On January 7, 2019 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported preliminary unaudited fourth quarter and full year 2018 financial results and provided 2019 financial guidance (Press release, AMAG Pharmaceuticals, JAN 7, 2019, View Source [SID1234532499]).
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The company will provide a portfolio update at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). A live audio webcast of the presentation and following breakout session will be accessible through the Investors section of AMAG’s website at www.amagpharma.com.
"In 2018, we achieved several key milestones including receiving two approvals from the U.S. Food and Drug Administration (FDA), launching both the Makena subcutaneous auto-injector and Feraheme broad label, and receiving FDA acceptance of our new drug application for VyleesiTM (bremelanotide). In addition, we bolstered our pipeline by adding two promising late-stage development assets, AMAG-423 and ciraparantag, targeting orphan patient populations," said William Heiden, AMAG’s president and chief executive officer.
"As we enter 2019, AMAG is in a unique position with a number of growing commercial products that together generate significant cash flows, allowing us to invest in the development and launch of our new pharmaceutical products. We have built an innovative and diversified portfolio that I believe positions us well for long-term growth and will deliver significant shareholder value," added Mr. Heiden.
Preliminary Fourth Quarter and Full Year 2018 Financial Results (unaudited)
Fourth Quarter 2018
AMAG expects total revenues from continuing operations for the fourth quarter of 2018 to be between $85 million and $90 million. This includes Makena (hydroxyprogesterone caproate injection) net product sales of between $46 million and $48 million, Feraheme and MuGard net product sales of between $34 million and $36 million, and Intrarosa net product sales of between $5 million and $6 million. The Makena subcutaneous auto-injector maintained market share in the fourth quarter, as compared to the third quarter, despite the entry of generic competition to the intramuscular product. In addition, Makena ex-factory sales were impacted by a reduction in channel inventory levels in the fourth quarter, as compared to third quarter, due to temporary supply constraints, which are now resolved. Fourth quarter Feraheme revenues grew approximately 34% over prior year, driven by continuing success of the product’s expanded label. Intrarosa revenues were driven by strong prescription volume and market share growth in the quarter.
For the fourth quarter of 2018, AMAG expects an operating loss of between $17 million and $27 million. Adjusted EBITDA (earnings before interest, taxes, depreciation and amortization) for the fourth quarter of 2018 is expected to be within the company’s forecasted range of between a loss of $5 million and positive adjusted EBITDA of $5 million.
Full Year 2018
AMAG expects full year 2018 revenues and adjusted EBITDA to be within the company’s most recently issued financial guidance range. Total revenues from continuing operations are expected to be between $471 million and $476 million. This includes Makena net product sales of between $321 million and $323 million, Feraheme and MuGard net product sales of between $134 million and $136 million, and Intrarosa net product sales of between $15 million and $16 million. As a result of the sale of Cord Blood Registry (CBR), which closed on August 6, 2018, CBR’s results have been excluded from the financial results.
For the full year of 2018, AMAG expects an operating loss of between $45 million and $55 million and adjusted EBITDA of between $115 million and $125 million.2
The company ended 2018 with approximately $394 million in cash and investments, $21.4 million of short-term debt and $320 million of 2022 convertible notes (principal amount outstanding).
The company expects to report final financial results for the fourth quarter and audited results for the full year of 2018 in February.
2019 Overview
The company has a number of goals and key milestones upcoming in 2019:
Expand use of Makena subcutaneous auto-injector
Drive Feraheme growth
Continue successful Intrarosa direct-to-consumer campaign
Submit Vyleesi frequent-dosing study results prior to updated PDUFA date of June 23, 2019; prepare for commercial launch in 2H-2019
Target full enrollment in AMAG-423 Phase 2b/3a study by year end
Initiate ciraparantag Phase 3a clinical study
Pursue in/out-licensing opportunities
Meet/exceed financial guidance
The company is providing the following financial guidance for 2019:
$ in millions
2019 Financial Guidance
Total revenue
$365 – $415
Operating loss
($131) – ($101)
Adjusted EBITDA
($65) – ($35)
"During 2018, we increased our financial guidance three times and reported that we achieved our financial objectives for the full year of 2018," said Ted Myles, AMAG’s chief financial officer. "We also completed the transformation of our balance sheet, and with nearly $400 million of cash on hand and approximately $20 million in near-term debt, we are well positioned to advance our portfolio of novel products."
"2019 will be a year of investment and we are in the fortunate position that our cash flow generating products and our balance sheet can support the development of our future products; each of which has significant revenue and growth prospects because they provide innovative therapeutic solutions to patients with unmet medical needs," added Mr. Myles.
Webcast Information
A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 37th Annual J.P. Morgan Healthcare Conference, will be accessible through the Investors section of the company’s website at www.amagpharma.com on January 9, 2019 at 7:30 a.m. PT (10:30 a.m. ET). Following the conference, the webcast will be archived on the company’s website until February 9, 2019.
Use of Non-GAAP Financial Measures
AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization). These non-GAAP financial measures exclude certain amounts, expenses 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. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational 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. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. 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