On April 23, 2020 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative cell therapy applications, reported the publication of a paper titled, "Cytokine network analysis of immune responses before and after autologous dendritic cell and tumor cell vaccine immunotherapies in a randomized trial," in the Journal of Translational Medicine (Press release, AIVITA Biomedical, APR 23, 2020, View Source [SID1234556526]). Robert O. Dillman, M.D., chief medical officer at AIVITA, and Gabriel I Nistor, M.D., chief scientific officer at AIVITA, authored the article.

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The publication provides insight into the innate and adaptive immune responses induced by patient-specific autologous dendritic cell vaccines (DCV) and autologous tumor cell vaccines (TCV), and their impact on survival. DCV was associated with a multipronged innate and adaptive immune response and correlated with improved survival compared to TCV.

In a randomized Phase 2 trial conducted in patients with melanoma, blood samples were obtained at one week before and one week after a course of three weekly injections, which either included dendritic cells loaded ex vivo with antigens from autologous irradiated tumor-initiating cells (DCV), or autologous irradiated tumor-initiating cells alone (TCV). Cytokine network analysis techniques used to analyze the serologic immune responses generated by each immunotherapy confirmed they triggered differing responses. The results help provide insight into a potential underlying immunologic mechanism of action that contributes to improved survival in DCV-treated patients.

"This analysis reinforces conclusions from our patient-specific cancer vaccine survival data, which suggested that ex-vivo processing of the same tumor antigens by autologous dendritic cells induces a more advantageous immune response than antigen-only based tumor cell vaccines," said Dr. Nistor. "This is reassuring as we continue to further optimize our unique approach in which we use enhanced autologous dendritic cells for targeting each patient’s own tumor."

AIVITA is currently conducting three independent clinical studies investigating its platform immunotherapy in patients with ovarian cancer, glioblastoma and melanoma. AIVITA uses 100% of proceeds from the sale of its ROOT of SKIN skincare line to support the development of its cancer therapeutic pipeline.

About AIVITA’S Clinical Trials

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous tumor-initiating cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the tumor-initiating cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s tumor-initiating cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

For additional information about AIVITA’s AV-MEL-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03743298

On April 23, 2020 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported financial results for the quarter ended March 31, 2020 (Press release, Edwards Lifesciences, APR 23, 2020, View Source [SID1234556558]).

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First Quarter Results and Outlook

Sales grew nearly 14% to $1.1 billion
TAVR sales grew 24%; underlying1 sales grew 25%
EPS was $1.47; adjusted1 EPS grew 14% to $1.51
Sales were significantly impacted by the effects of COVID-19 the last few weeks of Q1
2020 sales and EPS guidance substantially reduced as a result of COVID-19
"I want to recognize the extraordinary actions that our 14,000 employees around the world have taken to overcome the unique challenges associated with COVID-19," said Michael A. Mussallem, chairman and CEO. "On behalf of everyone at Edwards, I want to express our deep gratitude to our clinician partners and the global healthcare community for their tireless dedication to serving patients during this challenging time. We appreciate their strong leadership and brave commitment to patient care, and we are dedicated to supporting them as they address this global health crisis."

First Quarter 2020 Results

Sales for the quarter ended March 31, 2020 were $1.1 billion, up 14% over the prior year on both a reported and underlying basis. Diluted earnings per share for the quarter were $1.47, while adjusted earnings per share grew 14%, to $1.51.

Transcatheter Aortic Valve Replacement (TAVR)

For the quarter, the company reported global TAVR sales of $742 million, an increase of approximately 24% over the first quarter last year, or 25% on an underlying basis. Global TAVR sales growth through early March was consistent with the company’s fourth quarter global growth rate. This was dramatically impacted in the last few weeks of the quarter as procedures decreased as a result of COVID-19 disruptions. Globally, average selling prices were stable.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

First quarter TMTT sales were $10 million. From a commercial standpoint, the company experienced strong momentum with accelerated adoption of the PASCAL mitral valve system in Europe. TMTT sales were tracking to expectations until the last few weeks of the quarter, when sales declined abruptly due to the impact of COVID-19.

Edwards remains focused on transforming care for patients with mitral and tricuspid valvular disease by developing a portfolio of innovative therapies supported by a growing body of clinical evidence. The company continues to gain experience and make meaningful progress across its portfolio and investors can expect to hear informative updates regarding the PASCAL system, Cardioband and EVOQUE tricuspid replacement valve system at the upcoming EuroPCR medical meeting.

