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Net revenues | $ | 171,836 | $ | 140,022 | $ | 31,814 | $ | 23 | ||||||||
Cost of revenues | 81,736 | 66,182 | 15,554 | 24 | % | |||||||||||
Gross profit | $ | 90,100 | $ | 73,840 | $ | 16,260 | $ | 22 | % | |||||||
as % of net revenues | 52.4 | % | 52.7 | % |
Changes in the cost of revenues and the resulting gross margins were primarily driven by:
- Increase in depreciation and amortization expense related to the acquired BAQSIMI ® assets
- Increases in labor costs and certain component costs
- Charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value
- These factors were partially offset by increased sales of higher-margin products:
- BAQSIMI ® which was acquired in
June 2023 - Glucagon, Primatene MIST ® , and epinephrine
- Regadenoson launched in
April 2023
- BAQSIMI ® which was acquired in
Three Months Ended | ||||||||||||||||
Change | ||||||||||||||||
2024 | 2023 | Dollars | % | |||||||||||||
(in thousands) | ||||||||||||||||
Selling, distribution, and marketing | $ | 9,371 | $ | 7,109 | $ | 2,262 | 32 | % | ||||||||
General and administrative | 15,676 | 13,483 | 2,193 | 16 | % | |||||||||||
Research and development | 17,043 | 19,815 | (2,772 | ) | (14) | % | ||||||||||
Non-operating (expenses) income, net | (134 | ) | 136 | (270 | ) | NM |
- Selling, distribution, and marketing expenses increased primarily due to the expansion of our sales and marketing efforts related to BAQSIMI ®
- General and administrative expenses increased primarily due to an increase in expenses related to BAQSIMI ®
- Research and development expenses decreased due to the timing of clinical trial expenses, as well as a decrease in materials and supply expenses, primarily related to our insulin and inhalation pipeline products, as a result of a ramp-up in 2023
Cash flow provided by operating activities for the three months ended
Pipeline Information
The Company currently has four abbreviated new drug applications ("ANDAs") on file with the
Amphastar's Chinese subsidiary,
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 TM , 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 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 ® , including its potential for continued revenue growth, the success of our integration 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 | ||||||||
2024 | 2023 | |||||||
Net revenues: | ||||||||
Product revenues, net | $ | 157,629 | $ | 140,022 | ||||
Other revenues | 14,207 | - | ||||||
Total net revenues | 171,836 | 140,022 | ||||||
Cost of revenues | 81,736 | 66,182 | ||||||
Gross profit | 90,100 | 73,840 | ||||||
Operating expenses: | ||||||||
Selling, distribution, and marketing | 9,371 | 7,109 | ||||||
General and administrative | 15,676 | 13,483 | ||||||
Research and development | 17,043 | 19,815 | ||||||
Total operating expenses | 42,090 | 40,407 | ||||||
Income from operations | 48,010 | 33,433 | ||||||
Non-operating (expenses) income, net | (134 | ) | 136 | |||||
Income before income taxes | 47,876 | 33,569 | ||||||
Income tax provision | 4,126 | 6,752 | ||||||
Net income before equity in losses of unconsolidated affiliate | 43,750 | 26,817 | ||||||
Equity in losses of unconsolidated affiliate | (573 | ) | (785 | ) | ||||
Net income | $ | 43,177 | $ | 26,032 | ||||
Net income per share: | ||||||||
Basic | $ | 0.90 | $ | 0.54 | ||||
Diluted | $ | 0.81 | $ | 0.50 | ||||
Weighted-average shares used to compute net income per share: | ||||||||
Basic | 48,212 | 48,000 | ||||||
Diluted | 53,013 | 51,970 |
Table II
Condensed Consolidated Balance Sheet
(Unaudited; in thousands, except per share data)
2024 | 2023 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 201,148 | $ | 144,296 | ||||
Restricted cash | 235 | 235 | ||||||
Short-term investments | 88,407 | 112,510 | ||||||
Restricted short-term investments | 2,200 | 2,200 | ||||||
Accounts receivable, net | 138,114 | 114,943 | ||||||
Inventories | 115,494 | 105,833 | ||||||
Income tax refunds and deposits | 784 | 526 | ||||||
Prepaid expenses and other assets | 8,696 | 9,057 | ||||||
