Impax Laboratories Inc. Press Releases

Impax Laboratories Launches Authorized Generic of Zomig (zolmitriptan) Tablets and Orally Disintegrating Tablets in the U.S.

Fri, 17 May 2013 08:30:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that its generics division, Global Pharmaceuticals, commenced shipment of authorized generic Zomig® (zolmitriptan) tablets and orally disintegrating tablets, 2.5 mg and 5 mg, in the U.S., as part of a Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited (AstraZeneca).

Zomig® is indicated for the treatment of migraine headaches in adults. According to IMS Health data, U.S. sales of Zomig® tablets and orally disintegrating tablets were approximately $196 million in the 12 months ended April 2013.

Zomig® and Zomig-ZMT® are registered trademarks of the AstraZeneca group of companies. For more information about Zomig®, go to www.zomig.com.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. 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 and results of operations, fluctuations in revenues and operating income, the Company’s ability to promptly correct the issues raised in the warning letter and Form 483 observations received from the FDA, the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner, reductions or loss of business with any significant customer, the impact of consolidation of the Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the impact of market perceptions of the Company and the safety and quality of the Company’s products, the difficulty of predicting FDA filings and approvals, the Company’s ability to achieve returns on its investments in research and development activities, the Company’s inexperience in conducting clinical trials and submitting new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to conduct clinical trials and testing, impact of illegal distribution and sale by third parties of counterfeits or stolen products, the availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company’s ability to protect its intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage growth, including through potential acquisitions, the restrictions imposed by the Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on the Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake fault lines 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 the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com

Impax Laboratories to Present at the Bank of America Merrill Lynch 2013 Health Care Conference

Fri, 10 May 2013 09:20:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Bank of America Merrill Lynch Health Care Conference on Thursday, May 16, at 8:00 a.m. Pacific Standard Time. The conference will be held at the Encore at Wynn Las Vegas, Las Vegas, NV.

Individuals may listen to the live or an archived presentation made at the conference, which will be posted in the investor relations section of the Company’s web site at www.impaxlabs.com. This presentation will be archived on the Company’s web site for 30 days.

About Impax Laboratories, Inc.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Investor Relations and Corporate Communications
(215) 558-4526
www.impaxlabs.com

Impax Laboratories Reports First Quarter 2013 Results

Wed, 01 May 2013 16:01:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today reported first quarter 2013 adjusted net income of $25.3 million or $0.37 per diluted share, compared to $35.8 million or $0.53 per diluted share in the first quarter 2012. GAAP net income for the first quarter 2013 was $105.4 million or $1.55 per diluted share, compared to $12.4 million or $0.18 per diluted share in the prior year period.

For the first quarter 2013, total revenues were $148.5 million, an increase of 15%, compared to $128.6 million in the prior year period. The increase was due to United States (U.S.) sales of Zomig® and sales from the January 4, 2013, launch of generic oxymorphone hydrochloride extended-release tablets, for which there was no comparable amount for either product in the prior year period, partially offset by lower sales of the Company’s authorized generic Adderall XR® products as a result of additional generic competition.

Cash and short-term investments increased $50.1 million to $349.0 million as of March 31, 2013, compared to $298.9 million as of December 31, 2012, primarily due to the receipt of a one-time pre-tax payment of $48.0 million in connection with the settlement of litigation as described below. On April 18, 2013, the Company received a one-time pre-tax payment of $102.0 million from Endo Pharmaceuticals, Inc. (Endo) under a previously announced agreement. The payment is recorded as a receivable as of March 31, 2013 and is not reflected in the first quarter 2013 cash and cash equivalents balance.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), was $43.4 million in the first quarter 2013, compared to $62.1 million in the first quarter 2012.

The adjusted results in the first quarter 2013 primarily reflect the removal of the following pre-tax items:

The receipt of $102.0 million from Endo in connection with a previously announced settlement and license agreement.
The receipt of $48.0 million from Shire LLC (Shire) in connection with the settlement of litigation relating to supply of authorized generic Adderall XR products to the Company under the terms of the License and Supply Agreement with Shire (Shire Agreement).
Total charges of $18.1 million, including an inventory reserve on discontinued products ($6.7 million), as further described below, and a reserve of pre-launch inventory for RYTARY^TM ($5.0 million) and other generic products ($6.4 million) as a result of the delay in the anticipated regulatory approvals.
A charge of $7.1 million for amortization and acquisition costs from third-party business development transactions.

The adjusted results in the first quarter 2012 primarily reflect the removal of the following pre-tax items:

The receipt of the gross profit of $30.0 million earned from U.S. Zomig sales pursuant to the License Agreement with AstraZeneca UK Limited (AstraZeneca Agreement).
A charge of $5.2 million relating to an inventory adjustment as a result of a change in the strategic direction of certain generic products.

Please refer to the attached “Non-GAAP Financial Measures” for a reconciliation of GAAP to non-GAAP items.

In the first quarter 2013, the Company recorded an inventory reserve of $6.7 million as stated above. This charge was the result of a strategic review conducted by the Company with a third party consulting firm of the Company’s currently manufactured generic product portfolio. This review was completed during the first quarter 2013 and the Company decided to discontinue manufacturing a number of low-sales/low-margin mature products. The total net sales of these products in 2012 were less than 3% of the total Company product revenues, with minimal impact on net income. The Company is currently reviewing manufacturing costs and expects that the discontinuation of these products and other efficiencies will result in cost savings of approximately $10.0 million for the full year 2013, which has been reflected in the revised full year gross margin guidance.

“We expect that this decision will improve operating efficiencies and ensures that resources are allocated and aligned with our strategic growth priorities,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “We will continue to look for opportunities to free up resources that can be invested to best position Impax for a strong future.”

“On March 21, 2013, we submitted our responses to the recent Form 483 to the FDA and have requested a meeting with the San Francisco District Office to ensure that our plan and actions are in alignment with the FDA’s expectations. We expect to incur $10.0 million to $15.0 million in remediation costs during fiscal year 2013. While we have implemented numerous improvements across our manufacturing and quality operations over the past two years, we remain committed to resolving all observations and exceeding current Good Manufacturing Practices,” concluded Dr. Hsu.

Business Segment Information

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

(unaudited, amounts in thousands)	Three Months Ended March 31,
	2013		2012
Revenues:
Global Product sales, net	$	97,785	$	116,211
Rx Partner		3,114		2,978
Other revenues		737		4,076
Total revenues		101,636		123,265
Cost of revenues		61,444		63,106
Gross profit		40,192		60,159
Operating expenses:
Research and development		11,711		10,673
Patent litigation		4,278		4,038
Selling, general and administrative		5,043		4,317
Total operating expenses		21,032		19,028
Income from operations	$	19,160	$	41,131

In the first quarter 2013, Global Product sales, net, were $97.8 million, compared to $116.2 million in the prior year period. The decline was primarily due to lower sales of authorized generic Adderall XR products as a result of additional generic competition, partially offset by the January 4, 2013, launch of oxymorphone hydrochloride extended-release tablets.

