On August 9, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Decibel Therapeutics, Inc. (NASDAQ: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported a definitive agreement for the acquisition of Decibel by Regeneron at a price of $4.00 per share of Decibel common stock payable in cash at closing, with an additional non-tradeable contingent value right (CVR) to receive up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods (Press release, Decibel Therapeutics, AUG 9, 2023, View Source [SID1234634061]). The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million if the CVR milestones are achieved.

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"We at Decibel are deeply committed to discovering and advancing innovative new therapies with the potential to be transformative for people with severe forms of hearing loss. We have built a pipeline of gene therapy product candidates for the ear that we believe have such potential. After full consideration, the Decibel Board has determined that this transaction is the best way to maximize shareholder value and ultimately benefit patients," said Laurence E. Reid, Ph.D., President and Chief Executive Officer of Decibel. "We have collaborated with our colleagues at Regeneron for the past six years and have huge respect for their research and development capabilities. We have full confidence that with Regeneron’s expertise and resources the Decibel pipeline can be optimally developed, and our team is committed to enabling that long-term success."

Decibel and Regeneron established their initial collaboration in 2017, with an extension announced in 2021, and are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. DB-OTO, which is currently in the global Phase 1/2 CHORDTM clinical trial, is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include AAV.103 for people with GJB2-related hearing loss and AAV.104 for people with stereocilin (STRC)-related hearing loss.

"We are delighted to announce the planned acquisition of Decibel, who have been long-standing collaborators, notable for their deep scientific knowledge and commitment to people with hearing loss," said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, Chief Scientific Officer and President of Regeneron. "DB-OTO, our shared lead investigational gene therapy, will soon reach patients in its first clinical trial, offering new promise to children with this rare form of congenital hearing loss, as well as potential proof-of-concept for future gene therapies addressing more common forms of genetic hearing loss. We believe that Decibel’s assets and specialized team will further strengthen our genetic medicines portfolio, enabling Regeneron to accelerate the development of innovative genetic therapies and a rich pipeline of hearing loss treatments."

Congenital hearing loss is a significant unmet medical need with no approved medical therapies that affects approximately 1.7 out of every 1,000 children born in the United States. While hearing loss caused by mutations of the otoferlin gene is rare, the majority of permanent, congenital hearing loss cases diagnosed in developed countries are sensorineural and result from a single gene defect, making them appealing targets for gene therapy. Hearing aids and cochlear implants may offer benefits, but they fall short of replicating normal hearing function.

The merger agreement provides for Regeneron, through its wholly owned subsidiary Symphony Acquisition Sub, Inc., to initiate a tender offer to acquire all outstanding shares of Decibel at a price of $4.00 per share of Decibel common stock payable in cash at closing plus one CVR payable in cash subject to the terms and conditions contained in a contingent value rights agreement ("CVR Agreement"). CVR holders would become entitled to receive contingent payments as follows: (i) $2.00 in cash, upon the fifth participant being administered with DB-OTO in a clinical trial on or prior to December 31, 2024 (the DB-OTO Milestone); and (ii) $1.50 in cash, upon (a) the first participant being administered with DB-OTO in a registration enabling trial (as defined in the CVR Agreement) or (b) acceptance for review of a Biologics License Application by the U.S. Food and Drug Administration, a Marketing Authorization Application by the European Medicines Agency or the U.K. Medicines and Healthcare Products Regulatory Agency, or an equivalent application by the applicable national regulatory authority in any of Germany, France, Italy or Spain for DB-OTO, whichever occurs first, on or prior to December 31, 2028; provided the DB-OTO Milestone is achieved on or prior to December 31, 2024. There can be no assurance that any payments will be made with respect to the CVR. The closing of the tender offer will be subject to certain conditions, including the tender of at least a majority of the outstanding shares of Decibel common stock and other customary closing conditions. Upon the successful completion of the tender offer, Regeneron will acquire all shares not acquired in the tender through a second-step merger for the same consideration per share paid in the tender offer. The transaction is expected to close in the third quarter of 2023.

Regeneron’s legal advisor for the transaction is Wachtell, Lipton, Rosen & Katz. Centerview Partners LLC and Leerink Partners LLC are serving as Decibel’s financial advisors and Wilmer Cutler Pickering Hale and Dorr LLP is serving as Decibel’s legal advisor.

On August 9, 2023 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical leader in cell cycle checkpoint control developing innovative medicines based on cancer cell biology, reported second quarter financial results and provided a business update (Press release, Cyclacel, AUG 9, 2023, View Source [SID1234634059]).

