# EDGAR Filing Document

**Accession Number:** 0001297184
**File Stem:** 0001297184-23-000012
**Filing Date:** 2023-2
**Character Count:** 36260
**Document Hash:** fb8ee7f0cc4cb449d512373acf73f1fd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001297184-23-000012.hdr.sgml**: 20230228

**ACCESSION NUMBER**: 0001297184-23-000012

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230228

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230228

**DATE AS OF CHANGE**: 20230228

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Amphastar Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001297184
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 330702205
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36509
- **FILM NUMBER:** 23685762

**BUSINESS ADDRESS:**
- **STREET 1:** 11570 SIXTH STREET
- **CITY:** RANCHO CUCAMONGA
- **STATE:** CA
- **ZIP:** 91730
- **BUSINESS PHONE:** 909-980-9484

**MAIL ADDRESS:**
- **STREET 1:** 11570 SIXTH STREET
- **CITY:** RANCHO CUCAMONGA
- **STATE:** CA
- **ZIP:** 91730

?xml version='1.0' encoding='UTF-8'?

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#### 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): February 28, 2023

**Amphastar Pharmaceuticals, Inc.**

(Exact Name of Registrant as Specified in Charter)

---

| | | |
|:---|:---|:---|
| **De** **laware** | **001-36509** | **33-0702205** |
| (State or Other Jurisdiction of<br>Incorporation) | (Commission File Number) | (I.R.S. Employer Identification<br>Number) |

---

---

| | |
|:---|:---|
| **11570 6th Street** |  |
| **Rancho Cucamonga, California** | **91730** |
| (Address of Principal Executive Offices) | (Zip Code) |

---

Registrant's telephone number, including area code: **(909) 980-9484**

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:

---

| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share | AMPH | The NASDAQ Stock Market LLC |

---

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. ☐

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#### Item 2.02. Results of Operations and Financial Condition.
On February 28, 2023, Amphastar Pharmaceuticals, Inc. issued a press release announcing its financial results for the three months and fiscal year ended December 31, 2022. 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. | Description |
| 99.1 | [Press release, dated February 28, 2023, issued by Amphastar Pharmaceuticals, Inc.](amph-20230228xex99d1.htm) |
| 104 | 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.

---

| | | |
|:---|:---|:---|
| Date: February 28, 2023 | Amphastar Pharmaceuticals, Inc. | Amphastar Pharmaceuticals, Inc. |
|  | By: | /s/ WILLIAM J. PETERS |
|  |  | William J. Peters |
|  |  | Chief Financial Officer, Executive Vice President and Treasurer |

---

## Exhibit 99.1

EXHIBIT 99.1

**Amphastar Pharmaceuticals** **Reports Financial Results for the Three Months and Full-Year Ended December 31, 2022**

*Reports Net Revenues of $135.0 Million for the Three Months Ended December 31, 2022*

RANCHO CUCAMONGA, CA – February 28, 2023 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2022.

<u>Fourth Quarter Highlights</u>

● Net revenues of $135.0 million for the fourth quarter

● GAAP net income of $33.9 million, or $0.66 per share, for the fourth quarter

● Adjusted non-GAAP net income of $37.6 million, or $0.73 per share, for the fourth quarter

<u>Full-Year Highlights</u>

● Net revenues of $499.0 million for the fiscal year

● GAAP net income of $91.4 million, or $1.74 per share, for the fiscal year

● Adjusted non-GAAP net income of $103.2 million, or $1.97 per share, for the fiscal year

Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We are pleased to report our strongest quarter yet, driven by sales of epinephrine, Primatene MIST<sup>®</sup>, glucagon, and other finished pharmaceutical products. Looking ahead to 2023, we anticipate launching multiple new products to continue driving our growth."

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  | **Year Ended**  | **Year Ended**  |
|  | **December 31,**  | **December 31,**  | **December 31,**  | **December 31,**  |
|  | **2022** | **2021** | **2022** | **2021** |
|  | **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** | **(in thousands, except per share data)** |
| Net revenues | $135023 | $120887 | $498987 | $437768 |
| GAAP net income attributable to Amphastar | $33913 | $19760 | $91386 | $62116 |
| Adjusted non-GAAP net income attributable to Amphastar\* | $37638 | $20833 | $103186 | $67999 |
| GAAP diluted EPS attributable to Amphastar stockholders | $0.66 | $0.39 | $1.74 | $1.25 |
| Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders\* | $0.73 | $0.42 | $1.97 | $1.37 |

---

------

\* 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.

