On February 27, 2020 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported financial results for the three-month period and year ended December 31, 2019 (Press release, Spectrum Pharmaceuticals, FEB 27, 2020, View Source [SID1234554900]).

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"ROLONTIS is in active review by the FDA and we are preparing to launch shortly following approval," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "We believe this market represents a significant commercial opportunity and our prelaunch activities are well underway. We have a podium presentation on poziotinib in a few short weeks, we have taken steps to adjust our strategy and we have multiple data catalysts in 2020. I look forward to updating you on our progress throughout the year."

Pipeline Updates

ROLONTIS (eflapegrastim), a novel long-acting G-CSF

FDA is actively reviewing the BLA for ROLONTIS for the treatment of chemotherapy-induced neutropenia. The PDUFA target action date for the ROLONTIS BLA has been set for October 24, 2020.
In October 2019, Spectrum presented a poster at the ASCO (Free ASCO Whitepaper) Supportive Care in Oncology Symposium in San Francisco. The poster highlighted integrated efficacy data from the Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER, which studied more than 600 patients combined and met all primary and secondary endpoints.
An abstract reporting preclinical data on eflapegrastim or pegfilgrastim using "same day dosing" as chemotherapy has been accepted for presentation at the AACR (Free AACR Whitepaper) meeting April 24-29 in San Diego.
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations

The pre-specified primary endpoint in a Phase 2 clinical trial (ZENITH20) evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations was not achieved in Cohort 1.
Data from Cohort 1 will be presented in a podium presentation at the 11th Annual Congress on Pulmonary and Respiratory Medicine in Amsterdam on March 18th.
Cohort 2 of the ZENITH20 trial enrolling previously treated HER2 non-small cell lung cancer patients is fully accrued and is expected to have topline results by mid-year 2020. Cohort 3 of the ZENITH20 trial enrolling first-line EGFR NSCLC patients is expected to have topline results by year-end 2020. Either cohort has the potential to support a future NDA submission.
Three-Month Period Ended December 31, 2019 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $40.2 million, or $0.36 per basic and diluted share, in the three-month period ended December 31, 2019, compared to net loss of $53.1 million, or $0.50 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $23.3 million in the quarter, as compared to $29.9 million in the same period in 2018. Selling, general and administrative expenses were $15.1 million in the quarter, compared to $16.6 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $33.4 million, or $0.30 per basic and diluted share, in the three-month period ended December 31, 2019, compared to non-GAAP net loss of $43.4 million, or $0.41 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $22.4 million, as compared to $29.2 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $11.6 million, as compared to $14.0 million in the same period in 2018.

Twelve-Month Period Ended December 31, 2019 (All numbers are from Continuing Operations)

GAAP Results

Spectrum recorded net loss of $135.4 million, or $1.22 per basic and diluted share, in the twelve-month period ended December 31, 2019, compared to net loss of $126.7 million, or $1.23 per basic and diluted share, in the comparable period in 2018. Total research and development expenses were $79.3 million for the year, as compared to $75.2 million in the same period in 2018. Selling, general and administrative expenses were $61.4 million for the year, compared to $62.7 million in the same period in 2018.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $111.9 million, or $1.01 per basic and diluted share, in the twelve-month period ended December 31, 2019, compared to non-GAAP net loss of $124.3 million, or $1.20 per basic and diluted share, in the comparable period in 2018. Non-GAAP research and development expenses were $72.0 million, as compared to $72.1 million in the same period of 2018. Non-GAAP selling, general and administrative expenses were $45.5 million, as compared to $53.2 million in the same period in 2018.

Cash Position and Guidance

Spectrum reported cash, cash equivalents, restricted cash, and marketable securities of approximately $224 million as of December 31, 2019, compared to $204 million at December 31, 2018. Based on current operating plans, Spectrum expects that SG&A expense will increase in the second half of this year as we scale up our commercial operations in preparation to launch ROLONTIS.

