On November 8, 2023 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) reported the financial results and corporate updates for the first nine months 2023 (Press release, Evotec, NOV 8, 2023, View Source [SID1234637256]).

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HIGHLIGHTS

EVOTEC’S TOPLINE SUCCESS REFLECTS STRONG DEMAND

Group revenues increased by 14% (19% excluding fx-effects) to € 580.1 m (9M 2022: € 510.8 m); excluding a lower contribution from milestones, upfronts and license payments, Base business at € 575.3 m (9M 2022: € 502.8 m) continued to show comparable growth of 14%.
Costs of € 43.9 m were incurred in 2023 as a direct result of the cyber-incident in early April, including additional external expenditures and internal recovery contributions.
Total EVT Execute revenues (incl. intersegment revenues) up 3% to € 543.4 m (9M 2022: € 526.7 m), strongly affected by cyber-incident; EVT Innovate revenues up 64% to € 199.9 m (9M 2022: € 121.9 m).
Adjusted Group EBITDA increased by 13% to € 50.2 m (9M 2022: € 44.6 m); continued work on key collaborations has partially compensated for underutilised capacities as a result of the cyber-attack.

STRENGTHENING ACTIVITIES THROUGH INTEGRATED R&D AND PRECISION MEDICINE PLATFORMS

Multiple new and extended integrated drug discovery and development agreements all along the drug discovery & development value chain (e.g., new INDiGO agreement with Matchpoint Therapeutics)
Extension and expansion of strategic neurodegeneration partnership with Bristol Myers Squibb ("BMS"), and strong progress in strategic targeted protein degradation partnership with BMS
Co-owned pipeline progress: Positive Phase I read-out for EVT8683, start of Phase I trial for EVT401
Further value creation through academic partnerships (BRIDGEs): Launch of "LAB eN²" with Novo Nordisk and academic institutions Harvard University, Mass General Brigham, Yale University, and Beth Israel Deaconess Medical Center
New partnering agreement to strengthen biotech innovators in shared R&D economy with LabCentral, BioLabs, and MBC BioLabs

Events after Period-End

Launch of "65LAB", Evotec’s first BRIDGE partnership in Asia
Co-owned pipeline updates: Presentation of biomarkers data on EVT801, Exscientia decided to de-prioritise EXS21546
New participation in iCARE4CVD, a consortium to personalise prevention and treatment of cardiovascular diseases
New strategic partnership with Dewpoint Therapeutics in oncology

CORPORATE
Opening of new state-of-the-art biology facility on Dorothy Crowfoot Hodgkin Campus

Events after Period-End

Evotec receives SBTi validation and approval of its near-term emission reduction targets
In October, Evotec’s management started the social process of redeploying its chemistry activities out of Marcy (Lyon), as part of its Value Protection Plan ("VPP") 

BUSINESS OUTLOOK FOR FULL-YEAR 2023 AND MID-TERM GOALS 2025 CONFIRMED
Group revenues expected to be in a range of € 750 – 790 m or € 765 – 805 m at constant exchange rates (2022: € 751 m).
Adjusted Group EBITDA expected to be in the range of € 60 – 80 m, translating into € 70 – 90 m at constant exchange rates (2022: € 102 m).
Unpartnered research and development expenses expected to be in a range of € 60 – 70 m (2022: € 70 m).
Mid-term goals target revenue growth to > € 1,000 m, adjusted EBITDA of ≥ € 300 m and unpartnered research and development expenses of > € 100 m.

Due to the criminal cyber-attack discovered on 6 April 2023, productivity was affected in the second and third quarters. In response to the criminal cyber-attack, Evotec took immediate action to contain and remediate the attack by taking its external-facing systems offline. This was deemed necessary to protect all the Company’s partners and stakeholders and meant Evotec could ensure that the integrity of scientific data remained unaffected.

