LEXINGTON, Mass.–(BUSINESS WIRE)–Mar. 5, 2012–
Business Update
- Total revenues for the year ended
December 31, 2011 were$61.2 million , of which$52.1 million were net product revenues from Feraheme® (ferumoxytol) Injection for intravenous (IV) use. Feraheme net product revenues for the year included a$3.0 million favorable change in estimatedMedicaid reserves to reflect AMAG’s actual claims experience since launch, which the company recognized in the third quarter of 2011. For the fourth quarter, total revenues were$14.9 million , of which$12.8 million were Feraheme net product revenues. - Total Feraheme provider demand for 2011 was approximately 92,000 grams1, nearly all of which was for use in the non-dialysis setting for patients with chronic kidney disease (CKD), representing a 38% increase in non-dialysis provider demand over 2010. Feraheme non-dialysis provider demand for the fourth quarter of 2011 was approximately 16% percent higher than the fourth quarter of 2010.
- AMAG is continuing to work with
Jefferies & Company, Inc. to identify and evaluate various strategies to enhance stockholder value, including a potential sale of the company, and leverage AMAG’s core assets – Feraheme, AMAG’s commercial and drug development infrastructure, and the company’s cash balance.
“We are pleased with the progress that we are making in the strategic evaluation of our business and in our efforts to re-establish the growth of Feraheme in 2012,” said
Fourth Quarter and Full Year 2011 Financial Results (unaudited)
Total revenues for the quarter ended
Total operating costs and expenses for the quarter ended
The company reported a net loss of
2012 Goals
AMAG expects to achieve the following in 2012:
- Increase the demand for Feraheme by >15%, as measured by grams sold through to non-dialysis sites of care for U.S. CKD patients, assuming a consistent growth rate for the overall IV iron market, continued Feraheme market share growth in the hematology/oncology and hospital segments, and maintenance of Feraheme’s position as a market share leader in the non-dialysis nephrology segment;
- Receive a favorable decision on the company’s marketing authorization application for Feraheme for the treatment of IDA in adult patients with CKD in
Europe ; - Launch Feraheme, through our partner Takeda, in
Europe andCanada ; and - File the sNDA in
the United States for Feraheme for the broad iron deficiency anemia indication.
2012 Financial Guidance
The company reiterates its financial guidance to manage the business to achieve cash flow breakeven in 2012 based on the following guidance:
- Net Feraheme product revenues of
$53 –$57 million based on the commercial goals outlined above, excluding any royalties from sales outside the U.S.; - Milestones received totaling
$33 million associated with potential regulatory approvals and commercial launches in the EU andCanada ; - Cost of goods sold (COGS) of approximately 14% – 18% of total product sales;
- Total operating expenses, excluding COGS, of
$90 –$95 million , of which$40 –$45 million are expected to be research and development expenses and$50 –$55 million are expected to be selling, general and administrative expense; and - A 2012 year-end cash and investments balance of
$225 –$230 million .
Conference Call and Webcast Access
To access the conference call via telephone, dial (877) 412-6083 from
The call will be webcast live with slides and accessible through the Investors section of the Company’s website at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.amagpharma.com&esheet=50192807&lan=en-US&anchor=www.amagpharma.com&index=1&md5=a363d2b72051457f35bb4d98b12dfcbf on
About Feraheme
In
About
For additional company or product information, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.amagpharma.com&esheet=50192807&lan=en-US&anchor=www.amagpharma.com&index=2&md5=48ae5fabd79f12432b18e25618107ffe or http://feraheme.com.
