- Feraheme net product revenues in the United States for the second quarter of 2012 were $14.1 million, a 10% increase from the $12.8 million reported in the second quarter of 2011.
- Feraheme provider demand 1 for the second quarter of 2012 reached a record level of approximately 28,200 grams, a 15% increase from the second quarter of 2011.
- AMAG took further steps to streamline its cost structure in the second quarter. As previously announced, the company plans to divest its manufacturing facility and reduce its workforce by 45 positions.
- Ferumoxytol was approved in the European Union in June 2012 for the treatment of IDA in adult patients with chronic kidney disease, which triggered a $15 million milestone payment from Takeda Pharmaceutical Company Limited.
- The company reported positive data from two phase III clinical trials of Feraheme for the treatment of IDA regardless of the underlying cause and plans to submit a supplemental new drug application to the U.S. Food and Drug Administration by the end of 2012.
Second Quarter and Six Month 2012 Financial Results (unaudited)Total revenues for the quarter ended June 30, 2012 were $31.0 million, as compared to $15.4 million for the second quarter of 2011. For the six months ended June 30, 2012, AMAG reported total revenues of $46.5 million, as compared to revenues of $28.8 million for the same period in 2011. The change in total revenues in 2012 versus the comparable 2011 periods was due to increased physician demand for Feraheme and the recognition of a $15 million milestone associated with European regulatory approval of ferumoxytol in the second quarter of 2012. Revenues in the three- and six-months ended June 30, 2012 were favorably impacted by a reduction of reserves for product returns of $0.6 million and $1.1 million, respectively. Total operating costs and expenses for the quarter ended June 30, 2012 were $27.1 million, as compared to $35.6 million for the second quarter of 2011. Total operating costs and expenses for the six months ended June 30, 2012 were $55.3 million, as compared to $71.8 million for the same period in 2011. The decreases in total operating costs and expenses in the 2012 periods were due to decreased research and development costs associated with the company’s global iron deficiency anemia (IDA) registrational program and decreased selling, general and administrative expenses as the company realized the benefits of its streamlined cost structure. The company reported net income of $3.3 million, or $0.16 per basic and $0.15 per diluted share, for the quarter ended June 30, 2012, as compared to a net loss of $19.6 million, or a loss of $0.92 per basic and diluted share, for the second quarter of 2011. AMAG reported a net loss for the six months ended June 30, 2012 of $9.1 million, or a loss of $0.43 per basic and diluted share, as compared to a net loss of $41.9 million, or a loss of $1.98 per basic and diluted share for the same period in 2011.
As of June 30, 2012, the company’s cash, cash equivalents and investments totaled approximately $207 million. The $15 million dollar milestone payment from Takeda was recognized as revenue in the second quarter of 2012; however, the payment was received in July 2012 and is therefore not included in the June 30, 2012 cash balance.“During the second quarter, we also took important actions that led to multiple one-time items in our financial statements,” said Frank E. Thomas, executive vice president and chief operating officer of AMAG. “From de-risking our investment portfolio through the liquidation of our remaining auction rate securities, to streamlining our cost structure and taking the steps necessary to move to a completely outsourced manufacturing model, we believe these actions will strengthen our business and lead to more predictable operating margins in future periods.” 2012 Financial Guidance The company is updating its 2012 financial guidance. AMAG now expects:
- Net Feraheme product revenues of $55 – $58 million, excluding any royalties and product sales outside the U.S.;
- Milestones achieved totaling $33 million associated with regulatory approvals and commercial launches in the EU and Canada;
- Cost of goods sold (COGS) of approximately 20% – 24% of total product sales, which now includes accelerated depreciation and idle capacity associated with the planned closure of the company’s manufacturing facility;
- Total operating expenses, excluding COGS, of $90 – $95 million, including one-time charges associated with the planned closure of the company’s manufacturing facility and employee-related restructuring charges; and
- A 2012 year-end cash and investments balance of $225 – $230 million, excluding cash utilized to acquire or in-license additional marketed products.
A live webcast of the conference call and accompanying slides will be accessible through the Investors section of the Company’s website at www.amagpharma.com beginning at 8:00 a.m. ET. Following the conference call, the webcast replay will be available at approximately 10:00 a.m. ET and will be archived on the AMAG Pharmaceuticals, Inc. website until midnight August 26, 2012.About Feraheme In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011 and in the European Union in June 2012. For additional product information, please visit www.feraheme.com. About AMAG Pharmaceuticals, Inc. AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that manufactures and markets Feraheme® in the United States. For additional company information, please visit www.amagpharma.com. AMAG Pharmaceuticals and Feraheme are registered trademarks of AMAG Pharmaceuticals, Inc. 1IMS Health DDD Data (in grams) through the period ending June 30, 2012.
|AMAG Pharmaceuticals, Inc.|
|Condensed Consolidated Statements of Operations|
|(unaudited, amounts in thousands, except for per share data)|
|Three Months Ended June 30,||Six Months Ended June 30,|
|Product sales, net||$||14,420||$||13,081||$||28,128||$||24,103|
|License fee, collaboration and royalty revenues||16,592||2,321||18,364||4,684|
|Operating costs and expenses (1):|
|Cost of product sales||3,224||2,082||5,870||5,123|
|Research and development expenses||7,671||16,695||20,133||30,261|
|Selling, general and administrative expenses||15,101||16,826||28,282||36,460|
|Total operating costs and expenses||27,054||35,603||55,343||71,844|
|Operating Income (Loss)||3,958||(20,201)||(8,851)||(43,057)|
|Interest and dividend income, net||338||452||731||1,012|
|Other income (expense)||(1,471)||(209)||(1,471)||(208)|
|Net income (loss) before income taxes||2,825||(19,958)||(9,591)||(42,253)|
|Income tax benefit||494||396||494||396|
|Net income (loss)||$||3,319||$||(19,562)||$||(9,097)||$||(41,857)|
|Net income (loss) per basic share:||$||0.16||$||(0.92)||$||(0.43)||$||(1.98)|
|Net income (loss) per diluted share:||$||0.15||$||(0.92)||$||(0.43)||$||(1.98)|
|Weighted average shares outstanding used to compute net income (loss) per share:|
|(1) Stock-based compensation included in operating costs and expenses:|
|Cost of product sales||$||68||$||157||$||146||$||352|
|Research and development||$||525||$||639||$||947||$||1,281|
|Selling, general and administrative||$||984||$||1,825||$||2,169||$||5,463|
|AMAG Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|(unaudited, amounts in thousands)|
|June 30, 2012||December 31, 2011|
|Cash and cash equivalents||$||30,678||$||63,474|
|Accounts receivable, net||5,778||5,932|
|Receivable from collaboration||15,133||428|
|Other current assets||4,202||6,288|
|Total current assets||245,942||240,031|
|Net property, plant & equipment||7,831||9,206|
|Accrued expenses and other short-term liabilities||23,351||28,916|
|Total current liabilities||33,454||38,994|
|Other long-term liabilities||2,239||2,438|
|Total long-term liabilities||44,387||47,634|
|Total stockholders’ equity||176,392||180,596|
|Total liabilities and stockholders’ equity||$||254,233||$||267,224|
Such risks and uncertainties include: (1) uncertainties regarding our and Takeda’s 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 European Union, (3) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, (4) uncertainties regarding our ability to manufacture Feraheme, (5) uncertainties relating to our patents and proprietary rights, (6) uncertainty regarding our ability to acquire additional products for our portfolio, and (7) other risks identified in our Securities and Exchange Commission filings, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2012. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.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.