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Illumina Reports Preliminary Revenue for Second Quarter of Fiscal Year 2019

On July 11, 2019 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the second quarter of fiscal year 2019, and updated its 2019 revenue guidance (Press release, Illumina, JUL 11, 2019, View Source [SID1234537477]).

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Subject to quarter-end closing adjustments, the Company expects to report second quarter revenue of approximately $835 million, compared to $830 million in the second quarter of 2018.

The Company’s second quarter results were impacted by the following:

Approximately $30 million lower revenue than expected associated with population genomics initiatives, including a sizeable sequencing systems and consumables purchase that did not close as expected in the second half of June, which is now expected to close later in 2019.

Approximately $10 million lower revenue than expected associated with ongoing weakness in the direct-to-consumer (DTC) market, primarily impacting array services.

Approximately $10 million lower revenue than expected associated with Illumina’s non-high-throughput sequencing systems and consumables. While lighter than anticipated, NextSeq system and consumables shipments grew both sequentially and year-over-year, and average pull-through per NextSeq system was within Illumina’s target range.

NovaSeq consumable volume growth of 40% sequentially, and more than 100% year-over-year, with particularly strong growth in the S4 and S1 flow cells. NovaSeq system shipments were ahead of expectations in the second quarter, excluding the multi-system population genomics transaction referenced above.

"We are obviously disappointed with our second quarter financial results. Our preliminary analysis suggests that these challenges are transitory and do not reflect a macro change to the fundamentals of our business," said Francis deSouza, President and CEO. "Despite our shortfall this quarter, we remain as enthusiastic about the long-term growth prospects for our markets as we have ever been, and are committed to setting the industry’s bar for consistency and execution in the dynamic and rapidly growing world of genomics."

Financial outlook and guidance

Reflecting on the Company’s experience in 2019 so far, Illumina now expects fiscal year revenue growth of approximately 6%, primarily associated with lower near-term expectations in DTC, a more conservative assumption about the speed with which certain population genomics initiatives ramp, and lower non-high-throughput systems and consumables, including a delay in a partner program that is now expected to ramp in 2020.

Illumina now expects sequencing business revenue to grow approximately 10%, which includes sequencing consumables growth of approximately 15%, and sequencing service and other to be slightly down year-over-year.

The Company expects array business revenue to be down approximately 14% year-over-year, primarily reflecting ongoing DTC weakness.

Illumina continues to expect NovaSeq pull-through per system to be higher than the approximately $1 million per system reported for 2018.

The Company continues to expect 2019 NovaSeq system shipments to be flat to slightly up compared to 2018.

The Company will share additional guidance, including full year earnings per share guidance, on its upcoming quarterly conference call. In light of the Company’s lower revenue growth expectations for 2019, Illumina is taking immediate action to adjust operating expenses for the remainder of the year.
Quarterly conference call information
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 29, 2019. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (844) 647-5490, or 1 (615) 247-0295 outside North America, both with conference ID 3469888.

EORTC at ISCB 40, Annual Conference of the International Society for Clinical Biostatistics

On July 11, 2019 EORTC biostatisticians reported that it will present a number of abstracts at the 40th Annual Conference of the International Society for Clinical Biostatistics (ISCB 40) which will take place from 14 to 18 July 2019 in Leuven, Belgium (Press release, EORTC, JUL 11, 2019, View Source [SID1234537476]).

Oral presentations
Setting standards in patient-reported outcomes analysis for cancer randomized controlled trials: a SISAQOL initiative update

Lien Dorme and the SISAQOL team

Date: 15 July 2019 – 4:42-5:00PM

Location: Auditory BMW 6

There are no standards on how to analyse Patient Related Outcomes (PRO) data in cancer randomised clinical trials (RCTs). The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) Consortium has identified critical issues in PRO analyses in cancer RCTs and has developed standardized research objectives and analysis methods to address these issues. The analysis is presented here.

Prediction models for liver transplantation – comparisons between Cox models and machine learning techniques

George Kantidakis for his Master’s thesis work with the team of Marta Fiocco

Date: 16 July 2019 – 11:54AM-12:12PM

Location: Auditory BMW 5

Currently, Machine Learning (ML) is being discussed extensively. Questions on whether it has greater potential than Cox models when it comes to complex data have been posed. Criticism to ML is related to unsuitable performance measures and lack of interpretability, which is important for the clinicians to take decisions. In this presentation, ML techniques such as random forests and neural networks are applied to large data of 62294 patients and more than 600 variables from the United States. 106 prognostic factors are selected – 52 regarding donor and 54 regarding recipient characteristics – to predict survival of patients since liver transplantation.

