Centene Corporation Reports 2019 Results

On February 4, 2020 Centene Corporation (NYSE: CNC) reported its financial results for the fourth quarter and year ended December 31, 2019, reporting diluted earnings per share (EPS) of $0.49 and $3.14, respectively, and Adjusted Diluted EPS of $0.73 and $4.42, respectively (Press release, Centene , FEB 4, 2020, View Source [SID1234553862]).

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!

2020 Outlook

The Company expects to provide consolidated 2020 annual guidance, including WellCare Health Plans, Inc. (WellCare), on Tuesday, March 3, 2020, with a conference call at 8:30 AM (Eastern Time) on Wednesday, March 4, 2020. The Company continues to expect the WellCare acquisition to be no less than break even accretion for the first full year after closing and mid-to-upper single digit accretion in the second full year. Additionally, excluding the effect of the WellCare acquisition, the Company’s stand-alone 2020 guidance is unchanged from the guidance provided at our December investor day.

"I am pleased with our performance in the fourth quarter and full year 2019, resulting in 24% full year top and bottom line growth. This caps off another successful year for Centene and provides strong, positive momentum as we head into 2020. Having recently closed our acquisition of WellCare, we look ahead to 2020 and beyond with great confidence in the opportunities that lie ahead. Our company will have even greater scale and diversification, serving 1 in every 15 Americans, maintaining our leadership in government-sponsored healthcare. We are happy to welcome our WellCare colleagues to Centene and look forward to delivering on our strategy," said Michael F. Neidorff, Centene’s Chairman, President and Chief Executive Officer.

On January 23, 2020, we acquired all of the issued and outstanding shares of WellCare. The transaction is valued at approximately $19.6 billion, including the assumption of debt. The Centene and WellCare combination creates a premier healthcare enterprise focused on government-sponsored healthcare programs.

Fourth Quarter and Full Year Highlights

December 31, 2019 managed care membership of 15.2 million, an increase of 1.1 million members, or 8%, over December 31, 2018.
Total revenues of $18.9 billion for the fourth quarter of 2019, representing 14% growth compared to the fourth quarter of 2018, and $74.6 billion for the full year 2019, representing 24% growth year-over-year.
Health benefits ratio (HBR) of 88.4% for the fourth quarter of 2019, compared to 86.8% in the fourth quarter of 2018, and 87.3% for the full year 2019, compared to 85.9% for the full year 2018.
Selling, general and administrative (SG&A) expense ratio of 9.6% for the fourth quarter of 2019, compared to 9.9% for the fourth quarter of 2018. SG&A expense ratio of 9.3% for the full year 2019, compared to 10.7% for the full year 2018.
Adjusted SG&A expense ratio of 9.5% for the fourth quarter of 2019, compared to 9.9% for the fourth quarter of 2018. Adjusted SG&A expense ratio of 9.2% for the full year 2019, compared to 10.0% for the full year 2018.
Diluted EPS for the fourth quarter of 2019 of $0.49, compared to $0.57 for the fourth quarter of 2018, a decrease of 14%. Diluted EPS for the full year 2019 of $3.14, compared to $2.26 for the full year 2018, an increase of 39%.
Adjusted Diluted EPS for the fourth quarter of 2019 of $0.73, compared to $0.69 for the fourth quarter of 2018, an increase of 6%. Adjusted Diluted EPS for the full year 2019 of $4.42, compared to $3.54 for the full year 2018, an increase of 25%.
Operating cash flow of $(651) million and $1.5 billion for the fourth quarter and full year 2019, respectively, representing 1.1x net earnings for the full year 2019. Operating cash flow for the fourth quarter of 2019 was negatively affected by the timing of payments from several of our customers, including state directed payments.
Other Events