Conference Call

Thursday, February 27, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic:

(877) 837-3910, Conference ID# 4475135

International:

(973) 796-5077, Conference ID# 4475135

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on February 27, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On February 27, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported that Chuck Kummeth, President and Chief Executive Officer, will present at the Barclays Global Healthcare Conference on Wednesday, March 11, 2020 at 9:30 a.m. EST (Press release, Bio-Techne, FEB 27, 2020, View Sourcenews/detail/178/bio-techne-to-present-at-the-barclays-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/178/bio-techne-to-present-at-the-barclays-global-healthcare-conference" rel="nofollow">View Source [SID1234554917]). The conference will be held at the Loews Miami Beach Hotel in Miami Beach, FL. A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link https://cc.talkpoint.com/barc002/031020a_js/?entity=60_4GXRJYR.

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On February 27, 2020 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Nektar Therapeutics, FEB 27, 2020, View Source [SID1234554935]).

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Cash and investments in marketable securities at December 31, 2019 were approximately $1.6 billion as compared to $1.9 billion at December 31, 2018.

"Nektar’s progress over the past year has established a strong foundation for growth, with a robust portfolio of clinical-stage immuno-oncology and immunology candidates addressing multiple therapeutic areas," said Howard W. Robin, President and CEO of Nektar. "Our amended joint development plan with Bristol-Myers Squibb for bempegaldesleukin in combination with Opdivo expands the active registrational program for the doublet to five indications, including new Phase 3 studies in the adjuvant melanoma setting and muscle invasive bladder cancer. It also provides a path forward in first-line lung cancer and enhances our ability to pursue new combinations in additional indications."

Mr. Robin continued, "We also advanced NKTR-255, a novel IL-15 agonist that stimulates NK cells and memory T cells, into the clinic in combination with ADCC therapies. With NKTR-358, we have an opportunity to address the underlying immune imbalance associated with multiple autoimmune and chronic inflammatory diseases. Our partner Eli Lilly is on track to initiate a Phase 2 study in lupus, advance ongoing Phase 1b clinical trials in psoriasis and atopic dermatitis, and start an additional Phase 2 study in a new autoimmune indication this year."

Summary of Financial Results

Revenue in the fourth quarter of 2019 was $33.9 million as compared to $39.8 million in the fourth quarter of 2018. Revenue for the year ended December 31, 2019 was $114.6 million as compared to $1.2 billion in 2018 and was lower primarily due to the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement in the second quarter of 2018.

Total operating costs and expenses in the fourth quarter of 2019 were $143.5 million as compared to $140.1 million in the fourth quarter of 2018. Total operating costs and expenses for 2019 were $554.7 million as compared to $505.4 million in 2018. Total operating costs and expenses increased primarily as a result of increases in research and development (R&D) expense and general and administrative (G&A) expense.

R&D expense in the fourth quarter of 2019 was $110.4 million as compared to $108.9 million for the fourth quarter of 2018. R&D expense for the year ended December 31, 2019 was $434.6 million as compared to $399.5 million in 2018. R&D expense was higher in 2019 as compared to 2018 primarily because of the continued clinical development of bempegaldesleukin, including the registrational studies in melanoma, bladder cancer and renal cell carcinoma, and manufacture of Phase 2 drug supply for NKTR-358, which were partially offset by lower bempegaldesleukin and NKTR-181 manufacturing costs.

G&A expense was $27.1 million in the fourth quarter of 2019 as compared to $23.8 million in the fourth quarter of 2018. G&A expense for 2019 was $98.7 million as compared to $81.4 million in 2018. G&A expense was higher in the fourth quarter and full year 2019 as compared to the same periods in 2018 primarily due to non-cash stock based compensation expense, limited commercialization readiness activities for NKTR-181, as well as other costs related to personnel, facilities and outside services.

Net loss for the fourth quarter of 2019 was $112.2 million or $0.64 basic and diluted loss per share as compared to a net loss of $98.2 million or $0.57 basic and diluted loss per share in the fourth quarter of 2018. Net loss for the year ended December 31, 2019 was $440.7 million or $2.52 diluted loss per share as compared to net income of $681.3 million or $3.78 diluted earnings per share in 2018.

