GW Pharmaceuticals plc Reports 2013 Second Quarter Financial Results -Conference Call Today at 8:00 a.m. ET, 1:00 p.m. BST-

LONDON, June 3, 2013 /PRNewswire/ -- GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW," "the Company" or "the Group"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the second quarter and half year ended 31 March 2013.

CORPORATE HIGHLIGHTS

  • Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of US$30.4m (£19.5m).
  • Two pivotal Sativex® Phase 3 cancer pain trials in recruitment. Top-line results from both trials due in 2014. Data intended to lead to an NDA filing with the FDA in the U.S.
  • Sativex now approved in 21 countries (ex-U.S) as a treatment for Multiple Sclerosis spasticity
    • Reimbursement granted in Italy in May 2013. Launch expected in September 2013
    • Several additional launches in planning over next 12 months
    • Adverse pricing decision in Germany in March 2013
  • Significant clinical trial activity expected in H2 2013 for cannabinoid pipeline product candidates, including:
    • Phase 2 dose ranging trial of GWP42004 for the treatment of Type 2 diabetes expected to commence in the second half of 2013;
    • Phase 2a trial of GWP42003 for the treatment of ulcerative colitis on-going with data expected in early 2014;
    • Phase 2 trial of GWP42003 for the treatment of schizophrenia expected to commence in the second half of 2013;
    • Phase 1 trial of GWP42006 for the treatment of epilepsy expected to commence in the second half of 2013; and
    • Phase 1b/2a trial of THC:CBD for the treatment of glioma expected to commence in the second half of 2013.

FINANCIAL HIGHLIGHTS

  • Total revenue for the six months ended 31 March 2013 of £12.9m ($19.6m) compared to £11.1m in H1 2012
  • Net profit after tax for the six months ended 31 March 2013 of £0.1m ($0.2m) compared to a loss of £3.2m in H1 2012
  • Cash and cash equivalents at 31 March 2013 of £27.9m ($42.3m) compared to £29.3m as at 30 September 2012. Additional £18.2m of net proceeds after expenses from initial public offering on NASDAQ received after period end.

"I am pleased to report GW has made significant progress in the year to date. Most notably, we recently successfully completed a Nasdaq listing and initial public offering to U.S. investors," stated Justin Gover, GW's Chief Executive Officer. "We believe that this represents a significant corporate milestone for GW. With Sativex® advancing through Phase 3 trials in the U.S. for cancer pain, commercialization continuing in Europe and other parts of the world, four new clinical trials commencing in a highly promising cannabinoid product pipeline, and a strong balance sheet, we are very excited about the next phase in our company's evolution."

Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the 2013 second quarter financial results today at 8:00 a.m. ET / 1:00 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the US and Canada), or 00-800-2246-2666 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company's website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 415485.

Solely for the convenience of the reader, unless otherwise indicated, all pound sterling amounts stated in the Consolidated Balance Sheet as at 31 March 2013 and in the Consolidated Income Statement and cash flow statements for the 6 months ended 31 March 2013 have been translated into U.S dollars at the rate on 28 March 2013 of $1.518 to £1.00. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Condensed consolidated income statements
Three and six months ended 31 March 2013

 



Six

months

 ended

Six

months

 ended

Six

 months

 ended

Three

months

ended

Three

months

ended



31 March

31 March

31 March

31 March

31 March


Notes

2013

2013

2012

2013

2012










$000's

£000's

£000's

£000's

£000's

Revenue

2

19,605

12,915

11,078

7,739

6,093

Cost of sales


(999)

(658)

(522)

(245)

(119)

Research and development expenditure

3

(22,928)

(15,104)

(12,723)

(8,701)

(6,673)

Management and administrative expenses


(2,857)

(1,882)

(2,035)

(1,083)

(1,562)



_______

_______

_______

_______

_______

Operating loss


(7,179)

(4,729)

(4,202)

(2,290)

(2,261)

Interest income


124

82

102

36

41



_______

_______

_______

_______

_______

Loss before tax


(7,055)

(4,647)

(4,100)

(2,254)

(2,220)

Tax

4

7,242

4,771

928

330

553



_______

_______

_______

_______

_______

Profit/(loss) for the period


187

124

(3,172)

(1,924)

(1,667)



_______

_______

_______

_______

_______








Earnings/(loss) per share – basic and diluted

5

0.2c

0.1p

(2.4p)

(1.4p)

(1.3p)

Condensed consolidated statements of changes in equity
Six months ended 31 March 2013

 


Called-up

        Share





share

    premium

        Other

    Retained



capital

     account

   reserves

     earnings

      Total


£000's

£000's

£000's

£000's

£000's

Balance at 1 October 2011

133

65,866

20,184

(68,531)

17,652

Exercise of share options

-

72

-

-

72

Share-based payment transactions

-

-

-

500

500

Loss for the period

-

-

-

(3,172)

(3,172)


_________

_________

________

__________

________

Balance at 31 March 2012

133

65,938

20,184

(71,203)

15,052



















Balance at 1 October 2012

133

65,947

20,184

(65,032)

21,232

Expense of new equity issue

-

(684)

-


(684)

Share-based payment transactions

-

-

-

350

350

Profit for the period

-

-

-

124

124


_________

_________

________

__________

________

Balance at 31 March 2013

133

65,263

20,184

(64,558)

21,022


_________

_________

________

__________

________

 


