BioInvent Interim Report January 1 – March 31, 2020

On April 28, 2020 BioInvent Interim Report January 1 – March 31, 2020 (Press release, BioInvent, APR 28, 2020, View Source;march-31-2020-301048103.html [SID1234556728])

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Promising progress reported for BI-1206 in combination with rituximab

"We have made a strong start to 2020 and remain on track to deliver on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners."

Martin Welschof, CEO BioInvent

Financial information first quarter 2020

Net sales SEK 16.7 (17.4) million.
Loss after tax SEK -32.6 (-27.8) million.
Loss after tax per share before and after dilution SEK -0.07 (-0.08).
Cash flow from operating activities and investment activities SEK -35.4 (-40.5) million. Liquid funds as of March 31, 2020: SEK 117.1 (28.5) million.
Events in the first quarter

BioInvent and Transgene announced that the first clinical trial application for BT-001 was submitted and that the first-in-human trial is expected to start before the end of 2020 in Europe and the US.
BioInvent announced an agreement with SkylineDx to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206.
Events after the reporting period

In April 2020, promising progress was reported in the Phase I/lla trial of lead program BI-1206 in combination with rituximab. A complete response was observed in one follicular lymphoma patient and complete depletion of circulating tumoral cells in a mantle cell lymphoma patient. (R)
(R)= Regulatory event
Comments from the CEO

BioInvent has made a strong start to 2020 and remains on track for delivery on our goals. Our lead candidate, BI-1206, continues to make good progress, while we are developing promising preclinical assets and continuing the good work with our partners.

It was very pleasing to report promising progress in the Phase I/lla trial of BI-1206 in combination with rituximab for the treatment of Non-Hodgkin Lymphoma (NHL). Three separate responses have been observed across different subtypes of NHL at doses of BI-1206 below what is believed to be optimal. Particularly notable was that one patient in the 70mg cohort achieved a complete response and another patient had complete depletion of circulating mantle cell lymphoma cells. Of course, this is a very early stage in the study, and this part of it is designed to evaluate safety and tolerability. All the same, these initial signs of efficacy are very encouraging.

We have also concluded an agreement with SkylineDx, a molecular diagnostics company focusing on discovery of novel gene-based biomarkers, to characterize the gene expression and immunological signatures in tumors of patients pre- and post-treatment with BI-1206. This is particularly interesting because identifying the right patients who are likely to respond to treatment with BI-1206 will constitute a major asset in the development of this promising treatment and, along with FcγRIIB expression levels, should support the extension of its use to other malignancies.

Further along our pipeline, BioInvent and our partner Transgene have submitted the first clinical trial application for BT-001, a multifunctional oncolytic virus which was engineered to encode a Treg-depleting, anti-CTLA4 antibody from our proprietary n-CoDeR/F.I.R.S.TTM platforms. The first-in-human trial is expected to start before the end of 2020 in Europe and the U.S. and we believe that the potential to combine anti-CTLA4, anti-PD-1/PD/L1 and oncolytic immunotherapy could change the treatment paradigm for multiple solid tumors.

Thus, our technology platform continues to produce exciting potential new treatments, ready for developing through clinical trials and to address important unmet medical needs.

As BioInvent continues to bring new programs towards clinical development, financing is of course a priority and we will continue to use a combination of sources for funding. Firstly, we are engaged in several business development discussions with the aim of partnering one or more of the programs in our portfolio. Secondly, the collaboration with Pfizer, which is also a model for other potential collaborations which commercialize our platform. Thirdly, our manufacturing capabilities generate revenue, with the most recent agreement with CRUK expected to generate SEK 30 million. CRUK has the potential to become a long-term strategic partner, as it works with a number of small- to mid-sized companies that need manufacturing support. And our fourth option is to use capital markets for financing. Based on the support from our large institutional investors and increased interest in our programs we feel optimistic that a combination of these four sources will continue to support BioInvent financially. The Board of Directors follows the financing situation and is working on a plan to ensure the Group’s continued financing.

