GW Pharmaceuticals plc Reports 2013 Third Quarter Financial Results -Recent Nasdaq Listing Further Enhances Robust Financial Position; Sativex Continues to Progress in Late-Stage Clinical Trials in U.S.-

-Conference Call Today at 8:00 a.m. ET, 1:00 p.m. BST-

LONDON, Aug. 5, 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 third quarter ended 30 June 2013.

RECENT OPERATIONAL HIGHLIGHTS

  • Initial public offering on the NASDAQ Global Market completed in May 2013 raising total net proceeds before expenses of $30.4 million (£19.6 million)
  • Two pivotal Sativex® Phase 3 cancer pain trials in recruitment. Top-line results from both trials due in 2014. Data intended to lead to a New Drug Application (NDA) filing with the FDA in the U.S.
  • FDA filing of a Phase 3 Investigational New Drug Application (IND) for Sativex as a treatment for MS spasticity
  • Commercial launch of Sativex in Italy as a treatment for MS spasticity, earning £250,000 milestone
  • Submission of regulatory application in France for Sativex in the treatment of MS spasticity
  • Positive top-line results from a 12 month, placebo-controlled study of Sativex in patients with MS spasticity confirming the reassuring safety profile and providing further evidence of efficacy
  • Significant clinical trial activity for cannabinoid pipeline product candidates expected to continue in the second half of 2013
  • Two new patent allowances in the U.S. protecting Sativex delivery method and delivery device

FINANCIAL HIGHLIGHTS FOR THE THREE MONTHS ENDED 30 JUNE 2013

  • Sativex product sales revenues of £0.5 million ($0.8 million) for the three months ended 30 June 2013, compared to £0.1million for the three months ended 30 June 2012, reflecting increased shipments of inventory to commercial partners
  • Total revenue for the three months ended 30 June 2013 of £7.3 million ($11.0 million) compared to £14.5 million for the three months ended 30 June 2012, a period in which a £9.8 million milestone payment was received
  • Loss after tax for the three months ended 30 June 2013 of £2.0 million ($3.1 million) compared to a profit of £7.9 million for the three months ended 30 June 2012, which primarily reflected the impact of the £9.8 million milestone payment received in the comparable period last year
  • Cash and cash equivalents at 30 June 2013 of £43.6 million ($66.3 million) compared to £29.3 million as at 30 September 2012

"Following our successful Nasdaq listing in May, GW has established an important new US shareholder base and further enhanced its robust financial position," stated Justin Gover, GW's Chief Executive Officer. "GW continues to make good progress with the U.S. Phase 3 development of Sativex as a treatment for cancer pain, and is also now advancing plans for the US development of Sativex as a treatment for MS spasticity." In addition, the recent launch of Sativex in Italy and new regulatory application in France are expected to support further commercial progress in Europe, and provide important validation for Sativex and GW's position as a world leader in cannabinoid science. As we move forward in the second half of 2013, we expect a significant amount of clinical activity to occur with respect to our cannabinoid pipeline candidates."  

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the 2013 third 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 00800-2246-2666 (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 # 418183.

About GW Pharmaceuticals plc

Founded in 1998, 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. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 22 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has established a world leading position in the development of plant-derived cannabinoid therapeutics and 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 at least two additional programs expected to enter Phase 1 and Phase 2 clinical trials in the next 12 months. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding financial performance, 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.

Enquiries:

GW Pharmaceuticals plc

(Today) + 44 20 7831 3113

Justin Gover, Chief Executive Officer

(Thereafter) + 44 1980 557000

Stephen Schultz, VP Investor Relations (US)

401 500 6570



FTI Consulting (Media Enquiries)


Ben Atwell / Simon Conway / John Dineen (UK)

+ 44 20 7831 3113

Robert Stanislaro (US)

212 850 5657



Trout Group, LLC (US investor relations)


Seth Lewis / Todd James

646 378 2900

 

GW Pharmaceuticals plc
Condensed consolidated income statements






Condensed consolidated income statement for the three months ended 30 June 2013








Three months

 ended


Three months

ended


Three months

ended



30 June


30 June


30 June



2013


2013


2012



$000's


£000's


£000's

Revenue


11,038


7,258


14,455

Cost of sales


(406)


(267)


(15)

Research and development expenditure


(12,826)


(8,434)


(5,673)

Management and administrative expenses


(1,322)


(869)


(932)








Operating loss


(3,516)


(2,312)


7,835

Interest income


44


29


39

Interest payable


(68)


(45)


(1)








Loss before tax


(3,540)


(2,328)


7,873

Tax


456


300


-








Profit/(loss) for the period


(3,084)


(2,028)


7,873















Earnings/(loss) per share







– basic


(2.0c)


(1.3p)


5.9p

– diluted


(2.0c)


(1.3p)


5.7p

 

 


Condensed consolidated income statement for the nine months ended 30 June 2013








Nine months

 ended


Nine months

 ended


Nine  months

 ended



30 June


30 June


30 June



2013


2013


2012



$000's


£000's


£000's

Revenue


30,680


20,173


25,533

Cost of sales


(1,407)


