MannKind Corporation to Hold 2022 Fourth Quarter and Full Year Financial Results Conference Call on February 23, 2023

On February 16, 2023 MannKind Corporation (Nasdaq: MNKD) reported its 2022 fourth quarter and full year financial results and its management will host a conference call to discuss these results and corporate updates at 5:00 PM (Eastern Time) on Thursday, February 23, 2023 (Press release, Mannkind, FEB 16, 2023, View Source [SID1234627312]).

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Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven B. Binder.

Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.

M2GEN and Zephyr AI Announce Partnership to Better Identify Treatments and Cures for Patients with Cancer

On February 16, 2023 M2GEN, a bioinformatics company accelerating discoveries in oncology research through industry-leading data and analytics, and Zephyr AI, Inc. ("Zephyr AI"), a company building novel transparent AI to address unmet needs across the full spectrum of precision medicine – from prevention to treatment – to improve patient’s lives, reported a multi-year strategic partnership that will accelerate drug discovery and expanded use investigations for cancer treatments (Press release, M2Gen, FEB 16, 2023, View Source [SID1234627310]).

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This collaboration leverages Zephyr AI’s industry-leading machine learning platform, and M2GEN’s unmatched real-world data set (RWD) to create a best-in-class oncology discovery product. In this partnership, M2GEN will license its expansive RWD to Zephyr AI, providing the latter with access to the richest clinicogenomic data set available in oncology today. In return, Zephyr AI will become a bioinformatics partner for M2GEN, providing the company with AI and machine learning capabilities to enhance their products and services. Together, this partnership will yield critical insights enabling both companies to discover new cancer treatments and expanded use cases, better identify new targets, and improve clinical trial design.

"Cancer accounts for approximately 1 in 6 deaths globally. Even more troubling, by 2040, cancer is projected to claim an estimated 16.3 million lives around the world," said Grant Verstandig, Co-Founder and Executive Chairman of Zephyr AI. "The pairing of M2GEN’s extensive data set with Zephyr’s powerful analytical and bioinformatics capabilities allows us an extraordinary opportunity to change this narrative by enabling us to discover new uses for existing drugs and drug combinations; unearth novel drug targets; and inform the design of new medications. This partnership not only holds the potential to chart a new era of drug discovery and precision medicine, but to save innumerable lives."

M2GEN is the only bioinformatics company that has lifetime, patient-consented longitudinal clinical data, coupled with whole exome (WES) and whole transcriptome (WTS) sequencing, for both tumor and germline data. The company has lifetime data access from more than 350,000 patients, making it the largest patient-consented oncology research network of its kind. M2GEN’s data will be integrated into Zephyr’s trademark Vulnerability Network Method, which leverages groundbreaking algorithms to classify tumors and reveal new targets for drug discovery, label expansion, and precision care.
"Collaboration is core to everything we do at M2GEN, and this opportunity symbolizes the power of working in concert to accelerate the development of cancer treatments and cures," said Jim Gabriele, CEO of M2GEN. "Our data have been used successfully for indication expansion of many pharmaceutical products, including traditional treatments and immunotherapies such as CAR T-cell therapy. By joining forces with Zephyr AI, we will continue to transform cancer discovery, expedite research, and bring the right treatments to market, sooner, for countless patients with cancer."

LAVA Therapeutics Announces Initial Data from the Ongoing Phase 1/2a Clinical Trial of LAVA-1207 in Therapy Refractory mCRPC at the 2023 ASCO GU Symposium

On February 16, 2023 LAVA Therapeutics N.V. (Nasdaq: LVTX), a clinical stage immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma-delta T cell engagers to transform the treatment of cancer, reported initial clinical data from its ongoing Phase 1/2a study of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer (mCRPC) (Press release, Lava Therapeutics, FEB 16, 2023, View Source [SID1234627309]). The data are presented in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) taking place in San Francisco from February 16-18, 2023.

