First-Quarter Highlights (versus the
prior year period)
The Company set multiple Financial Records in the First-Quarter
-
Record total revenue of $323.3 million - up $264.4 million
-
Generic Flomax(R) launched on March 2 added $176.2 million of
revenue and $167.9 million of gross profit
-
Record total gross profit of $243.8 million - up $211.1 million
-
Gross profit margin increased to 75.4% - up from 55.4%
-
Record income from operations of $211.0 million - up $206.8 million
-
Record net income of $131.5 million - up $129.3 million
-
Record earnings per diluted share of $2.06 - up $2.02
HAYWARD, Calif., May 04, 2010 (BUSINESS WIRE) --Impax Laboratories, Inc.(NASDAQ:IPXL) today reported
significant growth in the first quarter of 2010 due to an increase in
sales from its Global product sales channel. Total revenue increased
$264.4 million to $323.3 million driven by the successful March 2
exclusive launch of generic Flomax(R) ($176.2 million of
revenue and $167.9 million of gross profit) and continued strong sales
of generic Adderall XR(R) for which there were no comparable
amounts in the first quarter 2009, as well as increased sales of the
Company's fenofibrate products. Net income increased to $131.5 million,
or $2.06 per diluted share, compared to $2.2 million, or $0.04 per
diluted share in the prior year period.
Larry Hsu, Ph.D., president and chief executive officer of Impax
Laboratories, said: "This has been a truly gratifying quarter as the
investments we've been making across our organization are producing
dramatic and record-breaking returns. A major contributor to our
impressive first quarter was the launch of generic Flomax(R),
the largest product launch in our history under the Global
Pharmaceuticals label. Our efforts to prepare for the launch were
well-rewarded as we achieved significant penetration of the market
during our eight-week exclusivity period. As anticipated, we do not
expect our future sales of generic Flomax(R) to remain at first
quarter 2010 levels as competing generic versions of the product entered
the market in late April and are likely to result in both price erosion
and reduction of our market share."
Dr. Hsu continued, "The recent increase in cash flow generated from our
operations, including our strong generic Flomax(R) and generic
Adderall XR(R) product sales, will contribute significantly to
our ongoing business development activities. We will continue our
fundamental investments in internal research and development to take
full advantage of our core competency in drug delivery formulation
technology, as well as our experience in product development. In
addition, we are aggressively looking at generic and brand opportunities
to acquire products, technologies or companies with strategic value to
create long-term growth opportunities. The range of these strategic
opportunities we can consider is expanding as our resources increase
significantly and our resolve to complete a transaction that meets our
focused objectives remains very high. These are exciting times for Impax
as we embark on another chapter in our long-term growth strategy."
First 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
March 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Global product sales, net
|
|
$309,105
|
|
$39,121
|
Private Label
|
|
672
|
|
1,297
|
Rx Partner
|
|
4,903
|
|
10,736
|
OTC Partner
|
|
1,765
|
|
1,858
|
Research Partner
|
|
3,385
|
|
2,611
|
Other
|
|
-
|
|
6
|
Total Revenues
|
|
319,830
|
|
55,629
|
Cost of revenues
|
|
76,432
|
|
23,233
|
Gross profit
|
|
243,398
|
|
32,396
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
9,435
|
|
10,275
|
Patent litigation
|
|
1,984
|
|
1,017
|
Selling, general and administrative
|
|
3,334
|
|
2,594
|
Total operating expenses
|
|
14,753
|
|
13,886
|
Income from operations
|
|
$228,645
|
|
$18,510
|
|
|
|
|
|
>
First Quarter 2010
Global Pharmaceuticals Division revenues in the first quarter 2010
increased $264.2 million to $319.8 million, driven by a significant
increase in Global product net sales, as discussed below.
During the first quarter of 2010, Global product net sales increased
$270.0 million to $309.1 million over the same period in 2009 primarily
due to strong sales of generic Flomax(R), generic Adderall XR(R),
and to a lesser extent, increased sales of the Company's fenofibrate
products. On March 2, 2010, the Company successfully launched generic
Flomax(R) which contributed $176.2 million to first quarter
2010 sales. The Company was the only supplier of generic Flomax(R)
during the period ending April 27, 2010, after which competitors entered
the market. Partially offsetting these gains was a $5.8 million decline
in Rx Partner revenues primarily attributable to reduced sales of
generic Wellbutrin(R) products as competition continues to
erode the Company's market share.