(925)


(537)

Research and development expenditure


(35,791)


(23,534)


(18,396)

Management and administrative expenses


(4,182)


(2,750)


(2,967)








Operating loss


(10,700)


(7,036)


3,633

Interest income


169


111


141

Interest payable


(69)


(45)


(1)








Loss before tax


(10,600)


(6,970)


3,773

Tax


7,712


5,071


928








Profit/(loss) for the period


(2,888)


(1,899)


4,701















Earnings/(loss) per share







– basic


(2.0c)


(1.3p)


3.5p

– diluted


(2.0c)


(1.3p)


3.4p




All activities relate to continuing operations.
The Group has no recognised gains or losses other than the losses above and therefore no separate consolidated statement of comprehensive income has been presented.



 

 

GW Pharmaceuticals plc
Condensed consolidated statements of changes in equity
Nine months ended 30 June 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

-


83


-


-


83

Share-based payment transactions

-


-


-


743


743

Profit for the period

-


-


-


4,701


4,701











Balance at 30 June 2012

133


65,949


20,184


(63,087)


23,179































Balance at 1 October 2012

133


65,947


20,184


(65,032)


21,232

Issue of share capital

45


19,567


-


-


19,612

Expense of new equity issue

-


(1,759)


-


-


(1,759)

Share-based payment transactions

-


-


-


573


573

Loss for the period

-


-


-


(1,899)


(1,899)











Balance at 30 June 2013

178


83,755


20,184


(66,358)


37,759











 




GW Pharmaceuticals plc
Condensed consolidated balance sheets
As at 30 June 2013








As at

30 June


As at

30 June


As at

30 September




2013


2013


2012










Non-current assets


$000's


£000's


 £000's


Intangible assets – goodwill


7,923


5,210


5,210


Property, plant and equipment


8,159


5,365


2,432


Deferred tax asset


1,795


1,180


-












17,877


11,755


7,642










Current assets








Inventories


6,803


4,473


3,537


Taxation recoverable


2,856


1,878


820


Trade receivables and other current assets


2,302


1,514


1,588


Cash and cash equivalents


66,281


43,583


29,335












78,242


51,448


35,280










Total assets


96,119


63,203


42,922










Current liabilities








Trade and other payables


(16,256)


(10,689)


(9,114)


Obligations under finance leases


(129)


(85)


-


Deferred revenue


(5,297)


(3,483)


(2,449)












(21,682)


(14,257)


(11,563)










Non-current liabilities








Obligations under finance leases


(2,961)


(1,947)


-


Deferred revenue


(14,052)


(9,240)


(10,127)










Total liabilities


(38,695)


(25,444)


(21,690)










Net assets


57,424


37,759


21,232


























Equity








Share capital


270


178


133


Share premium account


127,375


83,755


65,947


Other reserves


30,696


20,184


20,184


Accumulated deficit 


(100,917)


(66,358)


(65,032)










Total equity


57,424


37,759


21,232










 




 

GW Pharmaceuticals plc
Condensed consolidated cash flow statements
For the nine months ended 30 June 2013





Nine months

ended


Nine months

ended


Nine months

ended


 

30 June


 

30 June


 

30 June


2013


2013


2012








$000's


                £000's


                £000's

(Loss)/profit for the period

(2,888)


(1,899)


4,701

Adjustments for:

Interest income

Interest payable

Tax

 

(169)

69

(7,712)


 

(111)

45

(5,071)


 

(141)

1

(928)

Depreciation of property, plant and equipment

Other gains and losses

Decrease in provision for inventories

1,051

          630

(625)


691

414

(411)


565

(105)

(881)

Share-based payment charge

871


573


743








(8,773)


(5,769)


3,955

Increase in inventories

(797)


(524)


(716)

Decrease in trade receivables and other current assets

105


69


808

Increase/(decrease) in trade and other payables and deferred revenue

 

2,099


 

1,380


 

(2,377)







Cash (used)/generated by operations

(7,366)


(4,844)


1,670

Research and development tax credits received

4,307


2,832


428







Net cash (outflow)/inflow from operating activities

(3,059)


(2,012)


2,098

Investing activities






Interest received

175


115


104

Purchases of property, plant and equipment

(2,762)


(1,816)


(1,192)







Net cash outflow from investing activities

(2,587)


(1,701)


(1,088)

Financing activities






Proceeds on exercise of shares options

-


-


83

Proceeds of new equity issue

29,824


19,612


-

Expenses of new equity issue

(2,153)


(1,416)


-

Interest paid

(68)


(45)


(1)

Proceeds from finance leases

342


225


-







Net cash inflow from financing activities

27,945


18,376


82

Effect of foreign exchange rate changes

(631)


(415)


105

Net increase in cash and cash equivalents

21,668


14,248


1,197

Cash and cash equivalents at beginning of the period

44,613


29,335


28,319







Cash and cash equivalents at end of the period

66,281


43,583


29,516







 

 

SOURCE GW Pharmaceuticals plc



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