More detailed information and financial tables are available in our interim statement 9M published on the Evotec website under the following link: View Source

WEBCAST / CONFERENCE CALL
The Company is going to hold a conference call to discuss the results as well as provide an update on its performance. The conference call will be held in English.

Webcast details

Date: Wednesday, 08 November 2023

Time: 2.00 pm CET (01.00 pm GMT, 08.00 am EST)

To join the audio webcast and to access the presentation slides, please register via this link.

The on-demand version of the webcast will be available on our website: www.evotec.com/financial-reports.

Conference call details

To join via phone, please pre-register via this link. You will then receive a confirmation email with dedicated dial-in details such as telephone number, access code and PIN to access the call.

A simultaneous slide presentation for participants dialling in via phone is available under this link.

On November 8, 2023 Emergent BioSolutions Inc. (NYSE: EBS) reported selected financial results for the third quarter ended September 30, 2023 (Press release, Emergent BioSolutions, NOV 8, 2023, View Source [SID1234637255]). The selected financial results reported include limited third quarter and year-to-date results, as well as selected balance sheet and cash flow information. As part of our quarterly review process, the Company determined that its state deferred tax liability was overstated as of December 31, 2022, resulting in an understatement of the income tax benefits reflected on the Company’s income statement. While these non-cash items do not have any impact on the Company’s liquidity, cash flow, historical management compensation or covenant compliance, we have concluded that it is appropriate to delay the disclosure of full third quarter and year-to-date earnings information and the filing of our Quarterly Report on Form 10-Q for the period ended September 30, 2023 while we work to correct our prior period financial statements. We expect to complete this work in the near future.

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"As we work diligently toward filing our Form 10-Q, Emergent continues to strengthen its financial position and streamline operations, which remains critical to the company’s strategy to return to growth and preserve its unique capabilities to help protect and enhance life," said interim Chief Executive Officer Haywood Miller. "We are proud of the progress we are making across our core products business, including the recent over-the-counter launch of NARCAN Nasal Spray, which expands access and awareness to help save more lives impacted by the devastating opioid crisis. As we look ahead, we plan to continue protecting against public health threats for years to come."

On November 8, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2023 (Press release, Cullinan Oncology, NOV 8, 2023, View Source [SID1234637254]).

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"We have made tremendous strides through the first three quarters of 2023, while positioning Cullinan for a data-rich 2024," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "We are rapidly progressing CLN-619 and look forward to providing initial data from the combination therapy module, as well as additional monotherapy data, from the Phase 1 dose escalation study in the second quarter of 2024. We also expect to provide initial data from our disease-specific expansion cohorts in the first half of 2025. Our broad zipalertinib development program, being conducted in collaboration with our partners at Taiho, is also continuing, and we expect to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by the end of 2024. We expect to present data for CLN-049 and CLN-418 in the second half of 2024 as well. We finished Q3 with cash and investments of $482 million, which we now expect to provide runway into the second half of 2026, two quarters beyond previous guidance."

Portfolio Highlights

•
CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors
o
Enrollment continues in the ongoing Phase 1 study evaluating CLN-619 as both monotherapy and in combination with checkpoint inhibitor therapy. Accrual to the dose escalation phase of the combination module has been completed. Recruitment continues to the monotherapy disease specific expansion cohorts for patients with endometrial and cervical cancers. Cullinan also continues to evaluate additional disease specific expansion cohorts.

o
At the 2023 SITC (Free SITC Whitepaper) Annual Meeting, initial biomarker data from the ongoing Phase 1 study of CLN-619 were presented at a poster session, providing evidence for CLN-619’s mechanism of action and demonstrating that clinical activity, including objective response, has been observed in patients with tumor characteristics not typically responsive to checkpoint inhibitor therapy.

