TLCR Talecris Biotherapeutics Holdings Corp. (MM)

RESEARCH TRIANGLE PARK, N.C., Feb. 23, 2011 /PRNewswire/ -- Talecris Biotherapeutics Holdings Corp. ("Talecris") (Nasdaq: TLCR) today announced its financial results for the three and twelve months ended December 31, 2010 and filed its Form 10-K with the U.S. Securities and Exchange Commission (SEC).

Fourth quarter 2010 net revenue increased by $20.7 million or 5.3% to $410.8 million from $390.1 million in the fourth quarter of 2009.  Higher revenues from Talecris' principal products Gamunex-C®/Gamunex®  Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV) and Prolastin® Alpha-1 Proteinase Inhibitor (Human) (Prolastin, Prolastin A1PI, Prolastin-C A1PI) as well as Thrombate® III Antithrombin III (Human) in the fourth quarter of 2010 were partially offset by lower sales of albumin, hyperimmunes and contract manufacturing compared to the fourth quarter of 2009.  Fourth quarter 2010 gross margin was 41.2% compared to 39.2% in the fourth quarter of 2009.  Fourth quarter 2010 income from operations was $68.5 million versus $57.4 million for the fourth quarter of 2009, a 19.3% increase.  Net income was $17.1 million for the fourth quarter of 2010, an increase of $15.7 million compared to net income of $1.4 million for the fourth quarter of 2009.  Diluted earnings per share were $0.13 in the fourth quarter of 2010, including an after-tax charge of $6.3 million ($0.05 per diluted share) for costs associated with Talecris' definitive merger agreement with Grifols S.A. and Grifols, Inc. (Grifols) as well as an after-tax charge of $26.6 million ($0.20 per diluted share) as the result of the Plasma Centers of America, LLC (PCA) jury verdict and related interest expense, compared to diluted earnings per share of $0.01 (pro forma diluted EPS of $0.00) for the fourth quarter of 2009. Talecris' fourth quarter 2009 results included the after-tax charge of $0.5 million ($0.00 per diluted share) for CSL Limited (CSL) merger-related expenses as well as an after-tax charge of $26.3 million ($0.21 per diluted share) associated with the debt refinancing transactions.

On a non-GAAP basis excluding merger-related items in both periods, the 2010 PCA judgment and the 2009 debt refinancing charges, Talecris' net income was $50.0 million for the fourth quarter of 2010, an increase of 77.3% compared to $28.2 million for the fourth quarter of 2009.  On the same basis, diluted earnings per share for the 2010 fourth quarter were $0.38, an increase of 72.7% from $0.22 for the fourth quarter of 2009.  Additional information regarding the computation of non-GAAP financial measures is included in Exhibit B.

For the full year 2010, Talecris' net revenue increased by $68.4 million or 4.5% to $1,601.6 million compared to $1,533.2 million for the prior year.  Gross margin for the period was 43.1% compared to 41.2% in the full year of 2009.  Diluted earnings per share for the full year 2010 were $1.29 compared to $1.50 (pro forma diluted EPS of $1.26) for the full year 2009.  Talecris' full year 2010 results included an after-tax charge of $17.3 million ($0.13 per diluted share) for costs associated with the Grifols acquisition and an after-tax charge of $26.6 million ($0.21 per diluted share) as the result of the PCA judgment.  The full year 2009 diluted earnings per share included the $48.8 million after-tax benefit of the CSL merger termination fee ($0.48 per diluted share), which was partially offset by an after-tax charge of $9.3 million ($0.08 per diluted share) for CSL merger-related expenses, as well as an after-tax charge of $26.3 million ($0.26 per diluted share) associated with the company's debt refinancing transactions.

