On February 28, 2019 gle Pharmaceuticals, Inc. ("Eagle" or the "Company") (Nasdaq: EGRX) reported its financial results for the three months and full year ended December 31, 2018 (Press release, Eagle Pharmaceuticals, FEB 28, 2019, View Source [SID1234533800]). Highlights of, and subsequent to, the fourth quarter of 2018 include:

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Business and Recent Highlights:

· Commenced enrollment in a study to evaluate the neuroprotective effects of RYANODEX (dantrolene sodium) in collaboration with the United States Army Medical Research Institute of Chemical Defense ("USAMRICD"), the nation’s leading science and technology laboratory in the area of medical chemical countermeasures research and development;

· Announced positive results of pre-clinical study conducted to evaluate effects of RYANODEX in Acute Radiation Syndrome ("ARS");

·On February 20, 2019, the FDA issued a decision in favor of Eagle regarding the scope of BENDEKA’s Orphan Drug Exclusivity ("ODE"), further protecting the longevity of the BENDEKA franchise; and

·Executed a $50.0 million accelerated share repurchase ("ASR") as part of our $150.0 million share repurchase program (the "Share Repurchase Program").

Financial Highlights:

Fourth Quarter 2018

· Total revenue for the fourth quarter of 2018 was $56.1 million, compared to $46.8 million in the fourth quarter of 2017;

· Q4 2018 bendamustine hydrochloride 500ml solution ("Big Bag" or "BELRAPZO") product sales were $6.8 million; in February of 2019, the Company achieved peak market share of 10%, according to IQVIA Holdings Inc.;

· Q4 2018 RYANODEX product sales were $5.1 million, up 10% compared to Q4 2017;

· Q4 2018 net income was $12.6 million, or $0.88 per basic and $0.86 per diluted share, compared to net income of $9.1 million, or $0.61 per basic and $0.58 per diluted share in Q4 2017;

· Q4 2018 adjusted non-GAAP net income was $17.7 million, or $1.23 per basic and $1.20 per diluted share, compared to adjusted non-GAAP net income of $15.6 million, or $1.05 per basic and $1.00 per diluted share in Q4 2017; and

·Q4 2018, Eagle executed a $50.0 million ASR of common stock as part of the Share Repurchase Program.

Full Year 2018

· Total revenue for the twelve months ended December 31, 2018 was $213.3 million, compared to $236.7 million in 2017 including $37.5 million in milestone payments for BENDEKA, reflecting revenue growth of 7% when excluding milestone payments;

·2018 net income was $31.9 million, or $2.16 per basic and $2.09 per diluted share, compared to net income of $51.9 million, or $3.44 per basic and $3.27 per diluted share in 2017;

· 2018 adjusted non-GAAP net income was $59.2 million, or $4.01 per basic and $3.87 per diluted share, compared to adjusted non-GAAP net income of $69.0 million, or $4.57 per basic and $4.34 per diluted share in 2017;

· From August 2016 through December 31, 2018, Eagle has repurchased $154.0 million of its common stock; and

· Cash and cash equivalents were $78.8 million, accounts receivable was $66.5 million, and debt was $45.0 million as of December 31, 2018.

"We had another outstanding quarter, nearly doubling our product sales in Q4 2018 compared to Q4 2017 and generating 20% growth in total quarterly revenue year over year. We were able to deliver substantial cash flow throughout the year, repurchase $78 million of our own shares, and maintain a very strong balance sheet with which to execute our development and commercial activities," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"There are multiple exciting opportunities we plan to advance in 2019. The study initiated with the U.S. Military to evaluate RYANODEX in the treatment of nerve agent exposure is progressing nicely. Three of the six animal cohorts have now been challenged. The results of our pre-clinical study to evaluate the effect of RYANODEX in treating ARS are encouraging, and we are continuing our dialogue with the FDA regarding a path forward for EHS. As the year unfolds, we look forward to gaining greater clarity regarding our pipeline, exploring new opportunities with existing products, and delivering a very efficient business model that provides the cash necessary to execute our development, commercial activities, and potential licensing opportunities," concluded Tarriff.

Fourth Quarter 2018 Financial Results

Total revenue for the three months ended December 31, 2018 was $56.1 million, as compared to $46.8 million for the three months ended December 31, 2017. Royalty revenue was $35.7 million, compared to $36.4 million in the fourth quarter of 2017. BENDEKA royalties were $31.9 million, compared to $34.7 million in the fourth quarter of 2017. A summary of total revenue is outlined below:

Gross Margin was 67% during the fourth quarter of 2018, as compared to 71% in the fourth quarter of 2017. The year over year compression in gross margin resulted from the introduction of Big Bag revenue was partly offset by an expansion in RYANODEX gross margin.