•
Zipalertinib (EGFR ex20ins inhibitor): EGFR ex20ins NSCLC
o
In August 2023, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., announced the initiation of REZILIENT3, a global Phase 3 study evaluating zipalertinib plus chemotherapy versus chemotherapy alone in patients with EGFR exon 20 insertion mutation non-small-cell lung cancer (EGFR ex20ins NSCLC) in the first-line setting.
o
Enrollment continues in the pivotal Phase 2b portion of the REZILIENT1 study, evaluating zipalertinib in a cohort of patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, as well as in a separate cohort of patients progressing after prior treatment with a currently approved agent for EGFR ex20ins NSCLC.
•
CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
o
Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.
•
CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
o
Preclinical data, including target expression profiling data and robust anti-tumor activity supporting the development of CLN-418 in multiple solid tumors, were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
o
Enrollment continued in the ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
•
CLN-978 (CD19xCD3 T cell engager): B-NHL
o
In August 2023, Cullinan dosed the first patient in a Phase 1 study of CLN-978 in patients with R/R B-NHL.
o
Preclinical data demonstrating the effectiveness of CLN-978 against lymphoma cells expressing very low levels of CD19 were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Cullinan anticipates dosing the first patient in the CLN-617 first-in-human Phase 1 study by year end 2023.
o
A poster at the 2023 SITC (Free SITC Whitepaper) Annual Meeting highlighted preclinical data demonstrating the mechanism by which CLN-617 mediates a robust abscopal anti-tumor effect in preclinical models. A Trial in Progress poster for the ongoing Phase 1 study of CLN-617 in combination with pembrolizumab was also presented.

Upcoming Milestones

•
CLN-619
o
Cullinan expects to report initial data from the combination dose escalation module as well as an update on the monotherapy dose escalation module at a medical conference in the second quarter of 2024.
o
Cullinan expects to report initial data from disease specific dose expansion cohorts in the first half of 2025.
•
Zipalertinib
o
Cullinan expects completion of enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by year-end 2024.
•
CLN-049
o
Cullinan expects to provide a clinical data update in the second half of 2024.
•
CLN-418
o
Cullinan expects to provide a clinical data update in the second half of 2024.
Third Quarter 2023 Financial Results

•
Cash Position: Cash, cash equivalents, investments, and interest receivable were $481.9 million as of September 30, 2023. Cullinan now expects its cash resources to provide runway into the second half of 2026 based on its current operating plan. The extension from prior guidance is primarily driven by the receipt of approximately $38 million in net proceeds from Cullinan’s ATM equity program, increased interest income, and the prioritization of development plans in the longer term. Cullinan’s operating plan includes continued advancement of all programs to key data milestones in the near term.
•
R&D Expenses: Research and development (R&D) expenses were $33.8 million for the third quarter of 2023, compared to $27.4 million for the second quarter of 2023. R&D expenses for the third and second quarters of 2023 included $3.2 million and $3.2 million of equity-based compensation expenses, respectively. The increase in R&D expenses was primarily related to increased chemistry, manufacturing and controls costs and higher clinical costs.
•
G&A Expenses: General and administrative (G&A) expenses were $11.0 million for the third quarter of 2023, compared to $10.2 million for the second quarter of 2023. G&A expenses in the third and second quarters of 2023 included $4.5 million and $4.7 million of equity-based compensation expenses, respectively. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by higher personnel costs.
•
Net Loss: Net loss (before items attributable to noncontrolling interest) for the third quarter of 2023 was $39.2 million, compared with net loss of $32.2 million for the second quarter of 2023. Net losses included the items described above, partially offset by interest income of $5.9 million and $5.3 million in the third quarter and second quarter of 2023, respectively.

•
Shares Outstanding: As of October 31, 2023, Cullinan had 42,780,644 common shares outstanding plus 647,500 shares of non-voting preferred stock outstanding, each of which is convertible into 10 shares of common stock.

On November 8, 2023 ChromaDex Corp. (NASDAQ: CDXC) reported financial results for the third quarter of 2023 (Press release, ChromaDex, NOV 8, 2023, View Source [SID1234637253]).

