On March 2, 2020 UroGen Pharma Ltd. (Nasdaq:URGN) a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options, reported financial results for the fourth quarter and full year ended December 31, 2019 and provided an overview of the Company’s recent developments (Press release, UroGen Pharma, MAR 2, 2020, View Source [SID1234555067]).

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"At UroGen, we are eagerly awaiting potential approval of our lead product candidate, UGN-101, for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). The significant progress on key clinical, regulatory and commercial milestones in 2019 places us in a position of strength as we prepare to deliver the first non-surgical therapy for the treatment of LG UTUC. Our experienced commercial team has been working tirelessly to ensure we are prepared for launch, and we look forward to providing these patients with a new treatment option," said Liz Barrett, President and Chief Executive Officer (CEO) of UroGen. "We are also advancing multiple pipeline candidates in development for areas of unmet need in both low-grade and high-grade bladder cancer, including UGN-102 and UGN-302, respectively. As our team pioneers new treatments to improve patient care in specialty cancers and urologic diseases, we look forward to maximizing patient and shareholder value through the exciting events on the horizon".

2019 and Recent Highlights

UGN-101 (mitomycin gel) for instillation for Patients with LG UTUC Progress

Reported positive updated durability and complete response data from the pivotal Phase 3 OLYMPUS trial in September 2019. The data were consistent with previously reported results in May 2019 and January 2019.
Completed a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Received FDA filing acceptance and Priority Review of the NDA for UGN-101, with a PDUFA goal date of April 18, 2020. If approved, UGN-101 will be the first non-surgical, chemoablative treatment option for LG UTUC.
UGN-101 Commercial Readiness

Hired an internal team with a track record of success in urology and oncology as well as a veteran sales force leadership team with deep uro-oncology relationships.
Implemented innovative solutions around patient identification, reimbursement and seamless logistics to enhance physician adoption upon launch. Based on recent market research, 88% of urologists desire a new and differentiated treatment option for their patients.
Executed agreements with 3PL, a specialty distributor and a national partner to provide prepared admixture to urology clinics.
Pipeline Expansion and Developments

UGN-102 (mitomycin gel) for intravesical instillation for patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR NMIBC)
Completed enrollment ahead of schedule and reported positive interim results from the single-arm, open-label Phase 2b OPTIMA II trial of investigational UGN-102 for patients with LG IR NMIBC.
LG IR NMIBC is defined as those patients with one or two of the following criteria: multifocal disease, large tumors and rapid rates of recurrence. This is a patient population whereby the current standard of care, transurethral resection of bladder tumor, or TURBT, is used repeatedly to address chronic recurrence of disease. These patients experience what can be viewed as a form of surgical failure and many undergo multiple surgical procedures during life to "manage" bladder cancer recurrences.
There are no drugs currently approved by the FDA as first-line treatment for LG IR NMIBC. UGN-102 has the potential to provide a non-surgical treatment alternative for approximately 80,000 patients diagnosed with LG IR NMIBC.
UGN-201 (TLR7/8 agonist) for patients with high-grade non muscle invasive bladder cancer (HG NMIBC)
Shared nonclinical data of investigational UGN-201 (a TLR7/8 agonist) as a monotherapy and in combination with checkpoint inhibitors.
In murine models, UGN-201 in combination with local anti-CTLA-4 increased survival.
Entered into an exclusive worldwide license agreement with Agenus Inc. to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of high-grade urinary tract cancers, initially targeting HG NMIBC. The combination of UGN-201 and zalifrelimab is referred to as investigational agent UGN-302.
Corporate Achievements

Strengthened the Company’s financial position with a follow-on offering of approximately $162 million in January 2019.
2020 Anticipated Milestones and Product Development Plans

UGN-101

Publication of the final results of the primary endpoint from the OLYMPUS trial in patients with LG UTUC in 1H
UGN-101 potential approval and launch in Q2
UGN-102

Updated durability and complete response data from UGN-102 Phase 2b Study
Initiation of pivotal Phase 3 Study in 2H
UGN-302

Advancement to first in human clinical study following formulation and dose optimization
Fourth Quarter and Full Year 2019 Financial Results; 2020 Guidance

