On November 11, 2020 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that the Centers for Medicare & Medicaid Services (CMS) has established a permanent and product-specific J-code for Jelmyto (mitomycin) for pyelocalyceal solution that will take effect on January 1, 2021 (Press release, UroGen Pharma, NOV 11, 2020, View Source [SID1234570673]). The J-code is expected to replace the previously issued temporary C-code and will standardize and facilitate reimbursement in the hospital outpatient, ambulatory surgery center and physician office settings of care beginning on January 1, 2021.

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"Having a permanent J-code will simplify billing and streamline reimbursement, making it even more timely and reliable for physicians treating patients with Jelmyto," said Jeffrey Bova, Chief Commercial Officer of UroGen Pharma. "This should translate into improved access to Jelmyto for adult patients seeking a minimally invasive, potentially kidney-sparing treatment option for low-grade upper tract urothelial cancer."

J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like Jelmyto that are administered by a physician. Claims submission and payment are standardized with a J-code, facilitating and streamlining billing and reimbursement.

The J-code for Jelmyto (J9281) has been published online in the CMS Healthcare Common Procedure Coding System (HCPCS) Application Summaries and Coding Decisions (page 36).

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: side pain, urinary tract infection, blood in your urine, kidney problems, tiredness, nausea, stomach pain, trouble with urination, vomiting, low red blood cell count, frequent urination, itching, chills, and fever.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda/gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information at www.jelmyto.com.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

On November 11, 2020 Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, reported an exclusive licensing agreement with the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), for intellectual property related to a clinical-stage anti-CD33 chimeric antigen receptor T-cell (CAR-T) therapy candidate (Press release, Vor BioPharma, NOV 11, 2020, View Source [SID1234570672]). This CAR-T construct was devised by T-cell expert Dr. Terry Fry during his tenure at the Pediatric Oncology Branch of the NCI, where he oversaw development of this therapeutic candidate from bench to bedside; it is currently being evaluated in a multi-site Phase 1/2 clinical trial in children and young adults with relapsed or refractory acute myeloid leukemia (AML).

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"As a class, CAR-T cell therapies have had a major positive impact on the lives of certain patients with hematological malignancies. But because normal cells often express the same surface proteins as cancer cells, the utility and applicability of targeted therapies has been limited, in part, by on-target toxicity," said Christopher Slapak, MD, Vor’s Chief Medical Officer. "This agreement provides Vor with access to a promising CD33 CAR-T that could potentially be administered either as bridge-to-transplant therapy for relapsed or refractory patients with AML, or following transplant with our lead developmental candidate VOR33, whereby the CAR-T may selectively target leukemia cells while sparing normal myeloid cells."

Vor’s lead program VOR33, which is currently in pre-clinical development, consists of eHSCs that are engineered to provide AML patients with a donor-derived hematopoietic stem cell transplant that lacks the cell surface protein CD33, a clinically validated target for AML. The goal of removing this target is to make these eHSCs and their progeny treatment-resistant to anti-CD33 therapies. As such, Vor believes this CAR-T could be highly complementary to VOR33.

"This licensing agreement with the NCI is an important milestone for Vor, as it brings elements of a more complete AML treatment system under the same roof," said Hilary Eaton, PhD, Vor’s Senior Director of Business Development. "The combination of our next-generation, treatment-resistant eHSCs with companion therapeutics such as this CD33 CAR-T is designed to provide a single company solution for some patients suffering from hematological malignancies, potentially transforming outcomes and shifting the standard of care."

More information about the Phase 1/2 study of this CD33 CAR-T can be found at clinicaltrials.gov.

Other terms of the agreement have not been disclosed.

About VOR33

Vor’s lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, we believe that CD33 will become a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from acute myeloid leukemia.

On November 11, 2020 Novocure (NASDAQ: NVCR), a global oncology company working to extend survival in some of the most aggressive forms of cancer, reported that it has received the CE Mark for the NovoTTF-100L system from the Notified Body (TÜV) (Press release, NovoCure, NOV 11, 2020, View Source [SID1234570671]). The application of the CE mark enables Novocure to commercialize the device as a first-line treatment in combination with pemetrexed and platinum-based chemotherapy for unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) in the European Union and Switzerland.

