Coherus BioSciences eine (Seite 12)

[Sugar2000]

Extrem schwacher Tag... Hatte mir schon vorgestellt, dass die vorbörslichen Werte abschmelzen... Aber alles abgeben?!

[Brokerjay]

Newsflow stimmt, Pipeline prall gefüllt und viele Entscheidungen stehen an.
Umsatz q1 mit Udenyca war schwach. Bewertung berücksichtigt aber kaum die Pipeline.

Langfristig kann das noch richtig gut werden

[007coolinvestor]

https://finviz.com/quote.ashx?t=CHRS&ty=c&ta=1&p=d

Der Tag der Entscheidung naht

[Sugar2000]

Habe heute nachgelegt. Sehe es als Langfristanlage...

[007coolinvestor]

https://seekingalpha.com/news/3703205-coherus-bio-gains-9-on…

Coherus Bio gains 9% on positive toripalimab data in nasopharyngeal carcinoma
Jun. 04, 2021 4:42 AM ETCoherus BioSciences, Inc. (CHRS)By: Mamta Mayani, SA News Editor1 Comment
Coherus BioSciences (NASDAQ:CHRS), up 9% premarket and Shanghai Junshi Biosciences (OTCPK:SHJBF) announce positive results from the study “JUPITER-02”, a Phase 3 trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC).
The interim analysis met the primary endpoint of progression free survival (PFS) and secondary endpoints of objective response rate (ORR) assessed by BIRC.
A significant improvement in PFS (assessed by BIRC) was observed in the toripalimab plus chemotherapy arm compared to the chemotherapy alone (HR = 0.52 [95% CI: 0.36-0.74] two-sided p = 0.0003), median PFS of 11.7 vs. 8.0 months.
The 1-year PFS rates were 49% and 28%, respectively, for the toripalimab arm compared to placebo.
An improvement in PFS was observed across relevant subgroups including patients with high PD-L1 expression (TC or IC ≥ 1%; mPFS 11.4 vs. 8.2 month, HR = 0.59 [95% CI: 0.388 – 0.893]) or low PD-L1 expression (TC and IC<1%; mPFS 11.0 vs. 6.0 months, HR=0.35 [95% CI: 0.153 – 0.808]);
The ORR was 77.4% vs. 66.4% (P = 0.034); the median DoR was 10.0 vs. 5.7 months (HR = 0.50 [95% CI: 0.33-0.78]), P = 0.001);
Although median overall survival (OS) was not yet mature in either arm, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.60 [95% CI: 0.364-0.997], nominal P = 0.046).
A pre-specified second interim OS analysis will be performed at the same time as the final PFS analysis.
The safety profile of toripalimab was consistent with that observed in previously reported toripalimab clinical trials.
The results will be presented at the 2021 annual meeting of the American Society for Clinical Oncology (ASCO) on June 6, 2021.
Now read: ASCO 2021: A Plethora Of Cancer Therapeutic Investment Ideas

[007coolinvestor]

!

Dieser Beitrag wurde von CloudMOD moderiert. Grund: Kopie, Inhalt aus fremden Medien, Urheberrechtsverletzung, gg Punkt 9.5 der Nutzungsbedingungen.

[007coolinvestor]

Coherus BioSciences Reports First Quarter 2021 Financial Results and Immuno-oncology and Biosimilar Pipeline Progress

– Junshi Biosciences transaction is followed by rapid toripalimab progress including initiation of first BLA submission to the U.S. FDA, positive interim analysis in pivotal esophageal cancer trial, and selection for ASCO plenary session –

–Toripalimab is one of four additional Coherus product candidates projected for approval in the United States over
the next two years –

– First quarter UDENYCA® net sales of $83 million –

– Conference call today at 4:30 p.m. ET –

REDWOOD CITY, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus” or the “Company”, Nasdaq: CHRS), today reported financial results for the quarter ended March 31, 2021. The Company also provided a progress update on its anti-PD-1 antibody, toripalimab, its lead immuno-oncology candidate for the potential treatment of various solid tumors, as well as other late-stage pipeline product candidates including CHS-201, a biosimilar Lucentis® (ranibizumab), CHS-1420, a wholly owned biosimilar Humira® (adalimumab), and CHS-305, a biosimilar Avastin® (bevacizumab).

