Attached files

file filename
8-K - 8-K - Amphastar Pharmaceuticals, Inc.amph-20180808x8k.htm

EXHIBIT 99.1

 

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended June 30, 2018

 

Reports Net Revenues of $71.0 Million for the Three Months Ended June 30, 2018

 

RANCHO CUCAMONGA, CA –  August 8, 2018 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended June 30, 2018.

 

Second Quarter Highlights

 

·

Net revenues of $71.0 million for the second quarter

·

GAAP net loss of $2.8 million, or $0.06 per diluted share, for the second quarter

·

Adjusted non-GAAP net income of $1.2 million, or $0.03 per diluted share, for the second quarter

 

Dr. Jack Zhang, Amphastar’s CEO, commented: “We had an exciting three months with FDA approvals of calcium chloride, isoproterenol, and semi-purified heparin and heparin USP, the starting materials for enoxaparin. We  also announced the expansion of our Amphastar Nanjing Pharmaceuticals business. ANP has been making good progress and filed three Drug Master Files in the second quarter, including one for insulin API. We consider this an important milestone for our diabetes franchise.”

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30, 

 

June 30, 

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

(in thousands, except per share data)

 

Net revenues

    

$

71,040

    

$

65,187

    

$

129,433

    

$

121,857

 

GAAP net income (loss)

 

$

(2,790)

 

$

1,972

 

$

(10,036)

 

$

2,865

 

Adjusted non-GAAP net income (loss)*

 

$

1,220

 

$

5,430

 

$

(1,232)

 

$

9,905

 

GAAP diluted EPS

 

$

(0.06)

 

$

0.04

 

$

(0.22)

 

$

0.06

 

Adjusted non-GAAP diluted EPS*

 

$

0.03

 

$

0.11

 

$

(0.03)

 

$

0.21

 


 * 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.

 

Second Quarter Results

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

June 30, 

 

Change

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

Net revenues:

    

 

    

    

 

    

 

 

 

 

 

 

Naloxone

 

$

11,133

 

$

10,261

 

$

872

 

 8

%

Phytonadione

 

 

10,806

 

 

10,003

 

 

803

 

 8

%

Lidocaine

 

 

10,010

 

 

9,334

 

 

676

 

 7

%

Enoxaparin

 

 

8,715

 

 

8,288

 

 

427

 

 5

%

Medroxyprogesterone

 

 

6,365

 

 

 —

 

 

6,365

 

N/A

 

Epinephrine

 

 

3,687

 

 

10,648

 

 

(6,961)

 

(65)

%

Other finished pharmaceutical products

 

 

12,525

 

 

15,231

 

 

(2,706)

 

(18)

%

Total finished pharmaceutical products net revenues

 

$

63,241

 

$

63,765

 

$

(524)

 

(1)

%

API

 

 

7,799

 

 

1,422

 

 

6,377

 

448

%

Total net revenues

 

$

71,040

 

$

65,187

 

$

5,853

 

 9

%

 


 

Changes in net revenues were primarily driven by:

 

·

Launch of medroxyprogesterone acetate in the first quarter of 2018

·

Discontinuation of epinephrine injection vial product in the second quarter of 2017

·

Increased sales of insulin active pharmaceutical ingredient, or API, products due to the timing of customer purchases, as MannKind began purchasing RHI API under the Company’s purchase agreement

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

June 30, 

 

Change

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

Cost of Revenues

 

$

44,884

 

$

38,440

 

$

6,444

 

17

%

% of net revenues

 

 

63%

 

 

59%

 

 

 

 

 

 

 

Changes in cost of revenues and the resulting changes to gross margin were primarily due to:

 

·

Increased labor costs due to implementing new quality standards and increased hourly rates

·

Discontinuation of epinephrine injection vial product in the second quarter of 2017

·

These trends were partially offset by the launch of medroxyprogesterone, which has higher margins

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

June 30, 

 

Change

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

Selling, distribution and marketing

 

$

1,876

 

$

1,596

 

$

280

 

18

%

General and administrative

 

 

11,669

 

 

12,234

 

 

(565)

 

(5)

%

Research and development

 

 

15,468

 

 

10,732

 

 

4,736

 

44

%

 

·

Selling, distribution and marketing expenses increased primarily due to increased expenses at the Company’s Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, as well as increased freight costs

·

General and administrative expenses decreased primarily due to lower legal fees

·

Research and development expenses increased primarily due to increased expenditures for the Company’s pipeline products as well as an increase in pre-launch inventory relating to the production of Primatene® Mist ahead of its planned launch later this year, if we receive FDA approval

 

Cash flow provided by operating activities for the six months ended June 30, 2018 was $12.9 million.

