Announces Preliminary Fourth Quarter 2011 Financial Results and Reiterates 2012 Financial Outlook
Fourth Quarter 2011 Business Highlights and Estimated Financial Results (unaudited)
- Over the course of 2011, the company successfully completed the transition of Feraheme® provider demand from both dialysis and non-dialysis sites of care to entirely non-dialysis sites of care. Feraheme non-dialysis provider demand for the fourth quarter of 2011 was approximately 24,250 grams1, consistent with the third quarter of 2011, but 20% percent higher than the fourth quarter of 2010. Of particular note is Feraheme’s growth in the hematology/oncology market segment, which increased approximately 65% in 2011 over 2010.
- AMAG expects to report fourth quarter 2011 total revenues of between
$14.3 and $15.0 million, including between $12.4 and $13.1 millionin net Feraheme product revenues. Total operating costs and expenses are expected to be between $38 and $43 million, including certain restructuring costs and a $2 milliontermination fee paid to Allos Therapeutics.
- AMAG implemented a restructuring plan on
November 4, 2011to align its operating expenses with projected Feraheme revenues. The restructuring plan included a reduction in force of approximately 25 percent and was designed to position the company to achieve cash flow breakeven in 2012 without impacting growth of Feraheme sales. The company’s field sales team was realigned to a more strategically targeted account list and the number of territories was reduced from 72 to approximately 55 during the fourth quarter. The restructuring also included changes to the executive leadership team at AMAG, including the company’s chief executive officer and chief commercial officer.
- AMAG hired
Jefferies & Company, Inc.as a strategic advisor. Jefferiesis assisting the company in identifying and evaluating various strategies to enhance stockholder value and leverage AMAG’s core assets – Feraheme, AMAG’s commercial and drug development infrastructure, and the company’s balance sheet, which had more than $225 millionin cash and investments, and no debt, as of December 31, 2011.
“AMAG is committed to pursuing all avenues to maximize value for our shareholders, including the potential sale of the company,” said
Thomas continued, “Commercially, we have set out three key imperatives for 2012 – to drive increased provider demand over the comparable 2011 periods, to optimize the pricing strategy for Feraheme ahead of the potential launch of the broad iron deficiency anemia label, and to strengthen our commercial leadership team. Already this year, we are making progress on these initiatives and are fortunate to have attracted a commercial industry veteran to join our ranks –
Mr. Tucker brings a strong set of experiences to AMAG, including as president of U.S. commercial operations at
Global and Indication Expansion
During 2012, AMAG will continue to work with its partner,
- A Marketing Authorization Application for Feraheme for the treatment of IDA in patients with CKD is under review by the
European Medicines Agency. AMAG recently requested, and was granted, a 60-day extension to the filing timeline in order to fully respond to the final set of questions from the Agency to support the optimal label in the E.U. AMAG currently expects a decision from the Committee for Medicinal Products for Human Use(CHMP) in the first half of 2012.
Canada, the regulatory application for Feraheme for the treatment of IDA in CKD patients was approved in December 2011, and Feraheme is expected to be launched in Canadain 2012.
- Feraheme commercial launch in
Canadaand approval and commercial launch in Europewould trigger $33 millionin milestone payments from Takeda.
AMAG is seeking to expand the U.S. label for Feraheme to all adult patients with iron deficiency anemia regardless of the underlying cause through a 1,400 patient global registrational program. The broad IDA program, which is more than 98 percent enrolled, consists of two phase III studies, one comparing treatment with Feraheme to placebo, and the other comparing treatment with Feraheme to treatment with intravenous iron sucrose. The company plans to complete enrollment in this program this month and submit an sNDA to the
2012 Financial Outlook
The company is committed to managing the business to achieve cash flow breakeven in 2012 and is reiterating the guidance provided when the company announced the
- Low double-digit Feraheme product revenue growth;
- Total operating expenses, excluding COGS, expected to be between
$90– $100 million;
- A 2012 year-end cash and investments balance of
$225 – $230 million, including $33 millionin milestones associated with potential regulatory approvals and commercial launches in the EU and Canada.
A live audio webcast of the company’s presentation and the following breakout session, along with the accompanying slide presentation at the 30th Annual
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, our estimates of fourth quarter 2011 total revenues and Feraheme net product revenues; our estimate of fourth quarter 2011 Feraheme provider demand; our estimate of fourth quarter 2011 operating costs and expenses; our estimated year-end 2011 cash, cash equivalents and investments balance; statements regarding our attempts to achieve cash flow breakeven in 2012 without impacting Feraheme sales growth; our expectations regarding 2012 Feraheme provider demand trends; our expected 2012 Feraheme product revenue growth;; our expected 2012 operating expenses; any potential Feraheme regulatory approvals in the EU and
Such risks and uncertainties include: (1) uncertainties regarding our ability to successfully compete in the intravenous iron replacement market both in the U.S. and outside the U.S., (2) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme in new indications and in territories outside of the U.S., including the
We disclaim 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.
Feraheme is a registered trademark of
1IMS Health Monthly data for 4Q2010 ; AMAG wholesaler demand data for 4Q2011.
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
Feinstein Kean Healthcare
Lynn Blenkhorn, 508-851-0930