R&D expenses were $5.9 million for the quarter, compared to $9.4 million in the prior year quarter. The fourth quarter year over year decrease reflects a substantial reduction in fulvestrant expenses, partially offset by the cost of analytical work to support our vasopressin ANDA. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter was $4.4 million.

SG&A expenses in the fourth quarter of 2018 increased to $15.5 million in the fourth quarter of 2018 compared to $13.4 million in the fourth quarter of 2017. External legal expenses account for the year over year increase. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2018 SG&A expense was $11.3 million.

Net income for the fourth quarter of 2018 was $12.6 million, or $0.88 per basic and $0.86 per diluted share, compared to net income of $9.1 million, or $0.61 per basic and $0.58 per diluted share in the three months ended December 31, 2017, due to the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2018 was $17.7 million, or $1.23 per basic and $1.20 per diluted share, compared to adjusted non-GAAP net income of $15.6 million or $1.05 per basic and $1.00 per diluted share in the fourth quarter of 2017. For a full reconciliation of adjusted non-GAAP net income to the most comparable GAAP financial measures, please see the tables at the end of this press release.

Full Year 2018 Financial Results

The increase in product sales in 2018 was driven primarily by the launch of Big Bag, as well as continued growth in RYANODEX revenue. Royalty revenue totaled $142.9 million in 2018 compared to $153.9 million in 2017. In 2018, Eagle did not earn any license and other income. In 2017, Eagle earned certain contractual milestones in connection with the Company’s BENDEKA licensing agreement with Teva, as well as an upfront payment associated with the SymBio collaboration covering Japanese rights for bendamustine hydrochloride ready-to-dilute and rapid infusion injection products.

Gross margin was 71% in 2018, as compared to 76% in 2017. The year over year compression in gross margin resulted from the introduction of Big Bag revenue was partly offset by an expansion in RYANODEX gross margin.

R&D expense increased to $44.4 million in 2018, compared to $32.6 million in 2017, reflecting the cost of the fulvestrant trial as well as the vasopressin analytical work. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2018 was $37.8 million.

SG&A expenses decreased by $10.9 million to $60.5 million in 2018, compared to $71.4 million in 2017. In 2017, SG&A included increased marketing expense related to exertional heat stroke ("EHS") and the contract sales force agreement with Spectrum. The elimination of those expenses in 2018 was partly offset by an increase in external legal expenses. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2018 was $43.1 million.

Net income for the year ended December 31, 2018 was $31.9 million or $2.16 per basic and $2.09 per diluted share as compared to net income of $51.9 million or $3.44 per basic and $3.27 per diluted share for the year ended December 31, 2017, as a result of the factors discussed above.

Adjusted non-GAAP net income for 2018 was $59.2 million, or $4.01 per basic and $3.87 per diluted share, compared to adjusted non-GAAP net income of $69.0 million, or $4.57 per basic and $4.34 per diluted share in 2017.

Liquidity

As of December 31, 2018, the Company had $78.8 million in cash and cash equivalents and $66.5 million in net accounts receivable, $41.8 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $45.0 million in outstanding debt.

In the fourth quarter of 2018, we purchased $50.0 million of Eagle’s common stock as part of our $150.0 million Share Repurchase Program. From August 2016 through December 31, 2018, we have repurchased $154.0 million of our common stock, including the $50.0 million ASR. As disclosed on October 30, 2018, the Company’s Board of Directors retired the prior share repurchase programs and approved the new $150.0 million Share Repurchase Program (which includes the ASR).

Conference Call

As previously announced, Eagle management will host its fourth quarter and full year 2018 conference call as follows:

Date

Thursday, February 28, 2019

Time

8:30 A.M. EST

Toll free (U.S.)

877-876-9177

International

785-424-1672

Webcast (live and replay)

www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for one week after the call’s completion by dialing 800-283-4799 (US) or 402-220-0860 (International) and entering conference call ID EGRXQ418. The webcast will be archived for 30 days at the aforementioned URL.

On February 28, 2019 Coherus BioSciences, Inc. (Nasdaq: CHRS), reported financial results for the quarter and full year ended December 31, 2018 (Press release, Coherus Biosciences, FEB 28, 2019, View Source [SID1234533827]).

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Fourth Quarter 2018 and Recent Corporate Highlights Include:

On November 2, 2018, the U.S. Food and Drug Administration (FDA) approved UDENYCA (pegfilgrastim-cbqv) for patients with non-myeloid cancer receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. UDENYCA is Coherus’ first drug to receive FDA and European Commission approval.

In November 2018, Coherus received Q-Code medical billing status for UDENYCA from the Centers for Medicare and Medicaid Services, which became effective January 1, 2019.

On January 3, 2019, Coherus launched UDENYCA commercially in the U.S.