------

<u>Fourth Quarter Results</u> 

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  |  |  |
|  | **December 31,**  | **December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| **Net revenues:** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Primatene MIST<sup>®</sup> | $22279 | $21489 | $790 | 4% |
| &nbsp;&nbsp;&nbsp;&nbsp;Epinephrine | 21427 | 18868 | 2559 | 14% |
| &nbsp;&nbsp;&nbsp;&nbsp;Glucagon | 18319 | 15335 | 2984 | 19% |
| &nbsp;&nbsp;&nbsp;&nbsp;Lidocaine | 13286 | 12099 | 1187 | 10% |
| &nbsp;&nbsp;&nbsp;&nbsp;Phytonadione | 11666 | 13921 | (2255) | (16)% |
| &nbsp;&nbsp;&nbsp;&nbsp;Enoxaparin  | 7812 | 7942 | (130) | (2)% |
| &nbsp;&nbsp;&nbsp;&nbsp;Naloxone  | 4845 | 6546 | (1701) | (26)% |
| &nbsp;&nbsp;&nbsp;&nbsp;Other finished pharmaceutical products | 33082 | 21776 | 11306 | 52% |
| Total finished pharmaceutical products net revenues | $132716 | $117976 | $14740 | 12% |
| &nbsp;&nbsp;&nbsp;&nbsp;API | 2307 | 2911 | (604) | (21)% |
| Total net revenues | $135023 | $120887 | $14136 | 12% |

---

Changes in net revenues as compared to fourth quarter in prior year were primarily driven by:

● Primatene MIST <sup>®</sup> sales increased primarily due to an increase in unit volumes

● Epinephrine sales increased by $1.8 million due to an increase in average selling price, with the remainder of the increase due to increased unit volumes as a result of competitor shortages

● Glucagon sales increased primarily due to an increase in unit volumes

● Phytonadione sales decreased due to decreased unit volumes

● Naloxone sales decreased primarily due to a lower average selling price

● Other finished pharmaceutical product sales changes were primarily due to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o An increase in unit volumes for dextrose and sodium bicarbonate, which were in high demand due to competitor shortages

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Higher unit volumes of isoproterenol

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o L aunches of ganirelix and vasopressin, in June 2022 and August 2022, respectively

● Active Pharmaceutical ingredient ("API") sales decreased primarily due to the timing of customer purchases

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  |  |  |
|  | **December 31,**  | **December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| Net revenues | $135023 | $120887 | $14136 | 12% |
| Cost of revenues | 63855 | 64653 | (798) | (1)% |
| Gross profit | $71168 | $56234 | $14934 | 27% |
| *as % of net revenues* | *53%* | *47%* |  |  |

---

Changes in the cost of revenues and the resulting increase in gross margins were primarily driven by:

● Increased sales of higher-margin products such as Primatene MIST <sup>®</sup> , epinephrine, and glucagon, as well as the launches of ganirelix and vasopressin in 2022

● These factors were partially offset by overall increases in labor and input costs

------

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  |  |  |
|  | **December 31,**  | **December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| Selling, distribution, and marketing | $5472 | $4075 | $1397 | 34% |
| General and administrative  | 10628 | 10621 | 7 | 0% |
| Research and development | 17236 | 17286 | (50) | 0% |
| Non-operating income (expense), net | 3428 | 2910 | 518 | 18% |

---

● Selling, distribution, and marketing expenses increased primarily due to increased advertising and freight expenses

● Research and development expenses remained flat during the quarter as a result of a decrease in expenditure for materials and components, which was partially offset by an increase in clinical trial expense for our insulin and inhalation product pipeline

● The change in non-operating income, net is primarily a result of foreign currency gains

