Impax Laboratories, Inc. (NASDAQ: IPXL) today
reported strong growth in the second quarter of 2010 due to an
increase in sales from its Global Product sales channel. Total
revenue increased $94.7 million to $153.1 million driven by
continued strong sales of generic Adderall XR® and generic Flomax®
for which there were no amounts in the second quarter of 2009, as
well as increased sales of the Company’s fenofibrate products. Net
income increased to $31.3 million, or $0.48 per diluted share,
compared to $3.0 million, or $0.05 per diluted share in the prior
year period.
Larry Hsu, Ph.D., president and chief executive officer of Impax
Laboratories, said: “Once again our strategic focus drove results
that far exceeded the prior year. We benefited from the remaining
weeks of exclusive sales of generic Flomax® before competitors
entered the market in late April. This short-term exclusivity
period was significant, accounting for almost $204 million in sales
and $190 million in gross profit since our March 2010 launch of the
product. We also continued to see strong demand for our generic
Adderall XR® product; however, sales concentrated in a few large
accounts where pull-through was slow and on-going supply issues
with our supplier constrained our ability to expand our market
share. We have improved the management of our inventories and we
recently began to see an improvement in the supply of generic
Adderall XR®. We will aggressively work to fill customer
demand.”
Dr. Hsu continued, “Our strong financial performance for the
first half of 2010 has already exceeded full year 2009 results.
This exceptional performance has placed us in a stronger financial
position than at anytime in our history. With a very healthy
balance sheet consisting of more than $328 million in cash and
short-term investments and no debt, we have significant resources
to re-invest in our vital strategic initiatives. We continue to
aggressively pursue generic and brand opportunities to acquire
products, technologies or companies with compelling business
strategies to drive near and long term growth.”
Second Quarter 2010 Segment Information
The Company has two reportable segments, the Global
Pharmaceuticals Division (generic products) and the Impax
Pharmaceuticals Division (brand products) and does not allocate
general corporate services to either segment.
Global Pharmaceuticals Division Information
(amounts in thousands) Three Months Ended June 30 Six
Months Ended June 30, 2010 2009 2010 2009 (unaudited)
(unaudited) (unaudited) (unaudited) Revenues: Global Product sales,
net $ 137,638 $ 37,387 $ 446,743 $ 76,508 Private Label 339 2,220
1,011 3,517
Rx Partner
5,802 11,119 10,705 21,855 OTC Partner 2,309 1,628 4,074 3,486
Research Partner 3,384 2,833 6,769 5,444 Other - 5
- 11 Total Revenues 149,472 55,192
469,302 110,821 Cost of revenues 65,599
24,007 142,031 47,240 Gross profit 83,873
31,185 327,271 63,581 Operating
expenses: Research and development 10,929 9,578 20,364 19,853
Patent litigation 1,769 1,394 3,753 2,411 Selling, general and
administrative 3,113 2,473 6,448 5,066
Total operating expenses 15,811 13,445 30,565
27,330 Income from operations $ 68,062 $ 17,740 $ 296,706 $
36,251
Second Quarter 2010
Global Pharmaceuticals Division revenues in the second quarter
of 2010 increased $94.3 million to $149.5 million, driven by a
significant increase in Global Product sales, net, as discussed
below.
During the second quarter of 2010, Global Product sales, net,
increased $100.3 million to $137.6 million over the same period in
2009 primarily due to strong sales of generic Adderall XR®, generic
Flomax® and, to a lesser extent, increased sales of the Company’s
fenofibrate products. On March 2, 2010, the Company successfully
launched generic Flomax® which contributed $27.4 million to second
quarter 2010 sales ($203.7 million of sales for the six months
ended June 30, 2010). The Company was the only supplier of generic
Flomax® for the succeeding eight weeks ending April 27, 2010, after
which competitors entered the market, resulting in price erosion
and reduction in the Company’s market share. Partially offsetting
these gains was a $5.3 million decline in Rx Partner revenue and a
$1.9 million decline in Private Label revenue. The decline in Rx
Partner revenue is primarily attributable to reduced sales of
generic Wellbutrin® products as competition continues to erode the
Company’s market share, while Private Label products sales declined
due to lower demand for the Company’s generic loratadine/PSE
products.