The spread of COVID-19 has changed all our lives and BioInvent is no exception. We are taking all the necessary precautions and continue to monitor its spread and associated measures closely. BioInvent has clinical trials in process and clinical trials soon to be initiated and the global measures against COVID-19 and the need to prioritize healthcare resources will likely affect the timelines for these studies.

The precise impact is difficult to assess at this stage, given the rapidly developing situation. Currently, we still expect the early results from the Phase I open label study with a combination of BI-1206 and rituximab for treatment of NHL in H2 2020. Early clinical trial results for BI-1206 in combination with pembrolizumab and clinical trial initiations in other programs also remain on track. As the situation is still evolving, timelines are still subject to potential changes and we will provide updates as necessary.

BioInvent is delivering consistently on its strategy as we progress through 2020, despite the disruption caused to the world by the spread of COVID-19. We wish you and your families the best of health, and will continue to keep you up to date on our exciting progress.

Orexo Presents the Interim Report for Q1 2020

On April 28, 2020 Orexo reported the Interim Report for Q1 2020 (Press release, Orexo, APR 28, 2020, View Source [SID1234556727]).

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Q1 2020 highlights

Total net revenues of SEK 175.0 m (174.3), up 0.4 percent
EBITDA of SEK 39.1 m (12.0), up 225.8 percent
Net earnings of SEK 82.6 m (14.1), up 485.8 percent
US Pharma (Zubsolv US) net revenues of SEK 163.9 m (161.7), up 1.3 percent in SEK and -4.0 percent in local currency. HQ & Pipeline net revenues of SEK 11.1 m (12.6).
US Pharma (Zubsolv US) EBIT of SEK 75.9 m (68.2), up 11.2 percent, Digital Therapeutics EBIT of SEK -12.0 m (-) and HQ & Pipeline EBIT of SEK -29.9 m (-67.1)
Cash flow from operating activities of SEK 48.1 m (50.9), building a cash balance of SEK 861.4 m (647.4)
OX338 showed promising results from the human PK-study, assessing novel ketorolac formulations for treatment of pain
Application for vorvida submitted to FDA to enable commercialization in the US
Net sales potential for the development projects were communicated in connection to the company’s Capital Markets Day, see Operations/pharmaceuticals and digital therapies
Repurchased 14 percent of the company’s outstanding corporate bonds with a nominal value of SEK 40.5 m
Important events after the end of the period

Completed the program to repurchase 500,000 of the company’s ordinary shares, equalling to approx. 1.4 percent of the total issued ordinary shares in the company
James Noble elected Chairman of the Board and Charlotte Hansson elected as Board member at the Annual General Meeting. They replace Martin Nicklasson and Kristina Schauman who have declined re-election.
Financial outlook 2020 is reiterated
SEK m, unless otherwise stated

2020
Jan-Mar

2019
Jan-Mar

2019
Jan-Dec

Δ
2019-2020

Net revenues

175.0

174.3

844.8

0.4%

Cost of goods sold

-20.0

-25.3

-105.6

-21%

Operating expenses

-121.1

-147.9

-508.0

-18%

EBIT

34.0

1.1

231.2

2991%

EBIT margin, %

19.4

0.6

27.4

18.8 ppt

EBITDA

39.1

12.0

272.1

226%

Earnings per share, before dilution, SEK

2.38

0.41

6.33

483%

Earnings per share, after dilution, SEK

2.34

0.40

6.20

484%

Cash flow from operating activities

48.1

50.9

287.0

-5.6%

Cash and cash equivalents

861.4

647.4

816.8

33%

CEO Comments: Resilient business driving continued growth in challenging times

I am pleased to report a solid financial performance for the first quarter with both profitability and cash improving. This reflects the progress at our US Pharma operations with an EBIT contribution margin of 46 percent. The impact of COVID-19 has, both operationally and financially, been limited at this stage. Longer-term we anticipate demand for addiction treatments will increase alongside accelerated adoption of digital therapies as a consequence of the COVID-19 pandemic.