Surgical Structural Heart and Critical Care

Surgical Structural Heart sales for the quarter were $193 million, down 10% compared to the first quarter of 2019, and down 9% on an underlying basis. As expected, driven by the rapid adoption of TAVR, the U.S. surgical aortic valve procedure headwinds experienced in the fourth quarter persisted into the first quarter. This was partially offset by the continued adoption of the company’s premium INSPIRIS surgical aortic valve. During the last few weeks of March, there was a sharp deceleration in procedures related to COVID-19.

Critical Care sales were $183 million for the quarter, representing an increase of 4% versus the first quarter of 2019, or 1% on an underlying basis. This performance was lifted by strong demand for the company’s disposable pressure monitoring devices used in intensive care units as a result of the COVID-19 pandemic.

Additional Financial Results

For the quarter, the company’s adjusted gross margin was 76.7%, consistent with the prior year quarter. This year’s rate benefitted from a favorable product mix, offset by lower FX hedge gains and spending in support of the new European Medical Device regulations.

Selling, general and administrative expenses increased 10% to $308 million for the quarter, driven by additions that Edwards has made in field clinical personnel to support TAVR cases in the U.S. and TMTT in Europe.

Research and development for the first quarter increased 9% to $187 million, or 16.6% of sales. This increase was primarily the result of continued investments in the company’s transcatheter mitral and tricuspid therapies.

Free cash flow for the first quarter was $125 million, defined as cash flow from operating activities of $207 million, less capital spending of $82 million.

Cash, cash equivalents and short-term investments totaled $1.0 billion at March 31, 2020. Total debt was $595 million. The company purchased 3 million shares for $615 million during the first quarter.

Outlook

As it is difficult to accurately predict the progression of COVID-19 and the extent of the disruption to hospital procedures utilizing the Edwards therapies, there is a wide range of potential outcomes for sales and earnings for 2020. The company assumes the impact of COVID-19 on sales will be most severe in the second quarter, followed by a gradual recovery in the third quarter, and a fourth quarter that better resembles its original expectations for sales.

Overall, 2020 sales guidance for Edwards is now expected to be $4.0 to $4.5 billion versus the company’s previous range of $4.6 to $5.0 billion. Additionally, the company now expects full year 2020 adjusted earnings per share of $4.75 to $5.25 versus previous guidance of $6.15 to $6.40. For the second quarter of 2020, the company projects total sales to be between $700 and $900 million.

"This is a very difficult time for structural heart patients as they weigh the risk of COVID-19 versus the severe effects of progressive heart valve disease. We will continue to actively engage with healthcare providers as they confront extraordinary disruptions in 2020. There are still many patients in need and we remain confident in our long-term patient-focused strategy and innovation pipeline," said Mussallem.

On April 23, 2020 CStone Pharmaceuticals reported that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) of the precision therapy avapritinib for two indications, one for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations; the other for the treatment of adults with unresectable or metastatic fourth-line GIST (Press release, CStone Pharmaceauticals, APR 23, 2020, View Source [SID1234556527]). Developed by CStone’s partner Blueprint Medicines, avapritinib is an investigational, orally available, potent and selective inhibitor of KIT and PDGFRA mutant kinases. This is the first time CStone has submitted an NDA to the NMPA and marks another milestone in the Company’s transition toward commercialization.

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With an annual incidence rate of 1-1.5 per 100,000, there are approximately 14,000 to 21,000 new cases of GIST in China every year1, and around 90% of these cases are associated with dysregulated cell growth due to mutations in KIT or PDGFRA tyrosine kinases. In January 2020, avapritinib was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, and became the first precision medicine approved for the treatment of GIST harboring a PDGFRA exon 18 mutation in the United States.

"In just three months after avapritinib was approved by the U.S. FDA, CStone has submitted NDAs for this drug candidate in Taiwan and mainland China, which we hope will soon make this first-in-class precision therapy candidate accessible to patients with advanced GIST in Greater China," said Dr. Frank Jiang, Chairman and CEO of CStone. "As CStone continues to accelerate its transition toward commercialization, we plan to submit several NDAs in China across multiple indications for our lead assets in the next few months."

"Avapritinib has demonstrated outstanding antitumor activity and a well-tolerated safety profile in advanced PDGFRA exon 18 mutant GIST and fourth-line GIST. Due to the very limited benefits from approved treatment options in these two groups of GIST patients, there is an urgent unmet clinical need for new therapies," said Lin Shen, M.D., Professor and Director of Department of Gastrointestinal Oncology, Vice President of Peking University Cancer Hospital and Institute, and the principal investigator for the bridging study of avapritinib in GIST in China. "As a physician, I hope avapritinib will soon be available in our clinical practice for the treatment of advanced GIST."