On a non-GAAP basis excluding merger-related items in both periods, the 2010 PCA judgment and the 2009 debt refinancing charges, Talecris' net income was $210.0 million for the full year 2010, a 49.3% increase compared to $140.7 million for the full year 2009.  On the same basis, diluted earnings per share was $1.63 for the full year 2010 compared to $1.11 for the full year 2009, a 46.8% increase.  Additional information regarding the computation of non-GAAP financial measures is included in Exhibit B.

"The support for our proposed merger was evident by the overwhelming vote in favor of the merger by both Grifols' and Talecris' shareholders in the recent special meetings of shareholders," said Lawrence D. Stern, Talecris' chairman and chief executive officer.  "While we await approval from the U.S. Federal Trade Commission of the transaction, I am proud of the performance and record results that our company delivered in 2010 driven by strong growth in our U.S. and European businesses.  Our focus on demand generation through our expanded and reorganized sales force in the U.S., combined with the features and benefits of our products, contributed to 10.0% growth in U.S. Gamunex sales and 12.4% growth in U.S. Prolastin-C sales."

"Extracting more value from our operations is a key aspect of our long-term strategy at Talecris.  In 2010, we made significant progress towards this goal through our capital program.  Specifically, the construction of our North Fractionation Facility in Clayton, North Carolina is well underway.  We are on schedule to increase our fractionation capacity to 6.0 million liters by 2015," continued Mr. Stern.

*Excludes merger-related items, company’s debt refinancing transactions and PCA judgment; EPS reflects pro forma shares in 2009 for the IPO

*Excludes merger-related items, company's debt refinancing transactions and PCA judgment; EPS reflects pro forma shares in 2009 for the IPO

Talecris' Form 10-K is available on the SEC's website at www.sec.gov and on Talecris' website at http://ir.talecris.com

Discussion of Fourth Quarter 2010 Financial and Operating Results

Net revenue for the 2010 fourth quarter was $410.8 million compared to $390.1 million in the fourth quarter of 2009, an increase of $20.7 million or 5.3%.  Gamunex-C/Gamunex IGIV revenue increased $21.2 million or 10.2%, which consisted primarily of $17.8 million in higher volumes partially offset by unfavorable foreign exchange.  Gamunex-C/Gamunex IGIV experienced higher volumes of $23.3 million in the U.S. and Europe, which were partially offset by lower volumes of $5.5 million in other international markets and Canada.  U.S. Gamunex-C/Gamunex revenue grew 14.2% for the fourth quarter of 2010 compared to the fourth quarter of 2009.  Canadian Gamunex-C/Gamunex volumes were negatively impacted by lower sales to Canadian Blood Services due to their IGIV multi-source strategy.  Pricing was up $4.3 million for the period partially offset by $0.9 million of unfavorable foreign exchange.  

Prolastin-C/Prolastin A1PI revenues increased $4.5 million or 5.0%, largely due to improved pricing of $6.3 million partially offset by $2.3 million of unfavorable foreign exchange.  Growth in volume was driven by increased number of patients on Prolastin-C/Prolastin A1PI in both the U.S. and European markets.  In addition, Thrombate III revenues increased $2.5 million or 39.7%.  These increases were offset primarily by lower sales of albumin, reduced contract manufacturing for Canadian Blood Services due to their multi-source strategy and lower sales of hyperimmunes due to a customer system issue.  

Gross profit increased to $169.3 million for the 2010 fourth quarter compared to $152.9 million in the fourth quarter of 2009.  This increase was primarily due to lower unabsorbed infrastructure and start-up costs related to Talecris Plasma Resources, Inc. (TPR), which is Talecris' plasma collection platform, higher Gamunex-C/Gamunex IGIV and Prolastin-C/Prolastin A1PI revenue, as well as lower costs of production primarily driven by production mix associated with the conversion to Prolastin-C.  These increases were partially offset by increases in inventory impairment provisions. Unabsorbed TPR infrastructure and start-up costs declined by $8.5 million or 85.9% to $1.4 million for the fourth quarter of 2010 compared to $9.9 million for the fourth quarter of 2009.  Inventory impairment provisions during the fourth quarter of 2010 increased $12.4 million to $20.2 million primarily driven by higher provisions for work-in-process inventories related to a Gamunex-C/Gamunex IGIV production issue.  Talecris believes that the company has identified the cause of the issue and has implemented appropriate remediation steps.  Gross margin was 41.2% during the fourth quarter of 2010 compared to 39.2% for the 2009 fourth quarter, an increase of 200 basis points.  