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"These early data from the first five cohorts of our Phase 1/2a study indicate LAVA-1207 to have a favorable safety profile in patients with therapy refractory metastatic castration resistant prostate cancer. Importantly, preliminary signs of clinical activity were observed with disease stabilization and PSA reduction during dose escalation in these heavily pretreated patients," said Niven Mehra, M.D., Ph.D., medical oncologist at the Radboud University Medical Center in Nijmegen, The Netherlands. "We are encouraged by the progress of this trial and will continue to enroll patients for additional cohorts."

LAVA-1207 is an Fc-containing humanized bispecific antibody that directly engages prostate-specific membrane antigen (PSMA) and the Vδ2-T cell receptor chain of Vγ9Vδ2-T cells to mediate potent killing of PSMA-expressing prostate cancer cells. The objectives of the Phase 1/2a study (EudraCT 2021-001789-39; NCT05369000) are to investigate safety and tolerability, evaluate pharmacokinetic and pharmacodynamic effects, immunogenicity and preliminary antitumor activity of LAVA-1207. LAVA-1207 is administered via intravenous infusion every two weeks.

The data presented to date show that a total of 20 patients have been treated with doses ranging from 1.5 to 120 micrograms of LAVA-1207, with treatment duration ranging from 4 to 38 weeks. The safety profile is favorable to date, without occurrence of high grade (>2) cytokine release syndrome or dose-limiting toxicities. LAVA-1207 showed predictable and linear pharmacokinetics and on-mechanism pharmacodynamics including Vγ9Vδ2-T cell activation. Preliminary signs of anti-tumor activity were observed at week 8, with iRECIST stable disease (iSD) in 8 out of 14 evaluable patients and PSA levels stabilizing or decreasing. The largest overall decrease in PSA was 61% (46% vs baseline). The patient improved clinically with improvement in pain and fatigue. Dose escalation is continuing both in Europe and the U.S.

"We are encouraged by these initial data for LAVA-1207," said Stephen Hurly, president and chief executive officer of LAVA Therapeutics. "At LAVA Therapeutics, we are committed to transforming cancer therapy. I am thrilled to see our second clinical asset continuing to move forward, and an emerging safety profile with the potential for differentiation from prior generation PSMA directed bispecific T-cell engagers."

Details of the poster presentation are as follows:

Abstract #: 153

Abstract Title: Early dose escalation of LAVA-1207, a novel bispecific gamma-delta T cell engager (Gammabody), in metastatic castration-resistant prostate cancer (mCRPC) patients

Session Title: Poster Session A: Prostate Cancer

Poster Board #: E13

Session Date: Thursday, February 16, 2023

Session Time: 11:30 AM-1:00 PM PT; 5:45 PM-6:45 PM PT
Presenter: Niven Mehra, MD, PhD, Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands

LAVA-1207

LAVA-1207 is a Gammabody that conditionally activates Vγ9Vδ2 (Vgamma9 Vdelta2) T cells upon crosslinking to prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells, including metastatic castration-resistant prostate cancer (mCRPC).

Labcorp Announces 2022 Fourth Quarter and Full-Year Results Company Provides 2023 Guidance

On February 16, 2023 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the fourth quarter and year ended Dec. 31, 2022, full-year 2023 guidance (Press release, LabCorp, FEB 16, 2023, View Source [SID1234627308]).

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"We finished the year strong, with accelerated revenue growth in Diagnostics, continued strong underlying fundamentals in Drug Development and margin expansion," said Adam Schechter, chairman and CEO of Labcorp. "In 2022, we also advanced our strategy with the announcement of the spin of our Clinical Development business, which will be named Fortrea, and acceleration of several hospital partnerships and acquisitions. Looking ahead, we will continue to harness science, innovation and technology to drive sustained financial performance and address the evolving needs of our customers."

In the fourth quarter and throughout the year, Labcorp executed its strategic plan for long-term growth. Labcorp began the integration of the Ascension hospital system, adding nearly 5,000 employees and providing laboratory management services for nearly 100 hospitals across the system.

