On December 17, 2019 Eli Lilly and Company (NYSE: LLY) reported its 2020 financial guidance, highlighted by volume-based revenue growth and improving productivity, which are expected to result in operating margin expansion and strong earnings performance (Press release, Eli Lilly, DEC 17, 2019, View Source [SID1234552420]). The company also revised certain elements of its 2019 financial guidance and reviewed potential key events for the upcoming year, including important data readouts for several investigational medicines in its clinical pipeline, the possibility for two regulatory approvals, and up to three new launches in 2020.

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!

Josh Smiley, Lilly’s chief financial officer, outlined the company’s near-term growth prospects and provided 2020 financial guidance. "We expect 2020 to be a year of strong operating and financial performance for Lilly, characterized by revenue growth for our key medicines both in the U.S. and in international markets, ongoing productivity initiatives leading to further margin expansion, continued progress in our clinical pipeline of new medicines, and solid cash flow." said Smiley. "We are confident in our ability to deliver on our 2020 expectations, and thereby achieve or exceed the financial and pipeline commitments we had previously made for the period 2015-2020."

Commenting on the company’s cash flow expectations, Smiley added, "Our robust financial performance is expected to generate strong cash flow, which we will continue to deploy thoughtfully. Our capital allocation priorities remain unchanged, starting with funding our promising pipeline and our recently launched medicines, then leveraging business development to access additional external innovation opportunities, followed by returning cash to shareholders through our recently-increased dividend and our ongoing share repurchase program."

"Lilly is in the early phase of an exciting period of prolonged growth for the company, driven by an expanding portfolio of new medicines focused on diabetes, oncology, immunology, and neuroscience," said David A. Ricks, Lilly’s chairman and chief executive officer. "With an attractive commercial portfolio and limited patent exposure through the latter half of the upcoming decade, we are well positioned to deliver sustainable volume-based revenue growth and drive further operating margin expansion. As we continue to invest in our innovation-based strategy, we are confident in our ability to discover and develop important new medicines for patients."

2019 Financial Guidance

The company has updated certain elements of its 2019 financial guidance. On a reported basis, earnings per share for 2019 are now expected to be in the range of $8.57 to $8.67. The decrease in expected earnings per share on a reported basis is due to a net charge related to the repurchase of debt, and additional asset impairment, restructuring, and other special charges related to global cost reduction initiatives, largely offset by a gain on the sale of the company’s antibiotics business in China. On a non-GAAP basis, earnings per share for 2019 are still expected to be in the range of $5.75 to $5.85.

Non-GAAP guidance reflects adjustments presented in the earnings per share table above.

2020 Financial Guidance
The company today issued its 2020 financial guidance. Earnings per share for 2020 are expected to be in the range of $6.38 to $6.48 on a reported basis and $6.70 to $6.80 on a non-GAAP basis. Non-GAAP earnings per share for 2020 exclude amortization of intangible assets.

Numbers may not add due to rounding

The company anticipates 2020 revenue between $23.6 billion and $24.1 billion. Meeting its 2020 revenue forecast would allow the company to achieve or exceed the 7 percent revenue CAGR target it previously communicated for the time period 2015 – 2020. Revenue growth is expected to be driven by volume from key growth products including Trulicity, Taltz, Basaglar, Jardiance, Verzenio, Cyramza, Olumiant, Emgality, BaqsimiTM, and the expected launch of ReyvowTM. Revenue growth could also benefit from the potential launch of other new medicines. Revenue growth is expected to be partially offset by lower revenue for products that have lost patent exclusivity, including the expected entry of generic competition for Forteo in the U.S. Revenue growth is also expected to be partially offset by a low-single digit net price decline in the U.S. driven primarily by rebates and legislated increases to Medicare Part D cost sharing, patient affordability programs, and net price declines in China, Japan and Europe.

Gross margin as a percent of revenue rate is expected to be approximately 79 percent on a reported basis, and approximately 81 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are expected to be in the range of $6.1 billion to $6.3 billion. Research and development expenses are expected to be in the range of $5.6 billion to $5.9 billion.

Operating margin, defined as operating income as a percent of revenue, is expected to be 31 percent on a non-GAAP basis in 2020.

Other income (expense) is expected to be expense in the range of $100 million and $250 million.

