On April 26, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $90.3 million and completed approximately 186,000 Cologuard tests during the quarter ended Mar. 31, 2018 (Press release, Exact Sciences, APR 26, 2018, View Source [SID1234525738]). First-quarter 2018 revenue and Cologuard test volume both grew 87 percent from 2017.

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"The Exact Sciences team delivered strong growth to start the year by remaining relentlessly focused on our core priorities. By increasing awareness and adoption of Cologuard, we are making strides toward our mission of playing a role in the eradication of colon cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The success of Cologuard also positions us to develop tests that facilitate the early, accurate detection of other forms of cancer."

First-Quarter 2018 Financial Results

For the three-month period ended Mar. 31, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $90.3 million, an increase of 87 percent, and test volume was 186,000, an increase of 87 percent

Average recognized revenue per test was unchanged at $485; note that the prior period included approximately $4.3 million, or $43 per test, related to the one-time impact of certain payers meeting the company’s revenue recognition criteria for accrual-basis revenue accounting

Average cost per test was $123, an improvement of 28 percent

Gross margin was 75 percent, an increase of 970 basis points

Operating expenses were $103.9 million, an increase of 55 percent

Net loss was $39.4 million or $0.33 per share, compared to $34.9 million or $0.32 per share

Non-cash interest expense related to convertible debt was $5.1 million, or $0.04 per share

Cash utilization was $53.7 million, compared to $36.4 million

Cash, cash equivalents and marketable securities were $1.0 billion at the end of the quarter

Nearly 9,000 healthcare providers ordered their first Cologuard test during the first quarter, and 110,000 (rounded) have ordered since the test was launched

2018 Outlook

·The company continues to anticipate revenue of $420-$430 million and completed Cologuard test volume of 900,000-920,000 tests during 2018

·For the second quarter, the company anticipates completing 220,000-230,000 Cologuard tests

The company’s guidance for revenue and completed tests are forward-looking statements. They are subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

First-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Thursday, Apr. 26, 2018, at 5 p.m. ET to discuss first-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8289286. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk

for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.cologuardtest.com. Rx Only

On April 26, 2018 Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President, Representative Director, Gyo Sagara; "ONO") reported that it submitted an application for manufacturing and marketing approval of metyrosine (ONO-5371), a tyrosine hydroxylase inhibitor, for the improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with pheochromocytoma in Japan (Press release, Ono, APR 26, 2018, View Source [SID1234584588]).

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This application is based on a multi-center, open-label, non-comparative study and its
accompanying continuous administration study, Phase I/II study (ONO-5371-02), in patients with the symptoms associated with catecholamine excess secretion of pheochromocytoma, conducted in Japan.

Pheochromocytoma (PC) is a neuroendocrine tumor deriving from the adrenal medulla or the extraadrenal gland ganglion with 2,920 patients estimated in Japan. Catecholamine excessively produced from PC causes various symptoms, such as tachycardia, headache, palpitation, sweating, constipation,including hypertension. Sympatholytic drugs, α-blocker and β-blocker, for control of blood pressure and heart rate have been usually used to improve these symptoms. As there aremany cases where surgical removal of tumors is not applicable in patients with locally invasive or metastatic malignant PC, a long-term therapy, such as radiotherapy and chemotherapy is required. The chronic continuation of catecholamine excess secretion may increase a risk of causing cardiovascular-related adverse events such as heart failure or fatal arrhythmia.

Metyrosine is a product for which development companies were recruited in Japan at the "Review Committee on Unapproved or Off-label Drugs with High Medical Needs", established by the Ministry of Health, Labour and Welfare (MHLW). Further, in May 2015, the product was designated for the orphan drug by the MHLW for the indication of "Improvement of status of catecholamine excess secretion and its accompanying symptoms in patients with PC".

ONO obtained exclusive rights to develop and commercialize metyrosine in Japan for the
prevention, treatment and diagnosis of PC (and conditions and symptoms related thereto), in accordance with the license agreement concluded in October 2013 with Valeant Pharmaceuticals North America LLC (Valeant), an affiliate of Valeant Pharmaceuticals International, Inc. In the US, Valeant markets metyrosine under the tradename of "Demser" in the indication of PC.

Methyrosine
Metyrosine inhibits tyrosine hydroxylase related to the production of catecholamine, reduces catecholamine extremely produced from PC, and alleviates symptoms due to catecholamine excess secretion. Therefore, metyrosine is a promising drug with an efficacy in the improvement of the symptoms in patients who are not able to sufficiently control the symptoms with sympatholytic drugs.

