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Amphastar Pharmaceuticals, Inc. (AMPH) SEC Filing 8-K Material Event for the period ending Monday, May 9, 2022

Amphastar Pharmaceuticals, Inc.

CIK: 1297184 Ticker: AMPH

EXHIBIT 99.1

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended March 31, 2022

Reports Net Revenues of $120.4 Million for the Three Months Ended March 31, 2022

RANCHO CUCAMONGA, CA – May 9, 2022 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended March 31, 2022.

First Quarter Highlights

Net revenues of $120.4 million for the first quarter
GAAP net income of $24.3 million, or $0.47 per share, for the first quarter
Adjusted non-GAAP net income of $24.6 million, or $0.47 per share, for the first quarter

Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer, commented: “The first quarter continued where 2021 ended, with strong sales of our recently launched products, which confirms our strategy focused on complex products with commercial strength. We are optimistic that our growth trend will continue in 2022.”

Three Months Ended

March 31, 

2022

2021

(in thousands, except per share data)

Net revenues

    

$

120,368

    

$

103,020

GAAP net income attributable to Amphastar

$

24,253

$

5,041

Adjusted non-GAAP net income attributable to Amphastar*

$

24,586

$

13,553

GAAP diluted EPS attributable to Amphastar stockholders

$

0.47

$

0.10

Adjusted non-GAAP diluted EPS attributable to Amphastar stockholders*

$

0.47

$

0.27


 * Adjusted non-GAAP net income and Adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release.

First Quarter Results

Three Months Ended

March 31, 

Change

2022

2021

Dollars

    

%

(in thousands)

Net revenues:

    

    

    

    

Primatene Mist®

$

24,697

$

18,383

$

6,314

34

%

Epinephrine

15,156

15,578

(422)

(3)

%

Glucagon

10,984

7,984

3,000

38

%

Lidocaine

10,590

9,071

1,519

17

%

Phytonadione

10,475

9,565

910

10

%

Enoxaparin

10,124

10,658

(534)

(5)

%

Naloxone

7,413

6,341

1,072

17

%

Other finished pharmaceutical products

 

27,107

 

20,302

 

6,805

 

34

%

Total finished pharmaceutical products net revenues

$

116,546

$

97,882

$

18,664

 

19

%

API

3,822

5,138

(1,316)

(26)

%

Total net revenues

$

120,368

$

103,020

$

17,348

17

%

Changes in net revenues were primarily driven by:

Primatene Mist® sales increased due to an increase in unit volumes as a result of the continued success

of our advertising campaign
Glucagon sales increased due to an increase in unit volumes resulting from a full quarter of sales in 2022, compared to the same period in 2021, as the product was launched in February 2021
Lidocaine sales increased due to an increase in unit volumes
Phytonadione sales increased due to an increase in higher average selling price
Naloxone sales increased due to an increase in unit volumes
Other finished pharmaceutical product sales increased due to higher demand for certain products such as calcium chloride and sodium bicarbonate, largely due to market shortages
API sales decreased due to the timing of orders from MannKind and other customers

Three Months Ended

March 31, 

Change

2022

2021

Dollars

    

%

(in thousands)

Net revenues

$

120,368

$

103,020

$

17,348

17

%

Cost of revenues

64,542

58,074

6,468

11

%

Gross profit

$

55,826

$

44,946

$

10,880

24

%

as % of net revenues

46%

44%

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® and glucagon
Partially offset by an overall increase in labor cost, as well as increased costs for heparin, the starting material for enoxaparin, and a lower average selling price for enoxaparin

Three Months Ended

March 31, 

Change

2022

2021

Dollars

    

%

(in thousands)

Selling, distribution, and marketing

$

5,519

$

4,537

$

982

22

%

General and administrative

12,470

15,338

(2,868)

(19)

%

Research and development

16,223

14,765

1,458

10

%

Non-operating income (expense), net

7,419

(5,192)

12,611

(243)

%

Selling, distribution, and marketing expenses increased primarily due to increased freight expenses
General and administrative expenses decreased primarily due to a decrease in legal expenses and a decrease in expenses in China due to the previously-announced ANP restructuring
Research and development expenses increased due to:
An increase in expenses in testing, operating, and lab supplies as a result of an increase in expenditures on materials for our pipeline products
Partially offset by a decrease in clinical trial expense as a result of a shift in timing on some of our clinical trial studies
The change in non-operating income (expense), net is primarily a result of:
A $5.4 million gain related to a settlement in connection with the Regadenoson patent litigation in January 2022
A $4.4 million expense recorded in the first quarter of 2021 in connection with the Aventis litigation

Cash flow provided by operating activities for the three months ended March 31, 2022, was $50.8 million.


Share Buyback Program

On May 5, 2022, the Company’s Board of Directors authorized a $25 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 four ANDAs on file with the FDA targeting products with a market size of approximately $4 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 $9 billion. This market information is based on IQVIA data for the 12 months ended March 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.