2019 and Year-to-Date Business Highlights:

In February 2020, Nektar announced the publication of preclinical bempegaldesleukin data in two manuscripts in Nature Communications showing how bempegaldesleukin works synergistically with multiple immune-based therapies to enhance T-cell-mediated tumor control.
In January 2020, Nektar and Bristol-Myers Squibb announced a new joint development plan that expands the ongoing registrational program for bempegaldesleukin plus Opdivo (nivolumab) from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and muscle-invasive bladder cancer. In addition, a Phase 1/2 study will be initiated to evaluate bempegaldesleukin plus nivolumab in combination with axitinib in first-line RCC in order to support a future registrational trial. Bristol-Myers Squibb will also independently conduct and fund a Phase 1/2 study in first-line non-small-cell lung cancer with bempegaldesleukin and nivolumab.
In January 2020, Nektar made the strategic business decision to withdraw its New Drug Application (NDA) for NKTR-181, an investigational medicine in development for chronic pain and make no further investment into the program.
In December 2019, Nektar presented results from preclinical studies of NKTR-255, its IL-15 agonist, at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting highlighting the candidate’s potential in the treatment of hematological malignancies by restoring both NK cell and memory CD8 T cell compartments in patients.
In November 2019, Nektar presented updated results from the first-in-human Phase 1a study of NKTR-358 at the 2019 Annual Meeting of the American College of Rheumatology supporting development of the candidate as a first-in-class T regulatory cell stimulator for the treatment of autoimmune and other chronic inflammatory conditions.
In November 2019, Nektar presented new data from the Stage IV front-line melanoma cohort in the PIVOT-02 study at the 2019 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. At a median time of follow-up of 18.6 months, median progression free survival had not yet been reached.
In October 2019, Nektar announced that its partner Eli Lilly initiated two Phase 1b studies of NKTR-358, one in patients with psoriasis and one in patients with atopic dermatitis.
In October 2019, Nektar announced the initiation of a first-in-human, Phase 1 clinical study evaluating NKTR-255 as monotherapy for patients with relapsed or refractory non-Hodgkin lymphoma or multiple myeloma.
In September 2019, Nektar presented clinical data from its PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) demonstrating the promising clinical activity of the combination in patients with advanced or metastatic triple-negative breast cancer, particularly in patients with PD-L1 negative baseline tumors.
In August 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for bempegaldesleukin in combination with Opdivo (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma.
In June 2019, Nektar presented biomarker and clinical data from the ongoing PIVOT-02 study for bempegaldesleukin in combination with Opdivo (nivolumab) at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. Clinical data presented included 12-month follow-up for the Stage IV first-line melanoma patient cohort and showed a deepening and durability of response over time.
In April 2019, Nektar presented positive preclinical data on its immuno-oncology pipeline candidates, bempegaldesleukin and NKTR-255, at the 2019 AACR (Free AACR Whitepaper) Annual Meeting.
In March 2019, Nektar presented preliminary immune activation, safety and clinical activity data from the ongoing dose-escalation stage of the REVEAL study at the 2019 ASCO (Free ASCO Whitepaper)-SITC Meeting. The REVEAL Phase 1/2 study is evaluating the safety and efficacy of NKTR-262, a novel TLR agonist, in combination with bempegaldesleukin.
In February 2019, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with Opdivo (nivolumab) at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
The company also announced upcoming presentations at the following scientific congresses:

