8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): May 14, 2012

Cornerstone Therapeutics Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware	000-50767	04-3523569
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)
1255 Crescent Green Drive, Suite 250, Cary, NC		27518
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s telephone number, including area code: (919) 678-6611

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition.

On May 15, 2012, Cornerstone Therapeutics Inc. (the “Company”) announced its financial results for the three months ended March 31, 2012. A copy of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

On May 14, 2012, the Company and EKR Therapeutics, Inc. (“EKR Therapeutics”), a wholly owned subsidiary of EKR Holdings, Inc. (together with EKR Therapeutics, “EKR” ), announced that they had entered into an Agreement and Plan of Merger (the “Merger Agreement”) pursuant to which the Company will acquire EKR. EKR is a privately held specialty pharmaceutical company focused on the acute-care hospital setting. The Merger Agreement requires the Company to pay up to approximately $150 million to acquire EKR on a cash-free, debt-free basis. Pursuant to the Merger Agreement, the Company will pay an upfront cash purchase price of approximately $125 million, subject to working capital and similar adjustments. In addition, the Merger Agreement requires the Company to pay certain contingent consideration of up to $25 million upon the achievement of certain milestones related to regulatory approval of a new manufacturer for EKR’s Retavase^® product and net sales of Retavase during approximately the first three years following commercial relaunch of Retavase . The Merger Agreement contains customary representations, warranties and covenants, including covenants relating to obtaining the requisite approvals of EKR’s shareholders, restricting the solicitation of competing acquisition proposals by EKR, and EKR’s conduct of its business between the date of signing the Merger Agreement and the closing of the Merger.

A copy of the joint press release issued by Cornerstone and EKR regarding the transaction is attached hereto as Exhibit 99.2 and is incorporated herein by reference. The information required by the other applicable items of Form 8-K related to the transaction will be filed in a separate Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

See the Exhibit Index attached hereto.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CORNERSTONE THERAPEUTICS INC.
Date: May 15, 2012	By:	/s/ Andrew K. W. Powell
		Andrew K. W. Powell
		Executive Vice President, General Counsel and Secretary

EXHIBIT INDEX

Exhibit No.	Description of Document
Exhibit 99.1	Press release dated May 15, 2012, issued by the Company.
Exhibit 99.2	Joint press release, dated May 14, 2012, issued by the Company and EKR Therapeutics, Inc.

EX-99.1

Exhibit 99.1

Press Release

Cornerstone Therapeutics Reports First Quarter 2012 Financial Results

• Signs acquisition agreement with EKR Therapeutics, sharpening strategic focus on hospital and specialty markets

• Grows sales of core CUROSURF^® and ZYFLO^® products by 35% year over year

• Receives October 2012 PDUFA date for CRTX 080 for treatment of hyponatremia

CARY, N.C., May 15, 2012 – Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets, today announced results for the quarter ended March 31, 2012. For the quarter, net sales from CUROSURF^® and the ZYFLO^® family of products grew 35% to $20.1 million from $14.9 million in the first quarter of 2011.

Total net revenues were $22.2 million for the first quarter of 2012 versus $30.0 million reported for the first quarter of 2011, a decline of 26%, reflecting the divestiture of two product lines in March 2012 and the discontinued marketing of unapproved products.

Net loss for the first quarter of 2012 was $1.8 million, or a loss of $0.07 per diluted share, compared to net income of $1.7 million, or $0.07 per diluted share, for the first quarter of 2011. On a non-GAAP basis, net income for the first quarter of 2012 was $1.3 million, or $0.05 per diluted share, compared to non-GAAP net income of $4.5 million, or $0.17 per diluted share in the first quarter of 2011. Non-GAAP net income and net income per diluted share exclude stock-based compensation expense, amortization of product rights, transaction-related expenses and the gain on the divestiture of certain product rights.