Gross profit for the second quarter of 2010 increased $52.7
million to $83.9 million primarily due to sales of generic Adderall
XR®, generic Flomax® which contributed $22.4 million to second
quarter 2010 profits (total gross profit for the six months ended
June 30, 2010 was $190.3 million) and an increase in fenofibrate
sales. Gross profit margin of 56% for the second quarter 2010
declined from the 57% margin for the prior year period due to the
slightly higher concentration of lower-margin products.
Research and development expenses for the second quarter of 2010
increased $1.4 million to $10.9 million, compared to the prior year
primarily due to higher spending on clinical studies and outside
development costs.
Selling, general and administrative expenses for the second
quarter of 2010 increased $0.6 million to $3.1 million due to
increased customer freight and higher marketing expenses, both
related to higher sales levels as noted above.
Global Pharmaceuticals Division income from operations in the
second quarter 2010 increased $50.3 million to $68.1 million,
compared to $17.7 million in the prior year, due to the increase in
sales as noted above.
Impax Pharmaceuticals Division Information
(amounts in thousands) Three Months Ended June 30 Six
Months Ended June 30, 2010 2009 2010 2009 (unaudited)
(unaudited) (unaudited) (unaudited) Revenues: Promotional Partner $
3,500 $ 3,224 $ 7,003 $ 6,508 Research Partner 110 - 110 -
Total revenues 3,610 3,224 7,113 6,508 Cost of revenues 3,293 3,277
6,437 6,294 Gross profit 317 (53) 676 214 Operating
expenses: Research and development 10,755 6,134 19,629 11,649
Selling, general and administrative 738 727 1,547 1,767 Total
operating expenses 11,493 6,861 21,176 13,416 Loss from operations
$ (11,176) $ (6,914) $ (20,500) $ (13,202)
Second Quarter 2010
Promotional Partner revenues in the second quarter of 2010 were
$3.5 million, a slight increase over the prior year as the Company
continues to meet its physician detailing objectives.
The Company is currently investing in research and development
to develop brand products which provide longer product life cycles
and the potential for significantly higher profit margins than
generic products. In the second quarter of 2010, research and
development increased $4.6 million to $10.8 million, primarily due
to planned increased spending on clinical studies for the Company’s
leading drug candidate for Parkinson’s disease.
The Company’s planned increase in investment in research and
development during the second quarter of 2010 contributed to an
Impax Pharmaceuticals Division loss from operations of $11.2
million compared to a loss from operations of $6.9 million in the
second quarter of 2009.
Corporate and Other Information
(amounts in thousands) Three Months Ended June 30,
Six Months Ended June 30, 2010 2009
2010 2009 (unaudited)
(unaudited) (unaudited) (unaudited) Litigation settlement $
- $ 619 $ - $ 855 General and administrative 7,592
6,220 15,934 14,072 Total
operating expenses 7,592 6,839
15,934 14,927 Loss from operations $ (7,592 )
$ (6,839 ) $ (15,934 ) $ (14,927 )
Total corporate operating expenses for the second quarter of
2010 increased $0.8 million to $7.6 million, due to higher general
and administrative expenses attributable to increased compensation
and higher insurance costs related to increasing levels of business
activity.
Cash and Short-term Investments
Cash and short-term investments were $328.1 million as of June
30, 2010, as compared to $90.4 million as of December 31, 2009. The
change in cash and short-term investments from year-end 2009 is due
to strong product sales as noted above.
2010 Financial Outlook
The Company previously updated its full year 2010 forecast on
May 4, 2010. The Company provides this further update to its full
year 2010 forecast.
- Cash flows from operating
activities, before changes in working capital, less capital
expenditures (Free Cash Flow), planned to be positive.
- Updated May 2010 - gross margins
as a percent of total revenues to approximate 50% for the balance
of the year.
- Updated August 2010 - Total
research and development expenses across the generic and brand
divisions to approximate $83 million with generic R&D to
approximate $41 million and brand R&D to approximate $42
million (an increase of approximately $6 million due to higher
costs of clinical studies for the Company’s leading drug candidate
for Parkinson’s disease).
- Patent litigation expenses of
approximately $11 million.