Cost of revenues was $76.4 million for the first quarter 2010, an
increase of $53.2 million primarily related to the increase in Global
product net sales offset by lower Rx Partner sales.
Gross profit for the first quarter 2010 increased $211.0 million to
$243.4 million primarily due to sales of generic Flomax(R)
($167.9 million in the first quarter 2010), generic Adderall XR(R)
and an increase in fenofibrate sales. Gross profit margin of 76% for the
first quarter 2010 increased significantly over the 58% margin for the
prior year period primarily due to higher margin sales of generic Flomax(R)
and, to a lesser extent, fenofibrate.
Total research and development expenses for the first quarter 2010
decreased slightly by $0.8 million to $9.4 million, compared to the
prior year primarily due to lower spending on biostudies.
Total selling, general and administrative expenses for the first quarter
2010 increased $0.7 million to $3.3 million due to increased customer
freight and higher sales force incentive compensation, both related to
higher sales levels as noted above.
Generic division income from operations in the first quarter 2010
increased $210.1 million to $228.6 million, compared to $18.5 million in
the prior year, due to the increase in sales as noted above.
The Company's generic business development activities are primarily
focused on acquiring products/technologies/businesses in complementary
dosage forms where the Company's core competency in drug delivery and
formulation expertise can be combined to produce above-average growth in
high-value products. The Company has a number of opportunities under
consideration and has expanded the field of opportunities as the
Company's resources have increased. It is not possible to predict when
any such transaction will occur, if at all, but these activities are a
critical element of the Company's planned growth and management is
devoting significant time and attention to these activities.
Impax Pharmaceuticals Division Information
|
|
|
|
|
|
(amounts in thousands) |
|
Three Months Ended March 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
Promotional Partner revenues
|
|
$3,503
|
|
$3,284
|
Cost of revenues
|
|
3,144
|
|
3,017
|
Gross profit
|
|
359
|
|
267
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
8,874
|
|
5,514
|
Selling, general and administrative
|
|
809
|
|
1,040
|
Total operating expenses
|
|
9,683
|
|
6,554
|
Loss from operations
|
|
($9,324)
|
|
($6,287)
|
|
|
|
|
|
>
First Quarter 2010
Promotional Partner revenues in the first quarter 2010 were $3.5
million, a slight increase over the prior year as the Company continues
to meet its detailing objectives.
Cost of revenues for the first quarter 2010 were $3.1 million, up
slightly from the prior year.
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 first quarter of 2010, research and development increased $3.4
million to $8.9 million, due to planned increased spending on clinical
studies and to a lesser extent, staffing costs and incentives associated
with the management of these studies and the division.
The Company's planned increase in investment in research and development
during the first quarter of 2010 contributed to a brand division loss
from operations of $9.3 million compared to a loss from operations of
$6.3 million in the first quarter of 2009.
The Company's brand business development activities are focused on (1)
obtaining strategic partners for promotion and marketing the Company's
products outside the United States and (2) co-development agreements
with co-marketing rights where the Company's contribution to the venture
is its commercial capabilities in its current markets. The Company has a
number of opportunities under consideration and has expanded the field
of opportunities as the Company's resources have increased. It is not
possible to predict when any such transaction will occur, if at all, but
these activities are a critical element of the Company's planned growth
and management is devoting significant time and attention to these
activities.
Corporate and Other Information
|
|
|
|
|
|
(amounts in thousands)
|
|
Three Months Ended
March 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
Litigation settlement
|
|
-
|
|
$237
|
General and administrative
|
|
8,342
|
|
7,851
|
Total operating expenses
|
|
8,342
|
|
8,088
|
Loss from operations
|
|
($8,342)
|
|
($8,088)
|
|
|
|
|
|
>
Total corporate operating expenses for the first quarter 2010 increased
slightly by $0.3 million to $8.3 million.