“Our first quarter results highlight our increasing focus on the hospital and related specialty markets,” said Craig A. Collard, Chief Executive Officer of Cornerstone Therapeutics. “We announced our strategic growth plan in June 2011 and we have continued to execute on it. In 2012, the majority of our revenue and all of our growth are based upon specialty and hospital based products. We divested our anti-infective products, acquired our CRTX 080 (lixivaptan) product with the purchase of Cardiokine, and late yesterday we announced an agreement to acquire EKR Therapeutics Inc., another specialty pharmaceutical company serving the acute-care hospital setting. We have the focus, the pipeline and the infrastructure to support future growth and enhance stockholder value.”

A breakdown of net revenues by product for the first quarter ended March 31, 2012 (in thousands, except percentages) follows:

	Three Months Ended March 31,						Change
	2012			2011			$			%
Net product sales
CUROSURF	$	7,613		$	7,508		$	105			1	%
ZYFLO product family		12,448			7,412			5,036			68
ALLERX® Dose Pack products		(994	)		11,581			(12,575	)		NM
Anti-infective products		2,921			6,077			(3,156	)		(52	)
Other products		169			(2,603	)		2,772			NM
Total net product sales		22,157			29,975			(7,818	)		(26	)
License and royalty agreement revenues		4			22			(18	)		(82	)
Net revenues	$	22,161		$	29,997		$	(7,836	)		(26	)

Consistent with Cornerstone’s strategy, in March 2012 the Company sold the anti-infective product lines, Factive^® and Spectracef^®, to Merus Labs International Inc. and Vansen Pharma Inc., respectively, in exchange for cash consideration and the assumption of certain product-related liabilities. In an effort to expand into new treatment areas, Cornerstone acquired Cardiokine, Inc. in late 2011, adding its hospital product candidate for hyponatremia to the Company’s portfolio.

Gross margin (exclusive of license and royalty agreement revenues and amortization of product rights) for the first quarter of 2012 was 61% compared to 67% in the first quarter of 2011. The lower gross margin was primarily due to a higher percentage of total net sales coming from products having lower gross margins, specifically CUROSURF.

Selling, general and administrative expenses decreased $1.6 million, or 12%, for the first quarter of 2012 compared to the first quarter of 2011. The decrease was primarily due to the Company’s divestiture of its Factive and Spectracef product rights and respiratory sales force.

Research and development expenses increased $486,000, or 87%, during the first quarter of 2012 compared to the same period of 2011. The increase in research and development expenses was primarily driven by development costs related to CRTX 080, which was acquired in December 2011. These costs were partially offset by a reduction in spend related to CRTX 073 during the first quarter of 2012 due to the timing of the Company’s product development expenses, which remain consistent with the development plan.

As of March 31, 2012, the Company had $74.2 million in cash and cash equivalents, an increase of $0.2 million when compared to December 31, 2011.

Conference Call Information

Cornerstone Therapeutics will host a conference call today at 8:30 AM ET to discuss its financial results for the quarter ended March 31, 2012. To participate in the live conference call, please dial 888-378-4361 (U.S. callers) or 719-325-2481 (international callers), and provide passcode 5624262. A live webcast of the call will also be available through the Investor Relations section of the Company’s website. Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The conference call and webcast will be archived for 30 days. The telephone replay of the call will be available approximately two hours after completion of the call by dialing 888-203-1112 (U.S. callers) or 719-457-0820 (international callers), and providing passcode 5624262.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. Key elements of the Company’s strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the Company’s focus areas; and generate revenues by marketing approved generic products through the Company’s wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

Use of Non-GAAP Financial Measures

This press release highlights the Company’s financial results on both a GAAP and a non-GAAP basis. The GAAP results include certain costs and charges that are excluded from non-GAAP results. By publishing the non-GAAP financial measures, management intends to provide investors with additional information to further analyze the Company’s performance and underlying trends. Management evaluates results and makes operating decisions using both GAAP and non-GAAP measures included in this press release. Non-GAAP results are not prepared in accordance with GAAP, and non-GAAP information should be considered a supplement to, and not a substitute for, financial statements prepared in accordance with GAAP. Investors and potential investors are encouraged to review the reconciliation of non-GAAP financial measures to their most directly comparable GAAP measures attached to this press release. For more information about these non-GAAP measures, please see Part I, Item 2 of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on May 15, 2012.