Other revenues in the first quarter 2013 were $0.7 million, compared to $4.1 million in the prior year period. The decline is primarily the result of the extension of the revenue recognition period for the Joint Development Agreement with Valeant Pharmaceuticals International, Inc. (formerly Medicis Pharmaceutical Corporation) from November 2013 to December 2014 due to changes in the estimated timing of completion of certain research and development activities.

Gross profit in the first quarter 2013 decreased to $40.2 million, compared to $60.2 million in the prior year period. This decrease is primarily due to lower sales of authorized generic Adderall XR products and a $13.1 million inventory reserve for discontinued products and other generic products as a result of the delay in the anticipated regulatory approvals as described above. Gross margin in the first quarter 2013 decreased to 40%, compared to 49% in the prior year period, primarily due to the inclusion of the $13.1 million inventory charge in cost of revenues as described above.

Total Global Pharmaceuticals operating expenses in the first quarter 2013 increased to $21.0 million, compared to $19.0 million in the prior year period, with such difference primarily due to a $2.0 million milestone payment to a research and development partner.


Impax Pharmaceuticals Division Information

(unaudited, amounts in thousands)	Three Months Ended March 31,
	2013		2012
Revenues:
Impax Product sales, net	$	46,521	$	-
Other revenues		332		5,303
Total revenues		46,853		5,303
Cost of revenues		29,174		2,909
Gross profit		17,679		2,394
Operating expenses:
Research and development		7,894		8,143
Selling, general and administrative		12,764		3,061
Total operating expenses		20,658		11,204
Loss from operations	$	(2,979)	$	(8,810)

In the first quarter 2013, Impax Product sales, net, were $46.5 million as a result of U.S. sales of Zomig for which there was no comparable amount in the prior year period. The U.S. patents on Zomig tablets and orally disintegrating tablets expire on May 14, 2013. These two dosage forms represent approximately 90% of the Company’s quarterly sales of Zomig. As a result of the patent expiration, the Company expects generic competition that will significantly impact future sales of these two dosage forms. The Company is planning to launch authorized generic versions of both products upon patent expiration. Impax Pharmaceuticals will continue to commercialize the Zomig nasal spray which has U.S. patents expiring as late as May 2021.

Other revenues in the first quarter 2013 declined to $0.3 million, compared to $5.3 million in the prior year period. This decrease was due to a $3.5 million decline in promotional partner revenues as the Company’s detailing for Pfizer’s product Lyrica^® ended on June 30, 2012 and a $1.4 million decline related to the December 31, 2012 completion of the 24 month amortization period of the $11.5 million up-front payment received under the License, Development and Commercialization Agreement with Glaxo Group Limited.

Gross profit in the first quarter 2013 increased to $17.7 million, compared to $2.4 million in the prior year period, primarily due to U.S. Zomig sales. Gross margin in the first quarter 2013 decreased to 38%, compared to 45% in the prior year period. The first quarter 2013 gross margin was, however, negatively impacted by the inclusion in cost of revenues of $6.7 million for amortization and acquisition-related costs from the Zomig transaction and a $5.0 million charge for the reserve of RYTARY^TM pre-launch inventory as a result of the delay in the anticipated regulatory approval. In addition, beginning January 1, 2013, the Company paid AstraZeneca royalties on sales of Zomig under the terms of the AstraZeneca Agreement.

Total Impax Pharmaceuticals operating expenses in the first quarter 2013 increased to $20.7 million, compared to $11.2 million in the prior year period, primarily due to the expansion of the sales and marketing group during the third and fourth quarters of 2012 to support the anticipated launch of RYTARY^TM.


Corporate and Other

(unaudited, amounts in thousands)	Three Months Ended March 31,
	2013		2012
General and administrative expenses	$	11,910	$	13,855
Loss from operations	$	(11,910)	$	(13,855)

General and administrative expenses in the first quarter 2013 decreased to $11.9 million, compared to $13.9 million in the prior year period primarily due to lower corporate legal fees.

2013 Financial Guidance

The Company updated its 2013 financial guidance as noted below.

UPDATED - Gross margins as a percent of total revenues are expected to be in the mid 40% range.
Total R&D expenses across the generic and brand divisions of approximately $87.0 million to $95.0 million; generic R&D expenses of approximately $49.0 million to $53.0 million and brand R&D expenses of approximately $38.0 million to $42.0 million.
Patent litigation expenses of approximately $10.0 million to $12.0 million.
SG&A expenses of approximately $115.0 million to $120.0 million.
Amortization expense of approximately $14.0 million. Approximate 2013 quarterly impact on cost of goods sold: first quarter $7.0 million, second quarter $5.0 million, third quarter $1.0 million and fourth quarter $1.0 million.
Effective tax rate of approximately 32% to 34%.

Conference Call Information

The Company will host a conference call on May 1, 2013 at 4:30 p.m. EDT to discuss its results. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 32064217. 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).

About Impax Laboratories, Inc.

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:


Impax Laboratories, Inc.
Consolidated Statements of Operations
(unaudited, amounts in thousands, except share and per share data)


	Three Months Ended March 31,
	2013		2012
Revenues:
Global Pharmaceuticals Division	$	101,636	$	123,265
Impax Pharmaceuticals Division		46,853		5,303
Total revenues		148,489		128,568
Cost of revenues		90,618		66,015
Gross profit		57,871		62,553
Operating expenses:
Research and development		19,605		18,816
Patent litigation		4,278		4,038
Selling, general and administrative		29,717		21,233
Total operating expenses		53,600		44,087
Income from operations		4,271		18,466
Other income (expense), net		149,456		(48)
Interest income		276		255
Interest expense		(283)		(39)
Income before income taxes		153,720		18,634
Provision for income taxes		48,278		6,269
Net income	$	105,442	$	12,365

Net Income per share:
Basic	$	1.59	$	0.19
Diluted	$	1.55	$	0.18

Weighted average common shares outstanding:
Basic		66,487,470		65,122,240
Diluted		68,178,355		67,907,263


Impax Laboratories, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)


	March 31,		December 31,
	2013		2012
Assets
Current assets:
Cash and cash equivalents	$	197,577	$	142,162
Short-term investments		151,436		156,756
Accounts receivable, net		113,606		92,249
Other receivable		102,049		-
Inventory, net		82,090		89,764
Deferred income taxes		44,365		42,529
Prepaid expenses and other assets		7,804		22,083
Total current assets		698,927		545,543
Property, plant and equipment, net		176,963		180,758
Other assets		64,500		62,145
Intangible assets, net		40,809		47,950
Goodwill		27,574		27,574
Total assets	$	1,008,773	$	863,970

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses	$	151,199	$	134,082
Accrued profit sharing and royalty expenses		22,553		4,936
Deferred revenue		4,452		6,277
Total current liabilities		178,204		145,295
Deferred revenue		7,074		6,362
Other liabilities		25,038		21,210
Total liabilities		210,316		172,867
Total stockholders' equity		798,457		691,103
Total liabilities and stockholders' equity	$	1,008,773	$	863,970