Cash and Cash Equivalents
Cash and short-term investments was $130.4 million as of March 31, 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.
Cash flows from operating activities, before changes in working capital,
less capital expenditures (Free Cash Flow) were a positive $112.6
million in the first quarter 2010.
2010 Financial Outlook
The Company previously disclosed its 2010 financial outlook on January
11, 2010. As of May 4, 2010, the Company has updated its full year 2010
forecast as noted below.
-
Cash flows from operating activities, before changes in working
capital, less capital expenditures (Free Cash Flow), planned to be
positive.
-
Updated - gross margins as a percent of total revenues to approximate
50% for the balance of the year.
-
Total research and development expenses across the generic and brand
divisions to approximate $77 million with generic R&D to approximate
$41 million and brand R&D to approximate $36 million.
-
Patent litigation expenses of approximately $11 million.
-
Selling, general and administrative expenses of approximately $50
million.
-
Updated - 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 67229487.
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
its 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 March 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
Revenues:
|
|
|
|
|
Global Pharmaceuticals Division
|
|
$319,830
|
|
$55,629
|
Impax Pharmaceuticals Division
|
|
3,503
|
|
3,284
|
Total Revenues
|
|
323,333
|
|
58,913
|
|
|
|
|
|
Cost of revenues
|
|
79,576
|
|
26,250
|
Gross profit
|
|
243,757
|
|
32,663
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
Research and development
|
|
18,309
|
|
15,789
|
Patent litigation
|
|
1,984
|
|
1,017
|
Litigation settlement
|
|
-
|
|
237
|
Selling, general and administrative
|
|
12,485
|
|
11,485
|
Total operating expenses
|
|
32,778
|
|
28,528
|
Income from operations
|
|
210,979
|
|
4,135
|
Other income (expense), net
|
|
(18)
|
|
55
|
Interest income
|
|
82
|
|
149
|
Interest expense
|
|
(46)
|
|
(294)
|
Income before income taxes
|
|
210,997
|
|
4,045
|
Provision for income taxes
|
|
79,484
|
|
1,836
|
Net income before noncontrolling interest
|
|
131,513
|
|
2,209
|
Add back (profit) loss attributable to noncontrolling interest
|
|
(28)
|
|
10
|
Net Income
|
|
$131,485
|
|
$2,219
|
|
|
|
|
|
Net Income per share:
|
|
|
|
|
Basic
|
|
$2.16
|
|
$0.04
|
Diluted
|
|
$2.06
|
|
$0.04
|
|
|
|
|
|
Weighted average common shares outstanding:
|
|
|
|
|
Basic
|
|
61,008,015
|
|
59,711,133
|
Diluted
|
|
63,865,678
|
|
60,222,215
|
|
|
|
|
|
>
|
|
|
|
|
Impax Laboratories, Inc.
|
Condensed Consolidated Balance Sheets |
(amounts in thousands)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
|
ASSETS
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$83,747
|
|
$31,770
|
Short-term investments
|
|
46,615
|
|
58,599
|
Accounts receivable, net
|
|
324,692
|
|
185,854
|
Inventory, net
|
|
52,015
|
|
49,130
|
Current portion of deferred product manufacturing costs-alliance
agreements
|
|
11,435
|
|
11,624
|
Current portion of deferred income taxes
|
|
35,109
|
|
32,286
|
Prepaid expenses and other current assets
|
|
3,963
|
|
4,748
|
Total current assets
|
|
557,576
|
|
374,011
|
Property, plant and equipment, net
|
|
102,330
|
|
101,650
|
Deferred product manufacturing costs-alliance agreements
|
|
95,986
|
|
96,619
|
Deferred income taxes, net
|
|
44,570
|
|
48,544
|
Other assets
|
|
16,993
|
|
12,358
|
Goodwill
|
|
27,574
|
|
27,574
|
Total assets
|
|
$845,029
|
|
$660,756
|
|
|
|
|
|
Liabilities and Stockholders Equity
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
|
33,249
|
|
23,295
|
Accrued expenses
|
|
64,758
|
|
62,055
|
Accrued income taxes payable
|
|
78,582
|
|
31,627
|
Accrued profit sharing and royalty expenses
|
|
41,307
|
|
53,695
|
Current portion of deferred revenue-alliance agreements
|
|
33,433
|
|
33,196
|
Total current liabilities
|
|
251,329
|
|
203,868
|
Deferred revenue-alliance agreements
|
|
219,727
|
|
224,522
|
Other liabilities
|
|
12,212
|
|
10,139
|
Total liabilities
|
|
483,268
|
|
438,529
|
Stockholders equity
|
|
361,761
|
|
222,227
|
Total liabilities and stockholders equity
|
|
$845,029
|
|
$660,756
|
|
|
|
|
|
>
|
|
|
|
|
Impax Laboratories, Inc.