As of December 31, 2019, cash, cash equivalents and marketable securities totaled $195.6 million, excluding restricted cash.
Research and development expenses for the three months ended December 31, 2019 were $20.1 million, including non-cash share-based compensation expense of $1.9 million. Research and development expenses for the year ended December 31, 2019 were $49.3 million, including non-cash share-based compensation expense of $8.3 million. The research and development expenses for the three months and year ended December 31, 2019 included an in-process research and development charge of $10.0 million associated with the execution of the Agenus licensing agreement.
General and administrative expenses for the three months ended December 31, 2019 were $19.7 million, including non-cash share-based compensation expense of $6.2 million. General and administrative expenses for the year ended December 31, 2019 were $60.2 million, including non-cash share-based compensation expense of $21.7 million.
UroGen reported a net loss of $39.0 million, or basic and diluted net loss per ordinary share of $1.86, for the three months ended December 31, 2019. The Company reported a net loss of $105.1 million, or basic and diluted net loss per ordinary share of $5.12, for the year ended December 31, 2019.
The Company anticipates operating expenses in the range of $145 to $155 million for 2020. Non-cash stock-based compensation expense for 2020 is expected to be in the range of $32 to $36 million subject to market conditions, and other non-operating income for 2020 is anticipated to be approximately $2.5 million.
UroGen has 21.0 million ordinary shares outstanding.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 AM Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 49393633. An archive of the webcast will be available for two weeks on the Company’s website.

On March 2, 2020 Merck, a leading science and technology company, reported that ERBITUX (cetuximab) has been granted approval by the National Medical Products Administration (NMPA) of China for the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in combination with platinum-based therapy with fluorouracil (Press release, Merck & Co, MAR 2, 2020, View Source;839770456.html [SID1234555066]). Evidence from the pivotal Phase III CHANGE II study, on which the approval is based, shows the efficacy and safety of the EXTREME regimen (ERBITUX + cisplatin + 5-FU, followed by ERBITUX maintenance) vs platinum-based chemotherapy (cisplatin + 5-FU) alone for first-line treatment in Chinese patients with R/M SCCHN. The data showed that the addition of ERBITUX to platinum-based chemotherapy improved progression-free survival (PFS), overall survival (OS) and overall response rate (ORR), confirming the relevance of the EXTREME regimen specifically in this patient population.1

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"ERBITUX in combination with platinum-based therapy is a preferred treatment option for patients with R/M SCCHN globally and the CHANGE II study further demonstrates the benefits it can bring in the first-line setting for patients in China," said Professor Ye Guo, Shanghai East Hospital, Tongji University, China and principal investigator in the CHANGE II study. "The approval of ERBITUX in a first-line setting marks an important development for Chinese patients, who now have access to a new treatment option."

"ERBITUX and the EXTREME regimen play an important role in the treatment of patients with R/M SCCHN. We welcome the National Medical Products Administration’s decision to make it available to Chinese patients in the first-line setting," said Chris Round, Head of International Operations and Global Core Franchises, Merck, operating in China. "This approval marks a significant step forward in fulfilling our commitment as a global specialty innovator, including bringing medicines to markets with high unmet medical needs."

The approval is based on the CHANGE II study of 243 randomized patients (164 patients in the ERBITUX + platinum-based chemotherapy arm versus 79 patients in the platinum-based chemotherapy only arm) from China with R/M SCCHN, which found that adding ERBITUX to platinum-based chemotherapy improved progression-free survival (median 5.5 vs 4.2 months; hazard ratio [HR]=0.57; 95% confidence interval [CI]: 0.40–0.80), overall survival (median 10.2 vs 8.4 months; HR=0.71; 95% CI: 0.50–0.99) and overall response rate (50% vs 27%) with no new or unexpected safety findings.1

CHANGE II is the first Phase III trial in the Chinese population to prospectively evaluate an anti-epidermal growth factor receptor (EGFR) antibody in the first-line treatment of patients with R/M SCCHN. The data are consistent with previous international pivotal studies and reaffirm the efficacy of ERBITUX in combination with platinum-based therapy with fluorouracil for patients with R/M SCCHN.

In 2019, ERBITUX was made available in China for the first-line treatment of patients with RAS wild-type metastatic colorectal cancer in combination with FOLFOX or FOLFIRI, or in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.

