Exhibit 99.1

 

Novocure Reports Second Quarter 2018 Financial Results and Provides Company Update

 

Quarterly net revenues of $61.5 million, representing 60 percent growth versus the second quarter 2017 and 18 percent growth versus the first quarter 2018

 

Submission of local coverage determination reconsideration request to the durable medical equipment Medicare administrative contractors following June CMS announcement of new payment rules for durable medical equipment products

 

STELLAR data in mesothelioma will be presented at IASLC in late September

 

St. Helier, Jersey – Novocure (NASDAQ: NVCR) today reported financial results for the three and six months ended June 30, 2018. The company also highlighted continued commercial momentum for Optune and continued clinical development progress.

 

Second quarter 2018 highlights include:

 

Three months ended

June 30,

 

Six months ended

June 30,

 

 

2018

 

 

2017

 

% Change

 

 

2018

 

 

2017

 

% Change

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-financial

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Active patients at period end(1)

 

2,169

 

 

1,460

 

49%

 

 

2,169

 

 

1,460

 

49%

Prescriptions received in period(2)

 

1,244

 

 

1,059

 

17%

 

 

2,502

 

 

1,953

 

28%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Financial, in millions

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net revenues

$

61.5

 

$

38.4

 

60%

 

$

113.6

 

$

73.3

 

55%

Gross profit

$

41.7

 

$

25.2

 

65%

 

$

75.6

 

 

48.4

 

56%

Net loss

$

(15.5

)

$

(21.2

)

27%

 

$

(36.2

)

$

(39.2

)

8%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of period

$

114.5

 

$

80.2

 

 

 

 

 

 

 

 

 

 

Short-term investments at the end

of period

$

104.5

 

$

104.2

 

 

 

 

 

 

 

 

 

 

(1)

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.

 

“In the second quarter of 2018, Novocure demonstrated continued commercial momentum for Optune and continued progress on key clinical development programs,” noted Asaf Danziger, Novocure’s Chief Executive Officer. “We delivered record

 


 

quarterly revenue of $61.5 million, up 60 percent from the second quarter 2017 and 18 percent from the first quarter 2018. We continued to see steady growth in prescriptions for patients with newly diagnosed GBM, representing nearly 75% of prescriptions in the second quarter, which we believe is a sign of increasing physician confidence and belief in Optune.

 

“I am pleased to announce Novocure submitted a local coverage determination reconsideration request to the Medicare DME MACs on June 20. Our decision to file for coverage followed a CMS announcement of new payment rules for DME products earlier in June,” said William Doyle, Novocure’s Executive Chairman. “We believe the new CMS payment rules reflect the meaningful progress made during our multi-year dialogue with the agency and provide us with a path forward to secure Medicare coverage and payment for Optune.”

 

“Our STELLAR phase 2 pilot trial data in mesothelioma were accepted for presentation at the upcoming IASLC meeting in late September. Looking ahead, we are on track to start our sixth phase 3 pivotal trial, the INNOVATE 3 trial in recurrent ovarian cancer, later this year and just opened our phase 2 pilot HEPANOVA trial in advanced liver cancer,” continued Mr. Doyle. “Novocure is a global oncology company with a proprietary platform technology offering both a growing commercial business today and significant potential for future expansion into new indications. We believe our progress in the second quarter illustrates our ongoing commitment to execution.”

 

Second quarter 2018 operating statistics and financial update

There were 2,169 active patients on Optune at June 30, 2018, representing 49 percent growth versus June 30, 2017, and 8 percent growth versus March 31, 2018. Increased adoption drove the increase in active patients with steady growth in prescriptions for patients with newly diagnosed GBM, who typically have a longer duration of treatment with Optune, and year-over-year prescription growth.

 

 

In the United States, there were 1,575 active patients on Optune at June 30, 2018, representing 45 percent growth versus June 30, 2017.

 

In Germany and other EMEA markets, there were 557 active patients on Optune at June 30, 2018, representing 48 percent growth versus June 30, 2017.

 

In Japan, there were 37 active patients on Optune at June 30, 2018, representing 3,600 percent growth versus June 30, 2017.

