Centene Corporation Announces Updated 2020 Guidance

On March 3, 2020 Centene Corporation (NYSE: CNC) reported its updated 2020 financial guidance, incorporating the effect of the closing of the WellCare acquisition on January 23, 2020 (Press release, Centene , MAR 3, 2020, View Source [SID1234555149]). Total revenues are expected to be $104.8 billion to $105.6 billion, and diluted earnings per share are expected to be $3.00 to $3.14. Adjusted diluted earnings per share for 2020 are expected to be $4.56 to $4.76.

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!

"The Company is well positioned to maintain its momentum in 2020," said Michael Neidorff, Chairman, President and CEO of Centene.

For its 2020 fiscal year, the Company’s guidance is as follows:

Total revenues in the range of approximately $104.8 billion to $105.6 billion.
Diluted earnings per share of approximately $3.00 to $3.14.
Adjusted diluted earnings per share of approximately $4.56 to $4.76.
Health benefits ratio of approximately 85.9% to 86.3%.
Selling, general and administrative (SG&A) expense ratio of approximately 9.3% to 9.7%.
Adjusted SG&A expense ratio of approximately 8.9% to 9.3%, which excludes approximately $385 million of acquisition related expenses.
Effective tax rate of approximately 38.0% to 40.0%, including the effect of the Health Insurer fee.
Diluted shares outstanding of approximately 584.5 million to 587.5 million.
The Company’s guidance includes the following:

A benefit of $0.09 per diluted share as a result of the timing of the WellCare transaction, which closed on January 23, 2020. This includes the effect of the pro-ration of January’s results, substantially offset by the lack of a full year of synergy capture, and the lower share count due to the timing of the acquisition closure.
We received a potential rate decrease from the State of New York on February 6, 2020, which would result in an overall pre-tax net rate reduction of approximately $200 million. While not final, we have begun to develop initiatives to mitigate a portion of the potential rates for 2020. We currently expect $150 million of the adjustment to potentially lower our pre-tax earnings for the year, resulting in a $0.17 reduction to our GAAP and adjusted diluted earnings per share guidance.
Conference Call & Presentation

As previously announced, the Company will host a conference call Wednesday, March 4, 2020, at approximately 8:30 AM (Eastern Time) to review the 2020 financial guidance. Michael Neidorff and Jeffrey Schwaneke will host the conference call.

The Company has also posted slides to its website under the investor relations section as a supplement for 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: 0997408, 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 12 months or until 11:59 p.m. (Eastern Time) on Wednesday, March 3, 2021, at the aforementioned URL. In addition, a digital audio playback will be available until 9 a.m. (Eastern Time) on Thursday, March 12, 2020, by dialing 1-877-344-7529 in the U.S. and Canada, or +1-412-317-0088 from abroad, and entering access code 10139468.

Regeneron Announces Upcoming Investor Conference Presentations

On March 3, 2020 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, MAR 3, 2020, View Source [SID1234555148]):

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!

J.P. Morgan 2020 Biotech Conference Call Series at 12:00 p.m. ET on Friday, March 6, 2020
Oppenheimer 30th Annual Healthcare Conference at 8:35 a.m. ET on Wednesday, March 18, 2020
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

Innovent Biologics Announces First Patient Dosed in the Pivotal Registrational Trial of Pemigatinib in Patients with Advanced Cholangiocarcinoma in China

On March 3, 2020 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported that the Company achieved first patient dosing in a pivotal Phase 2 registrational trial of pemigatinib (IBI375), a FGFR1/2/3 inhibitor, in China (Press release, Innovent Biologics, MAR 3, 2020, View Source [SID1234555147]). The objective of this study is to evaluate the efficacy and safety of pemigatinib in patients with advanced cholangiocarcinoma with FGFR2 fusions or rearrangements who have progressed from at least one prior systemic therapy in China.

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!

Dr. Jian Zhou, Vice President of Zhongshan Hospital, Fudan University, stated: "The intrahepatic cholangiocarcinomas ("iCCAs") account for approximately 15~20% of all liver tumors with a significant uptrend. Most patients with iCCAs are not amenable to surgical resection with curative intent due to local invasion and metastasis at initial visit. Currently, the chemotherapy of gemcitabine combined with cisplatin is recommended as a first-line treatment for patients with advanced cholangiocarcinoma, with 15~26% overall response rate ("ORR"). Unfortunately, most patients will develop resistance to this chemotherapy, and the effective alternative therapies are limited. A previous study of pemigatinib, a FGFR targeted therapy, in patients with CCA who have FGFR2 fusions or rearrangements demonstrated significant efficacy and safety, with 36% ORR, 7.5 months median duration of response ("DOR"), and 21.1 months preliminary overall survival ("OS"), providing new hope for patients. We anticipate to achieve promising results for the trial of pemigatinib in Chinese patients with advanced cholangiocarcinoma."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "Cholangiocarcinoma, a malignant tumor arising from biliary epithelium cells, has poor prognosis and high unmet treatment needs due to lack of effective treatment. We are glad that the first patient dosing in the Phase 2 clinical trial of pemigatinib has been completed, and the data of the study will be used to support the new drug application ("NDA") for pemigatinib in China. It is an important milestone for pemigatinib to enter the Chinese market and we believe this trial in China will benefit patients with cholangiocarcinoma who have FGFR fusions or rearrangements and provide more treatment options to clinicians."