Operating expenses for the fourth quarter of 2010 were $100.8 million which represented an increase of $5.3 million or 5.6% versus $95.5 million incurred during the prior year period.  The increase in operating expenses resulted from an increase in SG&A expenses primarily driven by $7.3 million in higher sales and marketing expense in the fourth quarter of 2010 as the result of the sales force expansion.  This increase was partially offset primarily by a $4.5 million reduction in share-based compensation.  The company incurred $9.0 million in merger-related expenses including $2.3 million in retention expenses in SG&A related to the definitive merger agreement with Grifols.

Operating income was $68.5 million during the fourth quarter of 2010, which represented a 19.3% increase over the $57.4 million reported during the fourth quarter of 2009.  Operating margin was 16.7% in the 2010 fourth quarter compared to 14.7% in the 2009 fourth quarter, an increase of 200 basis points.

Total other non-operating expense for the 2010 fourth quarter includes a $43.7 million charge, including accrued interest, related to a judgment in favor of PCA against TPR in a breach of contract claim. The judgment related to the PCA litigation is discussed further in the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations—Matters Affecting Comparability—Plasma Centers of America (PCA) Judgment" in Talecris' 2010 Form 10-K on the SEC website as well as Talecris' Investor Relations website.

Net interest expense was $10.9 million in the 2010 fourth quarter compared to $13.0 million in the prior year period, a decrease of $2.1 million primarily due to lower debt levels.  The fourth quarter of 2010 reflected an income tax benefit of $2.8 million compared to an income tax provision of $0.1 million for the fourth quarter of 2009.  The fourth quarter 2010 income tax benefit was due to the recognition of the full year benefit from the application of credits for Federal Research and Experimentation and orphan drug clinical testing expenditures that were extended in the fourth quarter of 2010.  In addition, the company settled its audits by the Internal Revenue Service for the 2005, 2006, and 2007 tax years.  The Joint Committee on Taxation completed its review and agreed not to take exception to the refund approved by the IRS in its report dated 2009.  The favorable resolution of this matter resulted in a release of $4.7 million in previously unrecognized tax benefits.  

Net income was $17.1 million for the 2010 fourth quarter including an after-tax charge of $6.3 million in Grifols merger-related expenses and an after-tax charge of $26.6 million as the result of the PCA judgment.  This compares to $1.4 million in the fourth quarter of 2009, which included the after-tax charges of $0.5 million and $26.3 million for CSL merger-related expenses and the company's debt refinancing transactions, respectively.

Diluted earnings per share for the 2010 fourth quarter were $0.13 compared to $0.01 (pro forma diluted EPS of $0.00) for the 2009 fourth quarter.  The 2010 period included an after-tax charge of $0.05 per share related to costs associated with the Grifols acquisition as well as the after-tax charge of $0.20 per diluted share as the result of the PCA judgment, while the 2009 period included an after-tax charge of $0.21 per diluted share associated with the company's debt refinancing transactions. Total diluted shares outstanding were 129,880,242 for the 2010 fourth quarter and 125,025,013 for the 2009 fourth quarter.

On a non-GAAP basis excluding merger-related items in both periods, the 2010 PCA judgment and the 2009 debt refinancing charges, Talecris' net income of $50.0 million for the fourth quarter of 2010 increased 77.3% compared to $28.2 million for the fourth quarter of 2009.  On the same basis, earnings per diluted share, excluding merger-related items, the 2010 PCA judgment and the 2009 debt refinancing charges, for the 2010 fourth quarter were $0.38, an increase of 72.7% from $0.22 for the fourth quarter of 2009.  Additional information regarding the computation of non-GAAP financial measures is included in Exhibit B.

