Charles River Laboratories Announces Second-Quarter 2019 Results

– Second-Quarter Revenue of $657.6 Million –

– Second-Quarter GAAP Earnings per Share of $0.88 and Non-GAAP Earnings per Share of $1.63 –

– Updates 2019 Guidance –

Charles River Laboratories International, Inc. CRL today reported its results for the second quarter of 2019. For the quarter, revenue was $657.6 million, an increase of 12.3% from $585.3 million in the second quarter of 2018.

Acquisitions, principally the partial-quarter benefit from Citoxlab, contributed 5.7% to consolidated second-quarter revenue growth. The impact of foreign currency translation reduced reported revenue growth by 1.9%. Excluding the effect of these items, organic revenue growth of 8.5% was driven by all three business segments.

On a GAAP basis, second-quarter net income from continuing operations attributable to common shareholders was $43.7 million, a decrease of 16.2% from net income of $52.2 million for the same period in 2018. Second-quarter diluted earnings per share on a GAAP basis were $0.88, a decrease of 17.0% from $1.06 for the second quarter of 2018. The lower GAAP net income and earnings per share were driven primarily by a loss from the Company's venture capital investments of $0.07 per share in the second quarter of 2019, compared to a $0.16 gain for the same period in 2018. As previously disclosed, the Company's venture capital investment performance has been excluded from non-GAAP results.

On a non-GAAP basis, net income from continuing operations was $81.1 million for the second quarter of 2019, an increase of 13.7% from $71.3 million for the same period in 2018. Second‑quarter diluted earnings per share on a non-GAAP basis were $1.63, an increase of 12.4% from $1.45 per share for the second quarter of 2018. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating income, including the contribution from the Citoxlab acquisition, as well as a lower tax rate.

James C. Foster, Chairman, President and Chief Executive Officer, said, "Our solid, second-quarter results demonstrate the effectiveness of our strategy and the strong industry fundamentals that continue to fuel the pipelines of the biotech industry, and in turn, our growth. We have invested tremendous effort over time to add people and capacity to accommodate growing client demand; to maintain and enhance our scientific leadership; to strengthen our relationships with clients; and to work with them to devise outsourcing solutions that increase their productivity and speed-to-market. We have maintained our focus on early-stage drug research and manufacturing support solutions, strategically expanding our portfolio to provide clients with the critical capabilities they require to discover, develop, and safely manufacture new drugs. As a result, we believe that Charles River is a stronger company today than it has ever been. We will continue to invest in and enhance our industry-leading portfolio to fulfill our long-term strategic goals and become an even stronger partner to our clients across a wider array of scientific solutions."

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $136.1 million in the second quarter of 2019, an increase of 4.3% from $130.4 million in the second quarter of 2018. Organic revenue growth was 6.8%, driven primarily by higher revenue for research model services, as well as increased demand for research models in China. Research model services benefited from a large government contract in the Insourcing Solutions (IS) business, which commenced in September 2018, and strong client demand for the Genetically Engineered Models and Services business. The revenue increase was partially offset by lower sales volume for research models outside of China, particularly to large biopharmaceutical clients.

In the second quarter of 2019, the RMS segment's GAAP operating margin decreased to 23.2% from 26.3% in the second quarter of 2018. On a non-GAAP basis, the operating margin decreased to 25.5% from 26.8% in the second quarter of 2018. The GAAP and non-GAAP operating margin declines were driven primarily by lower sales volume for research models outside of China, the large IS government contract, and the compensation structure adjustment implemented in 2018. In addition, a non-cash charge related to the modification of a purchase option for the noncontrolling interest in Vital River (RMS China) reduced the GAAP operating margin.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $405.5 million in the second quarter of 2019, an increase of 17.1% from $346.4 million in the second quarter of 2018. Acquisitions contributed 9.6% to DSA revenue growth, due primarily to the revenue contribution from the Citoxlab acquisition, which was completed on April 29, 2019. Organic revenue growth of 8.7% was driven by both the Safety Assessment and Discovery Services businesses. By client segment, the DSA revenue increase was driven primarily by robust demand from biotechnology clients.

In the second quarter of 2019, the DSA segment's GAAP operating margin decreased to 15.7% from 16.3% in the second quarter of 2018. On a non-GAAP basis, the operating margin decreased to 21.1% from 21.5% in the second quarter of 2018. The GAAP and non-GAAP operating margin declines were driven primarily by higher costs associated with staff and capacity investments, including last year's compensation structure adjustment, partially offset by benefits from higher pricing and R&D tax credits associated with Citoxlab. In addition, acquisition and integration costs, principally amortization of intangible assets related to the Citoxlab acquisition, reduced the GAAP operating margin.

