Illumina Reports Financial Results for Second Quarter of Fiscal Year 2023

On August 9, 2023 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the second quarter of fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, AUG 9, 2023, View Source [SID1234634111]).

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"Illumina’s second quarter consolidated revenue grew 8% sequentially from the first quarter, and we saw higher-than-anticipated NovaSeq X shipments," said Charles Dadswell, Interim Chief Executive Officer. "Despite additional placements, we expect our second half revenue to be negatively impacted by customers remaining more cautious in their purchasing, a more protracted recovery in China, and a larger-than-expected temporary decline in high throughput consumables as customers transition to the NovaSeq X. In response, we are increasing customer support for the NovaSeq X and continue to manage our expense base in a disciplined way."

Second quarter consolidated results

GAAP

Non-GAAP (a)

Dollars in millions, except per share amounts

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue

$ 1,176

$ 1,162

$ 1,176

$ 1,162

Gross margin

62.2 %

66.0 %

66.5 %

69.4 %

Research and development ("R&D") expense

$ 358

$ 327

$ 345

$ 327

Selling, general and administrative ("SG&A") expense

$ 450

$ 410

$ 355

$ 339

Legal contingency and settlement

$ 12

$ 609

$ —

$ —

Operating (loss) profit

$ (88)

$ (579)

$ 82

$ 141

Operating margin

(7.5) %

(49.8) %

7.0 %

12.2 %

Tax rate

(163.8) %

16.0 %

39.3 %

25.8 %

Net (loss) income

$ (234)

$ (535)

$ 50

$ 91

Diluted (loss) earnings per share

$ (1.48)

$ (3.40)

$ 0.32

$ 0.57

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

Capital expenditures for free cash flow purposes were $47 million for Q2 2023. Cash flow provided by operations was $105 million, compared to $125 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $58 million for the quarter, compared to $54 million in the prior year period. Depreciation and amortization expenses were $108 million for Q2 2023. At the close of the quarter, the company held $1,559 million in cash, cash equivalents and short-term investments, compared to $2,037 million as of January 1, 2023. On July 12, 2023, the European Commission imposed a €432 million fine due to the completion of the GRAIL acquisition during the pendency of the European Commission’s review. While expected and accrued for over the last year, Illumina believes that the fine is unlawful, inappropriate, and disproportionate, and is appealing the decision. Illumina plans to issue a guarantee and defer the payment of the fine pending the outcome of the appeal of the EU General Court’s ruling that the European Commission has jurisdiction to review the GRAIL acquisition.

Second quarter segment results

Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina

GAAP

Non-GAAP (a)

Dollars in millions

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue (b)

$ 1,159

$ 1,156

$ 1,159

$ 1,156

Gross margin (c)

65.5 %

69.3 %

67.0 %

69.8 %

R&D expense

$ 274

$ 249

$ 261

$ 249

SG&A expense

$ 359

$ 339

$ 270

$ 270

Legal contingency and settlement

$ 12

$ 609

$ —

$ —

Operating profit (loss)

$ 115

$ (396)

$ 245

$ 288

Operating margin

9.9 %

(34.3) %

21.2 %

24.9 %

(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 Q2 2023 was flat as compared to Q2 2022, and up 2% on a constant currency basis. Amounts for Q2 2023 and Q2 2022 included intercompany revenue of $5 million and $6 million, respectively, which is eliminated in consolidation.

(c) The year-over-year decrease in gross margin was primarily driven by lower instrument margins due to the NovaSeq X launch, which is typical with a new platform introduction, less fixed cost leverage on lower manufacturing volumes, and higher field services and installation costs.

GRAIL

GAAP

Non-GAAP (a)

In millions

Q2 2023

Q2 2022

Q2 2023

Q2 2022

Revenue

$ 22

$ 12

$ 22

$ 12

Gross (loss) profit

$ (24)

$ (29)

$ 9

$ 4

R&D expense

$ 89

$ 86

$ 89

$ 86

SG&A expense

$ 91

$ 72

$ 85

$ 70

Operating loss

$ (204)

$ (187)

$ (164)

$ (152)

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

As previously stated, Illumina is committed to moving as quickly as possible through the legal and regulatory processes associated with its acquisition of GRAIL. If the company loses either its appeal in the US Court of Appeals for the Fifth Circuit or its appeal in the European Court of Justice (ECJ), Illumina expects to move quickly to divest GRAIL in a manner that serves the best interests of its shareholders. Should the company win both appeals, Illumina would undertake a detailed review of the GRAIL business, as it would no longer be subject to the hold separate, and determine the optimal outcome for the asset, also in the best interests of Illumina’s shareholders. Success in the ECJ appeal removes any fines; prevailing in the appeals increases the options to deliver value to shareholders. The legal and regulatory processes are finite; Illumina expects decisions from the US Court of Appeals for the Fifth Circuit in late 2023 and from the ECJ in late 2023 or early 2024.