The 2010 fourth quarter EBITDA was $34.8 million compared to $22.0 million in the 2009 fourth quarter.  Adjusted EBITDA was $91.0 million in the 2010 fourth quarter compared to adjusted EBITDA of $76.9 million in the 2009 fourth quarter.  

Discussion of Full Year 2010 Financial and Operating Results

Net revenue was $1,601.6 million for the full year 2010 compared to $1,533.2 million during the same period of 2009, representing an increase of $68.4 million or 4.5%.  The increase was mainly due to $45.2 million in higher Gamunex-C/Gamunex IGIV revenue, consisting of $45.2 million in higher volumes and improved pricing of $1.9 million, partially offset by unfavorable foreign exchange of $1.9 million.  Gamunex-C/Gamunex IGIV revenue growth was driven primarily by U.S. sales which grew 10.0% in the full year 2010 compared to the full year 2009.  The full year 2010 results also reflected $32.4 million in higher Prolastin-C/Prolastin A1PI sales as well as higher revenues related to Koate® DVI Factor VIII (Human), and Thrombate III, partially offset by reduced contract manufacturing for Canadian Blood Services due to their multi-source strategy, as well as lower sales of albumin, hyperimmunes and PPF powder.

Gross profit during the full year 2010 totaled $689.6 million compared to $632.1 million during the full year 2009, an increase of $57.5 million or 9.1%, driven primarily by higher Gamunex-C/Gamunex IGIV revenue, reduced unabsorbed TPR infrastructure and start-up costs, as well as lower costs of production primarily driven by production mix associated with the conversion to Prolastin-C.  These benefits were partially offset by increases in inventory impairment provisions and non-capitalizable capital expenditures.  Unabsorbed TPR infrastructure and start-up costs decreased $37.4 million or 85.0% to $6.6 million in the full year 2010 compared to $44.0 million for the same period of 2009.  Inventory impairment provisions during the full year 2010 increased $29.5 million to $60.6 million primarily driven by higher provisions for work-in-process inventories related to a Gamunex-C/Gamunex IGIV production issue.  Talecris believes that the company has identified the cause of the issue and has implemented appropriate remediation steps. Non-capitalizable expenditures for plant expansion during the full year 2010 were $39.9 million compared to $36.9 million during the full year 2009.  Gross margin was 43.1% during the period, an increase of 190 basis points from the gross margin of 41.2% for the full year 2009.

Operating expenses totaled $356.7 million for the full year 2010, a 1.2% decrease from the $361.2 million incurred for the full year 2009.  The decrease in operating expenses was attributed to a decrease in SG&A expenses primarily driven by lower share-based compensation expense of $28.4 million, the absence of $11.0 million of legal and retention expenses related to the company's terminated merger agreement with CSL, lower charitable donations of $9.0 million, lower legal expenses of $3.0 million related to the company's internal FCPA investigation and the absence of $5.7 million of management fees to Talecris Holdings LLC as a result of the termination of the management agreement at the time of Talecris' initial public offering.  These items were principally offset by higher sales and marketing expenses of $23.3 million during the full year of 2010 largely resulting from the sales force expansion and $25.9 million in Grifols merger-related expenses including $5.1 million in retention expenses within SG&A.  During the full year 2010, SG&A included $4.7 million of unfavorable foreign exchange as compared to favorable foreign exchange of $1.9 million during the prior year.  R&D spending decreased $1.6 million during the full year 2010 compared to the prior year.    

Operating income during the full year 2010 was $333.0 million compared to $271.0 million during the full year 2009, representing an increase of $62.0 million or 22.9%.  Operating margin was 20.8% for the full year 2010 compared to 17.7% for the full year 2009, an increase of 310 basis points.

