0001297184falseDE00012971842022-11-072022-11-07

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 7, 2022

Amphastar Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware

001-36509

33-0702205

(State or Other Jurisdiction of
Incorporation)

(Commission File Number)

(I.R.S. Employer Identification
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

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:

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.

Item 2.02. Results of Operations and Financial Condition.

On November 7, 2022, Amphastar Pharmaceuticals, Inc. issued a press release announcing its financial results for the three months ended September 30, 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:

Exhibit No.

    

Description

99.1

Press release, dated November 7, 2022, issued by Amphastar Pharmaceuticals, Inc.

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: November 7, 2022

Amphastar Pharmaceuticals, Inc.

By:

/s/ WILLIAM J. PETERS

William J. Peters

Chief Financial Officer, Executive Vice President and Treasurer

EXHIBIT 99.1

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2022

Reports Net Revenues of $120.1 Million for the Three Months Ended September 30, 2022

RANCHO CUCAMONGA, CA – November 7, 2022 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended September 30, 2022.

Third Quarter Highlights

Net revenues of $120.1 million for the third quarter
GAAP net income of $15.9 million, or $0.30 per share, for the third quarter
Adjusted non-GAAP net income of $20.2 million, or $0.38 per share, for the third quarter

Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer, commented: “We are pleased to report that our continued investment in capacity has successfully led to another quarter of solid growth driven by strong epinephrine, Primatene Mist®, and glucagon sales. Looking ahead to next year, we remain optimistic that our multiple pipeline product candidates will continue to progress through their respective stages of development and will ultimately position us to deliver continued growth in the future.”

Three Months Ended

Nine Months Ended

 

September 30, 

September 30, 

 

2022

2021

2022

2021

 

(in thousands, except per share data)

 

Net revenues

    

$

120,129

    

$

112,198

    

$

363,964

    

$

316,881

GAAP net income attributable to Amphastar

$

15,874

$

29,548

$

57,473

$

42,356

Adjusted non-GAAP net income attributable to Amphastar*

$

20,232

$

22,998

$

65,548

$

47,166

GAAP diluted EPS attributable to Amphastar stockholders

$

0.30

$

0.59

$

1.09

$

0.85

Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders*

$

0.38

$

0.46

$

1.24

$

0.95


 * 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

Three Months Ended

September 30, 

Change

2022

2021

Dollars

    

%

(in thousands)

Net revenues:

    

    

    

    

Epinephrine

$

19,502

$

13,892

$

5,610

40

%

Primatene Mist®

18,359

16,561

1,798

11

%

Glucagon

14,224

12,189

2,035

17

%

Phytonadione

13,978

11,591

2,387

21

%

Lidocaine

12,621

11,649

972

8

%

Enoxaparin

7,983

8,034

(51)

(1)

%

Naloxone

6,818

8,028

(1,210)

(15)

%

Other finished pharmaceutical products

 

23,635

 

27,046

 

(3,411)

 

(13)

%

Total finished pharmaceutical products net revenues

$

117,120

$

108,990

$

8,130

 

7

%

API

3,009

3,208

(199)

(6)

%

Total net revenues

$

120,129

$

112,198

$

7,931

7

%


Changes in net revenues were primarily driven by:

Primatene Mist® sales increased primarily due to increased unit volumes
Glucagon sales increased due to an increase in inventory levels, which allowed us to fill orders for the back-to-school season and meet the corresponding seasonal demand
Epinephrine sales increased by $3.3 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
Phytonadione sales increased due to a combination of an increase in unit volumes and a higher average selling price
Lidocaine sales increased primarily due to an increase in units of the injectable version
Naloxone sales decreased primarily due to a lower average selling price
Other finished pharmaceutical product sales changes were primarily due to:
oLower unit volumes of atropine and calcium chloride, largely due to competitors returning to their normal distribution levels
oAn increase in unit volume for dextrose, which was in high demand due to competitor shortages
oLaunches 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

September 30, 

Change

2022

2021

Dollars

    

%

(in thousands)

Net revenues

$

120,129

$

112,198

$

7,931

7

%

Cost of revenues

61,619

61,015

604

1

%

Gross profit

$

58,510

$

51,183

$

7,327

14

%

as % of net revenues

49%

46%

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 epinephrine, Primatene Mist®, phytonadione, and glucagon, as well as the launches of ganirelix and vasopressin in 2022
These factors were partially offset by overall increases in labor costs, as well as increases in costs for heparin, the starting material for enoxaparin

Three Months Ended

September 30, 

Change

2022

2021

Dollars

    

%

(in thousands)

Selling, distribution, and marketing

$

4,784

$

4,745

$

39

1

%

General and administrative

11,984

10,910

1,074

10

%

Research and development

18,514

10,759

7,755

72

%

Non-operating income (expense), net

(632)

12,877

(13,509)

(105)

%

General and administrative expenses increased primarily due to an increases in legal and compensation expenses
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
The increase was partially offset by a decrease in expenses in China due to the completion of the restructuring of Amphastar’s Chinese subsidiary, Amphastar Nanjing Pharmaceuticals Co., Ltd. (“ANP”), in 2021
The change in non-operating income (expense), net is primarily a result of a $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 nine months ended September 30, 2022 was $74.0 million.