<u>Year-End Results</u>

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Year Ended December 31,**  | **Year Ended December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| **Net revenues:** |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Primatene MIST<sup>®</sup> | $84309 | $73113 | $11196 | 15% |
| &nbsp;&nbsp;&nbsp;&nbsp;Epinephrine | 74204 | 57530 | 16674 | 29% |
| &nbsp;&nbsp;&nbsp;&nbsp;Glucagon | 55322 | 47639 | 7683 | 16% |
| &nbsp;&nbsp;&nbsp;&nbsp;Lidocaine | 52539 | 44413 | 8126 | 18% |
| &nbsp;&nbsp;&nbsp;&nbsp;Phytonadione | 49500 | 45498 | 4002 | 9% |
| &nbsp;&nbsp;&nbsp;&nbsp;Enoxaparin  | 34950 | 35962 | (1012) | (3)% |
| &nbsp;&nbsp;&nbsp;&nbsp;Naloxone  | 26269 | 27540 | (1271) | (5)% |
| &nbsp;&nbsp;&nbsp;&nbsp;Other finished pharmaceutical products | 109412 | 87875 | 21537 | 25% |
| Total finished pharmaceutical products net revenues | $486505 | $419570 | $66935 | 16% |
| &nbsp;&nbsp;&nbsp;&nbsp;API | 12482 | 18198 | (5716) | (31)% |
| Total net revenues | $498987 | $437768 | $61219 | 14% |

---

Changes in net revenues were primarily driven by:

● Primatene MIST <sup>®</sup> sales increased primarily due to increased unit volumes, which was primarily a result of the continued success of our advertising campaign throughout the year

● Epinephrine sales increased primarily due to an increase in unit volumes, arising from high demand due to competitor shortages, contributing $9.0 million in sales, as well as a higher average selling price, which contributed $7.7 million to the increase in sales

● Glucagon sales increased due to an increase in unit volumes as the prior year period did not include a full year of sales due to glucagon's launch in the first quarter of 2021

● Lidocaine sales increased due to an increase in unit volumes, which contributed $4.4 million, as well as a higher average selling price, which contributed $3.8 million to the increase in sales

● Phytonadione sales increased due to a higher average selling price

● Other finished pharmaceutical product sales changes were primarily due to:

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o Higher unit volumes of calcium chloride, dextrose, and sodium bicarbonate, which were in high demand due to competitor shortages

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;o L aunches of ganirelix and vasopressin in June 2022 and August 2022, respectively

● API sales decreased primarily due to the timing of customer purchases

------

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Year Ended December 31,**  | **Year Ended December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| Net revenues | $498987 | $437768 | $61219 | 14% |
| Cost of revenues | 250127 | 238029 | 12098 | 5% |
| Gross profit | $248860 | $199739 | $49121 | 25% |
| *as % of net revenues* | *50%* | *46%* |  |  |

---

Changes in the cost of revenues and the resulting increase in gross margins were primarily driven by:

● Increased sales of higher-margin products such as Primatene MIST <sup>®</sup> , epinephrine, and glucagon, as well as the launches of ganirelix and vasopressin in 2022

● These factors were partially offset by overall increases in labor and input costs

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Year Ended December 31,**  | **Year Ended December 31,**  | **Change** | **Change** |
|  | **2022** | **2021** | **Dollars** | **%** |
|  | **(in thousands)** | **(in thousands)** | **(in thousands)** |  |
| Selling, distribution, and marketing | $21531 | $17486 | $4045 | 23% |
| General and administrative  | 45061 | 51434 | (6373) | (12)% |
| Research and development | 74771 | 60932 | 13839 | 23% |
| Non-operating income (expense), net | 8543 | 14252 | (5709) | (40)% |

---

● Selling, distribution, and marketing expenses increased due to increased freight expense and advertising expense for Primatene MIST <sup>®</sup>

● General and administrative expenses decreased primarily due to a decrease in legal expenses and a decrease in expenses in China due to the restructuring of Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceutical, Co., Ltd. ("ANP"), in 2021

● Research and development expenses increased due to:

◾ Increases in expenditures for materials and components, primarily for our AMP-018 and insulin products candidates

◾ An increase in clinical trial expense primarily due to external studies related to our insulin and inhalation product pipeline

◾ This was partially offset by a decrease in expenses in China due to the completion of the restructuring of ANP in 2021

● The change in non-operating income, net is primarily due to:

---

| | |
|:---|:---|
| ◾ | $5.4 million litigation settlement received in January 2022 in connection with the Regadenoson patent litigation |

---

---

| | |
|:---|:---|
| ◾ | $13.6 million gain on the deconsolidation of Hanxin Pharmaceutical Technology Co., Ltd related to the ANP restructuring in 2021 |

---

Cash flow provided by operating activities for the year ended December 31, 2022 was $89.2 million.