On January 7, 2019, Coherus entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners.

In January 2019, Coherus entered into settlement and license agreements with AbbVie Inc. that grant the company global, royalty-bearing, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420 (adalimumab (Humira) biosimilar).

Fourth Quarter and Full Year 2018 Financial Results:

Research and development (R&D) expenses for the fourth quarter of 2018 were $26.7 million, as compared to $31.5 million for the same period in 2017. R&D expenses for the fiscal year 2018 were $110.2 million, as compared to $162.4 million for the same period in 2017. The decreases in R&D expenses were mainly due to the completion of the clinical trials and related manufacturing for the immunology biosimilar drug candidates, CHS-0214 (etanercept (Enbrel) biosimilar) and CHS-1420. These cost decreases were partially offset by increased costs associated with the manufacturing of UDENYCA. Coherus had approximately 330,000 cumulative units of UDENYCA released as of December 31, 2018.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2018 were $33.8 million, as compared to $15.0 million for the same period in 2017. SG&A expenses for the fiscal year 2018 were $94.2 million, as compared to $71.3 million for the same period in 2017. The increases in SG&A expenses in 2018 were mainly attributable to the costs associated with hiring a sales force and completing the commercial functions and infrastructure to launch and sell UDENYCA in the U.S.

Cash and cash equivalents and investments in marketable securities for the fourth quarter totaled $72.4 million as of December 31, 2018, before receiving $73.1 million in net proceeds from the senior secured credit facility in January 2019, or a pro forma total of $145.5 million, as compared to $117.2 million as of September 30, 2018. Cash used in operations was $47.4 million during the fourth quarter of 2018, as compared to $42.8 million during the third quarter of 2018.

Net loss attributable to Coherus for the fourth quarter of 2018 was ($62.6) million, or ($0.92) per share, compared to a net loss of ($49.1) million, or ($0.84) per share, for the same period in 2017. Net loss attributable to Coherus for 2018 was ($209.3) million, or ($3.22) per share, compared to a net loss of ($238.2) million, or ($4.48) per share, for 2017.

Guidance for the Next Twelve Months from December 31, 2018:

UDENYCA (pegfilgrastim-cbqv), Neulasta (pegfilgrastim) biosimilar

Secure receipt of transitional pass-through status in 340-B hospitals in April 2019.

Increase penetration of patient and provider support programs and access portals.

Secure parity payment status with all national and local payers.

CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of the anticipated filing of a 351(k) biologic license application (BLA) in the U.S.

CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (aflibercept (Eylea) biosimilar)

Complete manufacturing technology transfer to support clinical development of CHS-3351.

Continue preclinical development of CHS-2020.

Conference Call Information

When: Thursday, February 28, 2019 starting at 4:30 p.m. ET

Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)

Conference ID: 3398069

Webcast: View Source

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Fourth quarter and full year 2018 financial results, are posted on the Coherus website at View Source.

On February 28, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported the publication of an abstract demonstrating a biomarker for predicting clinical response in patients treated with pelareorep (Press release, Oncolytics Biotech, FEB 28, 2019, View Source [SID1234533842]). This analysis was conducted in patient samples from REO 024; a study of pelareorep and Keytruda in combination with chemotherapy in patients with second-line pancreatic cancer. Detailed results will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place March 30 through April 3 in Atlanta, Georgia.

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"With a simple blood draw, this biomarker data allows physicians to understand which patients are likely to respond to treatment, allowing for the design of clinical studies that are cheaper, faster and more likely to succeed," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "Our biomarker data that we will present at AACR (Free AACR Whitepaper) is immediately applicable to future clinical studies. Investigators should now be able to predict which patients will respond to pelareorep in combination with a checkpoint inhibitor. This biomarker will be evaluated in our clinical studies with checkpoint inhibitors, including both of our multiple myeloma studies, the AWARE-1 breast cancer study, and importantly, in the same setting this data was produced, our phase two second-line pancreatic study in combination with Keytruda."

"Using patient blood samples from our REO 024 study in second line pancreatic cancer, T cell receptor sequencing was performed with Adaptive Biotechnologies’ immunoSEQ Assay to measure the diversity or clonality of the T cell population," said Dr. Rita Laeufle, CMO of Oncolytics Biotech. "Results from this analysis demonstrate that higher clonality after one three-week cycle of treatment can identify patients likely to respond to combination treatment of pelareorep and a checkpoint inhibitor."

The results suggest that those patients with a statistically significant change in their T cell population demonstrate a clinical benefit from pelareorep treatment. High T cell clonality correlates with progression free survival at baseline (HR=0.05, p=0.01). Moreover, high clonality correlates with overall survival at both baseline (HR=0.124, p=0.01) and after one cycle of treatment (HR=0.08, p=0.01). This research highlights the potential utility of measuring T cell clonality as a predictive and prognostic biomarker of pelareorep therapy.

