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8-K - 8-K - Amphastar Pharmaceuticals, Inc.amph-20181108x8k.htm

EXHIBIT 99.1

 

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

 

Reports Net Revenues of $75.5 Million for the Three Months Ended September 30, 2018

 

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

 

Third Quarter Highlights

 

·

Net revenues of $75.5 million for the third quarter

·

GAAP net income attributable to Amphastar of $2.4 million, or $0.05 per diluted share, for the third quarter

·

Adjusted non-GAAP net income attributable to Amphastar of $5.7 million, or $0.12 per diluted share, for the third quarter

 

Dr. Jack Zhang, Amphastar’s CEO, commented: “This is a very exciting time for Amphastar with our recent approval of Primatene® Mist, our strong sales growth in the quarter and our return to profitability.”

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

 

2018

 

2017

 

2018

 

2017

 

 

 

(in thousands, except per share data)

 

Net revenues

    

$

75,543

    

$

57,916

    

$

204,976

    

$

179,773

 

GAAP net income (loss) attributable to Amphastar

 

$

2,389

 

$

99

 

$

(7,605)

 

$

2,860

 

Adjusted non-GAAP net income attributable to Amphastar*

 

$

5,721

 

$

3,419

 

$

4,168

 

$

13,219

 

GAAP diluted EPS attributable to Amphastar shareholders

 

$

0.05

 

$

0.00

 

$

(0.16)

 

$

0.06

 

Adjusted non-GAAP diluted EPS attributable to Amphastar shareholders*

 

$

0.12

 

$

0.07

 

$

0.09

 

$

0.28

 


 * Adjusted non-GAAP net income attributable to Amphastar and Adjusted non-GAAP diluted EPS attributable to Amphastar shareholders 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

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

Net revenues:

    

 

    

    

 

    

 

 

 

 

 

 

Enoxaparin

 

$

18,564

 

$

6,549

 

$

12,015

 

183

%

Lidocaine

 

 

9,875

 

 

9,596

 

 

279

 

 3

%

Naloxone

 

 

9,432

 

 

12,709

 

 

(3,277)

 

(26)

%

Phytonadione

 

 

8,968

 

 

9,352

 

 

(384)

 

(4)

%

Medroxyprogesterone

 

 

7,552

 

 

 —

 

 

7,552

 

N/A

 

Epinephrine

 

 

1,881

 

 

2,027

 

 

(146)

 

(7)

%

Other finished pharmaceutical products

 

 

15,495

 

 

14,222

 

 

1,273

 

 9

%

Total finished pharmaceutical products net revenues

 

$

71,767

 

$

54,455

 

$

17,312

 

32

%

API

 

 

3,776

 

 

3,461

 

 

315

 

 9

%

Total net revenues

 

$

75,543

 

$

57,916

 

$

17,627

 

30

%


 

 

Changes in net revenues were primarily driven by:

 

·

Increased sales of enoxaparin, primarily driven by higher average selling prices, as well as an increase in unit volumes

·

Sales of medroxyprogesterone acetate which launched in the first quarter of 2018 so was not included in third quarter of 2017 results

·

Decreased sales of naloxone primarily due to lower unit volumes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

September 30, 

 

Change

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Revenues

 

$

75,543

 

$

57,916

 

$

17,627

 

30

%

Cost of Revenues

 

 

46,283

 

 

37,363

 

 

8,920

 

24

%

Gross Profit

 

$

29,260

 

$

20,553

 

$

8,707

 

42

%

as % of net revenues

 

 

39%

 

 

35%

 

 

 

 

 

 

 

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

 

·

The launch of medroxyprogesterone acetate and isoproterenol hydrochloride, which both have higher margins

·

Higher average selling prices of enoxaparin

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

September 30, 

 

Change

 

 

 

2018

 

2017

 

Dollars

    

%

 

 

 

(in thousands)

 

 

 

Selling, distribution and marketing

 

$

1,963

 

$

1,756

 

$

207

 

12

%

General and administrative

 

 

13,407

 

 

11,665

 

 

1,742

 

15

%

Research and development

 

 

11,340

 

 

10,075

 

 

1,265

 

13

%

 

·

Selling, distribution and marketing expenses increased primarily due to increased freight costs

·

General and administrative expenses increased primarily due to higher legal fees

·

Research and development expenses increased primarily due to expenditures related to the expansion of our ANP facility as well as an increase in FDA, or Food and Drug Administration filing fees

 

Cash flow provided by operating activities for the nine months ended September 30, 2018 was $28.7 million.

