Impax Laboratories, Inc. (NASDAQ: IPXL) today
reported third quarter ended September 30, 2011 financial
results.
- Adjusted net income, increased 26% to
$20.0 million or $0.30 per diluted share, compared to adjusted net
income of $15.8 million or $0.24 per diluted share in the prior
year period.
- Unadjusted net income was $17.2
million, or $0.26 per diluted share, compared to $75.2 million, or
$1.15 per diluted share in the prior year period. The decline was
primarily attributable to the change in accounting for the Teva
Agreement as further described below.
- Total revenues of $119.8 million
increased $12.2 million, compared to adjusted revenue of $107.6
million in the prior year period. Third quarter 2010 revenue of
$304.0 million excludes $196.4 million of generic Rx Partner
revenue due to the change in accounting for the Teva
Agreement.
- Adjusted earnings before interest,
taxes, depreciation and amortization (EBITDA), was $32.5 million
compared to $27.8 million in the prior year period.
Please refer to “Non-GAAP Financial Measures” below for a
reconciliation of GAAP to non-GAAP items.
“During the third quarter, we continued to make significant
quality improvements and are diligently working to resolve the
manufacturing observations raised in the June warning letter. These
efforts remain a top priority throughout the Company. However, it
has not distracted us from continuing to focus on our business as
evidenced by our profitable results in the third quarter or
hindered our investments in new product opportunities,” said Larry
Hsu, Ph.D., president and CEO, Impax Laboratories, Inc.
Dr. Hsu continued, “We have provided the U.S. Food and Drug
Administration (FDA) with updates on our progress with quality
improvements and established dialogue with the agency. We have
implemented a global quality improvement program with the
assistance of our external consultants. Our focus remains on
working expeditiously to meet our internal goal of closing out the
warning letter by the end of February 2012, the timing of which is
dependent upon the FDA’s availability to re-inspect our Hayward
facility.”
Dr. Hsu concluded, “Throughout this process we have continued to
focus on growth initiatives. Our generic pipeline of 47 products
pending approval has never been larger and continues to expand as
we have already filed 10 new product applications in 2011. Within
our brand division, we remain on track to file a New Drug
Application for IPX066, our leading brand product candidate for
Parkinson’s Disease, by the end of this year. In addition, we
continue to pursue internally developed products and business
development candidates that are consistent with our stated
objectives of high growth and high margin opportunities.”
Segment Information – Third Quarter 2011
The Company has two reportable segments, the Global
Pharmaceuticals Division (generic products & services) and the
Impax Pharmaceuticals Division (brand products & services) and
does not allocate general corporate services to either segment.
Global Pharmaceuticals Division Information
Three Months Ended Nine
Months Ended September 30, September 30,
(unaudited, amounts in thousands)
2011
2010 2011 2010 Revenues: Global
Product sales, net $ 97,661 $ 91,579 $ 301,124 $ 539,333 Rx Partner
(a) 12,621 202,799 20,169 213,504 OTC Partner 879 2,365 4,006 6,439
Research Partner 3,385 3,384 13,154
10,153 Total revenues (a) 114,546 300,127 338,453 769,429 Cost of
revenues (a) 54,196 140,278 164,627
282,309 Gross profit (a) 60,350 159,849
173,826 487,120 Operating expenses: Research and development
11,487 12,819 34,728 32,608 Patent litigation 2,114 1,033 6,097
4,786 Selling, general and administrative 4,069 4,127
9,938 11,149 Total operating expenses 17,670
17,979 50,763 48,543 Income from operations
(a) $ 42,680 $ 141,870 $ 123,063 $ 438,577
(a) In the third quarter 2010, the Company materially modified
its Strategic Alliance Agreement with Teva and applied the revised
revenue recognition standards of FASB ASC 605-25 Multiple Element
Arrangements. Application of the revised standards resulted in the
recognition of previously deferred net revenue that would have been
recognized over the remaining life of the Teva agreement under the
prior standards. The following table reflects the impact on the
Global Pharmaceuticals Division results due to the change in
revenue recognition.