 

Pipeline Information

 

The Company currently has two abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of over $0.35 billion, three biosimilar products in development targeting products with a market size of over $15.0 billion, and 12 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IQVIA data for the 12 months ended June 30, 2018. The Company’s proprietary pipeline includes NDAs for Primatene® Mist and intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.

 

Amphastar Nanjing Pharmaceuticals currently has four APIs and starting materials approved by the FDA, ten Drug Master Files, or DMFs on file with the FDA and is developing eight additional DMFs.

 


 

Company Information

 

Amphastar is a specialty 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 is available at the Company’s website at www.amphastar.com.

 

Amphastar’s logo and other trademarks or service marks of Amphastar Pharmaceuticals, Inc., including, but not limited to Primatene®, Amphadase® and Cortrosyn®, are the property of Amphastar Pharmaceuticals, Inc.

 

Non-GAAP Financial Measures

 

To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles, or 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) and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, and impairment charges 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, August 8, 2018, at 2:00 p.m. Pacific Time.

 

To access the conference call, dial toll-free (877) 881-2595 or (315) 625-3083 for international callers, five minutes before the conference. The passcode for the conference call is 8783989.  

 

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 the Company’s expectations regarding future financial performance, backlog, sales and marketing of its products, market size and growth, the timing of FDA filings or approvals, including of DMFs of ANP, acquisitions and other matters related to its pipeline of product candidates, its share buyback program and other future events. These statements are not historical facts but rather are based on Amphastar’s historical performance and its current expectations, estimates, and projections regarding Amphastar’s 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. You can locate these reports through the Company’s website at http://ir.amphastar.com and on the SEC’s website at www.sec.gov.  Amphastar undertakes no obligation to revise or update information 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 Amphastar’s 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

 

Six Months Ended

 

 

 

June 30, 

 

June 30, 

 

 

    

2018

    

2017

    

2018

    

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

    

$

71,040

    

$

65,187

    

$

129,433

    

$

121,857

 

Cost of revenues

 

 

44,884

 

 

38,440

 

 

86,216

 

 

72,282

 

Gross profit

 

 

26,156

 

 

26,747

 

 

43,217

 

 

49,575

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating (income) expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, distribution, and marketing

 

 

1,876

 

 

1,596

 

 

3,597

 

 

3,075

 

General and administrative

 

 

11,669

 

 

12,234

 

 

22,667

 

 

23,572

 

Research and development

 

 

15,468

 

 

10,732

 

 

29,728

 

 

21,982

 

Gain on sale of intangible assets

 

 

 —

 

 

 —

 

 

 —

 

 

(2,643)

 

Total operating expenses

 

 

29,013

 

 

24,562

 

 

55,992

 

 

45,986

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

 

(2,857)

 

 

2,185

 

 

(12,775)

 

 

3,589

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-operating income (expense), net

 

 

(1,259)

 

 

988

 

 

(371)

 

 

1,088

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(4,116)

 

 

3,173

 

 

(13,146)

 

 

4,677

 

Income tax expense (benefit)

 

 

(1,326)

 

 

1,201

 

 

(3,110)

 

 

1,812

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(2,790)

 

$

1,972

 

$

(10,036)

 

$

2,865

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.06)

 

$

0.04

 

$

(0.22)

 

$

0.06

 

Diluted

 

$

(0.06)

 

$

0.04

 

$

(0.22)

 

$

0.06

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used to compute net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,557

 

 

46,025

 

 

46,535

 

 

46,047

 

Diluted

 

 

46,557

 

 

47,866

 

 

46,535

 

 

47,962

 

 


 

Table II

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet

(Unaudited; in thousands, except per share data)

 

 

 

 

 

 

 

 

 

    

June 30, 

    

December 31, 

 

 

2018

 

2017

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

48,070

 

$

65,594

Short-term investments

 

 

2,818

 

 

2,635

Restricted cash and short-term investments

 

 

4,155

 

 

4,155

Accounts receivable, net

 

 

41,279

 

 

35,996

Inventories

 

 

61,678

 

 

63,609

Income tax refunds and deposits

 

 

7,542

 

 

6,036

Prepaid expenses and other assets

 

 

4,404

 

 

9,753

Total current assets

 

 

169,946

 

 

187,778

 

 

 

 

 

 

 

Property, plant, and equipment, net

 

 

198,241

 

 

185,339

Goodwill and intangible assets, net

 

 

43,450

 

 

45,140

Other assets

 

 

11,752

 

 

8,663

Deferred tax assets

 

 

28,257

 

 

27,745

 

 

 

 

 

 

 

Total assets

 

$

451,646

 

$

454,665

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

67,092

 

$

57,555

Income taxes payable

 

