Perrigo to Release First Quarter 2023 Financial Results on May 9, 2023

On April 25, 2023 Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, reported that it plans to issue its first quarter 2023 results on Tuesday, May 9, 2023 (Press release, Perrigo Company, APR 25, 2023, View Source,-2023 [SID1234630484]). The Company will also host a conference call beginning at 8:30 A.M. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 1820838. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Tuesday, May 9, until midnight Tuesday, May 16, 2023. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 9673356.

ORIC Pharmaceuticals to Participate in the H.C. Wainwright BioConnect Investor Conference

On April 25, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on Tuesday, May 2, 2023, at 2:00 p.m. ET (Press release, ORIC Pharmaceuticals, APR 25, 2023, View Source [SID1234630483]).

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The live webcast of the discussion will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

OPKO Health to Report First Quarter 2023 Financial Results on May 3, 2023

On April 25, 2023 OPKO Health, Inc. (NASDAQ: OPK) will report operating and financial results for the three months ended March 31, 2023 after the close of the U.S. financial markets on Wednesday, May 3, 2023 (Press release, Opko Health, APR 25, 2023, View Source [SID1234630482]). OPKO’s senior management will provide a business update and discuss results as well as financial guidance during a conference call and live audio webcast on May 3rd beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 10, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 4576780. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

Labcorp Announces 2023 First Quarter Results

On April 25, 2023 Labcorp (NYSE: LH), a leading global life sciences company, reported results for the first quarter ended March 31, 2023, and updated full-year guidance (Press release, LabCorp, APR 25, 2023, View Source [SID1234630477]).

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"Labcorp’s first quarter results set the foundation for a strong 2023, led by continued industry leadership and strength in our Diagnostics and Central Laboratories, and strong fundamentals in our Early Development Research Laboratories," said Adam Schechter, chairman and CEO of Labcorp. "We are on track to complete the spin of Fortrea, our Clinical Development business, by mid-year, and anticipate the business to accelerate in the second half of the year. Labcorp remains well positioned for customers and shareholders as we pursue our mission to improve health and improve lives."

In the first quarter, Labcorp executed against its strategic plan to position the business for both short- and long-term growth. The company continued the integration of the Ascension health system laboratories. Labcorp employees are now managing laboratories in nearly 100 Ascension hospitals. As a large-scale integration, Ascension serves as a proof of concept for the company’s ability to generate profitable growth through future healthcare system partnerships.

The company progressed the planned spin-off of the Clinical Development business, which is expected to be completed in mid-2023, subject to satisfaction of certain customary conditions. The new public company name and brand was introduced as Fortrea in the first quarter of 2023. In early January 2023, Tom Pike was appointed to lead the Clinical Development business. Mr. Pike will become the chief executive officer and chairman of Fortrea upon completion of the spin-off. For more information, please visit fortrea.com.

On March 31, 2023, Labcorp issued its 2022 Corporate Responsibility Report. The report offers an overview of the company’s governance profile, diversity and inclusion initiatives, sustainability impact and community engagement.

On April 6, 2023, the company announced a quarterly cash dividend of $0.72 per share of common stock, payable on June 8, 2023, to stockholders of record at the close of business on May 18, 2023.

Consolidated Results

First Quarter Results

Revenue for the quarter was $3.78 billion, a decrease of (3.1%) from $3.90 billion in the first quarter of 2022. The decrease was due to organic revenue of (3.6%) and foreign currency translation of (0.7%), partially offset by acquisitions, net of divestitures, of 1.2%. The (3.6%) decrease in organic revenue was driven by an (11.6%) decrease in COVID-19 PCR and antibody testing (COVID-19 Testing), partially offset by a 7.9% 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 $341.0 million, or 9.0% of revenue, compared to $687.9 million, or 17.6%, in the first quarter of 2022. The company recorded amortization, restructuring charges, and special items, which together totaled $152.5 million in the quarter, compared to $106.1 million during the same period in 2022. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $493.5 million, or 13.1% of revenue, compared to $794.0 million, or 20.4%, in the first quarter of 2022. The decrease in operating income and margin was primarily due to a reduction in COVID-19 Testing. The margin decline was also negatively affected by the mix impact from the Ascension TSA and NHP-related constraints.

Net earnings for the quarter were $212.9 million compared to $491.6 million in the first quarter of 2022. Diluted EPS were $2.39 in the quarter compared to $5.23 during the same period in 2022. Adjusted EPS (excluding amortization, restructuring charges, and special items) were $3.82 in the quarter compared to $6.11 in the first quarter of 2022.