(unaudited amounts in
Three Months Ended Nine Months Ended
thousands) September 30, 2010 September 30, 2010
AsReported
Impact ofchange
AsReported
Impact ofchange
Adjusted Adjusted Rx Partner $ 202,799 $ 196,440 $ 6,359 $ 213,504
$ 196,440 $ 17,064 Total revenues 300,127 196,440 103,687 769,429
196,440 572,989 Cost of revenues 140,278 95,426 44,852 282,309
95,426 186,883 Gross profit 159,849 101,014 58,835 487,120 101,014
386,106 Income from operations $ 141,870 $ 101,014 $ 40,856 $
438,577 $ 101,014 $ 337,563
Excluding the third quarter 2010 change in revenue recognition
under the Teva Agreement, Global Pharmaceuticals Division revenues
increased $10.8 million to $114.5 million in the third quarter
2011, compared to $103.7 million in the prior year period, due to
higher Global Product sales, net, and Rx Partner sales.
For the third quarter 2011, Global Product sales, net, were
$97.7 million, up $6.1 million from the prior year period due to
higher sales of authorized generic Adderall XR® products ($46.9
million in the third quarter 2011 compared to $32.0 million in the
prior year period). Sales of generic Adderall XR® in the third
quarter 2011 were mitigated due to ongoing supply issues from the
Company’s supplier, resulting in insufficient supply to satisfy
customer demand. For the fourth quarter 2011, the Company currently
estimates generic Adderall XR® sales similar to those in the third
quarter 2011 based on estimates of shipments from the Company’s
supplier. This forecast includes estimated deliveries throughout
the fourth quarter, including those expected in late December.
Consistent with prior quarters, the Company’s expectations are
subject to receipt of expected quantities.
Partially offsetting the increase in generic Adderall XR®
product sales were lower sales of certain Global Products
principally due to the slowdown in manufacturing production levels
earlier in the year as the Company implemented manufacturing and
quality process improvements. The slowdown resulted in delays in
the release of certain products which caused the loss of some third
quarter 2011 orders. The Company is now producing product at a
normal pace and does not currently plan to reduce its manufacturing
of finished product.
Rx Partner revenue, excluding the third quarter 2010 change in
accounting for the Teva agreement as noted above, increased $6.3
million to $12.6 million, compared to the prior year period. The
increase was due to the receipt of $7.4 million from Teva
representing an adjustment to previous estimates of profit share
earned by the Company under the Teva Agreement.
Gross profit of $60.4 million represents a 53% gross margin in
the third quarter 2011, and was lower than the adjusted gross
margin of 57% (excludes the change in revenue recognition as noted
above) for the prior year period primarily due to lower sales of
certain higher margin products in the third quarter 2011.
Total generic operating expenses of $17.7 million in the third
quarter 2011 decreased slightly over the prior year period
primarily due to lower spending on research and development
partially offset by higher spending on patent litigation.
Impax Pharmaceuticals Division Information
Three Months Ended Nine Months Ended
September 30, September 30, (unaudited, amounts in
thousands)
2011 2010 2011
2010 Revenues: Rx Partner $ 1,438 $ - $ 4,313 $ -
Promotional Partner 3,535 3,535 10,605 10,538 Research Partner
330 330 989 440 Total revenues 5,303
3,865 15,907 10,978 Cost of revenues 2,999 2,843
8,840 9,280 Gross profit 2,304 1,022
7,067 1,698 Operating expenses: Research and
development 7,352 11,027 27,580 30,656 Selling, general and
administrative 1,632 930 4,116 2,478
Total operating expenses 8,984 11,957 31,696
33,134 Loss from operations $ (6,680 ) $ (10,935 ) $ (24,629
) $ (31,436 )
Impax Pharmaceuticals Division revenues in the third quarter
2011 increased $1.4 million to $5.3 million over the prior year
period due to the addition of Rx Partner revenues.