<u>Pipeline Information</u> 

The Company currently has three ANDAs on file with the FDA targeting products with a market size of over $3 billion, three biosimilar products in development targeting products with a market size of over $11 billion, and six generic products in development targeting products with a market size of over $9 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2022. The Company is 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.

------

<u>Company Information</u> 

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<sup>®</sup>, Primatene MIST<sup>®</sup>, Amphadase<sup>®</sup>, and Cortrosyn<sup>®</sup>, are the property of Amphastar.

<u>Non-GAAP Financial Measures</u> 

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, legal settlements, and other one-time events 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.

<u>Conference Call Information</u>

The Company will hold a conference call to discuss its financial results today, February 28, 2023, 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 <u>www.amphastar.com</u>.

<u>Forward-Looking Statements</u>

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, backlog, sales and marketing of our products, market size and expansion, 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, and other future events, such as the impact of the COVID-19 pandemic including its variants, the Russia-Ukraine conflict and resulting macroeconomic conditions, such as inflation and rising interest rates, and related responses of business and governments to the pandemic and international conflict 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, 2021, filed with the SEC on March 11, 2022, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, filed with the SEC on May 10, 2022, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, filed with the SEC on November 7, 2022. In particular, the extent of COVID-19 including its variants, the Russia-Ukraine conflict and resulting macroeconomic conditions, such as inflation and rising interest rates, impacts on our business will depend on several factors, including the actions taken by governments, businesses, and consumers in response, which continues 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)**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  | **Year Ended**  | **Year Ended**  |
|  | **December 31,**  | **December 31,**  | **December 31,**  | **December 31,**  |
|  | **2022** | **2021** | **2022** | **2021** |
| Net revenues | $135023 | $120887 | $498987 | $437768 |
| Cost of revenues | 63855 | 64653 | 250127 | 238029 |
| Gross profit | 71168 | 56234 | 248860 | 199739 |
| Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Selling, distribution, and marketing | 5472 | 4075 | 21531 | 17486 |
| &nbsp;&nbsp;&nbsp;&nbsp;General and administrative | 10628 | 10621 | 45061 | 51434 |
| &nbsp;&nbsp;&nbsp;&nbsp;Research and development | 17236 | 17286 | 74771 | 60932 |
| Total operating expenses | 33336 | 31982 | 141363 | 129852 |
| Income from operations | 37832 | 24252 | 107497 | 69887 |
| Non-operating income (expense), net | 3428 | 2910 | 8543 | 14252 |
| Income before income taxes | 41260 | 27162 | 116040 | 84139 |
| Income tax provision | 7290 | 7194 | 23477 | 20630 |
| Net income before equity in losses of unconsolidated affiliate | 33970 | 19968 | 92563 | 63509 |
| Equity in losses of unconsolidated affiliate | (57) | (208) | (1177) | (208) |
| Net income | $33913 | $19760 | $91386 | $63301 |
| Net income attributable to non-controlling interests | $— | $— | $— | $1185 |
| Net income attributable to Amphastar | $33913 | $19760 | $91386 | $62116 |
| Net income per share attributable to Amphastar stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | $0.70 | $0.41 | $1.88 | $1.30 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | $0.66 | $0.39 | $1.74 | $1.25 |
| &nbsp;&nbsp;Weighted-average shares used to compute net income per share attributable to Amphastar stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | 48298 | 47836 | 48551 | 47777 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | 51716 | 50057 | 52427 | 49784 |