In January 2020, Centene acquired all of the issued and outstanding shares of WellCare. The transaction is valued at approximately $19.6 billion, including the assumption of $1.95 billion of outstanding debt. The WellCare acquisition brings a high-quality Medicare platform and further extends our robust Medicaid offerings. In connection with the closing of the WellCare acquisition, Anthem, Inc. acquired WellCare’s Missouri Medicaid health plan, a WellCare Missouri Medicare Advantage health plan, and WellCare’s Nebraska Medicaid health plan. CVS Health Corporation acquired portions of Centene’s Illinois Medicaid and Medicare Advantage health plans. Centene also completed the exchange of substantially all of WellCare’s outstanding senior notes of approximately $1.95 billion aggregate principal amount of new notes issued by Centene and cash. Finally, the Centene board welcomed WellCare board members William Trubeck and James Dallas to Centene’s board of directors.
In February 2020, Centene announced the appointment of Chris Koster to Senior Vice President, Secretary and General Counsel, effective February 19, 2020. Centene also announced the appointment of Keith Williamson, former Secretary and General Counsel, to President of the Centene Charitable Foundation.
In February 2020, Centene announced the appointment of Jennifer Gilligan to Senior Vice President, Investor Relations, effective upon Edmund Kroll’s retirement in April 2020.
In February 2020, Centene began operating in Illinois under the first phase of an expanded contract for the Medicaid Managed Care Program. The expanded contract includes children who are in need through the Department of Children and Family Services/Youth Care by the Illinois Department of Healthcare and Family Services and Foster Care.
In January 2020, Centene announced its subsidiary Social Health Bridge has launched a new community partnership with the NHP Foundation, and its affiliate, Operation Pathways, to bring affordable housing to the local Louisiana community. Launching in New Orleans, Louisiana, on-site staff will help residents access education health events, preventative and social determinants of health screenings, and community referral assistance on premise at the housing community.
In January 2020, Centene expanded its offerings in the Health Insurance Marketplace in ten existing markets: Arizona, Florida, Georgia, Kansas, North Carolina, Ohio, South Carolina, Tennessee, Texas and Washington.
In January 2020, Centene began operating under a one-year emergency contract extension in response to protested contract awards. Louisiana’s state procurement officer overturned the Louisiana Department of Health’s plan to award Medicaid contracts to four health plans, excluding Centene’s Louisiana subsidiary. According to the chief procurement officer, the state health department failed to follow state law or its own evaluation and bid guidelines in its award.
In December 2019, Centene issued approximately $1.0 billion of 4.75% Senior Notes due 2025 (the "Additional 2025 Notes"), $2.5 billion of new 4.25% Senior Notes due 2027 (the "2027 Notes") and $3.5 billion of new 4.625% Senior Notes due 2029 (the "2029 Notes"). Centene used the net proceeds of the 2027 Notes and the 2029 Notes and a portion of the Additional 2025 Notes to finance the cash consideration payable in connection with the WellCare acquisition and to pay related fees and expenses.
In November 2019, Centene announced its Texas subsidiary, Superior HealthPlan, was awarded by the Texas Health and Human Services Commission a contract to continue to provide healthcare services to enrollees in the state’s STAR+PLUS program. The contract is expected to be effective on September 1, 2020, and will allow Superior HealthPlan to offer coverage in two new service areas, for a total of nine service areas.
In October 2019, Centene announced that retired United States Air Force General Lori J. Robinson was elected to serve on Centene’s Board of Directors as a Class I director. General Robinson was appointed to the Nominating and Governance Committee and the Government and Regulatory Affairs Committee.
Accreditations & Awards

In January 2020, FORTUNE magazine named Centene to its 2020 list of Blue Ribbon Companies for appearing on at least four of the 10 most rigorous 2019 annual rankings.
In January 2020, FORTUNE magazine named Centene to its 2020 list of the World’s Most Admired Companies.
In December 2019, Centene’s Texas subsidiary, Superior HealthPlan, earned Accreditation from the National Committee for Quality Assurance (NCQA).
In November 2019, several Centene subsidiaries earned Accreditation from NCQA, including Cenpatico Behavioral Health, Pennsylvania Health and Wellness, and Western Sky Community Care.
Statement of Operations: Three Months Ended December 31, 2019