In the third quarter 2011, the Company recognized $1.4 million
of Rx Partner revenue related to the $11.5 million up-front payment
(recognized over 24 months) received under the License, Development
and Commercialization Agreement with Glaxo Group Limited which was
entered into in December 2010.
The loss from operations in the third quarter 2011 was a result
of the Company’s strategy to invest 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.
Corporate and Other
Three Months Ended Nine
Months Ended September 30, September 30,
(unaudited, amounts in thousands)
2011
2010 2011 2010 General and
administrative expenses $ 10,617 $ 7,575 $ 34,352 $ 23,509 Loss
from operations $ (10,617 ) $ (7,575 ) $ (34,352 ) $ (23,509 )
General and administrative expenses in the third quarter 2011
increased $3.0 million compared to the prior year period primarily
due to an increase in legal fees.
Cash and short-term investments were $359.8 million as of
September 30, 2011, as compared to $348.4 million as of December
31, 2010.
2011 Financial Outlook
The Company updated its full year 2011 financial outlook as
noted below.
- Positive cash flows from operating
activities, less capital expenditures (Free Cash Flow).
- Gross margins as a percent of total
revenues of approximately 50%.
- Total research and development
(R&D) expenses across the generic and brand divisions to
approximate $87 million with generic R&D of approximately $47
million and brand R&D of approximately $40 million.
- Patent litigation expenses of
approximately $10 million. (Updated Nov. 1, 2011)
- Selling, general and administrative
expenses of approximately $65 million.
- Effective tax rate of approximately 34%
to 36%.
- Capital expenditures of approximately
$50 million. (Updated Nov. 1, 2011)
Conference Call Information
The Company will host a conference call on November 1, 2011 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 (855) 859-2056 (in the U.S.) and (404)
537-3406 (international callers). The access conference code is
18040631.
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, including the statements under
the heading “2011 Financial Outlook,” 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 and results of
operations, the ability to maintain an effective system of internal
control over financial reporting, fluctuations in revenues and
operating income, the ability to successfully develop and
commercialize pharmaceutical products, reductions or loss of
business with any significant customer or a reduction in sales of
any significant product, the impact of competition, the ability to
sustain profitability and positive cash flows, any delays or
unanticipated expenses in connection with the operation of the
Taiwan facility, the effect of foreign economic, political, legal
and other risks on operations abroad, 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,
the ability to successfully conduct clinical trials, reliance on
alliance and collaboration agreements, the availability of raw
materials, the ability to comply with legal and regulatory
requirements governing the pharmaceuticals and healthcare
industries, the regulatory environment, the ability to protect the
Company’s intellectual property, 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
(unaudited, amounts in thousands, except
share and per share data)
Three Months Ended Nine
Months Ended September 30, September 30,
2011 2010 2011
2010 Revenues: Global Pharmaceuticals Division $ 114,546 $
300,127 $ 338,453 $ 769,429 Impax Pharmaceuticals Division
5,303 3,865 15,907 10,978 Total revenues
119,849 303,992 354,360 780,407 Cost of revenues
57,195 143,121 173,467 291,589 Gross profit
62,654 160,871 180,893 488,818
Operating expenses: Research and development 18,839 23,846 62,308
63,264 Patent litigation 2,114 1,033 6,097 4,786 Selling, general
and administrative 16,318 12,632 48,406
37,136 Total operating expenses 37,271 37,511
116,811 105,186 Income from operations 25,383 123,360 64,082
383,632 Other income (expense), net 69 (91 ) (470 ) (134 ) Interest
income 268 405 879 680 Interest expense (53 ) (38 )
(81 ) (108 ) Income before income taxes 25,667
123,636 64,410 384,070 Provision for income taxes 8,486
48,501 20,844 146,114 Net income before
