On January 13, 2020 Personalised cancer treatment is one step closer to becoming a reality for more patients, thanks to a Cancer Council Beat Cancer Project grant awarded to University of South Australia researcher Dr Stephanie Reuter Lange to explore how computer-based modelling can optimise cancer treatment and remove the need for expensive clinical trials (Press release, University of South Australia, JAN 13, 2020, View Source [SID1234554068]).

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Dr Reuter Lange’s $300,000 project is one of two UniSA projects successful in today’s Cancer Council Beat Cancer Project funding announcement with Professor Peter Hoffmann also securing $100,000 to further critical work in identifying the extent of endometrial cancer and where it has spread.

While cancer treatments are most successful when personalised to an individual, Dr Reuter Lange says most cancer medicines are still administered with a "one size fits all" approach.

"Despite substantial improvements in the treatment of cancer, three out of 10 patients will still not survive longer than five years, due to either cancer progression or death from severe treatment-related side effects," Dr Reuter Lange says.

"There is no field of medicine in which individualisation of medicines is more important than in the area of oncology. There is large variability in how patients respond to many cancer medicines, which can result in either undertreatment that leads to cancer progression, or overtreatment that can have significant toxic side effects.

"The concept of dose individualisation means we can tailor the amount of a drug administered to an individual patient to maximise tumour response and minimise side effects. My focus will be to use computer-based modelling methods to identify dose individualisation strategies for best treatment practice."

While the merits of individualised drug dosages are clear, conducting the large-scale clinicial trials required to implement the treatment in practice is a complex and costly process which means cancer treatments currently on offer remain standardised rather than personalised.

Dr Reuter Lange’s work uses the science of mathematical and stasitical models to characterise drug behaviour, helping clinicians make an educated decision on the most appropriate treatment regimes.

"This work will provide an evidence-basis for dose individualisation of cancer therapies, offsetting the need for the conduct of costly, large-scale clinical trials," she says.

"Ultimately this work will lead to improved patient outcomes and provide a framework on which treatment guidelines can be based for the optimal use of new and existing cancer therapies."

UniSA Professor Hoffmann’s research project will focus on developing less intrusive diagnosis and treatment techniques for endometrial cancer, the most diagnosed gynaecological cancer in Australia.

According to Professor Hoffmann, radiological imaging is unreliable in determining the stage of endometrial cancer, meaning the majority of patients have to undergo surgical staging (and removal of lymph nodes) even though the minority will actually have cancer that has spread to the lymph nodes (metastatic disease).

He says the Cancer Council SA funding will go towards identifying molecular tissue markers that indicate the presence of metastatic disease so that future patients may not need to undergo unnecessary radical surgery (Lymphadenectomy) to get an accurate diagnosis.

Established in 2011 Cancer Council’s Beat Cancer Project is a collaboration between Cancer Council SA, the State Government, SAHMRI and the universities and providing research funding to improve the lives of all South Australians impacted by cancer. For more information on the project, go to cancersa.org.au/research/beat-cancer-project.

On January 13, 2020 Emergent BioSolutions Inc. (NYSE: EBS) reported selected preliminary unaudited 2019 financial results and its financial forecast for 2020 (Press release, Emergent BioSolutions, JAN 13, 2020, View Source [SID1234553059]).

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Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions Inc. stated, "Our preliminary results for 2019 reflect another strong year of execution on the part of the entire Emergent team. With total revenue of $1.1 billion, anticipated gross margin of 56% to 58%, which is a 200 to 400 basis point improvement over prior year, and margins on adjusted net income and adjusted EBITDA of 14% (1) and 26% (2), respectively, our financial performance reflects the consistency and durability of our business model and its focus on public health threat solutions. Moreover, we achieved our key operational goals for the year, which included securing over $3 billion of renewed contract value, expanding markets for our existing products and services portfolio, and continuing investments to advance our product pipeline and enhance our manufacturing infrastructure."

Continuing, Kramer stated, "As we enter 2020, we are planning for continued expansion of our business and a financial forecast that at the midpoint anticipates 11% year-over-year growth in total revenue along with strong absolute and relative gains in adjusted net income and adjusted EBITDA. We intend to achieve these outcomes while simultaneously expanding our portfolio of advanced stage product candidates that address serious global public health threats. As a result, we are confident in the strength of our business model as we pursue the sustained growth and value creation to be realized in the 2020-2024 growth strategy we announced at the Analyst & Investor Day we held in November, which contemplates annual revenue in excess of $2 billion by 2024."
PRELIMINARY 2019 FINANCIAL RESULTS (Unaudited)
The company is providing the following preliminary, unaudited financial results for full year 2019.

Total Revenue
For the full year 2019, the company anticipates total revenue of $1,100 to $1,105 million, the midpoint of which represents a $320 million or 41% increase from 2018, the second year in a row of approximately 40% year-over-year growth in total revenue. This annual increase is due primarily to the contribution of sales of NARCAN (naloxone HCl) Nasal Spray and ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) in 2019 as well as higher contracts and grants revenue, offset by lower anthrax vaccine revenue (now a combination of BioThrax (Anthrax Vaccine Adsorbed) and AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) (4)).

