On July 23, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported an update on its strategic collaboration with Celgene Corporation (NASDAQ: CELG), originally established in July 2016 (Press release, Jounce Therapeutics, JUL 23, 2019, View Source [SID1234537692]). Under the terms of a new license agreement, Celgene has licensed worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Jounce retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs, as Jounce and Celgene have also entered into a mutual agreement to terminate their original strategic collaboration agreement.

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Under the terms of the new license agreement for JTX-8064, Jounce receives a $50.0 million non-refundable license fee and is eligible to receive from Celgene up to $480 million in development, regulatory and commercial milestone payments, as well as royalties on potential worldwide sales. Celgene will be responsible for all development and commercialization of JTX-8064.

"We are grateful for Celgene’s investment and support of Jounce over the past three years as it has helped us grow our diversified pipeline and further enhance our translational science platform. We are proud of the many accomplishments we have achieved under the original agreement with Celgene and remain committed to developing innovative immunotherapies for patients with cancer," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The discovery and development of JTX-8064 showcases the strength of our translational science platform, validating our approach to discovering novel immunotherapies for patients in need. We look forward to the advancement of JTX-8064 by Celgene. Most importantly, we retain full global rights to all of our other programs, including vopratelimab, giving Jounce greater flexibility to create value for patients and shareholders moving forward. In addition to our ongoing clinical development programs, we are also poised to expand our broader pipeline and advance additional novel immunotherapy programs based on our translational science platform."

"We are pleased to have collaborated with Jounce for the last three years, and to continue our relationship with the licensing of worldwide rights to JTX-8064, a novel macrophage program coming from Jounce’s innovative, translational science platform," said Robert Hershberg, executive vice president and head of business development of Celgene. "We look forward to advancing its development toward an IND filing."

Clinical Program Guidance:
Jounce is currently enrolling patients in the Phase 2 EMERGE clinical trial of vopratelimab in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies. Jounce expects to report preliminary efficacy data and biomarker relationships to clinical outcomes from EMERGE in 2020.

Jounce is also currently conducting a Phase 1 clinical trial of JTX-4014, its PD-1 inhibitor. This Phase 1 clinical trial is nearing completion, and Jounce remains on track to identify the recommended Phase 2 dose of JTX-4014 in 2019.

Revised Financial Guidance:
As a result of the changes to the Celgene strategic collaboration, Jounce now expects to record approximately $50.0 million in cash revenue in 2019 related to the license of JTX-8064 and approximately $98.0 million in non-cash revenue in 2019 representing the remaining recognition of the upfront payment received in July 2016.

Based on its operating and development plans Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $80.0 million to $95.0 million.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 5:00 p.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6684846. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO­Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical trial that we refer to as ICONIC. In the initial Phase 1/2 portion of ICONIC, vopratelimab was found to be safe and well-tolerated, both alone and in combination with nivolumab, an anti-PD-1 antibody. At the June 2018 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), we reported Response Evaluation Criteria in Solid Tumors, or RECIST, responses and other tumor reductions as determined by investigator assessment that were associated with an ICOS pharmacodynamic biomarker. We subsequently reported that these responses were durable, lasting six or more months and that all responders, as determined by investigator assessments, remained on study for more than one year. ICONIC also included dose-escalation Phase 1 portions to assess vopratelimab in combination with pembrolizumab, an anti-PD-1 antibody, and in combination with ipilimumab, an antibody that binds to CTLA-4 on certain T cells. This Phase 1 portion established the safety of vopratelimab in combination with each of ipilimumab and pembrolizumab.

About JTX-4014
JTX-4014 is a well-characterized fully human IgG4 monoclonal antibody designed to block binding to PD-L1 and PD-L2. Jounce is developing JTX-4014 for potential use in combination with its pipeline of future product candidates. JTX-4014 is currently in Phase 1 clinical development, which is nearing completion.

About JTX-8064
JTX-8064 is an anti-Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) antibody and is the first candidate to emerge from Jounce’s Translational Science Platform efforts that focuses on tumor-associated macrophages. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supports the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.

On July 23, 2019 Centene Corporation (NYSE: CNC) reported its financial results for the second quarter ended June 30, 2019, diluted earnings per share (EPS) of $1.18, and Adjusted Diluted EPS of $1.34 (Press release, CENTENE, JUL 23, 2019, View Source [SID1234537688]).

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In summary, the 2019 second quarter results were as follows:

(1) A full reconciliation of Adjusted Diluted EPS is shown beginning on page five of this release.