Society of Toxicology (SOT) 59th Annual Meeting, Anaheim, CA

Presentation: "Bempegaldesleukin (NKTR-214), a novel IL-2 based immunotherapy, demonstrates superior nonclinical safety compared to that reported for recombinant human IL-2 (rhIL-2)", Leung, S., et al.
Session: Safety Assessment: Pharmaceutical—Drug Development
Date: Wednesday, March 18th, 10:45 a.m. – 12:30 p.m.
Presentation: "Toxicology Species Selection for Preclinical Safety Assessment of TLR7/8 Prodrug Agonist", Gunther, J., et al.
Session: Safety Assessment: Pharmaceutical—Drug Development
Date: Wednesday, March 18th, 10:45 a.m. – 12:30 p.m.
American Chemical Society National Meeting

Presentation: "NKTR-262: Discovery of a novel TLR 7/8 agonist prodrug that demonstrates synergistic anti-tumor effect in combination with NKTR-214, a CD-122 preferential IL-2 pathway agonist", Anand, N., et al.
Session: MEDI: Tissue Specific Delivery: TLR Agonists
Date: Tuesday, March 24th, 10:10 a.m. – 10:45 a.m.
Conference Call to Discuss Fourth Quarter and Year-End 2019 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Thursday, February 27, 2020.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through March 27, 2020.

To access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 2507828 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On February 27, 2020 Nordic Nanovector ASA (OSE: NANO) reported its results for the fourth quarter and full year 2019 (Press release, Nordic Nanovector, FEB 27, 2020, View Source;results-for-the-fourth-quarter-and-full-year-2019-301012304.html [SID1234554952]). A presentation by the company’s senior management team will take place today in Oslo at 08:30 CET, see details below.

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Jan H. Egberts, MD, Chairman of Nordic Nanovector, commented: "We currently have 47 patients enrolled in our pivotal PARADIGME Phase 2b trial evaluating Betalutin. The company will under its new management look into the current strategy and operational trial initiatives. We still aim to complete the patient enrolment in PARADIGME in the second half of 2020. The encouraging efficacy and safety profile demonstrated in the first part of the LYMRIT 37-01 Phase 1/2 trial with a single administration of Betalutin give the Board and management confidence in its potential to become an important option for patients with non-Hodgkin’s lymphoma (NHL).

Highlights Q4 2019

Pivotal Phase 2b PARADIGME trial of Betalutin in 3rd-line FL is progressing
47 patients have been enrolled in the PARADIGME trial
The company continues to aim for patient enrolment to be completed in the second half of 2020
A global agreement was signed with Isotope Technologies Garching GmbH (ITG) to ensure the supply of no-carrier-added lutetium-177, a key component of Betalutin
Successful completion of private placement of new shares raising approximately NOK 243 (USD 26.4 million) (gross)
DLBCL – 3 additional patients being enrolled into final dose cohort as one patient experienced a reversible DLT
Alpha37 project received grant funding of NOK 6 million (~USD 0.65 million) from Eurostars and NOK 12 million (~USD 1.3 million) from the Norwegian Research Council
New preclinical data offering insights to enchancing Betalutin-based combination therapies in NHL presented at ASH (Free ASH Whitepaper)
Events after Q4 2019

As announced in a separate release on 26 February 2020, Lars Nieba, Chief Technology Officer of Nordic Nanovector, has been appointed interim Chief Executive Officer to replace Eduardo Bravo, who has left the company to pursue other career opportunities.
Financial Highlights Q4 and FY’19

(Figures in brackets = same period 2018 unless otherwise stated)

Revenues for the fourth quarter amounted to NOK 0.0 million (NOK 0.0 million). Revenues for the full year 2019 were NOK 0.0 million (NOK 0.0 million).
Total operating expenses for the fourth quarter were NOK 139.3 million (NOK 96.3 million). Total operating expenses for the full year 2019 amounted to NOK 440.4 million (NOK 340.0 million).
Comprehensive loss for the fourth quarter amounted to NOK 137.5 million (loss of NOK 87.7 million). Comprehensive loss for the full year 2019 was NOK 433.2 million (NOK 336.8 million).
Cash and cash equivalents amounted to NOK 471 million at the end of December 2019 (NOK 440.1 million).
Outlook