Impax Laboratories, Inc.
Consolidated Statements of Cash Flows
(unaudited, amounts in thousands)


	Three Months Ended
	March 31,
	2013		2012
Cash flows from operating activities:
Net income	$	105,442	$	12,365
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		12,397		3,730
Provision for inventory reserves		22,804		4,094
Accretion of interest income on short-term investments		(158)		(171)
Deferred income taxes (benefit)		(2,800)		817
Tax impact related to the exercise of employee stock options		3		(1,632)
Deferred revenue		-		315
Deferred product manufacturing costs		-		(495)
Recognition of deferred revenue		(1,113)		(6,061)
Amortization of deferred product manufacturing costs		-		661
Accrued profit sharing and royalty expense		22,541		25,555
Payments of profit sharing and royalty expense		(4,925)		(40,755)
Share-based compensation expense		4,359		3,809
Other receivable		(102,049)		-
Changes in assets and liabilities:
Accounts receivable		(21,357)		34,590
Inventory		(15,130)		(7,855)
Prepaid expenses and other assets		12,561		(3,745)
Accounts payable and accrued expenses		22,645		(4,153)
Other liabilities		2,527		2,661
Net cash provided by operating activities		57,747		23,730

Cash flows from investing activities:
Purchase of short-term investments		(60,515)		(35,585)
Maturities of short-term investments		65,993		126,549
Purchases of property, plant and equipment		(9,361)		(8,165)
Payment for product licensing rights		-		(25,000)
Net cash (used in) provided by investing activities		(3,883)		57,799

Cash flows from financing activities:
Proceeds from exercise of stock options and ESPP		1,554		4,468
Tax impact related to the exercise of employee stock options and restricted stock		(3)		1,632
Net cash provided by financing activities		1,551		6,100

Net increase in cash and cash equivalents		55,415		87,629
Cash and cash equivalents, beginning of period		142,162		104,419
Cash and cash equivalents, end of period	$	197,577	$	192,048

Impax Laboratories, Inc.

Non-GAAP Financial Measures

Total 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 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 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 net income to adjusted net income.


(Unaudited, amounts in millions, except per share data)	Three Months Ended March 31,
	2013		2012
Net income	$	105.4	$	12.4
Adjusted to add (deduct):
Payments received from litigation settlements^(a)		(150.0)		-
Provision for inventory reserves^(b)		18.1		5.2
Amortization and acquisition-related costs^(c)		7.1		-
R&D partner milestone payment^(d)		2.0		-
Hayward facility remediation costs^(e)		1.9		1.0
Loss on asset disposal^(f)		0.9		-
Gross profit earned on Zomig® Agreement		-		30.0
Income tax effect		39.9		(12.8)
Adjusted net income	$	25.3	$	35.8

Adjusted net income per diluted share	$	0.37	$	0.53
Net income per diluted share	$	1.55	$	0.18


Impax Laboratories, Inc.
Non-GAAP Financial Measures

The following table reconciles reported net income to adjusted EBITDA.

(Unaudited, amounts in millions)	Three Months Ended March 31,
	2013		2012
Net income	$	105.4	$	12.4
Adjusted to add (deduct):
Interest income		(0.3)		(0.3)
Interest expense		0.3		0.0
Depreciation and other		5.3		3.7
Income taxes		48.3		6.3
EBITDA		159.0		22.1

Adjusted to add (deduct):
Payments received from litigation settlements^(a)		(150.0)		-
Provision for inventory reserves^(b)		18.1		5.2
Amortization and acquisition-related costs^(c)		7.1		-
R&D partner milestone payment^(d)		2.0		-
Hayward facility remediation costs^(e)		1.9		1.0
Loss on asset disposal^(f)		0.9		-
Gross profit earned on Zomig® Agreement		-		30.0
Share-based compensation		4.4		3.8
Adjusted EBITDA	$	43.4	$	62.1


(a)		As of March 31, 2013, the Company had a $102.0 million receivable in connection with a previously announced settlement and license agreement with Endo Pharmaceuticals, Inc., which was recorded as other income in the first quarter 2013. The $102.0 million receivable was received by the Company in April 2013. In addition, in connection with the settlement of litigation relating to supply of authorized generic Adderall XR® products to the Company under the terms of the Shire Agreement, the Company received a one-time payment of $48.0 million from Shire LLC in the first quarter 2013.
(b)		In the first quarter 2013, the Company recorded an inventory reserve charge relating to discontinued products ($6.7 million), and a reserve of pre-launch inventory for RYTARY^TM ($5.0 million) and other generic products ($6.4 million) as a result of the delay in the anticipated regulatory approvals.
(c)		Amortization and acquisition-related costs from the January 2012 AstraZeneca Agreement and the June 2012 Development, Distribution and Supply Agreement with TOLMAR, Inc.
(d)		In the first quarter 2013, the Company recorded a $2.0 million milestone payment under the terms of a research and development partnership agreement.
(e)		Remediation costs relating to the Hayward, CA. manufacturing facility.
(f)		In the first quarter 2013, the Company recorded a loss of $0.9 million on the disposal of an asset.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com

Impax Pharmaceuticals and GlaxoSmithKline Terminate Their Collaboration on IPX066 (RYTARYTM)

Mon, 29 Apr 2013 08:00:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that Impax and GlaxoSmithKline (GSK) are terminating their collaboration for the development and commercialization of IPX066 outside the United States (U.S.) and Taiwan. IPX066 (known as RYTARY™ in the U.S.) is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease and is not approved anywhere in the world.

Under the terms of the agreement entered into in December 2010, GSK’s right to develop and commercialize IPX066 outside the U.S. and Taiwan will transfer back to Impax effective at the end of July 2013. The decision has been reached because of delays in the anticipated regulatory approval and launch dates in countries in which GSK has rights to commercialize the product.

Impax intends to initiate activities to find a partner or partners for markets outside the U.S. looking to grow their non-US neurology franchise.

About RYTARY (IPX066)

RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of RYTARY, APEX-PD (early PD patients), ADVANCE-PD (advanced PD patients) and ASCEND-PD (advanced PD patients) have previously been announced.

About Impax Pharmaceuticals

Impax Pharmaceuticals is the branded products division of Impax Laboratories, Inc. Impax Pharmaceuticals is focused on targeting significant unmet needs, with a primary focus on developing treatments for central nervous system disorders. For more information, please visit its Web site at: www.impaxpharma.com.

About Impax Laboratories, Inc.

“Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995:

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Investor Relations and Corporate Communications

Impax Laboratories Schedules Conference Call and Webcast for First Quarter 2013 Financial Results

Wed, 03 Apr 2013 08:00:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) announced today that the Company will release its first quarter 2013 financial results on Wednesday, May 1, 2013, after the close of the U.S. financial markets. The Company will host a conference call and live webcast with the investment community at 4:30 p.m., Eastern Time on May 1, 2013.