|
Condensed Consolidated Statement of Cash Flows |
(amounts in thousands)
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
2010
|
|
2009
|
|
|
(unaudited)
|
|
(unaudited)
|
Cash flows from operating activities:
|
|
|
|
|
Net income
|
|
$131,485
|
|
$2,219
|
Adjustments to reconcile net income to net cash (used in) provided
by operating activities:
|
|
|
|
|
Depreciation
|
|
2,946
|
|
2,544
|
Amortization of 3.5% Debentures discount and deferred financing costs
|
|
-
|
|
150
|
Amortization of Wachovia Credit Agreement deferred financing costs
|
|
25
|
|
-
|
Bad debt expense
|
|
91
|
|
23
|
Deferred income taxes (benefit)
|
|
1,151
|
|
(3,027)
|
Provision for uncertain tax positions
|
|
12
|
|
218
|
Tax benefit related to the exercise of employee stock options
|
|
(738)
|
|
-
|
Deferred revenue-Alliance Agreements
|
|
5,495
|
|
19,723
|
Deferred product manufacturing costs-Alliance Agreements
|
|
(3,427)
|
|
(9,919)
|
Deferred revenue recognized-Alliance Agreements
|
|
(10,053)
|
|
(15,205)
|
Amortization deferred product manufacturing costs-Alliance Agreements
|
|
4,249
|
|
7,666
|
Accrued profit sharing and royalty expense
|
|
41,307
|
|
72
|
Profit sharing and royalty payments
|
|
(53,695)
|
|
(252)
|
Payments on exclusivity period fee
|
|
-
|
|
(3,000)
|
Payments on accrued litigation settlements
|
|
(5,865)
|
|
(4,007)
|
Share-based compensation expense
|
|
2,785
|
|
1,437
|
Accretion of interest income on short-term investments
|
|
(64)
|
|
(36)
|
Changes in assets and liabilities:
|
|
|
|
|
Accounts receivable
|
|
(138,929)
|
|
(18,530)
|
Inventory
|
|
(2,885)
|
|
2,546
|
Prepaid expenses and other assets
|
|
(3,870)
|
|
2,042
|
Accounts payable and accrued expenses
|
|
64,678
|
|
(3,481)
|
Other liabilities
|
|
2,089
|
|
734
|
Net cash provided (used in) by operating activities
|
|
$36,787
|
|
($18,083)
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
Purchase of short-term investments
|
|
(23,055)
|
|
(27,810)
|
Maturities of short-term investments
|
|
35,103
|
|
18,245
|
Purchases of property, plant and equipment
|
|
(3,116)
|
|
(3,881)
|
Net cash provided by (used in) investing activities
|
|
$8,932
|
|
($13,446)
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
Repayment of long-term debt
|
|
-
|
|
(36)
|
Tax benefit related to the exercise of employee stock options
|
|
738
|
|
-
|
Proceeds from exercise of stock options and purchases under the ESPP
|
|
5,520
|
|
334
|
Net cash provided by financing activities
|
|
$6,258
|
|
$298
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
$51,977
|
|
($31,231)
|
Cash and cash equivalents, beginning of period
|
|
$31,770
|
|
$69,275
|
Cash and cash equivalents, end of period
|
|
$83,747
|
|
$38,044
|
|
|
|
|
|
>

SOURCE: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue
Sr. Director
Investor Relations and Corporate Communications
215-933-3526
www.impaxlabs.com