Estimated pro forma fourth quarter 2014 product sales of
2015 sales guidance of
“The preliminary 2014 financial results and 2015 guidance that we are issuing today both reinforce the key themes of continuing operational excellence on our current business and the transformative nature of our acquisition of
Preliminary 2014 Financial Results (unaudited)
AMAG’s preliminary unaudited financial results for the fourth quarter and full year 2014 include the results of
Fourth Quarter 2014
AMAG expects total revenues of between
$52.8 million and $54.5 million. This includes approximately $6.0 millionof revenue recognized from AMAG’s collaboration agreement with Takeda Pharmaceutical Company Limited(Takeda) for commercialization of Feraheme (ferumoxytol) Injection/RiensoTM outside of the U.S., which was mutually terminated in December 2014.
Net product sales totaled between
$47.2 million and $48.2 million, including between $23.8 million and $24.3 millionof sales from Feraheme in the U.S. (which includes approximately $1.8 millionin revenue associated with a favorable change in estimated Feraheme product returns reserves) and between $23.1 million and $23.6 millionof sales from Makena®(hydroxyprogesterone caproate injection).
Total operating expenses are expected to be between
$41.5 million and $42.8 million. Excluding non-cash and one-time charges1, adjusted operating expenses are expected to be between $28.2 million and $29.5 million, which includes Lumara Healthexpenses from the closing date.
AMAG expects pro forma net product sales of between
$72.7 million and $74.7 millionfor the fourth quarter of 2014. The pro forma amounts represent total net product sales as if the acquisition of Lumara Health(and Makena) had occurred as of the beginning of the fourth quarter.
- AMAG expects total revenues of between
Full Year 2014
AMAG expects 2014 total revenues of between
$123.8 million and $125.5 million. This includes approximately $14.0 millionof revenue recognized from AMAG’s collaboration agreement with Takeda.
Net product sales totaled between
$110.1 million and $111.1 million. U.S. Feraheme net sales are expected to be between $85.8 million and $86.3 millionand Makena sales are expected to be between $23.1 million and $23.6 million. The 19% growth in 2014 Feraheme sales over 2013 was driven by significant increases in volume, as well as increasing net revenue per gram.
Total operating expenses for 2014 are expected to be between
$104.6 million and $105.9 million. Excluding non-cash and one-time charges2, adjusted operating expenses are expected to be between $84.2 million and $85.5 million, which includes Lumara Healthexpenses from the closing date.
AMAG expects 2014 pro forma net product sales of between
$252.0 million and $255.5 million, including U.S. Feraheme net product sales and pro forma Makena sales of $165.0 million to $168.0 million. The pro forma amounts represent total net product sales as if the acquisition of Lumara Health(and Makena) had occurred as of the beginning of 2014.
The company ended 2014 with approximately $143.6 million in cash and investments,
$540 millionin debt and 25.6 million basic shares outstanding.
- AMAG expects 2014 total revenues of between
Additional Business Updates
As part of a multi-pronged line extension/lifecycle management program for Makena, the company announced today that a preservative-free, single-dose (1 mL) vial for Makena has been filed and is under review at the
U.S. Food and Drug Administration( FDA) with a decision expected in the second quarter of 2015. Makena is currently only available in a 5-dose (5 mL) vial.
June 2014, AMAG proposed to the FDAcertain changes to the current Feraheme label for the treatment of iron deficiency anemia (IDA) in adult chronic kidney disease (CKD) patients to mitigate the risk of hypersensitivity. In January 2015, the FDAresponded with recommended label changes that go beyond what the company proposed in June 2014. The company plans to submit a response to the FDA’srecommendations and will work with the FDAto finalize an updated label.
AMAG is awaiting feedback from the
FDAregarding the study design that AMAG submitted to the FDAin 2014 to generate additional safety data to support expansion of the U.S. Feraheme label beyond the current CKD indication to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment.
As announced in
December 2014, AMAG will regain all worldwide development and commercialization rights for Feraheme/Rienso following the transfer of marketing authorizations. Previously, Takeda had been commercializing the product outside of the U.S. under a March 2010license arrangement with AMAG.
2015 Financial Outlook
The company expects to achieve the following in 2015:
Total revenue of between
$380 million and $420 million, including:
Total product sales of between
$335 million and $375 million, including:
Makena net sales of between
$245 million and $270 million;
Feraheme and MuGard net sales of between
$90 million and $105 million; and
- Makena net sales of between
Collaboration revenue of approximately
$45 millionrelated to the Takeda agreement, which was mutually terminated in December 2014, most of which is non-cash.
- Total product sales of between
Non-GAAP adjusted EBITDA3 of between
$180 million and $200 million; and
Non-GAAP cash earnings3 of between
$150 million and $170 million.
Heiden concluded by stating, “2014 was a transformative year for AMAG. We are now on track to becoming a highly profitable specialty pharmaceutical company with strong growth potential across a diversified portfolio in attractive market segments. I want to thank my colleagues for their unwavering commitment to excellence and to pursuing opportunities that make real differences in the lives of thousands of patients and their families. As we begin 2015, we are excited by our prospects for future growth and shareholder value creation through continued revenue growth from our current products and future portfolio expansion.”
A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 33rd Annual
About Makena® (hydroxyprogesterone caproate injection)
Makena® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional U.S. product information, including full prescribing information, please visit www.makena.com.
About Feraheme® (ferumoxytol) Injection /Rienso
Feraheme received marketing approval from the
Ferumoxytol received marketing approval in
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components. Serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported in patients receiving Feraheme/Rienso. Serious adverse reactions of clinically significant hypotension have been reported in the post-marketing experience of Feraheme.
For additional U.S. product information, including full prescribing information, please visit www.feraheme.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including among others, statements regarding AMAG’s expectations as to preliminary fourth quarter and full year financial results, including total revenues, net product sales (actual and pro forma), and operating expenses; expectations regarding integration efforts and status for the
Such risks and uncertainties include, among others: (1) demand for Feraheme and AMAG’s ability to successfully compete in the intravenous iron replacement market as a result of the
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
|Non-GAAP Financial Measures Reconciliation for Forward-Looking Guidance|
|($ in millions)||2015 Guidance|
|GAAP Net Income||$95 – $105|
|Add – depreciation and amortization of intangibles||$50 – $55|
|Add – interest expense, net||$40|
|EBITDA||$185 – $200|
|Less – non-cash collaboration revenue||$41 – $42|
|Add – non-cash inventory step-up||$10 – $12|
|Add – stock compensation||$12 – $14|
|Add – adjustment to contingent consideration||$15 – $16|
|Add – severance and restructuring||$2 – $3|
|Adjusted EBITDA||$180 – $200|
|Less – cash interest expense, net||$30|
|Cash earnings||$150 – $170|
1 Non-cash and one-time charges include
2 Non-cash and one-time charges include
3 See summary of non-GAAP adjustments at conclusion of press release
AMAG Pharmaceuticals, Inc. Katie Payne, 617-498-3303