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MPM is a rare cancer that has been strongly linked to asbestos exposure. More than 13,000 people are diagnosed with mesothelioma in Europe annually. The U.S. FDA approved the NovoTTF-100L System (known as Optune Lua in the U.S.) as a treatment for MPM in May 2019 under the Humanitarian Device Exemption (HDE) pathway. Optune Lua was the first treatment for MPM approved by the FDA in more than 15 years. Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM. Now having the CE mark for its MPM therapy in Europe, Novocure will begin commercialization and to identify and pursue pathways for reimbursement in selected markets.

"We are extremely pleased to have CE marking for our NovoTTF-100L System, making our therapy commercially available for patients with MPM in Europe," said Pritesh Shah, Novocure’s Chief Commercial Officer. "Obtaining the CE mark for our NovoTTF-100L System represents another step forward on our patient-forward mission of striving to extend survival in some of the most aggressive forms of cancer. Our commercial team in EMEA is now focused on establishing pathways for reimbursement to expand access to our therapy for MPM patients."

About NovoTTF-100L

NovoTTF-100L is a noninvasive, antimitotic cancer treatment for MPM. NovoTTF-100L delivers Tumor Treating Fields, which is a cancer therapy using electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.

Approved Indications

NovoTTF-100L/Optune Lua is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

Important Safety Information

Contraindications

Do not use NovoTTF-100L/Optune Lua in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of NovoTTF-100L/Optune Lua together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.

Do not use NovoTTF-100L/Optune Lua in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with NovoTTF-100L/Optune Lua may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

NovoTTF-100L/Optune Lua can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.

The most common (≥10%) adverse events involving NovoTTF-100L/Optune Lua in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.

Other potential adverse effects associated with the use of NovoTTF-100L/Optune Lua include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.

If the patient has an underlying serious skin condition on the treated area, evaluate whether this may prevent or temporarily interfere with NovoTTF-100L/Optune Lua treatment.

Do not prescribe NovoTTF-100L/Optune Lua for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of NovoTTF-100L/Optune Lua in these populations have not been established.

Please visit www.optunelua.com to see NovoTTF-100L/Optune Lua Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions. This website is primarily intended for a U.S. audience.

On November 11, 2020 Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, reported that interim data from the expansion cohort of its ongoing Phase 1 study of the Company’s mRNA personalized cancer vaccine (PCV) mRNA-4157 in combination with Merck’s Keytruda1 at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting (SITC 2020) (Press release, Moderna Therapeutics, NOV 11, 2020, View Source [SID1234570670]). The dose expansion cohort included 10 patients with HPV(-) Head and Neck Squamous Cell Carcinoma (HNSCC) and 17 patients with Micro-Satellite Stable Colorectal Cancer (MSS-CRC). The data shared today showed that mRNA-4157 given in combination with Keytruda is well tolerated at all dose levels and produced responses as measured by tumor shrinkage by RECIST 1.1 criteria in HPV(-) HNSCC patients. No responses were observed in the MSS-CRC group of patients.

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Tolerability data to date consistently demonstrate that mRNA-4157 is well tolerated. Adverse events are typically low grade and reversible. In the dose expansion cohort, the Overall Response Rate (ORR) in the HPV(-) HNSCC group of patients as measured by RECIST 1.1 is 50% (5/10) with two patients achieving a complete response (CR) with no detectable disease, and three patients achieving partial response (PR), all of which are ongoing. Median progression free survival (mPFS) is 9.8 months, which compares favorably to the published ORR and mPFS of 14.6% and 2.0 months respectively, for Keytruda monotherapy. Including four patients with stable disease, the Disease Control Rate (DCR) is 90% (9/10). Median duration of response has not been reached. The HPV(-) HNSCC cohort continues to recruit and Moderna has decided to expand the size of the current cohort based on the interim data reported today.

Moderna also announced that Dr. Praveen Aanur has joined Moderna as Vice President, Therapeutic Area Head for Oncology Development. Dr. Aanur joins Moderna from Bristol-Myers Squibb (NYSE: BMY) where he was responsible for multiple regulatory submissions across BMS’ immuno-oncology portfolio. In his seven years at BMS, Dr. Aanur had a wide range of roles increasing responsibility across Clinical Development and Translational Research. Dr. Aanur started his career as a physician and completed his Hematology-Oncology Fellowship at Oregon Health Sciences University, and a Fellowship in Bone Marrow Transplantation at Memorial Sloan Kettering in New York where he was also a clinical investigator in the Bone Marrow Transplant Unit. He holds an MBBS from Bangalore University, an MPH from the University of Alabama, and an MBA from Columbia University School of Business.