Safe Harbor Statement

Statements in this press release regarding the progress and timing of our product development programs and related trials; our future opportunities; our strategy, future operations and opportunities, including our plans regarding the manner and timing for the manufacture and sale of our newly-acquired cardiovascular products, anticipated financial position, future revenues and projected costs; our management’s prospects, plans and objectives; and any other statements about management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Any statements that are not statements of historical fact (including, without limitation, statements containing the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements.

There are a number of important factors that could cause our actual results or events to differ materially from those indicated by such forward-looking statements, including risks relating to our “critical accounting estimates”; our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products; our ability to replace the revenues from our marketed unapproved products, which we ceased manufacturing and distributing at the end of 2010, our propoxyphene products, which we voluntarily withdrew from the U.S. market in November 2010 at the request of the U.S. Food and Drug Administration, or FDA, and our anti-infective products, which we divested in March 2012; the adverse impact of returns of previously sold inventory; patient, physician and third-party payer acceptance of our products as safe and effective therapeutic products; our heavy dependence on the commercial success of a relatively small number of currently marketed products; our ability to maintain regulatory approvals to market and sell our products; our ability to obtain FDA approval to market and sell our products under development; our ability to enter into additional strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to manage and control unknown liabilities in connection with any acquisitions; our ability to successfully manage growth or integrate acquired businesses and operations; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products; difficulties relating to clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our product candidates and whether such results will be indicative of results obtained in later clinical trials; our ability to develop and commercialize our product candidates before our competitors develop and commercialize competing products; our ability to satisfy FDA and other regulatory requirements; and our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the SEC on March 6, 2012 and in our subsequent filings with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

TRADEMARKS

Curosurf^® is owned by Chiesi Farmaceutici S.p.A and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States. Spectracef^® is owned by Meiji Seika Kaisha Ltd. Factive^® is owned by LG Life Sciences, Ltd.

FINANCIAL TABLES FOLLOW

Contacts

Investor Relations Contact:

Josh Franklin, Vice President, Strategy and Business Development, +1-919-678-6520, josh.franklin@crtx.com

Media Relations Contact:

Fleishman-Hillard, Andrea Moody, +1-919-457-0743, andrea.moody@fleishman.com

CORNERSTONE THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(UNAUDITED)

(In thousands, except share and per share data)

	Three Months Ended March 31,
	2012			2011
Net revenues	$	22,161		$	29,997
Costs and expenses:
Cost of product sales (exclusive of amortization of product rights)		8,686			10,034
Selling, general and administrative		11,664			13,269
Research and development		1,045			559
Gain on divestiture of product rights		(1,492	)		—
Amortization of product rights		5,301			3,595
Total costs and expenses		25,204			27,457
(Loss) income from operations		(3,043	)		2,540
Other expenses, net:
Interest expense, net		(2	)		(41	)
Total other expenses		(2	)		(41	)
(Loss) income before income taxes		(3,045	)		2,499
Benefit from (provision for) income taxes		1,220			(757	)
Net (loss) income	$	(1,825	)	$	1,742
Comprehensive (loss) income	$	(1,825	)	$	1,742
Net (loss) income per share, basic	$	(0.07	)	$	0.07
Net (loss) income per share, diluted	$	(0.07	)	$	0.07
Weighted-average common shares, basic		25,817,185			25,479,891
Weighted-average common shares, diluted		25,817,185			26,088,851