Results from the Phase I NAVIGATOR study of avapritinib in PDGFRA exon 18 mutant GIST and fourth-line GIST were presented at the Connective Tissue Oncology Society Annual Meeting in November 2019. As of the data cutoff date of November 16, 2018:

43 patients with PDGFRA exon 18 mutant GIST and 111 patients with fourth-line GIST were treated at a starting dose of 300 or 400 mg once daily and evaluable for response assessments.
In patients with PDGFRA Exon 18 mutant GIST, the overall response rate (ORR) was 86% with one response pending confirmation, and the median duration of response (DOR) was not reached.
In patients with fourth-line GIST, the ORR was 22% with one response pending confirmation, and the median DOR was 10.2 months.

The Phase I/II bridging study conducted by CStone in patients with advanced GIST in China has produced encouraging preliminary results demonstrating avapritinib was well-tolerated, and safety and pharmacokinetic profiles were consistent with those previously reported for the global NAVIGATOR study.

"The current treatment approach for GIST in China is mainly based on sequential tyrosine kinase inhibitors (TKIs), but the approved TKIs only offer limited efficacy2 in patients with PDGFRA D842V mutations. Moreover, Chinese patients with fourth-line GIST face challenges on multiple fronts, including drug-resistant mutations and a lack of effective treatment options," said Dr. Jason Yang, Chief Medical Officer of CStone. "I am pleased that the bridging study in China has yielded results consistent with those from the global NAVIGATOR study, and I hope patients with advanced GIST who are in urgent need for new treatment options will benefit from this precision therapy in the near future."

CStone Pharmaceuticals and Blueprint Medicines have an exclusive collaboration and license agreement for the development and commercialization of avapritinib and certain other drug candidates in mainland China, Hong Kong, Macau and Taiwan. Blueprint Medicines retains development and commercial rights for these licensed products in the rest of the world.

On April 23, 2020 Idera Pharmaceuticals, Inc. ("Idera") (Nasdaq: IDRA) reported that updates on ILLUMINATE-206 and ILLUMINATE-101, two studies investigating intratumoral tilsotolimod, Idera’s investigational Toll-like receptor 9 (TLR9) agonist, will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020, as part of a "Clinical Trial Poster Session (Press release, Idera Pharmaceuticals, APR 23, 2020, View Source [SID1234556543])."

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ILLUMINATE-206 is an ongoing phase 2, open-label, multicohort, multicenter study to test the safety and efficacy of intratumoral tilsotolimod in combination with Yervoy* (ipilimumab) and Opdivo (nivolumab) for the treatment of solid tumors. The trial initiated in September 2019 with the microsatellite stable colorectal cancer (MSS-CRC) cohort. A description of the trial in progress will be presented.

ILLUMINATE-101 was a phase 1b trial of intratumoral tilsotolimod monotherapy in patients with refractory solid tumors, which was completed in December 2019. Final results will be presented.

Hani M. Babiker, M.D., from the University of Arizona Cancer Center will present both studies. The abstract titles are as follows:

Abstract # 10614: Tilsotolimod engages the TLR9 pathway to promote antigen presentation and Type-I IFN signaling in solid tumors

Abstract # 10591: A phase 2 multicenter study to evaluate the efficacy of tilsotolimod in combination with nivolumab and ipilimumab for treatment of microsatellite-stable colorectal cancer (ILLUMINATE-206)
"We are very pleased that Dr. Babiker from the University of Arizona Cancer Center will present information from our studies investigating tilsotolimod in solid tumors," stated Elizabeth Tarka, M.D., Idera’s Chief Medical Officer. "We continue to be excited about the broader potential of tilsotolimod beyond melanoma."

The abstracts and video presentations will be available at 12:01 AM ET on Monday, April 27. Video presentations will be available for viewing on demand through the virtual meeting platform.

About Tilsotolimod (IMO-2125)

Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate and adaptive immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint and costimulation therapies. For more information on tilsotolimod trials, please visit ClinicalTrials.gov.

On April 23, 2020 eHealth, Inc. (NASDAQ: EHTH), a leading private online health insurance marketplace, reported its financial results for the first quarter ended March 31, 2020 (Press release, eHealth Insurance, APR 23, 2020, View Source [SID1234556559]).

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Scott Flanders, chief executive officer of eHealth stated, "In this challenging environment shaped by the COVID-19 pandemic, our company mission to connect every person with the highest quality, most affordable health insurance for their life circumstances is more relevant and important than ever. As social distancing measures remain in place around the country, we are glad to be able to continue to meet consumers wherever it is easiest, most convenient, and safest for them to engage – online and by speaking to a licensed insurance agent over the phone."