About CHANGE II

CHANGE II is a multicenter, randomized, open-label, Phase III trial assessing the efficacy and safety of the EXTREME regimen vs platinum-based therapy for Chinese patients with first-line recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). The trial included 243 patients in China ≥18 years of age with histologically confirmed R/M SCCHN and no prior systemic chemotherapy for R/M disease. The primary objective was to demonstrate superior PFS time per Response Evaluation Criteria on Solid Tumors (RECIST).

About ERBITUX (cetuximab)

ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells (antibody-dependent cell-mediated cytotoxicity [ADCC]).

ERBITUX has already obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998.

References

Guo Y, Luo Y, Zhang Q et al. First-line (1L) cisplatin and 5-FU ± cetuximab in Chinese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): the randomized, Phase III CHANGE II trial. LBA6. Presented Saturday, November 24, 2018. Session Time: 3:30-4:20PM Room 311. ESMO (Free ESMO Whitepaper) Asia 2018.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

On March 2, 2020 The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) reported a quarterly dividend of forty-five cents ($0.45) per share on the $.10 par value Common Stock of the corporation (Press release, Bristol-Myers Squibb, MAR 2, 2020, View Source [SID1234555065]). The next quarterly dividend will be payable on May 1, 2020, to stockholders of record at the close of business on April 3, 2020.

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The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable June 1, 2020 to stockholders of record at the close of business on May 5, 2020.

On March 2, 2020 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a chemistry-driven approach to leveraging the microbiome organ to treat disease and improve human health, reported financial results for the fourth quarter and full year ended December 31, 2019, and provided a corporate update (Press release, Kaleido Biosciences, MAR 2, 2020, View Source [SID1234555064]).

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"2019 was a transformational year for Kaleido as we validated our platform with patient clinical data, advanced our pipeline, continued to build our library of Microbiome Metabolic Therapies (MMT), and completed our Initial Public Offering," said Alison Lawton, President and Chief Executive Officer of Kaleido. "We initiated five clinical studies with three MMTs, including our first Phase 2 trial, and the results we reported from the three completed studies support our development programs for KB195 in urea cycle disorders and KB174 in hepatic encephalopathy. We also established collaborations with leaders at the forefront of microbiome research."

Ms. Lawton continued, "We enter 2020 with strong momentum as we aim to deliver key data sets later this year, first from our Phase 2 trial in patients with UCD and then our multi-drug resistant pathogens clinical study with KB109. We also anticipate reporting in vivo findings from our programs in immuno-oncology and cardiometabolic and liver diseases before year end. Importantly, through efficient resource management during Q4 2019 and into 2020, we now anticipate that we have sufficient cash to extend our runway into Q1 2021."

Recent Highlights

Announced positive top-line results from a proof of concept clinical study of KB174 in patients with well-compensated cirrhosis and plans to advance the program into a clinical study in patients with hepatic encephalopathy (HE) in the second half of 2020.
Multiple abstracts relating to KB174 and Kaleido’s MMT development program for HE have been accepted for presentation during The International Liver Congress, the Annual Meeting of the European Association for the Study of the Liver (EASL), April 15-19, 2020, and Digestive Disease Week (DDW), May 2-5, 2020.
Announced a collaboration with Janssen to explore the potential for MMTs to promote healthy function of the gut microbiome and effects on childhood-onset of atopic, immune and metabolic conditions.
Anticipated Milestones

Top-line data expected in Q4 2020 from:
Phase 2 clinical trial (UNLOCKED) of KB195 in patients with UCD inadequately controlled on standard of care; and
Clinical study of KB109 (VITORA) in patients colonized with multi-drug resistant pathogens.
In vivo findings from ongoing programs in immuno-oncology and cardiometabolic and liver diseases also expected in Q4 2020.
Fourth Quarter and Full Year 2019 Financial Results

For the full year 2019, Kaleido reported a net loss of $86.3 million, or $3.36 per common share, compared to $61.7 million, or $12.09 per common share, for the prior year. Kaleido reported a net loss of $19.5 million, or $0.65 per common share, for the fourth quarter of 2019 compared to $21.2 million, or $3.81 per common share, for the same period in 2018. Related to the measures announced in October 2019 to focus resources on pipeline programs and extend cash runway, headcount was reduced by approximately 25 percent and the fourth quarter net loss figure was inclusive of a one-time severance charge of $1.2 million. Additionally, the 2019 fourth quarter net loss includes non-cash stock-based compensation expenses of $2.2 million, as compared to $2.4 million in the fourth quarter of 2018. The full year 2019 net loss included non-cash stock-based compensation expenses of $10.1 million, as compared to $7.0 million in 2018.

