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8-K - FORM 8-K - CORNERSTONE THERAPEUTICS INCd392608d8k.htm

Exhibit 99.1

 

LOGO

Press Release

Cornerstone Therapeutics Reports Second Quarter 2012 Financial Results

 

   

Closes acquisition of EKR Therapeutics, expanding hospital product portfolio and commercial infrastructure

 

   

Strong growth in product sales, fueled by 64% increase in ZYFLO® and 8% increase in CUROSURF® sales year over year

 

   

FDA approves ANDA for CRTX 067, a generic equivalent for the product currently sold under the Tussionex® brand name

 

   

FDA review of CRTX 080 NDA underway; Advisory Committee meeting set for September 13th

CARY, N.C., August 9, 2012 – Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on commercializing products for the hospital and related specialty markets, today announced results for the quarter ended June 30, 2012.

Total net revenues were $21.5 million for the second quarter of 2012 versus $28.0 million reported for the second quarter of 2011, a decline of 23%, reflecting the divestiture of certain non-strategic assets. Net sales from the ZYFLO family of products and CUROSURF grew 64% and 8% to $10.8 million and $9.3 million respectively, for the second quarter of 2012 versus second quarter 2011.

Net loss for the second quarter of 2012 was $4.4 million, or a loss of $0.17 per diluted share, compared to net income of $197,000, or $0.01 per diluted share, for the second quarter of 2011. On a non-GAAP basis, net income for the second quarter of 2012 was $2.8 million, or $0.11 per diluted share, remaining substantially unchanged from non-GAAP net income of $2.8 million, or $0.11 per diluted share, in the second 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, acquisition accounting adjustments related to inventory sold and the gain on the divestiture of certain product rights.

“We laid out our strategic plan in June 2011 to transform the Company and we continue to make significant progress towards our goals,” said Craig A. Collard, Chief Executive Officer. “We closed the acquisition of EKR Therapeutics and we expect to complete our integration on schedule by the end of Q3. We are integrating quickly and have identified up to $18 million in annualized expenses related to the EKR business which we believe we can eliminate as we align our sales force, reduce administrative resources and combine our operations.”

As part of the acquisition of EKR Therapeutics, Inc., on June 26, 2012 Cornerstone acquired full product rights to CARDENE® I.V. and RETAVASE®. Cornerstone began to actively market CARDENE I.V. at the end of the second quarter to the hospital channel alongside CUROSURF.


CARDENE I.V. net product sales for the period from the acquisition date to June 30, 2012 were $736,000. CARDENE I.V. net product sales from January 1, 2012 through the acquisition date were approximately $26 million. These pre-acquisition sales are unaudited and not included in Cornerstone’s historical financial results.

In July 2012, Cornerstone announced that the FDA approved CRTX 067, the generic of the Tussionex® product.

“We are excited about expanding our generic portfolio of products and look forward to launching this product before the start of the upcoming respiratory season,” commented Collard.

On July 24, 2012 the FDA announced that the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) had scheduled a review of the NDA for CRTX 080, Cornerstone’s investigational candidate for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The advisory committee meeting is scheduled for September 13, 2012 in advance of the October 29, 2012 Prescription Drug User Fee Act (PDUFA) date.

A breakdown of net revenues by product for the second quarter and six months ended June 30, 2012 (in thousands, except percentages) follows:

 

     Three Months Ended                  Six Months Ended              
     June 30,      Change     June 30,     Change  
     2012     2011      $     %     2012     2011     $     %  

Net product sales

                 

CUROSURF

   $ 9,269      $ 8,547       $ 722        8   $ 16,882      $ 16,055      $ 827        5

ZYFLO product family

     10,788        6,585         4,203        64        23,236        13,997        9,239        66   

CARDENE product family

     736        —           736        NM        736        —          736        NM   

ALLERX® Dose Pack products

     (131     9,173         (9,304     NM        (1,125     20,754        (21,879     NM   

Anti-infective products

     172        3,556         (3,384     (95     3,093        9,633        (6,540     (68

Other products

     637        103         534        518        806        (2,500     3,306        NM   
  

 

 

   

 

 

    

 

 

     

 

 

   

 

 

   

 

 

   

Total net product sales

     21,471        27,964         (6,493     (23     43,628        57,939        (14,311     (25

License and royalty agreement revenues

     —          75         (75     NM        4        97        (93     (96
  

 

 

   

 

 

    

 

 

     

 

 

   

 

 

   

 

 

   

Net revenues

   $ 21,471      $ 28,039       $ (6,568     (23   $ 43,632      $ 58,036      $ (14,404     (25
  

 

 

   

 

 

    

 

 

     

 

 

   

 

 

   

 

 

   

Gross margin (exclusive of license and royalty agreement revenues and amortization of product rights) for the second quarter of 2012 was 59%, as compared to gross margin of 67% in the second quarter of 2011. The lower gross margin was primarily due to a relatively higher percentage of total net product sales derived from products with lower gross margins, specifically CUROSURF.

