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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Illumina Reports Financial Results for First Quarter of Fiscal Year 2023; Announces Commitment to Accelerate Margin Growth

On April 25, 2023 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the first quarter of fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, APR 25, 2023, View Source [SID1234630470]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The year is off to a solid start, led by NovaSeq X outperforming expectations in both customer demand and manufacturing supply," said Francis deSouza, Chief Executive Officer. "We shipped 67 NovaSeq X instruments in the first quarter, exceeding our plan. Demand remains strong, with our quarter-end NovaSeq X order book standing at over 200 instruments. We continue to work closely with our customers and partners to help them manage the challenging macroeconomic environment and to deliver on our 2023 goals. Our commitment to higher margins will set Illumina on the best path to deliver long-term sustainable success for our shareholders."

First quarter consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts Q1 2023 Q1 2022 Q1 2023 Q1 2022
Revenue $ 1,087 $ 1,223 $ 1,087 $ 1,223
Gross margin 60.3 % 66.6 % 64.7 % 69.9 %
Research and development ("R&D") expense $ 341 $ 323 $ 339 $ 323
Selling, general and administrative ("SG&A") expense $ 378 $ 308 $ 343 $ 320
Operating (loss) profit $ (64) $ 184 $ 21 $ 212
Operating margin (5.7) % 15.0 % 1.9 % 17.3 %
Tax rate 103.9 % 38.3 % 27.3 % 17.8 %
Net income $ 3 $ 86 $ 13 $ 169
Diluted earnings per share $ 0.02 $ 0.55 $ 0.08 $ 1.07

(a) See the tables included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

__________________________________
1 The company only provides non-GAAP measures for operating margin targets because of the difficulty of projecting with reasonable certainty the financial impact of specific GAAP operating adjustments. Please see Illumina’s "Statement regarding use of non-GAAP financial measures" for more information.

Capital expenditures for free cash flow purposes were $52 million for Q1 2023. Cash flow provided by operations was $10 million, compared to $172 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $(42) million for the quarter, compared to $111 million in the prior year period. Depreciation and amortization expenses were $107 million for Q1 2023. At the close of the quarter, the company held $1,518 million in cash, cash equivalents and short-term investments, compared to $2,037 million as of January 1, 2023. During the first quarter, the company used $500 million to repay the outstanding principal of our 2023 term notes that matured in March.

First quarter segment results
Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina
GAAP Non-GAAP (a)
Dollars in millions Q1 2023 Q1 2022 Q1 2023 Q1 2022
Revenue (b)
$ 1,076 $ 1,221 $ 1,076 $ 1,221
Gross margin (c)
63.8 % 69.7 % 65.2 % 70.2 %
R&D expense $ 259 $ 238 $ 257 $ 238
SG&A expense $ 286 $ 251 $ 257 $ 267
Operating profit $ 142 $ 362 $ 187 $ 352
Operating margin 13.2 % 29.6 % 17.4 % 28.8 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
(b) Core Illumina revenue for Q1 2023 was down 12% from Q1 2022, and down 10% on a constant currency basis. Amounts for Q1 2023 and Q1 2022 included intercompany revenue of $9 million and $8 million, respectively, which is eliminated in consolidation.
(c) The year-over-year decrease in gross margin was primarily driven by less fixed cost leverage on lower manufacturing volumes and lower instrument margins due to the NovaSeq X launch, which is typical for a new platform introduction.

GRAIL
GAAP Non-GAAP (a)
In millions Q1 2023 Q1 2022 Q1 2023 Q1 2022
Revenue $ 20 $ 10 $ 20 $ 10
Gross (loss) profit $ (25) $ (29) $ 9 $ 5
R&D expense $ 86 $ 85 $ 86 $ 85
SG&A expense $ 93 $ 58 $ 87 $ 54
Operating loss $ (204) $ (172) $ (164) $ (134)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

Key announcements by Illumina since Illumina’s last earnings release
•Launched Illumina Complete Long Read Prep, Human, which enables access to both long- and short-read data on the same instrument for the first time
•Partnered with Henry Ford Health, a not-for-profit health care organization in the Detroit metro area, to assess the impact of comprehensive genomic testing in cardiovascular disease
•Launched Illumina Connected Insights, a new cloud-based software enabling tertiary analysis for clinical next-generation sequencing (NGS) data, with applications for oncology and soon rare diseases
•Celebrated the company’s 25th anniversary, a quarter-century after its founding in San Diego in April 1998

•Expanded strategic partnership with Myriad Genetics to broaden access and availability of oncology homologous recombination deficiency (HRD) testing in the United States; under the agreement, Illumina TruSight Oncology 500 HRD (TSO 500 HRD), a research-use-only test, is now available in the US
•Received the international privacy certification (ISO/IEC 27701) of six of Illumina’s cloud-based informatics programs, recognizing that the company implements, and complies with, robust, international data privacy requirements
•Exceeded more than 200 orders for the revolutionary NovaSeq X, representing a diverse customer base spanning research and clinical customer segments in nearly 30 countries
•Was granted expedited appellate review of the FTC order to divest GRAIL