 

Certain GAAP and non-GAAP measures for comparative periods in 2017 were revised for immaterial errors.

 

Pipeline Information

 

The Company currently has four abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of approximately $0.7 billion, three biosimilar products in development targeting products with a market size of over $14 billion, and 11 generic products in development targeting products with a market size of over $12 billion. This market information is based on IQVIA data for the 12 months ended September 30, 2018. The Company’s proprietary pipeline includes a  new drug application for intranasal naloxone. The Company is currently developing four other proprietary products, which include injectable, inhalation and intranasal dosage forms.

 


 

Amphastar’s Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, currently has nine Drug Master Files, or DMFs, on file with the FDA and is developing nine 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) attributed to Amphastar Pharmaceuticals, Inc. and (ii) Adjusted non-GAAP diluted EPS attributed to Amphastar Pharmaceuticals, Inc. shareholders,  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, November 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 5587773.  

 

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 the DMFs of ANP, the timing of product launches, 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

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

    

2018

    

2017

    

2018

    

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

    

$

75,543

    

$

57,916

    

$

204,976

    

$

179,773

 

Cost of revenues

 

 

46,283

 

 

37,363

 

 

132,680

 

 

109,754

 

Gross profit

 

 

29,260

 

 

20,553

 

 

72,296

 

 

70,019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating (income) expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, distribution, and marketing

 

 

1,963

 

 

1,756

 

 

5,560

 

 

4,831

 

General and administrative

 

 

13,407

 

 

11,665

 

 

36,074

 

 

35,237

 

Research and development

 

 

11,340

 

 

10,075

 

 

40,830

 

 

32,117

 

Gain on sale of intangible assets

 

 

 —

 

 

 —

 

 

 —

 

 

(2,643)

 

Total operating expenses

 

 

26,710

 

 

23,496

 

 

82,464

 

 

69,542

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

 

2,550

 

 

(2,943)

 

 

(10,168)

 

 

477

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-operating income (expense), net

 

 

24

 

 

829

 

 

(347)

 

 

1,917

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

2,574

 

 

(2,114)

 

 

(10,515)

 

 

2,394

 

Income tax expense (benefit)

 

 

958

 

 

(2,213)

 

 

(2,137)

 

 

(466)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

1,616

 

$

99

 

$

(8,378)

 

$

2,860

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to non-controlling interests

 

$

(773)

 

$

 —

 

$

(773)

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) attributable to Amphastar

 

$

2,389

 

$

99

 

$

(7,605)

 

$

2,860

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share attributable to Amphastar shareholders:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.05

 

$

0.00

 

$

(0.16)

 

$

0.06

 

Diluted

 

$

0.05

 

$

0.00

 

$

(0.16)

 

$

0.06

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,241

 

 

46,101

 

 

46,437

 

 

46,065

 

Diluted

 

 

48,281

 

 

48,215

 

 

46,437

 

 

48,046

 

 

The comparative periods in 2017 were revised for immaterial errors.


 

Table II

Amphastar Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheet

(Unaudited; in thousands, except per share data)

 

 

 

 

 

 

 

 

 

    

September 30, 

    

December 31, 

 

 

2018

 

2017

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

68,734

 

$

65,594

Short-term investments

 

 

2,829

 

 

2,635

Restricted cash and short-term investments

 

 

4,155

 

 

4,155

Accounts receivable, net

 

 

43,816

 

 

35,996

Inventories

 

 

65,414

 

 

63,609

Income tax refunds and deposits

 

 

3,186

 

 

6,036

Prepaid expenses and other assets

 

 

6,670

 

 

9,753

Total current assets

 

 

194,804

 

 

187,778

 

 

 

 

 

 

 

Property, plant, and equipment, net

 

 

202,526

 

 

180,545

Goodwill and intangible assets, net

 

 

42,727

 

 

45,140

Other assets

 

 

11,127

 

 

8,663

Deferred tax assets

 

 

29,458

 

 

28,946

 

 

 

 

 

 

 

Total assets

 

$

480,642

 

$

451,072

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

76,362

 

$

57,555

Income taxes payable

 

 

1,667

 

 

3,325

Current portion of long-term debt and capital leases

 

 

18,592

 

 

6,312

Total current liabilities

 

 

96,621

 

 

67,192

 

 

 

 

 

 

 

Long-term reserve for income tax liabilities

 

 

879

 

 

879

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

 

 

32,606

 