- Selling, general and
administrative expenses of approximately $50 million.
- Updated May 2010 - estimated
consolidated effective tax rate of approximately 40% (without
renewal in 2010 of the federal R&D tax credit).
- Capital expenditures expected to
be approximately $20 million.
Conference Call Information
The Company will host a conference call today at 11:00 a.m. EDT
to discuss its results. The number to call from within the United
States is (877) 356-3814 and (706) 758-0033 internationally. The
call can also be accessed via a live Webcast through the Investor
Relations section of the Company’s Web site, www.impaxlabs.com. A
replay of the conference call will be available shortly after the
call for a period of seven days. To access the replay, dial (800)
642-1687 (in the U.S.) and (706) 645-9291 (international callers).
The access conference code is 87118465.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of branded
products. Impax markets its generic products through its Global
Pharmaceuticals Division and markets third-party branded products
through the Impax Pharmaceuticals Division. Additionally, where
strategically appropriate, Impax has developed marketing
partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a
full range of capabilities in its Hayward, Philadelphia and Taiwan
facilities. For more information, please visit the Company's Web
site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are
forward-looking in nature and express the beliefs and expectations
of management. Such statements are based on current expectations
and involve a number of known and unknown risks and uncertainties
that could cause the Company’s future results, performance or
achievements to differ significantly from the results, performance
or achievements expressed or implied by such forward-looking
statements. Such risks and uncertainties include, but are not
limited to, the effect of current economic conditions on the
Company’s industry, business, financial position, results of
operations and market value of its common stock, the ability to
maintain an effective system of internal control over financial
reporting, fluctuations in revenues and operating income,
reductions or loss of business with any significant customer, the
impact of competitive pricing and products and regulatory actions
on the Company’s products, the ability to sustain profitability and
positive cash flows, the ability to maintain sufficient capital to
fund operations, any delays or unanticipated expenses in connection
with the operation of the Taiwan facility, the ability to
successfully develop and commercialize pharmaceutical products, the
uncertainty of patent litigation, consumer acceptance and demand
for new pharmaceutical products, the difficulty of predicting Food
and Drug Administration filings and approvals, the inexperience of
the Company in conducting clinical trials and submitting new drug
applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to
comply with legal and regulatory requirements governing the
healthcare industry, the regulatory environment, exposure to
product liability claims and other risks described in the Company’s
periodic reports filed with the Securities and Exchange Commission.
Forward-looking statements speak only as to the date on which they
are made, and Impax undertakes no obligation to update publicly or
revise any forward-looking statement, regardless of whether new
information becomes available, future developments occur or
otherwise.
Impax Laboratories, Inc. Consolidated
Statements of Operations
(amounts in thousands, except
share and per share data)
Three Months Ended June 30, Six Months Ended June 30,
2010 2009 2010
2009 (unaudited) (unaudited) (unaudited) (unaudited)
Revenues: Global Pharmaceuticals Division $ 149,472 $ 55,192 $
469,302 $ 110,821 Impax Pharmaceuticals Division 3,610
3,224 7,113 6,508
Total Revenues 153,082 58,416
476,415 117,329 Cost of revenues
68,892 27,284 148,468
53,534 Gross profit 84,190 31,132
327,947 63,795 Operating
expenses: Research and development 21,684 15,712 39,993 31,502
Patent litigation 1,769 1,394 3,753 2,411 Litigation settlement -
619 - 855 Selling, general and administrative 11,443
9,420 23,929 20,905 Total
operating expenses 34,896 27,145
67,675 55,673 Income from operations
49,294 3,987 260,272
8,122 Other (expense) income, net (25 ) 3 (42 ) 58 Interest
income 192 307 274 456 Interest expense (23 ) (256 )
(70 ) (550 ) Income before income taxes 49,438 4,041
260,434 8,086 Provision for income taxes 18,130
1,043 97,613 2,879 Net
income before noncontrolling interest 31,308 2,998 162,821 5,207
Add back loss attributable to noncontrolling interest 40
15 12 25 Net
Income $ 31,348 $ 3,013 $ 162,833 $ 5,232
Net Income per share: Basic $ 0.51 $ 0.05
$ 2.65 $ 0.09 Diluted $ 0.48 $ 0.05
$ 2.51 $ 0.09 Weighted average common
shares outstanding: Basic 61,876,599 60,112,308 61,444,707
59,912,829 Diluted 65,538,805 60,552,344 64,887,770 60,384,179
Impax Laboratories,
Inc.