The financial results and live webcast will be accessible through the Investor Relations section of the Company's Web site, www.impaxlabs.com.

To access the call through a conference line, dial (877) 356-3814 (in the U.S.) and (706) 758-0033 (international callers). The conference ID is 32064217.

A replay of the conference call will be available for seven days shortly after the call. To access the replay, dial (855) 859-2056 (in the U.S.) and (404) 537-3406 (international callers). The access code for the replay is 32064217.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia, Pennsylvania and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com

Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting

Tue, 19 Mar 2013 08:00:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced the presentation of results from its RYTARY^TM(IPX066) Phase III and open-label extension trials at the 65^th Annual Meeting of the American Academy of Neurology in San Diego, CA on March 18, 2013. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease. The IPX066 data was presented as part of a poster session, entitled “Movement Disorders: Parkinson’s Disease Therapy.”

The presentation of IPX066 posters was as follows:

Date and Time (all posters):
March 18, 2013 from 2:00-6:30, with authors in attendance from 5:30-6:30 PM (local time)

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064

Presentation Title and Number:
Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063

On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA for IPX066 at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in Hayward, California would be required before the NDA for IPX066 may be approved. On March 4, 2013, the Company announced the receipt of a Form 483 following an inspection by the FDA of the Hayward facility. The Form 483 contained several observations specific to IPX066 which the Company believes must be satisfactorily resolved before the NDA for IPX066 may be approved.

Open-Label Extension Study in Advanced Parkinson’s Disease (PD) Patients
Advanced PD patients with motor fluctuations who completed either study B08-11, a Phase 2, randomized, open-label, 2-period (1 week per period), crossover pharmacokinetic and pharmacodynamic study of IPX066 vs. immediate-release carbidopa-levodopa (IR CD-LD ) or Study B09-02, a randomized, double-blind, active-controlled, parallel group, 13-week comparison of IPX066 vs. IR CD-LD, were eligible for study B09-03, an open-label extension study lasting 9 months.

Three hundred forty nine (349) of 395 eligible advanced PD patients (88.4%) entered the open-label extension study and 313 completed. The most commonly reported adverse events (AEs) during the open-label extension trial were dyskinesia, fall, pain in extremity, hallucinations and arthralgia. The most common AEs reported in the previous trials were headache, nausea, dyskinesia, insomnia and dizziness.

Open-Label Extension Study in Early PD Patients
Early PD patients who completed Study B08-05, a randomized, double-blind, fixed dose study of IPX066 vs. placebo over 30 weeks, were eligible for study B09-03, an open-label extension study lasting nine months. Two hundred sixty eight (268) of 300 eligible early PD patients (89.3%) entered into the extension study and 254 completed. During the open-label extension, the most frequently reported AEs were nausea, insomnia, hypertension and headache. There were 16 serious AEs each reported by one (0.4%) patient. No new patterns of AEs were observed.

Analysis of IPX066 Dosing in Study B09-02
IPX066 dosing in advanced PD patients was evaluated using data from Study B09-02.

IPX066 doses were individually titrated by study investigators according to their clinical evaluation. During this clinical trial, the total daily IPX066 levodopa dose was approximately double that of the levodopa IR dose received. The extended levodopa plasma concentration provided PD patients with higher levodopa exposures without higher overall levodopa maximum concentration. During this clinical study, the median dosing frequency was three times/day for IPX066 while the median dosing frequency was five times/day for CD-LD IR.

About RYTARY (IPX066)

About the Impax GSK Collaboration

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the U.S. and Taiwan.

About Impax Pharmaceuticals

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia, Pennsylvania 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:

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Sr. Director, Investor Relations and Corporate Communications
215-558-4526

RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data to be Presented at the American Academy of Neurology Conference

Fri, 15 Mar 2013 08:00:00 -0400

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the RYTARY^TM Phase III and open-label extension trials will be presented at the 65th Annual Meeting of the American Academy of Neurology in San Diego, California, held from March 16 to March 23. IPX066 is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease.

The presentation of IPX066 posters is as follows:

Date: March 18, 2013 (all posters)
Time: 2:00-6:30, with authors in attendance from 5:30-6:30 PM PT (all posters)
Location: San Diego Convention Center

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Motor Fluctuations in Advanced Parkinson’s Disease
Abstract / Poster Number: 3706/ P01.065

Presentation Title and Number:
Long-Term Safety of IPX066 Extended-Release Carbidopa-Levodopa Capsules
in Patients with Early Parkinson’s Disease
Abstract / Poster Number: 3662/ P01.064

Presentation Title and Number:
Analysis of IPX066 Dosing Data in Advanced Parkinson's Disease (PD) Patients
Abstract / Poster Number: 49/ P01.063

About RYTARY^TM (IPX066)

RYTARY is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson’s disease. It is not approved or licensed anywhere in the world. Results from the phase III studies of RYTARY, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.

On January 21, 2013, Impax received a complete response letter which indicated that the FDA could not approve the NDA at that time. The complete response letter stated that satisfactory resolution and verification of the deficiencies identified during the inspection of the manufacturing facility in Hayward California would be required before the NDA for IPX066 may be approved. On March 4, 2013, the Company announced the receipt of a Form 483 following an inspection by the FDA of the Hayward facility. The Form 483 contained several observations specific to IPX066 which the Company believes must be satisfactorily resolved before the NDA for IPX066 may be approved.

RYTARY has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for registration and commercialization.

About the Impax GSK Collaboration

About Impax Pharmaceuticals

Impax Pharmaceuticals is the branded products division of Impax Laboratories, Inc. Impax Pharmaceuticals is focused on targeting significant unmet needs, with a primary focus on developing treatments for neurological disorders. For more information, please visit its Web site at www.impaxpharma.com.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. 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:

Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20130315005276/en/

Source: Impax Laboratories, Inc.

Impax Laboratories
Mark Donohue, 215-558-4526
Sr. Director, Investor Relations and Corporate Communications

Impax Provides an Update on FDA Inspection of Hayward Facility

Mon, 04 Mar 2013 16:05:00 -0500

Conference Call and Webcast Scheduled for 5:00 p.m. ET

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the U.S. Food and Drug Administration (FDA) completed its re-inspection of the Company’s Hayward manufacturing facility in connection with the previously disclosed Form 483 issued in March 2012. In addition to the re-inspection, the FDA conducted a Pre-Approval Inspection (PAI) for RYTARY^TM, as analytical method validation and a portion of the stability data were generated in Hayward, and a general Good Manufacturing Practices (GMP) inspection. At the conclusion of this inspection, the FDA issued a new Form 483 with twelve (12) observations, three (3) of which are designated as repeat observations from inspections that occurred prior to the Warning Letter.

“We have committed significant resources in our efforts to meet FDA requirements and are clearly disappointed by this news,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “The analytical method assessment observations arose from our internal work and review as a part of the ongoing quality improvement program designed to assess and enhance our Quality Control Laboratory Analytical Methods and to ensure they meet or exceed internal and industry standards. Resolving the FDA concerns remains a top priority and we intend to complete this work as quickly as possible.”