On April 26, 2018 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that its first quarter 2018 financial results will be reported on Tuesday, May 8, 2018 (Press release, BioCryst Pharmaceuticalsa, APR 26, 2018, View Source [SID1234525717]).

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BioCryst will host a conference call and webcast at 11:00 a.m. Eastern Time to discuss financial results and to provide an update regarding the Company’s clinical development programs. The call will be led by Jon P. Stonehouse, President & Chief Executive Officer, Thomas R. Staab II, Senior Vice President & Chief Financial Officer, and Dr. Bill Sheridan, Senior Vice President and Chief Medical Officer.

Links to a live audio webcast and replay of the presentation may be accessed on the BioCryst website events page at View Source

On April 26, 2018 Exelixis, Inc. (NASDAQ:EXEL) reported that data from clinical trials of cabozantinib will be the subject of 15 presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting in Chicago, June 1-5, 2018 (Press release, Exelixis, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344886 [SID1234525739]).

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Poster presentations will include detailed subset results from the CELESTIAL phase 3 pivotal trial in advanced hepatocellular carcinoma (HCC) comparing outcomes by age and in patients whose only prior treatment was sorafenib. CELESTIAL was the basis for Exelixis’ supplemental New Drug Application filed with the U.S. Food and Drug Administration for CABOMETYX (cabozantinib) tablets as a treatment for patients with previously treated advanced HCC. Additionally, longer follow-up data from the phase 1 trial of cabozantinib in combination with nivolumab with or without ipilimumab in patients with metastatic genitourinary cancers will be featured, along with preliminary safety and efficacy data on cabozantinib plus nivolumab in patients with metastatic urothelial carcinoma refractory to checkpoint inhibitor therapy.

"We’re excited about the potential of cabozantinib, both alone and in combination with other therapies, across a range of difficult-to-treat cancers and look forward to presenting data from our clinical trials in genitourinary cancers, advanced hepatocellular carcinoma and other tumor types," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Our data at ASCO (Free ASCO Whitepaper) underscore our dedication to maximizing results and expanding possibilities for people living with many different cancer types."

Cabozantinib to be featured in 15 presentations
The full schedule of cabozantinib presentations expected at the meeting is as follows:

Poster Discussion

[Abstract 4019] "Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC) who have Received Prior Sorafenib: Results from the Randomized Phase 3 CELESTIAL Trial"
Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A
Discussed at the Poster Discussion Session on Sunday, June 3, 4:45 – 6:00 p.m., CDT, Hall D2

Poster Presentations

[Abstract 4528] "Clinical Efficacy Of Cabozantinib Plus Nivolumab (CaboNivo) and CaboNivo Plus Ipilimumab (CaboNivoIpi) in Patients (pts) with Chemotherapy-refractory Metastatic Urothelial Carcinoma (mUC) either Naïve (n) or Refractory (r) to Checkpoint Inhibitor (CPI)"
Rosa Maria Nadal, M.D., M.D., Ph.D., National Cancer Institute, National Institutes of Health
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 4556] "Quality-Adjusted Time without Symptoms or Toxicity (Q-TWiST): Analysis of Cabozantinib (Cabo) vs Sunitinib (Sun) in Patients with Advanced Renal Cell Carcinoma (aRCC) of Intermediate or Poor Risk (Alliance A031203)"
Ronald C. Chen, M.D., MPH, University of North Carolina at Chapel Hill
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 4579] "Cabozantinib (Cabo) in Advanced Non-clear Cell Renal Cell Carcinoma (nccRCC): A Retrospective Multicenter Analysis"
Nieves Martinez Chanza, Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4593] "A Phase I-II Study to Evaluate Safety and Efficacy of the Combination of Niraparib plus Cabozantinib in Patients with Advanced Kidney/Urothelial Carcinoma"
Daniel E. Castellano, M.D., Hospital 12 de Octubre
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4598] "A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib vs Sunitinib in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (RCC; CheckMate 9ER)"
Toni K. Choueiri, M.D., Dana-Farber Cancer Institute
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4601] "CANTATA: A Randomized Phase 2 Study of CB-839 in Combination with Cabozantinib vs. Placebo with Cabozantinib in Patients with Advanced/Metastatic Renal Cell Carcinoma"
Nizar M. Tannir, M.D., FACP, The University of Texas MD Anderson Cancer Center
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS4603] "CABOPRE: Phase II Study of Cabozantinib Prior to Cytoreductive Nephrectomy (CN) in Locally Advanced and/or Metastatic Renal Cell Carcinoma (mRCC)"
Guillermo de Velasco, M.D., Ph.D., Department of Medical Oncology, University Hospital 12 de Octubre, i + 12, Madrid, Spain
Session: Genitourinary (Nonprostate) Cancer
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 1026] "A Phase II Study of Cabozantinib (Cabo) Alone or in Combination with Trastuzumab (T) in Patients (pts) with Breast Cancer Brain Metastases (BCBM)"
Jose Pablo Leone, M.D., Dana-Farber Cancer Institute
Session: Breast Cancer – Metastatic
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract TPS1119] "A Phase II Study of Nivolumab in Combination with Cabozantinib for Metastatic Triple-Negative Breast Cancer (mTNBC)"
Romualdo Barroso-Sousa, M.D., Ph.D., Dana-Farber Cancer Institute
Session: Breast Cancer – Metastatic
Poster presented Saturday, June 2, 8:00 – 11:30 a.m. CDT, Hall A