CORNERSTONE THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

	March 31, 2012 (Unaudited)		December 31, 2011 (Note 1)
Assets
Current assets:
Cash and cash equivalents	$	74,199	$	73,968
Accounts receivable, net		14,000		11,894
Inventories, net		9,167		9,419
Prepaid expenses		2,534		3,753
Income tax receivable		801		1,900
Deferred income tax asset		168		2
Other current assets		6,788		6,112
Total current assets		107,657		107,048
Property and equipment, net		1,394		1,574
Product rights, net		97,825		106,960
Goodwill		15,218		15,218
Amounts due from related parties		38		38
Deferred income tax asset, less current portion		1,579		523
Other assets		72		953
Total assets	$	223,783	$	232,314
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	9,093	$	10,012
Accrued expenses		30,280		37,125
Deferred revenue		820		1,428
Other current liabilities		430		90
Total current liabilities		40,623		48,655
Acquisition-related contingent liability		8,800		8,800
Other long-term liabilities		670		56
Total liabilities		50,093		57,511
Commitments and contingencies, Note 6
Stockholders’ equity
Preferred stock - $0.001 par value, 5,000,000 shares authorized; no shares issued and outstanding		—		—
Common stock - $0.001 par value, 90,000,000 shares authorized; 25,845,194 and 25,803,864 shares issued and outstanding as of March 31, 2012 and December 31, 2011, respectively		26		26
Additional paid-in capital		163,915		163,203
Retained earnings		9,749		11,574
Total stockholders’ equity		173,690		174,803
Total liabilities and stockholders’ equity	$	223,783	$	232,314

CORNERSTONE THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

	Three Months Ended March 31,
	2012			2011
Cash flows from operating activities
Net (loss) income	$	(1,825	)	$	1,742
Adjustments to reconcile net income to net cash (used in) provided by operating activities:
Amortization and depreciation		5,455			3,713
Provision for prompt payment discounts		664			1,067
Provision for (recovery) of inventory allowances		12			(268	)
Gain on sale of product rights		(1,492	)		—
Stock-based compensation		675			379
Deferred revenue		(608	)		(13,210	)
Provision for deferred income taxes		(1,222	)		251
Changes in operating assets and liabilities:
Accounts receivable		(2,770	)		35,239
Inventories		(325	)		2,141
Prepaid expenses and other assets		1,424			6,599
Accounts payable		(1,969	)		705
Accrued expenses		(1,827	)		(3,580	)
Income taxes receivable		1,099			421
Net cash (used in) provided by operating activities		(2,709	)		35,199
Cash flows from investing activities
Purchase of property and equipment		(80	)		(57	)
Proceeds from sale of product rights		3,000			—
Net cash provided by (used in) investing activities		2,920			(57	)
Cash flows from financing activities
Proceeds from exercise of common stock options and warrants		23			9
Excess tax benefit from stock-based compensation		38			2
Purchase of treasury stock		(24	)		—
Principal payments on capital lease obligation		(17	)		(20	)
Net cash provided by (used in) financing activities		20			(9	)
Net increase in cash and cash equivalents		231			35,133
Cash and cash equivalents as of beginning of period		73,968			50,945
Cash and cash equivalents as of end of period	$	74,199		$	86,078

CORNERSTONE THERAPEUTICS INC.

RECONCILIATION OF NON-GAAP FINANCIAL MEASURES

The following tables reconcile our non-GAAP measures to the most directly comparable GAAP financial measures (in thousands, except share and per share data):

	For the three months ended March 31,
	2012			2011
GAAP (loss) income from operations	$	(3,043	)	$	2,540
Add: stock-based compensation		675			379
Add: amortization of product rights		5,301			3,595
Add: transaction-related expenses(1)		742			—
Less: gain on divestiture of product rights		(1,492	)		—
Non-GAAP income from operations	$	2,183		$	6,514
GAAP net (loss) income	$	(1,825	)	$	1,742
Add: stock-based compensation		675			379
Add: amortization of product rights		5,301			3,595
Add: transaction-related expenses(1)		742			—
Less: gain on divestiture of product rights		(1,492	)		—
Less: tax effects related to above items(2)		(2,094	)		(1,204	)
Non-GAAP net income	$	1,307		$	4,512
GAAP net (loss) income per share, diluted	$	(0.07	)	$	0.07
Non-GAAP net income per share, diluted	$	0.05		$	0.17
Shares used in diluted net income per share calculation:
GAAP net income		25,817,185			26,088,851
Non-GAAP net income		26,292,839			26,088,851

¹  Transaction-related expenses include costs related to our completed divestiture of our anti-infective franchise and certain transaction-related fees associated with both anticipated transactions and certain transactions that were not consummated.