A new measure to report the treatment effect in clinical trials involving competing risks

Eva Cantagallo and the BENEFIT team

Date: 17 July 2019 – 3:48-4:06PM

Location: Auditory BMW 6

Generalized pairwise comparisons (GPC) is a recent approach to describe the treatment effect in two-group clinical trials, using the net benefit as a measure of overall treatment effect. This method allows the use of a threshold of clinically relevant difference between the two groups and the simultaneous analysis of prioritized outcomes. In this presentation, the BENEFIT team expand GPC methods to a competing risks setting and provide a new measure of the treatment effect, while offering the advantages of classical GPC.

Poster
Validation of imaging biomarkers for treatment response in multicenter cancer trials conducted by EORTC

Bart Jacobs and the EORTC Imaging Group statisticians
Date: 16 July 2019 – 12:30-13:30PM

Location: Entrance Hall O&N1 + O&N2

Within QuIC-ConCePT, an EU funded initiative to qualify and validate imaging biomarkers for cancer response, two concurrent multi-centre clinical trials were performed. EORTC 1217 (NCT02273271) studied SUV measured with 3’-deoxy-3’-[18F]fluorothymidine-PET and ADC measured with diffusion weighted imaging-MRI in patients with early stage non-small cell lung cancer. EORTC 1423 (NCT02355353) focused on ADC in colorectal cancer patients with resectable liver metastases. Both trials hypothesized that early changes in these biomarkers (14 days post start of neo-adjuvant chemotherapy) could be predictive for pathological response at time of surgery. This potential relation could fasten decisions in early endpoints and would provide a cost-effective tool for early phase clinical trials benefiting both patients and investigators.

Newly Published Study Establishes Evidence-Based Population for Clinical Use of DecisionDx-Melanoma in Patients with Thin Cutaneous Melanoma Tumors

On July 11, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported the publication of a study that establishes an evidence-based population to guide appropriate use of the DecisionDx-Melanoma test in patients with thinner tumors (Press release, Castle Biosciences, JUL 11, 2019, View Source [SID1234537475]). The study was published in the peer-reviewed journal SKIN: The Journal of Cutaneous Medicine.

Current best practice for the use of DecisionDx-Melanoma includes informing two key treatment plan decisions following a melanoma diagnosis. First, for most patients with cutaneous melanoma who are eligible for a sentinel lymph node biopsy (SLNB), DecisionDx-Melanoma can identify patients at low risk of positivity and inform the decision to undergo this surgical procedure. This can include patients with tumor thickness less than or equal to 2.0 mm with no minimum thickness criteria.

The second use for DecisionDx-Melanoma is designed to predict an individual’s risk of recurrence to help physicians determine an appropriate level of follow-up, imaging and referrals. Previously published validation studies have reported that the test can accurately determine risk of recurrence in patients with Stage I-III melanoma, including tumors with a thickness less than 1.0 mm. The purpose of this study was to determine whether an evidence-based thickness threshold can be established for this second use to further guide appropriate clinical use of the test in patients with thinner (1.0 mm or less) melanoma tumors.

Key Study Findings:

An analysis of a large, multicenter dataset (n=1,479) that calculated event rates by tumor thickness and DecisionDx-Melanoma class result found a separation of recurrence rates between Class 1A (lowest risk) and Class 2B (highest risk) at a threshold of 0.3 mm.
In a separate analysis of tumors ≤1.0 mm thick tested clinically (n=8,944) and at a large dermatopathology practice (n=437), tumors with a thickness between 0.3 mm and 1.0 mm showed a 10.8% and 15.7% non-Class 1A result, respectively, suggesting that there is a benefit of risk assessment for this portion of the thin tumor population.
In two multicenter studies (n=403) that included 160 patients with tumors ≤1.0 mm, most patient management changes made following DecisionDx-Melanoma testing were recommended for those with a tumor thickness ≥0.3 mm.
These results suggest a minimum Breslow thickness of 0.3 mm as an appropriate population to use DecisionDx-Melanoma to guide decisions on follow-up for cutaneous melanoma patients. Based on a previously published validation study, the test can also be used to inform decisions on SLNB in most eligible patients with tumor thickness less than or equal to 2.0 mm (no minimum tumor thickness).

"Accurate risk assessment is especially important in patients with thinner melanomas because a substantial proportion of melanoma-specific deaths occur in patients initially diagnosed with thin melanomas," commented study co-author Clay J. Cockerell, M.D., Cockerell Dermatopathology, Dallas, Texas. "These results establish an evidence-based population of patients with thin tumors who are appropriate for DecisionDx-Melanoma testing to inform follow-up decisions in the context of current melanoma management strategies."

The full published study results can be accessed at the journal’s website.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 3,100 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and five prospective risk of recurrence studies including more than 780 patients. Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter study cohorts that included more than 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

More information about the test and disease can be found at www.SkinMelanoma.com.