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"Both clinical programs with fadraciclib and plogosertib are progressing well, and we are on track to report on important readouts this year," said Spiro Rombotis, President and Chief Executive Officer. "Based on data collected to date we believe that fadraciclib’s next generation CDK inhibitor profile is differentiated from other molecules in its class. Similarly plogosertib could emerge as a PLK1 inhibitor with novel epigenetic activity. We look forward to presenting data from these two programs in the coming months."

"We are completing dose escalation level 6A with six patients in the 065-101 study of fadraciclib as a single agent and expect to select the recommended Phase 2 dosing schedule shortly. A patient with endometrial cancer in dose level 6A has documented tumor shrinkage after one cycle," said Mark Kirschbaum, M.D., Chief Medical Officer. "In the 140-101 study of plogosertib as a single agent we are recruiting patients at dose level 5. Anticancer activity has been observed thus far in four out of twelve patients, with adenoid cystic carcinoma, biliary, non-small cell lung, and ovarian cancer respectively, who stayed on treatment for three to eight cycles. The activity at low level, continuous exposure may be due to the effects of plogosertib operating through a novel epigenetic mechanism which we are continuing to investigate. If confirmed, we will design clinical studies that could exploit these findings."

Key Upcoming Milestones

• Report final data from dose escalation stage and RP2D determination from the 065-101 study of oral fadraciclib in patients with advanced solid tumors and lymphoma
• First patient dosed with oral fadraciclib in Phase 2 proof-of-concept stage of 065-101 study in patients with advanced solid tumors and lymphoma
• Report Phase 1 data from 140-101 study of oral plogosertib in patients with advanced solid tumors and lymphoma
• Elaborate novel mechanism of action of plogosertib

Financial Highlights

As of June 30, 2023, cash equivalents totaled $10.2 million, compared to $18.3 million as of December 31, 2022. Net cash used in operating activities was $8.2 million for the six months ended June 30, 2023 compared to $8.7 million for the same period of 2022. The Company estimates that its available cash will fund currently planned programs through the end of 2023. The operating plan includes discretionary expenditures, which if not incurred could extend liquidity requirements into the second quarter of 2024.

Research and development (R&D) expenses were $4.7 million for the three months ended June 30, 2023, as compared to $4.2 million for the same period in 2022. R&D expenses relating to fadraciclib were $3.0 million for the three months ended June 30, 2023, as compared to $2.6 million for the same period in 2022 due to increased non-clinical expenditures. R&D expenses related to plogosertib were $1.4 million for the three months ended June 30, 2023, as compared to $1.5 million for the same period in 2022 due to clinical trial costs associated with the progression of the Phase 1/2 study.

General and administrative expenses for the three months ended June 30, 2023 and 2022, remained relatively flat at $1.6 million.

Total other expense, net, for the three months ended June 30, 2023, was $0.1 million compared to an income of $0.2 million for the same period of the previous year.

United Kingdom research & development tax credits for the three months ended June 30, 2023 were $0.6 million compared to $1.0 million for the same period of the previous year due to taxation legislative changes that took effect in April 2023. Research & development tax credits are directly correlated to qualifying research and development expenditure.

Net loss for the three months ended June 30, 2023, was $5.4 million, compared to $4.6 million for the same period in 2022.

Conference call information:

Call: (800) 225-9448 / international call: (203) 518-9708

Archive: (800) 839-6136 / international archive: (402) 220-2572

Code for live and archived conference call is CYCCQ223. Webcast link

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On August 9, 2023 Clarity Pharmaceuticals (ASX: CU6) ("Clarity", "the Company"), a clinical stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the successful completion of cohort 2 and advancement to cohort 3 in the dose escalation phase of its Phase I/II theranostic trial, SECuRE, evaluating 64Cu/67Cu SAR-bisPSMA in patients with mCRPC (Press release, Clarity Pharmaceuticals, AUG 9, 2023, View Source [SID1234634058]).

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The SECuRE trial (NCT04868604)1 is a Phase I/IIa theranostic trial for identification and treatment of Prostate-Specific Membrane Antigen (PSMA) expressing mCRPC using 64Cu/67Cu SAR-bisPSMA. 64Cu SAR-bisPSMA is used to visualise PSMA expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The trial is a multi-centre, single arm, dose escalation trial with a cohort expansion involving up to 44 patients in the US. The aim of the trial is to determine the safety and efficacy of 67Cu SAR-bisPSMA for the treatment of prostate cancer.