“Over the next two years, we project four additional Coherus product candidates will be approved in the United States, including three biosimilars and our anti-PD-1 antibody, toripalimab,” said Denny Lanfear, CEO of Coherus. “We believe this diversified product portfolio has the potential to generate significant revenue growth and fuel our investments in novel immuno-oncology therapies with the potential to improve care and outcomes for cancer patients.”

“With significant new clinical data and the first U.S. BLA submission underway, toripalimab is already exceeding our expectations,” Lanfear continued. “During a rigorous multi-year evaluation of the global checkpoint inhibitor landscape, we defined the preclinical and clinical properties required for our investment in a PD-1 blocking antibody. Toripalimab’s demonstrated potency, unique molecular properties and advanced pivotal clinical development program in numerous cancer types surpassed our stringent criteria. It is gratifying to see the accumulating external validation for toripalimab including selection for ASCO’s plenary session, Breakthrough Therapy Designation from the FDA for nasopharyngeal carcinoma, and the additional recent approvals in China. We believe these developments and the external interest we have already received to evaluate potential toripalimab combinations positions this product candidate as a significant potential growth driver for Coherus for many years.”

FIRST QUARTER 2021 FINANCIAL HIGHLIGHTS

GAAP net loss of $173 million for the first quarter of 2021 was primarily driven by the $145 million upfront payment to Junshi Biosciences for U.S. and Canada rights to the anti-PD-1 antibody toripalimab and one-time charges associated with the termination of the CHS-2020 biosimilar program as part of the strategic realignment of research and development resources toward immuno-oncology.
Non-GAAP net income for the first quarter of 2021 was $0.4 million, or $0.01 per share.
Cash flow from operations was $1.4 million.
Net product revenue, consisting of net sales of UDENYCA® (pegfilgrastim-cbqv) was $83 million for the first quarter of 2021. With approximately 20% share of the overall pegfilgrastim market, UDENYCA maintains its position as the leading pegfilgrastim biosimilar.
Coherus had cash, cash equivalents and marketable securities of $400 million at March 31, 2021.
In April 2021, the Company received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares of Coherus stock at a price per share of $20.06.

PIPELINE HIGHLIGHTS

Toripalimab, a PD-1 blocking antibody product candidate, in collaboration with Junshi Biosciences:

Junshi Biosciences initiated the rolling submission of the biologics license application (“BLA”) with the U.S. Food and Drug Administration (“FDA”) for toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”). The FDA has granted toripalimab Breakthrough Therapy Designation for this indication. The BLA submission is expected to be completed mid-year 2021, with potential approval in the first half of 2022.
Results of JUPITER-02, a randomized, double-blind, placebo-controlled, multi-center, Phase 3 clinical trial evaluating toripalimab for first-line NPC, will be featured in the plenary session and in the official press program of the 2021 ASCO Annual Meeting in early June.
In JUPITER-06, a randomized, double-blind, placebo-controlled, multi-center, Phase 3 clinical trial with 514 patients enrolled, toripalimab in combination with paclitaxel/cisplatin as first-line treatment for patients with advanced esophageal squamous cell carcinoma (“ESCC”) achieved the pre-specified primary endpoints of progression free survival (“PFS”) and overall survival (“OS”) at the interim analysis. Data from the study are expected later in 2021.
Coherus and Junshi Biosciences plan to file additional toripalimab BLA supplements with the FDA over the next three years for multiple rare and highly prevalent tumor types, including non-small cell lung cancer (“NSCLC”). An ongoing Phase 3 clinical study of toripalimab in combination with standard chemotherapy as the first-line treatment of patients with advanced NSCLC reached its primary endpoint of PFS at the interim analysis in December 2020. Top-line results are expected later in 2021.