Selling, general and administrative expenses decreased $2.7 million, or 23%, for the second quarter of 2012 compared to the second quarter of 2011. The decrease was primarily due to a reduction in certain employee-related costs driven by the divestiture of the anti-infective product rights and respiratory sales force in March 2012.

As of June 30, 2012, the Company had $38.6 million in cash and cash equivalents compared to $74.0 million at December 31, 2011. The decrease primarily represents the cash-on-hand used to help fund the EKR Therapeutics acquisition.

Conference Call Information

Cornerstone Therapeutics Inc. will host a conference call at 8:30 a.m. ET today to discuss financial results. To participate in the live conference call, please dial 888-461-2023 (U.S.


callers) or 719-325-2436 (international callers), and provide passcode 6297534. 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 6297534.

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 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 II, Item 7 of our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 6, 2012 and Part I, Item 2 of our Quarterly Report on Form 10-Q to be filed with the SEC on August 9, 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 manufacture, market and sell our products and product candidates, including our lixivaptan compound, CRTX 080, and RETAVASE; 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; our substantial indebtedness and debt covenants; 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. ZYFLO CR® and ZYFLO® are registered trademarks of Cornerstone Therapeutics Inc. Tussionex® is owned by UCB Manufacturing, Inc.


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 June 30,     Six Months Ended June 30,  
     2012     2011     2012     2011  

Net revenues

   $ 21,471      $ 28,039      $ 43,632      $ 58,036   

Costs and expenses:

        

Cost of product sales (exclusive of amortization of product rights)

     8,901        9,189        17,587        19,223   

Selling, general and administrative

     8,890        11,604        19,812        24,874   

Research and development

     686        614        1,731        1,173   

Gain on divestiture of product rights

     —          —          (1,492     —     

Transaction-related expenses

     5,438        —          6,180        —     

Amortization of product rights

     3,189        6,092        8,490        9,686   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     27,104        27,499        52,308        54,956   
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income from operations

     (5,633     540        (8,676     3,080   

Other expenses:

        

Interest expense, net

     (113     (42     (115     (83
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other expenses

     (113     (42     (115     (83
  

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income before income taxes

     (5,746     498        (8,791     2,997   
  

 

 

   

 

 

   

 

 

   

 

 

 

Benefit from (provision for) income taxes

     1,393        (301     2,613        (1,058
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income

   $ (4,353   $ 197      $ (6,178   $ 1,939   
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive (loss) income

   $ (4,353   $ 197      $ (6,178   $ 1,939   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income per share, basic

   $ (0.17   $ 0.01      $ (0.24   $ 0.08   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income per share, diluted

   $ (0.17   $ 0.01      $ (0.24   $ 0.07   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares, basic

     26,058,941        25,673,667        25,937,656        25,577,314   
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares, diluted

     26,058,941        26,246,073        25,937,656        26,167,997   
  

 

 

   

 

 

   

 

 

   

 

 

 


CORNERSTONE THERAPEUTICS INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

     June 30,         
     2012      December 31,  
     (Unaudited)      2011  

Assets

     

Current assets:

     

Cash and cash equivalents

   $ 38,558       $ 73,968   

Accounts receivable, net

     19,566         11,894   

Inventories, net

     41,740         9,419   

Prepaid expenses

     3,567         3,753   

Income tax receivable

     1,691         1,900   

Deferred income tax asset

     36         2   

Other current assets

     14,389         6,112   
  

 

 

    

 

 

 

Total current assets

     119,547         107,048   
  

 

 

    

 

 

 

Property and equipment, net

     1,762         1,574   

Product rights, net

     253,050         106,960   

Goodwill

     37,473         15,218   

Amounts due from related parties

     —           38   

Deferred income tax asset, less current portion

     —           523   

Other assets

     179         953   
  

 

 

    

 

 

 

Total assets

   $ 412,011       $ 232,314   
  

 

 

    

 

 

 

Liabilities and Stockholders’ Equity

     

Current liabilities:

     

Accounts payable

   $ 22,244       $ 10,012   

Accrued expenses

     44,099         37,125   

Acquisition-related contingent payments

     6,134         —     

Deferred revenue

     381         1,428   

Other current liabilities

     451         90   
  

 

 

    

 

 

 

Total current liabilities

     73,309         48,655   
  

 

 

    

 

 

 

Acquisition-related contingent payments, less current portion

     40,454         8,800   

Long-term debt

     89,489         —     

Deferred tax liability

     32,765         —     

Other long-term liabilities

     5,031         56   
  

 

 

    

 

 

 

Total liabilities

     241,048         57,511   
  

 

 

    

 

 

 