Manufacturing Support (Manufacturing)

Revenue for the Manufacturing segment was $116.0 million in the second quarter of 2019, an increase of 7.0% from $108.5 million in the second quarter of 2018. Organic revenue growth was 9.8%, driven primarily by strong demand in the Microbial Solutions and Biologics Testing Solutions businesses.

In the second quarter of 2019, the Manufacturing segment's GAAP operating margin decreased to 28.6% from 31.5% in the second quarter of 2018. On a non-GAAP basis, the operating margin decreased to 30.9% from 33.6% in the second quarter of 2018. The GAAP and non-GAAP operating margin declines were driven primarily by higher costs to support growth-related investments in the Microbial Solutions and Biologics Testing Solutions businesses.

Updates 2019 Guidance

The Company is updating 2019 financial guidance, which was previously provided on May 7, 2019.

The Company is narrowing its guidance ranges for both reported and organic revenue growth. Foreign exchange is now expected to reduce reported revenue growth by 1% to 1.5% in 2019.

The Company is reducing its GAAP earnings per share guidance by $0.10 to reflect higher acquisition-related costs, the venture capital investment loss in the second quarter, and other items. Non-GAAP earnings per share guidance is being increased by $0.05, due primarily to the benefit from a lower-than-expected tax rate. The Company is reaffirming its free cash flow guidance.

The Company's revenue and earnings per share guidance is as follows:

Footnotes to Guidance Table:

(1) The contribution from acquisitions reflects only those acquisitions which have been completed.

(2) Organic revenue growth is defined as reported revenue growth adjusted for acquisitions and foreign currency translation.

(3) Amortization of intangible assets includes an estimate of approximately $0.20 for the impact of the Citoxlab acquisition based on the preliminary purchase price allocation.

(4) These charges, which primarily include severance and other costs, relate primarily to the Company's planned efficiency initiatives. Other projects in support of global productivity and efficiency initiatives are expected, but these charges reflect only the decisions that have already been finalized.

(5) These adjustments are related to the evaluation and integration of acquisitions, and primarily include transaction, advisory, and certain third-party integration costs, as well as certain costs associated with acquisition-related efficiency initiatives. In addition, these adjustments include a charge associated with modification of a purchase option for the remaining 8% equity interest in Vital River. These costs will be partially offset by an anticipated discrete tax benefit.

(6) Other items include third-party costs, net of insurance reimbursements, associated with the remediation of the unauthorized access into the Company's information systems, which was detected in March 2019.

(7) Venture capital investment performance only includes recognized gains or losses. The Company does not forecast future venture capital investment gains or losses.

(8) The reconciliation of 2019 free cash flow guidance is as follows: Cash flow from operating activities of $480-$490 million, less capital expenditures of ~$170 million, equates to free cash flow of $310-$320 million.

Webcast

Charles River has scheduled a live webcast on Wednesday, July 31, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Investor Day

Charles River will host a Meeting with Management on Thursday, September 12, from 8:00 a.m. to 12:30 p.m. ET. The meeting will be webcast live on the Investor Relations section of the Company's website at ir.criver.com .

Non-GAAP Reconciliations/Discontinued Operations

The Company reports non-GAAP results in this press release, which exclude often-one-time charges and other items that are outside of normal operations. A reconciliation of GAAP to non-GAAP results is provided in the schedules at the end of this press release. In addition, the Company reports results from continuing operations, which exclude results of the Phase I clinical business that was divested in 2011. The Phase I business is reported as a discontinued operation.