"We are encouraged by these interim data from our personalized cancer vaccine program, which involves designing and manufacturing a unique vaccine for each patient based on their specific tumor," said Stephen Hoge, M.D., President of Moderna. "This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with pembrolizumab. I would also like to welcome Dr. Aanur to Moderna and look forward to working closely with him to continue building our oncology therapeutic area."

About Moderna’s Immuno-Oncology Programs

Moderna’s oncology programs are currently focused on two main areas: cancer vaccines and intratumoral immuno-oncology (I/O) therapies. Moderna is developing these potential mRNA treatments with strategic collaborators Merck and AstraZeneca. The company currently has five I/O programs in development, including two programs in Phase 2 trials.

An advantage of Moderna’s mRNA platform is that it allows for investigational medicines that combine in a single mRNA therapy several different approaches to activate the immune system to attack cancer, either with mRNA encoding for common tumor proteins found across cancer types or multiple mRNAs encoding for various immunomodulatory proteins.

Moderna’s investigational PCVs are designed to use neoantigens identified from an individual’s tumor to program the body’s immune system to elicit a more effective anti-tumor response. Upon sequencing the tumor, Moderna’s proprietary algorithms predict the neoantigens (antigens encoded by tumor-specific mutated genes) most likely to trigger the immune system to attack a particular cancer. Today, mRNA encoding up to 34 unique neoantigens can be delivered in a single vaccine. Moderna develops and manufactures these investigational PCVs at its personalized vaccines unit within its Massachusetts manufacturing facility.

On November 11, 2020 Humanigen, Inc., (HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab, reported financial results for the third quarter and nine months ended September 30, 2020, provided an overview of recent accomplishments and issued spending expense guidance for the remainder of 2020 (Press release, Humanigen, NOV 11, 2020, View Source [SID1234570669]).

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"We’ve achieved many important milestones in the third quarter, including completing a public offering to begin trading on Nasdaq, being selected for the National Institutes of Health’s ACTIV-5/Big Effect Trial, strengthening our management team, adding clinical trial sites in Brazil for our Phase 3 clinical trial of lenzilumab in patients with COVID-19, and expanding our manufacturing capacity with new agreements with Catalent and Thermo Fisher," said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. "For the last two months of 2020, we remain focused on enrollment of the Phase 3 trial of lenzilumab for patients hospitalized with COVID-19, in which we recently announced a positive analysis of interim Phase 3 data. As enrollment continues for this trial within the United States and in Brazil, we anticipate applying for an EUA in the first quarter of 2021. I’m pleased with how our team has remained dedicated to advancing promising therapeutics for cytokine storm and would like to thank the dedicated health care providers and essential workers who continue to expose themselves to risk during this pandemic."

Third Quarter 2020 Review and Recent Corporate Updates

Completed an underwritten public offering and uplisted to the Nasdaq Capital Market in September 2020. Humanigen raised net proceeds of approximately $72.7 million from the sale of 9,200,000 shares in the offering, including 1,200,000 shares sold upon the full exercise by the underwriters of their over-allotment option, after deducting the underwriting discounts and commissions and estimated offering costs.
Announced execution of a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in support of Operation Warp Speed (OWS) to support the development of lenzilumab as a potential treatment for patients with COVID-19.
Released an interim analysis of blinded data safety monitoring board data from the Phase 3 study suggesting that lenzilumab had a clinically meaningful impact on patient recovery, with an estimated 37 percent more recoveries observed in the lenzilumab arm of the randomized, placebo-controlled, double-blinded study versus current standard of care which includes antivirals and steroids.
Selected to take part in the ACTIV-5 "Big Effect Trial" funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) to evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients. The trial is currently enrolling up to 100 patients in each arm of the study with an interim analysis for efficacy after 50 patients have been enrolled in each arm.
Published a case-control study in the Mayo Clinic Proceedings Journal that demonstrate that an 80% reduction in relative risk of invasive mechanical ventilation (IMV) and/or death for patients treated with lenzilumab compared to the matched control group.
Strengthened our management team with the addition of Dr. Dale Chappell as chief scientific officer, David Tousley as chief accounting and administrative officer, Timothy Morris as chief operating officer and chief financial officer, Bob Atwill as head of Asia-Pacific region and Edward Jordan as chief commercial officer.
Expanded manufacturing capabilities for lenzilumab with supply agreements with Catalent Biologics, Lonza and Thermo Fisher.
Third Quarter 2020 Financial Results