The abstract, authored by Dr. Grey Wilkinson, a translational scientist at Oncolytics Biotech, and his colleagues, in collaboration with Northwestern University, UT Health San Antonio and Adaptive Biotechnologies can be found online at View Source!/6812/presentation/4866. Full details from the poster presentation will be announced after it is presented.

Poster Board Number: 1
Presentation Number: 2272
Title:
Exploratory analysis of T cell repertoire dynamics upon systemic treatment with the oncolytic virus pelareorep in combination with pembrolizumab and chemotherapy in patients with advanced pancreatic adenocarcinoma
Date:
Monday, April 1
Lecture Time: 1:00 p.m. ET – 5:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 20
Speakers: Grey Wilkinson
Session Category:
Clinical Research

Session:
Current Developments in Non-invasive Biomarkers for Assessment of Cancer 3

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On February 28, 2019 Synlogic(Nasdaq:SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will present at the following upcoming investor conferences (Press release, Synlogic, FEB 28, 2019, View Source [SID1234533866]):

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Chardan’s 1st Annual Microbiome Medicines Summit at 2:05pm ET on Thursday, March 7, 2019, in New York City.
Cowen and Company 39th Annual Health Care Conference at 11:20 am ET, on Monday, March 11, 2019, in Boston.
Live webcasts of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. Archived copies of the webcasts will be available on the Synlogic website for approximately 30 days after the event.

On February 28, 2019 Incyte Corporation (Nasdaq:INCY) reported that seven abstracts showcasing data from its cancer research portfolio will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 (Press release, Incyte, FEB 28, 2019, View Source [SID1234533786]). The meeting will be held March 29 – April 3, 2019, at the Georgia World Congress Center in Atlanta, Georgia.

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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

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Accepted abstracts feature data from clinical studies involving Incyte’s anti-PD-1 monoclonal antibody, INCMGA00121, in patients with advanced solid tumors, as well as pre-clinical characterizations of the Company’s oral, small molecule PD-L1 inhibitor program and its PD-L1xCD137 bispecific antibody.

"Data accepted for presentation during the upcoming AACR (Free AACR Whitepaper) Annual Meeting demonstrate our ongoing commitment to advancing innovative research as we seek to bring forward novel therapies for patients with cancer," stated Dashyant Dhanak, Ph.D., Chief Scientific Officer, Incyte. "In particular, we are pleased to present, for the first time at a major medical meeting, early data on our oral PD-L1 inhibitor program—whose lead candidate, INCB86550, recently entered clinical trials."

Key abstracts include:

Clinical

Pharmacodynamic correlates in a phase 1 study of INCMGA00012, a PD-1 antagonistic monoclonal antibody (Abstract #CT085/9, Phase 1 Clinical Trials: Part 3)

Monday, April 1, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 16
Assessment of flat dosing strategy for INCMGA00012 in patients with advanced tumors(Abstract #LB-268/14, Late-Breaking Research: Experimental and Molecular Therapeutics)

Wednesday, April 3, 2019, 8:00 a.m. – 12:00 p.m. ET, Poster Section 40
Pre-Clinical

Oral Presentations

Novel small-molecule antagonists of the PD-1/PD-L1 axis that mediate cell surface PD-L1 dimerization and internalization (Abstract #4483, Novel Therapeutics)

Tuesday, April 2, 2019, 3:00 p.m. – 5:00 p.m. ET, Georgia Ballroom 3 – Georgia World Congress Center (Building C)
Preclinical characterization of potent and selective oral PD-L1 small-molecule antagonists (Abstract #4480, Novel Therapeutics)

Tuesday, April 2, 2019, 3:00 p.m. – 5:00 p.m. ET, Georgia Ballroom 3 – Georgia World Congress Center (Building C)
Poster Presentations

A bispecific Fc-silenced IgG1 antibody (MCLA-1452) requires PD-L1 binding to activate CD137 (Abstract #539/3, Therapeutic Antibodies I)

Sunday, March 31, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 23
An unbiased screen identifies a CD137xPD-L1 bispecific IgG1 antibody with unique T cell activation and binding properties (Abstract #541/5, Therapeutic Antibodies I)

Sunday, March 31, 2019, 1:00 p.m. – 5:00 p.m. ET, Poster Section 23
Characterization of human cancer cell line xenografts in humanized mice (Abstract #1050/1, Human in Mouse)

Monday, April 1, 2019, 8:00 a.m. – 12:00 p.m. ET, Poster Section 4
Full session details and data presentation listings for AACR (Free AACR Whitepaper) 2019 can be found at: View Source!/6812.