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; 26,202,162 and 25,803,864 shares issued and outstanding as of June 30, 2012 and December 31, 2011, respectively

     26         26   

Additional paid-in capital

     165,541         163,203   

Retained earnings

     5,396         11,574   
  

 

 

    

 

 

 

Total stockholders’ equity

     170,963         174,803   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 412,011       $ 232,314   
  

 

 

    

 

 

 


CORNERSTONE THERAPEUTICS INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

     Six Months Ended June 30,  
     2012     2011  

Cash flows from operating activities

    

Net (loss) income

   $ (6,178   $ 1,939   

Adjustments to reconcile net income to net cash (used in) provided by operating activities:

    

Amortization and depreciation

     8,788        7,429   

Provision for prompt payment discounts

     1,257        1,998   

Provision for (recovery) of inventory allowances

     261        (235

Acquisition accounting adjustment on inventory sold

     159        —     

Gain on sale of product rights

     (1,492     —     

Impairment of product rights

     —          2,500   

Stock-based compensation

     1,343        884   

Deferred revenue

     (1,047     (24,765

Provision for deferred income taxes

     (1,943     468   

Changes in operating assets and liabilities:

    

Accounts receivable

     (1,205     48,645   

Inventories

     (1,080     1,366   

Prepaid expenses and other assets

     6,995        9,009   

Accounts payable

     8,492        1,358   

Accrued expenses

     (17,414     (7,925

Income taxes receivable

     209        (1,212
  

 

 

   

 

 

 

Net cash (used in) provided by operating activities

     (2,855     41,459   
  

 

 

   

 

 

 

Cash flows from investing activities

    

Acquisition of business, net of cash acquired

     (125,920     —     

Purchase of property and equipment

     (99     (333

Proceeds from sale of product rights

     3,000        —     
  

 

 

   

 

 

 

Net cash used in investing activities

     (123,019     (333
  

 

 

   

 

 

 

Cash flows from financing activities

    

Proceeds from term loans

     90,000        —     

Proceeds of debt financing costs

     (511     —     

Proceeds from exercise of common stock options and warrants

     818        311   

Excess tax benefit from stock-based compensation

     256        452   

Payments related to net settlement of restricted stock

     (79     —     

Principal payments on capital lease obligation

     (20     (41
  

 

 

   

 

 

 

Net cash provided by financing activities

     90,464        722   
  

 

 

   

 

 

 

Net (decrease) increase in cash and cash equivalents

     (35,410     41,848   

Cash and cash equivalents as of beginning of period

     73,968        50,945   
  

 

 

   

 

 

 

Cash and cash equivalents as of end of period

   $ 38,558      $ 92,793   
  

 

 

   

 

 

 

Supplemental schedule of non-cash investing and financing activities

    

Acquisition of business, contingent consideration at fair value

   $ 37,788        —     
  

 

 

   

 

 

 


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     For the six months ended  
     June 30,     June 30,  
     2012     2011     2012     2011  

GAAP (loss) income from operations

   $ (5,633   $ 540      $ (8,676   $ 3,080   

Add: stock-based compensation

     668        505        1343        884   

Add: amortization of product rights

     3,189        6,092        8,490        9,686   

Add: acquisition adjustments related to inventory sold

     159        —          159        —     

Add: transaction-related expenses

     5,438        —          6,180        —     

Less: gain on divestiture of product rights

     —          —          (1,492     —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP income from operations

   $ 3,821      $ 7,137      $ 6,004      $ 13,650   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP net (loss) income

   $ (4,353   $ 197      $ (6,178   $ 1,939   

Add: stock-based compensation

     668        505        1343        884   

Add: amortization of product rights

     3,189        6,092        8,490        9,686   

Add: acquisition adjustments related to inventory sold

     159        —          159        —     

Add: transaction-related expenses

     5,438        —          6,180        —     

Less: gain on divestiture of product rights

     —          —          (1,492     —     

Less: tax effects related to above items(1)

     (2,292     (3,987     (4,363     (3,731
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income

   $ 2,809      $ 2,807      $ 4,139      $ 8,778   
  

 

 

   

 

 

   

 

 

   

 

 

 

GAAP net (loss) income per share, diluted

   $ (0.17   $ 0.01      $ (0.24   $ 0.07   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income per share, diluted

   $ 0.11      $ 0.11      $ 0.16      $ 0.34   
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used in diluted net income per share calculation:

        

GAAP net income

     26,058,941        26,246,073        25,937,656        26,167,997   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP net income

     26,693,195        26,246,073        26,492,610        26,167,997   
  

 

 

   

 

 

   

 

 

   

 

 

 

 

1 

Tax effects for three months ended June 30, 2012 and 2011 are calculated using effective tax rates of 24.2% and 60.4%, respectively. Tax effects for six months ended June 30, 2012 and 2011 are calculated using effective tax rates of 29.7% and 35.3%, respectively.