Mr. Flanders continued, "Building on our strong momentum of the past two years, and our record performance in 2019, we are pleased to deliver another quarter of outperformance. The fundamentals of our business are strong and we are achieving strong operating metrics across the business by executing on a clear strategy and making targeted investments to drive growth. Our updated 2020 annual guidance reflects our outperformance to-date, but does not include the additional investments we are contemplating and planning for this year’s Annual Enrollment Period. These will be provided in conjunction with our second quarter results."

GAAP — First Quarter of 2020 Results

Revenue — Revenue for the first quarter of 2020 totaled $106.4 million, a 55% increase compared to $68.8 million for the first quarter of 2019. Commission revenue for the first quarter of 2020 totaled $99.7 million, a 55% increase compared to $64.2 million for the first quarter of 2019. Other revenue for the first quarter of 2020 was $6.7 million, a 48% increase compared to $4.5 million for the first quarter of 2019.

Revenue from our Medicare segment was $96.2 million for the first quarter of 2020, a 75% increase compared to $54.9 million for the first quarter of 2019. Revenue from our Individual, Family and Small Business segment was $10.3 million for the first quarter of 2020, a 26% decrease compared to $13.9 million for the first quarter of 2019.

Income (Loss) from Operations — Income from operations for the first quarter of 2020 was $1.0 million compared to loss from operations of $9.2 million for the first quarter of 2019.

Pre-Tax Income (Loss) — Pre-tax income for the first quarter of 2020 was $1.4 million compared to pre-tax loss of $8.6 million for the first quarter of 2019.

Benefit from Income Taxes — Benefit from income taxes for the first quarter of 2020 was $2.0 million compared to $3.5 million for the first quarter of 2019.

Net Income (Loss) — Net income for the first quarter of 2020 was $3.5 million, or $0.13 net income per diluted share, compared to net loss of $5.2 million, or $0.24 net loss per diluted share, for the first quarter of 2019.

Segment Profit — Medicare segment profit was $22.0 million for the first quarter of 2020, a 103% increase compared to $10.8 million for the first quarter of 2019. Profit from our Individual, Family and Small Business segment was $2.6 million for the first quarter of 2020, a 57% decrease, compared to $6.0 million for the first quarter of 2019.

Non-GAAP — First Quarter of 2020 Results

Non-GAAP Net Income — Non-GAAP net income for the first quarter of 2020 was $10.3 million, or $0.39 non-GAAP net income per diluted share, compared to non-GAAP net income of $7.2 million, or $0.33 non-GAAP net income per diluted share, for the first quarter of 2019.

Non-GAAP net income and non-GAAP net income per diluted share for the first quarter of 2020 are calculated by excluding $8.7 million of stock-based compensation expense, $0.5 million of amortization of intangible assets and $2.4 million of the income tax effect of these non-GAAP adjustments from GAAP net income and GAAP net income per diluted share.

Non-GAAP net income and non-GAAP net income per diluted share for the first quarter of 2019 are calculated by excluding $3.2 million of stock-based compensation expense, $13.3 million of expense for the change in fair value of earnout liability related to our acquisition of GoMedigap, $0.5 million of amortization of intangible assets, and $4.7 million of the income tax effect of these non-GAAP adjustments from GAAP net loss and GAAP net loss per diluted share.

Adjusted EBITDA — Adjusted EBITDA was $11.1 million for the first quarter of 2020 compared to $8.6 million for the first quarter of 2019. Adjusted EBITDA is calculated by adding stock-based compensation, change in fair value of earnout liability related to our acquisition of GoMedigap, depreciation and amortization expense, amortization of intangible assets, other income, net, and benefit from income taxes to GAAP net income (loss).

Approved Members, New Paying Members and Estimated Membership

Approved Members — The number of approved members for all Medicare products, which includes Medicare Advantage, Medicare Supplement and Medicare Part D Prescription Drug Plans, was 84,702 in the first quarter of 2020, a 46% increase compared to 57,899 in the first quarter of 2019. The number of approved members for major medical individual and family plan products declined by 19% in the first quarter of 2020 to 9,365 compared to 11,598 in the first quarter of 2019.

New Paying Members — The number of new paying members for all Medicare products was 161,564 in the first quarter of 2020, a 61% increase compared to 100,113 in the first quarter of 2019. The number of new paying members for major medical individual and family plan products was 15,510, a 28% decrease compared to 21,402 in the first quarter of 2019. New Paying Members consist of approved members from the period presented and any periods prior to the period presented from whom we have received an initial commission payment during the period presented.