²  Tax effects for three months ended March 31, 2012 and 2011 are calculated using effective tax rates of (40.1)% and 30.3%, respectively.

EX-99.2

Exhibit 99.2

Press Release

Cornerstone Therapeutics to Acquire EKR Therapeutics, Accelerating Expansion in Hospital

Market

• Cornerstone expands hospital product portfolio with cardiovascular products CARDENE^® I.V. and RETAVASE^®

• Transaction expected to be accretive in Q312 on a non-GAAP EPS basis

• Terms include initial $125 million in cash plus up to an additional $25 million in milestone payments over three years

• Cornerstone management will provide details on transaction during its first quarter 2012 results call at 8:30AM ET Tuesday, May 15, 2012

CARY, N.C., and BEDMINSTER, N.J., May 14, 2012 – Cornerstone Therapeutics Inc. (NASDAQ: CRTX) and EKR Therapeutics, Inc. today announced that they have entered into a definitive merger agreement whereby Cornerstone Therapeutics will acquire EKR Therapeutics, a privately-held specialty pharmaceutical company focused on the acute-care hospital setting. The acquisition expands Cornerstone’s product offerings and commercial infrastructure in the hospital market. The transaction is subject to customary closing conditions, including adoption of the merger agreement by EKR’s stockholders and expiration or termination of any waiting period under U.S. anti-trust laws. The transaction is currently expected to close in late June 2012.

As part of the transaction, Cornerstone will acquire product rights to CARDENE^® I.V. and RETAVASE^®. CARDENE I.V. is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. RETAVASE is indicated for use in the management of acute myocardial infarction (AMI) in adults, for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. In 2011, EKR generated $58 million in net revenue, primarily from sales of CARDENE I.V. In 2013, Cornerstone is targeting FDA approval of a new active ingredient supplier and relaunch of RETAVASE, which could increase revenues significantly versus 2012. These products complement Cornerstone’s existing hospital products: CUROSURF^®, which is indicated for the treatment of neonatal respiratory distress syndrome (RDS) in preterm infants, as well as CRTX 080, a product candidate for treatment of hyponatremia.

“This transaction brings Cornerstone critical mass in the hospital-based therapeutics area and represents a major step forward in our strategy to focus on the hospital channel,” said Craig A. Collard, Cornerstone’s Chief Executive Officer. “With a significantly expanded product portfolio and larger sales and additional account management infrastructure, we believe we have enhanced our platform to drive future growth.”

Mr. Collard continued, “We plan to pursue additional hospital product licensing opportunities and company acquisitions that complement our enhanced hospital presence. We believe this strategy will position Cornerstone for growth and bring the Company to the next level of value creation.”

“The successful launch of CARDENE I.V., and development successes of RETAVASE have been great achievements for EKR,” said John E. Bailye, CEO of EKR Therapeutics. “We are very proud of the work our employees have done, particularly our sales organization who has established CARDENE I.V. as an important hospital franchise. We are pleased that Cornerstone recognizes the value of our business and look forward to their success in progressing these products, which will benefit clinicians and the patients they serve.”

Under the terms of the agreement, Cornerstone will make an initial cash payment of approximately $125 million, subject to adjustment in accordance with the terms of the merger agreement, and make certain additional payments contingent upon the achievement of certain milestones related to regulatory approval of a new active ingredient supplier for RETAVASE and sales of RETAVASE during approximately the first three years following commercial relaunch. Pursuant to the merger agreement, a newly formed, wholly owned subsidiary of Cornerstone will merge with and into EKR, with EKR continuing after the Merger as the surviving corporation and a wholly owned subsidiary of Cornerstone. The EKR Board of Directors has approved the merger agreement and recommended its adoption by EKR’s stockholders.