| AMAG Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (unaudited, amounts in thousands, except for per share data) | ||||||||||||||||||||
| Three Months Ended Dec. 31, | Twelve Months Ended Dec. 31, | |||||||||||||||||||
| 2011 | 2010 | 2011 | 2010 | |||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Product sales, net | $ | 12,908 | $ | 15,284 | $ | 52,813 | $ | 59,978 | ||||||||||||
License fee, collaboration and royalty revenues | 1,999 | 1,936 | 8,436 | 6,267 | ||||||||||||||||
| Total revenues | 14,907 | 17,220 | 61,249 | 66,245 | ||||||||||||||||
Operating costs and expenses (1): | ||||||||||||||||||||
| Cost of product sales | 2,739 | 2,438 | 10,531 | 7,606 | ||||||||||||||||
| Research and development expenses | 12,985 | 13,279 | 58,140 | 54,462 | ||||||||||||||||
Selling, general and administrative expenses | 15,173 | 19,493 | 68,863 | 84,939 | ||||||||||||||||
| Restructuring expenses | 3,508 | 2,224 | 3,508 | 2,224 | ||||||||||||||||
| Total operating costs and expenses | 34,405 | 37,434 | 141,042 | 149,231 | ||||||||||||||||
Operating Loss | (19,498 | ) | (20,214 | ) | (79,793 | ) | (82,986 | ) | ||||||||||||
Interest and dividend income, net | 357 | 418 | 1,747 | 1,741 | ||||||||||||||||
| Other income (expense) | 1 | 6 | (193 | ) | (380 | ) | ||||||||||||||
Net loss before income taxes | (19,140 | ) | (19,790 | ) | (78,239 | ) | (81,625 | ) | ||||||||||||
Income tax benefit | 559 | 10 | 1,170 | 472 | ||||||||||||||||
Net loss | $ | (18,581 | ) | $ | (19,780 | ) | $ | (77,069 | ) | $ | (81,153 | ) | ||||||||
Net loss per share – basic and diluted: | $ | (0.87 | ) | $ | (0.94 | ) | $ | (3.64 | ) | $ | (3.90 | ) | ||||||||
Weighted average shares outstanding used to compute net loss per share: | ||||||||||||||||||||
Basic and diluted | 21,248 | 21,123 | 21,189 | 20,806 | ||||||||||||||||
| (1) Stock-based compensation included in operating costs and expenses: | ||||||||||||||||||||
| Cost of product sales | $ | 133 | $ | 141 | $ | 616 | $ | 441 | ||||||||||||
| Research and development | 509 | 812 | 1,874 | 3,508 | ||||||||||||||||
| Selling, general and administrative | 598 | 2,834 | 7,548 | 10,574 | ||||||||||||||||
| Condensed Consolidated Balance Sheets (unaudited, amounts in thousands) | ||||||||||
| December 31, 2011 | December 31, 2010 | |||||||||
| Cash and cash equivalents | $ | 63,474 | $ | 112,646 | ||||||
| Short-term investments | 148,703 | 147,619 | ||||||||
| Accounts receivable | 5,932 | 5,785 | ||||||||
| Inventories | 15,206 | 16,344 | ||||||||
| Receivable from collaboration | 428 | 441 | ||||||||
| Other current assets | 6,288 | 7,949 | ||||||||
| Total current assets | 240,031 | 290,784 | ||||||||
Property, plant & equipment, net | 9,206 | 11,235 | ||||||||
| Long-term investments | 17,527 | 33,597 | ||||||||
| Other assets | 460 | 460 | ||||||||
| Total assets | $ | 267,224 | $ | 336,076 | ||||||
| ||||||||||
| Accounts payable | $ | 3,732 | $ | 4,553 | ||||||
| Accrued expenses | 28,916 | 25,555 | ||||||||
| Deferred revenues – short term | 6,346 | 6,603 | ||||||||
| Total current liabilities | 38,994 | 36,711 | ||||||||
Deferred revenues – long term | 45,196 | 51,292 | ||||||||
| Other long term liabilities | 2,438 | 2,787 | ||||||||
| Total long term liabilities | 47,634 | 54,079 | ||||||||
Total stockholders’ equity | 180,596 | 245,286 | ||||||||
Total liabilities and stockholders’ equity | $ | 267,224 | $ | 336,076 | ||||||
The important safety information below is based on
Important Safety Information About Feraheme
Indication and contraindications
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.
Warnings and precautions
Feraheme may cause life-threatening hypersensitivity reactions including anaphylaxis and/or anaphylactoid reactions. Anaphylactic type reactions, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience. In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following each Feraheme injection and the drug should only be administered when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse reactions
In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥ 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
Post-marketing safety experience
The following adverse reactions have been identified during post-approval use of Feraheme. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following serious adverse reactions have been reported from the post-marketing spontaneous reports with Feraheme: life-threatening anaphylactic/anaphylactoid reactions, cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, unresponsiveness, loss of consciousness, tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have occurred up to 30 minutes after the administration of Feraheme injection. Reactions have occurred following the first dose or subsequent doses of Feraheme.
For full prescribing information, please visit http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.feraheme.com&esheet=50192807&lan=en-US&anchor=www.feraheme.com&index=4&md5=54856f0a5afe24a1b41a819947396b17.
Forward-looking Statement
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 plans to grow Feraheme revenues in 2012 and operate as a leaner, more nimble organization; our plan to achieve cash flow breakeven status in 2012; our plans regarding our strategic alternatives review process; our 2012 goals, including our expectation to increase Feraheme gram demand by greater than 15% in non-dialysis sites of care, our expectation to receive a favorable decision on our marketing authorization application for Feraheme in
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 the broader IDA indication 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.
Source:
Investors:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303
or
Media:
Feinstein Kean Healthcare
Lynn Blenkhorn, 508-851-0930,
Lynn.blenkhorn@fkhealth.com