noncontrolling interest 17,181 75,135 43,566 237,956 Add back loss
attributable to noncontrolling interest 39 28
67 40 Net Income $ 17,220 $ 75,163 $ 43,633 $ 237,996
Net Income per share: Basic $ 0.27 $ 1.20 $ 0.68 $ 3.85 Diluted $
0.26 $ 1.15 $ 0.65 $ 3.65 Weighted average common shares
outstanding: Basic 64,387,413 62,435,116 63,937,796 61,778,465
Diluted 66,986,758 65,470,341 67,318,658 65,171,055
Impax
Laboratories, Inc. Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)
September 30, December
31, 2011 2010 Assets Current assets: Cash and
cash equivalents $ 138,210 $ 91,796 Short-term investments 221,595
256,605 Accounts receivable, net 106,003 82,054 Inventory, net
50,126 44,549 Deferred product manufacturing costs 1,385 2,012
Deferred income taxes 40,650 39,271 Prepaid expenses and other
current assets 2,914 4,407 Total current assets
560,883 520,694 Property, plant and equipment, net
114,607 106,280 Deferred product manufacturing costs 7,631 8,223
Deferred income taxes, net 5,454 5,069 Other assets 36,209 25,478
Goodwill 27,574 27,574 Total assets $ 752,358 $
693,318 Liabilities and Stockholders' Equity Current
liabilities: Accounts payable $ 17,309 $ 18,812 Accrued expenses
74,307 72,788 Accrued income taxes payable 226 2,393 Accrued profit
sharing and royalty expenses 22,602 14,147 Deferred revenue
23,432 18,276 Total current liabilities 137,876
126,416 Deferred revenue 21,753 44,195 Other liabilities
15,959 14,558 Total liabilities 175,588 185,169 Total
stockholders' equity 576,770 508,149 Total
liabilities and stockholders' equity $ 752,358 $ 693,318
Impax
Laboratories, Inc. Consolidated Statements of Cash Flows
(unaudited, amounts in thousands)
Nine Months Ended September 30, 2011
2010 Cash flows from operating activities: Net
income $ 43,633 $ 237,996 Adjustments to reconcile net income to
net cash (used in) provided by operating activities: Depreciation
and amortization 11,883 9,066 Amortization of Credit Agreement
deferred financing costs 20 25 Accretion of interest income on
short-term investments (665 ) (374 ) Deferred income taxes 4,322
46,657 Provision for uncertain tax positions 142 35 Tax benefit
related to the exercise of employee stock options (6,086 ) (4,337 )
Deferred revenue 2,182 22,947 Deferred product manufacturing costs
(1,275 ) (9,739 ) Recognition of deferred revenue (19,489 )
(224,454 ) Amortization deferred product manufacturing costs 2,494
106,746 Accrued profit sharing and royalty expense 67,210 86,985
Payments of profit sharing and royalty expense (58,759 ) (125,445 )
Payments of accrued litigation settlements - (5,865 ) Share-based
compensation expense 9,632 7,706 Bad debt expense 163 215 Changes
in assets and liabilities: Accounts receivable (24,112 ) 90,072
Inventory (5,577 ) 7,094 Prepaid expenses and other assets (9,606 )
(11,225 ) Accounts payable, accrued expenses and income taxes
payable (6,871 ) 22,349 Other liabilities 1,213 3,431
Net cash provided by operating activities 10,454
259,885 Cash flows from investing activities: Purchase of
short-term investments (280,602 ) (306,784 ) Maturities of
short-term investments 316,277 173,178 Purchases of property, plant
and equipment (18,433 ) (10,541 ) Net cash provided
by (used in) investing activities 17,242 (144,147 )
Cash flows from financing activities: Tax benefit related to
the exercise of employee stock options 6,086 4,337 Proceeds from
exercise of stock options and ESPP 12,632 13,927 Net
cash provided by financing activities 18,718 18,264
Net increase in cash and cash equivalents 46,414 134,002
Cash and cash equivalents, beginning of period 91,796
31,770 Cash and cash equivalents, end of period $ 138,210 $ 165,772
Impax Laboratories, Inc.Third Quarter
2011Non-GAAP Financial Measures
Total adjusted revenues, adjusted net income, adjusted net
income per diluted share and adjusted EBITDA, are not measures of
financial performance under generally accepted accounting
principles (GAAP) and should not be construed as substitutes for,
or superior to, GAAP revenues, net income, and net income per
diluted share as a measure of financial performance. However,
management uses both GAAP financial measures and the disclosed
non-GAAP financial measures internally to evaluate and manage the
Company’s operations and to better understand its business.