Research and development (R&D) expenses were $14.1 million for the three months ended December 31, 2019 and $64.2 million for the full year ended December 31, 2019, compared to $15.2 million for the three months ended December 31, 2018 and $42.1 million for the full year ended December 31, 2018. The 2019 full year increase in R&D was primarily driven based on increases in direct costs related to the KB195 program, R&D headcount, external manufacturing and research costs, and consulting fees.

General and administrative (G&A) expenses were $4.9 million for the three months ended December 31, 2019 and $22.4 million for the full year ended December 31, 2019, compared to $5.6 million for the three months ended December 31, 2018 and $18.6 million for the full year ended December 31, 2018. The 2019 full year increase in G&A was primarily due to increased facility-related expenses. The fourth quarter 2019 decrease in G&A, as compared to the fourth quarter of 2018, was primarily due to reduced personnel-related costs.

As of December 31, 2019, the Company reported cash and cash equivalents of $71.2 million. Kaleido expects that its cash and cash equivalents will enable it to fund its planned operating expenses and capital expenditure requirements into the first quarter of 2021.

About Microbiome Metabolic Therapies (MMT)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome organ’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its human-centric discovery and development platform to study MMTs in microbiome samples in an ex vivo setting, followed by advancing MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.

On March 2, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and twelve months ended December 31, 2019 (Press release, Eagle Pharmaceuticals, MAR 2, 2020, View Source [SID1234555063]).

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Business and Recent Highlights:

On a non-GAAP basis, invested $14 million, or $0.63 per diluted share in Q4 2019, to advance the Company’s pipeline, bringing total R&D, plus legal expenses related to Vasopressin and PEMFEXY, for the full year to $43 million, or $2.30 per diluted share.
Received final approval from FDA for its novel product, PEMFEXY (ready-to-dilute pemetrexed for injection), a branded alternative to ALIMTA. This approval follows the Company’s settlement agreement with Eli Lilly and Company in December 2019 and allows for an initial entry of PEMFEXY (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.
Entitled to a milestone payment from Japanese licensing partner SymBio, upon approval of its ready-to-dilute bendamustine product, TREAKISYM, expected in September; future royalties and milestones could range from $10 million to $25 million per year for launches of the 500 ml bag and then the 50 ml bag.
Announced collaboration and agreement on terms for an exclusive worldwide license with the University of Pennsylvania ("UPenn") for the development of dantrolene sodium for the potential treatment of people living with Alzheimer’s disease. At the 2019 Alzheimer’s Association International Conference in July, Eagle and UPenn shared results from a proof-of-concept preclinical study documenting that intranasal administration of dantrolene sodium provided therapeutic effects on memory and cognition in an animal model.
Resubmitted New Drug Application ("NDA") for RYANODEX for the treatment of exertional heat stroke ("EHS"), in conjunction with body cooling, to FDA. Eagle anticipates approval by its PDUFA date of July 8, 2020, with the potential to be commercially available for the upcoming heat season.
Announced a strategic collaboration with TYME Technologies to advance pivotal trials and commercialization of SM-88, an investigational oral tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells, leading to cell death through oxidative stress and exposure to the body’s immune system. Eagle will be responsible for 25% of the promotional sales efforts of SM-88 and will receive 15% of net revenues of SM-88 in the United States. TYME retains all commercial rights to SM-88 outside the U.S. and reserves the right to repurchase Eagle’s U.S. co-promotion right for $200 million.
Entered into a research agreement with NorthShore University HealthSystem to study dantrolene sodium for the treatment of traumatic brain injury ("TBI"), including concussion, for which there are currently no drug treatments. A readout of data on the current animal studies is expected later this year. After completion of the study, Eagle plans to meet with the FDA and discuss the path forward, including the design of human studies.
Granted Orphan Drug Designation by FDA for RYANODEX for the treatment of exposure to organophosphates, a class of chemicals that includes potent pesticides and chemical weapons, known as nerve agents ("NA").
Eagle is currently working on the design of a second study for RYANODEX for the treatment of brain damage secondary to NA exposure. This indication is being developed under the FDA’s "Animal Rule," which requires that efficacy studies are conducted in two animal species. The Company expects to commence the study this year, with the intention to file an NDA for this indication before year-end 2020.
Completed dosing in pilot clinical study of its innovative fulvestrant product candidate, a novel therapeutic that has the potential to enhance estrogen receptor ("ER") inhibition and improve patient outcomes in ER positive breast cancer patients. Initial data from the pilot study has not yielded the anticipated results. The Company has additional clinical work under way and remains encouraged about the outcome of this important program.
Financial Highlights