In connection with the EKR transaction, Cornerstone and its majority shareholder, Chiesi Farmaceutici, SpA, have entered into a debt financing commitment, including customary covenants, whereby Chiesi will provide to Cornerstone a senior secured term loan facility comprised of (i) a five-year Term Loan A of up to $60 million at 7.5% interest per annum and (ii) a five-year Term Loan B of up to $30 million at 6.5% per annum. Term Loan B may be converted into common stock of the Company at $7.098 per share at Chiesi’s option at any time during the 24 months following the closing of the debt financing.

Advisors

Stifel Nicolaus Weisel is acting as financial advisor and Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, L.L.P. is acting as legal advisor to Cornerstone Therapeutics. Lazard is acting as financial advisor and Foley & Lardner LLP is acting as legal advisor to EKR.

About Cornerstone Therapeutics

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. Key elements of the Company’s strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the Company’s focus areas; and generate revenues by marketing approved generic products through the Company’s wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit www.crtx.com.

About EKR Therapeutics

Since its inception, EKR has focused on acute-care hospital products. With its professional field sales force, commitment to excellence in customer service and medical education, EKR is an experienced provider of acute-care specialty products.

Conference Call Information

Cornerstone Therapeutics will host a conference call at 8:30 a.m. ET on Tuesday, May 15, 2012, to discuss the transaction as well as financial results for the quarter ended March 31, 2012. To participate in the live conference call, please dial 888-378-4361 (U.S. callers) or 719-325-2481 (international callers), and provide passcode 5624262. A live webcast of the call will also be available through the Investor Relations section of the Company’s website. Please allow extra time prior to the webcast to register, download and install any necessary audio software.

The conference call and webcast will be archived for 30 days. The telephone replay of the call will be available approximately two hours after completion of the call by dialing 888-203-1112 (U.S. callers) or 719-457-0820 (international callers), and providing passcode 5624262.

Safe Harbor Statement

Statements in this press release regarding the progress and timing of our product development programs and related trials; our future opportunities; our strategy, future operations and opportunities, including our plans regarding the manner and timing for the manufacture and sale of our newly-acquired cardiovascular products, anticipated financial position, future revenues and projected costs; our management’s prospects, plans and objectives; and any other statements about management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Any statements that are not statements of historical fact (including, without limitation, statements containing the words “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements.

There are a number of important factors that could cause our actual results or events to differ materially from those indicated by such forward-looking statements, including risks relating to our “critical accounting estimates”; our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products; our ability to replace the revenues from our marketed unapproved products, which we ceased manufacturing and distributing at the end of 2010, our propoxyphene products, which we voluntarily withdrew from the U.S. market in November 2010 at the request of the U.S. Food and Drug Administration, or FDA, and our anti-infective products, which we divested in March 2012; the adverse impact of returns of previously sold inventory; patient, physician and third-party payer acceptance of our products as safe and effective therapeutic products; our heavy dependence on the commercial success of a relatively small number of currently marketed products; our ability to maintain regulatory approvals to market and sell our products; our ability to obtain FDA approval to market and sell our products under development; our ability to enter into additional strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all; our ability to manage and control unknown liabilities in connection with any acquisitions; our ability to successfully manage growth or integrate acquired businesses and operations; our ability to maintain compliance with NASDAQ listing requirements; adverse side effects experienced by patients taking our products; difficulties relating to clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our product candidates and whether such results will be indicative of results obtained in later

clinical trials; our ability to develop and commercialize our product candidates before our competitors develop and commercialize competing products; our ability to satisfy FDA and other regulatory requirements; and our ability to obtain, maintain and enforce patent and other intellectual property protection for our products and product candidates and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the SEC on March 6, 2012 and in our subsequent filings with the SEC. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this press release reflect our expectations and beliefs only as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law. Our forward-looking statements do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this release.