[Abstract 6088] "A Phase II Trial of Cabozantinib (CABO) for the Treatment of Radioiodine (RAI)-Refractory Differentiated Thyroid Carcinoma (DTC) in the First-line Setting"
Marcia S. Brose, M.D., Ph.D., Department of Otorhinolaryngology, Head and Neck Surgery and the Abramson Cancer Center of the University of Pennsylvania
Session: Head and Neck Cancer
Poster presented Saturday, June 2, 1:15 – 4:45 p.m. CDT, Hall A

[Abstract 3555] "A Phase I/II Trial of Cabozantinib (C) with or without Panitumumab (P) in Patients (pts) with RAS Wild-Type (WT) Metastatic Colorectal Cancer (mCRC): Clinical Outcomes in Pts with MET Amplification (amp) Detected in Blood"
Jingquan Jia, M.D., Ph.D., Duke University Medical Center
Session: Gastrointestinal (Colorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract 4088] "Outcomes in Patients (pts) who had Received Sorafenib (S) as the Only Prior Systemic Therapy in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Advanced Hepatocellular Carcinoma (HCC)"
Robin Kate Kelley, M.D., University of California San Francisco
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract 4090] "Outcomes Based on Age in the Phase 3 CELESTIAL Trial of Cabozantinib (C) versus Placebo (P) in Patients (pts) with Advanced Hepatocellular Carcinoma (HCC)"
Lorenza Rimassa, M.D., Humanitas Clinical and Research Center
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

[Abstract TPS4157] "A Phase II Trial of Cabozantinib and Erlotinib for Patients with EGFR and c-MET Co-expressing Metastatic Pancreatic Adenocarcinoma"
Olumide B. Gbolahan, MBBS, Indiana University School of Medicine
Session: Gastrointestinal (Noncolorectal) Cancer
Poster presented Sunday, June 3, 8:00 – 11:30 a.m., CDT, Hall A

About the CELESTIAL Study
CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms during the blinded treatment phase of the trial. The primary endpoint for the trial is overall survival, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.

About Genitourinary Cancers
Genitourinary cancers are those that affect the urinary tract, bladder, kidneys, ureter, prostate, testicles, penis or adrenal glands — parts of the body involved in reproduction and excretion — and include renal cell carcinoma (RCC) and urothelial carcinoma.1

The American Cancer Society’s 2018 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12 percent, with no identified cure for the disease.4 Approximately 30,000 patients in the U.S. and 70,000 globally require treatment.5

Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.6 Urothelial carcinoma occurs mainly in older people; 90 percent of patients with bladder cancer are 55 years or older.7 Bladder cancer is the fourth most common cancer in men and accounts for about five percent of all new cases of cancer in the U.S. each year.7,8 In 2015, an estimated 708,000 people were living with bladder cancer in the U.S.8

About HCC
Liver cancer is the second-leading cause of cancer death worldwide, accounting for more than 700,000 deaths and nearly 800,000 new cases each year.9 In the U.S., the incidence of liver cancer has more than tripled since 1980.2 HCC is the most common form of liver cancer, making up about three-fourths of the estimated nearly 42,000 new cases in the U.S. in 2018. HCC is the fastest-rising cause of cancer-related death in U.S.10 Without treatment, patients with advanced HCC usually survive less than 6 months.11

About CABOMETYX (cabozantinib)
CABOMETYX tablets are approved in the United States for the treatment of patients with advanced RCC. CABOMETYX tablets are also approved in the European Union, Norway, Iceland, Australia, Switzerland and South Korea for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy. Ipsen also submitted to the EMA the regulatory dossier for cabozantinib as a treatment for first-line advanced RCC in the European Union on August 28, 2017; on March 23, 2018, the CHMP provided a positive opinion for CABOMETYX for the first-line treatment of intermediate- or poor-risk advanced RCC. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan, including RCC.

