-
Full-year 2012 financial guidance updated based on strong
first-half demand of Feraheme -
Product revenue and provider demand increased for second
consecutive quarter -
Operating expenses down approximately 30% from the second
quarter of 2011 -
Ferumoxytol approved in
Europe triggering$15 million milestone
company focused on the development and commercialization of Feraheme®
(ferumoxytol) Injection for intravenous (IV) use to treat iron
deficiency anemia (IDA), today reported unaudited consolidated financial
results for the second quarter ended
Business Update
-
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 reported in the second quarter of 2011.
million -
Feraheme provider demand1 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 inJune 2012 for the
treatment of IDA in adult patients with chronic kidney disease, which
triggered a$15 million milestone payment fromTakeda 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.
“Since joining AMAG, I have been focusing on our two key financial
growth drivers. First, is to ensure that Feraheme reaches its full
commercial potential and second, to add complimentary products to our
portfolio. I am confident that success on these two fronts will create
significant value for AMAG shareholders,” commented
president and chief executive officer of AMAG. “With another strong
quarter of growing Feraheme revenues and continued aggressive operating
expense management under our belt, I believe that our core business is
sound and we are indeed ready to add additional products to our
portfolio, leveraging our commercial footprint and driving us to
profitability.”
Second Quarter and Six Month 2012 Financial Results (unaudited)
Total revenues for the quarter ended
as compared to
months ended
million
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
regulatory approval of ferumoxytol in the second quarter of 2012.
Revenues in the three- and six-months ended
impacted by a reduction of reserves for product returns of
and
Total operating costs and expenses for the quarter ended
were
of 2011. Total operating costs and expenses for the six months ended
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
compared to a net loss of
and diluted share, for the second quarter of 2011. AMAG reported a net
loss for the six months ended
of
million
period in 2011.
As of
investments totaled approximately
milestone payment from Takeda was recognized as revenue in the second
quarter of 2012; however, the payment was received in
therefore not included in the
“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 andCanada ; -
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.
Conference Call and Webcast Access
slides today at
telephone, dial 877-412-6083 from
international access. A telephone replay of the conference call will be
available from approximately
or 404-537-3406 for international access. The passcode for the live call
and the telephone replay is 10874179.
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
replay will be available at approximately
archived on the
26, 2012
About Feraheme
In
(IV) use is indicated for the treatment of iron deficiency anemia in
adult chronic kidney disease (CKD) patients. Feraheme received
marketing approval from the
30, 2009
thereafter. Ferumoxytol received marketing approval in
product information, please visit www.feraheme.com.
About
manufactures and markets Feraheme® in
additional company information, please visit www.amagpharma.com.
1IMS Health DDD Data (in grams) through the period ending
AMAG Pharmaceuticals, Inc. |
||||||||||||
Condensed Consolidated Statements of Operations |
||||||||||||
(unaudited, amounts in thousands, except for per share data) |
||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||
Revenues: | ||||||||||||
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 | ||||||||
Total revenues | 31,012 | 15,402 | 46,492 | 28,787 | ||||||||
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 | ||||||||
Restructuring Expense | 1,058 | – | 1,058 | – | ||||||||
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 |
||||||||||||
Basic | 21,370 | 21,167 | 21,359 | 21,156 | ||||||||
Diluted | 21,649 | 21,167 | 21,359 | 21,156 | ||||||||
(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 | ||
Short-term investments | 176,571 | 148,703 | ||||
Accounts receivable, net | 5,778 | 5,932 | ||||
Inventories | 13,580 | 15,206 | ||||
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 | ||||
Long-term investments | – | 17,527 | ||||
Other assets | 460 | 460 | ||||
Total assets | $ | 254,233 | $ | 267,224 | ||
Accounts payable | $ | 3,757 | $ | 3,732 | ||
Accrued expenses and other short-term liabilities | 23,351 | 28,916 | ||||
Deferred revenues | 6,346 | 6,346 | ||||
Total current liabilities | 33,454 | 38,994 | ||||
Deferred revenues | 42,148 | 45,196 | ||||
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 | ||
Forward-looking Statements
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
intention to divest our manufacturing facility and reduce our workforce
by 45 positions, our expectation to submit a supplemental new drug
application to the
our belief that we are ready to add additional products to our
portfolio, and our belief that our recent initiatives will strengthen
our business and lead to more predictable operating margins in future
periods, are forward-looking statements which involve risks and
uncertainties that could cause actual results to differ materially from
those discussed in such forward-looking statements.
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
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
Commission
quarter ended
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.
Source:
AMAG Pharmaceuticals, Inc.
Amy Sullivan, 617-498-3303