The second cohort of the dose escalation, where 3 participants received a single administration of 8GBq of 67Cu SAR-bisPSMA, has been completed. No DLTs have been reported in any of the patients dosed to date. The SRC, responsible for assessing safety of participants and overseeing the general progress of the trial, has assessed the data and recommended progressing the trial to cohort 3, increasing the dose to 12GBq. The third cohort will be the last to assess single doses of 67Cu SAR-bisPSMA and will be followed by a multi-dose cohort, pending safety evaluation. The 3 participants in cohort 2 have been monitored by their physicians for safety and treatment response as per the trial protocol. All 3 participants in cohort 2 remain on the trial following their recent administration of 8GBq of 67Cu SAR-bisPSMA and are demonstrating a PSA reduction, with 2 of the 3 participants exhibiting an initial PSA reduction of ~90%. A PSA decline of 50% or greater is one of the primary endpoints of the SECuRE trial and a commonly used surrogate endpoint for efficacy in this patient population.

Dr Luke Nordquist, CEO, Urologic Medical Oncologist and Principal Investigator at the Urology Cancer Center / XCancer Omaha, NE, commented, "We are excited by the remarkable PSA declines seen in all three patients in cohort 2 with just a single dose of 8GBq of 67Cu SAR-bisPSMA. I have not observed PSA responses like this after a single dose of any agent and, considering the excellent safety profile we have seen to date in the first two cohorts of this study, we really look forward to progressing the development of this promising therapy. While in the VISION trial2 with 177Lu PSMA-617 we did see a >80% reduction in PSA in roughly 33% of patients, this was after up to six 7.4GBq doses of 177Lu PSMA-617 spaced out over a period of up to 30 weeks. If a single 8GBq dose of 67Cu SAR-bisPSMA can deliver so much benefit to the patients, we are excited to see how a single 12GBq dose will benefit patients in cohort 3 and to explore the effect of multiple dosing. If similar responses can be replicated in larger patient numbers, 67Cu SAR-bisPSMA may become the gold standard therapeutic agent for patients with mCRPC once approved."

Additional therapy cycles of 67Cu SAR-bisPSMA have been requested by clinicians under the FDA EAP for patients who participated in the SECuRE trial. SPECT-CT images depicted below were collected 48 hours after the first, third and fourth administrations of 4GBq of 67Cu SAR-bisPSMA in a patient from cohort 1 who received additional cycles under the EAP.

SPECT-CT images collected following the third and fourth therapy cycle demonstrate a reduction in the intensity of therapeutic 67Cu SAR-bisPSMA product uptake at the tumour sites. A reduction of greater than 50% in PSA levels was observed in this patient following the first administration of 4GBq of therapeutic 67Cu-SAR-bisPSMA and a drop of greater than 90% in PSA was observed after the fourth administration of 4GBq of 67Cu-SAR-bisPSMA.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are very excited to observe such a dramatic response in prostate cancer patients from cohort 2 following a single dose of 8GBq of 67Cu SAR-bisPSMA. SAR-bisPSMA aims to be a best-in-class PSMA product due to its differentiation from all other PSMA-targeted products in the market and in development that only have a single PSMA-targeting agent. We purposely designed and optimised SAR-bisPSMA to have two PSMA-targeting agents to address the challenges of low uptake and retention that the first generation of PSMA products suffer from. In pre-clinical and clinical development to date, we have observed two to three times the uptake of SAR-bisPSMA in tumours, followed by retention in tumours out to at least 96 hours. Although our data is early, the higher uptake and retention of product, coupled with the advantageous properties of copper-67, has shown quite impressive responses from single doses and we look forward to exploring the clinical benefits of 67Cu SAR-bisPSMA at the higher 12GBq level and over multiple treatment cycles. With commercial quantities of the 67Cu radioisotope now being routinely produced domestically in the US by our exclusive supplier, NorthStar, we see a clear path to commercialisation as we continue to push forward through clinical trials for 67Cu SAR-bisPSMA and bringing this product to the greater prostate cancer patient population.

"Prostate cancer is one of the largest oncology indications worldwide and, based on our estimates, represents a US$5-10 billion therapy market for PSMA targeting radiopharmaceuticals. Radiopharmaceuticals are expected to play an increasingly important role in the management of patients with prostate cancer, however, challenges associated with the current generation of products prevail. Clarity’s Targeted Copper Theranostic (TCT) platform represents the next-generation platform in radiopharmaceuticals to improve treatment outcomes for children and adults with cancer as well as resolve the supply and manufacturing issues associated with the first generation of products. Because of these characteristics, TCTs are ideally positioned to enable the field to expand into the oncology market, addressing large indications such as prostate cancer and beyond.

"We look forward to sharing more data on 67Cu SAR-bisPSMA as the SECuRE trial continues to progress and any further updates from patients who may receive single or multiple doses of 67Cu SAR-bisPSMA in our programs," said Dr Taylor.