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Third Quarter 2023 and Recent Highlights

Total net sales were $19.5 million, with $17.4 million from Tru Niagen, up 14% and 19% from the prior year quarter, respectively.
Strong gross margin of 61.4%, an increase of 160 basis points, compared to 59.8% from the prior year quarter.
Sales and marketing expense as a percentage of net sales was 31.0%, an improvement of 340 basis points, compared to 34.4% from the prior year quarter.
Net loss was $1.0 million or $(0.01) per share, remaining stable compared to the prior year quarter, a notable achievement as the prior year’s results included the one-time Employee Retention Tax Credit recognition of $2.1 million ($0.03 per share).
Adjusted EBITDA, a non-GAAP measure, was a positive $0.5 million, a $1.7 million improvement from the prior year quarter.
In August 2023, launched Tru Niagen on iHerb, a global destination for supplements, expanding ChromaDex’s worldwide reach.
Clinical study published in August 2023 in the peer-reviewed journal Cell Reportsfound that supplementation of NR effectively reduced inflammation in both healthy subjects and immune cells derived from psoriasis patients.
In October 2023, launched Tru Niagen 1,000 mg, the most researched dosage in clinical studies, empowering customers to elevate their NAD levels by up to 150% after three weeks.
In October 2023, Zesty Paws, a prominent name in pet supplements, partnered with ChromaDex to launch a Healthy Aging NAD+ Precursor supplement for pets, featuring Niagen. This partnership marks the entry into the longevity category for pets and extends the power of Niagen to animal companions.
"We had a solid quarter, delivering 14% year-over-year revenue growth, a net loss of only $1.0 million, positive Adjusted EBITDA of $0.5 million, and positive operating cash flows for the third consecutive quarter, ending with $26.8 million in cash and no debt," said ChromaDex Chief Executive Officer, Rob Fried. "These results serve as a testament to our commitment to financial discipline and operational efficiency. ChromaDex is in its strongest financial position to date, and we expect to unlock commercial opportunities driven by new innovation in 2024 and beyond."

Results of operations for the three months ended September 30, 2023 compared to the prior year quarter

ChromaDex reported a net sales increase of 14%, or $2.4 million, to $19.5 million. The increase in total net sales was driven by growth in Tru Niagen sales, partially offset by lower Niagen ingredient sales.

Gross marginpercentageimproved 160 basis points to 61.4%. The improvement in gross margin percentage is primarily driven by supply chain management optimization efforts, including improvements in yield loss, and benefits from economies of scale, partly offset by changes in business mix.

Operating expensedecreased 1%, or $0.2 million, to $13.1 million due to a $0.3 million reduction in general and administrative expense, partially offset by a slight increase in sales and marketing expense.

Net loss was $1.0 million, or $0.01 loss per share, consistent with the net loss of $1.0 million or $0.01 loss per share for the third quarter of 2022. Notably, the third quarter of 2022 included a one-time recognition of the Employee Retention Tax Credit recognition of $2.1 million, or $0.03 per share, further underlining the improvements in performance this quarter compared to the prior year quarter. Adjusted EBITDA, a non-GAAP measure, was a positive $0.5 million, a $1.7 million improvement from the third quarter of 2022. See "Reconciliation of Non-GAAP Financial Measures" for a reconciliation of non-GAAP Adjusted EBITDA to net loss, the most directly comparable GAAP measure.

Net cash inflow from operating activities was $6.5 million for the nine months ended September 30, 2023, showing a significant improvement compared to a net cash outflow of $14.8 million in the prior year. This improvement can be attributed to a $10.1 million reduction in net loss and positive cash impacts of $4.1 million from inventory management, $3.0 million from lower prepaid expenses and other assets, $1.5 million from reduced trade receivables, $1.6 million from higher accrued expenses and $0.9 million from higher provisions for doubtful trade receivables.