Please see Important Safety Information below and full U.S. prescribing information at View Source

U.S. Important Safety Information

Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In two RCC studies, the incidence of Grade ≥ 3 hemorrhagic events was 3% in CABOMETYX-treated patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
Gastrointestinal (GI) Perforations and Fistulas: In RCC studies, fistulas were reported in 1% of CABOMETYX-treated patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, gastrointestinal (GI) perforations were reported in 1% of CABOMETYX-treated patients. Monitor patients for symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a fistula which cannot be appropriately managed or a GI perforation.
Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. In RCC studies, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX-treated patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
Hypertension and Hypertensive Crisis: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension, including hypertensive crisis. In RCC studies, hypertension was reported in 44% (18% Grade ≥ 3) of CABOMETYX-treated patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.
Diarrhea: In RCC studies, diarrhea occurred in 74% of patients treated with CABOMETYX. Grade 3 diarrhea occurred in 11% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Palmar-Plantar Erythrodysesthesia (PPE): In RCC studies, palmar-plantar erythrodysesthesia (PPE) occurred in 42% of patients treated with CABOMETYX. Grade 3 PPE occurred in 8% of patients treated with CABOMETYX. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
Embryo-fetal Toxicity may be associated with CABOMETYX. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.
Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.
Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.
Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.
Please see accompanying full Prescribing Information View Source

On April 26, 2018 Novocure (NASDAQ: NVCR) reported financial results for the quarter and year ended March 31, 2018, highlighting year-over-year growth in active patients and net revenues (Press release, NovoCure, APR 26, 2018, View Source [SID1234525761]). Novocure is a global oncology company developing a proprietary platform called Tumor Treating Fields for the treatment of solid tumor cancers. Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die.

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An "active patient" is a patient who is on Optune under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(2) A "prescription received" is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

"We are pleased with our continued commercial momentum during the first quarter 2018. Our ongoing sales and marketing efforts, the December 2017 publication of final EF-14 analysis in JAMA and our strong presence at SNO in November 2017 all contributed to growing awareness and confidence in Optune," said Asaf Danziger, Novocure’s Chief Executive Officer. "We had more than 2,000 patients on therapy at quarter end, representing thirteen consecutive quarters of active patient growth since the initial presentation of our EF-14 data in newly diagnosed glioblastoma. We delivered $52.1 million in first quarter 2018 revenues and approached $200 million in trailing twelve-month revenues, further establishing our position as a global oncology company with increasing commercial scale."

"In March 2018, the National Comprehensive Cancer Network (NCCN) updated its globally recognized Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Central Nervous System Cancers to include alternating electric field therapy as a category 1 treatment for newly diagnosed glioblastoma in combination with temozolomide after maximal safe resection and completion of radiation therapy in March 2018," continued Mr. Danziger. "We believe the updated NCCN guidelines will further increase physician awareness, especially in the radiation oncology and medical oncology communities, helping us to reach patients earlier in the course of this aggressive disease."

"I am very pleased to announce that last week we reported positive top-line results from our STELLAR phase 2 pilot trial in mesothelioma. These results exceeded the results of the interim analysis for all efficacy endpoints and demonstrated clinically meaningful improvements in overall survival and progression free survival," added William Doyle, Novocure’s Executive Chairman. "Mesothelioma is the first indication outside of the brain for which Novocure will pursue FDA approval."

"We believe a significant opportunity remains to increase penetration and reimbursement in our active GBM markets and to expand into additional geographic markets. In parallel, we will advance our clinical pipeline in additional indications with high unmet needs," noted Mr. Doyle. "With more than $216 million cash on hand at the end of the quarter, we believe we are in a position of strength to continue to execute our two-pronged strategy."

First quarter 2018 operating statistics and financial update

There were 2,009 active patients on Optune at March 31, 2018, representing 59 percent growth versus March 31, 2017, and 10 percent growth versus December 31, 2017. The increase in active patients was driven primarily by prescription growth and by an increase in the percentage of active patients with a newly diagnosed GBM diagnosis who typically have a longer duration of treatment with Optune. In the first quarter 2018, approximately two-thirds of Optune prescriptions were written for newly diagnosed GBM.