The 2020 effective tax rate is expected to be approximately 15 percent on both a reported basis and on a non-GAAP basis.

The following table summarizes the company’s 2020 financial guidance.

Non-GAAP guidance reflects adjustments presented in the earnings per share table above.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the 2020 financial guidance conference call through a link on Lilly’s website at www.lilly.com. The conference call will begin at 9:00 a.m. Eastern time (ET) today and will be available for replay via the website.

On December 16, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported the commercial launch of its Cchek Prostate Cancer Confirmation test (Cchek PCC), the first test developed with the Cchek artificial intelligence driven, flow cytometry based, liquid biopsy technology platform (Press release, Anixa Biosciences, DEC 16, 2019, View Source [SID1234553929]).

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 Cchek PCC test will be offered as a CLIA validated test through Anixa’s partner laboratory, ResearchDx. This test has been independently validated by ResearchDx and is designed to confirm the need for prostate biopsy, as a means to minimize unnecessary invasive procedures and reduce healthcare costs associated with traditional methods of prostate cancer diagnosis and the associated adverse events.

Amit Kumar, Ph.D., Chief Executive Officer of Anixa, stated, "This is a major milestone for Anixa and our partner-based business model. From the start, our goal with Cchek has been to develop an inexpensive blood test that accurately detects the existence of cancer by measuring the body’s immune response."

Data shows that more than 90% of prostate biopsies performed in the U.S. are negative, which indicates that over a million men undergo unnecessary, painful and anxiety-provoking procedures every year. The goal of Cchek PCC is to reduce the number of unnecessary biopsies by between 40% and 50%, while still accurately identifying those patients that require a biopsy to diagnose their prostate cancer.

Dr. Kumar continued, "In the coming months, we expect to conduct a number of activities to support the marketing of Cchek PCC, including the development of marketing materials, education of key opinion leaders in urology, and development of a reimbursement path for the test. We expect Cchek PCC to be broadly available throughout the U.S. by April 2020."

About Cchek
Cchek is an early cancer detection technology, which measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method with greater affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed.

On December 16, 2019 Sysmex Inostics reported that new data presented by Dr. Ben Ho Park, Professor of Medicine and Director of Precision Oncology at Vanderbilt University and colleagues at the recent San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas demonstrated a potential utility for monitoring tumor-specific mutations (TSMs) in the circulation of early stage triple-negative breast cancer patients (Press release, Sysmex Inostics, DEC 16, 2019, View Source [SID1234552414]). The investigators utilized Sysmex Inostics’ highly sensitive SafeSEQ technology to detect rare variants down to 0.05% mutant allele fraction (MAF) to explore the rate of detection of ctDNA variants independent of the need for a tissue biopsy.

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!

This initial data was generated as a pilot investigation as part of the PREDICT DNA trial ("Pathologic Response Evaluation and Detection In Circulating Tumor DNA"), the first prospective, multi-center study designed to verify cell-free circulating tumor DNA (ctDNA) as a biomarker for treatment response and recurrence in early stage breast cancer, with the primary aim of determining the negative predictive value of a negative ctDNA result after neoadjuvant therapy for the achievement of pathologic complete response. Essentially the trial measures whether patients who undergo neoadjuvant chemotherapy to treat tumors prior to surgery still have ctDNA in their blood after the therapy but before surgery. Dr. Park shared, "We give chemotherapy to early stage breast cancer patients and probably 70 percent of those patients don’t need it, but we generally can’t define who has micro-metastatic disease and who doesn’t." The PREDICT DNA trial is aiming to understand whether ultrasensitive next-generation sequencing with a SafeSEQ targeted cancer mutation panel can identify and monitor ctDNA of early-stage breast cancer patients to more precisely administer neoadjuvant therapy and surgery in newly diagnosed patients.

A total of 228 patients with Stage II and III triple-negative or HER2-positive breast cancer have been enrolled at 22 sites, of which 77 with matched pre- and post-neoadjuvant therapy samples were available at the time of the pilot study. Using SafeSEQ, tumor-specific mutations were identified in 48% (37/77) of the pre therapy samples, of which 89% had detectable plasma TP53 mutations, 11% had PIK3CA mutations, and 11% had co-occurring TP53 and PIK3CA mutations. A cohort of patient plasma specimens underwent orthogonal testing with OncoBEAM digital PCR technology, with 100% concordance of results with SafeSEQ.