Significant continued improvement in cash position – SEK 39 m in EBITDA and SEK 861 m in cash

Our Q1 performance is in line with expectations, with a decline in the demand for Zubsolv due to generic competition in some previously exclusive contracts with United Health Group and Humana. The reduction in sales volume has been offset by higher average net prices, a reduction in product returns and improved gross margins. Early indicators suggest COVID-19 is impacting market dynamics, resulting in an increase in the average prescription size and an uptick in demand for Zubsolv was seen during March. This partially reflects increased inventory build but feedback from the market also indicates a higher demand for treatment as access to illegal drugs declines. Longer-term the COVID-19 pandemic is expected to increase demand for addiction treatment, in line with previously challenging economic market conditions, which saw an increase in substance misuse.

One effect of the uncertainty caused by COVID-19 has been a weakening of the SEK. With all of our revenues and EBIT contribution from our US operations being USD denominated this translates into a positive impact on Orexo’s financial results. We have leveraged this opportunity to reduce exposure to USD, through repurchasing of our corporate bond and of 500,000 shares, and realizing an exchange rate gain of SEK 29 m.

Digital Therapies – high growth opportunity with potential to increase access to treatment

The impact from COVID-19 is already being felt by most businesses but for some it presents an opportunity to accelerate the adoption of new technologies including video conferencing and digital health. Orexo, with its increasing focus on digital therapeutics, could play an important role in providing treatments for patients at a time when COVID-19 is severely impacting access to treatment. Subject to receiving FDA clearance for vorvida, a digital therapy designed to offer patients high quality psychotherapy to treat harmful alcohol misuse, Orexo will review opportunities for an accelerated launch.

During the quarter we hosted a Capital Markets Day and provided some additional insights on the market potential and initial investment required to develop our digital therapeutics offering. Digital therapies are still in their infancy in terms of market adoption but present an attractive market opportunity. Based on Orexo’s conservative estimates we believe vorvida and OXD01, for the treatment of opioid use disorder, have a combined revenue potential which could exceed USD 400 m.

In light of COVID-19 and changes to market access for digital therapies, we will consider investing in an earlier and broader launch, if the opportunity exists for both vorvida and OXD01.

R&D – promising pipeline of next wave therapeutics to address growing market opportunity

Our pipeline development remains on track at present and we plan to initiate the first exploratory study for OX125 in H1 2020 and the pivotal trial for OX124 late in H2 this year. Both projects are rescue medications for the treatment of opioid overdose and are based on new and unique technologies involving partners in different geographies. If COVID-19 continues indefinitely and travel restrictions remain in place, this could impact trial timelines.

During the Capital Markets Day we also provided analysis of the revenue potential of our pipeline, including the combined potential of OX124 and OX125, estimated at USD 110-170 m in the current market environment. The market opportunity for OX338, our phase I candidate for the treatment of pain without using opioids, is harder to estimate as it applies to a very broad market, but is conservatively valued at USD 100 m. I am pleased with our pipeline development to date and expect to file for regulatory approval of OX124 as early as next year, a product which has the potential to exceed Zubsolv revenues and could become an important growth driver for Orexo.

Summary and Outlook

I am very proud of how the Orexo team has responded to the global crisis presented by COVID-19, minimizing to date any material negative impact on our business whilst also ensuring the safety of our employees and partners. We will continue to monitor government guidance including US lockdown measures, which may impact our financial outlook if they continue into H2 2020. That said Orexo is a profitable and well-funded business with a promising pipeline of next-generation treatments, including innovative digital therapies, and is well placed to weather the current challenges posed by COVID-19.

Uppsala, Sweden, April 28, 2020

Nikolaj Sørensen
President and CEO

Presentation

At 2.00 pm CET, the same day as the announcement of the report, Orexo invites analysts, investors and media to attend an audiocast with a web presentation where Nikolaj Sørensen, CEO, and Joseph DeFeo, CFO, will present the report. After the presentation a Q&A will be held. Questions can also be sent in advance to [email protected], no later than 11.00 am CET. Please view the instructions below on how to participate.
Internet: View Source
Telephone: SE +46 8 50 55 83 55 UK +44 33 33 00 92 73 US +1 83 38 23 05 89
The presentation material will be available on Orexo’s website prior to the audiocast.

