Veracyte to Acquire Decipher Biosciences

On February 3, 2021 Veracyte, Inc. (Nasdaq: VCYT) and Decipher Biosciences, Inc., a commercial-stage precision oncology company focused on urologic cancers, reported they have entered into a definitive agreement through which Veracyte will acquire Decipher, further solidifying Veracyte’s global leadership in the genomic cancer diagnostics market while accelerating revenue growth (Press release, Veracyte, FEB 3, 2021, View Source [SID1234574535]).

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"By combining Decipher Biosciences’ leadership in urologic cancers with our comprehensive genomic testing menu, Veracyte will be able to serve patients across the clinical care continuum in 7 of the 10 most prevalent cancers in the United States with highly differentiated and clinically impactful tests, significantly accelerating revenue growth and driving shareholder value. Further, with our best-in-class nCounter diagnostics platform, we are well-positioned to deliver comprehensive genomic cancer testing to physicians and their patients worldwide," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "I am also delighted that Dr. Tina Nova, Decipher’s president and CEO, and a veteran diagnostics industry leader, will join Veracyte as general manager, urologic cancers, and that Decipher’s talented employees will also join our team."

Dr. Nova has been a member of Veracyte’s board since 2015, but was not involved in Veracyte’s deliberations regarding the transaction and is resigning from the Veracyte board in connection with the transaction.

Decipher has established a market-leading position for its comprehensive portfolio of tests in urologic cancers, which leverage whole transcriptome analysis and proprietary machine learning algorithms to improve patient decision-making across the clinical care continuum and accelerate adoption of new therapies. Collectively, Decipher’s genomic tests have been used by more than 3,200 urologists and radiation oncologists, including at all 28 National Comprehensive Cancer Network (NCCN) centers in the United States. The Decipher Prostate Biopsy and post-radical prostatectomy (RP) tests are included in NCCN guidelines and the Decipher Prostate RP test is the only genomic molecular diagnostic test recommended in NCCN guidelines for use in patients with localized prostate cancer. They are also broadly reimbursed by Medicare and private payers and included in practice-changing clinical trials, with growing adoption within the urology community. Further, the company’s Decipher Bladder test is expected to launch commercially in 2021 and its kidney cancer test is in development. Decipher GRID, a large, well-annotated urologic cancer database, is fueling the company’s biopharmaceutical partnerships and product innovation.

"Our goal is to enable better treatment decisions and patient outcomes in urologic cancers by providing valuable information about the underlying biology of a patient’s tumor," said Dr. Nova. "Our team has made significant progress in advancing our mission and is thrilled to join Veracyte to benefit from their expertise and infrastructure, accelerating commercial expansion of our tests in the United States and globally."

Global Leadership in Genomic Diagnostics for Cancer

Veracyte currently offers high-value advanced genomic tests that address unmet clinical needs at multiple points in the care continuum for lung cancer, breast cancer, thyroid cancer and interstitial lung diseases, and its lymphoma subtyping test is in development. With the addition of Decipher’s genomic tests in prostate, bladder and kidney cancers, Veracyte will provide an expanded comprehensive testing menu and, with the nCounter system, is uniquely positioned to make its tests available to physicians and their patients in global markets, where hospitals and laboratories can perform them locally. Veracyte estimates that approximately 1.1 million patients in the United States alone, based on cancer incidence, will potentially be able to benefit from the company’s comprehensive menu of advanced genomic tests.

In addition, the Decipher GRID is expected to augment Veracyte’s extensive biorepositories, further positioning Veracyte to advance biopharmaceutical company partnerships and its pipeline development efforts.

The transaction will also provide Veracyte with increased operational flexibility by including Decipher Bioscience’s state-of-the-art facilities in Southern California and its highly qualified team.

Revenue Growth Acceleration

Decipher Biosciences grew its 2020 total revenue by more than 130% to approximately $39 million to $40 million, compared to $16.5 million in 2019. This included total revenue between $11.75 million and $12.25 million for the three months ended December 31, 2020. Decipher’s genomic test volume for 2020 was between 15,500 and 16,500. The annualized total revenue for the combined company based on the midpoint of the total revenue that each company expects to report for the three months ended December 31, 2020 is approximately $186 million. Veracyte expects the acquisition of Decipher Biosciences to significantly accelerate its revenue growth in 2021 and to expand the near-term addressable market for Veracyte’s current and pipeline genomic tests from approximately $10 billion to an estimated $12 billion. Veracyte estimates that the acquisition will further expand its long-term addressable market beyond approximately $50 billion. The transaction is also expected to be accretive to Veracyte’s gross margins and accelerate its path to profitability.

The foregoing revenue amounts are preliminary, have not been audited and are subject to change in connection with the completion of each company’s financial statements for the year ended December 31, 2020.