CHS-201, a biosimilar Lucentis® (ranibizumab) product candidate in collaboration with Bioeq AG:

Bioeq AG expects to file the CHS-201 BLA mid-year 2021, following a supportive pre-BLA meeting with the FDA earlier in the first quarter of 2021. Bioeq reviewed new manufacturing data with the FDA, which the agency requested last year, as well as other elements of the BLA filing.

CHS-1420, a wholly owned biosimilar Humira® (adalimumab) product candidate:

The FDA accepted for review the BLA for CHS-1420 and assigned a target action date in December 2021. The FDA has completed the on-site portion of the pre-approval drug substance CMC inspection, with no Form 483s being issued. Coherus plans to launch CHS-1420 on or after July 1, 2023, if approved.

CHS-305, a biosimilar Avastin® (bevacizumab) product candidate in collaboration with Innovent Biologics (Suzhou) Co. Ltd:

Coherus initiated the three-way pharmacokinetic study to facilitate the potential BLA submission. Recruitment into the study has been slower than expected as a result of the COVID-19 pandemic, and Coherus now expects data from this study around year end 2021.

Coherus is planning an analyst day event in the fourth quarter of 2021.

FIRST QUARTER 2021 FINANCIAL RESULTS

Net product revenue, consisting of net sales of UDENYCA®, was $83 million for the first quarter of 2021. Net Product revenue declined in comparison to the prior quarter and the first quarter of 2020 due to an increase in discounts and allowances, as well as a reduction in ex-factory units sold due to seasonal fluctuations in wholesale inventory levels in the fourth quarter of 2020 and the first quarter of 2021.

Research and development (R&D) expenses for the first quarter of 2021 were $203.5 million, compared to $33.1 million for the same period in 2020. The increase was mainly due to the $145 million upfront payment to Junshi Biosciences upon the closing of the collaboration agreement in March, the $11.5 million charge related to the termination of the CHS-2020 program, and higher development costs in support of the advancement of toripalimab and the biosimilar pipeline product candidates.

Selling, general and administrative (SG&A) expenses were $39.4 million in the first quarter of 2021 as compared to $35.4 million in the year ago quarter. The increase was primarily driven by an increase in stock based compensation expense.

Net loss for the first quarter of 2021 was $172.9 million, or $2.37 per share on a diluted basis, compared to a net income of $35.6 million, or $0.48 per share on a diluted basis for the same period in 2020.

Non-GAAP net income for the first quarter of 2021 was $0.4 million, or $0.01 per share on a diluted basis, compared to non-GAAP net income of $49.8 million, or $0.67 per share on a diluted basis for the same period in 2020. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net income and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $399.5 million as of March 31, 2021, compared to $541.2 million at year end 2020. Subsequent to quarter end, Coherus received $50 million from Junshi Biosciences’ acquisition of 2,491,988 shares at a price per share of $20.06.

2021 FINANCIAL OUTLOOK

Coherus expects UDENYCA® revenue and market penetration to rise in the second half of 2021, assuming the COVID-19 pandemic recedes and treatment patterns normalize, and subject to pricing trends in the overall pegfilgrastim market.

Excluding the $145 million upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year R&D and SG&A expenses in a range of $370 million to $400 million. External R&D spending is focused on manufacturing-related activities in preparation for the potential launch of toripalimab and CHS-1420, if approved, and development activities for CHS-305 and for additional presentations of UDENYCA®. Increases in SG&A spending in 2021 are primarily driven by marketing activities and headcount to support UDENYCA and the potential launches in 2022 of toripalimab and CHS-201 (Lucentis biosimilar).

This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 to be filed with the Securities & Exchange Commission on May 6, 2021.