Total current assets | 555,078 | 489,600 | ||||||
Property, plant, and equipment, net | 288,523 | 282,746 | ||||||
Finance lease right-of-use assets | 516 | 564 | ||||||
Operating lease right-of-use assets | 31,352 | 32,333 | ||||||
Investment in unconsolidated affiliate | - | 527 | ||||||
607,064 | 613,295 | |||||||
Long-term investments | 15,163 | 14,685 | ||||||
Other assets | 23,369 | 25,910 | ||||||
Deferred tax assets | 53,252 | 53,252 | ||||||
Total assets | $ | 1,574,317 | $ | 1,512,912 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable and accrued liabilities | $ | 116,697 | $ | 93,366 | ||||
Accrued payments for BAQSIMI ® | 128,245 | 126,090 | ||||||
Income taxes payable | 5,857 | 1,609 | ||||||
Current portion of long-term debt | 428 | 436 | ||||||
Current portion of operating lease liabilities | 3,942 | 3,906 | ||||||
Total current liabilities | 255,169 | 225,407 | ||||||
Long-term reserve for income tax liabilities | 6,066 | 6,066 | ||||||
Long-term debt, net of current portion and unamortized debt issuance costs | 594,006 | 589,579 | ||||||
Long-term operating lease liabilities, net of current portion | 28,739 | 29,721 | ||||||
Other long-term liabilities | 17,981 | 22,718 | ||||||
Total liabilities | 901,961 | 873,491 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Preferred stock: par value | - | - | ||||||
Common stock: par value | 6 | 6 | ||||||
Additional paid-in capital | 476,072 | 486,056 | ||||||
Retained earnings | 452,445 | 409,268 | ||||||
Accumulated other comprehensive loss | (8,769 | ) | (8,478 | ) | ||||
(247,398 | ) | (247,431 | ) | |||||
Total equity | 672,356 | 639,421 | ||||||
Total liabilities and stockholders' equity | $ | 1,574,317 | $ | 1,512,912 |
Table III
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
Three Months Ended | ||||||||
2024 | 2023 | |||||||
GAAP net income | $ | 43,177 | $ | 26,032 | ||||
Adjusted for: | ||||||||
Intangible asset amortization | 6,167 | 241 | ||||||
Share-based compensation | 7,360 | 6,111 | ||||||
Expenses related to BAQSIMI ® acquisition | 1,826 | 1,217 | ||||||
Income tax provision on pre-tax adjustments | (3,234 | ) | (1,458 | ) | ||||
Adjusted non-GAAP net income | $ | 55,296 | $ | 32,143 | ||||
Adjusted non-GAAP net income per share: | ||||||||
Basic | $ | 1.15 | $ | 0.67 | ||||
Diluted | $ | 1.04 | $ | 0.62 | ||||
Weighted-average shares used to compute adjusted non-GAAP net income per share: | ||||||||
Basic | 48,212 | 48,000 | ||||||
Diluted | 53,013 | 51,970 |
Three Months Ended | ||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non-operating (expenses) income, net | Income tax provision | |||||||||||||||||||
GAAP | $ | 81,736 | $ | 9,371 | $ | 15,676 | $ | 17,043 | $ | (134 | ) | $ | 4,126 | |||||||||||
Intangible asset amortization | (6,147 | ) | - | (3 | ) | (17 | ) | - | - | |||||||||||||||
Share-based compensation | (2,125 | ) | (260 | ) | (3,876 | ) | (1,099 | ) | - | - | ||||||||||||||
Expenses related to BAQSIMI ® acquisition | - | - | - | - | 1,826 | - | ||||||||||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 3,234 | ||||||||||||||||||
Non-GAAP | $ | 73,464 | $ | 9,111 | $ | 11,797 | $ | 15,927 | $ | 1,692 | $ | 7,360 | ||||||||||||
Three Months Ended | ||||||||||||||||||||||||
Cost of revenue | Selling, distribution and marketing | General and administrative | Research and development | Non-operating (expenses) income, net | Income tax provision | |||||||||||||||||||
GAAP | $ | 66,182 | $ | 7,109 | $ | 13,483 | $ | 19,815 | $ | 136 | $ | 6,752 | ||||||||||||
Intangible asset amortization | (211 | ) | - | (30 | ) | - | - | - | ||||||||||||||||
Share-based compensation | (1,706 | ) | (209 | ) | (3,357 | ) | (839 | ) | - | - | ||||||||||||||
Expenses related to BAQSIMI ® acquisition | - | - | (1,217 | ) | - | - | - | |||||||||||||||||
Income tax provision on pre-tax adjustments | - | - | - | - | - | 1,458 | ||||||||||||||||||
Non-GAAP | $ | 64,265 | $ | 6,900 | $ | 8,879 | $ | 18,976 | $ | 136 | $ | 8,210 |
SOURCE:
View the original press release on accesswire.com