Share Buyback Program

On November 3, 2022, the Company’s Board of Directors authorized a $50 million increase to the Company’s share buyback program, which is expected to continue for an indefinite period of time. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs.

Purchases may be made through the open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions, or other means, as determined by the Company’s management and in accordance with the requirements of the Securities and Exchange Commission and applicable laws.

The timing and actual number of shares repurchased will depend on a variety of factors including price, corporate and regulatory requirements, and other conditions.

Pipeline Information

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 $12 billion, and eight 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 September 30, 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.

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, 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.

Conference Call Information

The Company will hold a conference call to discuss its financial results today, November 7, 2022, 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 and business trends, 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, 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, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022. 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)

Three Months Ended

Nine Months Ended

 

September 30, 

September 30, 

 

    

2022

    

2021

    

2022

    

2021

 

Net revenues

    

$

120,129

    

$

112,198

    

$

363,964

    

$

316,881

Cost of revenues

 

61,619

 

61,015

 

186,272

 

173,376

Gross profit

 

58,510

 

51,183

 

177,692

 

143,505

Operating expenses:

Selling, distribution, and marketing

 

4,784

 

4,745

 

16,059

 

13,411

General and administrative

 

11,984

 

10,910

 

34,433

 

40,813

Research and development

 

18,514

 

10,759

 

57,535

 

43,646

Total operating expenses

 

35,282

 

26,414

 

108,027

 

97,870

Income from operations

 

23,228

 

24,769

 

69,665

 

45,635

Non-operating income (expenses), net

 

(632)

 

12,877

 

5,115

 

11,342

Income before income taxes

 

22,596

 

37,646

 

74,780

 

56,977

Income tax provision

 

6,559

 

6,686

 

16,187

 

13,436

Net income before equity in losses of unconsolidated affiliate

16,037

30,960

58,593

43,541

Equity in losses of unconsolidated affiliate

(163)

(1,120)

Net income

$

15,874

$

30,960

$

57,473

$

43,541

Net income attributable to non-controlling interests

$

$

1,412

$

$

1,185

Net income attributable to Amphastar

$

15,874

$

29,548

$

57,473

$

42,356

Net income per share attributable to Amphastar stockholders:

Basic

$

0.32

$

0.62

$

1.18

$

0.89

Diluted

$

0.30

$

0.59

$

1.09

$

0.85

Weighted-average shares used to compute net income per share attributable to Amphastar stockholders:

Basic

 

48,904

 

48,022

 

48,635

 

47,758

Diluted

 

52,788

 

50,009

 

52,665

 

49,693


Table II

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; in thousands, except share data)

    

September 30, 

    

December 31, 

2022

2021

ASSETS

Current assets:

Cash and cash equivalents

$

157,244

$

126,353

Restricted cash

235

235

Short-term investments

26,843

10,320

Restricted short-term investments

 

2,200

 

2,200

Accounts receivable, net

 

77,099

 

78,804

Inventories

 

103,250

 

92,807

Income tax refunds and deposits

 

11,365

 

126

Prepaid expenses and other assets

 

5,986

 

7,274

Total current assets

 

384,222

 

318,119

Property, plant, and equipment, net

 

232,741

 

244,244

Finance lease right-of-use assets

601

353

Operating lease right-of-use assets

26,456

26,894

Investment in unconsolidated affiliate

2,690

3,985

Goodwill and intangible assets, net

 

37,037

 

38,870

Other assets

 

20,549

 

16,665

Deferred tax assets

 

22,399

 

22,399

Total assets

$

726,695

$

671,529

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$

95,796

$

89,545

Income taxes payable

 

1,531

 

9,081

Current portion of long-term debt

 

1,680

 

2,202

Current portion of operating lease liabilities

3,183

2,982

Total current liabilities

 

102,190

 

103,810

Long-term reserve for income tax liabilities

 

6,531

 

6,531

Long-term debt, net of current portion and unamortized debt issuance costs

 

74,011

 

74,776

Long-term operating lease liabilities, net of current portion

24,366

24,703

Deferred tax liabilities

 