A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release
•Announced that the 140,000 participant NHS trial has successfully reached its halfway point, with over half of the study participants having returned for their second annual blood draw, and is currently progressing as planned to achieve its targeted retention rates
•Announced that FirstHealth of the Carolinas, Inc., a health system serving patients in 15 counties in the mid-Carolinas, will offer Galleri to eligible patients in North Carolina
•Expanded existing partnership with Providence Health System, one of the largest health systems in the western US, to offer multi-cancer early detection screening as part of clinical care to eligible individuals across the entire Providence health system, consisting of 53 hospitals and 900 clinics across seven states
•Announced that John Hancock, one of the largest life insurers in the US, expanded access to Galleri to eligible life insurance customers participating in the John Hancock Vitality PLUS program following a successful pilot program
•Presented new data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 showcasing the performance of its methylation technology, which had a cancer detection rate of 92% in patients with relapsed or refractory disease across six hematological malignancies

A full list of recent GRAIL announcements can be found in GRAIL’s Newsroom.

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance, including the company’s Core Illumina and GRAIL segments. Please see our Reconciliation of Consolidated Non-GAAP Financial Guidance included in this release for a reconciliation of these GAAP and non-GAAP financial measures.

For fiscal year 2023, the company continues to expect consolidated revenue growth of 7% to 10% compared to fiscal year 2022. The company continues to expect Core Illumina revenue growth of 6% to 9% compared to fiscal year 2022. GRAIL revenue is still expected to be in the range of $90 million to $110 million.

The company now expects GAAP diluted loss per share of $(0.28) to $(0.03) and still expects non-GAAP diluted earnings per share of $1.25 to $1.50. The GAAP and non-GAAP diluted (loss) earnings per share guidance ranges continue to assume that the existing R&D capitalization requirements are not repealed in fiscal year 2023 and, as a result, reflect a tax expense impact of approximately $75 million.

Commitment to higher margins; announcing $100 million in run rate cost savings
The company commits to achieving Core Illumina non-GAAP operating margins of 25% in 2024 and 27% in 2025.

Building on the cost reduction steps announced in November 2022, Illumina will further reduce its annualized run rate expenses by more than $100 million beginning later in 2023. These cost savings will accelerate progress toward higher margins as well as free up capital to increase investment in high-growth areas. The company will continue to prioritize and invest in initiatives that generate highly differentiated products that are valued by Illumina’s customers.

Illumina will achieve these savings through a combination of several actions. We will leverage the recent modularization of R&D innovation created as part of the NovaSeq X development, including XLEAP-SBS and new flow cell technology, to lower the cost and accelerate time to market for future platforms. The company will achieve additional savings through leveraging its global footprint, enabling activities at more cost-effective hubs. The company is also streamlining its organization and processes, including rationalizing its global real estate portfolio and third-party vendor spend, as well as accelerating IT optimization efforts.

The company only provides non-GAAP measures for operating margin targets because of the difficulty of projecting with reasonable certainty the financial impact of specific GAAP operating adjustments. Please see Illumina’s "Statement regarding use of non-GAAP financial measures" for more information.

Conference call information
The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Tuesday, April 25, 2023. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 877.502.9276 or +1.313.209.4906 outside North America, both using conference ID 1539055. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Guardant Health and Parker Institute for Cancer Immunotherapy (PICI) launch research collaboration to study connection between cancer biomarkers and immunotherapy treatment response

On April 25, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and the Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world, reported a research collaboration agreement to study the correlation between molecular cancer biomarkers and patient response to immunotherapy treatment across more than 14 different types of cancer (Press release, Guardant Health, APR 25, 2023, View Source [SID1234630471]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, Guardant Health will analyze patient blood samples from PICI’s RADIOHEAD (Resistance Drivers for Immuno-Oncology Patients Interrogated by Harmonized Molecular Datasets) prospective study of 1,200 individuals on standard-of-care immune checkpoint inhibitor (ICI) treatment regimens in community hospitals. The testing, which will be conducted with GuardantINFINITY, will provide a multi-dimensional analysis of each patient’s tumor response based on both genomic and epigenomic profiling. The study will use blood samples drawn at multiple points during the treatment regimen and will assess the connection between the presence of specific cancer biomarkers and real-world clinical outcomes, including survival and immune-related adverse events.

"By breaking down barriers and forging deep collaboration, PICI can accelerate the development of breakthrough immune therapies and turn all cancers into curable diseases," said Tarak Mody, PhD, chief business officer at PICI. "This mission-focused collaboration with Guardant Health aims to identify the molecular drivers of treatment response in clinical practice, provide significant learnings in PD1 resistance mechanisms, and serve as a valuable resource to the PICI research network for biomarker discovery, target validation, and clinical trial design."

The project marks the first real-world immuno-oncology study collaboration for Guardant Health and will enable the company to significantly expand its access to real-world outcomes data for immunotherapies correlated to specific biomarkers, cancer type and stage.

"The collaborative study with PICI is an excellent opportunity for us to explore the value of genomic and epigenomic tumor profiling in real-world immuno-oncology therapy settings," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The study will generate deeper insights about the tumor microenvironment and its response to therapy, which will enable us to respond to cancer evolution faster and, eventually, modify immunotherapy treatment paradigms for better patient outcomes."

Guardant Health and PICI intend to begin publishing data generated by the study later in 2023.