Total other non-operating expense for the year ended December 31, 2010 includes a $43.7 million charge, including accrued interest, related to a judgment in favor of PCA against TPR in a breach of contract claim.  The judgment related to the PCA litigation is discussed further in the section titled "Management's Discussion and Analysis of Financial Condition and Results of Operations—Matters Affecting Comparability—Plasma Centers of America (PCA) Judgment" in Talecris' 2010 Form 10-K on the SEC website as well as Talecris' Investor Relations website.

Net interest expense was $45.8 million for the full year 2010 compared to $74.5 million for the prior year period, a decrease of $28.7 million due largely to lower debt levels.  Income tax expense for the full year 2010 was $78.4 million resulting in a 32.1% effective tax rate compared to $75.0 million for the full year 2009 or a 32.8% effective tax rate.

Net income for the full year 2010 was $166.1 million, an increase of $12.2 million compared to net income of $153.9 million for the full year 2009.  The 2010 period included an after-tax charge of $17.3 million for costs associated with the Grifols acquisition as well as the PCA judgment after-tax charge of $26.6 million, while the 2009 period included the after-tax income from the CSL merger termination fee of $48.8 million which was partially offset by an after-tax charge of $9.3 million for CSL merger-related expenses, as well as an after-tax charge of $26.3 million associated with the company's debt refinancing transactions.

Diluted earnings per share for the full year 2010 were $1.29 including an after-tax charge of $0.13 per diluted share for costs associated with the Grifols acquisition and the after-tax charge of $0.21 per diluted share as the result of the PCA judgment.  This compares to $1.50 (pro forma diluted EPS of $1.26) in the full year 2009, which included income of $0.48 per diluted share related to the after-tax effect of the CSL merger termination fee partially offset by after-tax charges of $0.08 per diluted share for merger-related expenses and $0.26 per diluted share associated with the company's debt refinancing transactions. Total diluted shares outstanding were 128,927,053 for the full year 2010 compared to diluted shares outstanding of 102,514,363 for the full year 2009.

On a non-GAAP basis excluding merger-related items in both periods, the 2010 PCA judgment and the 2009 debt refinancing charges, Talecris' net income of $210.0 million for the full year 2010 increased 49.3% compared to $140.7 million for the full year 2009.  On the same basis, earnings per diluted share, excluding merger-related items, the 2010 PCA judgment and the 2009 debt refinancing charges, for the full year 2010 were $1.63, an increase of 46.8% from $1.11 for the full year 2009.  Additional information regarding the computation of non-GAAP financial measures is included in Exhibit B.

EBITDA for the full year 2010 was $326.3 million, a decrease of $6.0 million from $332.3 million in the full year 2009 which included income of $75.0 million related to the CSL merger termination.  In the full year of 2010, adjusted EBITDA was $417.2 million, a decrease of $30.1 million, compared to $447.3 million in the full year 2009 which included income of $75.0 million related to the CSL merger termination.

Recent Events

Talecris achieved a number of financial and commercial milestones in the fourth quarter of 2010 and since the conclusion of the fourth quarter.  These include:

• On February 14, 2011, Talecris held a special meeting at which holders of a majority of the company's outstanding common stock approved the adoption of the Agreement and Plan of Merger, dated as of June 6, 2010, among Grifols and Talecris Biotherapeutics Inc.  The completion of the transaction is subject to obtaining certain regulatory approvals and other customary conditions;
• On January 31, 2011, Talecris began sales promotion in the U.S. for Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI).  Gamunex-C is the first and only immune globulin to provide both the intravenous route of administration and a new subcutaneous route of administration.  The intravenous delivery mode is approved to treat PI, chronic inflammatory demyelinating polyneuropathy, and idiopathic thrombocytopenic purpura.  The subcutaneous mode is approved to treat only PI.  A required post-marketing study will be initiated in the second half of 2011;  
• On December 13, 2010, a jury in the General Court of Justice, Superior Court Division, Wake County, North Carolina, rendered a verdict in the amount of $37.0 million in favor of PCA against TPR in a breach of contract claim, which was confirmed by the court in post trial motions.  The company intends to appeal.  The jury verdict, if sustained, will accrue at 8% simple interest from the date of breach, which is approximately $6.7 million at December 31, 2010.  The company has included a charge of $43.7 million (approximately $26.6 million after tax) in its consolidated income statement for the year ended December 31, 2010 related to the judgment;
• During the fourth quarter of 2010, Talecris initiated a Phase II clinical trial for a direct-acting thrombolytic Plasmin for the treatment of acute Peripheral Arterial Occlusion; and
• During the fourth quarter of 2010, Talecris initiated a clinical trial evaluating the safety and pharmacokinetic profile of two doses of Prolastin-C A1PI.  The study will investigate the safety and pharmacokinetic profile of a higher dose, 120 mg/kg weekly, of Prolastin-C A1PI, versus the licensed dose of 60 mg/kg weekly.

Use of Non-GAAP Financial Measures

This press release and the accompanying tables include non-GAAP financial measures including adjusted net income, adjusted EPS, EBITDA, adjusted EBITDA, and Consolidated Cash Flow.  For a description of these non-GAAP financial measures, including the reasons management uses these measures and reconciliations of these non-GAAP financial measures to the most directly comparable financial measures prepared in accordance with U.S. Generally Accepted Accounting Principles, please see the section of the accompanying tables titled "Non-GAAP Financial Measures," in Exhibit B.

Cautionary Statement Regarding Forward-looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, quotations from management, statements regarding strategic and operation plans, expected charges and pro forma financial information.  Forward-looking statements are based on current beliefs and expectations and are subject to inherent risks and uncertainties.  You are cautioned not to place undue reliance on forward-looking statements.  Although Talecris believes that the forward-looking statements contained in this press release are reasonable, there is no assurance that expectations will be fulfilled.

The following factors, among others, could cause actual results to differ materially from those expressed or implied in forward-looking statements: impact of the announcement of the company's definitive merger agreement with Grifols and the potential impact of completion, termination or delay of the proposed merger with Grifols; the unprecedented volatility in the global economy and fluctuations in financial markets; changes in economic conditions, political tensions, trade protection measures, licensing requirements, and tax matters in the countries in which the company conducts business; the impact of competitive products and pricing; the impact of recently enacted and proposed additional U.S. healthcare reform legislation, legal proceedings or regulatory action affecting, among other things, the U.S. healthcare system, pharmaceutical pricing and reimbursement, including Medicaid and Medicare; legislation or regulations in markets outside of the U.S. affecting product pricing, reimbursement, access, or distribution channels; Talecris' ability to procure adequate quantities of plasma and other materials which are acceptable for use in manufacturing processes from the company's own plasma collection centers or from third-party vendors; Talecris' ability to maintain compliance with government regulations and licenses, including those related to plasma collection, production and marketing; Talecris' ability to identify growth opportunities for existing products and Talecris' ability to identify and develop new product candidates through the company's research and development activities; and the timing of, and Talecris' ability to, obtain and/or maintain regulatory approvals for new product candidates, the rate and degree of market acceptance, and the clinical utility of the company's products; unexpected shut-downs of Talecris' manufacturing and storage facilities or delays in opening new planned facilities; potential sanctions, if any, that the Department of Justice (DOJ) or other federal agencies, may impose on the company as a result of Talecris' internal FCPA investigation; and other risks identified in the company's most recent filing on Form 10-K and other SEC filings, all of which are available on the company's website.  Talecris undertakes no duty to update any forward-looking statement.

Exhibits

Matters Affecting Comparability (Exhibit A)

Non-GAAP Financial Measures (Exhibit B)

About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.

Talecris Biotherapeutics is a global biotherapeutic and biotechnology company that discovers, develops and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, neurology, critical care, and hemostasis.

