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-

05 Aug, 2013, 02:00 ET from GW Pharmaceuticals plc

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



RELATED LINKS

http://www.gwpharm.com