Operating cash flow for the quarter was $121.2 million compared to $356.0 million in the first quarter of 2022. The decrease in operating cash flow was due to lower COVID Testing earnings, partially offset by higher Base Business earnings. Capital expenditures totaled $93.9 million compared to $117.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $27.3 million compared to $238.8 million in the first quarter of 2022.

At the end of the quarter, the company’s cash balance and total debt were $0.4 billion and $5.4 billion, respectively. During the quarter, the company paid out $64.4 million in dividends.

First Quarter Segment Results

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

Diagnostics

Revenue for the quarter was $2.38 billion, a decrease of (2.9%) from $2.45 billion in the first quarter of 2022. The decrease was due to organic revenue of (4.7%) and foreign currency translation of (0.3%), partially offset by acquisitions of 2.0%. The (4.7%) decrease in organic revenue was due to a (18.4%) decrease in COVID-19 Testing, partially offset by a 13.7% increase in the Base Business. Total Base Business growth compared to the Base Business in the prior year was 19.8%, which includes the benefit from the Ascension lab management agreement of approximately 7% as well as the positive impact from weather and revenue days of approximately 2%.

Total volume (measured by requisitions) decreased by (3.3%) as organic volume decreased by (5.6%) and acquisition volume contributed 2.3%. Organic volume was impacted by a (12.7%) decrease in COVID-19 Testing, partially offset by a 7.1% increase in the Base Business. Price/mix increased by 0.4% due to Base Business growth of 6.6%, partially offset by COVID-19 Testing of (5.7%), currency of (0.3%), and acquisitions of (0.2%). Base Business volume increased 11.0% compared to the Base Business last year, which includes the combined favorable impact from weather and revenue days of approximately 2%. Price/mix was up 8.8% 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 $441.5 million, or 18.5% of revenue, compared to $683.1 million, or 27.8%, in the first quarter of 2022. The decrease in adjusted operating income and margin was due to a reduction in COVID-19 Testing. Excluding COVID-19 Testing, operating income and margin were up due to the benefit of Base Business organic growth and LaunchPad savings, which were partially offset by higher personnel expense.

Drug Development

Revenue for the quarter was $1.40 billion, a decrease of (4.0%) from $1.46 billion in the first quarter of 2022. The decrease was primarily due to an organic decline of (2.4%), foreign currency translation of (1.5%), and acquisitions net of divestitures of (0.1%). The decrease in organic revenue was negatively impacted by approximately (8.0%) due to NHP-related constraints, reduced COVID-19 vaccine and therapeutic work, and the loss of the previously mentioned FSP contract.

Adjusted operating income for the quarter was $123.9 million, or 8.8% of revenue, compared to $168.6 million, or 11.6%, in the first quarter of 2022. Adjusted operating income and margin decreased due to NHP-related constraints, reduced COVID vaccine and therapeutic work, and the FSP contract loss, partially offset by demand growth and LaunchPad savings.

Net orders and net book-to-bill during the trailing twelve months were $7.15 billion and 1.27, respectively. Backlog at the end of the quarter was $16.62 billion, an increase of 9.4% compared to last year. The company expects approximately $4.89 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2023

Labcorp is updating 2023 full year guidance to reflect its first quarter performance and full year outlook. The following guidance assumes foreign exchange rates effective as of March 31, 2023, for the remainder of the year. Enterprise level guidance includes the estimated impact from currently anticipated capital allocation, including acquisitions, share repurchases and dividends.

(Dollars in billions, except per share data)

Previous


Updated


Results


2023 Guidance


2023 Guidance



2022


Low

High


Low

High

Revenue


Total Labcorp Enterprise (1)(2)

$14.9


1.0 %

4.0 %


1.5 %

4.0 %

Base Business (1)(2)

$13.7


8.5 %

10.5 %


9.5 %

11.0 %

COVID-19 Testing (2)

$1.1


(90.0 %)

(75.0 %)


(90.0 %)

(80.0 %)


Total Diagnostics (3)

$9.2


(2.0 %)

1.5 %


(0.5 %)

2.0 %

Base Business

$8.1


10.5 %

12.5 %


12.5 %

14.0 %

COVID-19 Testing

$1.1


(90.0 %)

(75.0 %)


(90.0 %)

(80.0 %)


Total Drug Development (4)