The Company is working diligently to address the observations raised by the FDA and will respond to these new observations within the fifteen (15) business day period from the receipt of the Form 483.

Currently, the Company has not been informed by the FDA of the impact this latest Form 483 will have on the resolution or timing of resolving the warning letter or whether any further regulatory action may be taken as to its manufacturing operations. Until remedial action is complete and the FDA has confirmed compliance with current GMP, approval of pending and new applications listing the Hayward facility as a manufacturing location of finished dosage forms may be withheld.

The Company has provided a redacted version of the Form 483 as an exhibit in a Current Report on Form 8-K filed with the SEC concurrently with the issuance of this press release.

Conference Call Information

The Company will host a conference call today at 5:00 p.m. EDT. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 18793480. 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).

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. 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 and results of operations, fluctuations in revenues and operating income, the Company’s ability to promptly correct the issues raised in the warning letter received from the FDA, the Company’s ability to successfully develop and commercialize pharmaceutical products in a timely manner, reductions or loss of business with any significant customer, the impact of consolidation of the Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, the increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the impact of market perceptions of the Company and the safety and quality of the Company’s products, the difficulty of predicting FDA filings and approvals, the Company’s ability to achieve returns on its investments in research and development activities, the Company’s inexperience in conducting clinical trials and submitting new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to conduct clinical trials and testing, impact of illegal distribution and sale by third parties of counterfeits or stolen products, the availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company’s ability to protect its intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage growth, including through potential acquisitions, the restrictions imposed by the Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s ability to maintain an effective system of internal control over financial reporting, the effect of terrorist attacks on the Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake fault lines 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 the Company undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Sr. Director, Investor Relations and Corporate Communications
www.impaxlabs.com

Impax Laboratories to Present at the Cowen & Company 33rd Annual Health Care Conference

Fri, 01 Mar 2013 08:00:00 -0500

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the Company will present at the Cowen & Company 33^rd Annual Health Care Conference on Wednesday, March 6, at 8:00 a.m. Eastern Standard Time. The conference will be held at The Boston Marriott Copley Place, Boston, MA.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. 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.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue, 215-558-4526
Sr. Director, Investor Relations and Corporate Communications
www.impaxlabs.com

Impax Laboratories Reports Fourth Quarter and Full Year 2012 Results

Mon, 25 Feb 2013 16:01:00 -0500

Company Updates 2013 Financial Guidance
Provides Update on IPX159 Phase IIb Trial in Restless Legs Syndrome

HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Laboratories, Inc. (NASDAQ: IPXL) today reported fourth quarter 2012 adjusted net income of $20.5 million or $0.30 per diluted share, compared to $21.9 million or $0.33 per diluted share in the fourth quarter 2011. Adjusted net income for the fourth quarter 2012 excludes $15.7 million or $0.23 per diluted share, primarily related to amortization and acquisition costs from third-party business development transactions in 2012. GAAP net income for the fourth quarter 2012 was $4.8 million or $0.07 per diluted share, compared to $21.9 million or $0.33 per diluted share in the prior year period.

For the fourth quarter 2012, total revenues were $141.1 million, a decrease of 11%, compared to $158.6 million in the prior year period, primarily due to lower sales of the Company’s authorized generic Adderall XR® products as a result of additional competition, partially offset by United States (U.S.) sales of Zomig®. Total revenues for the fourth quarter 2012 included the recognition of $9.0 million of previously deferred revenue related to a product marketed under the generic OTC Partner alliance agreement with Pfizer (Pfizer Agreement).

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA), was $38.3 million in the fourth quarter 2012, compared to $40.4 million in the fourth quarter 2011. Cash and short-term investments were $298.9 million as of December 31, 2012. Please refer to the attached “Non-GAAP Financial Measures” for a reconciliation of GAAP to non-GAAP items.

Full Year 2012 results

For the full year 2012, adjusted net income was $130.8 million or $1.91 per diluted share, compared to $66.0 million or $0.98 per diluted share for the full year 2011. The increase was primarily driven by U.S. sales of Zomig under the AstraZeneca License Agreement. Adjusted results exclude acquisition-related costs, as well as other items noted in the attached reconciliation table. GAAP net income for the full year 2012 was $55.9 million or $0.82 per diluted share, compared to $65.5 million or $0.97 per diluted share in 2011.

Total revenues for the full year 2012 increased 13% to $581.7 million, compared to $512.9 million for the full year 2011, primarily due to U.S. sales of Zomig and higher sales of fenofibrate products, partially offset by lower sales of authorized generic Adderall XR. Adjusted EBITDA was $228.5 million for the full year 2012, compared to $126.4 million in the prior year.

“While our adjusted full year 2012 financial results improved over last year, it was still a challenging year for Impax. We faced a few obstacles on two of our key objectives for 2012 - successfully resolving the warning letter at our Hayward facility and obtaining approval of our first internally developed branded product candidate RYTARY^TM,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “The resolution of the quality issues in Hayward continues to be a top priority throughout the company.”

The Company recently completed its Phase IIb trial of its investigational drug candidate IPX159 in primary Restless Legs Syndrome (RLS). Analysis of the study data indicated that although the results showed a modest improvement in addressing RLS symptoms, such results did not achieve the statistical criteria for its primary efficacy endpoints compared to placebo and does not support advancement of the program in RLS.

Dr. Hsu continued, “These obstacles, however, are not preventing us from continuing to invest in developing future generic and branded product opportunities or moving forward with our long-term growth strategy. In 2012 we made significant progress in diversifying our generics business by expanding our alternative dosage form portfolio from 9 products in 2011 to 33 currently marketed and pipeline products. We also focused on building a brand pipeline through both internal R&D and external business development activities.”

“We ended 2012 with almost $300 million in cash and short-term investments, and no debt. In addition, we expect the pre-tax receipt of approximately $150 million from Endo Health Solutions and Shire under previously announced agreements. These resources combined with our strong balance sheet will help to support our business objectives,” concluded Dr. Hsu.

The Company also announced that the United States Patent Office had granted a second formulation patent for IPX066 (RYTARY^TM), an extended-release capsule formulation of carbidopa and levodopa. The patent (No. 8,377,474), titled “Controlled Release Formulations of Levodopa and Uses Thereof” extends through 2028.