2023 Full Year Outlook

Looking forward, for the full year, the Company expects between 14% – 16% revenue growth year-over-year, driven by its global e-commerce business, steady growth from new and existing partnerships, upside realized from new partnerships in the first nine months of 2023 and realistic opportunities in the pipeline for the fourth quarter of 2023. The Company projects that gross margin will remain stable year over year as cost savings initiatives and benefits from economies of scale are expected to largely offset continued inflationary pressures. Moreover, further optimization, coupled with new and focused customer acquisition strategies are expected to result in reduced selling and marketing expense as a percentage of net sales. The Company plans to increase investments in research and development to drive innovation, and expects general and administrative expense to be flat to down $1 million year over year.

Investor Conference Call

A live webcast will be held Wednesday, November 8, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s third-quarter financial results and provide a general business update.

To listen to the webcast, or to view the earnings press release and its accompanying financial exhibits, please visit the Investors Relations section of ChromaDex’s website at View Source The toll-free dial-in information for this call is 1-888-330-2446 with Conference ID: 4126168.

The webcast will be recorded, and will be available for replay via the website from 7:30 p.m. Eastern time on November 8, 2023 through 11:59 p.m. Eastern time on November 15, 2023. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

On November 8, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter of 2023 (Press release, Charles River Laboratories, NOV 8, 2023, View Source [SID1234637252]). For the quarter, revenue was $1.03 billion, an increase of 3.8% from $989.2 million in the third quarter of 2022.

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Acquisitions contributed 0.2% to consolidated third-quarter revenue growth. The impact of foreign currency translation benefited reported revenue growth by 1.4%. The divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 1.9%. Excluding the effect of these items, organic revenue growth of 4.1% was driven primarily by the Discovery and Safety Assessment (DSA) and the Research Models and Services (RMS) business segments.

On a GAAP basis, third-quarter net income attributable to common shareholders was $87.4 million, a decrease of 9.4% from $96.5 million for the same period in 2022. Third-quarter diluted earnings per share on a GAAP basis were $1.69, a decrease of 10.1% from $1.88 for the third quarter of 2022. The lower GAAP net income and earnings per share were driven primarily by site consolidation and associated costs, as well as non-operating items, including a loss on certain venture capital and other strategic investments, increased interest expense, and a higher tax rate. GAAP earnings per share included a loss from the Company’s certain venture capital and other strategic investments of $0.11 per share in the third quarter of 2023, compared to a gain of $0.04 per share for the same period in 2022. Certain venture capital and other strategic investment performance has been excluded from the Company’s non-GAAP results.

On a non-GAAP basis, net income was $140.5 million for the third quarter of 2023, an increase of 4.2% from $134.7 million for the same period in 2022. Third-quarter diluted earnings per share on a non-GAAP basis were $2.72, an increase of 3.4% from $2.63 per share for the third quarter of 2022. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating income, partially offset by increased interest expense and a higher tax rate.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We were pleased that our third-quarter financial results exceeded our expectations, and that some early signs of more favorable demand trends began to emerge, such as a sequential improvement in the Safety Assessment cancellation rate. However, we also experienced continued pressure from current client spending patterns, which began to have a discernable impact on the RMS segment and our Microbial Solutions business in the third quarter."

"We believe our business model is resilient, and will benefit from our efforts to ensure that our cost structure remains aligned with the current pace of demand. We remain guided by the imperatives that differentiate us: Strengthening our unique portfolio, enhancing our scientific expertise, providing outstanding client service, and driving greater operating efficiencies. In this market environment, we will focus on market share and our unique role in the drug discovery and non-clinical development process to further distinguish ourselves. We believe this will increasingly enable clients to choose to partner with Charles River to derive additional value through our flexible and efficient outsourcing solutions," Mr. Foster concluded.