Use of Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, such as non-GAAP earnings per diluted share, which exclude the amortization of intangible assets, and other charges related to our acquisitions; expenses associated with evaluating and integrating acquisitions and divestitures, as well as fair value adjustments associated with contingent consideration; charges, gains, and losses attributable to businesses or properties we plan to close, consolidate, or divest; severance and other costs associated with our efficiency initiatives; the write-off of deferred financing costs and fees related to debt financing; third-party costs associated with the remediation of unauthorized access into our information systems detected in March 2019; and investment gains or losses associated with our venture capital investments. This press release also refers to our revenue in both a GAAP and non-GAAP basis: "constant currency," which we define as reported revenue growth adjusted for the impact of foreign currency translation, and "organic revenue growth," which we define as reported revenue growth adjusted for foreign currency translation, acquisitions, and divestitures. We exclude these items from the non-GAAP financial measures because they are outside our normal operations. Commencing in the first quarter of 2019, we exclude the performance of our venture capital investments due to the determination that such investment gains or losses are not core to our overall operations. There are limitations in using non-GAAP financial measures, as they are not prepared in accordance with generally accepted accounting principles, and may be different than non-GAAP financial measures used by other companies. In particular, we believe that the inclusion of supplementary non-GAAP financial measures in this press release helps investors to gain a meaningful understanding of our core operating results and future prospects without the effect of these often-one-time charges, and is consistent with how management measures and forecasts the Company's performance, especially when comparing such results to prior periods or forecasts. We believe that the financial impact of our acquisitions and divestitures (and in certain cases, the evaluation of such acquisitions and divestitures, whether or not ultimately consummated) is often large relative to our overall financial performance, which can adversely affect the comparability of our results on a period-to-period basis. In addition, certain activities and their underlying associated costs, such as business acquisitions, generally occur periodically but on an unpredictable basis. We calculate non-GAAP integration costs to include third-party integration costs incurred post-acquisition. Presenting revenue on an organic basis allows investors to measure our revenue growth exclusive of acquisitions, divestitures, and foreign currency exchange fluctuations more clearly. Non-GAAP results also allow investors to compare the Company's operations against the financial results of other companies in the industry who similarly provide non-GAAP results. The non-GAAP financial measures included in this press release are not meant to be considered superior to or a substitute for results of operations prepared in accordance with GAAP. The Company intends to continue to assess the potential value of reporting non-GAAP results consistent with applicable rules and regulations. Reconciliations of the non-GAAP financial measures used in this press release to the most directly comparable GAAP financial measures are set forth in this press release, and can also be found on the Company's website at ir.criver.com.

Caution Concerning Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "expect," "intend," "will," "would," "may," "estimate," "plan," "outlook," and "project," and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements also include statements regarding the projected future financial performance of Charles River and our specific businesses, including revenue (on both a reported, constant-currency, and organic growth basis), operating margins, earnings per share, the expected impact of foreign exchange rates, and the expected benefit of our life science venture capital investments; the future demand for drug discovery and development products and services, including our expectations for future revenue trends; our expectations with respect to the impact of acquisitions, including the acquisition of Citoxlab, on the Company, our service offerings, client perception, strategic relationships, revenue, revenue growth rates, and earnings; the development and performance of our services and products, including our investments in our portfolio; market and industry conditions including the outsourcing of services and spending trends by our clients; the potential outcome of and impact to our business and financial operations due to litigation and legal proceedings; the impact of U.S. tax reform enacted in the fourth quarter of 2017; and Charles River's future performance as delineated in our forward-looking guidance, and particularly our expectations with respect to revenue, the impact of foreign exchange, and enhanced efficiency initiatives. Forward-looking statements are based on Charles River's current expectations and beliefs, and involve a number of risks and uncertainties that are difficult to predict and that could cause actual results to differ materially from those stated or implied by the forward-looking statements. Those risks and uncertainties include, but are not limited to: the ability to successfully integrate businesses we acquire; risks and uncertainties associated with the unauthorized access into its information systems reported on April 30, 2019, including the timing and effectiveness of adding enhanced security features and monitoring procedures, the status and effectiveness of the ongoing remediation process, the percentage of clients affected by the unauthorized access, and the potential revenue and financial impact related to the incident; the ability to execute our efficiency initiatives on an effective and timely basis (including divestitures and site closures); the timing and magnitude of our share repurchases; negative trends in research and development spending, negative trends in the level of outsourced services, or other cost reduction actions by our clients; the ability to convert backlog to revenue; special interest groups; contaminations; industry trends; new displacement technologies; USDA and FDA regulations; changes in law; the impact of Brexit; continued availability of products and supplies; loss of key personnel; interest rate and foreign currency exchange rate fluctuations; changes in tax regulation and laws; changes in generally accepted accounting principles; and any changes in business, political, or economic conditions due to the threat of future terrorist activity in the U.S. and other parts of the world, and related U.S. military action overseas. A further description of these risks, uncertainties, and other matters can be found in the Risk Factors detailed in Charles River's Annual Report on Form 10-K as filed on February 13, 2019, as well as other filings we make with the Securities and Exchange Commission. Because forward-looking statements involve risks and uncertainties, actual results and events may differ materially from results and events currently expected by Charles River, and Charles River assumes no obligation and expressly disclaims any duty to update information contained in this news release except as required by law.

About Charles River

Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them. To learn more about our unique portfolio and breadth of services, visit www.criver.com.

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