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): May 13, 2015
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)) | |
Item 2.02. Results of Operations and Financial Condition.
On May 13, 2015, Amphastar Pharmaceuticals, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2015. 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 May 13, 2015, 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: May 13, 2015 | Amphastar Pharmaceuticals, Inc. |
|
| By: | /s/ JASON B. SHANDELL Jason B. Shandell President |
|
EXHIBIT INDEX
| Exhibit No. | Description |
| 99.1 | Press release, dated May 13, 2015, issued by Amphastar Pharmaceuticals, Inc. |
EXHIBIT 99.1
RANCHO CUCAMONGA, Calif., May 13, 2015 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc. (Nasdaq:AMPH) ("Amphastar" or the "Company") today reported results for the first quarter ended March 31, 2015.
|
Three Months Ended March 31, |
||||
| 2015 | 2014 | |||
| (in thousands, except per share data) | ||||
| Net revenues | $ 56,886 | $ 45,870 | ||
| GAAP net loss | $ (665) | $ (1,619) | ||
| Adjusted non-GAAP net loss* | $ (374) | $ (141) | ||
| GAAP diluted EPS | $ (0.01) | $ (0.04) | ||
| Adjusted non-GAAP diluted EPS* | $ (0.01) | $ (0.00) | ||
| *see Table II for reconciliation of non-GAAP measures to the most directly comparable GAAP measures | ||||
First Quarter Results
For the three months ended March 31, 2015, the Company reported net revenues of $56.9 million, an increase of 24% from $45.9 million for the first quarter of 2014.
During the quarter, net revenues of enoxaparin were $23.8 million, a decrease of 9% compared to $26.1 million for the first quarter of 2014, with increased unit volume partially offsetting a decrease in the average selling price.
Other finished pharmaceutical product revenues were $27.1 million for the quarter, an increase of 37% compared to $19.8 million for the first quarter of 2014.
Sales of the Company's insulin API products were $6.0 million during the quarter.
Cost of revenues were $43.6 million, or 77% of revenues, and $33.4 million, or 73% of revenues, for the three months ended March 31, 2015 and 2014, respectively, representing an increase of $10.2 million, or 31%. This increase was primarily due to the cost of revenues at the Company's French subsidiary, AFP, as the Company prepared to increase production to meet demand in connection with its supply agreement with MannKind. Decreases in the average selling price of enoxaparin also contributed to the increase in cost of revenues on a percentage basis.
Selling, distribution, and marketing expenses were $1.5 million and $1.3 million for the three months ended March 31, 2015 and 2014, respectively. General and administrative expenses were $12.5 million and $6.8 million for the three months ended March 31, 2015 and 2014, respectively. The increase is primarily due to the inclusion of expenses at AFP, which the Company acquired in April 2014 and an increase of $3.3 million in expenses relating to a litigation settlement.
For the three months ended March 31, 2015, research and development expenses increased by 6% to $6.6 million from $6.2 million, compared to the first quarter of 2014. The increase was primarily due to increases in clinical trial expenses and other expenses related to purchases of materials, as well as other research and development supplies during the three months ended March 31, 2015.
Income tax benefit was $5.5 million and $0.9 million for the three months ended March 31, 2015 and 2014, respectively. The increase was primarily related to a pre-tax loss that occurred during the three months ended March 31, 2015 and the reversal of a deferred tax valuation allowance, which had previously been reserved.
The Company reported a quarterly net loss of $0.7 million, or $0.01 per fully diluted share, for the three months ended March 31, 2015, compared to a net loss of $1.6 million, or $0.04 per fully diluted share, for the first quarter of 2014. The Company reported an adjusted non-GAAP quarterly net loss of $0.4 million, or $0.01 per fully diluted share, for the three months ended March 31, 2015, compared to adjusted non-GAAP net loss of $0.1 million, or $0.00 per fully diluted share, for the first quarter of 2014.
The Company's cash and cash equivalents, and short-term investments at March 31, 2015 were $70.1 million. Cash flow provided by operating activities was $1.3 million in the quarter.
Pipeline Information
The Company currently has three abbreviated new drug applications, or ANDAs, filed with the FDA targeting products with a market size of over $0.5 billion, and another ten generic products in development targeting products with a market size of over $15.0 billion. This market information is based on IMS Health data for the 12 months ended March 31, 2015. The proprietary pipeline includes a new drug application, or NDA, for Primatene® and an NDA supplement for Amphadase®. The Company is currently developing six other proprietary drugs including injectables, inhalation products, and other dosage forms.
Dr. Jack Zhang, CEO, commented: "We are pleased to announce that the FDA has granted Amphastar fast-track designation for an NDA that we plan to file later this year."
Company Information
Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable and inhalation products. Additionally, in 2014, the Company commenced sales of insulin active pharmaceutical ingredient 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.