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a TCT that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

On August 9, 2023 ChromaDex Corp. (NASDAQ:CDXC) reported financial results for the second quarter of 2023 (Press release, ChromaDex, AUG 9, 2023, View Source [SID1234634056]).

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Second Quarter 2023 and Recent Highlights

Total net sales were $20.3 million, with $16.9 million from Tru Niagen, up 21% and 16% from the prior year quarter, respectively.
Strong gross margin of 60.8% and a $1.8 million reduction in operating expenses.
Sales and marketing expense as a percentage of net sales was 29.6%, an improvement of 1,830 basis points, compared to 47.9% from the prior year quarter.
Net loss was $2.2 million or $(0.03) per share, an improvement of $4.2 million, or $0.06 per share, from the prior year quarter.
Adjusted EBITDA, a non-GAAP measure, was a positive $0.2 million, a $4.9 million improvement from the prior year quarter.
Two published abstracts, originally presented in April 2023, highlighted the significance of NAD+ in glaucoma patients and that supplementation with nicotinamide riboside, NR, shows promising effects.(1)
ChromaDex External Research Program (CERP) celebrated its 10th anniversary, signing more than 275 global research agreements with over 235 independent, expert investigators to uncover the full potential of NAD+ with Niagen. This research has shown that the health benefits of Niagen translate from preclinical models to human clinical studies for brain, heart and muscle health with remarkable consistency. Looking to the next 10 years, there is great anticipation for emerging benefits in sensory, infant, maternal and reproductive health to be translated from preclinical to human studies.
"This was another excellent quarter, delivering 21% year-over-year revenue growth, positive Adjusted EBITDA of $0.2 million and positive operating cash flows for the second consecutive quarter," said ChromaDex Chief Executive Officer, Rob Fried. "We are again raising our 2023 revenue outlook by 2.5% to at least 15% growth, underscoring our commitment to consistent profitable growth."

(1) Refers to two independent clinical study abstracts originally presented in April 2023 at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting and recently published in the peer-reviewed ARVO journal, Investigative Ophthalmology & Visual Science.

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

ChromaDex reported a net sales increase of 21%, or $3.6 million, to $20.3 million. The increase in net sales was fueled by growth in sales of Tru Niagen and growth in Niagen ingredient sales.

Gross marginpercentageimproved 80 basis points to 60.8%. The improvement in gross margin percentage is primarily driven by economies of scale and supply chain management optimization efforts, partly offset by changes in business mix.

Operating expensedecreased 11%, or $1.8 million, to $14.7 million driven by a $2.0 million reduction in sales and marketing expense slightly offset by higher research and development expense and general and administrative expense.

Net loss was $2.2 million, or $0.03 loss per share, compared to a net loss of $6.4 million or $0.09 loss per share for the second quarter of 2022. Adjusted EBITDA, a non-GAAP measure, was a positive $0.2 million, a $4.9 million improvement from Q2 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 $6.1 million for the six months ended June 30, 2023, showing a significant improvement compared to a net cash outflow of $11.0 million in the prior year. This improvement can be attributed to a $10.0 million reduction in net loss, a positive impact of $4.9 million from inventory management, as well as other favorable changes in working capital.

2023 Full Year Outlook

Looking forward, for the full year, the Company expects at least 15.0% revenue growth year-over-year. The projected growth considers only recurring, steady revenue growth from the e-commerce business and established partnerships, as well as upside from newer partnerships realized in the first half of the year. However, potential upside which is not reflected in this growth, lies within new partnerships, channels, and products. 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, mainly during the latter half of the year, 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, August 9, 2023 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss ChromaDex’s second-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 August 9, 2023 through 11:59 p.m. Eastern time on August 16, 2023. The replay of the call can also be accessed by dialing 800-770-2030, using the Replay ID: 4126168.

On August 9, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the second quarter of 2023 (Press release, Charles River Laboratories, AUG 9, 2023, View Source [SID1234634054]). For the quarter, revenue was $1.06 billion, an increase of 8.9% from $973.1 million in the second quarter of 2022.

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Acquisitions contributed 0.2% to consolidated second-quarter revenue growth. The divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 2.3%, and the impact of foreign currency translation reduced reported revenue growth by 0.2% for the quarter. Excluding the effect of these items, organic revenue growth of 11.2% was driven primarily by the Research Models and Services (RMS) and Discovery and Safety Assessment (DSA) business segments.