Net Income (GAAP and Adjusted)
For the full year 2019, the company anticipates net income of $53 to $63 million, which reflects the impact of two significant items, contingent consideration related to the Adapt acquisition and a non-cash impairment. The company also anticipates adjusted net income of $150 to $160 million, the midpoint of which represents a $33 million or 27% increase from 2018, reflecting the impact of both increased product sales as well as higher average margins on the products contributing to product sales in 2019. (See "Reconciliation of Net Income to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and reconciliation tables.)

Note:
The preliminary 2019 financial results are subject to revision and will be finalized upon completion of the company’s external audit, which is anticipated by late February 2020. The company’s final audited financial results could differ materially from these selected preliminary results.
2020 FINANCIAL FORECAST

For the full year of 2020, the company’s financial forecast includes the impact of the following items:

continued growth in sales of NARCAN Nasal Spray to a range of $285 — $315 million;

combined deliveries of AV7909 (4) and BioThrax to the Strategic National Stockpile (SNS) in a range of $270 — $300 million;

deliveries of ACAM2000 in a range of $180 — $200 million under procurement contracts with the U.S. government and other foreign governments;

deliveries of raxibacumab to the SNS under the anticipated follow-on procurement contract with the ASPR;

domestic and international sales of the other medical countermeasures that comprise Other Product sales;

continued expansion of CMO services revenue;

continued improvement of gross margin in a range of 200 — 400 basis points, driven by improved product mix; and

continued investment in discretionary development projects funded by the company, most notably the anticipated Phase 3 studies for both the Chikungunya and FLU-IGIV product candidates, among other R&D projects.

The outlook for 2020 does not include estimates for potential new corporate development or other M&A transactions.

PRESENTATION WEBCAST
The company will provide an update on the current business and discuss preliminary 2019 financial results, the forecast and corporate goals for 2020, and long-term goals for the five-year period 2020-2024 during its presentation at the 38th Annual J.P. Morgan Healthcare Conference on January 14, 2020 at 10:30 AM Pacific time.

A live webcast of the presentation can be accessed through Emergent’s website. Visit www.emergentbiosolutions.com and select the "Investors" section. An on-demand replay of the webcast can also be accessed in the investors section after the presentation has concluded.

FOOTNOTES

Adjusted Net Income margin is defined as Adjusted Net Income divided by total revenues. For the 2019 Preliminary Results, we reference this metric using the midpoints of the relevant factors. Specifically: $155/$1,103 = 14%.

Adjusted EBITDA margin is defined as Adjusted EBITDA divided by total revenues. For the 2019 Preliminary Results, we reference this metric using the midpoints of the relevant factors. Specifically: $285/$1,103 = 26%.

See "Reconciliation of Net Income to Adjusted Net Income, EBITDA and Adjusted EBITDA" for a definition of terms and a reconciliation tables.

AV7909 is a product candidate not yet approved by the FDA or any other health regulatory agency but procured by the U.S. government under special circumstances.

RECONCILIATION OF NET INCOME TO ADJUSTED NET INCOME, EBITDA AND ADJUSTED EBITDA
This press release contains five financial measures (Adjusted Net Income, Adjusted Net Income margin, EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization), Adjusted EBITDA and Adjusted EBITDA margin) that are considered "non-GAAP" financial measures under applicable Securities and Exchange Commission rules and regulations. These non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with generally accepted accounting principles. The Company’s definition of these non-GAAP measures may differ from similarly titled measures used by others. Adjusted Net Income adjusts for specified items that can be highly variable or difficult to predict, or reflect the non-cash impact of charges resulting from purchase accounting. All adjustments are tax effected utilizing the federal statutory tax rate for the US, except for changes in the fair value of contingent consideration as the vast majority is non-deductible for tax purposes. Adjusted Net Income margin is defined as Adjusted Net Income divided by total revenues. EBITDA reflects net income excluding the impact of depreciation, amortization, interest expense and provision for income taxes. Adjusted EBITDA also excludes specified items that can be highly variable and the non-cash impact of certain purchase accounting adjustments. Adjusted EBITDA margin is defined as Adjusted EBITDA divided by total revenues. The Company views these non-GAAP financial measures as a means to facilitate management’s financial and operational decision-making, including evaluation of the Company’s historical operating results and comparison to competitors’ operating results. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to the corresponding GAAP financial measure may provide a more complete understanding of factors and trends affecting the Company’s business.

The determination of the amounts that are excluded from these non-GAAP financial measures are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the Company’s consolidated financial statements and publicly filed reports in their entirety.

On January 13, 2020 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered into a 15-year, non-exclusive partnership with Illumina to broaden the adoption of distributable next-generation sequencing (NGS) based testing in oncology (Press release, Hoffmann-La Roche, JAN 13, 2020, View Source [SID1234553094]). As the understanding of the genomic drivers of cancer evolves, NGS has the potential to transform cancer risk prediction, detection, diagnosis, treatment and monitoring.