---

------

**Table II**

**Amphastar Pharmaceuticals, Inc.**

**Condensed Consolidated Balance Sheets**

**(Unaudited; in thousands, except share data)**

---

| | | |
|:---|:---|:---|
|  | **December 31,** <br>**2022** | **December 31,** <br>**2021** |
| **ASSETS** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $156098 | $126353 |
| &nbsp;&nbsp;&nbsp;&nbsp;Restricted cash | 235 | 235 |
| &nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 19664 | 10320 |
| &nbsp;&nbsp;&nbsp;&nbsp;Restricted short-term investments | 2200 | 2200 |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts receivable, net | 88804 | 78804 |
| &nbsp;&nbsp;&nbsp;&nbsp;Inventories | 103584 | 92807 |
| &nbsp;&nbsp;&nbsp;&nbsp;Income tax refunds and deposits | 171 | 126 |
| &nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other assets | 7563 | 7274 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 378319 | 318119 |
| Property, plant, and equipment, net | 238266 | 244244 |
| Finance lease right-of-use assets | 753 | 353 |
| Operating lease right-of-use assets | 25554 | 26894 |
| Investment in unconsolidated affiliate | 2414 | 3985 |
| Goodwill and intangible assets, net | 37298 | 38870 |
| Other assets | 20856 | 16665 |
| Deferred tax assets | 38527 | 22399 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $741987 | $671529 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Accounts payable and accrued liabilities | $84242 | $89545 |
| &nbsp;&nbsp;&nbsp;&nbsp;Income taxes payable | 4571 | 9081 |
| &nbsp;&nbsp;&nbsp;&nbsp;Current portion of long-term debt | 3046 | 2202 |
| &nbsp;&nbsp;&nbsp;&nbsp;Current portion of operating lease liabilities | 3003 | 2982 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 94862 | 103810 |
| Long-term reserve for income tax liabilities | 7225 | 6531 |
| Long-term debt, net of current portion and unamortized debt issuance costs | 72839 | 74776 |
| Long-term operating lease liabilities, net of current portion | 23694 | 24703 |
| Deferred tax liabilities | 144 | 534 |
| Other long-term liabilities | 14565 | 15653 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 213329 | 226007 |
| Commitments and contingencies |  |  |
| Stockholders' equity: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Common stock: par value $0.0001; 300,000,000 shares authorized; 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively | 6 | 6 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 455077 | 422423 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Retained earnings | 271723 | 180337 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (8624) | (6765) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Treasury stock | (189524) | (150479) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total equity | 528658 | 445522 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities and stockholders' equity | $741987 | $671529 |

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**Table III**

**Amphastar Pharmaceuticals, Inc.**

**Reconciliation of Non-GAAP Measures**

**(Unaudited; in thousands, except per share data)**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | **Three Months Ended**  | **Three Months Ended**  | **Year Ended**  | **Year Ended**  |
|  | **December 31,**  | **December 31,**  | **December 31,**  | **December 31,**  |
|  | **2022** | **2021** | **2022** | **2021** |
| GAAP net income | $33913 | $19760 | $91386 | $63301 |
| Adjusted for: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Intangible amortization | 331 | 360 | 1419 | 1290 |
| &nbsp;&nbsp;&nbsp;&nbsp;Share-based compensation | 4304 | 3850 | 17860 | 18687 |
| &nbsp;&nbsp;&nbsp;&nbsp;Impairment of long-lived assets |  | 9 |  | 348 |
| &nbsp;&nbsp;&nbsp;&nbsp;Gain on ANP Restructuring |  |  |  | (13587) |
| &nbsp;&nbsp;&nbsp;&nbsp;Reserves for litigation and settlements |  | (2717) | (4929) | 274 |
| &nbsp;&nbsp;&nbsp;&nbsp;Income tax provision on pre-tax adjustments | (910) | (429) | (2550) | (2043) |
| Non-GAAP net income  | $37638 | $20833 | $103186 | $68270 |
| Non-GAAP net income attributable to non-controlling interests | $— | $— | $— | $271 |
| Non-GAAP net income attributable to Amphastar | $37638 | $20833 | $103186 | $67999 |
| Non-GAAP net income per share attributable to Amphastar stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | $0.78 | $0.44 | $2.13 | $1.42 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | $0.73 | $0.42 | $1.97 | $1.37 |
| &nbsp;&nbsp;Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;Basic | 48298 | 47836 | 48551 | 47777 |
| &nbsp;&nbsp;&nbsp;&nbsp;Diluted | 51716 | 50057 | 52427 | 49784 |