TRADEMARKS

Curosurf^® is owned by Chiesi Farmaceutici S.p.A. and is licensed to Cornerstone Therapeutics for sales and marketing purposes in the United States. Cardene^® I.V. and Retavase^® are registered trademarks of EKR Therapeutics, Inc.

IMPORTANT SAFETY INFORMATION

Cardene Important Safety Information

Cardene^® I.V. (nicardipine hydrochloride) Premixed Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits. Cardene I.V. Premixed Injection is contraindicated in patients with advanced aortic stenosis because part of the effect of Cardene I.V. is secondary to reduced afterload. In administering nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage. Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with Cardene I.V. The mechanism of this effect has not been established. Titrate slowly when using Cardene I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects. Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow. When Cardene I.V. was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment. To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours. Most common adverse reactions are headache (15%), hypotension (6%), nausea/vomiting (5%) and tachycardia (4%).

Retavase Important Safety Information

Retavase^® (Reteplase) is indicated for use in the management of acute myocardial infarction (AMI) in adults for the improvement of ventricular function following AMI, the reduction of the incidence of congestive heart failure and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms. Thrombolytic therapy increases the risk of bleeding, therefore Retavase (reteplase, recombinant) is contraindicated patients with: active internal bleeding, a history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, intracranial neoplasm, arteriovenous malformation, or aneurysm, known bleeding diathesis, and, severe uncontrolled hypertension. The most common complication encountered during Retavase^® therapy is bleeding. The sites of bleeding include both internal bleeding sites (intracranial, retroperitoneal, gastrointestinal, genitourinary, or respiratory) and superficial bleeding sites (venous cutdowns, arterial punctures, and sites of recent surgical intervention). The concomitant use of heparin anticoagulation may contribute to bleeding. As fibrin is lysed during Retavase^® therapy, bleeding from recent puncture sites may occur. Therefore, thrombolytic therapy requires careful attention to all potential bleeding sites. Noncompressible arterial puncture must be avoided and internal jugular and subclavian venous punctures should be avoided to minimize bleeding from noncompressible sites. If serious bleeding occurs, concomitant anticoagulant therapy should be terminated immediately. In addition, the second bolus of Retavase^® should not be given if serious bleeding occurs before it is administered. Each patient being considered for therapy with Retavase^® should be carefully evaluated and anticipated benefits weighed against the potential risks associated with therapy. Cholesterol embolism, which can be lethal, has been reported rarely in patients treated with thrombolytic agents; the true incidence is unknown. Coronary thrombolysis may result in arrhythmias associated with reperfusion. It is recommended that antiarrhythmic therapy for bradycardia and/or ventricular irritability be available when Retavase^® is administered. Patients administered Retavase^® as treatment for myocardial infarction have experienced many events which are frequent sequelae of myocardial infarction and may or may not be attributable to Retavase^® therapy. These events include cardiogenic shock, arrhythmias (e.g., sinus bradycardia, accelerated idioventricular rhythm, ventricular premature depolarizations, supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation), AV block, pulmonary edema, heart failure, cardiac arrest, recurrent ischemia, reinfarction, myocardial rupture, mitral regurgitation, pericardial effusion, pericarditis, cardiac tamponade, venous thrombosis and embolism, and electromechanical dissociation. These events can be life-threatening and may lead to death. Other adverse events have been reported, including nausea and/or vomiting, hypotension, and fever. Rare but serious allergic reactions have been reported in patients receiving Retavase^® in clinical trials.

Investor Relations Contact:

Josh Franklin, Vice President, Strategy and Business Development, +1-919-678-6520, josh.franklin@crtx.com

Media Relations Contact:

Fleishman-Hillard, Andrea Moody, +1-919-457-0743, andrea.moody@fleishman.com

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