Nordic Nanovector aspires to become a leader in the field of targeted radioimmunotherapies for haematological cancers by developing, manufacturing and commercialising innovative products to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced radioimmunotherapy candidate, is developing a highly differentiated, competitive, clinical profile. Nordic Nanovector is confident that Betalutin could become an attractive and convenient once-only therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Betalutin is being developed for recurrent FL, based on the promising results from the LYMRIT 37-01 Phase 1/2 clinical trial. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway. The company will under its new management look into the current strategy and operational trial initiatives. We still aim to complete the patient enrolment in PARADIGME in the second half of 2020. The study’s preliminary data read-out is planned a few months later. A BLA filing to gain marketing approval for Betalutin is expected to start in the first half of 2021. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin in core markets.

Nordic Nanovector intends to maximize the value of Betalutin across the major types of NHL (FL and DLBCL) and in earlier treatment lines in combination with standard treatments. The company is also evaluating opportunities with other CD37-targeting radioimmunotherapies across NHL and other haematological cancer indications.

Presentation and webcast – Q4 and Full Year 2019 results

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: BJØRVIKA

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation is available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2019.

On February 27, 2020 Coherus BioSciences, Inc. ("Coherus" or the "Company", Nasdaq: CHRS), reported corporate events and reported financial results for the quarter and full year ended December 31, 2019 (Press release, Coherus Biosciences, FEB 27, 2020, View Source [SID1234554901]).

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Fourth Quarter 2019 and Recent Corporate Highlights

Coherus’ commercial capabilities advanced its core mission to expand choice, improve patient access and lower healthcare costs in the United States:

UDENYCA (pegfilgrastim-cbqv) launch continues to deliver strong results using its validated branded-biosimilar approach across all market segments:

• UDENYCA continues to be the U.S. market-leading pegfilgrastim biosimilar and achieved approximately 20.5% unit market share, as measured by IQVIA, at year-end 2019.
• UDENYCA was the top pharmaceutical launch in 2019 based on IQVIA sales figures.

Strong financial position to support pipeline and potential long-term growth:

• Cash flow was positive after just two quarters post-launch in 2019.
• Cash flow from operating activities was $28.4 million for the full year and $17.7 million for the fourth quarter of 2019.
• Coherus had cash and cash equivalents of $177.7 million at December 31, 2019.
• Net product revenue for the fourth quarter of 2019 was $123.9 million, and net income was $39.2 million, or $0.53 per share on a fully diluted basis.
• Net product revenue for the full-year 2019 was $356.1 million. Net income attributable to Coherus for the same period was $89.8 million, or $1.23 per share on a fully diluted basis.

Coherus completed key licensing transactions to enhance its midterm product pipeline in the United States:

• Acquired exclusive rights from Bioeq AG ("Bioeq"), a Swiss biopharmaceutical joint venture, to commercialize Bioeq’s Lucentis (ranibizumab) biosimilar candidate in the United States.
• Entered into a license agreement with Innovent Biologics, (Suzhou) Co., Ltd., ("Innovent"), a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin (bevacizumab) in the United States and Canada.
• Under the terms of the agreement with Innovent, Coherus also acquired an option to commercialize Innovent’s biosimilar to Rituxan (rituximab) in the United States and Canada.

The Company advanced its internal pipeline in ophthalmology and immunology:
• Further advanced internally developed ophthalmology product candidate, CHS-2020, a biosimilar candidate to Eylea (aflibercept), which is in the preclinical stage.
• Completed certain development and regulatory objectives for its internally developed immunology product, CHS-1420, a biosimilar candidate to Humira (adalimumab), to support a potential BLA filing with the U.S. FDA in 2020.
Fourth Quarter and Full Year 2019 Financial Results

Net product revenue for fourth quarter of 2019 was $123.9 million. Cost of goods sold for the same quarter was $7.8 million, resulting in a gross profit margin of 94%.