Further, management believes the inclusion of non-GAAP financial
measures provides meaningful supplementary information to and
facilitates analysis by investors in evaluating the Company’s
financial performance, results of operations and trends. The
Company’s calculation of total adjusted revenues, adjusted net
income, adjusted net income per diluted share and adjusted EBITDA,
may not be comparable to similarly designated measures reported by
other companies, since companies and investors may differ as to
what type of events warrant adjustment.
The following table reconciles reported total revenues to total
adjusted revenues.
Three Months Ended Nine Months Ended
(unaudited, amounts in thousands) September 30, September 30, 2011
2010 2011 2010 Total revenues $ 119,849
$ 303,992 $ 354,360 $ 780,407 Change in accounting principle – Teva
Agreement (a) - (196,440 ) - (196,440 )
Total adjusted revenues $ 119,849 $ 107,552 $ 354,360 $ 583,967
The following table reconciles reported net income to adjusted
net income.
Three months ended Nine months ended
(unaudited, amounts in millions, except per share data) September
30, September 30, 2011 2010 2011 2010
Net income $ 17.2 $ 75.2 $ 43.6 $ 238.0 Adjusted to add (deduct):
Share-based compensation 3.5 2.5 9.6 7.7 Employee severance - - 0.8
- Change in accounting principle (a) - (101 ) - (101 ) Income tax
effect (0.8 ) 39.2 (2.1 ) 38.4 Adjusted
net income $ 19.9 $ 15.8 $ 51.9 $ 183.1 Adjusted net income
per diluted share $ 0.30 $ 0.24 $ 0.77 $ 2.81 Net income per
diluted share $ 0.26 $ 1.15 $ 0.65 $ 3.65
Impax Laboratories, Inc.
Third Quarter 2011 Non-GAAP Financial Measures
The following table reconciles reported
net income to adjusted EBITDA.
Three months ended
Nine months ended
September 30,
September 30, 2011 2010 2011 2010 Net
income $ 17.2 $ 75.2 $ 43.6 $ 238.0 Adjusted to add (deduct):
Interest income (0.3 ) (0.4 ) (0.9 ) (0.7 ) Interest expense 0.1
0.0 0.1 0.1 Depreciation and amortization 3.5 3.0 11.9 9.1 Income
taxes 8.5 48.5 20.8 146.1 EBITDA
29.0 126.3 75.6 392.6 Adjusted to add
(deduct): Share-based compensation 3.5 2.5 9.6 7.7 Employee
severance - - 0.8 - Change in accounting principle (a) -
(101.0 ) - (101.0 ) Adjusted EBITDA $ 32.5 $
27.8 $ 86.0 $ 299.3
(a) Material Modification to Teva
AgreementIn July 2010, the Company entered into a
material modification of its Strategic Alliance Agreement with
Teva, and as a result the Company will apply the revised accounting
standards of FASB ASC 605-25 Multiple Element Arrangements (“ASC
605-25”) which became effective for agreements entered into or
materially modified on or after June 15, 2010, to its recognition
of revenue under the Teva Agreement. The Company applied the
accounting principles of ASC 605-25 on a prospective basis
beginning in the quarter ended September 30, 2010. For the three
months and nine months ended September 30, 2010, the application of
ASC 605-25 resulted in recognition in the quarter ended September
30, 2010 of previously deferred revenue and related costs, with the
effect of increasing RX Partner revenue by $196.4 million and
increasing cost of revenues by $95.4 million. Basic earnings per
share increased by approximately $0.98 and $0.99 for the three and
nine months ended September 30, 2010, respectively, as a result of
the prospective application of ASC 605-25.
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