Amphastar Pharmaceuticals, Inc.
Amphastar Pharmaceuticals, Inc. (Form: 8-K, Received: 11/08/2017 16:27:21)

 

 

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 8, 2017

 

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))

 

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 8, 2017, Amphastar Pharmaceuticals, Inc. issued a press release announcing its financial results for the three months ended September 30, 2017. 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 8, 2017, issued by Amphastar Pharmaceuticals, Inc.

 

 


 

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 8, 2017

Amphastar Pharmaceuticals,  Inc.

 

 

 

By:

/ s/ WILLIAM J. PETERS

 

 

William J. Peters

 

 

Chief Financial Officer and Senior Vice President

 


 

EXHIBIT INDEX

 

 

 

 

Exhibit No.

    

Description

99.1

 

Press release, dated November 8, 2017, issued by Amphastar Pharmaceuticals, Inc.

 


EXHIBIT 99.1

 

Amphastar Pharmaceuticals Reports Financial Results for the Three Months Ended September 30, 2017

 

Reports Net Revenues of $57.9 Million for the Three Months Ended September 30, 2017

 

RANCHO CUCAMONGA, CA –  November 8, 2017 – Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) (“Amphastar” or the “Company”) today reported results for the three months ended September 30, 2017.

 

Third Quarter Highlights

 

·

Net revenues of $57.9 million for the third quarter

·

GAAP net income of $0.2 million, or $0.00 per diluted share, for the third quarter

·

Adjusted non-GAAP net income of $3.5 million, or $0.07 per diluted share, for the third quarter

 

Dr. Jack Zhang, Amphastar’s CEO, commented: “The third quarter was a successful one for Amphastar with approvals of both sodium bicarbonate and neostigmine. Approvals like these will help us diversify our sales base.”

   

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 

 

September 30, 

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(in thousands, except per share data)

 

Net revenues

    

$

57,916

    

$

64,223

    

$

179,773

    

$

191,622

 

GAAP net income

 

$

175

 

$

3,890

 

$

3,040

 

$

13,274

 

Adjusted non-GAAP net income*

 

$

3,495

 

$

6,648

 

$

13,399

 

$

22,557

 

GAAP diluted EPS

 

$

0.00

 

$

0.08

 

$

0.06

 

$

0.29

 

Adjusted non-GAAP diluted EPS *

 

$

0.07

 

$

0.14

 

$

0.28

 

$

0.49

 


  * 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 II of this press release.

 

Third Quarter Results

 

For the three months ended September 30, 2017, the Company reported net revenues of $57.9 million, a decrease of 10% compared to $64.2 million for the three months ended September 30, 2016.

 

For the three months ended September 30, 2017, net revenues of enoxaparin were $6.5 million, representing a decrease of 58% compared to $15.4 million for the three months ended September 30, 2016. Of the decrease, $5.8 million was due to lower unit volumes, while the remainder was due to lower pricing.

 

Other finished pharmaceutical product revenues were $47.9 million for the three months ended September 30, 2017, representing an increase of 10% compared to $43.7 million for the three months ended September 30, 2016. Sales of lidocaine increased to $9.6 million for the three months ended September 30, 2017 from $8.3 million for the three months ended September 30, 2016 primarily due to increases in average selling price.  Sales of epinephrine decreased to $2.0 million for the three months ended September 30, 2017 from $5.3 million for the three months ended September 30, 2016 primarily as a result of the discontinuation of the Company’s epinephrine injection, USP vial product in the second quarter of 2017 in accordance with the FDA’s request. The Company’s epinephrine injection, USP vial product,  was marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. 

 


 

Sales of the Company’s insulin active pharmaceutical ingredient, or API, products were $3.5 million for the three months ended September 30, 2017, compared to $5.2 million for the three months ended September 30, 2016, as the Company did not ship any API to MannKind in the third quarter of 2017. 

 

Cost of revenues were $37.3 million, or 64% of revenues, and $36.6 million, or 57% of revenues, for the three months ended September 30, 2017 and 2016, respectively, representing an increase of $0.7 million.  The related decline in gross margin is primarily attributable to the discontinuation of the epinephrine vial products and lower pricing for enoxaparin.

 

Selling, distribution, and marketing expenses were $1.8 million and $1.3 million for the three months ended September 30, 2017 and 2016, respectively. For the three months ended September 30, 2017, general and administrative expenses increased to $11.7 million from $10.8 million for the three months ended September 30, 2016, primarily due to an increase in legal expenses relating to the Company’s July 2017 patent trial.

 

For the three months ended September 30, 2017, research and development expenses increased by 3% to $10.0 million from $9.7 million for the three months ended September 30, 2016, primarily due to an increase in expenditures on materials related to our pipeline products.

 

The Company recorded an income tax benefit of $2.2 million for the three months ended September 30, 2017, compared to an income tax expense of $2.1 million for the three months ended September 30, 2016.

 

The Company recognized net income of $0.2 million, or $0.00 per fully diluted share, for the three months ended September 30, 2017, compared to a net income of $3.9 million, or $0.08 per fully diluted share, for the three months ended September 30, 2016. The Company’s adjusted non-GAAP quarterly net income was $3.5 million, or $0.07 per fully diluted share, for the three months ended September 30, 2017, compared to an adjusted non-GAAP net income of $6.6 million, or $0.14 per fully diluted share, for the three months ended September 30, 2016. Please see the discussion in the section entitled “Non-GAAP Financial Measures” and the reconciliation of GAAP to non-GAAP measures in Table II of this press release.