Net loss for the three months ended September 30, 2020 was $30.8 million or $0.71 per share as compared to $2.4 million or $0.11 per share for the third quarter of 2019. The increase in net loss for the quarter was primarily due to an increase in research and development expenses of $21.9 million from $0.5 million for the three months ended September 30, 2019 to $22.4 million for the three months ended September 30, 2020. The increase is primarily due to reservation fees, technology transfer expenses and material manufacturing costs of lenzilumab for the Phase 3 clinical study and in anticipation of filing for an Emergency Use Authorization (EUA) in 2021 and increase in enrollment in the Phase 3 clinical trial related to lenzilumab in hospitalized patients with COVID-19. The increase in the net loss for the third quarter of 2020 was also due an increase in general and administrative expenses of $6.8 million to $8.3 million from $1.5 million for the three months ended September 30, 2019. The increase is primarily due to increased compensation costs including stock based compensation expense related to the hiring of a chief operating and financial officer and a chief commercial officer, an increase in bonus expense upon the completion of certain corporate milestones, and an increase in legal, accounting and public and investor relations expenses in preparation for the listing on Nasdaq including a non-cash charge of $1.9 million for warrants issued to certain consultants which became exercisable upon the completion of the listing on Nasdaq.

Nine months ended September 30, 2020 Financial Results

Net loss for the nine months ended September 30, 2020 was $57.2 million or $1.79 per share as compared to $8.3 million or $0.37 per share for the first nine months of 2019. The increase in net loss for the period was due to an increase in research and development expenses of $42.1 million to $44.2 million from $2.1 million for the nine months ended September 30, 2019. The increase is primarily due to material manufacturing costs of lenzilumab for the Phase 3 clinical study and the initiation in May of 2020 of the Phase 3 clinical trial for lenzilumab in hospitalized patients with COVID-19. The increase in the net loss for the nine months ending September 30, 2020 was also due to an increase in general and administrative expenses of $6.6 million to $11.7 million from $5.1 million for the nine months ended September 30, 2019. The increase is primarily due to increased compensation costs including stock based compensation expense related to the hiring of function heads in the third quarter of 2020 and increased bonus expense upon the completion of certain corporate milestones, and an increase in legal, accounting and public and investor relations expenses in connection with for the listing on Nasdaq.

Cash and cash equivalents

Net cash used in operating activities, net of balance sheet changes, was $23.0 million for the third quarter of 2020. In the third quarter of 2020 the company raised $72.7 million in net proceeds from its underwritten public offering of common stock. As of September 30, 2020, the Company had cash and cash equivalents of $91.4 million.

Expense Guidance for the Fourth quarter and Full Year 2020

We expect our expenses to continue to increase significantly in the remaining three months of 2020 as a result of securing additional manufacturing capacity for the production of lenzilumab, the expansion of enrollment of patients and sites for the clinical trials for COVID-19 and the initiation of commercial preparation activities in anticipation of submitting an EUA in the first quarter of 2021.

"Spending for the third quarter 2020 was higher than consensus due to an increase in manufacturing expenses as we secured additional capacity for lenzilumab to support the clinical trials and prepare for the filing for the EUA early next year. R&D expense may double as we expand the Phase 3 clinical study and continue the production of lenzilumab in the fourth quarter 2020," commented Timothy E. Morris, chief operating and financial officer of Humanigen. "Our current cash balance is sufficient to complete the phase 3 trial and file the EUA. Now that we are part of Operation Warp Speed and following the announcement of the CRADA, we will explore the possibility of financial assistance from the US government to support development of lenzilumab."

A summary of key financial highlights as of and for the periods ended September 30, 2020 and 2019 is as follows ($ in thousands):