 

1,607

 

 

3,325

Current portion of long-term debt and capital leases

 

 

18,891

 

 

6,312

Total current liabilities

 

 

87,590

 

 

67,192

 

 

 

 

 

 

 

Long-term reserve for income tax liabilities

 

 

879

 

 

879

Long-term debt and capital leases, net of current portion

 

 

33,695

 

 

40,844

Deferred tax liabilities

 

 

1,325

 

 

1,361

Other long-term liabilities

 

 

7,631

 

 

7,060

Total liabilities

 

 

131,120

 

 

117,336

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; 50,661,676 and 46,416,789 shares issued and outstanding as of June 30, 2018 and 50,039,212 and 46,623,581 shares issued and outstanding as of December 31, 2017, respectively

 

 

 5

 

 

 5

Additional paid-in capital

 

 

322,357

 

 

313,891

Retained earnings

 

 

66,780

 

 

76,235

Accumulated other comprehensive loss

 

 

(3,166)

 

 

(2,100)

Treasury stock

 

 

(65,450)

 

 

(50,702)

Total stockholders’ equity

 

 

320,526

 

 

337,329

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

451,646

 

$

454,665

 

 


 

Table III

Amphastar Pharmaceuticals, Inc.

Reconciliation of Non-GAAP Measures

(Unaudited; in thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Six Months Ended

 

 

June 30, 

 

June 30, 

 

    

2018

    

2017

    

2018

    

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net income (loss)

    

$

(2,790)

    

$

1,972

    

$

(10,036)

    

$

2,865

Adjusted for:

 

 

 

 

 

 

 

 

 

 

 

 

Intangible amortization

 

 

722

 

 

705

 

 

1,451

 

 

1,426

Share-based compensation

 

 

4,196

 

 

4,298

 

 

8,862

 

 

8,749

Impairment of long-lived assets

 

 

145

 

 

 —

 

 

743

 

 

 —

Income tax expense on pre-tax adjustments

 

 

(1,053)

 

 

(1,545)

 

 

(2,252)

 

 

(3,135)

Non-GAAP net income (loss)

 

$

1,220

 

$

5,430

 

$

(1,232)

 

$

9,905

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.03

 

$

0.12

 

$

(0.03)

 

$

0.22

Diluted

 

$

0.03

 

$

0.11

 

$

(0.03)

 

$

0.21

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used to compute non-GAAP net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,557

 

 

46,025

 

 

46,535

 

 

46,047

Diluted

 

 

48,495

 

 

47,866

 

 

46,535

 

 

47,962

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

44,884

    

$

1,876

    

$

11,669

    

$

15,468

    

$

(1,326)

Intangible amortization

 

 

(683)

 

 

 —

 

 

(39)

 

 

 —

 

 

 —

Share-based compensation

 

 

(981)

 

 

(104)

 

 

(2,743)

 

 

(368)

 

 

 —

Impairment of long-lived assets

 

 

(3)

 

 

 —

 

 

(1)

 

 

(141)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,053

Non-GAAP

 

$

43,217

 

$

1,772

 

$

8,886

 

$

14,959

 

$

(273)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

38,440

    

$

1,596

    

$

12,234

    

$

10,732

    

$

1,201

Intangible amortization

 

 

(669)

 

 

 —

 

 

(36)

 

 

 —

 

 

 —

Share-based compensation

 

 

(897)

 

 

(65)

 

 

(2,985)

 

 

(351)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,545

Non-GAAP

 

$

36,874

 

$

1,531

 

$

9,213

 

$

10,381

 

$

2,746

 


 

Reconciliation of Non-GAAP Measures (continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

86,216

    

$

3,597

    

$

22,667

    

$

29,728

    

$

(3,110)

Intangible amortization

 

 

(1,372)

 

 

 —

 

 

(79)

 

 

 —

 

 

 —

Share-based compensation

 

 

(2,141)

 

 

(211)

 

 

(5,636)

 

 

(874)

 

 

 —

Impairment of long-lived assets

 

 

(77)

 

 

 —

 

 

(4)

 

 

(662)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

2,252

Non-GAAP

    

$

82,626

    

$

3,386

    

$

16,948

    

$

28,192

    

$

(858)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Six Months Ended June 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

72,282

    

$

3,075

    

$

23,572

    

$

21,982

    

$

1,812

Intangible amortization

 

 

(1,354)

 

 

 —

 

 

(72)

 

 

 —

 

 

 —

Share-based compensation

 

 

(2,028)

 

 

(149)

 

 

(5,768)

 

 

(804)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

3,135

Non-GAAP

    

$

68,900

    

$

2,926

    

$

17,732

    

$

21,178

    

$

4,947