On January 7, 2019 Coherus BioSciences, Inc. (the "Company") reported that it has entered into a credit agreement (the "Agreement") with affiliates of Healthcare Royalty Partners (together, the "Lenders") (Press release, Coherus Biosciences, JAN 7, 2019, View Source [SID1234532628]). The Agreement consists of a six-year term loan facility for an aggregate principal amount of $75,000,000 (the "Borrowings"). The obligations of the Company under the loan documents are guaranteed by the Company’s material domestic U.S. subsidiaries (the "Guarantors").

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The Borrowings under the Agreement bear interest through maturity at 7.00% per annum plus LIBOR (customarily defined). If the consolidated net sales (customarily defined) for UDENYCA, the Company’s pegfilgrastim (Neulasta) biosimilar, for the fiscal year ending December 31, 2019, are in excess of $250,000,000, then the interest rate will be reduced as of January 1, 2020 to 6.75% per annum plus LIBOR. Interest is payable quarterly in arrears.

Principal payments on the Borrowings are required to be paid in equal quarterly installments beginning on the four year anniversary of the Closing Date (or, if consolidated net sales of UDENYCA in the fiscal year ending December 31, 2021 are less than $375,000,000, beginning on the three year anniversary of the Closing Date), with the outstanding balance to be repaid on January 7, 2025 (the "Maturity Date").

The Company is also required to make mandatory prepayments of the Borrowings under the Agreement, subject to specified exceptions, with the proceeds of asset sales, extraordinary receipts, debt issuances and specified other events including the occurrence of a change in control.

If all or any of the Borrowings are prepaid or required to be prepaid under the Agreement, then the Company shall pay, in addition to such prepayment, a prepayment premium (the "Prepayment Premium") equal to (i) with respect to any prepayment paid or required to be paid on or prior to the three year anniversary of the Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, plus all required interest payments that would have been due on the Borrowings prepaid or required to be prepaid through and including the three year anniversary of the Closing Date, (ii) with respect to any prepayment paid or required to be paid after the three year anniversary of the Closing Date but on or prior to the four year anniversary of the Closing Date, 5.00% of the Borrowings prepaid or required to be prepaid, (iii) with respect to any prepayment paid or required to be paid after the four year anniversary of the Closing Date but on or prior to the five year anniversary of the Closing Date, 2.50% of the Borrowings prepaid or required to be prepaid, and (iv) with respect to any prepayment paid or required to be prepaid thereafter, 1.25% of the Borrowings prepaid or required to be prepaid.

In connection with the Agreement, the Company paid a closing fee to the Lenders of $1,125,000. Upon the prepayment or repayment of the Borrowings (or upon the date such prepayment or repayment is required to be paid), the Company is required to pay an additional exit fee in an amount equal to 4.00% of the total principal amount of the Borrowings.

The obligations under the Agreement are secured by a lien on substantially all of the Company’s and the Guarantors’ tangible and intangible property, including intellectual property. The Agreement contains certain affirmative covenants, negative covenants and events of default, including, covenants and restrictions that among other things, restrict the ability of the Company and its subsidiaries to, incur liens, incur additional indebtedness, make loans and investments, engage in mergers and acquisitions, in asset sales, and declare dividends or redeem or repurchase capital stock. Additionally, the consolidated net sales for UDENYCA must not be lower than $70,000,000 for the fiscal year ending December 31, 2019, (b) $125,000,000 for the fiscal year ending December 31, 2020, and (c) $150,000,000 for each fiscal year thereafter. A failure to comply with these covenants could permit the Lenders under the Agreement to declare the Borrowings, together with accrued interest and fees, to be immediately due and payable.

On January 7, 2019 Affimed N.V. is presented the corporate presentation (Presentation, Affimed, JAN 7, 2019, View Source [SID1234532575]).