Additionally, the company has progressed the planned spin-off of its Clinical Development business, which is expected to be completed in mid-2023, subject to satisfaction of certain customary conditions. In early January 2023, Tom Pike was announced to lead the Clinical Development business and will become the chief executive officer and chairman of the Board of Fortrea upon completion of the spin-off.

On January 12, 2023, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on March 13, 2023, to stockholders of record at the close of business on February 23, 2023. In addition, the Board of Directors has approved an additional $1.00 billion for share repurchases, bringing the total available authorization to approximately $1.53 billion.

Consolidated Results

Fourth Quarter Results

Revenue for the quarter was $3.67 billion, a decrease of (9.4%) from $4.06 billion in the fourth quarter of 2021. The decrease was due to organic revenue of (9.4%) and foreign currency translation of (1.3%), partially offset by acquisitions of 1.3%. The (9.4%) decrease in organic revenue was driven by a (13.4%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 3.9% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $90.7 million, or 2.5% of revenue, compared to $730.6 million, or 18.0%, in the fourth quarter of 2021. The company recorded impairment charges, amortization, restructuring charges, and special items, which together totaled $419.2 million in the quarter, compared to $171.5 million during the same period in 2021. Included in these numbers are goodwill and other asset impairment charges of $270.3 million in the fourth quarter of 2022, which primarily related to the Early Development business due to short-term labor and NHP supply constraints. Adjusted operating income (excluding impairment charges, amortization, restructuring charges, and special items) for the quarter was $509.9 million, or 13.9% of revenue, compared to $902.2 million, or 22.2%, in the fourth quarter of 2021. The decrease in operating income and margin was due to a reduction in COVID-19 Testing. LaunchPad savings and lower personnel expense were essentially offset by lower COVID-related demand and inflationary costs.

Net earnings for the quarter were $76.1 million compared to $553.0 million in the fourth quarter of 2021. Diluted EPS were $0.86 in the quarter compared to $5.75 during the same period in 2021. Adjusted EPS (excluding impairment charges, amortization, restructuring charges, and special items) were $4.14 in the quarter compared to $6.77 in the fourth quarter of 2021.

Operating cash flow for the quarter was $653.6 million compared to $697.5 million in the fourth quarter of 2021. The decrease in operating cash flow was due to lower COVID Testing earnings, partially offset by higher Base Business earnings. Capital expenditures totaled $117.9 million compared to $150.0 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $535.7 million compared to $547.5 million in the fourth quarter of 2021.

At the end of the quarter, the company’s cash balance and total debt were $0.4 billion and $5.3 billion, respectively. During the quarter, the company invested $150.4 million on acquisitions, paid out $63.6 million in dividends, and repurchased $300.0 million of stock representing approximately 1.4 million shares. At the end of the quarter, we had $532 million of share repurchase authorization remaining.

Full Year Results

Revenue was $14.88 billion, a decrease of (7.7%) from $16.12 billion in 2021. The decrease was due to organic revenue of (7.5%) and foreign currency translation of (1.0%), partially offset by acquisitions net of divestitures of 0.8%. The (7.5%) decrease in organic revenue was due to a (10.0%) decrease in COVID-19 Testing, partially offset by a 2.5% increase in the Company’s organic Base Business.

Operating income was $1.77 billion, or 11.9% of revenue, compared to $3.26 billion, or 20.2%, in 2021. The company recorded impairment charges, amortization, restructuring charges, and special items, which together totaled $775.2 million compared to $571.5 million during 2021. Adjusted operating income (excluding impairment charges, amortization, restructuring charges, and special items) was $2.55 billion, or 17.1% of revenue, compared to $3.83 billion, or 23.8%, in 2021. The decrease in operating income was primarily due to lower COVID-19 Testing and higher personnel costs, as well as goodwill and other asset impairment charges, partially offset by a recovery in the Base Business.