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This agreement brings together complementary capabilities of each company to broaden global adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic (IVD) tests on Illumina’s NextSeq 550Dx System, as well as on its future portfolio of diagnostic (Dx) sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 (TSO 500) with new companion diagnostic (CDx) claims. The financial terms of the deal were not disclosed.

Under the IVD terms of the agreement, Roche will develop, manufacture and commercialise AVENIO IVD tests for both tissue and blood for use on Illumina’s NextSeq 550Dx System. Illumina will continue to sell the NextSeq 550Dx Systems and core sequencing consumables. Under the CDx terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TSO 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx System. Illumina will lead the development and regulatory approval process and will continue to manufacture, supply and commercialise TSO 500. Roche will support the development of the claims and regulatory filings.

"As a leader in diagnostic innovation that helps save and improve lives, Roche is pleased to enter into a collaboration agreement with Illumina to leverage our combined expertise in clinical oncology and next-generation sequencing," said Thomas Schinecker, CEO of Roche Diagnostics. "This collaboration is uniquely positioned to improve medical value and clinical decision making globally by combining the unique capabilities of the Roche Group including Foundation Medicine with Illumina and will provide more patients with access to NGS to characterise their disease and identify the right treatment for them. This builds upon our strategy of accelerating clinical research, streamlining workflows and expanding assay menus to broaden access to genomic data and lower barriers to routine use."

About Roche in Genomic Sequencing
With Roche Sequencing Solutions and Foundation Medicine, Roche is dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Roche Sequencing Solutions provide reagents and software needed for labs to determine the genomic characteristics of solid and liquid-based samples through a single DNA workflow. With the research-use-only and future IVD AVENIO family of Next Generation Sequencing oncology assays, Roche aims to make sequencing simple and accessible for everyday use.

On January 13, 2020 Adimab, LLC, the global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that 11 new partner programs entered clinical development in 2019 (Press release, Adimab, JAN 13, 2020, View Source [SID1234553110]). This brings the total number of Adimab partner programs that have entered the clinic to 32. Partners initiating clinical trials in 2019 include Alector, Dragonfly Therapeutics, Hanmi Pharmaceutical, IASO Therapeutics, Innovent Biologics, Inc., Roche, Surface Oncology, and others.

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"This is the second year in a row that we have seen 11 or more new programs enter the clinic and we don’t expect that trend to slow anytime soon. In particular, we have seen younger companies backed by leading venture capital firms show remarkable success in translating new biological insight into clinical programs. On average, these venture-backed partners have advanced two out of every three discovery programs towards the clinic – that’s an incredible success rate compared to the industry at large," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "People aren’t very good at pricing failure. We see many antibody discovery shops push their cheap alternatives, but too many of those programs fail for technical or developability reasons."

In 2019, Adimab partners exercised ten commercial licenses to advance programs into product development, bringing the total number of optioned programs to more than 60. Partners exercising commercial options in 2019 include Acceleron, Innovent Biologics, Inc., Scholar Rock, Surface Oncology, and others.

"While the majority of the programs in the clinic came from Adimab’s core antibody discovery platform, there are now several programs in the clinic that came from new applications of Adimab’s technology. Some programs are antibodies that originally came from other technologies that we subsequently engineered to enhance their properties, or simply ‘fixed’ to reduce developability liabilities. We are also seeing a growing number of bispecific and CAR programs entering the clinic, and we expect that trend to continue in the coming years," said Guy Van Meter, Chief Business Officer of Adimab.

On January 13, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported preliminary unaudited revenue results for the fourth quarter and full year 2019 (Press release, NuVasive, JAN 13, 2020, View Source [SID1234553127]).

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Fourth Quarter 2019 Highlights

Revenue of approximately $310 million, increased approximately 8% on both a reported and constant currency basis;
U.S. Spinal Hardware revenue increased approximately 8%;
U.S. Surgical Support revenue increased approximately 3%; and
International revenue increased approximately 14% on a reported and constant currency basis.
Full Year 2019 Highlights

Revenue of approximately $1.17 billion, increased approximately 6% on a reported basis and approximately 7% on a constant currency basis;
U.S. Spinal Hardware revenue increased approximately 7%;
U.S. Surgical Support revenue increased approximately 1%; and
International revenue increased approximately 10% on a reported basis and 12% on a constant currency basis.
NuVasive will report its full financial results for 2019 and provide its financial outlook for 2020 during its earnings announcement planned for late February.

"NuVasive delivered consistent above-market growth in 2019, with growth in the fourth quarter across all business lines," said J. Christopher Barry, chief executive officer of NuVasive. "We made meaningful progress throughout the organization last year, including the launch of differentiated new products and advancing enabling technologies to support our continued leadership in minimally invasive spine surgery."

38th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15, 2020
NuVasive will participate in the 38th Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15 at the Westin St. Francis in San Francisco. Mr. Barry will represent the Company in a presentation scheduled for 10:00 a.m. PT/1:00 p.m. ET.

A live webcast of the presentation will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com. A replay of the presentation will remain available on the website for 30 days after the live webcast.