This information is information that Orexo AB (publ.) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 8.00 am CET on April 28, 2020.

Theravance Biopharma to Report First Quarter 2020 Financial Results on May 6, 2020

On April 28, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported that it will report its first quarter 2020 financial results and provide a business update after market close on Wednesday, May 6, 2020. An accompanying conference call and simultaneous webcast will be hosted at 5:00 p.m. ET (2:00 p.m. PT/9:00 p.m. GMT) that day (Press release, Theravance, APR 28, 2020, View Source [SID1234556726]).

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Conference Call Information

To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 8371418. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investor Relations section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through June 5, 2020. An audio replay will also be available through 8:00 p.m. ET on May 13, 2020 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 8371418.

Centene Corporation Reports First Quarter 2020 Results

On April 28, 2020 Centene Corporation (NYSE: CNC) reported its financial results for the first quarter ended March 31, 2020, reporting diluted earnings per share (EPS) of $0.08 and Adjusted Diluted EPS of $0.86 (Press release, Centene , APR 28, 2020, View Source [SID1234556725]).

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(1) A full reconciliation of Adjusted SG&A expense ratio and Adjusted Diluted EPS are shown on page seven of this release.

Both diluted EPS and Adjusted Diluted EPS have been negatively impacted by $0.05 due to lower investment income and incremental senior note interest expense. Taking into account the $0.05 per diluted share, our Adjusted Diluted EPS was in line with our expectations and the guidance of high $0.80 to low $0.90 range provided on March 4, 2020.

"We all recognize the unprecedented nature of the COVID-19 pandemic and the significant impact from both a health and economic perspective. This is not a business as usual environment and economic recovery will be choppy. In this challenging landscape that we all face, Centene has the team, systems, expertise and financial strength to rise to the occasion," said Michael F. Neidorff, Chairman, President and Chief Executive Officer of Centene. "We are confident in our approach to navigate the crisis while executing on our priorities and remain highly committed to meeting the needs of our members, providers and our state customers."

First Quarter Highlights

On January 23, 2020, Centene acquired all of the issued and outstanding shares of WellCare Health Plans, Inc. (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. Our consolidated financial statements as of and for the three months ended March 31, 2020 reflect WellCare operations beginning January 23, 2020.
March 31, 2020 managed care membership of 23.8 million, an increase of 9.0 million members, or 61%, over March 31, 2019.
Total revenues of $26.0 billion for the first quarter of 2020, representing 41% growth compared to the first quarter of 2019.
Health benefits ratio (HBR) of 88.0% for the first quarter of 2020, compared to 85.7% in the first quarter of 2019.
Selling, general and administrative (SG&A) expense ratio of 9.9% for the first quarter of 2020, compared to 9.6% for the first quarter of 2019.
Adjusted SG&A expense ratio of 8.6% for the first quarter of 2020, compared to 9.5% for the first quarter of 2019.
Diluted EPS for the first quarter of 2020 of $0.08, compared to $1.24 for the first quarter of 2019, reflecting an increase of acquisition related expenses due to the closing of the WellCare acquisition.
Adjusted Diluted EPS for the first quarter of 2020 of $0.86, compared to $1.39 for the first quarter of 2019. Both diluted EPS and Adjusted Diluted EPS for the first quarter of 2020 have been negatively impacted by $0.05 due to lower investment income and incremental senior note interest expense. The $0.05 of lower investment and other income resulted from a sharp decrease in interest rates, which caused a fair value decrease to our exchange traded fund portfolio, as well as incremental interest expense associated with our decision to defer the redemption of the 2022 senior debt securities.
Share repurchases of 9 million shares of Centene common stock for $500 million through the Company’s stock repurchase program during the three months ended March 31, 2020, using divestiture proceeds.
Operating cash flow of $(240) million for the first quarter 2020. Operating cash flow was negatively affected by a delay in premium payments from the state of New York of approximately $700 million and growth in our Medicare Prescription Drug Plan (PDP) business, which used working capital.
Other Events