Net earnings were $1.28 billion compared to $2.38 billion in 2021. Diluted EPS were $13.97 compared to $24.39 in 2021. Adjusted EPS (excluding impairment charges, amortization, restructuring charges, and special items) were $19.94 compared to $28.52 in 2021.

Operating cash flow was $1.96 billion compared to $3.11 billion in 2021. The decrease in operating cash flow was primarily due to lower COVID Testing earnings. Capital expenditures totaled $481.9 million compared to $460.4 million in 2021. As a result, free cash flow (operating cash flow less capital expenditures) was $1.47 billion compared to $2.65 billion in 2021.

During the year the company repurchased $1.10 billion of stock representing approximately 4.7 million shares and invested $1.16 billion on acquisitions.

Fourth Quarter Segment Results

The following segment results exclude impairment charges, amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics
Revenue for the quarter was $2.29 billion, a decrease of (12.8%) from $2.62 billion in the fourth quarter of 2021. The decrease was due to organic revenue of (14.3%) and foreign currency translation of (0.3%), partially offset by acquisitions of 1.7%. The (14.3%) decrease in organic revenue was due to a (20.7%) decrease in COVID-19 Testing, partially offset by a 6.4% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 10.6%, which includes the benefit from the Ascension lab management agreement of approximately 7% and the negative impact from weather and fewer revenue days of (1.2%).

Total volume (measured by requisitions) decreased by (11.8%) as organic volume decreased by (13.8%) and acquisition volume contributed 2.0%. Organic volume was impacted by a (14.3%) decrease in COVID-19 Testing, partially offset by a 0.5% increase in Base Business. Price/mix decreased by (1.0%) due to COVID-19 Testing of (6.4%), currency of (0.3%), and acquisitions of (0.2%), partially offset by Base Business of 5.9%. Base Business volume increased 3.0% compared to the Base Business last year, which includes the combined unfavorable impact from weather and fewer revenue days of approximately (1.2%). Price/mix was up 7.6% in the Base Business compared to the Base Business last year, which includes the benefit of the Ascension lab management agreement.

Adjusted operating income for the quarter was $387.0 million, or 16.9% of revenue, compared to $775.9 million, or 29.6%, in the fourth quarter of 2021. The decrease in adjusted operating income and margin was due to a reduction in COVID-19 Testing and the mix impact from Ascension. Excluding COVID-19 Testing and Ascension, operating income and margin were up due to the benefit of Base Business growth and LaunchPad savings, which were partially offset by higher personnel expense and other inflationary costs.

Drug Development
Revenue for the quarter was $1.39 billion, a decrease of (4.1%) from $1.45 billion in the fourth quarter of 2021. The decrease was primarily due to foreign currency translation of (3.1%). The benefit of acquisitions of 0.4% was offset by a (1.5%) decrease in organic revenue, which was negatively impacted by approximately 5.0% due to reduced COVID-19 related work and the Ukraine/Russia crisis.

Adjusted operating income for the quarter was $208.5 million, or 15.0% of revenue, compared to $205.7 million, or 14.2%, in the fourth quarter of 2021. Adjusted operating income and margin increased due to LaunchPad savings and lower personnel costs, partially offset by lower COVID-related demand, the Ukraine/Russia crisis, and inflationary costs.

Net orders and net book-to-bill during the trailing twelve months were $7.28 billion and 1.27, respectively. Backlog at the end of the quarter was $16.30 billion, an increase of 8.9% compared to last year. The company expects approximately $4.85 billion of its backlog to convert into revenue in the next twelve months.

2023 Guidance

The following guidance assumes foreign exchange rates effective as of Dec. 31, 2022, for the full year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends. The guidance also assumes that the Clinical Development business will be with Labcorp for the full year. Upon completion of the planned spin-off, currently anticipated in mid-2023 (subject to satisfaction of certain customary conditions), we expect to provide updated guidance.