For the fourth quarter of 2019, total revenues increased 14% to $18.9 billion from $16.6 billion in the comparable period in 2018. The increase over the prior year was primarily due to growth in the Health Insurance Marketplace business, expansions and new programs in many of our states in 2019, particularly Arkansas, Illinois, Iowa, New Mexico and Pennsylvania, and our recent acquisitions in Spain. These increases were partially offset by the health insurer fee moratorium in 2019.
HBR of 88.4% for the fourth quarter of 2019 represents an increase from 86.8% in the comparable period in 2018. The year over year increase was attributable to the Health Insurance Marketplace business where margins have normalized, as expected, from favorable performance in 2018. The increase was also due to the health insurer fee moratorium and a moderate increase in flu related costs. HBR for the fourth quarter was higher than our expectations driven by higher than expected medical costs on our Marketplace business and slightly higher than projected flu costs. Overall, the Marketplace business performed well in 2019 with margins within our stated 5% – 10% range.
HBR increased sequentially from 88.2% in the third quarter of 2019. The increase was primarily attributable to normal seasonality in the Health Insurance Marketplace business.
The SG&A expense ratio was 9.6% for the fourth quarter of 2019, compared to 9.9% in the fourth quarter of 2018. The Adjusted SG&A expense ratio was 9.5% for the fourth quarter of 2019, compared to 9.9% in the fourth quarter of 2018. The SG&A and Adjusted SG&A expense ratios both benefited from the leveraging of expenses over higher revenues and lower variable compensation costs in 2019. The decrease to the SG&A expense ratio was partially offset by an increase in acquisition related expenses over the fourth quarter of 2018.
During the fourth quarter of 2019, Centene redeemed the outstanding principal balance on its $1,400 million 5.625% Senior Notes due February 15, 2021, plus applicable premium for early redemption and accrued and unpaid interest through the redemption date. Centene recognized a pre-tax loss on extinguishment of $30 million on the redemption of the $1,400 million 5.625% Senior Notes, including the call premium, the write-off of unamortized debt issuance costs and a loss on the termination of the $600 million interest rate swap agreement associated with the notes.
The effective tax rate was 22.3% for the fourth quarter of 2019, compared to 32.5% in the fourth quarter of 2018. The decrease in the effective tax rate was due to the impact of the health insurer fee moratorium.
Statement of Operations: Year Ended December 31, 2019

For the full year 2019, total revenues increased 24% to $74.6 billion from $60.1 billion in the comparable period of 2018. The increase over the prior year was primarily due to the acquisition of Fidelis Care, growth in the Health Insurance Marketplace business, and expansions and new programs in many of our states in 2018 and 2019, particularly Arkansas, Illinois, Iowa, New Mexico and Pennsylvania. These increases were partially offset by the health insurer fee moratorium in 2019. Total revenues also increased due to at-risk, state directed and pass through payments of approximately $825 million from the State of California and pass through payments of approximately $531 million from the State of New York.
HBR of 87.3% for the full year 2019 represents an increase from 85.9% in the comparable period in 2018. The HBR increase compared to last year was driven by the Health Insurance Marketplace business where margins have normalized, as expected, from the favorable performance in 2018 and the health insurer fee moratorium. Also, the 2018 HBR benefited from the recognition of the IHSS program reconciliation.
The SG&A expense ratio was 9.3% for the full year 2019, compared to 10.7% for the full year 2018. The year-over-year decrease was primarily due to $336 million of lower acquisition related expenses. The Adjusted SG&A expense ratio was 9.2% for the full year 2019, compared to 10.0% for the full year 2018. The SG&A and Adjusted SG&A expense ratios both decreased due to the acquisition of Fidelis Care, which operates at a lower SG&A expense ratio, the Veterans Affairs contract expiration in 2018, and lower variable compensation costs in 2019.
For the full year 2019, the effective tax rate was 26.5%, consistent with our previous guidance.
Balance Sheet