Transaction Terms and Other Information

Under the terms of the definitive agreement, Decipher Biosciences will become a wholly-owned subsidiary of Veracyte. At closing, Veracyte will pay $600 million in total consideration to Decipher security holders, consisting of $250 million in cash and up to $350 million in stock consideration, subject to customary purchase price adjustments. The number of Veracyte shares issued at the closing will be based on a fixed price of $54.30 per share, resulting in a maximum issuance of 6.4 million common shares. However, without changing the total consideration paid at closing, Veracyte has the option, at its sole discretion, until the earlier of March 15, 2021 and the fourth business day following the closing of any potential equity financing, to substitute cash in lieu of shares in any amount up to the entire stock consideration or $350 million. The transaction, which has been unanimously approved by Veracyte’s board of directors and by an independent special committee appointed by the Decipher Biosciences board of directors, is expected to close by May 2021, subject to regulatory approval and the satisfaction of other customary conditions.

Upon finalization of the transaction, Dr. Nova will become general manager of Veracyte’s urologic cancer business unit. Prior to the signing of the transaction, Dr. Nova resigned from Veracyte’s board of directors. Decipher Bioscience’s laboratory and other operations will remain in San Diego.

Advisors

Goldman Sachs & Co. LLC is serving as financial advisor to Veracyte, and Fenwick & West LLP is serving as legal advisor. Evercore Group, LLC is serving as financial advisor to Decipher Biosciences, and Cooley LLP is serving as legal advisor.

Conference Call and Webcast Details

In a separate press release issued today, Veracyte announced its preliminary financial results for the fourth quarter and full year ended December 31, 2020.

The company will host a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the transaction, as well as its preliminary fourth quarter and full-year 2020 financial results. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

Bio-Techne Announces Expanded Simple Plex Immunoassay Cartridge Portfolio

On February 3, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that ProteinSimple, a Bio-Techne brand, has expanded its Simple PlexTM immunoassay cartridge portfolio to include nine new cartridge formats (Press release, Bio-Techne, FEB 3, 2021, View Source [SID1234574534]). These new cartridge offerings provide Simple Plex users with increased flexibility in the number of samples and biomarker assays run on each cartridge. Simple Plex assay cartridges, run on the EllaTM platform, utilizing state-of-the-art microfluidics to deliver a fully automated immunoassay solution. Researchers can customize cartridge lots from a menu of over 200 validated assays. Until now, Simple Plex assay cartridges were only available in formats delivering one, four, or eight assays run simultaneously. The expanded portfolio of cartridge offerings provides users new options to better align their assay panels with the throughput requirements of their studies.

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Dave Eansor, President of Bio-Techne’s Protein Sciences Segment commented, "This expanded selection of Simple Plex cartridges offers researchers the flexibility to automate their immunoassay workflow for projects of any scope or size using the Ella platform."

The Ella platform allows users to perform high-quality immunoassays with no manual intervention, enabling sub-picogram level sensitivity, 4+ logs of dynamic range and a high level of reproducibility. Ella’s innovative immunoassay workflow decreases the potential for user error and empowers staff to spend their time on higher value activities. Factory calibration of each Simple Plex assay cartridge eliminates the need to generate standard curves. Setting up an assay simply requires loading diluted samples into the cartridge. Once loaded, the Ella instrument performs every step of the immunoassay automatically, from wash steps to final quantification of results in just 90 minutes.

Veracyte Announces Preliminary Fourth Quarter and Full-Year 2020 Financial Results

On February 3, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported preliminary results for the fourth quarter and full year ended December 31, 2020 (Press release, Veracyte, FEB 3, 2021, View Source [SID1234574533]).

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The company expects to report total revenue of between $34.0 million and $35.0 million and product and testing volume of between 13,000 and 13,200 tests for the fourth quarter ended December 31, 2020, an increase of 16% and 14% at the midpoint of the range, respectively, compared to the fourth quarter of 2019. The company expects to report total revenue of between $117.0 million and $118.0 million and product and testing volume of between 44,400 and 44,600 tests for the full year ended 2020, compared to $120.4 million and 40,292 tests for full-year 2019. In addition, the company expects to report cash and cash equivalents of between $345.0 million and $350.0 million as of December 31, 2020.

"We continued the strong rebound in our business during the fourth quarter, with revenue and genomic testing and product volume exceeding pre-pandemic levels," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Moreover, I am incredibly proud of our team’s performance throughout 2020 as we advanced our vision of improving outcomes for patients all over the world at every step of their journey. With our comprehensive menu of advanced genomic tests that address unmet needs across the care continuum, our platform for serving global markets and our robust pipeline, we believe we are well-positioned for long-term, sustained growth."