Key announcements by Illumina since Illumina’s last earnings release

Announced the five founding members of the Alliance for Genomic Discovery (AGD), in which AbbVie, Amgen, AstraZeneca, Bayer, and Merck will co-fund the sequencing of 250,000 whole-genomes and have access to the data for use in drug discovery and therapeutic development
Launched DRAGEN 4.2, which expands upon award-winning accuracy combined with renowned flexibility and scalability to enable efficient workflows and extract meaningful insights from genomic data
Announced strategic partnership with Pillar Biosciences, Inc. to make Pillar’s suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products
Unveiled PrimateAI-3D, an artificial intelligence (AI) algorithm that predicts with unprecedented accuracy disease-causing genetic mutations in patients
Named three new independent directors to the board: Stephen P. MacMillan, Chairman, President and CEO of Hologic, Scott B. Ullem, Corporate Vice President and CFO of Edwards Lifesciences, and Andrew Teno, Portfolio Manager at Icahn Capital LP
Elected Stephen P. MacMillan as non-executive chair of the board
Appointed Charles Dadswell, General Counsel, as Interim Chief Executive Officer
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 results from the prospective SYMPLIFY study, showing strong performance of Galleri in the symptomatic population of more than 6,000 patients and demonstrated the feasibility of using a Multi-Cancer Early Detection (MCED) test to assist clinicians with decisions regarding referral from primary care
Presented data at ASCO (Free ASCO Whitepaper), showing support that real-world performance of Galleri is consistent with previous large-scale clinical studies, including the cancer signal detection (CSD) rate and accuracy of the Cancer Signal Origin (CSO) prediction to guide diagnostic workup
Announced results from a retrospective analysis of the interventional PATHFINDER study, demonstrating that in the majority of cases (78%), the test’s CSO-directed initial diagnostic evaluation led to a diagnostic resolution
Completed second year study visits for the NHS-Galleri study, in which 130,000 participants came back for their second appointment (retention rate of 91.3%)
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 now expects consolidated revenue growth of approximately 1% compared to fiscal year 2022. The company now expects Core Illumina revenue to be approximately flat 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 $(2.08) to $(1.93) and non-GAAP diluted earnings per share of $0.75 to $0.90. 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.

Conference call information

The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Wednesday, August 9, 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 877.400.0505 or +1.313.209.4906 outside North America, both using conference ID 8615466. 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.

Cardiff Oncology Reports Second Quarter 2023 Results and Provides Business Update

On August 9, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers, reported financial results for the second quarter ended June 30, 2023, and provided a business update (Press release, Cardiff Oncology, AUG 9, 2023, View Source [SID1234634110]).

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"2023 has been transformative for Cardiff Oncology, highlighted by the advancement of our lead program to the first-line mCRC setting and an expansion of our relationship with Pfizer," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The shifting of our clinical development program to the first-line was a data-driven decision based on a strong signal from new clinical and preclinical findings, with agreement from the FDA. There are 48,000 new patients in the U.S. annually in the first-line RAS-mutated mCRC setting, with no ongoing clinical trials or new treatments approved in the past 20 years. We believe that there is a tremendous opportunity for onvansertib to provide a meaningful benefit to a substantial number of patients who are fighting cancer in challenging indications. Looking ahead, we anticipate commencing enrollment in our first-line trial this fall with interim topline data expected in mid-2024."