Research and development (R&D) expenses for the fourth quarter of 2019 were $34.9 million, as compared to $26.7 million for the same period in 2018. The increase in R&D expenses for the quarter year-over-year was mainly due to the $11.1 million in upfront and milestone payments to Bioeq for the development of Bioeq’s Lucentis biosimilar in the fourth quarter of 2019. R&D expenses for the fiscal year 2019 were $94.2 million, as compared to $110.2 million for the same period in 2018. The decrease in R&D expenses for the full year-over-year was due primarily to the capitalization of UDENYCA manufacturing costs that had a $33.9 million impact since the approval of UDENYCA on November 2, 2018. This decrease was offset by an increase of $15.6 million, which was primarily related to the upfront and milestone payments to Bioeq for $11.1 million and the development of other biosimilar product candidates.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2019 were $36.1 million, as compared to $33.8 million for the same period in 2018. SG&A expenses for the full year 2019 were $137.0 million, as compared to $94.2 million for the same period in 2018. The increases in SG&A expenses for the quarter year-over-year and the full year-over-year were mainly attributable to an increase in sales force personnel and related commercial functions in connection with the commercialization of UDENYCA.

Cash and cash equivalents: As of December 31, 2019, Coherus had $177.7 million of cash and cash equivalents compared to $72.4 million as of December 31, 2018. During 2019, Coherus generated $28.4 million in operating cash flow, used $12.7 million in investing activities, including $11.1 million in upfront and milestone payments to Bioeq, and received net cash proceeds of $73.0 million, included in cash flow from financing activities, related to the issuance of debt to HealthCare Royalty Partners in January 2019.

Assets and working capital: As of December 31, 2019, Coherus had $408.9 million in total assets compared to $99.5 million as of December 31, 2018. Working capital increased from $51.2 million at the beginning of 2019 to $228.0 million at the end of 2019. The quadrupling in working capital was mainly due to increases in UDENYCA trade receivables of $142.0 million.

Net income attributable to the Company for the fourth quarter of 2019 was $39.2 million, or $0.53 per share on a fully diluted basis, compared to a net loss of ($62.6) million, or ($0.92) per share on a basic and fully diluted basis for the same period in 2018. Net income attributable to Coherus for the fiscal year 2019 was $89.8 million, or $1.23 per share on a fully diluted basis, compared to a net loss of ($209.3) million, or ($3.22) per share on a basic and fully diluted basis for 2018.

Guidance for the Next Twelve Months from December 31, 2019

Coherus will continue delivering on the promise of biosimilars and laying the foundation for long-term growth across its three therapeutic areas:

Oncology

UDENYCA (pegfilgrastim-cbqv)
• Maintain market position as the leading pegfilgrastim biosimilar of choice, leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments including ample product supply.
• Increase penetration against all Neulasta dosage forms, while maintaining average selling price (ASP) discipline.
Advance its Avastin (bevacizumab) oncology biosimilar candidate in-licensed from Innovent toward the filing of a BLA with the U.S. FDA in late 2020 or early 2021 depending on FDA interaction timing and development requirements, with an expected launch directly upon approval.
Diligence the option to commercialize Innovent’s Rituxan (rituximab) oncology biosimilar in the U.S.
Ophthalmology

Facilitate Bioeq filing a BLA with the FDA for the biosimilar candidate to Lucentis (ranibizumab) in 2020, with expected product launch in the United States to address a $6 billion anti-VEGF ophthalmology market, if approved.
Advance internally developed CHS-2020 Eylea (aflibercept) ophthalmology biosimilar currently in preclinical stage to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
Immunology

Complete certain development and regulatory objectives with CHS-1420, Humira (adalimumab) immunology biosimilar candidate to support the filing of a BLA with the U.S. FDA in 2020 with an expected competitive launch in 2023 in the largest biologics market, if approved.
CHS-131

The Company has decided to pursue strategic alternatives for its program in CHS-131, a small molecule for nonalcoholic steatohepatitis (NASH) and multiple sclerosis.
Conference Call Information

When: Thursday, February 27, 2020 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9658203
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 2019 financial results, are posted on the Coherus website at View Source.