[Brokerjay]

Das ist auch mein Punkt, eigentlich schon seit 2 Jahren.
Absolut hohe cashflows, gut gefüllte Pipeline, sinnvolle Kooperation und Lizenzen erworben.

Irgendwann zündet das, bis dahin unter 12 Euro nachkaufen

[007coolinvestor]

Der Börsenkurs von CHS ist mir echt ein Rätzel. Das Unternehmen mach mE wirklich fortschritte.

Presentation: Plenary Session, June 6, 2021, 1:00 p.m. – 4:00 p.m. Eastern Daylight Time Publication: June 3, 2021, 5:00 p.m. Eastern Daylight Time “We are excited that results of JUPITER-02, a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, have been selected for presentation during ASCO’s plenary session, which traditionally features high-impact studies,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “Treatment of nasopharyngeal carcinoma, a specific type of head-and-neck cancer, is challenging, as the diagnosis usually occurs when the cancer is in an advanced stage and treatment options are limited.” In addition to the JUPITER-02 late-breaking abstract, ASCO accepted for publication or presentation more than two dozen additional abstracts, primarily investigator-sponsored studies, that evaluate the utility of toripalimab in a variety of cancer types including lung cancer, melanoma, urothelial carcinoma, gastroesophageal cancer, and hepatobiliary malignancies.

[007coolinvestor]

REDWOOD CITY, Kalifornien, 23. April 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: CHRS) hat von seinem Immunonkologie-Partner Junshi Biosciences die Mitteilung erhalten, dass das unabhängige Datenüberwachungskomitee der klinischen Studie JUPITER-06 festgestellt hat, dass Toripalimab, ein monoklonaler Anti-PD-1-Antikörper, in Kombination mit Paclitaxel/Cisplatin als Erstlinienbehandlung für Patienten mit fortgeschrittenem Plattenepithelkarzinom der Speiseröhre (ESCC), die vordefinierten primären Endpunkte des progressionsfreien Überlebens (PFS) und des Gesamtüberlebens (OS) bei der Zwischenanalyse erreicht hat. JUPITER-06 ist eine randomisierte, doppelblinde, placebokontrollierte, multizentrische, klinische Phase-3-Studie, die 2019 mit 514 Patienten gestartet wurde. Die Zwischenanalyse zeigte, dass Toripalimab in Kombination mit Paclitaxel/Cisplatin das PFS und OS von Patienten mit fortgeschrittenem ESCC im Vergleich zur alleinigen Paclitaxel/Cisplatin-Chemotherapie signifikant verlängerte. Daten aus der Studie werden noch in diesem Jahr erwartet. Anfang 2021 hat Coherus die Rechte zur Entwicklung und Vermarktung von Toripalimab in den Vereinigten Staaten und Kanada einlizenziert. Mehr als 2.100 Patienten wurden in klinischen Studien mit Toripalimab behandelt, und es laufen oder sind bereits klinische Zulassungsstudien abgeschlossen, in denen Toripalimab für ein breites Spektrum von Tumorarten untersucht wird, darunter Krebserkrankungen der Lunge, des Nasen-Rachen-Raums, der Speiseröhre, des Magens, der Blase, der Brust, der Leber, der Niere und der Haut. In den USA läuft die rollende Einreichung des ersten Toripalimab Biologics License Application (BLA) für die Behandlung des rezidivierenden oder metastasierten Nasopharynxkarzinoms (NPC). Die U.S. Food and Drug Administration (FDA) hat Toripalimab für diese Indikation die Breakthrough Therapy Designation erteilt. Darüber hinaus hat die FDA den Fast-Track-Status für die Entwicklung von Toripalimab zur Behandlung des Schleimhautmelanoms und den Orphan-Drug-Status für NPC, Schleimhautmelanom und Weichteilsarkom erteilt. Coherus und Junshi Biosciences planen, in den nächsten drei Jahren weitere BLAs für Toripalimab bei der FDA einzureichen, und zwar für mehrere seltene Krebsarten und hochprävalente Krebsarten.