Upcoming expected milestones

mPDAC data readout from Phase 2 trial expected in Q3 ’23
SCLC data readout from Phase 2 trial expected in Q3 ’23 (investigator-initiated trial with UPMC)
First patient dosed in first-line mCRC trial expected fall ’23
TNBC data readout from Phase 1b/2 trial expected Q4 ’23/Q1 ’24 (investigator-initiated trial with Dana-Farber Cancer Institute)
First-line mCRC randomized data readout expected in mid-2024
Company highlights for the quarter ended June 30, 2023 and resent announcements

Announced new lead program in mCRC and expanded Pfizer relationship.
Cardiff Oncology will initiate a first-line trial, CRDF-004, a Phase 2 randomized trial generating preliminary safety and efficacy data and evaluating two different doses of onvansertib to confirm an optimal dose. Onvansertib will be added to standard-of-care consisting of FOLFIRI plus bevacizumab, or FOLFOX plus bevacizumab.
Contingent upon the results of CRDF-004, Cardiff Oncology will initiate CRDF-005, a Phase 3, randomized trial with registrational intent. The FDA has agreed that a seamless trial with objective response rate at an interim point is an acceptable endpoint to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.
Pfizer Ignite will be responsible for the clinical execution of the CRDF-004 trail, leveraging Pfizer’s significant R&D capabilities, scale and expertise.
Our new partnership with Pfizer Ignite expands the relationship established in November 2021 when Pfizer made an equity investment in Cardiff Oncology and nominated Adam Schayowitz, Ph.D., Vice President & Medicine Team Group Lead for Breast Cancer, Colorectal Cancer and Melanoma, Pfizer Global Product Development as a Scientific Advisory Board member.
Second Quarter 2023 Financial Results

Liquidity, cash burn, and cash runway

As of June 30, 2023, Cardiff Oncology had approximately $89.4 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the second quarter of 2023 was approximately $7.1 million, an increase of approximately $0.4 million from $6.7 million for the same period in 2022.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into 2025.

Operating results

Total operating expenses were approximately $12.3 million for the three months ended June 30, 2023, an increase of $1.8 million from $10.5 million for the same period in 2022. The increase in operating expenses was primarily due to higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing

On August 9, 2023 Georgiamune Inc., a privately held, clinical stage biotechnology company, reported the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody (Press release, Georgiamune, AUG 9, 2023, View Source [SID1234634109]). Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

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The clearance of Georgiamune’s first IND represents a significant milestone for the company as it embarks on its first clinical trial in oncology. GIM-122, a first-in-class dual-functioning monoclonal antibody, targets a highly novel mechanism discovered through the distinguished academic work of Georgiamune’s Founder and Chief Executive Officer Dr. Samir Khleif and developed by the company to overcome immunotherapy resistance.

Georgiamune will initiate a first-in-human, open-label, phase 1/2 dose-escalation with enrichment and dose expansion study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and antitumor activity of GIM-122 as a single agent in adults with advanced solid malignancies who have failed treatment with a checkpoint inhibitor. Georgiamune plans to initiate its phase 1/2 clinical trial in the second half of 2023 and continue development of its extensive first-in-class pipeline for cancer and autoimmune diseases with high unmet needs.Dr. Khleif stated, "Georgiamune is a discovery and early clinical development biotech company focused on transforming immunotherapy by reprogramming the immune system for the treatment of cancer and autoimmune diseases. The acceptance of our first IND is a testament to the hard work and dedication of our talented team, and brings us closer to fulfilling our mission of transforming cancer patient care."

In addition to the IND acceptance, Georgiamune has successfully closed an oversubscribed $75M Series A financing round, securing substantial financial support from leading biotech investors and venture capital firms. General Catalyst and Parker Institute for Cancer Immunotherapy (PICI) co-led the round. Mubadala Capital, Alexandria Venture Investments, Catalio Capital Management, CJNV BioVenture, and Verition Fund Management also participated.

"Georgiamune’s therapeutic approach to unlock and reprogram the immune system seeks to enable patients to recover from cancer or autoimmune diseases, and is a remarkable example of leveraging nature’s mechanisms for improved healthcare solutions, a core part of our Health Assurance thesis," said Deep Nishar, Managing Director at General Catalyst. "We are proud to support Georgiamune in getting its novel therapies to patients worldwide, in what we believe will help people live higher quality and longer lives."

"PICI is proud to support Georgiamune in bringing this novel technology to cancer patients worldwide," said John Connolly, PhD, Chief Scientific Officer at PICI. "Georgiamune’s approach of leveraging fundamental discoveries in next generation checkpoint blockade to develop novel immuno-oncology treatments is directly in line with PICI’s mission to accelerate breakthrough therapies to patients."