Estimated Membership — Total estimated membership as of March 31, 2020 was 1,136,954, a 19% increase compared to 952,239 estimated members we reported as of March 31, 2019. Estimated Medicare membership as of March 31, 2020 was 725,943, a 44% increase compared to 503,877 estimated members reported as of March 31, 2019. Estimated major medical individual and family plan membership as of March 31, 2020 was 113,483, a 13% decrease compared to 130,297 estimated members reported as of March 31, 2019.

Cash — First Quarter of 2020

Cash Flows — Net cash provided by operating activities was $8.9 million for the first quarter of 2019, compared to net cash provided by operating activities of $12.7 million for the first quarter of 2019.

2020 Guidance

Based on information available as of April 23, 2020, eHealth is updating its guidance for the full year ending December 31, 2020 previously provided on February 20, 2020. These expectations are forward-looking statements and eHealth assumes no obligation to update these statements. Actual results may be materially different and are affected by the risk factors and uncertainties identified in this press release and in eHealth’s annual and quarterly filings with the Securities and Exchange Commission.

The following is the updated guidance for the full year ending December 31, 2020:

Total revenue is expected to be in the range of $600.0 million to $640.0 million, compared to the previous guidance of $580.0 million to $620.0 million. Revenue from the Medicare segment is expected to be in the range of $553.0 million to $589.0 million, compared to the previous guidance of $533.0 million to $569.0 million. Revenue from the Individual, Family and Small Business segment is expected to be in the range of $47.0 million to $51.0 million, consistent with the previous guidance.
GAAP net income is expected to be in the range of $70.0 million to $85.0 million, compared to the previous guidance of $68.0 million to $83.0 million.
Adjusted EBITDA(a) is expected to be in the range of $125.0 million to $140.0 million, compared to the previous guidance of $120.0 million to $135.0 million.
Medicare segment profit(b) is expected to be in the range of $157.0 million to $174.0 million, compared to the previous guidance of $152.0 million to $169.0 million. Individual, Family and Small Business segment profit is expected to be in the range of $17.0 million to $18.0 million, consistent with the previous guidance.
Corporate(c) shared service expenses, excluding stock-based compensation and depreciation and amortization expense, is expected to be in range of $49.0 million to $52.0 million, consistent with the previous guidance.
Cash used in operations is expected to be in the range of $61.0 million to $64.0 million, compared to the previous guidance of $52.0 million to $55.0 million, and cash used for capital expenditures is expected to be $18.0 million to $20.0 million, consistent with the previous guidance.
GAAP net income per diluted share is expected to be in the range of $2.55 to $3.10, compared to the previous guidance of $2.64 to $3.23 per share.
Non-GAAP net income per diluted share(d) is expected to be in the range of $3.41 to $3.90, compared to the previous guidance of $3.56 to $4.09 per share.

Adjusted EBITDA is calculated by adding stock-based compensation, change in fair value of earnout liability, depreciation and amortization expense, amortization of intangible assets, other income, net, and provision (benefit) for income taxes to GAAP net income (loss).

Segment profit is calculated as revenue for the applicable segment less Marketing and Advertising, Customer Care and Enrollment, Technology and Content and General and Administrative operating expenses, excluding stock-based compensation, change in fair value of earnout liability, depreciation and amortization expense and amortization of intangible assets, that are directly attributable to the applicable segment and other indirect Marketing and Advertising, Customer Care and Enrollment and Technology and Content operating expenses, excluding stock-based compensation, depreciation and amortization expense and amortization of intangible assets, allocated to the applicable segment based on usage.

Corporate consists of other indirect General and Administrative operating expenses, excluding stock-based compensation and depreciation and amortization expense, which are managed in a corporate shared services environment and, since they are not the responsibility of segment operating management, are not allocated to the reportable segments.

Non-GAAP net income per diluted share is calculated by adding stock-based compensation expense per diluted share, change in fair value of earnout liability per diluted share, intangible asset amortization expense per diluted share and the income tax effect of these non-GAAP adjustments to GAAP net income per diluted share.

Webcast and Conference Call Information

A Webcast and conference call will be held today, Thursday, April 23, 2020 at 5:00 p.m. Eastern / 2:00 p.m. Pacific Time. The live Webcast and supporting presentation slides will be available on the Investor Relations section of eHealth’s website at View Source Individuals interested in listening to the conference call may do so by dialing (877) 930-8066 for domestic callers and (253) 336-8042 for international callers. The participant passcode is 8091632. A telephone replay will be available two hours following the conclusion of the call for a period of seven days and can be accessed by dialing (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The call ID for the replay is 8091632. The live and archived webcast of the call will also be available on eHealth’s website at View Source under the Investor Relations section.