 

The Company’s cash and cash equivalents, short-term investments, and unrestricted short-term investments were $73.6 million as of September 30, 2017.  Cash flow provided by operating activities for the nine months ended September 30, 2017, was $29.4 million.

 

Pipeline Information

 

The Company currently has five abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of over $0.8 billion, three biosimilar products in development targeting products with a market size of over $15.0 billion, and 11 generic products in development targeting products with a market size of over $12.0 billion. This market information is based on IMS Health data for the 12 months ended September 30, 2017. 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. 

 

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, that 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, 2017, 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 2898299.  

 

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, acquisitions and other matters related to its pipeline of product candidates, the timing for completion of construction at the Company’s IMS facility, 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, 

 

 

    

2017

    

2016

    

2017

    

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

    

$

57,916

    

$

64,223

    

$

179,773

    

$

191,622

 

Cost of revenues

 

 

37,275

 

 

36,611

 

 

109,557

 

 

107,394

 

Gross profit

 

 

20,641

 

 

27,612

 

 

70,216

 

 

84,228

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating (income) expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling, distribution, and marketing

 

 

1,756

 

 

1,291

 

 

4,831

 

 

3,975

 

General and administrative

 

 

11,665

 

 

10,801

 

 

35,237

 

 

31,129

 

Research and development

 

 

10,040

 

 

9,723

 

 

32,022

 

 

28,922

 

Gain on sale of intangible assets

 

 

 —

 

 

 —

 

 

(2,643)

 

 

 —

 

Total operating expenses

 

 

23,461

 

 

21,815

 

 

69,447

 

 

64,026

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) from operations

 

 

(2,820)

 

 

5,797

 

 

769

 

 

20,202

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-operating income (expense), net

 

 

829

 

 

204

 

 

1,917

 

 

(633)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(1,991)

 

 

6,001

 

 

2,686

 

 

19,569

 

Income tax expense (benefit)

 

 

(2,166)

 

 

2,111

 

 

(354)

 

 

6,295

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

175

 

$

3,890

 

$

3,040

 

$

13,274

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.00

 

$

0.09

 

$

0.07

 

$

0.29

 

Diluted

 

$

0.00

 

$

0.08

 

$

0.06

 

$

0.29

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,101

 

 

45,398

 

 

46,065

 

 

45,132

 

Diluted

 

 

48,215

 

 

47,953

 

 

48,046

 

 

46,365

 

 


 

Table II

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, 

 

    

2017

    

2016

    

2017

    

2016

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP net income

    

$

175

    

$

3,890

    

$

3,040

    

$

13,274

Adjusted for:

 

 

 

 

 

 

 

 

 

 

 

 

Intangible amortization

 

 

713

 

 

701

 

 

2,139

 

 

1,751

Share-based compensation

 

 

4,157

 

 

3,555

 

 

12,905

 

 

11,604

Impairment of long-lived assets

 

 

 —

 

 

 —

 

 

 —

 

 

331

Income tax expense on pre-tax adjustments

 

 

(1,550)

 

 

(1,498)

 

 

(4,685)

 

 

(4,403)

Non-GAAP net income

 

$

3,495

 

$

6,648

 

$

13,399

 

$

22,557

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net income per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.08

 

$

0.15

 

$

0.29

 

$

0.50

Diluted

 

$

0.07

 

$

0.14

 

$

0.28

 

$

0.49

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

46,101

 

 

45,398

 

 

46,065

 

 

45,132

Diluted

 

 

48,215

 

 

47,953

 

 

48,046

 

 

46,365

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

37,275

    

$

1,756

    

$

11,665

    

$

10,040

    

$

(2,166)

Intangible amortization

 

 

(677)

 

 

 —

 

 

(36)

 

 

 —

 

 

 —

Share-based compensation

 

 

(815)

 

 

(88)

 

 

(2,948)

 

 

(306)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,550

Non-GAAP

 

$

35,783

 

$

1,668

 

$

8,681

 

$

9,734

 

$

(616)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

36,611

    

$

1,291

    

$

10,801

    

$

9,723

    

$

2,111

Intangible amortization

 

 

(511)

 

 

 —

 

 

(190)

 

 

 —

 

 

 —

Share-based compensation

 

 

(675)

 

 

(45)

 

 

(2,593)

 

 

(242)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

1,498

Non-GAAP

 

$

35,425

 

$

1,246

 

$

8,018

 

$

9,481

 

$

3,609

 


 

Reconciliation of Non-GAAP Measures (continued)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2017

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

109,557

    

$

4,831

    

$

35,237

    

$

32,022

    

$

(354)

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

    

$

104,683

    

$

4,594

    

$

26,414

    

$

30,912

    

$

4,331

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Selling,

 

General

 

Research

 

Income

 

 

Cost of

 

distribution

 

and

 

and

 

tax expense

 

 

revenue

 

and marketing

 

administrative

 

development

 

(benefit)

GAAP

    

$

107,394

    

$

3,975

    

$

31,129

    

$

28,922

    

$

6,295

Intangible amortization

 

 

(1,492)

 

 

 —

 

 

(259)

 

 

 —

 

 

 —

Share-based compensation

 

 

(2,245)

 

 

(176)

 

 

(8,339)

 

 

(844)

 

 

 —

Impairment of long-lived assets

 

 

 —

 

 

 —

 

 

 —

 

 

(331)

 

 

 —

Income tax expense on pre-tax adjustments

 

 

 —

 

 

 —

 

 

 —

 

 

 —

 

 

4,403

Non-GAAP

    

$

103,657

    

$

3,799

    

$

22,531

    

$

27,747

    

$

10,698