 

Additionally, 1,244 prescriptions were received in the three months ended June 30, 2018, representing 17 percent growth compared to the same period in 2017, and a 1 percent decline versus the three months ended March 31, 2018. The year-over-year

 


 

increase in prescriptions was driven primarily by commercial activities in the United States and Germany and initial launch efforts in Japan. We saw steady growth in prescriptions for newly diagnosed GBM with more than 900 Optune prescriptions, nearly 75% of the total, written for patients with newly diagnosed GBM.

 

 

In the United States, 947 prescriptions were received in the three months ended June 30, 2018, representing 18 percent growth compared to the same period in 2017.

 

In Germany and other EMEA markets, 265 prescriptions were received in the three months ended June 30, 2018, representing 4 percent growth compared to the same period in 2017.

 

In Japan, 32 prescriptions were received in the three months ended June 30, 2018, representing 3,100 percent growth compared to the same period in 2017.

 

For the three months ended June 30, 2018, net revenues were $61.5 million, representing 60 percent growth versus the same period in 2017. Revenue growth was driven by increased Optune adoption in the United States and Germany, initial launch efforts in Japan and by a decrease in the gross-to-net revenue spread

 

For the three months ended June 30, 2018, cost of revenues was $19.8 million compared to $13.2 million for the same period in 2017, representing an increase of 51 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 June 30, 2018, were $11.4 million compared to $9.4 million for the same period in 2017, representing an increase of 21 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 costs associated with regulatory affairs.

 

Sales and marketing expenses for the three months ended June 30, 2018, were $19.2 million compared to $16.4 million for the same period in 2017, representing an increase of 17 percent. This was primarily due to increased marketing and market access 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 June 30, 2018, were $18.2 million compared to $15.0 million for the same period in 2017, representing an

 


 

increase of 21 percent. This was primarily due to an increase in non-cash share-based compensation and an increase in professional services.

 

Personnel costs for the three months ended June 30, 2018, included $10.2 million in non-cash share-based compensation expenses, comprised of $0.3 million in cost of revenues; $1.3 million in research, development and clinical trials; $1.9 million in sales and marketing; and $6.8 million in general and administrative expenses. Total non-cash share-based compensation expenses for the second quarter 2017 were $7.6 million.

 

Net loss for the three months ended June 30, 2018, was $15.5 million compared to net loss of $21.2 million for the same period in 2017, representing a 27 percent improvement in net income.

 

At June 30, 2018, we had $114.5 million in cash and cash equivalents and $104.5 million in short-term investments, for a total balance of $219.0 million in cash, cash equivalents and short-term investments. This represents an increase of $2.6 million in cash and investments since March 31, 2018.

 

Anticipated clinical trial milestones

 

Phase 2 pilot STELLAR trial in mesothelioma data presentation (2H 2018)

 

First patient enrollment in phase 2 pilot HEPANOVA trial in advanced liver cancer (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 second quarter 2018 financial results today, Thursday, July 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 6554507.

 

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.

 

 


 

About Novocure

Novocure is a global oncology company developing a proprietary platform technology called Tumor Treating Fields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division. Novocure’s commercialized product is approved for the treatment of adult patients with glioblastoma. Novocure has ongoing or completed clinical trials investigating Tumor Treating Fields in brain metastases, non-small cell lung cancer, pancreatic cancer, ovarian cancer and mesothelioma.

 

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New Hampshire, Malvern, Pennsylvania and New York City. Additionally, the company has offices in Germany, Switzerland, Japan and Israel. For additional information about the company, please visit www.novocure.com or follow us at www.twitter.com/novocure.

 

Forward-Looking Statements

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical trial progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions as well as more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 22, 2018, with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

 


 

Consolidated Statements of Operations

USD in thousands (except share and per share data)

 

 

 

Three months ended June 30,

 

 

Six months ended June 30,

 

 

Year ended

December 31,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

2017

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Net revenues

 

$

61,514

 

 

$

38,376

 

 

$

113,639

 

 

$

73,256

 

 

$

177,026

 

Cost of revenues

 

 

19,833

 

 

 

13,152

 

 

 

38,071

 

 

 

24,816

 

 

 

55,609

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

41,681

 

 

 

25,224

 

 

 

75,568

 

 

 

48,440

 

 

 

121,417

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

11,362

 

 

 

9,371

 

 

 

22,466

 

 

 

18,782

 

 

 

38,103

 

Sales and marketing

 

 

19,196

 

 

 

16,360

 

 