At December 31, 2019, the Company had cash, investments and restricted deposits of $21.4 billion, including $7.2 billion held by unregulated entities, reflecting the net proceeds from our $7.0 billion senior note issuance in advance of the closing of the WellCare acquisition. Medical claims liabilities totaled $7.5 billion. Total debt was $13.7 billion, which includes $93 million of borrowings on our $2.0 billion revolving credit facility at quarter end. The debt to capitalization ratio was 51.7% at December 31, 2019, excluding $194 million of non-recourse debt. Excluding non-recourse debt and the senior notes issued to fund the WellCare acquisition in advance of closing, our debt to capital was 34.3%.

A reconciliation of the Company’s change in days in claims payable from the immediately preceding quarter-end is presented below:

Days in claims payable, September 30, 2019

Days in claims payable, December 31, 2019

State directed payments that we receive at the end of each quarter are recorded as a component of medical claims liability until paid. We have received state directed payments at the end of most quarters, which has increased our medical claims liability and our days in claims payable. In the fourth quarter of 2019, we did not have any material state directed payments included in our medical claims liability, which decreased our days in claims payable by two days.

Outlook

The Company expects to provide consolidated 2020 annual guidance, including the WellCare acquisition, on Tuesday, March 3, 2020, with a conference call at 8:30 AM (Eastern Time) on Wednesday, March 4, 2020. The Company continues to expect the WellCare acquisition to be no less than break even accretion for the first full year after closing and mid-to-upper single digit accretion in the second full year. Additionally, excluding the effect of the WellCare acquisition, the Company’s stand-alone 2020 guidance is unchanged from the guidance provided at our December investor day.

Conference Call

As previously announced, the Company will host a conference call Tuesday, February 4, 2020, at approximately 8:30 AM (Eastern Time) to review the financial results for the fourth quarter and year ended December 31, 2019. Michael Neidorff and Jeffrey Schwaneke will host the conference call.

Investors and other interested parties are invited to listen to the conference call by dialing 1-877-883-0383 in the U.S. and Canada; +1-412-902-6506 from abroad, including the following Elite Entry Number: 6744563 to expedite caller registration; or via a live, audio webcast on the Company’s website at www.centene.com, under the Investors section.

A webcast replay will be available for on-demand listening shortly after the completion of the call for the next twelve months or until 11:59 PM (Eastern Time) on Tuesday, February 9, 2021, at the aforementioned URL. In addition, a digital audio playback will be available until 9:00 AM (Eastern Time) on Tuesday, February 11, 2020, by dialing 1-877-344-7529 in the U.S. and Canada, or +1-412-317-0088 from abroad, and entering access code 10138090.

Non-GAAP Financial Presentation

The Company is providing certain non-GAAP financial measures in this release as the Company believes that these figures are helpful in allowing investors to more accurately assess the ongoing nature of the Company’s operations and measure the Company’s performance more consistently across periods. The Company uses the presented non-GAAP financial measures internally to allow management to focus on period-to-period changes in the Company’s core business operations. Therefore, the Company believes that this information is meaningful in addition to the information contained in the GAAP presentation of financial information. The presentation of this additional non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP.

Specifically, the Company believes the presentation of non-GAAP financial information that excludes amortization of acquired intangible assets and acquisition related expenses, as well as other items, allows investors to develop a more meaningful understanding of the Company’s performance over time. The tables below provide reconciliations of non-GAAP items ($ in millions, except per share data):

The amortization of acquired intangible assets per diluted share presented above is net of an income tax benefit of $0.04 and $0.04 for the three months ended December 31, 2019 and 2018, respectively, and $0.14 and $0.12 for the year ended December 31, 2019 and 2018, respectively.