$5.7


5.0 %

7.0 %


3.5 %

5.5 %



Adjusted EPS

$19.94


$16.00

$18.00


$16.25

$17.75


Free Cash Flow (5)

$1.5


$1.0

$1.2


$1.0

$1.2




(1) 2023 Updated Guidance includes an impact from foreign currency translation of 0.1%, previous 2023 Guidance was 0.0%

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

(3) 2023 Updated Guidance includes an impact from foreign currency translation of (0.2%), previous 2023 Guidance was (0.2)%

(4) 2023 Updated Guidance includes an impact from foreign currency translation of 0.6%, previous 2023 Guidance was 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 April 25, 2023, will be available at the Labcorp Investor Relations website beginning at 9:00 a.m. ET. This webcast will be archived and accessible through April 11, 2024.

National Multicenter Trial Opens to Study ImmunityBio’s Tri-Ad5 Cancer Vaccines Plus N-803 to Prevent Cancer in People with Lynch Syndrome

On April 25, 2023 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported the opening of a clinical trial to study its investigational Tri-Ad5 vaccine combination (Adenovirus 5 CEA/MUC1/brachyury) together with its IL-15 superagonist N-803, an immune-enhancer, for people with a hereditary condition known as Lynch syndrome (Press release, ImmunityBio, APR 25, 2023, View Source [SID1234630467]). This Phase 2b trial (NCT05419011) sponsored by the National Cancer Institute, part of the National Institutes of Health, will study whether Tri-Ad5 in combination with N-803 works to prevent colorectal and other cancers in study participants.

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Each of the three vaccines in Tri-Ad5 targets different proteins associated with precancer and cancer cells. The vaccine combination is studying whether activation of dendritic cells and training the immune system to recognize those proteins will destroy the precancer cells before the cancer advances. N-803 is designed to enhance the effects of the vaccines by increasing proliferation and activation of natural killer (NK) and T cells, thereby increasing the potential for cancer prevention in study participants.

"We are excited to partner with the NCI on this important cancer vaccine study to potentially prevent or delay the onset of cancer for people who carry the gene associated with Lynch syndrome," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "Lynch syndrome affects tens of thousands of people each year and the average age of cancer diagnosis for them is just 44. People known to have the gene for Lynch syndrome can be followed closely by their doctors with regular examinations and scans to watch for the development of cancer but, currently, there is no treatment that prevents the development of cancer in these patients. We hope to change that with this innovative study developed by the NCI."

Lynch syndrome is one of the most common hereditary cancer syndromes. Not only can people with Lynch syndrome develop colorectal cancer some 20 years before the average age of diagnosis for this cancer, they are also at an increased risk of developing multiple types of other cancers, including endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain, and small intestinal cancers. Colorectal cancer is the second-deadliest cancer type in the U.S., and approximately 3% to 5% of the 153,000 cases of colorectal cancer annually are thought to be due to Lynch Syndrome, as are 2% to 3% of all cases of endometrial cancer.2 "The Tri-Ad5 vaccine trial will be the largest Lynch syndrome cancer prevention study done in the U.S.," said Asad Umar, D.V.M., Ph.D., a senior advisor to the director for translational research in NCI’s Division of Cancer Prevention (DCP) and a scientific lead for the trial.

To learn more about this study, please visit View Source

For patients interested in enrolling in this study, please contact NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615) and/or the website: View Source and/or [email protected].

About ImmunityBio’s Tri-Ad5 Vaccines

ImmunityBio’s Tri-Ad5 vaccines target three tumor-associated antigens: brachyury, carcinoembryonic antigen (CEA), and mucin-1 (MUC1). Pre-clinical studies have demonstrated Tri-Ad5 vaccines elicit cytotoxic T cell-mediated tumor cell death and the establishment of memory T cells, and thus may provide protection against the growth and metastasis of cancer. Tri-Ad5 vaccines utilize a second-generation replication-defective human adenovirus serotype 5 (Ad5) vector with viral genes deleted to allow for production of the antigen and a vigorous immune response, without generating a host response to the vector and with the ability to overcome previous adenovirus immunity in cancer patients. Notably, in a phase 1 NCI trial, Tri-Ad5 generated antigen-specific T cells to MUC1, CEA, and/or brachyury in all 10 patients with no evidence of antigenic competition. The safety of multiple ImmunityBio product candidates utilizing the Ad5 technology has been demonstrated in phase 1 and 2 clinical trials for cancers across multiple tumor types.