242

 

534

Other long-term liabilities

 

14,190

 

15,653

Total liabilities

 

221,530

 

226,007

Commitments and contingencies

Stockholders’ equity:

Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding

 

 

Common stock: par value $0.0001; 300,000,000 shares authorized; 57,994,848 and 48,612,545 shares issued and outstanding as of September 30, 2022 and 56,440,202 and 47,714,912 shares issued and outstanding as of December 31, 2021, respectively

 

6

 

6

Additional paid-in capital

 

448,741

 

422,423

Retained earnings

 

237,810

 

180,337

Accumulated other comprehensive loss

 

(9,931)

 

(6,765)

Treasury stock

 

(171,461)

 

(150,479)

Total equity

505,165

445,522

Total liabilities and stockholders’ equity

$

726,695

$

671,529


Table III

Amphastar Pharmaceuticals, Inc.

Reconciliation of Non-GAAP Measures

(Unaudited; in thousands, except per share data)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2022

    

2021

    

2022

    

2021

GAAP net income

    

$

15,874

    

$

30,960

    

$

57,473

    

$

43,541

Adjusted for:

Intangible amortization

 

392

 

377

 

1,088

 

930

Share-based compensation

 

4,299

 

3,919

 

13,556

 

14,837

Impairment of long-lived assets

 

 

25

 

 

339

Gain on ANP Restructuring

(13,587)

(13,587)

Reserves for litigation and settlements

800

(4,929)

2,991

Income tax provision on pre-tax adjustments

 

(1,133)

 

921

 

(1,640)

 

(1,614)

Non-GAAP net income

$

20,232

$

22,615

$

65,548

$

47,437

Non-GAAP net loss attributable to non-controlling interests

$

$

(383)

$

$

271

Non-GAAP net income attributable to Amphastar

$

20,232

$

22,998

$

65,548

$

47,166

Non-GAAP net income per share attributable to Amphastar stockholders:

Basic

$

0.41

$

0.48

$

1.35

$

0.99

Diluted

$

0.38

$

0.46

$

1.24

$

0.95

Weighted-average shares used to compute non-GAAP net income per share attributable to Amphastar stockholders:

Basic

 

48,904

 

48,022

 

48,635

 

47,758

Diluted

 

52,788

 

50,009

 

52,665

 

49,693

Three Months Ended September 30, 2022

 

Selling,

General

Research

Non-operating

 

Non-controlling

Cost of

distribution

and

and

income

Income

 

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

tax provision

    

adjustment

GAAP

$

61,619

$

4,784

$

11,984

$

18,514

$

(632)

$

6,559

$

Intangible amortization

(206)

(186)

Share-based compensation

(915)

(178)

(2,810)

(396)

Reserves for litigation and settlements

(800)

Income tax provision on pre-tax adjustments

1,133

Non-GAAP

$

60,498

$

4,606

$

8,188

$

18,118

$

(632)

$

7,692

$


Three Months Ended September 30, 2021

 

Selling,

General

Research

Non-operating

 

Non-controlling

Cost of

distribution

and

and

income

Income

 

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

tax provision

    

adjustment

GAAP

$

61,015

$

4,745

$

10,910

$

10,759

$

12,877

$

6,686

$

1,412

Intangible amortization

(242)

(135)

4

Share-based compensation

(889)

(164)

(2,533)

(333)

8

Impairment of long-lived assets

(25)

4

Gain on ANP Restructuring

(13,587)

(2,062)

Income tax provision on pre-tax adjustments

(921)

251

Non-GAAP

$

59,884

$

4,581

$

8,217

$

10,426

$

(710)

$

5,765

$

(383)

Nine Months Ended September 30, 2022

Selling,

General

Research

Non-operating

Non-controlling

Cost of

distribution

and

and

income

Income

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

tax provision

    

adjustment

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)

Reserves for litigation and 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

$

Nine Months Ended September 30, 2021

 

Selling,

General

Research

Non-operating

 

Non-controlling

Cost of

distribution

and

and

income

Income

 

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

tax provision

    

adjustment

GAAP

$

173,376

$

13,411

$

40,813

$

43,646

$

11,342

$

13,436

$

1,185

Intangible amortization

(728)

(202)

26

Share-based compensation

(2,967)

(438)

(10,069)

(1,363)

870

Impairment of long-lived assets

(84)

(33)

(222)

7

Gain on ANP Restructuring

(13,587)

(2,062)

Reserves for litigation and settlements

(1,295)

1,696

Income tax provision on pre-tax adjustments

1,614

245

Non-GAAP

$

169,597

$

12,973

$

29,214

$

42,061

$

(549)

$

15,050

$

271