The acquisition related expenses per diluted share presented above are net of an income tax benefit of $0.02 and $0.00 for the three months ended December 31, 2019 and 2018, respectively, and $0.06 and $0.25 for the year ended December 31, 2019 and 2018, respectively. Acquisition related expenses for 2019 include net carrying costs on the $7.0 billion senior notes issued in preparation of the WellCare acquisition of approximately $13 million, or $0.02 per diluted share, net of an income tax benefit of approximately $0.01.

The non-cash impairment is net of an income tax benefit of $0.08 for the year ended December 31, 2019. Debt extinguishment costs are net of an estimated income tax benefit of $0.02 for the three months and year ended December 31, 2019. The California Minimum MLR adjustment is net of an income tax benefit of $0.02 for the year ended December 31, 2018

To provide clarity on the way management defines certain key metrics and ratios, the Company is providing a description of how the metric or ratio is calculated as follows:

Health Benefits Ratio (HBR) (GAAP) = Medical costs divided by premium revenues.
SG&A Expense Ratio (GAAP) = Selling, general and administrative expenses divided by premium and service revenues.
Adjusted SG&A Expenses (non-GAAP) = Selling, general and administrative expenses, less acquisition related expenses.
Adjusted SG&A Expense Ratio (non-GAAP) = Adjusted selling, general and administrative expenses divided by premium and service revenues.
Adjusted Net Earnings (non-GAAP) = Net earnings less amortization of acquired intangible assets, less acquisition related expenses, less the goodwill and intangible impairment, less debt extinguishment costs, less the 2018 impact of retroactive changes to the California minimum MLR, net of the income tax effect of the adjustments.
Adjusted Diluted EPS (non-GAAP) = Adjusted net earnings divided by weighted average common shares outstanding on a fully diluted basis.
Debt to Capitalization Ratio (GAAP) = Total debt, divided by total debt plus total stockholder’s equity.
Debt to Capitalization Ratio Excluding Non-Recourse Debt (non-GAAP) = Total debt less non-recourse debt, divided by total debt less non-recourse debt plus total stockholder’s equity.
Average Medical Claims Expense (GAAP) = Medical costs for the period, divided by number of days in such period. Average Medical Claims Expense is most often calculated for the quarterly reporting period.
Days in Claims Payable (GAAP) = Medical claims liabilities, divided by average medical claims expense. Days in Claims Payable is most often calculated for the quarterly reporting period.
In addition, the following terms referenced in this press release and other Company filings are defined as follows:

State Directed Payments: Payments directed by a state that have minimal risk, but are administered as a premium adjustment. These payments are recorded as premium revenue and medical costs at close to a 100% HBR. The Company has little visibility to the timing of these payments until they are paid by a state.
Pass Through Payments: Non-risk supplemental payments from a state that the Company is required to pass through to designated contracted providers. These payments are recorded as premium tax revenue and premium tax expense.

Zimmer Biomet Announces Fourth Quarter and Full-Year 2019 Financial Results

On February 4, 2020 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter and year ended December 31, 2019 (Press release, Zimmer Holdings, FEB 4, 2020, View Source [SID1234553861]). The Company reported fourth quarter net sales of $2.126 billion, an increase of 2.6% over the prior year period, and an increase of 3.2% on a constant currency basis. Net sales for the full year were $7.982 billion, an increase of 0.6% over 2018 and an increase of 2.2% on a constant currency basis. Net earnings for the fourth quarter were $321 million and $478 million on an adjusted basis, and for the full year were $1.132 billion and $1.626 billion on an adjusted basis.

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!

Diluted earnings per share were $1.54 for the fourth quarter and $5.47 for the full year. Adjusted diluted earnings per share were $2.30 for the fourth quarter, an increase of 5.5% over the prior year period, and were $7.87 for the full year, an increase of 3.0% over 2018.