Third-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $186.8 million in the third quarter of 2023, an increase of 3.7% from $180.1 million in the third quarter of 2022. The impact of foreign currency translation benefited revenue by 0.5% in the quarter. Organic revenue growth of 3.2% was primarily driven by research model services, particularly the Insourcing Solutions (IS) business. Revenue growth for small research models in all geographic regions also contributed, principally driven by increased pricing. This was partially offset by lower revenue growth in the Cell Solutions business and the timing of large research model shipments within China.

In the third quarter of 2023, the RMS segment’s GAAP operating margin decreased to 15.2% from 19.9% in the third quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 18.9% from 23.5%. The GAAP and non-GAAP operating margin decreases were driven primarily by the revenue mix and reduced operating leverage from lower revenue growth, as well as the timing of large model shipments within China.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $664.0 million in the third quarter of 2023, an increase of 7.2% from $619.5 million in the third quarter of 2022. The impact of foreign currency translation benefited revenue by 1.5%, and the SAMDI Tech acquisition contributed 0.4% to reported DSA revenue growth in the quarter. Organic revenue growth of 5.3% was driven by the Safety Assessment business, primarily as a result of higher pricing and increased study volume.

In the third quarter of 2023, the DSA segment’s GAAP operating margin decreased to 22.1% from 22.9% in the third quarter of 2022. The decrease in the GAAP operating margin was primarily attributable to site consolidation, impairment, and associated costs related to the closure of a small Discovery Services site in California. On a non-GAAP basis, the operating margin increased to 27.2% from 26.2% in the third quarter of 2022. The non-GAAP operating margin improvement was primarily driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $175.7 million in the third quarter of 2023, a decrease of 7.3% from $189.6 million in the third quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 9.9%. The impact of foreign currency translation benefited revenue by 1.7% in the quarter. Organic revenue growth of 0.9% reflected higher revenue in the CDMO business, which was almost entirely offset by lower revenue in the Biologics Testing Solutions and Microbial Solutions businesses.

In the third quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 15.0% from 16.6% in the third quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 24.5% from 28.6% in the third quarter of 2022. The GAAP and non-GAAP operating margin declines were driven by each of the Manufacturing segment’s businesses.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was previously provided on August 9, 2023. As it moves into the fourth quarter, the Company is narrowing its revenue growth and non-GAAP earnings per share ranges. The updates principally reflect a shift in the gating of the financial results in the second half of the year, as demonstrated by the third-quarter financial performance that exceeded the Company’s prior expectations.

The Company’s 2023 guidance for revenue growth and earnings per share is as follows:

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.5% – 3.5%

2.5% – 4.5%

Impact of divestitures/(acquisitions), net

~1.5%

~1.5%

Impact of 53rd week in 2022

~1.5%

~1.5%

Unfavorable/(favorable) impact of foreign exchange

0.0% – (0.5)%

0.0% – (0.5)%

Revenue growth, organic (1)

5.5% – 6.5%

5.5% – 7.5%

GAAP EPS estimate

$7.30 – $7.50

$7.60 – $8.20

Acquisition-related amortization

$2.00 – $2.05

~$2.00

Acquisition and integration-related adjustments (2)

~$0.25

$0.20 – $0.25

Costs associated with restructuring actions (3)

$0.30 – $0.35

~$0.10

Certain venture capital and other strategic investment losses/(gains), net (4)

$0.18

$0.06

Other items (5)

~$0.40

~$0.30

Non-GAAP EPS estimate

$10.50 – $10.70

$10.30 – $10.90

Footnotes to Guidance Table:

(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.

(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives.

(3) These adjustments primarily include site consolidation, severance, impairment, and other costs related to the Company’s restructuring actions.

(4) Certain venture capital and other strategic investment performance only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments.

(5) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; and certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) investigations by the U.S. government into the NHP supply chain related to our Safety Assessment business.

Webcast

Charles River has scheduled a live webcast on Wednesday, November 8th, 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.