"Georgiamune’s innovative therapeutic approach targets critical challenges in immunotherapy, adeptly tuning the immune system to reestablish equilibrium in cancer and autoimmune conditions and presenting a promising way forward for patients with high unmet needs," said Ayman AlAbdallah, Partner at Mubadala Capital. "We are proud to partner with the Georgiamune team as they emerge from a period of intense research and development and advance several groundbreaking preclinical and clinical programs."

City of Hope receives $32.3 million from the California Institute for Regenerative Medicine to advance innovative therapies for patients

On August 9, 2023 Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States and a leading research center for diabetes and other life-threatening illnesses, reported that they have been awarded $32.3 million from the California Institute for Regenerative Medicine (CIRM) to support three novel Phase 1 clinical trials evaluating innovative cell and gene therapy treatments for patients with HIV, acute myeloid leukemia and severe aplastic anemia (Press release, City of Hope, AUG 9, 2023, View Source [SID1234634108]).

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Researchers at City of Hope were awarded $32.3 million from the California Institute for Regenerative Medicine (CIRM) to support three novel Phase 1 clinical trials evaluating innovative cell and gene therapy treatments for patients with HIV, acute myeloid leukemia and severe aplastic anemia. (Photo credit: City of Hope)
Researchers at City of Hope were awarded $32.3 million from the California Institute for Regenerative Medicine (CIRM) to support three novel Phase 1 clinical trials evaluating innovative cell and gene therapy treatments for patients with HIV, acute myeloid leukemia and severe aplastic anemia. (Photo credit: City of Hope)
Beckman Research Institute of City of Hope was awarded two-thirds of the $50 million in this latest round of CIRM awards, the highest of any entity in the state.

"These CIRM awards are a testament to City of Hope’s commitment to the advancement of gene therapies for the treatment of human diseases," said John D. Carpten, Ph.D., City of Hope’s chief scientific officer, Irell & Manella Cancer Center Director’s Distinguished Chair and Morgan & Helen Chu Director’s Chair of the Beckman Research Institute. "Through our tireless pursuit of best-in-class research and innovation, we believe our work at City of Hope will benefit patients living with HIV or impacted by cancer, and we thank CIRM for its support to help make this a reality."

City of Hope is a leader in gene therapies, including bone marrow and blood stem cells transplants. As one of the highest volume transplant centers in the nation and the largest in California, more than 18,000 transplants have been performed at City of Hope since it became one of the first cancer centers in the U.S. to perform the therapy in 1976. City of Hope and other institutions also developed a pretransplant treatment for older adults and other patients that resulted in the fifth patient in the world — and the oldest — to achieve long-term remission for leukemia and HIV. (The patient had also received stem cells from a donor with a rare genetic mutation that makes people resistant to most HIV strains.)

Potential bispecific CAR T therapy for HIV

City of Hope is at the forefront of another cellular therapy known as chimeric antigen receptor therapy (CAR) T cell therapy, which uses a patient’s own immune system to fight cancer and has the potential to target other diseases, such as HIV.

More than 80 CAR T and other immune effector cell trials have been conducted to date at City of Hope and over 1,200 patients have been treated with CAR T therapy, either in clinical trials, which may use CARs developed by City or Hope, or Food & Drug Administration-approved CAR T cell therapies.

"City of Hope made a major advancement when our transplant team helped Paul Edmonds, globally known as the ‘City of Hope patient,’ go into remission for both HIV and leukemia," said John A. Zaia, M.D., the Aaron D. Miller and Edith Miller Chair for Gene Therapy at City of Hope. "We are hoping to evaluate a CAR T therapy for HIV in a Phase 1 clinical trial so that one day more people with HIV might be able to achieve long-term HIV remission."

CIRM awarded Zaia $11.3 million for the clinical trial. Up to 12 healthy people with HIV will be treated in this first-in-human study performed at City of Hope and the University of California San Diego. The investigators include John Baird, M.D., Angelo Cardoso, M.D., Ph.D., Joycelynne Palmer, Ph.D., and Xiuli Wang, Ph.D., at City of Hope and colleagues at UCSD.

Zaia’s team will test a novel approach City of Hope scientists developed where a patient’s immune T cells are engineered to target both the HIV antigen gp120 and a common virus that infects nearly all persons living with HIV, namely cytomegalovirus. The researchers’ aim is for these bispecific HIV-CAR T cells to persist and eliminate HIV-infected cells so that antiviral drugs are no longer needed.