"In 2019 we continued to successfully execute our plan to reposition the company for success, driven by our global team’s focus on our One ZB mission and culture," said Bryan Hanson, President and CEO of Zimmer Biomet. "We continued to invest for growth and drove improved performance in 2019, especially in the second half of the year. We are operating from a position of strength for 2020 and beyond. I am proud of the entire ZB team and their unyielding commitment to the ZB mission and bettering the lives of patients around the world."

Key drivers in the fourth quarter included solid performance from the Americas and Asia Pacific, with continued strong results across our global Knee and Hip businesses. Additionally, ROSA Knee System sales accelerated from the third quarter of 2019.

Please see the attached schedules accompanying this press release for additional details on performance in the quarter, including sales by Zimmer Biomet’s three geographies and six product categories.

Recent Highlights

Fourth quarter launch, positive customer feedback and good momentum for the Persona Revision and Avenir Complete products
The Company began a number of restructuring initiatives, including reorganizing business units to create greater strategic alignment, increased efficiency and improved resource allocation for accelerated growth
Zimmer Biomet named 2019 Medtech Company of the Year by Medical Device and Diagnostic Industry (MD+DI)
Geographic and Product Category Sales

The following sales tables provide results by geography and product category for the three-month period and year ended December 31, 2019, as well as the percentage change compared to the prior year periods, on both a reported basis and a constant currency basis.

Cash Flow and Balance Sheet

Operating cash flow for the fourth quarter was $423 million and free cash flow was $295 million. In the fourth quarter, the Company paid down $161 million of debt, net of debt proceeds, paid $49 million in dividends and declared a dividend of $0.24 per share. Operating cash flow for the full year was $1.586 billion and free cash flow was $1.063 billion. In the full year, the Company paid down $716 million of debt, net of debt proceeds, paid $197 million in dividends and declared dividends of $0.96 per share.

Guidance

The Company is providing the following full-year 2020 financial guidance:

Projected Year Ending December 31, 2020

Expected to be negative in the first half of the year and slightly positive in the second half of the year based on current foreign currency exchange rates

These measures are non-GAAP financial measures for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts. See "Forward-Looking Non-GAAP Financial Measures."

Conference Call

The Company will conduct its fourth quarter and full-year 2019 investor conference call today, February 4, 2020, at 8:30 a.m. Eastern Time. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Haemonetics 3rd Quarter Fiscal 2020 Earnings Release Available on Investor Relations Website

On February 4, 2020 Haemonetics Corporation (NYSE: HAE) reported that financial results for its third quarter fiscal 2020, which ended Dec. 28, 2019, are available on its Investor Relations website (Press release, Haemonetics, FEB 4, 2020, View Source [SID1234553860]).

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!

In addition, the Company is also posting the earnings release and results tables that will be referenced on its webcast.

Direct link to Earnings Release 3Q and YTD FY 20:

View Source

Direct link to Results Tables 3Q and YTD FY 20 for reference on webcast conference call:

View Source

The Company will host a conference call with investors and analysts to discuss and answer questions about the results at 8 a.m. EST Feb. 4, 2020. The call can be accessed with the following information:

U.S. / Canada toll free (877) 848-8880; International (716) 335-9512
Conference ID required for access: 1906607
A live webcast of the call can be accessed on Haemonetics’ Investor Relations website.
Direct link to conference call webcast: View Source

Leap Therapeutics to Present at 22nd Annual BIO CEO & Investor Conference

On February 4, 2020 Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported that Douglas E. Onsi, Chief Financial Officer, will present a corporate overview at the 22nd Annual BIO CEO & Investor Conference, being held in New York City on February 10-11, 2020 (Press release, Leap Therapeutics, FEB 4, 2020, View Source;investor-conference-300998023.html [SID1234553859]).

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!

Leap Presentation Details:

22nd Annual BIO CEO & Investor Conference
Date: Tuesday, February 11, 2020
Time: 11:15 a.m. Eastern Time

The presentation will be webcast live and may be accessed on the Investors page of the company’s website at View Source, where a replay of the event will also be available for a limited time.