The preliminary revenue and cash information presented in this press release is based on Veracyte’s current expectations, is unaudited and may be adjusted as a result of, among other things, the completion of Veracyte’s quarterly and annual financial closing procedures and audit by Veracyte’s independent registered public accounting firm. Actual results may differ materially from those disclosed in this press release. Veracyte will report its full financial results and other metrics during its fourth quarter and full-year 2020 financial results later this month.

GSK delivers FY 2020 reported sales of £34 billion, +1% AER, +3% CER and Adjusted EPS of 115.9p, -6% AER, -4% CER, in line with guidance; Total EPS 115.5p, +23% AER

On February 3, 2021 GlaxoSmithKline reported that Strong growth of new and specialty products; on track to deliver two exciting new companies (Press release, GlaxoSmithKline, FEB 3, 2021, View Source [SID1234574532])

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Strong sales performance from key growth drivers in HIV, Respiratory, Oncology and Consumer Healthcare offset disruption from COVID-19 to adult vaccinations
Pharmaceuticals £17 billion -3% AER, -1% CER; new and specialty products £9.7 billion +11% AER, +12% CER
Vaccines £7 billion -2% AER, -1% CER. Shingrix £2 billion +10% AER, +11% CER
Consumer Healthcare £10 billion +12% AER, +14% CER (pro-forma -2% CER*)
New Biopharma product portfolio strengthened with 9 approvals in 2020 and Cabenuva in the US in January 2021
Effective cost control supports delivery of adjusted earnings per share in line with FY 2020 guidance
Total Group operating margin 22.8%. Total EPS 115.5p +23% AER, +26% CER
Adjusted Group operating margin 26.1%. Adjusted EPS 115.9p -6% AER, -4% CER
Q4 net cash flow from operations £4 billion. Free cash flow £3 billion
Significant progress on Biopharma pipeline with over 20 assets now in late-stage clinical trials
20+ new product launches planned by 2026, 10+ with potential peak annual revenues in excess of $1 billion
Pivotal study starts/data expected in 2021 for RSV vaccine in older adults, COVID-19 assets, long-acting anti IL-5 antagonist, daprodustat and dostarlimab
Oncology momentum building: 15 potential medicines in trials, including 9 immuno-oncology and 3 cell therapies
20+ deals executed, including acquisitions of new antibody, mRNA and genetics/genomics technologies
On track for separation into new standalone Biopharma and Consumer Healthcare companies in 2022
2020 targets met with £0.3 billion annual cost savings and £1.1 billion divestment proceeds achieved
Biopharma investor update in June to set out progress on innovation, commercial execution and growth outlook together with capital allocation priorities
Sustained progress and leadership in ESG
Sector leading in key indices, including DJSI and Sustainalytics, and #1 rank in 2021 Access to Medicines Index
New environmental targets set to achieve net zero impact on climate and net positive impact on nature by 2030
2021 Adjusted EPS expected to decline by a mid to high-single digit percentage in CER
Reflects further growth in new and specialty products and Consumer Healthcare, increased investment in our pipeline and deferral of strong growth in Vaccines performance due to impact of COVID-19 immunisation programmes
2022 outlook remains unchanged. Continue to expect meaningful improvement in revenues and margins
Dividend of 23p/share declared for Q4 2020; 80p/share for FY 2020. Expected dividend of 80p/share for FY 2021
Distribution policy for new GSK to be implemented in 2022 to support growth and investment. Aggregate distributions expected to be lower than at present
Emma Walmsley, Chief Executive Officer, GSK said:
"2020 was an extraordinary year for all of us, and one of significant ogress for GSK. We invested in our pipeline and new launches, readied the company for separation, and had to rapidly mobilise and respond to the pandemic. I am extremely proud of the agility and resilience our teams have shown. We delivered our guidance for the year, offsetting the significant impact of COVID-19 on adult vaccinations, with strong performances of new products and effective cost control.

"Importantly, progress against our strategic goals remains firmly on track. We are building a high value biopharma pipeline, have substantially integrated our Consumer JV and have delivered all our first year targets for our two year separation programme. This means we are in a strong position to launch new competitive, standalone Biopharma and Consumer healthcare companies in 2022. In doing so, we have high confidence that we can achieve meaningful global impact to health and significant value creation for shareholders."

Chi-Med to Announce 2020 Final Results

On February 3, 2021 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) reported that it will be announcing its final results for the year ended December 31, 2020 on Thursday, March 4, 2021 at 12:00 noon Greenwich Mean Time (GMT) / 8:00 pm Hong Kong Time (HKT) / 7:00 am Eastern Standard Time (EST) (Press release, Hutchison China MediTech, FEB 3, 2021, https://www.chi-med.com/chi-med-to-announce-2020-final-results/ [SID1234574531]).

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Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management.

The conference call and audio webcast will take place at 1:00 pm GMT / 9:00 pm HKT / 8:00 am EST on Thursday, March 4, 2021 and will be webcast live via the company website at www.chi-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.