UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event Reported): November 8, 2021
Amphastar Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
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Delaware |
001-36509 |
33-0702205 |
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(State or Other Jurisdiction of
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(Commission File Number) |
(I.R.S. Employer Identification
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11570 6th Street |
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Rancho Cucamonga, California |
91730 |
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(Address of Principal Executive Offices) |
(Zip Code) |
Registrant's telephone number, including area code: (909) 980-9484
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.0001 per share |
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AMPH |
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The NASDAQ Stock Market LLC |
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 8, 2021, Amphastar Pharmaceuticals, Inc. issued a press release announcing its financial results for the three months ended September 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
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Exhibit No. |
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Description |
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99.1 |
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Press release, dated November 8, 2021, issued by Amphastar Pharmaceuticals, Inc. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: November 8, 2021 |
Amphastar Pharmaceuticals, Inc. |
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By: |
/s/ WILLIAM J. PETERS |
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William J. Peters |
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Chief Financial Officer and Executive Vice President |
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EXHIBIT 99.1
Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2021
Reports Net Revenues of $112.2 Million for the Three Months Ended September 30, 2021
RANCHO CUCAMONGA, CA – November 8, 2021 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended September 30, 2021.
Third Quarter Highlights
| ● | Net revenues of $112.2 million for the third quarter |
| ● | GAAP net income of $29.5 million, or $0.59 per share, for the third quarter |
| ● | Adjusted non-GAAP net income of $23.0 million, or $0.46 per share, for the third quarter |
Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer, commented: “We delivered record sales due to the continued momentum driven by the strength of our glucagon, Primatene Mist® and our epinephrine products. These products should continue to be the primary drivers of growth until we receive further approvals for products in our pipeline, which we project will happen in 2022.”
* Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders are non-GAAP financial measures. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.
Third Quarter Results
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Three Months Ended |
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September 30, |
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Change |
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2021 |
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2020 |
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Dollars |
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% |
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(in thousands) |
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Net revenues: |
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Primatene Mist® |
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$ |
16,561 |
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$ |
12,988 |
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$ |
3,573 |
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28 |
% |
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Epinephrine |
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13,892 |
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5,370 |
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8,522 |
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159 |
% |
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Glucagon |
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12,189 |
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— |
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12,189 |
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N/A |
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Lidocaine |
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11,649 |
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10,657 |
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992 |
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9 |
% |
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Phytonadione |
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11,591 |
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10,470 |
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1,121 |
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11 |
% |
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Enoxaparin |
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8,034 |
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11,647 |
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(3,613) |
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(31) |
% |
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Naloxone |
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8,028 |
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8,739 |
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(711) |
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(8) |
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Other finished pharmaceutical products |
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27,046 |
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21,464 |
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5,582 |
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26 |
% |
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Total finished pharmaceutical products net revenues |
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$ |
108,990 |
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$ |
81,335 |
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$ |
27,655 |
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34 |
% |
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API |
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3,208 |
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2,096 |
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1,112 |
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53 |
% |
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Total net revenues |
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$ |
112,198 |
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$ |
83,431 |
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$ |
28,767 |
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34 |
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Changes in net revenues were primarily driven by:
| ● | Primatene Mist® increased volumes resulting from the continued success of our advertising campaign |
| ● | Glucagon for injection emergency kit, which was launched in the first quarter of 2021 |
| ● | Epinephrine sales increased due to higher demand as a result of competitor shortages |
| ● | Other finished pharmaceutical product sales increased due to higher demand, largely due to competitors shortages |
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, the starting material for enoxaparin, and lower pricing for enoxaparin |
| ● | Selling, distribution, and marketing expenses increased primarily due to the marketing and distribution expenses for Primatene Mist® |
| ● | General and administrative expenses decreased primarily due to a decrease in legal expenses |
| ● | Research and development expenses decreased due to: |
| o | A decrease in clinical trial expense as a result of the completion of one of our clinical trial studies at the end of 2020 |
| o | A decrease in expenses in China due to the restructuring of ANP and the deconsolidation of Hanxin and its subsidiaries |
| ● | Non-operating income, net, increased as a result of the $13.6 million gain on the deconsolidation of Hanxin relating to the ANP restructuring |
Cash flow provided by operating activities for the nine months ended September 30, 2021, was $57.6 million.
Pipeline Information
The Company currently has five ANDAs on file with the FDA targeting products with a market size of approximately $2.5 billion, three biosimilar products in development targeting products with a market size of approximately $13 billion, and eight generic products in development targeting products with a market size of approximately $12 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2021. The Company is currently developing multiple proprietary products with injectable and intranasal dosage forms.
Amphastar’s Chinese subsidiary, ANP, currently has 17 Drug Master Files, or DMFs, on file with the FDA and is developing several additional DMFs.
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 U.S. generally accepted accounting principles (“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 stockholders, which exclude amortization expense, share-based compensation, impairment charges, executive severance expense, and legal settlements, 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, 2021, at 2:00 p.m. Pacific Time.