About Advanced Cholangiocarcinoma and FGFR2 Fusion/Rearrangement

Cholangiocarcinoma is a malignant tumour arising from biliary epithelium cells, and cholangiocarcinomas are categorized as intrahepatic or extrahepatic according to anatomical location. The incidence of cholangiocarcinoma has increased progressively over the past years. Surgical resection remains the mainstay of potentially curative treatment, but only a minority of patients have early stage disease that is amenable to surgical resection with curative intent. Unfortunately, most patients who have undergone a surgical resection will relapse. For patients with advanced or unresectable cholangiocarcinoma, the available systemic therapies are of limited effectiveness: the median overall survival with the current standard-of-care chemotherapy regimen is less than 1 year.

Fibroblast growth factor receptors ("FGFRs") play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers. Amounts of studies have demonstrated that FGFR2 fusion/rearrangement can lead to the development and/or progression of cholangiocarcinoma, FGFR- targeted therapeutics have produced striking benefits in these patients.

About Pemigatinib

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

In November of 2019, the United States Food and Drug Administration (the "U.S. FDA"), accepted for Priority Review the NDA for pemigatinib, submitted by Incyte Biosciences International Sàrl ("Incyte"), for the treatment of previously treated, locally advanced cholangiocarcinoma with FGFR2 fusions or rearrangements. The Prescription Drug User Fee Act ("PDUFA") target action date is May 30, 2020.

Previously, the U.S. FDA granted pemigatinib Breakthrough Therapy designation for the treatment of previously treated, advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. Additionally, the U.S. FDA granted pemigatinib Orphan Drug designation for the treatment of cholangiocarcinoma, a designation granted to investigational compounds intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the pemigatinib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

eHealth, Inc. Prices Follow-On Offering of Common Stock

On March 3, 2020 eHealth, Inc. (NASDAQ:EHTH), which owns eHealth.com, a leading private online health insurance exchange, reported the pricing of its follow-on public offering of 1,800,000 shares of its common stock at a price to the public of $115.00 per share (Press release, eHealthInsurance, MAR 3, 2020, View Source [SID1234555146]). In addition, the Company has granted the underwriters a 30-day option to purchase up to 270,000 additional shares of its common stock. eHealth intends to use the net proceeds of the offering for general corporate purposes, including working capital.

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!

RBC Capital Markets, Credit Suisse and Deutsche Bank Securities are acting as joint book-running managers for the offering. Craig-Hallum Capital Group, Raymond James and SunTrust Robinson Humphrey are acting as co-managers for the offering.

An immediately effective registration statement relating to the common stock was filed with the Securities and Exchange Commission (SEC) on December 17, 2018 and amended on January 22, 2019 and March 2, 2020. The offering of these securities is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus, when available, may also be obtained from RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, New York 10281-8098, or by fax at (212) 428-6260; from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd Floor, New York, New York 10010, or by phone at 1-800-221-1037 or by email at [email protected]; or from Deutsche Bank Securities Inc., Attention: Prospectus Group, 60 Wall Street, New York, NY 10005, or by telephone at (800) 503-4611 or by email at [email protected].

Senti Biosciences Announces Dr. Jose Iglesias as Chief Medical Officer

On March 3, 2020 Senti Biosciences, Inc., the gene circuit company focused on outsmarting complex diseases with intelligent medicines, reported that Jose Iglesias, M.D., has joined the company as Chief Medical Officer (CMO) (Press release, Senti Biosciences, MAR 3, 2020, View Source [SID1234555145]). In this position, Dr. Iglesias will lead the clinical development of Senti’s next-generation cell and gene therapy product candidates focused on the treatment of solid and liquid tumors.

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!

"We are excited to have Jose join our team as chief medical officer," said Tim Lu, CEO of Senti Biosciences. "He brings a wealth of experience in oncology clinical development to Senti in that he has designed and implemented clinical trials of novel cancer therapies across all development phases. This expertise will be critical as we advance our SENTI-101 program into the clinic later this year, in addition to our upcoming pipeline programs."

"I’m thrilled to be joining such a talented and diverse team at Senti Biosciences, a company that is pioneering the development of gene circuit-based therapies," said Dr. Iglesias. "I look forward to stewarding these novel therapies through the clinic and into approved treatments for cancer patients with high unmet needs."

Dr. Iglesias has more than three decades of global clinical development experience in the biopharmaceutical industry. He has previously held multiple CMO and clinical development leadership roles at companies such as Abraxis, Celgene, Eli Lilly, Boston Biomedical, Apobiologix, Biothera Pharmaceuticals and Bionomics. In these roles, he has led the clinical development of biologics and small molecules in both solid and liquid tumors, bringing extensive experience to Senti’s growing oncology pipeline. While at Abraxis and Celgene, Dr. Iglesias designed and implemented the Phase 3 development of ABRAXANE for the treatment of metastatic pancreatic, breast and non-small cell lung cancers.

About Senti Biosciences’ SENTI-101 Program

Senti’s gene circuit platform enables the programming of any cell and gene therapy modality, including immune cells, stem cells and viral vectors. Senti’s SENTI-101 program uses tumor-homing allogeneic cells as a drug delivery vehicle to achieve localized, combinatorial expression of two cytokines, IL-12 and IL-21. This pair of cytokines activates a multifactorial immune response against solid tumors, and turns immunologically cold tumors hot. In the second half of 2020, Senti intends to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a first-in-human clinical study of SENTI-101 in patients with ovarian cancer.