Fourth Quarter 2019

Total revenue for Q4 2019 was $48.3 million, compared to $56.1 million in Q4 2018, primarily reflecting lower product sales of BENDEKA and RYANODEX and lower argatroban royalty revenue, partially offset by higher product sales of BELRAPZO and higher BENDEKA royalty revenue following an increase in the royalty rate effective October 1, 2019.
Q4 2019 net income was $1.0 million, or $0.07 per basic and diluted share, compared to net income of $12.6 million, or $0.88 per basic and $0.86 per diluted share in Q4 2018.
Q4 2019 adjusted non-GAAP net income was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to adjusted non-GAAP net income of $17.7 million, or $1.23 per basic and $1.20 per diluted share, in Q4 2018.
Cash and cash equivalents were $109.8 million, net accounts receivable was $48.0 million, and debt was $39.0 million as of December 31, 2019.
Full Year 2019

Total revenue for the 12 months ended December 31, 2019 was $195.9 million, compared to $213.3 million in 2018. 2019 included a $9.0 million milestone payment for BENDEKA.
2019 net income was $14.3 million, or $1.04 per basic and $1.01 per diluted share, compared to net income of $31.9 million, or $2.16 per basic and $2.09 per diluted share in 2018.
2019 adjusted non-GAAP net income was $36.9 million, or $2.68 per basic and $2.61 per diluted share, compared to adjusted non-GAAP net income of $59.2 million, or $4.01 per basic and $3.87 per diluted share in 2018.
From August 2016 through December 31, 2019, Eagle has repurchased $171.9 million of its common stock.
"Based on the current strength of our marketed products, and assuming an on-time approval for RYANODEX for exertional heat stroke and an affirmation of our orphan drug decision by the Appellate Court for BENDEKA, we believe that 2020 could be the best year in Eagle’s history in terms of total revenue and gross profit. We believe we are at the start of what could be a period of accelerated growth for Eagle," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

"We have multiple product candidates underway that have the potential to expand treatment options and provide first-in-class therapies to bridge significant care gaps across CNS/critical care and oncology patient populations. With a number of exciting studies under way in our critical care and oncology pipeline, we look forward to multiple data readouts this year, all of which will help us progress these important initiatives. We remain focused on realizing the full potential of our pipeline assets and creating value for our stakeholders," concluded Tarriff.

Fourth Quarter 2019 Financial Results

Total revenue for the three months ended December 31, 2019 was $48.3 million, as compared to $56.1 million for the three months ended December 31, 2018.

Q4 2019 BELRAPZO product sales were $7.6 million, compared to $6.8 million in Q4 2018.

Q4 2019 RYANODEX product sales were $3.5 million, compared to $5.1 million in Q4 2018.

Royalty revenue was $32.8 million in the fourth quarter of 2019, compared to $35.7 million in the fourth quarter of 2018. BENDEKA royalties were $32.4 million in the fourth quarter of 2019, compared to $31.9 million in the fourth quarter of 2018. A summary of total revenue is outlined below:

Three Months Ended December 31,

2019

2018

(unaudited)

(unaudited)

Revenue (in thousands):

Product sales

$15,421

$20,343

Royalty revenue

32,837

35,711

Total revenue

$48,258

$56,054

Gross Margin was 76% during the fourth quarter of 2019, as compared to 67% in the fourth quarter of 2018. The expansion in gross margin in the fourth quarter of 2019 was primarily driven by a decrease in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, and the increase in BENDEKA royalty revenue.

R&D expense was $11.3 million for the fourth quarter of 2019, compared to $5.9 million in the fourth quarter of 2018. The increase is largely attributable to spending on fulvestrant and payroll expenses. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense during the fourth quarter of 2019 was $9.1 million.

SG&A expense in the fourth quarter of 2019 increased to $22.5 million compared to $15.5 million in the fourth quarter of 2018. External legal spend associated with litigation on pemetrexed and vasopressin, as well as payroll costs, account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, fourth quarter 2019 SG&A expense was $17.8 million.