Condensed Consolidated Balance Sheets
(amounts in thousands)
June 30, December 31, 2010 2009 (unaudited) ASSETS Current
assets: Cash and cash equivalents $ 177,444 $ 31,770 Short-term
investments 150,666 58,599 Accounts receivable, net 136,015 185,854
Inventory, net 42,576 49,130 Current portion of deferred product
manufacturing costs-alliance agreements 10,647 11,624 Current
portion of deferred income taxes 35,047 32,286 Prepaid expenses and
other current assets 2,380 4,748 Total current assets
554,775 374,011 Property, plant and equipment, net
103,021 101,650 Deferred product manufacturing costs-alliance
agreements 96,962 96,619 Deferred income taxes, net 43,086 48,544
Other assets 22,704 12,358 Goodwill 27,574 27,574
Total assets $ 848,122 $ 660,756 LIABILITIES AND
STOCKHOLDERS EQUITY Current liabilities: Accounts payable $ 20,291
$ 23,295 Accrued expenses 73,144 62,055 Accrued income taxes
payable 47,054 31,627 Accrued profit sharing and royalty expenses
30,671 53,695 Current portion of deferred revenue-alliance
agreements 33,477 33,196 Total current liabilities
204,637 203,868 Deferred revenue-alliance agreements
224,347 224,522 Other liabilities 12,034 10,139 Total
liabilities $ 441,018 $ 438,529 Total stockholders equity
407,104 222,227 Total liabilities and stockholders equity $
848,122 $ 660,756
Impax Laboratories,
Inc.
Condensed Consolidated Statement of Cash Flows
(amounts in thousands)
Six Months Ended June 30, 2010 2009 (unaudited) (unaudited)
Cash flows from operating activities: Net income $ 162,833 $ 5,232
Adjustments to reconcile net income to net cash provided by (used
in) operating activities: Depreciation 6,068 5,192 Amortization of
3.5% Debentures discount and deferred financing costs - 301
Amortization of Credit Agreement deferred financing costs 25 25 Bad
debt expense 153 45 Deferred income taxes (benefit) 7,026 (6,972)
Provision for uncertain tax positions 24 463 Tax benefit related to
the exercise of employee stock options (4,329) - Deferred
revenue-Alliance Agreements 21,764 33,891 Deferred product
manufacturing costs-Alliance Agreements (8,791) (15,957) Deferred
revenue recognized-Alliance Agreements (21,658) (30,785)
Amortization deferred product manufacturing costs-Alliance
Agreements 9,425 13,884 Accrued profit sharing and royalty expense
71,902 424 Profit sharing and royalty payments (94,925) (277)
Payments on exclusivity period fee - (6,000) Payments on accrued
litigation settlements (5,865) (4,556) Share-based compensation
expense 5,234 3,193 Accretion of interest income on short-term
investments (168) (277) Changes in assets and liabilities: Accounts
receivable 49,686 (10,269) Inventory 6,554 (703) Prepaid expenses
and other assets (7,852) 1,899 Accounts payable,accrued expenses
and income taxes payable 29,151 7,751 Other liabilities
1,859 1,437 Net cash provided by (used in) operating
activities $ 228,116 $ (2,059) Cash flows from investing
activities: Purchase of short-term investments (195,450) (41,772)
Maturities of short-term investments 103,551 31,687 Purchases of
property, plant and equipment (7,690) (5,367) Net
cash used in investing activities $ (99,589) $ (15,452) Cash
flows from financing activities: Repayment of long-term debt -
(12,823) Tax benefit related to the exercise of employee stock
options 4,329 - Proceeds from exercise of stock options and the
ESPP 12,818 3,257 Net cash provided by (used in)
financing activities $ 17,147 $ (9,566) Net increase
(decrease) in cash and cash equivalents $ 145,674 $ (27,077) Cash
and cash equivalents, beginning of period $ 31,770 $ 69,275 Cash
and cash equivalents, end of period $ 177,444 $ 42,198
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