In the United States, there were 1,445 active patients on Optune at March 31, 2018, representing 55 percent growth versus March 31, 2017.
In Germany and other EMEA markets, there were 544 active patients on Optune at March 31, 2018, representing 64 percent growth versus March 31, 2017.
In Japan, there were 20 active patients on Optune at March 31, 2018, representing 900 percent growth versus March 31, 2017.
Additionally, 1,258 prescriptions were received in the three months ended March 31, 2018, representing 41 percent growth compared to the same period in 2017, and 15 percent growth versus the three months ended December 31, 2017. The increase in prescriptions was driven primarily by commercial activities in our currently active markets.

In the United States, 946 prescriptions were received in the three months ended March 31, 2018, representing 38 percent growth compared to the same period in 2017.
In Germany and other EMEA markets, 282 prescriptions were received in the three months ended March 31, 2018, representing 37 percent growth compared to the same period in 2017.
In Japan, 30 prescriptions were received in the three months ended March 31, 2018, representing 900 percent growth compared to the same period in 2017.
For the three months ended March 31, 2018, net revenues were $52.1 million, representing 49 percent growth versus the same period in 2017. Revenue growth was primarily driven by increased Optune adoption in the United States and Germany and initial launch efforts Japan, partially offset by the absence of one-time benefits from the 2017 cash to accrual revenue recognition transition.

For the three months ended March 31, 2018, cost of revenues was $18.2 million compared to $11.7 million for the same period in 2017, representing an increase of 56 percent. The increase was primarily driven by the cost of shipping transducer arrays to a higher volume of commercial patients, as well as an increase in field equipment depreciation.

Research, development and clinical trials expenses for the three months ended March 31, 2018, were $11.1 million compared to $9.4 million for the same period in 2017, representing an increase of 18 percent. This was primarily due to an increase in clinical trial and personnel expenses for our LUNAR, METIS, and PANOVA trials and an increase in investigator sponsored trial costs.

Sales and marketing expenses for the three months ended March 31, 2018, were $18.1 million compared to $14.8 million for the same period in 2017, representing an increase of 23 percent. This was primarily due to increased marketing expenses, increased personnel and facility expenses to support our geographical expansion in Japan and Austria and an increase in share-based compensation.

General and administrative expenses for the three months ended March 31, 2018, were $17.3 million compared to $12.4 million for the same period in 2017, representing an increase of 39 percent. This was primarily due to increase in share-based compensation.

Personnel costs for the three months ended March 31, 2018, included $8.5 million in non-cash share-based compensation expenses, comprised of $0.2 million in cost of revenues; $0.9 million in research, development and clinical trials; $1.4 million in sales and marketing; and $6.0 million in general and administrative expenses. Total non-cash share-based compensation expenses for the first quarter 2017 were $4.6 million.

Net loss for the three months ended March 31, 2018, was $20.7 million compared to net loss of $18.0 million for the same period in 2017, representing a decline of 15 percent.

At March 31, 2018, we had $111.6 million in cash and cash equivalents and $104.7 million in short-term investments, for a total balance of $216.3 million in cash, cash equivalents and short-term investments.

Anticipated clinical trial milestones

Phase 2 pilot STELLAR trial in mesothelioma data presentation (2H 2018)
Initiation of phase 3 pivotal trial in recurrent ovarian cancer (2H 2018)
Data collection from phase 3 pivotal METIS trial in brain metastases (2020)
Data collection from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2021)
Data collection from phase 3 pivotal PANOVA 3 trial in locally advanced pancreatic cancer (2022)
Conference call details

Novocure will host a conference call and webcast to discuss first quarter 2018 financial results today, Thursday, April 26, 2018, at 8 a.m. EDT. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 2384187.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call.

Upcoming investor events

Novocure will be participating in two investor conferences in May. Dr. Eilon Kirson, Novocure’s Chief Scientific Officer and Head of Research and Development, will participate in a fireside chat at the Deutsche Bank 43rd Annual Healthcare Conference on May 9, 2018, in Boston. Dr. Kirson’s presentation will begin at 8:40 a.m. EDT and will be followed by a Q&A session.

Additionally, William Doyle, Novocure’s Executive Chairman, will participate in the UBS 2018 Global Healthcare Conference on May 22, 2018, in New York. Mr. Doyle’s presentation will begin at 8:30 a.m. EDT and will be followed by a Q&A session.

Live audio webcasts of these presentations can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the relevant presentation.