In April 2020, Centene’s subsidiary, Centurion, was awarded a contract by the Kansas Department of Administration to provide healthcare services in the Department of Corrections’ facilities. The two-year contract is expected to commence on July 1, 2020 and includes two, two-year renewal options.
In April 2020, Centurion began providing medical services, behavioral healthcare, and substance abuse treatment within four prisons and six community corrections centers across the state of Delaware.
In February 2020, Centene issued $2.0 billion 3.375% Senior Notes due 2030. The Company used a portion of the net proceeds to redeem all of its outstanding $1.0 billion 6.125% Senior Notes due 2024, including the call premiums, accrued interest and costs and expenses related to the redemption and termination of the $1.0 billion interest rate swap associated with the notes. The Company also intended to use remaining proceeds to redeem its $1.0 billion 4.75% Senior Notes due 2022, and related interest and premiums. However, as a result of the spread of COVID-19 and the resulting disruption and volatility in the global capital markets, the Company has deferred the redemption of the 2022 notes at this time.
Accreditations

In March 2020, Centene’s Iowa subsidiary, Iowa Total Care, earned Accreditation from the National Committee for Quality Assurance (NCQA).
In February 2020, Centene’s subsidiary, Envolve People Care, earned Accreditation from NCQA.
In January 2020, Centene’s subsidiary, Sunshine Health Plan, earned Accreditation from NCQA.
COVID-19 Pandemic

In March and April 2020, Centene announced a series of actions in support of various populations impacted by the COVID-19 crisis. A detailed list of specific actions taken by the Company in response to the pandemic is shown on page 16 of this release.

(1) Membership includes Medicare Advantage, Medicare Supplement, Special Needs Plans, and Medicare-Medicaid Plans (MMP).

(2) Membership includes dual-eligible ABD & LTSS and dual-eligible Medicare membership in the table above.

Revenues

The following table sets forth supplemental revenue information for the three months ended March 31, 2020 ($ in millions):

(3) Medicare includes Medicare Advantage, Medicare Supplement, Special Needs Plans, and MMP.

n.m.: not meaningful

Statement of Operations: Three Months Ended March 31, 2020

For the first quarter of 2020, total revenues increased 41% to $26.0 billion from $18.4 billion in the comparable period in 2019. The increase over the prior year was due to the acquisition of WellCare, growth in the Health Insurance Marketplace business, expansions and new programs in many of our states throughout 2019 and 2020, particularly Iowa and Pennsylvania, and the reinstatement of the health insurer fee in 2020, partially offset by the divestiture of our Illinois health plan and the timing of pass through payments from the state of New York.
HBR of 88.0% for the first quarter of 2020 represents an increase from 85.7% in the comparable period in 2019. The year-over-year increase was attributable to the Health Insurance Marketplace business where margins continue to normalize, as expected and consistent with the previous guidance shared. The increase also includes the acquisition of WellCare and new or expanded markets, which initially operate at a higher HBR. These increases were partially offset by the reinstatement of the health insurer fee.
The SG&A expense ratio was 9.9% for the first quarter of 2020, compared to 9.6% in the first quarter of 2019. The increase to the SG&A expense ratio was driven by higher acquisition related expenses due to the closing of the WellCare acquisition, partially offset by the addition of the WellCare business, which operates at a lower SG&A ratio.
The Adjusted SG&A expense ratio was 8.6% for the first quarter of 2020, compared to 9.5% in the first quarter of 2019. The Adjusted SG&A expense ratio benefited from the addition of the WellCare business, which operates at a lower SG&A ratio, and the leveraging of expenses over higher revenues.
During the first quarter of 2020, the Company recorded $72 million of non-cash impairment of its third-party care management software business.
During the first quarter of 2020, the Company recognized a $93 million gain in investment and other income related to the divestiture of certain products of the Company’s Illinois health plan as part of the previously announced divestiture agreements associated with the WellCare Acquisition.
During the first quarter of 2020, the Company issued $2.0 billion 3.375% Senior Notes due 2030 (the 2030 Notes). The Company used a portion of the net proceeds from the 2030 Notes to redeem all of its outstanding $1.0 billion 6.125% Senior Notes due 2024. The Company recognized a pre-tax loss on extinguishment of approximately $44 million, including the call premium, the write-off of unamortized debt issuance costs, and a loss on the termination of the $1.0 billion interest rate swap associated with the notes.
The effective tax rate was 64.9% for the first quarter of 2020, compared to 24.2% in the first quarter of 2019. The increase in the effective tax rate was driven by the reinstatement of the health insurer fee in 2020, the non-deductibility of certain acquisition related expenses, and the tax impact associated with the Illinois divestiture. For the first quarter of 2020, our effective tax rate on adjusted earnings was 24.8%.
Balance Sheet