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On January 7, 2019 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported it will provide a strategic business update to the investor community at the 37th Annual J.P. Morgan Healthcare Conference (Press release, Regeneron, JAN 7, 2019, View Source [SID1234532574]). Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, will discuss commercial and pipeline progress across the company’s portfolio. Slides and a webcast from the presentation may be accessed from the "Investors & Media" page of Regeneron’s website at View Source

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"Regeneron continues to advance an innovative, homegrown portfolio of marketed and investigational therapies for patients with a range of serious diseases," said Dr. Schleifer. "In 2018, we saw continued strong growth for EYLEA (aflibercept) Injection in retinal diseases and Dupixent (dupilumab) Injection in atopic dermatitis, as well as a positive initial reception to our two new launches — Libtayo (cemiplimab-rwlc) Injection for advanced cutaneous squamous cell carcinoma and Dupixent for asthma. On the development front, we now have more than 20 investigational candidates in human clinical trials and look forward to entering several more this year, as we continue to leverage our cutting-edge science and technology to bring new hope to patients in need."

EYLEA: Strengthening Market Leadership Position

·EYLEA† achieved $4.07 billion in 2018 U.S. net sales (based on preliminary, unaudited fourth quarter 2018 U.S. net sales of $1.07 billion), representing approximately 10 percent growth over 2017. (1)

·The U.S. Food and Drug Administration (FDA) has assigned an action date of May 13, 2019 for a new EYLEA indication in diabetic retinopathy.

·Regeneron is also advancing next-generation ophthalmology treatments, such as a high-dose formulation of EYLEA, which is expected to enter clinical trials in 2019.

Dupixent: Continued Growth and New Indications

· Dupixent*† uptake continues to accelerate in both its FDA-approved indications with positive trends in new-to-brand prescriptions following a direct-to-consumer television campaign for moderate-to-severe atopic dermatitis and the 2018 asthma launch.

· Additional important regulatory milestones are expected for Dupixent this year, including a March 11, 2019 FDA action date for adolescent atopic dermatitis (age 12-17), a European Medicines Association (EMA) decision for asthma and an FDA filing for chronic rhinosinusitis with nasal polyps.

·In 2019, Regeneron also expects to report results from a Phase 3 study of Dupixent in pediatric patients (age 6-11) with atopic dermatitis and initiate a Phase 2/3 program in Chronic Obstructive Pulmonary Disease. Phase 2 studies in grass allergy and peanut allergy are ongoing, as are combination studies with REGN3500* (IL-33 antibody) in atopic dermatitis and asthma.

* Collaboration program with Sanofi

Immuno-Oncology Platform

·Regeneron has seen encouraging early uptake from the U.S. launch of Libtayo*† for advanced cutaneous squamous cell carcinoma (CSCC). An EMA decision on Libtayo for advanced CSCC is expected in the first half of 2019, and pivotal and earlier studies in other cancers are continuing to enroll.

·Regeneron’s CD20xCD3 bispecific antibody, REGN1979, continues to progress with a potentially pivotal Phase 2 study in Follicular Lymphoma anticipated to begin in the first half of 2019 and a potentially pivotal Phase 2 study in Diffuse Large B-Cell Lymphoma anticipated to begin in the second half of 2019.

·Supported by Regeneron’s proprietary science and technology platforms, the company is advancing a new class of costimulatory bispecific antibodies for cancer, with two candidates expected to enter human clinical studies in 2019. These therapies have the potential to be used in combination with other Regeneron immuno-oncology therapies to address difficult-to-treat cancers.

·Earlier today, Regeneron and Sanofi announced a restructuring of their 2015 Immuno-oncology Discovery and Development Agreement. Regeneron and Sanofi have selected two investigational bispecific antibodies (MUC16xCD3 for mucin16-expressing cancers and BCMAxCD3 for multiple myeloma) for continued collaborative development. Regeneron will retain exclusive rights to all its other immuno-oncology programs, including additional xCD3 bispecifics and the new class of costimulatory bispecific antibodies. The bispecific antibody REGN1979 (CD20xCD3) remains exclusively owned by Regeneron.

"Over the last few years, we’ve made excellent progress with our immuno-oncology portfolio, which includes Libtayo, the first and only approved treatment for advanced cutaneous squamous cell carcinoma, as well as our first clinical-stage bispecific antibody, REGN1979," said Dr. Yancopoulos. "Regeneron now has one approved and five clinical-stage immuno-oncology therapies for a range of targets and modalities, which have the opportunity to be used as monotherapy or in combination with other agents. We’re particularly encouraged to be entering two new therapies into the clinic this year from our costimulatory bispecific portfolio. Building on our deep antibody engineering expertise, this new class of bispecific agents has the promise to treat certain cancers where other classes of immunotherapy have proven inadequate."