The authors of the study concluded that SafeSEQ’s ultrasensitive detection of ctDNA has ‘significant clinical implications as an affordable and non-invasive first-pass assay in patients with sparse tumor biopsy tissue’. This preliminary data also demonstrates clinical feasibility of identifying tumor-specific mutations in individuals using minimally-invasive liquid biopsy before neoadjuvant treatment for personalized disease response monitoring without the need for biopsy tissue for NGS analysis.

"There is a paramount need for prospective studies using liquid biopsy," said Dr. Ben Ho Park, Professor of Medicine and Director of Precision Oncology, Vanderbilt University Medical Center. "These exciting preliminary results from the PREDICT DNA Trial represent an important first step in understanding the role of liquid biopsy testing for the management of early stage breast cancer and helping the medical community map out a path to make precision medicine a reality for patients across the continuum of care."

Presentation Details: Saturday 14 December 2019 7am – 9am, Poster Session 6, P6-10-05

Hunter, N. et al (2019) Pathologic Response Evaluation and Detection In Circulating Tumor DNA (PREDICT DNA): Initial results piloting a tissue-biopsy independent method of identifying and monitoring tumor-specific mutations in early stage breast cancer: TBCRC 040 Presented at the San Antonio Breast Cancer Symposium in San Antonio, Texas. ClinicalTrials.gov Identifier: NCT02743910

This work supported by the Translational Breast Cancer Research Consortium.

On December 16, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the fourth quarter of 2019 (Press release, Zimmer Holdings, DEC 16, 2019, View Source [SID1234552413]).

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 cash dividend of $0.24 per share is payable on January 31, 2020 to stockholders of record as of the close of business on December 27, 2019.

On December 16, 2019 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported an agreement by its subsidiary Belgian Volition SPRL to acquire an epigenetic reagent company, Octamer GmbH ("Octamer"), for approximately $725,000 consisting of cash and shares of restricted common stock of Volition (Press release, VolitionRX, DEC 16, 2019, View Source [SID1234552412]). The closing of the acquisition is subject to customary conditions and is expected to occur in January 2020. This strategic acquisition helps secure the supply of one of the key components of Volition’s Nu.QTM tests, the recombinant nucleosome used as the calibrant.

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!

Commenting on the announcement Cameron Reynolds, Chief Executive Officer of Volition said, "I could not be happier that through this acquisition we will be working with one of the world’s leading nucleosome experts, Dr. Adrian Schomburg. Not only will this deal secure the supply of a wide range of our key components, but it will also facilitate the transfer of know-how and expertise so that we can develop the capability to manufacture recombinant nucleosomes ourselves. This deal enhances our goal of becoming one of the world’s leading epigenetics companies."

Regarding the transaction, Dr. Adrian Schomburg, Founder and CEO of Octamer said, "I believe that the progress that Volition has made to date on nucleosomes in circulation is very exciting and have confidence that this deal is a good convergence of our two technologies and companies. I look forward to working together to bring these transformative diagnostic agents into everyday diagnostic practice."

In addition to nucleosomes, Octamer manufactures and sells histones, octamers and DNA templates. These reagents can be used for custom applications in epigenetic research and drug discovery. Octamer is already revenue generating and has many business development opportunities that Volition plans to exploit in 2020 and beyond.

About the Acquisition

The aggregate purchase price is €650,000 Euros (approximately $725,000), consisting of €350,000 cash and approximately 73,000 shares of common stock of Volition, for 100% of the outstanding shares of Octamer. The shares of common stock will be issued by Volition to the seller in a private placement in reliance on an exemption from the registration requirements of the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder. The shares of common stock will not be registered under the Securities Act or any state securities laws and unless so registered may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws. In connection with the transaction, the parties will also enter into a five-year royalty agreement the provides for single-digit royalties based on the sales by Octamer of recombinant nucleosomes to pharmaceutical companies for use in the development, manufacture and screening of molecules for use as therapeutic drugs, as well as a consulting arrangement with Dr. Schomburg. The acquisition includes the transfer of Standard Operating Procedures and key assets in addition to onsite training for Belgian Volition scientists.