 

37,331

 

 

 

31,116

 

 

 

63,528

 

General and administrative

 

 

18,208

 

 

 

15,023

 

 

 

35,533

 

 

 

27,445

 

 

 

59,114

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating costs and expenses

 

 

48,766

 

 

 

40,754

 

 

 

95,330

 

 

 

77,343

 

 

 

160,745

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(7,085

)

 

 

(15,530

)

 

 

(19,762

)

 

 

(28,903

)

 

 

(39,328

)

Financial expenses, net

 

 

2,860

 

 

 

2,183

 

 

 

7,713

 

 

 

4,629

 

 

 

9,169

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

 

(9,945

)

 

 

(17,713

)

 

 

(27,475

)

 

 

(33,532

)

 

 

(48,497

)

Income taxes

 

 

5,565

 

 

 

3,461

 

 

 

8,759

 

 

 

5,687

 

 

 

13,165

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(15,510

)

 

$

(21,174

)

 

$

(36,234

)

 

$

(39,219

)

 

$

(61,662

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per ordinary share

 

$

(0.17

)

 

$

(0.24

)

 

$

(0.40

)

 

$

(0.45

)

 

$

(0.70

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of ordinary shares used in

   computing basic and diluted net loss per share

 

 

91,331,862

 

 

 

88,218,868

 

 

 

90,658,735

 

 

 

87,835,926

 

 

 

88,546,719

 


 


 

Consolidated Balance Sheets

USD in thousands (except share data)

 

 

 

June 30,

 

 

December 31,

 

 

 

2018

 

 

2017

 

 

 

Unaudited

 

 

Audited

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

114,456

 

 

$

78,592

 

Short-term investments

 

 

104,499

 

 

 

104,719

 

Restricted cash

 

 

2,169

 

 

 

2,126

 

Trade receivables

 

 

37,643

 

 

 

29,567

 

Receivables and prepaid expenses

 

 

11,216

 

 

 

8,105

 

Inventories

 

 

19,906

 

 

 

22,025

 

Total current assets

 

 

289,889

 

 

 

245,134

 

 

 

 

 

 

 

 

 

 

LONG-TERM ASSETS:

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

8,891

 

 

 

9,031

 

Field equipment, net

 

 

8,108

 

 

 

9,036

 

Severance pay fund

 

 

111

 

 

 

111

 

Other long-term assets

 

 

2,877

 

 

 

1,986

 

Total long-term assets

 

 

19,987

 

 

 

20,164

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

309,876

 

 

$

265,298

 

 

 


 

 

 

June 30,

 

 

December 31,

 

 

 

2018

 

 

2017

 

 

 

Unaudited

 

 

Audited

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Trade payables

 

$

20,434

 

 

$

17,206

 

Other payables and accrued expenses

 

 

24,813

 

 

 

32,996

 

Total current liabilities

 

 

45,247

 

 

 

50,202

 

 

 

 

 

 

 

 

 

 

LONG-TERM LIABILITIES:

 

 

 

 

 

 

 

 

Long-term loan, net of discount and issuance costs

 

 

149,195

 

 

 

97,342

 

Employee benefit liabilities

 

 

2,473

 

 

 

2,453

 

Other long-term liabilities

 

 

880

 

 

 

1,737

 

Total long-term liabilities

 

 

152,548

 

 

 

101,532

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

197,795

 

 

 

151,734

 

 

 

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

 

 

 

 

 

Share capital -

 

 

 

 

 

 

 

 

Ordinary shares no par value, unlimited shares authorized; issued and outstanding:

  92,503,273 shares and 89,478,032 shares at June 30, 2018 (unaudited)  and

   December 31, 2017, respectively

 

 

-

 

 

 

-

 

Additional paid-in capital

 

 

729,684

 

 

 

697,165

 

Accumulated other comprehensive loss

 

 

(1,273

)

 

 

(1,343

)

Accumulated deficit

 

 

(616,330

)

 

 

(582,258

)

Total shareholders' equity

 

 

112,081

 

 

 

113,564

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

 

$

309,876

 

 

$

265,298

 

 

Media and Investor Contact:

Ashley Cordova

acordova@novocure.com

212-767-7558

 

 

View differences made from one to another to evaluate Novocure Ltd's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 8-K Corporate News to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Novocure Ltd.

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account