At March 31, 2020, the Company had cash, investments and restricted deposits of $22.2 billion and maintained $2.0 billion of cash and cash equivalents held by unregulated entities. Medical claims liabilities totaled $11.4 billion. Total debt was $17.3 billion, which included $588 million of borrowings on our $2.0 billion revolving credit facility at quarter end. The debt to capitalization ratio was 41.9% at March 31, 2020, excluding $202 million of non-recourse debt. Our debt to capital ratio would have been 38.9% at March 31, 2020, when netting unregulated cash and cash equivalents with debt, and excluding non-recourse debt.

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, December 31, 2019

Timing of claims payments

Days in claims payable, March 31, 2020 (1)

(1) A pro-forma adjustment has been made to medical costs to include a full quarter of WellCare medical costs. Using actual medical costs, days in claims payable was 51.

Adjusted Diluted EPS excludes estimated amortization of acquired intangible assets of $0.98 to $1.00 per diluted share, acquisition related expenses of $0.62 to $0.66 per diluted share, the gain on the sale of the Illinois health plan of approximately $0.10 per diluted share, debt extinguishment costs of approximately $0.07 per diluted share, non-cash asset impairment of $0.10 per diluted share.

A rollforward of total revenues and Adjusted Diluted EPS from our previous guidance to our current guidance is shown in the tables below (total revenues in billions):

Conference Call

As previously announced, the Company will host a conference call Tuesday, April 28, 2020, at approximately 8:30 AM (Eastern Time) to review the financial results for the first quarter ended March 31, 2020. 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: 7601227 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, April 27, 2021, at the aforementioned URL. In addition, a digital audio playback will be available until 9:00 AM (Eastern Time) on Tuesday, May 5, 2020, by dialing 1-877-344-7529 in the U.S. and Canada, or +1-412-317-0088 from abroad, and entering access code 10141297.

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):

Other adjustments include the following adjustments for the three months ended March 31, 2020: (a) divestiture gain of $93 million, or $0.10 per diluted share, (b) non-cash impairment of $72 million, or $0.10 per diluted share, and (c) debt extinguishment costs of $44 million, or $0.06 per diluted share.

The income tax effects of adjustments are based on the effective income tax rates applicable to each adjustment.

The amortization of acquired intangible assets per diluted share presented above is net of an income tax benefit of $0.07 and $0.04 for the three months ended March 31, 2020 and 2019, respectively, and an estimated $0.30 to $0.32 for the year ended December 31, 2020.

The acquisition related expenses per diluted share presented above are net of an income tax benefit of $0.08 and $0.01 for the three months ended March 31, 2020 and 2019, respectively, and an estimated $0.09 to $0.10 for the year ended December 31, 2020.