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, the timing and results of clinical trials, our share buyback program, the impact of the restructuring of ANP, 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 Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 15, 2021 and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 9, 2021. In particular, the extent of COVID-19’s impact on our business will depend on several factors, including the severity, duration and extent of the pandemic including its variants, as well as actions taken by governments, businesses, and consumers in response to the pandemic, all of which continue to evolve and remain uncertain at this time. You can locate these reports through our website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov. The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements 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 our 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)
Table II
Amphastar Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(Unaudited; in thousands, except share data)
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September 30, |
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December 31, |
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2021 |
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2020 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
106,610 |
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$ |
92,642 |
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Restricted cash |
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235 |
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1,865 |
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Short-term investments |
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8,021 |
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12,977 |
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Restricted short-term investments |
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2,200 |
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2,200 |
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Accounts receivable, net |
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78,090 |
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66,005 |
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Inventories |
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100,240 |
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96,831 |
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Income tax refunds and deposits |
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520 |
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385 |
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Prepaid expenses and other assets |
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7,755 |
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6,777 |
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Total current assets |
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303,671 |
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279,682 |
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Property, plant, and equipment, net |
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242,924 |
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260,055 |
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Finance lease right-of-use assets |
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428 |
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612 |
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Operating lease right-of-use assets |
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27,663 |
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20,042 |
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Equity method investment |
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4,193 |
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— |
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Goodwill and intangible assets, net |
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39,192 |
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40,615 |
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Other assets |
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11,610 |
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5,250 |
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Deferred tax assets |
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21,996 |
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24,980 |
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Total assets |
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$ |
651,677 |
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$ |
631,236 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
88,911 |
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$ |
95,504 |
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Income taxes payable |
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3,960 |
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1,077 |
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Current portion of long-term debt |
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2,256 |
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12,263 |
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Current portion of operating lease liabilities |
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2,862 |
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3,357 |
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Total current liabilities |
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97,989 |
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112,201 |
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Long-term reserve for income tax liabilities |
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4,709 |
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4,709 |
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Long-term debt, net of current portion and unamortized debt issuance costs |
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75,552 |
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34,186 |
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Long-term operating lease liabilities, net of current portion |
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25,466 |
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17,464 |
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Deferred tax liabilities |
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2,901 |
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741 |
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Other long-term liabilities |
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14,884 |
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13,212 |
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Total liabilities |
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221,501 |
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182,513 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding |
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— |
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— |
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Common stock: par value $0.0001; 300,000,000 shares authorized; 56,051,662 and 47,982,690 shares issued and outstanding as of September 30, 2021 and 54,760,922 and 47,495,439 shares issued and outstanding as of December 31, 2020, respectively |
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6 |
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5 |
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Additional paid-in capital |
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412,917 |
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410,061 |
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Retained earnings |
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160,577 |
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117,773 |
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Accumulated other comprehensive loss |
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(6,277) |
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(3,721) |
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Treasury stock |
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(137,047) |
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(121,812) |
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Total Amphastar Pharmaceuticals, Inc. stockholders’ equity |
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430,176 |
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402,306 |
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Non-controlling interests |
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— |
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46,417 |
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Total equity |
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430,176 |
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448,723 |
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Total liabilities and stockholders’ equity |
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$ |
651,677 |
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$ |
631,236 |
Table III
Amphastar Pharmaceuticals, Inc.
Reconciliation of Non-GAAP Measures
(Unaudited; in thousands, except per share data)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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GAAP net income |
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$ |
30,960 |
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$ |
4,793 |
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$ |
43,541 |
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$ |
6,889 |
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Adjusted for: |
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Intangible amortization |
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377 |
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262 |
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930 |
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771 |
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Share-based compensation |
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3,919 |
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4,370 |
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14,837 |
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13,846 |
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Impairment of long-lived assets |
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25 |
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130 |
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339 |
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160 |
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Gain on ANP Restructuring |
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(13,587) |
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— |
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(13,587) |
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— |
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Expense related to executive separation agreement |
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— |
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— |
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— |
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4,869 |
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Reserves for litigation and settlements |
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— |
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— |
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2,991 |
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— |
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Income tax (benefit) provision on pre-tax adjustments |
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921 |
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(943) |
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(1,614) |
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(3,392) |
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Non-GAAP net income |
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$ |
22,615 |
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$ |
8,612 |
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$ |
47,437 |
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$ |
23,143 |
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Non-GAAP net income (loss) attributable to non-controlling interests |
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$ |
(383) |
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$ |
983 |
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$ |
271 |
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$ |
(479) |
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Non-GAAP net income attributable to Amphastar |
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$ |
22,998 |
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$ |
7,629 |
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$ |
47,166 |
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$ |
23,622 |
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Non-GAAP net income per share attributable to Amphastar stockholders: |
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Basic |
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$ |
0.48 |
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$ |
0.16 |
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$ |
0.99 |
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$ |
0.50 |
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Diluted |
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$ |
0.46 |
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$ |
0.15 |
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$ |
0.95 |
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$ |
0.48 |
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Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders: |
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Basic |
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48,022 |
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47,496 |
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47,758 |
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46,886 |
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Diluted |
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50,009 |
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49,848 |
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49,693 |
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48,922 |