2016 total revenue increased 45 percent
Provides update on Makena® next-generation program
Anticipates 2017 GAAP revenue of
“AMAG achieved record growth in 2016, driven by an experienced commercial team that consistently delivers strong results and will serve us well for the long term as our portfolio expands,” said
“In addition to meeting or exceeding the revenue growth targets we have set for 2017, other key priorities include filing supplemental new drug applications for the Makena subcutaneous auto-injector and the Feraheme label expansion, as well as the acquisition or licensing of additional products to drive further shareholder value. We are also pleased to announce the licensing of Rekynda, a potential treatment for a significant unmet medical need in women’s health,” Mr. Heiden added.
Preliminary Fourth Quarter and Full Year 2016 Financial Results (unaudited)
Fourth Quarter 2016
AMAG expects total GAAP revenue to be between
AMAG expects fourth quarter 2016 total non-GAAP revenue to be between
The weighted average basic and diluted shares outstanding for the fourth quarter of 2016 totaled 34.3 million and 35.1 million, respectively. Non-GAAP diluted shares for fourth quarter of 2016 totaled 35.1 million.1
Full Year 2016
AMAG expects 2016 total GAAP revenue to be between
AMAG expects 2016 non-GAAP revenue to be between
The company ended 2016 with approximately
Makena Subcutaneous Auto-Injector Development Program Update
AMAG’s successful Makena intramuscular (IM) injection product has orphan drug exclusivity through
Assuming the PK data, once fully collected and analyzed, shows comparable bioavailability between the SC and IM injections, the company intends to file a supplemental new drug application (sNDA) for the SC auto-injector in the second quarter of 2017. Preliminary data from the PK study show a higher reporting rate in the SC arm (~25 percent of subjects vs. <5 percent of subjects in the IM arm) of a transient burning/stinging sensation associated with the injection. Similar observations were also reported in the SC arm of the company's open label, parallel comparative pain study (also initiated in
“We believe that the subcutaneous auto-injector offers the potential for greater convenience for healthcare providers and an alternative administration method to the intramuscular injection for patients,” stated
2017 Financial Guidance2
The company expects to achieve the following financial results in 2017:
|$ in millions||2017 GAAP Guidance||2017 Non-GAAP Guidance|
|Makena||$410 - $440||$410 - $440|
|Feraheme and MuGard||$100 - $110||$100 - $110|
|CBR||$110 - $120||$115 - $125|
|Total revenue||$620 - $670||$625 - $675|
|Includes Rekynda (bremelanotide)|
|Net income3||$19 - $60||N/A|
|Operating income3||$103 - $173||N/A|
|Adjusted EBITDA||N/A||$270 - $340|
“After a strong performance in 2016, we are forecasting approximately 20 percent top-line growth in 2017,” stated
Use of Non-GAAP Financial Measures
AMAG has presented certain non-GAAP financial measures, including non-GAAP revenues and non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, revenue, or income from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP).
Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance and prospects for future performance and allows investors to better compare performance over different periods. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions, including in compensation decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP financial measures, and AMAG encourages investors to review its consolidated financial statements and publicly filed reports in their entirety. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. Due to the adjustments made to GAAP net income to calculate non-GAAP net income, the non-GAAP measures are higher than GAAP net income. Non-GAAP net income should not be considered a measure of our liquidity. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited consolidated financial statements.
AMAG is a biopharmaceutical company focused on developing and delivering important therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families we serve. Our products support the health of patients in the areas of maternal health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine. For additional company information, please visit www.amagpharma.com.
This press release contains forward-looking information about
Such risks and uncertainties include, among others, (1) the possibility that the closing conditions set forth in the Rekynda license agreement, including any required filings under Rule 3-05 of Regulation S-X, will not be met and that the parties will be unable to consummate the proposed transactions, (2) uncertainties regarding AMAG’s and Palatin’s ability to successfully and timely complete clinical development programs and obtain regulatory approval for Rekynda in
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals® and Feraheme® are registered trademarks of
1 See share count reconciliation at the conclusion of this press release.
2 See GAAP to non-GAAP reconciliation for 2017 financial guidance at the conclusion of this press release.
3 2017 GAAP financial guidance excludes potential accounting impact of
- Tables Follow –
|AMAG Pharmaceuticals, Inc.
Reconciliation of 2017 Financial Guidance of Non-GAAP Adjusted EBITDA
(unaudited, amounts in millions)
|GAAP Net Income||$19 - 60|
|Interest expense, net||71|
|Provision for income tax||13 - 42|
|Operating income||$103 - $173|
|Purchase accounting adjustments related to CBR deferred revenue||6|
|Depreciation and intangible asset amortization||127|
|Non-cash inventory step-up adjustments||2|
|Adjustments to contingent consideration||5|
|Non-GAAP adjusted EBITDA||$270 - $340|
|AMAG Pharmaceuticals, Inc.
Share Count Reconciliation
(amounts in millions)
|Three Months Ended December 31, 2016|
|Weighted average basic shares outstanding||34.3|
|Employee equity incentive awards||0.8|
|GAAP diluted shares outstanding||35.1|
|Effect of bond hedge adjustment||--|
|Non-GAAP diluted shares outstanding||35.1|
Linda LennoxVice President, Investor Relations 908-627-3434 Media: Katie PayneVice President, External Affairs 617-498-3303