Net income for the fourth quarter of 2019 was $1.0 million, or $0.07 per basic and diluted share, compared to net income of $12.6 million, or $0.88 per basic and $0.86 per diluted share, in the fourth quarter of 2018, due to the factors discussed above.

Adjusted non-GAAP net income for the fourth quarter of 2019 was $6.7 million, or $0.49 per basic and $0.48 per diluted share, compared to adjusted non-GAAP net income of $17.7 million or $1.23 per basic and $1.20 per diluted share in the fourth quarter of 2018. 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 2019 Financial Results

Total revenue for the year ended December 31, 2019 was $195.9 million, as compared to $213.3 million for the year ended December 31, 2018. A summary of total revenue is outlined below:

Twelve Months Ended December 31,

2019

2018

Revenue (in thousands):

Product sales

$73,989

$70,835

Royalty revenue

112,903

142,927

License and other income

9,000

—

Total revenue

$195,892

$213,312

Product sales increased $3.6 million in the year ended December 31, 2019, primarily driven by increases in sales of BELRAPZO and BENDEKA. The increased sales were partially offset by decreases in product sales of RYANODEX due to lower volume on a low reorder cycle period and the discontinuation of Non-Alcohol Docetaxel Injection in September 2018. Royalty revenue totaled $112.9 million in 2019 compared to $142.9 million in 2018. BENDEKA royalties were $111.2 million in 2019, compared to $134.4 million in 2018. In 2019, Eagle received a milestone payment of $9 million for BENDEKA.

Gross margin was 69% in 2019, as compared to 71% in 2018. The compression in gross margin in 2019 was primarily driven by an increase in product sales of BELRAPZO, an increase in BENDEKA product sales to our marketing partner, on which Eagle earns no profit, the decrease in RYANODEX product sales, and the decrease in BENDEKA royalty revenue.

R&D expense decreased to $36.8 million in 2019, compared to $44.4 million in 2018, primarily reflecting a decrease in project spending for the Company’s fulvestrant formulation, partially offset by the cost of bringing vasopressin to market. Excluding stock-based compensation and other non-cash and non-recurring items, R&D expense in 2019 was $31.1 million.

SG&A expenses increased by $15.9 million to $76.4 million in 2019, compared to $60.5 million in 2018. External legal spend associated with litigation on pemetrexed and vasopressin, as well as payroll costs, account for the year-over-year increase. Excluding stock-based compensation and other non-cash and non-recurring items, SG&A expense in 2019 was $56.4 million.

Net income for the year ended December 31, 2019 was $14.3 million or $1.04 per basic and $1.01 per diluted share as compared to net income of $31.9 million or $2.16 per basic and $2.09 per diluted share for the year ended December 31, 2018, as a result of the factors discussed above.

Adjusted non-GAAP net income for 2019 was $36.9 million, or $2.68 per basic and $2.61 per diluted share, compared to adjusted non-GAAP net income of $59.2 million, or $4.01 per basic and $3.87 per diluted share in 2018.

2020 Expense Guidance

R&D spend in 2020, on a non-GAAP basis, is expected to be $46-$50 million, as compared to $31.1 million in 2019.
SG&A spend in 2020, on a non-GAAP basis, is expected to be $61-$64 million, as compared to $56.4 million in 2019.
The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-Looking Statements section of this press release.

Liquidity

As of December 31, 2019, the Company had $109.8 million in cash and cash equivalents plus $48.0 million in net accounts receivable, $38.3 million of which was due from Teva Pharmaceutical Industries Ltd. The Company had $39.0 million in outstanding debt. Therefore, at December 31, 2019, the Company had net cash plus receivables of $118.8 million.

In the fourth quarter of 2019, we purchased $3.0 million of Eagle’s common stock as part of our $150.0 million Share Repurchase Program. From August 2016 through December 31, 2019, we have repurchased $171.9 million of our common stock.

Conference Call

As previously announced, Eagle management will host its fourth quarter 2019 conference call as follows:

Date

Monday, March 2, 2020

Time

8:30 A.M. EDT

Toll free (U.S.)

877-876-9173

International

785-424-1667

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 800-839-3020 (US) or 402-220-7234 (International) and entering conference call ID EGRXQ419. The webcast will be archived for 30 days at the aforementioned URL.