GW Pharmaceuticals plc Reports 2013 Third Quarter Financial Results

gw-logoLONDON, 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

 

 

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