Fourth Quarter and Full Year 2012 Business Segment Information

Global Pharmaceuticals Division Information


	Three Months Ended				Twelve Months Ended
(unaudited, amounts in thousands)	December 31,				December 31,
	2012		2011		2012		2011
Revenues:
Global Product sales, net	$	79,771	$	142,694	$	421,875	$	443,818
Rx Partner		1,793		6,164		6,445		26,333
OTC Partner		9,365		1,015		11,602		5,021
Research Partner		995		3,384		8,760		16,538
Total revenues		91,924		153,257		448,682		491,710
Cost of revenues		51,665		78,086		229,355		242,713
Gross profit		40,259		75,171		219,327		248,997
Operating expenses:
Research and development		13,350		11,441		48,540		46,169
Patent litigation		3,191		1,409		9,772		7,506
Selling, general and administrative		4,065		2,578		15,377		11,313
Total operating expenses		20,606		15,428		73,689		64,988
Income from operations	$	19,653	$	59,743	$	145,638	$	184,009

Fourth Quarter 2012

Global Pharmaceuticals Division revenues in the fourth quarter 2012 declined to $91.9 million, compared to $153.3 million in the prior year period. The decline was primarily due to lower sales of authorized generic Adderall XR products as a result of additional generic competition and lower sales of Rx Partner products through the Company’s Strategic Alliance Agreement with Teva Pharmaceutical Industries Ltd. (Teva Agreement).

OTC Partner revenues in the fourth quarter 2012 increased to $9.4 million, compared to $1.0 million in the prior year period, due to the recognition of $9.0 million of previously deferred revenue under the Pfizer Agreement. The Global Division’s OTC Partner Sales Channel is no longer considered a core area of the Company’s generic business.

Research Partner revenues in the fourth quarter 2012 declined to $1.0 million, compared to $3.4 million in the prior year period, resulting from the extension of the revenue recognition period for the Joint Development Agreement with Valeant Pharmaceuticals International, Inc., formerly Medicis Pharmaceutical Corporation (Valeant Agreement) from November 2012 to November 2013 due to changes in the estimated timing of completion of certain research and development activities.

Gross profit in the fourth quarter 2012 was $40.3 million, compared to $75.2 million in the prior year period, primarily due to lower sales of authorized generic Adderall XR products. Gross margin in the fourth quarter 2012 decreased to 44%, compared to 49% in the prior year period, primarily due to the recognition of $8.6 million of previously deferred OTC Partner manufacturing costs under the Pfizer Agreement as described above.

Total generic operating expenses in the fourth quarter 2012 increased to $20.6 million, compared to $15.4 million in the prior year period, primarily due to higher patent litigation expenses and a one-time back-log fee required under the Generic Drug Fee User Amendments of 2012 for pending Abbreviated New Drug Applications.

Full Year 2012

Global Pharmaceuticals Division revenues for the full year 2012 declined to $448.7 million, compared to $491.7 million for the full year 2011, principally resulting from a decrease in Global Product sales, net and Rx Partner revenues.

Global Product sales, net, for the full year 2012 declined to $421.9 million, compared to $443.8 million in the prior year, primarily as a result of lower sales of authorized generic Adderall XR partially offset by higher sales of fenofibrate products.

Rx Partner revenues for the full year 2012 declined to $6.4 million, compared to $26.3 million in the prior year, primarily due to a profit-share adjustment from Teva under the Teva Agreement realized in 2011 for which there was no similar amount realized in 2012, as well as lower sales of products marketed through the Teva Agreement.

Research Partner revenues for the full year 2012 declined to $8.8 million, compared to $16.5 million in the prior year. The decline was due to the extension of the revenue recognition period for the Valeant Agreement as described above, and the recognition of a $3.0 million milestone payment in 2011 under the same agreement for which there was no such milestone payment recognized in 2012.

OTC Partner revenues for the full year 2012 increased to $11.6 million, compared to $5.0 million in the prior year, due to the recognition of $9.0 million of previously deferred revenue under the Pfizer Agreement as described above.

Gross profit for the full year 2012 declined to $219.3 million, compared to $249.0 million in the prior year. Gross margin for the full year 2012 decreased to 49%, compared to 51% in the prior year. The decline in both gross profit and gross profit margin were primarily due to lower sales of authorized generic Adderall XR products and lower profit share recognized under the Teva Agreement as described above.

Total generic operating expenses for the full year 2012 increased to $73.7 million, compared to $65.0 million in the prior year, due to increased patent litigation activity related to several cases which were not present in the prior year, higher executive-level compensation costs as a result of vacancies during the prior year period, higher marketing expenses and business development activities. Partially offsetting the increase was the reimbursement of $5.0 million for legal fees received in 2012 pursuant to the settlement of a lawsuit.

Impax Pharmaceuticals Division Information


	Three Months Ended						Twelve Months Ended
(unaudited, amounts in thousands)	December 31,						December 31,
	2012			2011			2012			2011
Revenues:
Impax Product sales, net	$	46,698		$	-		$	118,121		$	-
Rx Partner		2,125			1,437			6,500			5,750
Research Partner		330			330			1,319			1,319
Promotional Partner		-			3,535			7,070			14,140
Total revenues		49,153			5,302			133,010			21,209
Cost of revenues		25,261			3,071			69,783			11,911
Gross profit		23,892			2,231			63,227			9,298
Operating expenses:
Research and development		9,273			8,952			32,780			36,532
Selling, general and administrative		15,630			3,319			37,896			7,435
Total operating expenses		24,903			12,271			70,676			43,967
Loss from operations	$	(1,011	)	$	(10,040	)	$	(7,449	)	$	(34,669	)

Fourth Quarter 2012

Impax Pharmaceuticals Division revenues in the fourth quarter 2012 increased $43.9 million to $49.2 million, compared to the prior year period, due to U.S. sales of Zomig for which there was no comparable amount in the prior year period. This increase was partially offset by a $3.5 million decline in Promotional Partner revenues as the Company’s detailing for Pfizer’s product Lyrica^® ended on June 30, 2012.

Gross profit in the fourth quarter 2012 increased $21.7 million to $23.9 million, compared to the prior year period, due to U.S. Zomig sales. Gross margin in the fourth quarter 2012 increased to 49%, compared to 42% in the prior year period. The fourth quarter 2012 gross margin was, however, negatively impacted by the inclusion of $23.4 million in cost of revenues for amortization and acquisition-related costs from the Zomig transaction.

Total brand operating expenses in the fourth quarter 2012 increased to $24.9 million, compared to $12.3 million in the prior year period, due to the expansion of the sales and marketing group, pre-launch planning costs for RYTARY^TM and higher selling, general and administration expenses related to Zomig.

Full Year 2012

Impax Pharmaceuticals Division revenues for the full year 2012 increased $111.8 million to $133.0 million, compared to the full year 2011, due to U.S. sales of Zomig for which there was no comparable amount in the prior year. This increase was partially offset by a $7.1 million decline in Promotional Partner revenues as detailing for Pfizer’s product Lyrica ended on June 30, 2012.

For the full year 2012, gross profit increased $53.9 million to $63.2 million over the prior year, due to the addition of U.S. Zomig sales. Gross margin for the full year 2012 increased to 48%, compared to 44% for the prior year. The full year 2012 gross margin was, however, negatively impacted by the inclusion of $59.3 million in cost of revenues for amortization and acquisition-related costs due to the Zomig transaction.