Actinium Highlights Two Presentations at the Health Physics Society Annual Meeting Supporting the Safety Profile of Iomab-B for SIERRA Trial Caregivers

On July 11, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported its presence at the Health Physics Society ("HPS") 64th Annual Meeting that is being held July 7th – 11th in Orlando, Florida (Press release, Actinium Pharmaceuticals, JUL 11, 2019, View Source [SID1234537474]). During HPS, Actinium presented the findings of two studies that support the safety of healthcare professionals who provide care to patients treated with Iomab-B, Actinium’s lead product candidate, which is being studied in the pivotal Phase 3 SIERRA trial. The studies evaluated radiation exposure to healthcare professionals who cared for patients treated with Iomab-B and the exposure from handling blood samples from patients following Iomab-B infusion. Both studies reported minimal radiation exposure to the respective healthcare professionals. One study of 105 healthcare professionals from 5 SIERRA sites that provided care to patients receiving Iomab-B observed a mean cumulative radiation exposure of 0.09 mSv or millisieverts, which is significantly less than the 50 mSv annual occupational dose limit for staff. Iomab-B is an ARC or Antibody Radiation-Conjugate comprised of the CD45 targeting antibody, apamistamab, and the radioisotope iodine-131 that is intended to be a re-induction and conditioning agent prior to a BMT or Bone Marrow Transplant. The SIERRA trial is a multicenter, 150 patient study for patients with active, relapsed or refractory AML or Acute Myeloid Leukemia that is the only randomized Phase 3 trial to offer a potentially curative BMT to this patient population for which there is no standard of care.

Details of the HPS presentations on Iomab-B are as follows:

Title: Occupational Radiation Exposures to Clinical Staff Working With 131I – Iomab-B

Summary: Data from 105 healthcare professionals from five SIERRA sites was analyzed. Staff monitored when only providing care to Iomab-B treated patients had a mean cumulative exposure of 0.07 mSv despite high levels of radiation being administered with targeted Iomab-B while staff who provided care for multiple patients, including those receiving other forms or radiation therapy, had a mean cumulative exposure of 0.11 mSv. Radiation exposure levels to all staff were found to be minimal, with mean cumulative exposure of 0.09 mSv, contributing minimal exposure to the 50 mSv annual occupational limit. The study sited training, education, customized physical shielding and more advanced safety procedures as leading to minimal additional radiation exposure.

Title: Iomab-B Study Blood Sample Handling and Occupational Radiation Extremity Exposure

Summary: Radiation exposure levels were minimal and not a safety concern to clinical staff involved in blood specimen collecting and handling.

Dr. Qing Liang, Actinium’s Vice President, Head of Radiation Sciences, said, "The safety of patients and site staff is our number one concern, so I am excited that the data from these studies demonstrated minimal radiation exposure to staff caring for patients in the Iomab-B SIERRA trial. I am confident that our collective efforts, together with the supportive data presented here at the Health Physics Society Meeting, will have a positive impact on the SIERRA trial, Iomab-B and our other ARC therapeutic candidates."

"Staff at clinical sites are often surprised to learn that they can be exposed to higher amounts of radiation when flying on an airplane than compared to providing care to patients treated with Iomab-B. These study data solidly support this fact with the 0.09 mSv mean exposure to staff significantly lower than the 50 mSv annual occupational limit and even lower than the annual radiation 3 mSv, we all receive from natural background. Since joining Actinium, I have focused on building relationships with the radiation safety and nuclear medicine caregivers at existing and prospective sites for our SIERRA trial, educating site staff and working with my clinical colleagues to further optimize the SIERRA trial for patients and site staff. I believe that such efforts bode well not only for the SIERRA trail but also for Iomab-B in a commercial setting, assuming its approval," Concluded Dr. Liang."

The Health Physics Society has nearly 4,000 members including scientists, safety professionals, physicists, engineers and other professionals from academia, industry, the federal government and national laboratories.

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "The SIERRA trial is a complex study involving multiple stakeholders at sites, including transplant physicians, radiation safety officers, nuclear medicine physicians and the nursing staff who provide care that is critical for these patients. Our team has worked intensely to address the needs of each of these stakeholders and I am proud that our efforts have taken Iomab-B from the single center where it was originally studied at to 19 clinical trials sites in the SIERRA trial thus far. The two studies presented at HPS which demonstrated that staff can safely provide care to patients with minimal radiation exposure are important and augment the promising interim feasibility and safety data that we have presented from the SIERRA trial. We are focused on continuing to generate positive data from the SIERRA trial for Iomab-B as we see a tremendous opportunity to improve outcomes for a significant number of patients with our ARC’s focused on targeted conditioning for BMT and cell therapies."

AbbVie to Host Second-Quarter 2019 Earnings Conference Call

On July 11, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will announce its second-quarter 2019 financial results on Friday, July 26 before the market opens (Press release, AbbVie, JUL 11, 2019, View Source [SID1234537473]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time (9 a.m. Eastern). It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.