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, May 9, 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 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, 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, 2021, filed with the SEC on March 11, 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

March 31, 

    

2022

    

2021

Net revenues

    

$

120,368

    

$

103,020

Cost of revenues

 

64,542

 

58,074

Gross profit

 

55,826

 

44,946

Operating expenses:

Selling, distribution, and marketing

 

5,519

 

4,537

General and administrative

 

12,470

 

15,338

Research and development

 

16,223

 

14,765

Total operating expenses

 

34,212

 

34,640

Income from operations

 

21,614

 

10,306

Non-operating income (expenses), net

 

7,419

 

(5,192)

Income before income taxes

 

29,033

 

5,114

Income tax provision

 

4,077

 

1,155

Net income before equity in losses of unconsolidated affiliate

24,956

3,959

Equity in losses of unconsolidated affiliate

(703)

Net income

$

24,253

$

3,959

Net loss attributable to non-controlling interests

$

$

(1,082)

Net income attributable to Amphastar

$

24,253

$

5,041

Net income per share attributable to Amphastar stockholders:

Basic

$

0.50

$

0.11

Diluted

$

0.47

$

0.10

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

Basic

 

48,138

 

47,520

Diluted

 

51,979

 

49,518


Table II

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet

(Unaudited; in thousands, except per share data)

    

March 31, 

    

December 31, 

2022

2021

ASSETS

Current assets:

Cash and cash equivalents

$

172,627

$

126,353

Restricted cash

235

235

Short-term investments

14,383

10,320

Restricted short-term investments

 

2,200

 

2,200

Accounts receivable, net

 

73,166

 

78,804

Inventories

 

95,147

 

92,807

Income tax refunds and deposits

 

223

 

126

Prepaid expenses and other assets

 

6,434

 

7,274

Total current assets

 

364,415

 

318,119

Property, plant, and equipment, net

 

243,248

 

244,244

Finance lease right-of-use assets

278

353

Operating lease right-of-use assets

27,843

26,894

Investment in unconsolidated affiliate

3,318

3,985

Goodwill and intangible assets, net

 

38,436

 

38,870

Other assets

 

16,301

 

16,665

Deferred tax assets

 

22,399

 

22,399

Total assets

$

716,238

$

671,529

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$

95,810

$

89,545

Income taxes payable

 

13,116

 

9,081

Current portion of long-term debt

 

2,159

 

2,202

Current portion of operating lease liabilities

3,279

2,982

Total current liabilities

 

114,364

 

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

 

74,348

 

74,776

Long-term operating lease liabilities, net of current portion

25,489

24,703

Deferred tax liabilities

 

487

 

534

Other long-term liabilities

 

15,494

 

15,653

Total liabilities

 

236,713

 

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; 57,495,402 and 48,752,175 shares issued and outstanding as of March 31, 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

 

433,454

 

422,423

Retained earnings

 

204,590

 

180,337

Accumulated other comprehensive loss

 

(7,245)

 

(6,765)

Treasury stock

 

(151,280)

 

(150,479)

Total equity

479,525

445,522

Total liabilities and stockholders’ equity

$

716,238

$

671,529


Table III

Amphastar Pharmaceuticals, Inc.

Reconciliation of Non-GAAP Measures

(Unaudited; in thousands, except per share data)

Three Months Ended

March 31, 

    

2022

    

2021

GAAP net income

    

$

24,253

    

$

3,959

Adjusted for:

Intangible amortization

 

352

 

276

Share-based compensation

 

5,022

 

4,834

Impairment of long-lived assets

 

 

6

Reserves for litigation and settlements

(5,346)

5,695

Income tax provision (benefit) on pre-tax adjustments

 

305

 

(2,229)

Non-GAAP net income

$

24,586

$

12,541

Non-GAAP net loss attributable to non-controlling interests

$

$

(1,012)

Non-GAAP net income attributable to Amphastar

$

24,586

$

13,553

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

Basic

$

0.51

$

0.29

Diluted

$

0.47

$

0.27

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

Basic

 

48,138

 

47,520

Diluted

 

51,979

 

49,518

Three Months Ended March 31, 2022

 

Selling,

General

Research

Non-operating

Income

 

Non-controlling

Cost of

distribution

and

and

income

tax provision

 

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

(benefit)

    

adjustment

GAAP

$

64,542

$

5,519

$

12,470

$

16,223

$

7,419

$

4,077

$

Intangible amortization

(235)

(117)

Share-based compensation

(1,385)

(168)

(2,861)

(608)

Reserves for litigation and settlements

(5,346)

Income tax provision (benefit) on pre-tax adjustments

(305)

Non-GAAP

$

62,922

$

5,351

$

9,492

$

15,615

$

2,073

$

3,772

$


Three Months Ended March 31, 2021

 

Selling,

General

Research

Non-operating

Income

 

Non-controlling

Cost of

distribution

and

and

income

tax provision

 

interest

    

revenue

    

and marketing

    

administrative

    

development

    

(expense), net

    

(benefit)

    

adjustment

GAAP

$

58,074

$

4,537

$

15,338

$

14,765

$

5,192

$

1,155

$

(1,082)

Intangible amortization

(242)

(34)

11

Share-based compensation

(1,146)

(127)

(2,968)

(593)

71

Impairment of long-lived assets

(6)

2

Reserves for litigation and settlements

(1,295)

(4,400)

Income tax provision (benefit) on pre-tax adjustments

2,229

(14)

Non-GAAP

$

56,686

$

4,410

$

11,035

$

14,172

$

792

$

3,384

$

(1,012)


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Ticker: AMPH
CIK: 1297184
Form Type: 8-K Corporate News
Accession Number: 0001297184-22-000026
Submitted to the SEC: Mon May 09 2022 4:22:57 PM EST
Accepted by the SEC: Mon May 09 2022
Period: Monday, May 9, 2022
Industry: Pharmaceutical Preparations
Events:
  1. Earnings Release
  2. Financial Exhibit

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