Condensed consolidated balance sheets
As at 31 March 2013




As at
31 March

As at

31 March

As at

30 September


Notes

2013

2013

2012






Non-current assets


$000's

£000's

 £000's

Intangible assets – goodwill


7,909

5,210

5,210

Property, plant and equipment


4,331

2,853

2,432

Deferred tax asset

4

2,248

1,481

-



_________

__________

__________



14,488

9,544

7,642



_________

__________

__________

Current assets





Inventories

6

6,127

4,036

3,537

Taxation recoverable


1,940

1,278

820

Trade receivables and other current assets

7

1,735

1,143

1,588

Cash and cash equivalents


42,339

27,891

29,335



_________

__________

__________



52,141

34,348

35,280



_________

__________

__________

Total assets


66,629

43,892

42,922



_________

__________

__________

Current liabilities





Trade and other payables

8

(14,512)

(9,560)

(9,114)

Deferred revenue

9

(5,686)

(3,746)

(2,449)



_________

__________

__________



(20,198)

(13,306)

(11,563)






Non-current liabilities





Deferred revenue

9

(14,519)

(9,564)

(10,127)



_________

__________

__________

Total liabilities


(34,717)

(22,870)

(21,690)



_________

__________

__________

Net assets


31,912

21,022

21,232



_________

__________

__________











Equity





Share capital


202

133

133

Share premium account


99,069

65,263

65,947

Other reserves


30,639

20,184

20,184

Accumulated deficit 


(97,998)

(64,558)

(65,032)



_________

__________

__________

Total Equity


31,912

21,022

21,232



_________

_________

_________

 


Condensed consolidated cash flow statements
For the six months ended 31 March 2013




Six months

 ended

Six months

ended

Six months

ended


 

31 March

 

31 March

 

31 March


2013

2013

2012






$000's

 £000's

£000's

Profit/(loss) for the period

188

124

(3,172)

Adjustments for:

Interest income

Tax

 

(124)

(7,242)

 

(82)

(4,771)

 

(102)

(928)

Depreciation of property, plant and equipment

Other gains and losses

Decrease in provision for inventories

676

562

(214)

445

370

(141)

379

(163)

(460)

Share-based payment charge

531

350

500


__________

__________

__________


(5,623)

(3,705)

(3,946)

Increase in inventories

(543)

(358)

(113)

Decrease in trade receivables and other current assets

669

441

922

Increase in trade and other payables and deferred revenue

1,791

1,180

952


__________

__________

__________

Cash (used)/generated by operations

(3,706)

(2,442)

(2,185)

Research and development tax credits received

4,299

2,832

428


__________

__________

__________

Net cash inflow/(outflow) from operating activities

593

390

(1,757)

Investing activities




Interest received

131

86

155

Purchases of property, plant and equipment

(1,315)

(866)

(738)


__________

__________

__________

Net cash outflow from investing activities

(1,184)

(780)

(583)

Financing activities




Proceeds on exercise of shares options

-

-

72

Expense of new equity issue

(1,039)

(684)

-


__________

__________

__________

Net cash outflow from financing activities

(1,038)

(684)

72

Effect of foreign exchange rate changes

(562)

(370)

163

Net decrease in cash and cash equivalents

(2,192)

(1,444)

(2,105)

Cash and cash equivalents at beginning of the period

44,531

29,335

28,319


__________

__________

__________

 

Cash and cash equivalents at end of the period

42,339

27,891

26,214


__________

__________

__________

* Please see the Form 6-K filed with the Securities and Exchange Commission on June 3, 2013 for the more detailed financial information and notes.


About GW Pharmaceuticals plc

GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. In 14 years of operations, GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development processes, GW's intellectual property portfolio and its regulatory and manufacturing expertise. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis ("MS") in 21 countries outside the United States ("U.S."). GW is also evaluating Sativex in a Phase 3 program for the treatment of cancer pain, and anticipates that top-line results from two Phase 3 trials will be available in 2014, the first of which is expected to be available in mid-2014. This program is intended to support the submission of a New Drug Application ("NDA") for Sativex in cancer pain with the U.S. Food and Drug Administration ("FDA") and in other markets around the world. GW believes that MS spasticity represents an attractive indication for Sativex in the U.S. and the Company intends on pursuing an additional clinical development program for this significant opportunity. GW has a deep pipeline of additional cannabinoid product candidates, including two distinct compounds, GWP42004 and GWP42003, in Phase 2 clinical development for Type 2 diabetes and ulcerative colitis, respectively, and two additional programs expected to advance into Phase 1 and Phase 2 clinical trials in the next 12 months.

Enquiries:

 

GW Pharmaceuticals plc

(Today) + 44 20 7831 3113

Justin Gover, Chief Executive Officer

(Thereafter) + 44 1980 557000

Stephen Schultz, VP Investor Relations

+ 1 401 500 6570



FTI Consulting (Media Enquiries)


Ben Atwell / Simon Conway / John Dineen (UK)

+ 44 20 7831 3113

Robert Stanislaro (US)

+1 212 850 5657



Trout Group, LLC (US investor relations)


Seth Lewis

+1 646 378 2900



Cautionary statement

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the timing of clinical trials, the relevance of GW products commercially available and in development, the size of Sativex market opportunities, and the development and regulatory clearance of the GW's products.  Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission, including the prospectus related to the Nasdaq offering filed by GW with the SEC on May 1, 2013. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

 

SOURCE GW Pharmaceuticals plc



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