EXHIBIT A:  MATTERS AFFECTING COMPARABILITY

Talecris believes that the comparability of the financial results between the periods presented is significantly impacted by the following items:

Plasma Center of America (PCA) Judgment

On December 13, 2010, a jury in the General Court of Justice, Superior Court Division, Wake County, North Carolina, rendered a verdict in the amount of $37.0 million in favor of PCA against TPR in a breach of contract claim, which was confirmed by the court in post trial motions.  The company intends to appeal.  The jury verdict, if sustained, will accrue at 8% simple interest from the date of breach, which is approximately $6.7 million at December 31, 2010.  The company has included a charge of $43.7 million (approximately $26.6 million after tax) in its consolidated income statement for the year ended December 31, 2010 related to the judgment.

Definitive Merger Agreement with Grifols

The company has entered into agreements with investment bankers related to its definitive merger agreement with Grifols.  Talecris incurred fees totaling $2.5 million under these agreements during 2010. During 2010, the company also incurred legal, accounting, and other fees of $18.3 million associated with the merger agreement.  The company is obligated to pay additional fees totaling $21.3 million upon successful closing of the transaction.  

Under the terms of the merger agreement with Grifols, the company is permitted to offer retention amounts up to a total of $15.0 million to employees.  As of December 31, 2010, Talecris has offered retention amounts totaling approximately $10.2 million to employees of which $2.9 million was paid during 2010 and the remaining amounts are expected to be paid in 2011, subject to the terms of the retention agreements.  The company incurred retention expenses, including fringe benefits, of $6.9 million during the year ended December 31, 2010.  The remaining retention amounts will likely be recognized ratably through the second quarter of 2011, but Talecris may offer additional retention packages.

Financial Impact of IPO and Refinancing Transactions

As discussed in Talecris' 2009 Form 10-K, the company completed IPO and refinancing transactions during the fourth quarter of 2009, which has resulted in lower average borrowings during the three months and year ended December 31, 2010 as compared to the three months and year ended December 31, 2009, and correspondingly lower interest expense during the year ended December 31, 2010.  For the three months ended December 31, 2010 and 2009, interest expense was $11.8 million and $11.1 million, respectively, and for the year ended December 31, 2010 and 2009, interest expense was $47.3 million and $56.9 million, respectively.    

Foreign Corrupt Practices Act (FCPA)

Talecris is conducting an internal investigation into potential violations of the FCPA that the company became aware of during the conduct of an unrelated review.  The FCPA investigation is being conducted by outside counsel under the direction of a special committee of the board of directors.  During the years ended December 31, 2010 and 2009, Talecris incurred $5.0 million and $8.0 million, respectively, of legal costs associated with the internal investigation into this matter, which are recorded in SG&A in the consolidated income statement.  The company expects to complete the internal FCPA investigation and present the findings to the Department of Justice (DOJ) in 2011. The preliminary findings of the company's investigation indicate that it is probable that there were FCPA violations by persons associated with the company that the DOJ or other regulators may assert are attributable to the company.  Even though Talecris self-disclosed this matter to the DOJ, it or other federal agencies may seek to impose sanctions on the company that may include, among other things, debarment, injunctive relief, disgorgement, fines, penalties, appointment of a monitor, appointment of a new control staff or enhancements of existing compliance and training programs.  Any such sanctions or related loss of business could have a material adverse effect on Talecris or the company's results of operations.  It is possible, however, that any sanctions that DOJ or other federal agencies might otherwise consider imposing would be reduced, if not eliminated, in light of the comprehensive compliance measures that Talecris has implemented. Given the preliminary nature of the company's findings, Talecris' continuing investigation and the uncertainties regarding this matter, the company is unable to estimate the financial outcome.  Additional information regarding the investigation into potential violations of the FCPA is included in the footnotes to the consolidated financial statements and in the section of the 2010 Form 10-K entitled, "Risk Factors."