Other adjustments include the following items:

(1) gain related to the divestiture of certain products of the Company’s Illinois health plan of $0.10 per diluted share, net of income tax expense of $0.07 for the three months ended March 31, 2020, and an estimated $0.10 per diluted share, net of income tax expense of $0.06 for the year ended December 31, 2020;

(2) non-cash impairment of our third party-care management software system of $0.10 per diluted share, net of an income tax benefit of $0.03 for the three months ended March 31, 2020, and an estimated $0.10 per diluted share, net of an income tax benefit of $0.03 for the year ended December 31, 2020; and

(3) debt extinguishment costs of $0.06 per diluted share, net of an income tax benefit of $0.02 for the three months ended March 31, 2020, and an estimated $0.07 per diluted share, net of an income tax benefit of $0.02 for the year ended December 31, 2020.

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, as well as adjustments for other items, 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.

Decipher Identifies a Molecular Subtype Most Likely to Benefit from Neoadjuvant KEYTRUDA Immunotherapy in Bladder Cancer Patients

On April 28, 2020 Decipher Biosciences, a commercial-stage precision oncology company committed to improving patient care, initially focused on urologic cancers, reported that patients with the molecular subtype Basal Claudin Low, identified by the Decipher Bladder test and studied in the PURE-01 clinical trial, received the most benefit in progression-free survival from neoadjuvant KEYTRUDA (pembrolizumab) immunotherapy in patients with muscle-invasive bladder cancer (MIBC) (Press release, Decipher Biosciences, APR 28, 2020, View Source [SID1234556724]).

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Identification of patients who benefit from immune checkpoint inhibitors, such as KEYTRUDA (a PD-1 inhibitor), is an unmet need in numerous disease settings for clinicians and pharmaceutical development teams. Currently, the use of KEYTRUDA is approved for patients with locally advanced or metastatic bladder cancer who are either platinum-ineligible or who have disease progression on platinum-based chemotherapy, and also for patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high risk, non-muscle-invasive bladder cancer. The PURE-01 clinical trial examined the use of KEYTRUDA prior to surgical removal of the bladder in platinum-eligible patients with non-metastatic MIBC.

"Identification of a predictive biomarker to a PD-1 inhibitor is essential for us to move the use of immunotherapy earlier in bladder cancer," said Andrea Necchi, MD, medical oncologist at the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan. "The results of this study support the further examination of subtyping classifiers and their inclusion in ongoing and future immunotherapy clinical trials."

Standard of care for patients with MIBC is cisplatin-based neoadjuvant chemotherapy (NAC) followed by surgical removal of the bladder, however, many patients suffer from comorbidities prohibiting the use of NAC, resulting in low utilization. Immunotherapy is a promising alternative, as demonstrated in the PURE-01 clinical trial, with rates of response and progression-free survival with neoadjuvant KEYTRUDA similar to rates reported for NAC.

In the PURE-01 clinical trial, the Basal Claudin Low molecular subtype represented 13% of patients with a unique tumor profile and RNA expression enriched for immune activity. These patients demonstrated exceptional improvement in two-year progression-free survival. Other Basal Claudin Low patients treated with the standard of care NAC had significantly worse outcomes with ~ 50% rate of disease progression.

The study, led by Dr. Necchi and titled "Impact of Molecular Subtyping and Immune Filtration on Pathological Response and Outcome Following Neoadjuvant Pembrolizumab in Muscle-Invasive Bladder Cancer," was published in the peer-reviewed journal European Urology on March 9, 2020. Additionally, the website UroToday published a "Beyond the Abstract" commentary by Dr. Necchi highlighting the findings from the study.

About Decipher Bladder

Decipher Bladder is a genomic test that measures the molecular profile of bladder cancer using gene expression analysis from transurethral resected bladder cancer specimens. It was developed in bladder cancer patients with muscle-invasive disease who face the question of immediate cystectomy or systemic treatment in the neoadjuvant setting prior to cystectomy. The assay results are reported as one of five molecular subtypes (Luminal, Luminal-Infiltrated, Basal, Basal Claudin Low or Neuroendocrine-like), each of which has distinct biological composition, clinical behavior and predicted benefit from NAC.