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** | **Three Months Ended December 31, 2022** |
|  | <br>**Cost of** <br>**revenue** | **Selling,**<br>**distribution**<br>**and marketing** | **General** <br>**and**<br>**administrative** | **Research**<br>**and**<br>**development** | **Non-operating**<br>**income** <br>**(expense), net** | <br>**Income**<br>**tax provision** | **Non-controlling** <br>**interest** <br>**adjustment** |
| GAAP | $63855 | $5472 | $10628 | $17236 | $3428 | $7290 | $— |
| Intangible amortization | (205) |  | (126) |  |  |  |  |
| Share-based compensation | (941) | (186) | (2791) | (386) |  |  |  |
| Income tax provision on pre-tax adjustments |  |  |  |  |  | 910 |  |
| Non-GAAP | $62709 | $5286 | $7711 | $16850 | $3428 | $8200 | $— |

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** | **Three Months Ended December 31, 2021** |
|  | <br>**Cost of** <br>**revenue** | **Selling,**<br>**distribution**<br>**and marketing** | **General** <br>**and**<br>**administrative** | **Research**<br>**and**<br>**development** | **Non-operating**<br>**income** <br>**(expense), net** | <br>**Income**<br>**tax provision** | **Non-controlling** <br>**interest** <br>**adjustment** |
| GAAP | $64653 | $4075 | $10621 | $17286 | $2910 | $7194 | $— |
| Intangible amortization | (235) |  | (125) |  |  |  |  |
| Share-based compensation | (811) | (158) | (2553) | (328) |  |  |  |
| Impairment of long-lived assets | (9) |  |  |  |  |  |  |
| Reserves for litigation and settlements |  |  |  |  | (2717) |  |  |
| Income tax provision on pre-tax adjustments |  |  |  |  |  | 429 |  |
| Non-GAAP | $63598 | $3917 | $7943 | $16958 | $193 | $7623 | $— |

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** | **Year Ended December 31, 2022** |
|  | <br>**Cost of** <br>**revenue** | **Selling,**<br>**distribution**<br>**and marketing** | **General** <br>**and**<br>**administrative** | **Research**<br>**and**<br>**development** | **Non-operating**<br>**income** <br>**(expense), net** | <br>**Income**<br>**tax provision** | **Non-controlling** <br>**interest** <br>**adjustment** |
| GAAP | $250127 | $21531 | $45061 | $74771 | $8543 | $23477 | $— |
| Intangible amortization | (865) |  | (554) |  |  |  |  |
| Share-based compensation | (4179) | (726) | (11180) | (1775) |  |  |  |
| Reserves for litigation and settlements |  |  | (800) |  | (5729) |  |  |
| Income tax provision on pre-tax adjustments |  |  |  |  |  | 2550 |  |
| Non-GAAP | $245083 | $20805 | $32527 | $72996 | $2814 | $26027 | $— |

---

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| | | | | | | | |
|:---|:---|:---|:---|:---|:---|:---|:---|
|  | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** | **Year Ended December 31, 2021** |
|  | <br>**Cost of** <br>**revenue** | **Selling,**<br>**distribution**<br>**and marketing** | **General** <br>**and**<br>**administrative** | **Research**<br>**and**<br>**development** | **Non-operating**<br>**income** <br>**(expense), net** | <br>**Income**<br>**tax provision** | **Non-controlling** <br>**interest** <br>**adjustment** |
| GAAP | $238029 | $17486 | $51434 | $60932 | $14252 | $20630 | $1185 |
| Intangible amortization | (963) |  | (327) |  |  |  | 26 |
| Share-based compensation | (3778) | (596) | (12622) | (1691) |  |  | 870 |
| Impairment of long-lived assets | (93) |  | (33) | (222) |  |  | 7 |
| Gain on ANP Restructuring |  |  |  |  | (13587) |  | (2062) |
| Reserves for litigation and settlements |  |  | (1295) |  | (1021) |  |  |
| Income tax provision on pre-tax adjustments |  |  |  |  |  | 2043 | 245 |
| Non-GAAP | $233195 | $16890 | $37157 | $59019 | $(356) | $22673 | $271 |

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