Non-GAAP Financial Measures
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 generally accepted accounting principles in the U.S. or "GAAP." In addition to disclosing its financial results determined in accordance with GAAP, the Company is disclosing certain non-GAAP results 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 the most directly comparable GAAP financial measure. 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 measure 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 13, 2015, 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 44093916. The call will be webcast live and 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 that are not historical are forward-looking statements, including, among other things, statements relating to the Company's expectations regarding sales and marketing of its products, the timing of FDA filings and other matters related to its pipeline of product candidates and other future events. These statements are not historical facts but rather are based on Amphastar's current expectations, estimates, and projections regarding Amphastar's business, operations and other similar or related factors. Words such as "may," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expects," "intends," "plans," "projects," "believes," "estimates," 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. Amphastar undertakes no obligation to revise or update information in this press release to reflect events or circumstances in the future, even if new information becomes available.
| Table I | ||
| Amphastar Pharmaceuticals, Inc. | ||
| Condensed Consolidated Statement of Operations | ||
| (Unaudited; in thousands, except per share data) | ||
| Three Months ended March 31, | ||
| 2015 | 2014 | |
| Net revenues | $ 56,886 | $ 45,870 |
| Cost of revenues | 43,606 | 33,362 |
| Gross profit | 13,280 | 12,508 |
| Operating expenses: | ||
| Selling, distribution, and marketing | 1,522 | 1,259 |
| General and administrative | 12,451 | 6,845 |
| Research and development | 6,568 | 6,209 |
| Impairment of long-lived assets | -- | 164 |
| Total operating expenses | 20,541 | 14,477 |
| Loss from operations | (7,261) | (1,969) |
| Non-operating income (expense), net | 1,064 | (502) |
| Loss before income taxes | (6,197) | (2,471) |
| Income tax benefit | (5,532) | (852) |
| Net loss | $ (665) | $ (1,619) |
| Net loss per common share: | ||
| Basic | $ (0.01) | $ (0.04) |
| Diluted | $ (0.01) | $ (0.04) |
| Weighted-average shares used to compute net loss per common share: | ||
| Basic | 44,601 | 38,769 |
| Diluted | 44,601 | 38,769 |
| Table II | ||||||
| Amphastar Pharmaceuticals, Inc. | ||||||
| Reconciliation of Non-GAAP Measures | ||||||
| (Unaudited; in thousands, except per share data) | ||||||
| Three Months Ended March 31, | ||||||
| 2015 | 2014 | |||||
|
GAAP |
Non-GAAP Adjustments* | Non-GAAP As Adjusted |
GAAP |
Non-GAAP Adjustments* | Non-GAAP As Adjusted | |
| Net revenues | $ 56,886 | $ -- | $ 56,886 | $ 45,870 | $ -- | $ 45,870 |
| Cost of revenues | 43,606 | (933) | 42,673 | 33,362 | (738) | 32,624 |
| Gross profit | 13,280 | 933 | 14,213 | 12,508 | 738 | 13,246 |
| Operating expenses: | ||||||
| Selling, distribution, and marketing | 1,522 | (39) | 1,483 | 1,259 | (21) | 1,238 |
| General and administrative | 12,451 | (1,525) | 10,926 | 6,845 | (1,207) | 5,638 |
| Research and development | 6,568 | (212) | 6,356 | 6,209 | (126) | 6,083 |
| Impairment of long-lived assets | -- | -- | -- | 164 | (164) | -- |
| Total operating expenses | 20,541 | (1,776) | 18,765 | 14,477 | (1,518) | 12,959 |
| Income (loss) from operations | (7,261) | 2,709 | (4,552) | (1,969) | 2,256 | 287 |
| Non-operating income (expense), net | 1,064 | -- | 1,064 | (502) | -- | (502) |
| Loss before income taxes | (6,197) | 2,709 | (3,488) | (2,471) | 2,256 | (215) |
| Income tax benefit | (5,532) | 2,418 | (3,114) | (852) | 778 | (74) |
| Net loss | $ (665) | $ 291 | $ (374) | $ (1,619) | $ 1,478 | $ (141) |
| Net loss per common share: | ||||||
| Basic | $ (0.01) | $ (0.01) | $ (0.04) | $ (0.00) | ||
| Diluted | $ (0.01) | $ (0.01) | $ (0.04) | $ (0.00) | ||
| Weighted-average shares used to compute net loss per common share: | ||||||
| Basic | 44,601 | 44,601 | 38,769 | 38,769 | ||
| Diluted | 44,601 | 44,601 | 38,769 | 38,769 | ||
| * Non-GAAP adjustments include reversal of intangible amortization expense and share-based compensation as follows, as well as the reversal of impairment of long-lived assets: | ||||||||
| Three Months Ended March 31, | ||||||||
| 2015 | 2014 | |||||||
| Intangible Amortization Expense | Share-Based Compensation Expense | Impairment of Long-Lived Assets |
Total Non- GAAP Adjustment |
Intangible Amortization Expense | Share-Based Compensation Expense | Impairment of Long-Lived Assets |
Total Non- GAAP Adjustment |
|
| Cost of revenues | (445) | (488) | (933) | (446) | (292) | (738) | ||
| Selling, distribution, and marketing | -- | (39) | (39) | -- | (21) | (21) | ||
| General and administrative | (35) | (1,490) | (1,525) | (31) | (1,176) | (1,207) | ||
| Research and development | -- | (212) | (212) | -- | (126) | (126) | ||
| Impairment of long-lived assets | -- | -- | (164) | (164) | ||||
CONTACT: Amphastar Pharmaceuticals, Inc.
Bill Peters
Chief Financial Officer
(909) 980-9484