(Dollars in billions, except per share data)
Results 2023 Guidance
2022 Low High
Revenue
Total Labcorp Enterprise (1)(2)
$14.9 1.0% 4.0%
Base Business (2)
$13.7 8.5% 10.5%
COVID-19 Testing $1.1 (90.0%) (75.0%)
Total Diagnostics (3)
$9.2 (2.0%) 1.5%
Base Business $8.1 10.5% 12.5%
COVID-19 Testing $1.1 (90.0%) (75.0%)
Total Drug Development (4)
$5.7 5.0% 7.0%
Adjusted EPS $19.94 $16.00 $18.00
Free Cash Flow (5)
$1.47 $1.0 $1.2
(1) 2023 Guidance includes an impact from foreign currency translation of 0.0%
(2) Enterprise level revenue is presented net of intersegment transaction eliminations
(3) 2023 Guidance includes an impact from foreign currency translation of (0.2%)
(4) 2023 Guidance includes an impact from foreign currency translation of 0.2%
(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures
The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at www.Labcorp.com. Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by registering at this link, which will provide a dial-in number and unique PIN to access the call. It is recommended that participants join 10 minutes prior to the start of the call, although participants may register and join at any time during the call. A live webcast of Labcorp’s quarterly conference call on Feb. 16, 2023, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through Feb. 2, 2024.

Labcorp Announces 2022 Fourth Quarter and Full-Year Results

On February 16, 2023 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the fourth quarter and year ended Dec. 31, 2022, full-year 2023 guidance (Press release, LabCorp, FEB 16, 2023, View Source [SID1234627307]).

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"We finished the year strong, with accelerated revenue growth in Diagnostics, continued strong underlying fundamentals in Drug Development and margin expansion," said Adam Schechter, chairman and CEO of Labcorp. "In 2022, we also advanced our strategy with the announcement of the spin of our Clinical Development business, which will be named Fortrea, and acceleration of several hospital partnerships and acquisitions. Looking ahead, we will continue to harness science, innovation and technology to drive sustained financial performance and address the evolving needs of our customers."

In the fourth quarter and throughout the year, Labcorp executed its strategic plan for long-term growth. Labcorp began the integration of the Ascension hospital system, adding nearly 5,000 employees and providing laboratory management services for nearly 100 hospitals across the system.

Additionally, the company has progressed the planned spin-off of its Clinical Development business, which is expected to be completed in mid-2023, subject to satisfaction of certain customary conditions. In early January 2023, Tom Pike was announced to lead the Clinical Development business and will become the chief executive officer and chairman of the Board of Fortrea upon completion of the spin-off.

On January 12, 2023, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on March 13, 2023, to stockholders of record at the close of business on February 23, 2023. In addition, the Board of Directors has approved an additional $1.00 billion for share repurchases, bringing the total available authorization to approximately $1.53 billion.

Consolidated Results

Fourth Quarter Results

Revenue for the quarter was $3.67 billion, a decrease of (9.4%) from $4.06 billion in the fourth quarter of 2021. The decrease was due to organic revenue of (9.4%) and foreign currency translation of (1.3%), partially offset by acquisitions of 1.3%. The (9.4%) decrease in organic revenue was driven by a (13.4%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 3.9% increase in the company’s organic Base Business. Base Business includes Labcorp’s operations except for COVID-19 Testing.

Operating income for the quarter was $90.7 million, or 2.5% of revenue, compared to $730.6 million, or 18.0%, in the fourth quarter of 2021. The company recorded impairment charges, amortization, restructuring charges, and special items, which together totaled $419.2 million in the quarter, compared to $171.5 million during the same period in 2021. Included in these numbers are goodwill and other asset impairment charges of $270.3 million in the fourth quarter of 2022, which primarily related to the Early Development business due to short-term labor and NHP supply constraints. Adjusted operating income (excluding impairment charges, amortization, restructuring charges, and special items) for the quarter was $509.9 million, or 13.9% of revenue, compared to $902.2 million, or 22.2%, in the fourth quarter of 2021. The decrease in operating income and margin was due to a reduction in COVID-19 Testing. LaunchPad savings and lower personnel expense were essentially offset by lower COVID-related demand and inflationary costs.