 

40,844

Deferred tax liabilities

 

 

1,303

 

 

1,361

Other long-term liabilities

 

 

7,963

 

 

7,060

Total liabilities

 

 

139,372

 

 

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; 50,883,467 and 46,159,652 shares issued and outstanding as of September 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

 

 

330,265

 

 

313,891

Retained earnings

 

 

65,618

 

 

72,642

Accumulated other comprehensive loss

 

 

(3,576)

 

 

(2,100)

Treasury stock

 

 

(72,896)

 

 

(50,702)

Total Amphastar stockholders’ equity

 

 

319,416

 

 

333,736

Non-controlling interests

 

 

21,854

 

 

 —

Total equity

 

 

341,270

 

 

333,736

 

 

 

 

 

 

 

Total liabilities and stockholders’ equity

 

$

480,642

 

$

451,072

 

The December 31, 2017 figures were revised for immaterial errors.

 


 

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, 

 

    

2018

    

2017

    

2018

    

2017

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net income (loss)

    

$

1,616

    

$

99

    

$

(8,378)

    

$

2,860

Adjusted for:

 

 

 

 

 

 

 

 

 

 

 

 

Intangible amortization

 

 

271

 

 

713

 

 

1,722

 

 

2,139

Share-based compensation

 

 

3,908

 

 

4,157

 

 

12,770

 

 

12,905

Impairment of long-lived assets

 

 

10

 

 

 —

 

 

390

 

 

 —

Income tax expense on pre-tax adjustments

 

 

(788)

 

 

(1,550)

 

 

(3,040)

 

 

(4,685)

Non-GAAP net income

 

$

5,017

 

$

3,419

 

$

3,464

 

$

13,219

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net loss attributable to non-controlling interests

 

$

(704)

 

$

 —

 

$

(704)

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income attributable to Amphastar

 

$

5,721

 

$

3,419

 

$

4,168

 

$

13,219

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.12

 

$

0.07

 

$

0.09

 

$

0.29

Diluted

 

$

0.12

 

$

0.07

 

$

0.09

 

$

0.28

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,241

 

 

46,101

 

 

46,437

 

 

46,065

Diluted

 

 

48,281

 

 

48,215

 

 

48,713

 

 

48,046

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

46,283

    

$

1,963

    

$

13,407

    

$

11,340

    

$

958

Intangible amortization

 

 

(230)

 

 

 —

 

 

(41)

 

 

 —

 

 

 —

Share-based compensation

 

 

(884)

 

 

(86)

 

 

(2,615)

 

 

(323)

 

 

 —

Impairment of long-lived assets

 

 

 —

 

 

 —

 

 

 —

 

 

(10)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

788

Non-GAAP

 

$

45,169

 

$

1,877

 

$

10,751

 

$

11,007

 

$

1,746

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

37,363

    

$

1,756

    

$

11,665

    

$

10,075

    

$

(2,213)

Intangible amortization

 

 

(677)

 

 

 —

 

 

(36)

 

 

 —

 

 

 —

Share-based compensation

 

 

(815)

 

 

(88)

 

 

(2,948)

 

 

(306)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,550

Non-GAAP

 

$

35,871

 

$

1,668

 

$

8,681

 

$

9,769

 

$

(663)

 

The comparative periods in 2017 were revised for immaterial errors.


 

Reconciliation of Non-GAAP Measures (continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

132,680

    

$

5,560

    

$

36,074

    

$

40,830

    

$

(2,137)

Intangible amortization

 

 

(1,602)

 

 

 —

 

 

(120)

 

 

 —

 

 

 —

Share-based compensation

 

 

(3,025)

 

 

(297)

 

 

(8,251)

 

 

(1,197)

 

 

 —

Impairment of long-lived assets

 

 

(77)

 

 

 —

 

 

(4)

 

 

(309)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

3,040

Non-GAAP

    

$

127,976

    

$

5,263

    

$

27,699

    

$

39,324

    

$

903

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

109,754

    

$

4,831

    

$

35,237

    

$

32,117

    

$

(466)

Intangible amortization

 

 

(2,031)

 

 

 —

 

 

(108)

 

 

 —

 

 

 —

Share-based compensation

 

 

(2,843)

 

 

(237)

 

 

(8,715)

 

 

(1,110)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

4,685

Non-GAAP

    

$

104,880

    

$

4,594

    

$

26,414

    

$

31,007

    

$

4,219

 

The comparative periods in 2017 were revised for immaterial errors.