Diluted and Adjusted Diluted EPS for the second quarter of 2019 benefited from solid operating performance across our business segments, the net impact of the reconciliation of the 2018 risk adjustment program exceeding our expectations by $0.05 per diluted share and a gain related to the acquisition of Ribera Salud of $0.03 per diluted share.

Michael F. Neidorff, Centene’s Chairman, President and Chief Executive Officer, stated, "Our strong second quarter results demonstrate Centene’s favorable financial and operating momentum. Our pending WellCare acquisition will bolster and diversify our product offerings, significantly increase our scale and provide access to new markets – enhancing Centene’s long-term growth outlook."

Second Quarter Highlights

June 30, 2019 managed care membership of 15.0 million, an increase of 2.2 million members, or 17%, over June 30, 2018.
Total revenues for the second quarter of 2019 of $18.4 billion, representing 29% growth compared to the second quarter of 2018.
Health benefits ratio (HBR) of 86.7% for the second quarter of 2019, compared to 85.7% in the second quarter of 2018.
Selling, general and administrative (SG&A) expense ratio of 9.1% for the second quarter of 2019, compared to 9.6% for the second quarter of 2018.
Adjusted SG&A expense ratio of 9.0% for the second quarter of 2019, compared to 9.6% for the second quarter of 2018.
Diluted EPS for the second quarter of 2019 of $1.18, compared to $0.75 for the second quarter of 2018, an increase of 57%.
Adjusted Diluted EPS for the second quarter of 2019 of $1.34, compared to $0.90 for the second quarter of 2018, an increase of 49%.
Operating cash flow of $917 million for the second quarter of 2019, representing 1.9x net earnings.
Other Events

In July 2019, our Oregon subsidiary, Trillium Community Health Plan, was notified by the Oregon Health Authority (OHA) of its intent to award Trillium an expanded contract to serve as a coordinated care organization for six counties in the state. Pending successful completion of OHA’s readiness review and additional contract negotiations, the contract is scheduled to begin on January 1, 2020.
In June 2019, our Spanish subsidiary, Primero Salud, acquired additional ownership in Ribera Salud, increasing our ownership in the Spanish healthcare company from 50% to 90%.
In June 2019, all proposals regarding the pending acquisition of WellCare Health Plans, Inc. (WellCare) were approved by Centene and WellCare shareholders.
Accreditations & Awards

In July 2019, FORTUNE announced Centene’s position of #168 in its annual ranking of the largest companies globally by revenue.
In July 2019, Centene was recognized with a 100 percent score on the Disability Equality Index (DEI) as one of the Best Places to Work for People with Disabilities.
In May 2019, FORTUNE announced Centene’s position of #51 in its annual ranking of America’s largest companies by revenue.
In May 2019, Centene and several of its subsidiaries earned Accreditation from NCQA, including California Health & Wellness and Health Net Community Solutions.
Membership

Medicare includes Medicare Advantage, Medicare Supplement, Special Needs Plans, and MMP.

Statement of Operations: Three Months Ended June 30, 2019

For the second quarter of 2019, total revenues increased 29% to $18.4 billion from $14.2 billion in the comparable period in 2018. The increase over the prior year was primarily due to the acquisition of Fidelis Care, growth in the Health Insurance Marketplace business, expansions and new programs in many of our states in 2018 and 2019, particularly Arkansas, New Mexico, and Pennsylvania. These increases were partially offset by the health insurer fee moratorium in 2019.
Sequentially, total revenues decreased 1% from the first quarter of 2019 primarily due to significant pass through payments from the States of California and New York in the first quarter.
HBR of 86.7% for the second quarter of 2019 represents an increase from 85.7% in the comparable period in 2018. The increase was primarily attributable to the Health Insurance Marketplace business where margins have normalized, as expected, from the favorable performance in 2018. The increase was also due to the health insurer fee moratorium and the acquisition of Fidelis Care, which operates at a higher HBR.
HBR increased sequentially from 85.7% in the first quarter of 2019. The increase was primarily due to the normal seasonality in the Health Insurance Marketplace business.
The SG&A expense ratio was 9.1% for the second quarter of 2019, compared to 9.6% in the second quarter of 2018. The Adjusted SG&A expense ratio was 9.0% for the second quarter of 2019, compared to 9.6% in the second quarter of 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 effective tax rate was 25.7% for the second quarter of 2019, compared to 36.9% in the second quarter of 2018. The decrease in the effective tax rate was due to the impact of the health insurer fee moratorium.
Balance Sheet

At June 30, 2019, the Company had cash, investments and restricted deposits of $15.9 billion, including $801 million held by unregulated entities. Medical claims liabilities totaled $7.4 billion. The Company’s days in claims payable was 47 days, which is a decrease of one day over the first quarter of 2019. Total debt was $7.1 billion, which includes $513 million of borrowings on our $2.0 billion revolving credit facility at quarter end. The debt to capitalization ratio was 36.3% at June 30, 2019, excluding $158 million of non-recourse debt.