Net earnings for the quarter were $76.1 million compared to $553.0 million in the fourth quarter of 2021. Diluted EPS were $0.86 in the quarter compared to $5.75 during the same period in 2021. Adjusted EPS (excluding impairment charges, amortization, restructuring charges, and special items) were $4.14 in the quarter compared to $6.77 in the fourth quarter of 2021.

Operating cash flow for the quarter was $653.6 million compared to $697.5 million in the fourth quarter of 2021. The decrease in operating cash flow was due to lower COVID Testing earnings, partially offset by higher Base Business earnings. Capital expenditures totaled $117.9 million compared to $150.0 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $535.7 million compared to $547.5 million in the fourth quarter of 2021.

At the end of the quarter, the company’s cash balance and total debt were $0.4 billion and $5.3 billion, respectively. During the quarter, the company invested $150.4 million on acquisitions, paid out $63.6 million in dividends, and repurchased $300.0 million of stock representing approximately 1.4 million shares. At the end of the quarter, we had $532 million of share repurchase authorization remaining.

Full Year Results

Revenue was $14.88 billion, a decrease of (7.7%) from $16.12 billion in 2021. The decrease was due to organic revenue of (7.5%) and foreign currency translation of (1.0%), partially offset by acquisitions net of divestitures of 0.8%. The (7.5%) decrease in organic revenue was due to a (10.0%) decrease in COVID-19 Testing, partially offset by a 2.5% increase in the Company’s organic Base Business.

Operating income was $1.77 billion, or 11.9% of revenue, compared to $3.26 billion, or 20.2%, in 2021. The company recorded impairment charges, amortization, restructuring charges, and special items, which together totaled $775.2 million compared to $571.5 million during 2021. Adjusted operating income (excluding impairment charges, amortization, restructuring charges, and special items) was $2.55 billion, or 17.1% of revenue, compared to $3.83 billion, or 23.8%, in 2021. The decrease in operating income was primarily due to lower COVID-19 Testing and higher personnel costs, as well as goodwill and other asset impairment charges, partially offset by a recovery in the Base Business.

Net earnings were $1.28 billion compared to $2.38 billion in 2021. Diluted EPS were $13.97 compared to $24.39 in 2021. Adjusted EPS (excluding impairment charges, amortization, restructuring charges, and special items) were $19.94 compared to $28.52 in 2021.

Operating cash flow was $1.96 billion compared to $3.11 billion in 2021. The decrease in operating cash flow was primarily due to lower COVID Testing earnings. Capital expenditures totaled $481.9 million compared to $460.4 million in 2021. As a result, free cash flow (operating cash flow less capital expenditures) was $1.47 billion compared to $2.65 billion in 2021.

During the year the company repurchased $1.10 billion of stock representing approximately 4.7 million shares and invested $1.16 billion on acquisitions.

Fourth Quarter Segment Results

The following segment results exclude impairment charges, amortization, restructuring charges, special items, and unallocated corporate expenses.

Diagnostics

Revenue for the quarter was $2.29 billion, a decrease of (12.8%) from $2.62 billion in the fourth quarter of 2021. The decrease was due to organic revenue of (14.3%) and foreign currency translation of (0.3%), partially offset by acquisitions of 1.7%. The (14.3%) decrease in organic revenue was due to a (20.7%) decrease in COVID-19 Testing, partially offset by a 6.4% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 10.6%, which includes the benefit from the Ascension lab management agreement of approximately 7% and the negative impact from weather and fewer revenue days of (1.2%).

Total volume (measured by requisitions) decreased by (11.8%) as organic volume decreased by (13.8%) and acquisition volume contributed 2.0%. Organic volume was impacted by a (14.3%) decrease in COVID-19 Testing, partially offset by a 0.5% increase in Base Business. Price/mix decreased by (1.0%) due to COVID-19 Testing of (6.4%), currency of (0.3%), and acquisitions of (0.2%), partially offset by Base Business of 5.9%. Base Business volume increased 3.0% compared to the Base Business last year, which includes the combined unfavorable impact from weather and fewer revenue days of approximately (1.2%). Price/mix was up 7.6% in the Base Business compared to the Base Business last year, which includes the benefit of the Ascension lab management agreement.