Nanospectra Biosciences Initiates Pivotal Study of AuroLase Therapy for Ablation of Prostate Tissue

On February 4, 2020 Nanospectra Biosciences, Inc., a medical device company pioneering a novel use of nanomedicine for selective thermal ablation, reported the start of a pivotal study to determine the efficacy of using MRI/US fusion imaging technology to direct focal ablation of prostate tissue using nanoparticle-directed laser ablation (Press release, Nanospectra Biosciences, FEB 4, 2020, View Source [SID1234553858]). The initial two patient procedures in the pivotal trial have been completed at the University of Michigan, which also participated in the pilot study. The AuroLase pivotal study follows the successful first-in-human pilot study that enrolled 46 subjects at three U.S. sites.

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!

Clinical and functional outcomes of a subset of subjects at the lead site in the feasibility study were published in the prestigious Proceedings of the National Academy of Sciences (PNAS) last August in a paper titled, ‘Gold Nanoshell-Localized Photothermal Ablation of Prostate Tumors in a Clinical Pilot Device Study’. Thirteen of the first 15 prostate cancer patients treated in the clinical trial of the nanoparticle-based, focal therapy showed no detectable signs of cancer upon biopsy in the target ablation zone a year after treatment. The final results of the feasibility study are expected later this year.

The pivotal study is an open-label, multi-center, single-treatment study of AuroLase Therapy for the focal ablation of prostate tissue via nanoparticle directed near infrared irradiation and approved by the FDA under the original IDE. Up to sixty patients will be enrolled at up to eight clinical trial sites throughout the U.S.

Efficacy of focal ablation of prostate tissue will be assessed by MRI/Ultrasound guided target biopsy six months after laser treatment and at one year via targeted biopsy and standard systematic biopsy. Per standard of care, patient follow up will continue beyond the one-year study visit but will be outside the scope of the study. Patients will be consented for up to five years in order to track their disease status and progression or recurrence, if any.

"With AuroLase Therapy, we aspire to deliver a new standard of care for primarily intermediate risk localized prostate cancer patients and clinicians with the potential to significantly reduce side effects, retain all downstream clinical options for future treatment, and enable a more rapid return to a normal lifestyle than surgery, radiation or traditional focal therapies," said David Jorden, CEO of Nanospectra. "We appreciate the high level of interest and collaboration that we have received from our expert investigators, regulatory authorities and partners that has enabled us to move forward expeditiously with this pivotal study while the final study visits for subjects in the feasibility study continue over the first half of this year."

Dr. Ardeshir Rastinehad, Vice Chair of Lenox Hill Urology and System Director of Prostate Cancer/Northwell Health System and the initial study’s lead principal investigator, will present preliminary feasibility study data at the 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer. The conference will be held at the Westin Washington DC City Center on February 9 – 11, 2020.

For additional information on the pivotal study titled "An Extension Study of MRI/US Fusion Imaging and Biopsy in Combination with Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue" visit www.clinicaltrials.gov referencing NCT04240639.

About AuroLase Therapy
Nanospectra’s AuroLase Therapy utilizes the unique ‘optical tunability’ of a new class of nanoparticles, called AuroShells. The particles are delivered intravenously and accumulate in the tumor. The tumor is illuminated with a near-infrared laser. The particles selectively absorb the photonic laser energy, converting the light into heat, which in turn, destroys the tumor and the blood vessels supplying it; sparing adjacent tissue. AuroLase Therapy is used with an FDA-cleared laser that emits near-infrared energy and an FDA-cleared fiber optic probe for energy delivery percutaneously. AuroShell particles (also known as "nanoshells") consist of a gold metal shell and a non-conducting silica core and serve as the exogenous absorber of the near-infrared laser energy delivered by the probe. Nanospectra’s proprietary technology platform is demonstrated to be safe and effective in initial clinical trials and viable for multiple applications including solid tumors, tissue and drug delivery.