Outlook

The Company’s annual guidance for 2019 has been updated to reflect the second quarter performance and the reinvestment of $0.05 per diluted share in Centene Forward related initiatives in the second half of 2019.

Adjusted Diluted EPS excludes amortization of acquired intangible assets of $0.46 to $0.47 per diluted share and acquisition related expenses of $0.13 to $0.15 per diluted share.

Adjusted SG&A expense ratio excludes acquisition related expenses of $73 million to $84 million.

Conference Call

As previously announced, the Company will host a conference call Tuesday, July 23, 2019, at approximately 8:30 AM (Eastern Time) to review the financial results for the second quarter ended June 30, 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: 9467577 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, July 21, 2020, at the aforementioned URL. In addition, a digital audio playback will be available until 9:00 AM (Eastern Time) on Tuesday, July 30, 2019, by dialing 1-877-344-7529 in the U.S. and Canada, or +1-412-317-0088 from abroad, and entering access code 10132753.

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 2018 impact of retroactive changes to the California minimum medical loss ratio (MLR) of $30 million of expense.

The income tax effects of adjustments are based on the effective income tax rates applicable to adjusted (non-GAAP) results.

The amortization of acquired intangible assets per diluted share presented above is net of an income tax benefit of $0.04 and $0.02 for the three months ended June 30, 2019 and 2018, respectively, and $0.07 and $0.05 for the six months ended June 30, 2019 and 2018, respectively, and an estimated $0.14 for the year ended December 31, 2019.

The acquisition related expenses per diluted share presented above are net of an income tax benefit of $0.01 for the three months ended June 30, 2019, and $0.03 and $0.01 for the six months ended June 30, 2019 and 2018, respectively, and an estimated $0.05 for the year ended December 31, 2019.

Other adjustments include the 2018 impact of retroactive changes to the California MLR, which is net of an income tax benefit of $0.02 per diluted share for both the three and six months ended June 30, 2018.

On July 23, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its second quarter 2019 financial results and provide an update on the company’s business and outlook on Tuesday, August 6, 2019 at 4:30 p.m. (ET) after closing of the market (Press release, PTC Therapeutics, JUL 23, 2019, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-host-conference-call-to-discuss-second-quarter-2019-financial-results-300888784.html [SID1234537687]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 6594813. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for two weeks.

On July 23, 2019 Bruker Corporation (Nasdaq: BRKR) reported it will report second quarter 2019 financial results on Thursday, August 1, 2019, after the market closes (Press release, Bruker, JUL 23, 2019, View Source [SID1234537686]). The Company will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and current business trends.

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To listen to the webcast, investors can go to View Source and click on the "Earnings Webcast" hyperlink in the "Latest Results" section. A slide presentation will be referenced during the webcast and will be posted to the company’s website shortly before the webcast begins.

Investors can also listen to the earnings webcast via telephone by dialing 1-888-437-2685 (U.S. toll free) or +1-412-317-6702 (international), and referencing "Bruker’s Second Quarter 2019 Earnings Conference Call".

Bruker is enabling investors to pre-register for the earnings conference call so that they can expedite their entry into the call and avoid the need to wait for a live operator. In order to pre-register for the call, investors can visit View Source and enter their contact information. Investors will then be issued a personalized phone number and PIN to dial into the live conference call. Individuals can pre-register any time prior to the start of the conference call on August 1.

A telephone replay of the conference call will be available by dialing 1-877-344-7529 (U.S. toll free) or +1-412-317-0088 (international) and entering conference number: 10133865. The replay will be available beginning one hour after the end of the conference call through September 1, 2019.

For Further Information:

Miroslava Minkova

Director, Investor Relations & Corporate Development

Tel: +1 (978) 663-3660, ext. 1479

Email: [email protected]

On July 23, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the second quarter 2019 on Tuesday, August 6 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, JUL 23, 2019, View Source [SID1234537685]). On the same date, Halozyme will release financial results for the second quarter ended June 30, 2019 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 5549627.