On a GAAP basis, second-quarter net income attributable to common shareholders was $97.0 million, a decrease of 11.3% from $109.3 million for the same period in 2022. Second-quarter diluted earnings per share on a GAAP basis were $1.89, a decrease of 11.3% from $2.13 for the second quarter of 2022. GAAP earnings per share included a loss from the Company’s venture capital and other strategic investments of $0.03 per share in the second quarter of 2023, compared to a loss of $0.14 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 $138.3 million for the second quarter of 2023, a decrease of 2.5% from $141.9 million for the same period in 2022. Second-quarter diluted earnings per share on a non-GAAP basis were $2.69, a decrease of 2.9% from $2.77 per share for the second quarter of 2022.

The lower GAAP and non-GAAP net income and earnings per share were driven primarily by non-operating items, including increased interest expense and a higher tax rate, as well as the impact of the Avian Vaccine divestiture.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We were pleased with our second-quarter financial results, highlighted by another strong quarter for the DSA segment and the expected improvement in the RMS and Manufacturing segments. We believe our significant scientific breadth and experience, as well as the substantial scale and duration of our DSA backlog, are important differentiators during times of macroeconomic or funding uncertainty."

"We are also closely monitoring the near-term demand trends that show more cautious spending by biopharmaceutical clients. In this environment, we believe clients will look for scientific partners who can provide even more efficiency and speed to market, and that they will continue to choose Charles River in order to derive additional value through our flexible and efficient outsourcing solutions. We believe these factors will enable us to effectively manage the business and give us confidence in our revenue growth and non-GAAP earnings per share guidance for the year, which we are narrowing to the upper ends of the previous ranges," Mr. Foster concluded.

Second-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $209.9 million in the second quarter of 2023, an increase of 12.6% from $186.4 million in the second quarter of 2022. The impact of foreign currency translation reduced revenue by 1.3% in the quarter. Organic revenue growth of 13.9% was driven by broad-based growth for research models in all geographies, particularly in China, as well as for research model services, primarily the Insourcing Solutions (IS) business.

In the second quarter of 2023, the RMS segment’s GAAP operating margin increased to 23.3% from 21.2% in the second quarter of 2022, and on a non-GAAP basis, the operating margin increased to 26.4% from 24.9%. The GAAP and non-GAAP operating margin increases were driven primarily by the timing of large model shipments in China.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $663.5 million in the second quarter of 2023, an increase of 12.1% from $591.9 million in the second quarter of 2022. The SAMDI Tech acquisition contributed 0.3% to reported DSA revenue growth, and the impact of foreign currency translation was negligible in the quarter. Organic revenue growth of 11.7% was driven by the Safety Assessment business, as a result of higher pricing and study volume.

In the second quarter of 2023, the DSA segment’s GAAP operating margin increased to 24.3% from 21.8% in the second quarter of 2022, and on a non-GAAP basis, the operating margin increased to 27.6% from 25.3%. The GAAP and non-GAAP operating margin increases were driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $186.5 million in the second quarter of 2023, a decrease of 4.2% from $194.8 million in the second quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 10.8%, and the impact of foreign currency translation was negligible. Organic revenue growth of 6.6% for the quarter was driven primarily by the CDMO and Microbial Solutions businesses.

In the second quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 13.1% from 32.1% in the second quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 22.9% from 28.6% in the second quarter of 2022. The GAAP and non-GAAP operating margin declines were primarily the result of lower operating margins in the Biologics Testing and CDMO businesses. The GAAP operating margin decline was also driven by an acquisition-related adjustment in the CDMO business that benefited second-quarter 2022 results.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was previously provided on May 11, 2023. The Company is narrowing its revenue growth and non-GAAP earnings per share outlooks to largely reflect its solid first-half financial performance and the successful implementation of mitigation efforts around NHP supply constraints. These benefits are anticipated to be partially offset by near-term demand trends as biopharmaceutical clients appear to be reprioritizing their pipelines and tightening R&D budgets.

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

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.5% – 4.5%

2.0% – 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% – 7.5%

5.0% – 7.5%

GAAP EPS estimate

$7.60 – $8.20

$7.45 – $8.45

Acquisition-related amortization

~$2.00

~$2.00

Acquisition and integration-related adjustments (2)

$0.20 – $0.25

~$0.10

Venture capital and other strategic investment losses/(gains), net (3)

$0.06

$0.03

Other items (4)

~$0.40

$0.30 – $0.35

Non-GAAP EPS estimate

$10.30 – $10.90

$9.90 – $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) 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.

(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; 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; and (c) severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, August 9th, 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 virtual Meeting with Management on Thursday, September 21st, beginning at 8:30 a.m. ET. Investors will have the opportunity to listen to a webcast of the virtual event through the Investor Relations section of the Company’s website at ir.criver.com. A replay will be accessible through the same website.