Comparability of Outstanding Common Shares and Pro Forma Diluted Earnings per Common Share

As discussed in Talecris' 2010 Form 10-K, the company completed IPO and refinancing transactions during the fourth quarter of 2009.  Talecris' IPO consisted of 56,000,000 shares of common stock, of which 28,947,368 shares were newly issued and sold by Talecris and 27,052,632 shares were sold by the selling stockholder, Talecris Holdings, LLC.  The net primary proceeds to Talecris of $519.7 million were used to repay amounts outstanding under Talecris' then existing First and Second Lien Term Loans.  In connection with the IPO, Talecris also converted 1,000,000 shares of the company's Series A preferred stock and 192,310 shares of Series B preferred stock into 85,846,320 shares of common stock and issued 2,381,548 shares of common stock to settle $45.3 million of accrued dividends upon the conversion of Series A and B preferred stock.  The issuance of new common shares has resulted in a significant increase in the number of common shares used in Talecris' computation of diluted earnings per common share.  The application of the net primary proceeds to Talecris from the IPO to repay the company's then existing indebtedness has resulted in a significant reduction in interest expense during the three months and year ended December 31, 2010 as compared to the prior year periods.  

Talecris believes that the comparability of its financial results for the periods presented is enhanced by the following pro forma presentation of diluted earnings per common share.  In the table below, the pro forma diluted earnings per common share computation for year ended December 31, 2009 reflects an adjustment to net income for reduced interest expense as if the net primary proceeds to Talecris from the IPO of $519.7 million had been applied to repay debt at the beginning of 2009, net of interest rate differences from the issuance of the 7.75% Notes.  The pro forma adjustment to the denominator reflects the impacts for the issuance of common shares to convert preferred stock, settle accrued dividends on the preferred stock and complete the IPO as if these events occurred at the beginning of 2009.

Definitive Merger Agreement with CSL

Talecris entered into a definitive merger agreement with CSL on August 12, 2008, which was subject to the receipt of certain regulatory approvals as well as other customary conditions.  The U.S. Federal Trade Commission filed an administrative complaint before the Commission challenging the merger and a complaint in Federal district court seeking to enjoin the merger during the administrative process.  On June 8, 2009, the merger parties agreed to terminate the definitive merger agreement and as a result, CSL paid Talecris a merger termination fee of $75.0 million during the 2009 second quarter.  The U.S. Federal Trade Commission's complaints were subsequently dismissed.  Talecris incurred retention expense, including fringe benefits of $9.2 million for the year ended December 31, 2009, and legal costs associated with the regulatory review process of $6.0 million during the year ended December 31, 2009.  All retention amounts were paid during 2009.

EXHIBIT B:  NON-GAAP FINANCIAL MEASURES

Description of Adjustments and Reconciliations of U.S. GAAP to Non-GAAP Financial Measures

Merger-related Items, PCA Judgment and Charges Related to Debt Refinancing Transactions

Talecris believes a meaningful comparison of its results for the periods presented is enhanced by a quantified presentation of the impact of the 2010 Grifols merger-related expenses and the PCA judgment as well as the 2009 CSL merger termination fee, CSL merger-related expenses, and the charges related to debt refinancing transactions.  The impacts of these items on net income and diluted earnings per share are illustrated in the table below.

In addition, the 2010 diluted earnings per share reflects a significant increase in the number of common shares used in the computation of diluted earnings per share as discussed below and in "Exhibit A: Matters Affecting Comparability."   

The adjusted net income and diluted earnings per share amounts in the table below are non-GAAP financial measures and should not be considered a substitute for any performance measure determined in accordance with U.S. GAAP.  Additional information regarding the use of these non-GAAP financial measures is included in Talecris' Form 10-K filed with the SEC on February 23, 2011, which is available on SEC's website at www.sec.gov and Talecris' website at http://ir.talecris.com.