Trial to focus on a difficult blood cancer to treat

CIRM awarded a City of Hope team led by Elizabeth Budde, M.D., Ph.D., nearly $12 million to develop and conduct a first-in-human Phase 1 immunotherapy trial for acute myeloid leukemia (AML), which has the highest mortality rate of all blood cancers.

"It is critical to find more effective therapies for patients whose AML has relapsed," said Budde, a City of Hope associate professor in the Department of Hematology & Hematopoietic Cell Transplantation. "We are hopeful that this novel therapy will eventually enable City of Hope and other institutions to offer a new treatment for patients whose AML has returned. We are very grateful for the recognition and support from CIRM."

Most AML patients who go into remission after one treatment will develop the disease again and will then need a blood stem cell transplant from a donor. Even after a transplant, patients can still relapse, leaving them with few treatment options.

The CIRM-funded trial will be the first to use T cells, a type of immune cell, from a healthy donor who has donated stem cells for the AML patient to undergo a transplant. These cells will be reengineered in a laboratory to express CD33CARs, or special receptors on a cell’s surface.

These CARs will target the CD33 protein, which is found in more than 80% of AML cases. T cells harboring the CD33CARs will also be multiplied to millions and then infused back into the patient. The CARs are living cells and expected to multiply inside a patient’s body and recognize and kill the cancer cells.

Before receiving the CAR T cell therapy, patients will receive chemotherapy to prepare their bodies to accept the CAR T cells.

The trial, which will enroll up to 18 AML patients who have relapsed after receiving a transplant, will evaluate the CAR T therapy’s safety and its effectiveness in eliminating leukemia cells.

City of Hope’s David Horne, Ph.D., Marissa Del Real, Ph.D., Karam Sandhu, M.D., and Anthony Stein, M.D., are co-investigators on this project.

Finding a better treatment for severe aplastic anemia

A City of Hope research team received $9.05 million from CIRM to start a clinical trial using a novel blood stem cell transplantation procedure for severe aplastic anemia, a rare bone marrow disease that can turn into blood cancer and is currently difficult to treat. If successful, the treatment could also be used for other autoimmune diseases, such as treatment-resistant type 1 diabetes.

Currently, a blood stem cell transplant from a related or unrelated donor whose human leukocyte antigen (HLA) genes match a patient’s HLA is the most effective treatment for severe aplastic anemia. But it is difficult to find unrelated donor matches for people of color due to a limited number of donors from various racial and ethnic groups. Transplants can also cause severe side effects, particularly in older patients.

Defu Zeng, Ph.D., a City of Hope professor with the Department of Immunology & Theranostics within the Arthur Riggs Diabetes & Metabolism Research Institute, has led research on the potential new therapy, which involves induction of mixed chimerism in adult patients. Mixed chimerism refers to transplanting blood-forming stem cells from a healthy, half-matched family member donor into a patient who has received a milder, less toxic chemotherapy treatment free of radiation that removes some, but not all, of the patient’s diseased bone marrow stem cells.

The Phase 1 trial is expected to start later this year and will enroll up to six patients.

"City of Hope has extensive expertise performing bone marrow and stem cell transplants for patients with blood cancers and other diseases, and we are consistently looking for ways to improve the process and effectively treat more patients with transplants, regardless of any barriers," said Ryotaro Nakamura, City of Hope’s Jan & Mace Siegel Professor in Hematology & Hematopoietic Cell Transplantation in the Division of Leukemia, Department of Hematology & Hematopoietic Cell Transplantation, and the trial’s principal investigator. "We are hopeful that this will provide another treatment option for patients with this devastating disease and thankful for CIRM’s funding."

City of Hope has treated patients with sickle cell diseases using this novel therapy in a clinical trial also funded by CIRM.

Kintara Therapeutics to Present at the Emerging Growth Conference

On August 9, 2023 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that its President and CEO, Robert E. Hoffman will present in the Emerging Growth Conference on Wednesday, August 9, 2023 at 12:00 pm ET (Press release, Kintara Therapeutics, AUG 9, 2023, View Source [SID1234634107]).

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For investors who are interested in participating, please use the link below to register and receive any conference updates:

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