Additional Research and Development Updates

· In 2018, Regeneron entered four new molecules into the clinic: REGN4018, a MUC16xCD3 bispecific antibody for cancer; REGN4461, a leptin receptor (LEPR) agonist for lipodystrophy and obesity; REGN4659, a CTLA-4 antibody for cancer; and REGN5069, a GFRa3 antibody for pain.

· In 2019, four to six new molecules are expected to enter clinical development, including REGN5458, the BCMAxCD3 bispecific antibody which has already initiated a Phase 1 study, as well as two costimulatory bispecific antibodies for cancer.

· The Regeneron Genetics Center (RGC) continues to make important discoveries, including validating the genetic role of IL-33 in asthma and identifying a new genetic variant that protects against chronic liver disease. The RGC has now sequenced over 500,000 human exomes linked to detailed patient electronic health records and anticipates sequencing up to 500,000 more exomes in 2019.

Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within "Bayer collaboration revenue" in its Statements of Operations.

The Company’s 2019 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.

This press release uses non-GAAP unreimbursed R&D and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the estimated income tax effect of reconciling items.

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control (such as the Company’s stock price on the dates share-based grants are issued or changes in the fair value of the Company’s equity investments) or items that are not associated with normal, recurring operations (such as changes in applicable laws and regulations). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP.

On January 7, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), is reported that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. (the "Agreements") for its lead product candidate eftilagimod alpha as part of a cancer vaccine (Press release, Immutep, JAN 7, 2019, View Source [SID1234532573]).

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The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine (a therapy containing cancer antigens to boost a patient’s own immune cells to recognize and kill cancer cells related to the antigens) containing CYTLIMIC’s innovative cancer peptide vaccine, called CYT001.

The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs.

Under the collaboration agreement, Immutep will receive an upfront payment of US$500,000 and is eligible to receive up to US$4.5M in milestone payments upon the achievement of milestones by CYTLIMIC.

This therapeutic cancer vaccine with efti is the third example wherein efti is being evaluated in clinical studies in a combination.

Immutep retains complete exclusivity over its patent rights specifically covering its own clinical development programs and those it is conducting in conjunction with its other collaboration partners evaluating IMP321 in combination with either chemotherapy (AIPAC trial) or PD-1 / PD-L1 immunotherapy (INSIGHT and TACTI trials).

In addition to the collaboration agreement, Immutep has entered into a supply agreement to provide efti to CYTLIMIC for the manufacture of CYT001 for use in the clinical development and commercialisation of the vaccine. The Parties have also entered into a service agreement where Immutep will provide technical support services to CYTLIMIC during the development and commercialisation of CYT001.

Commenting on the Agreements, Immutep CEO Marc Voigt said: "We are very excited to be working alongside CYTLIMIC to help evaluate efti as part of an innovative cancer vaccine that has potential as a new therapy. Efti is generating interest globally. Following the agreements with CYTLIMIC, it is now being evaluated as part of three different combination therapy types: as part of a therapeutic cancer vaccine, as a chemo-immunotherapy and in an IO combination, showing its broad therapeutic potential."

Commenting on the collaboration, CYTLIMIC President and CEO, Shun Doi, Ph.D. said: "We are delighted with the engagement with Immutep, which will strongly help realize an innovative cancer vaccine-immunotherapy. Our own studies have shown that the combination of LAG-3Ig and Poly IC synergistically boost the efficacy of peptide vaccine, and thus I believe the combination of efti in our vaccine CYT001, which is also unique as an application of artificial intelligence, is an important step to add a new solution in cancer immunotherapy world."

On January 7, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported it has published the presentation that Chairman and Chief Executive Officer Joseph C. Papa is scheduled to present at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, today, Monday, Jan. 7, 2019, at 2:00 p.m. PST (5:00 p.m. EST) (Press release, Valeant, JAN 7, 2019, View Source [SID1234532572]).

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Entitled "Pivoting to Offense," the presentation provides an overview of the Company’s recent performance and accomplishments in its transformation and offers insight into future catalysts. The presentation is available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source