Total brand operating expenses for the full year 2012 increased to $70.7 million, compared to $44.0 million in the prior year, primarily due to higher sales and marketing expenses related to Zomig, pre-launch marketing expenses related to RYTARY™, and higher compensation costs related to the expansion of the sales and marketing group. In addition, the Company incurred $8.9 million in 2012 for charges related to its branded products sales force which had been included as a component of cost of revenues in the prior year period as the sales force was previously engaged in providing co-promotion services for Pfizer’s product Lyrica, as described above.

Corporate and Other


	Three Months Ended						Twelve Months Ended
(unaudited, amounts in thousands)	December 31,						December 31,
	2012			2011			2012			2011
General and administrative expenses	$	13,745		$	14,174		$	55,197		$	49,729
Loss from operations	$	(13,745	)	$	(14,174	)	$	(55,197	)	$	(49,729	)

Fourth Quarter 2012

General and administrative expenses of $13.7 million in the fourth quarter 2012 were slightly lower as compared to $14.2 million in the prior year period.

Full Year 2012

General and administrative expenses for the full year 2012 increased to $55.2 million, compared to $49.7 million for the prior year, primarily due to increased headcount, severance-related charges, higher professional fees and IT initiatives in support of strategic growth, partially reduced by lower litigation expenses.

Cash and Short-term Investments

Cash and short-term investments were $298.9 million as of December 31, 2012, compared to $346.4 million as of December 31, 2011. The decline was primarily due to the Zomig and TOLMAR, Inc. transactions and investments in property, plant and equipment.

2013 Financial Guidance

The Company provided its 2013 financial guidance on January 7, 2013, which included estimated launch expenses related to the anticipated approval of RYTARY^TM and product launch in the first quarter 2013 as the Prescription Drug User Fee Act date for a review of the New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) was January 21, 2013. On January 18, 2013, the Company received a complete response letter from the FDA indicating that the FDA requires a satisfactory re-inspection of the Company’s Hayward facility as a result of the warning letter issued in May 2011 before the NDA may be approved due to the facility’s involvement in the development of RYTARY^TM, and supportive manufacturing and distribution activities. Since the timing for resolution of the warning letter and further review of the NDA by the FDA is currently unknown, estimated launch expenses have been removed from the 2013 selling, general and administrative (SG&A) guidance. However, the Company is continuing pre-launch planning for RYTARY^TM and expenses associated with such pre-launch activities are included within the updated SG&A guidance set forth below.

Gross margins as a percent of total revenues in the low to mid 50% range.
UPDATED - Total R&D expenses, excluding patent litigation expenses, across the generic and brand divisions of approximately $87.0 million to $95.0 million; generic R&D expenses of approximately $49.0 million to $53.0 million and brand R&D expenses of approximately $38.0 million to $42.0 million.
UPDATED - Patent litigation expenses of approximately $10.0 million to $12.0 million.
UPDATED - SG&A expenses of approximately $115.0 million to $120.0 million.
Amortization expense of approximately $14.0 million. Approximate 2013 quarterly impact on cost of goods sold: first quarter $7.0 million, second quarter $5.0 million, third quarter $1.0 million and fourth quarter $1.0 million.
UPDATED - Effective tax rate of approximately 32% to 34%.

Conference Call Information

The Company will host a conference call on February 25, 2013 at 4:30 p.m. EDT to discuss its results. The call can also be accessed via a live Webcast through the Investor Relations section of the Company’s Web site, www.impaxlabs.com. The number to call from within the United States is (877) 356-3814 and (706) 758-0033 internationally. The conference ID is 90423980. 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).

About Impax Laboratories, Inc.

Impax Laboratories, Inc. (Impax) 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 central nervous system disorder 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 develops marketing partnerships to fully leverage its technology platform and pursues partnership opportunities that offer alternative dosage form technologies, such as injectables, nasal sprays, inhalers, patches, creams and ointments. 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 and results of operations, fluctuations in the Company’s revenues and operating income, the Company’s ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of consolidation of the Company’s customer base, the impact of competition, the Company’s ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company’s Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company’s operations abroad, the uncertainty of patent litigation, increased government scrutiny on the Company’s agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the Company’s inexperience in conducting clinical trials and submitting new drug applications, the Company’s ability to successfully conduct clinical trials, the Company’s reliance on third parties to conduct clinical trials and testing, the availability of raw materials and impact of interruptions in the Company’s supply chain, the use of controlled substances in the Company’s products, disruptions or failures in the Company’s information technology systems and network infrastructure, the Company’s reliance on alliance and collaboration agreements, the Company’s dependence on certain employees, the Company’s ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company’s ability to protect the Company’s intellectual property, exposure to product liability claims, changes in tax regulations, the Company’s ability to manage the Company’s growth, including through potential acquisitions, the restrictions imposed by the Company’s credit facility, uncertainties involved in the preparation of the Company’s financial statements, the Company’s ability to maintain an effective system of internal control over financial reporting, any manufacturing difficulties or delays, the effect of terrorist attacks on the Company’s business, the location of the Company’s manufacturing and research and development facilities near earthquake fault lines 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						Twelve Months Ended
	December 31,						December 31,
	2012			2011			2012			2011
Revenues:
Global Pharmaceuticals Division	$	91,924		$	153,257		$	448,682		$	491,710
Impax Pharmaceuticals Division		49,153			5,302			133,010			21,209
Total revenues		141,077			158,559			581,692			512,919
Cost of revenues		76,926			81,157			299,138			254,624
Gross profit		64,151			77,402			282,554			258,295
Operating expenses:
Research and development		22,623			20,393			81,320			82,701
Patent litigation		3,191			1,409			9,772			7,506
Selling, general and administrative		33,440			20,071			108,470			68,477
Total operating expenses		59,254			41,873			199,562			158,684
Income from operations		4,897			35,529			82,992			99,611
Other expense, net		(119	)		(2,089	)		(138	)		(2,492	)
Interest income		318			270			1,089			1,149
Interest expense		(25	)		(76	)		(632	)		(157	)
Income before income taxes		5,071			33,634			83,311			98,111
Provision for income taxes		272			11,772			27,438			32,616
Net income	$	4,799		$	21,862		$	55,873		$	65,495

Net Income per share:
Basic	$	0.07		$	0.34		$	0.85		$	1.02
Diluted	$	0.07		$	0.33		$	0.82		$	0.97

Weighted average common shares outstanding:
Basic		66,217,421			64,687,753			65,660,271			64,126,855
Diluted		68,419,888			67,029,407			68,404,551			67,319,989


Impax Laboratories, Inc.
Condensed Consolidated Balance Sheets
(unaudited, amounts in thousands)

	December 31,		December 31,
	2012		2011
Assets
Current assets:
Cash and cash equivalents	$	142,162	$	104,419
Short-term investments		156,756		241,995
Accounts receivable, net		92,249		153,773
Inventory, net		89,764		54,177
Deferred income taxes		42,529		37,853
Prepaid expenses and other assets		22,083		7,718
Total current assets		545,543		599,935
Property, plant and equipment, net		180,758		118,158
Other assets		62,145		45,942
Intangible assets, net		47,950		2,250
Goodwill		27,574		27,574
Total assets	$	863,970	$	793,859

Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses	$	134,082	$	93,071
Accrued profit sharing and royalty expenses		4,936		40,766
Deferred revenue		6,277		23,024
Total current liabilities		145,295		156,861
Deferred revenue		6,362		17,131
Other liabilities		21,210		16,926
Total liabilities		172,867		190,918
Total stockholders' equity		691,103		602,941
Total liabilities and stockholders' equity	$	863,970	$	793,859


Impax Laboratories, Inc.
Consolidated Statements of Cash Flows
(unaudited, amounts in thousands)

	Twelve Months Ended
	December 31,
	2012			2011
Cash flows from operating activities:
Net income	$	55,873		$	65,495
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		77,934			15,710
Accretion of interest income on short-term investments		(639	)		(870	)
In-process research and development charge		1,550			-
Deferred income taxes (benefit)		(18,861	)		13,641
Tax benefit related to the exercise of employee stock options		(4,702	)		(6,535	)
Deferred revenue		2,278			2,568
Deferred product manufacturing costs		(2,823	)		(1,721	)
Recognition of deferred revenue		(29,099	)		(25,579	)
Amortization of deferred product manufacturing costs		11,669			3,111
Accrued profit sharing and royalty expense		72,106			107,760
Payments of profit sharing and royalty expense		(107,935	)		(81,145	)
Share-based compensation expense		16,303			12,685
Bad debt expense		-			163
Changes in assets and liabilities:
Accounts receivable		61,524			(71,882	)
Inventory		(35,587	)		(9,628	)
Prepaid expenses and other assets		(20,753	)		(17,627	)
Accounts payable and accrued expenses		24,117			(2,042	)
Other liabilities		3,254			2,254
Net cash provided by operating activities		106,209			6,358

Cash flows from investing activities:
Purchase of short-term investments		(210,688	)		(359,646	)
Maturities of short-term investments		296,566			375,126
Purchases of property, plant and equipment		(66,900	)		(30,524	)
Payment for product licensing rights, net		(104,760	)		-
Net cash used in investing activities		(85,782	)		(15,044	)

Cash flows from financing activities:
Proceeds from exercise of stock options and ESPP		12,614			14,774
Tax benefit related to the exercise of employee stock options and restricted stock		4,702			6,535
Net cash provided by financing activities		17,316			21,309

Net increase in cash and cash equivalents		37,743			12,623
Cash and cash equivalents, beginning of year		104,419			91,796
Cash and cash equivalents, end of year	$	142,162		$	104,419

Impax Laboratories, Inc.

Non-GAAP Financial Measures

The following table reconciles reported net income to adjusted net income.


	Three months ended					Twelve months ended
(Unaudited, amounts in millions, except per share data)	December 31,					December 31,
	2012			2011		2012			2011
Net income	$	4.8		$	21.9	$	55.9		$	65.5
Adjusted to add (deduct):
Amortization and acquisition-related costs^(a)		23.8			-		60.2			-
Change in OTC Partner deferred revenue recognition, net^(b)		(0.4	)		-		(0.4	)		-
Generic product withdraw costs		-			-		2.0			-
Patent litigation settlement		-			-		(5.0	)		-
Gross profit earned on Zomig® Agreement^(c)		-			-		46.2			-
Acquisition related in process R&D^(d)		-			-		1.6			-
Employee severance		-			-		1.9			0.8
Inventory adjustment		-			-		3.5			-
Lower of cost or market charge		-			-		1.7			-
Income tax effect		(7.7	)		-		(36.8	)		(0.3	)
Adjusted net income	$	20.5		$	21.9	$	130.8		$	66.0

Adjusted net income per diluted share	$	0.30		$	0.33	$	1.91		$	0.98
Net income per diluted share	$	0.07		$	0.33	$	0.82		$	0.97


Impax Laboratories, Inc.
Non-GAAP Financial Measures

The following table reconciles reported net income to adjusted EBITDA.

	Three months ended						Twelve months ended
(Unaudited, amounts in millions)	December 31,						December 31,
	2012			2011			2012			2011
Net income	$	4.8		$	21.9		$	55.9		$	65.5
Adjusted to add (deduct):
Interest income		(0.3	)		(0.3	)		(1.1	)		(1.1	)
Interest expense		0.0			0.1			0.6			0.2
Depreciation and other		5.9			3.8			17.7			15.7
Income taxes		0.3			11.8			27.4			32.6
EBITDA		10.7			37.3			100.5			112.9

Adjusted to add:
Amortization and acquisition-related costs^(a)		23.8			-			60.2			-
Change in OTC Partner deferred revenue recognition, net^(b)		(0.4	)		-			(0.4	)		-
Generic product withdraw costs		-			-			2.0			-
Patent litigation settlement		-			-			(5.0	)		-
Gross profit earned on Zomig® Agreement^(c)		-			-			46.2			-
Acquisition related in process R&D^(d)		-			-			1.6			-
Employee severance		-			-			1.9			0.8
Inventory adjustment		-			-			3.5			-
Lower of cost or market charge		-			-			1.7			-
Share-based compensation		4.2			3.1			16.3			12.7
Adjusted EBITDA	$	38.3		$	40.4		$	228.5		$	126.4


(a)		Amortization and acquisition-related costs from the January 2012 Distribution, License, Development and Supply Agreement with AstraZeneca UK Limited and the June 2012 Development, Distribution and Supply Agreement with TOLMAR, Inc.
(b)		The net effect of $9.0 million of previously deferred revenue and $8.6 million of deferred manufacturing costs under the Pfizer Agreement.
(c)		On February 1, 2012, the Company announced that it had entered into the AstraZeneca License Agreement. As part of the AstraZeneca License Agreement, AstraZeneca granted to the Company an exclusive license to commercialize the tablet, orally disintegrating and nasal spray formulations of Zomig® (zolmitriptan) products for the treatment of migraine headaches in the United States and in certain U.S. territories. Under the terms of the AstraZeneca License Agreement, the Company agreed to pay AstraZeneca quarterly payments totaling $130.0 million during 2012. During the specified product transition period pursuant to the AstraZeneca License Agreement, the Company received the benefit of the gross profit ($46.2 million) from U.S. Zomig sales by AstraZeneca commencing from January 1, 2012 and ending when the Company commenced commercialization of the Zomig products. The benefit of the gross profit received from AstraZeneca is recorded as a reduction of the $130.0 million paid by the Company to AstraZeneca during 2012 and is not reflected within the Company’s income.
(d)		Acquisition related in-process R&D from the June 2012 Development, Distribution and Supply Agreement with TOLMAR, Inc.

Source: Impax Laboratories, Inc.

Impax Laboratories, Inc.
Mark Donohue
Investor Relations and Corporate Communications
215-558-4526
www.impaxlabs.com