Adjusted operating income for the quarter was $387.0 million, or 16.9% of revenue, compared to $775.9 million, or 29.6%, in the fourth quarter of 2021. The decrease in adjusted operating income and margin was due to a reduction in COVID-19 Testing and the mix impact from Ascension. Excluding COVID-19 Testing and Ascension, operating income and margin were up due to the benefit of Base Business growth and LaunchPad savings, which were partially offset by higher personnel expense and other inflationary costs.

Drug Development

Revenue for the quarter was $1.39 billion, a decrease of (4.1%) from $1.45 billion in the fourth quarter of 2021. The decrease was primarily due to foreign currency translation of (3.1%). The benefit of acquisitions of 0.4% was offset by a (1.5%) decrease in organic revenue, which was negatively impacted by approximately 5.0% due to reduced COVID-19 related work and the Ukraine/Russia crisis.

Adjusted operating income for the quarter was $208.5 million, or 15.0% of revenue, compared to $205.7 million, or 14.2%, in the fourth quarter of 2021. Adjusted operating income and margin increased due to LaunchPad savings and lower personnel costs, partially offset by lower COVID-related demand, the Ukraine/Russia crisis, and inflationary costs.

Net orders and net book-to-bill during the trailing twelve months were $7.28 billion and 1.27, respectively. Backlog at the end of the quarter was $16.30 billion, an increase of 8.9% compared to last year. The company expects approximately $4.85 billion of its backlog to convert into revenue in the next twelve months.

2023 Guidance

The following guidance assumes foreign exchange rates effective as of Dec. 31, 2022, for the full year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends. The guidance also assumes that the Clinical Development business will be with Labcorp for the full year. Upon completion of the planned spin-off, currently anticipated in mid-2023 (subject to satisfaction of certain customary conditions), we expect to provide updated guidance.

(Dollars in billions, except per share data)

Results

2023 Guidance

2022

Low

High

Revenue

Total Labcorp Enterprise (1)(2)

$14.9

1.0%

4.0%

Base Business (2)

$13.7

8.5%

10.5%

COVID-19 Testing

$1.1

(90.0%)

(75.0%)

Total Diagnostics (3)

$9.2

(2.0%)

1.5%

Base Business

$8.1

10.5%

12.5%

COVID-19 Testing

$1.1

(90.0%)

(75.0%)

Total Drug Development (4)

$5.7

5.0%

7.0%

Adjusted EPS

$19.94

$16.00

$18.00

Free Cash Flow (5)

$1.47

$1.0

$1.2

(1) 2023 Guidance includes an impact from foreign currency translation of 0.0%

(2) Enterprise level revenue is presented net of intersegment transaction eliminations

(3) 2023 Guidance includes an impact from foreign currency translation of (0.2%)

(4) 2023 Guidance includes an impact from foreign currency translation of 0.2%

(5) Free Cash Flow consists of operating cash flow less capital expenditures

Use of Adjusted Measures

The company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, free cash flow, and certain segment information. The company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the company’s operational performance. The company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the company’s financial results with the financial results of other companies. However, the company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures and an identification of the components that comprise "special items" used for certain adjusted financial information are included in the tables accompanying this press release.

The company today is providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the company’s website at www.Labcorp.com. Analysts and investors are directed to the website to review this supplemental information.

A conference call discussing Labcorp’s quarterly results will be held today at 9:00 a.m. ET and is available by registering at this link, which will provide a dial-in number and unique PIN to access the call. It is recommended that participants join 10 minutes prior to the start of the call, although participants may register and join at any time during the call. A live webcast of Labcorp’s quarterly conference call on Feb. 16, 2023, will be available at Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through Feb. 2, 2024.