GW Pharmaceuticals plc Reports Second Quarter 2015 Financial Results and Operational Progress
May 11 2015 - 7:00AM
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 2015.
RECENT OPERATIONAL HIGHLIGHTS
- Epidiolex® (CBD) childhood epilepsy program:
- Dravet syndrome - Two Phase 3 pivotal trials recently commenced
with top-line data expected from the first trial by end of
2015
- Lennox-Gastaut syndrome - First Phase 3 trial in Lennox-Gastaut
syndrome commenced (see separate announcement today). Second Phase
3 trial on track to start in calendar Q2 2015
- Tuberous Sclerosis Complex selected as additional new target
indication with Phase 3 trial expected to start in H2 2015
- Recent data on 137 patients from expanded access program
presented at American Academy of Neurology further reinforces
signals of clinical effect seen in previous data disclosures
- Approx. 290 children currently on treatment in expanded access
program at 17 U.S. clinical sites
- Approx. 420 children authorized for treatment by FDA under
Expanded Access Treatment INDs and additional 225 patients
authorized by FDA under 4 U.S. State programs
- Notice of Allowance issued by the U.S. Patent and Trademark
Office (USPTO) covering the use of CBD in the treatment of partial
seizures.
- Cannabidivarin (CBDV) epilepsy program:
- Phase 2 CBDV epilepsy study in 130 patients underway
- Notice of Allowance issued by the USPTO for patent application
covering use of CBDV for the treatment of epilepsy
- Cannabinoid pipeline product candidates:
- Orphan drug designation granted for CBD in the treatment of
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE). Phase 1 trial
expected to commence in H2 2015
- Recruitment complete in a Phase 2a study for the treatment of
schizophrenia - data expected H2 2015
- First of three Sativex Phase 3 cancer pain trials did not show
a statistically significant difference for Sativex compared with
placebo. Two additional Phase 3 cancer pain trials expected to read
out in H2 2015
- Phase 1b study of GWP42002:GWP42003 underway for the treatment
of Recurrent Glioblastoma Multiforme (GBM)
- Phase 2 study of GWP42004 in type-2 diabetes underway with
expected completion in 2016
FINANCIAL HIGHLIGHTS
- Follow-on offering closed 5 May 2015 raising total net proceeds
after expenses of approximately $167.8 million (£110.4 million).
- Revenue for the six months ended 31 March 2015 of £14.3 million
($21.3 million) compared to £15.0 million for the six months ended
31 March 2014.
- Loss for the six months ended 31 March 2015 of £10.9 million
($16.2 million) compared to £8.0 million for the six months ended
31 March 2014.
- Cash and cash equivalents at 31 March 2015 of £148.6 million
($220.7 million) compared to £164.5 million as at 30 September
2014.
"During the second quarter, we commenced our pivotal Phase 3
trials program for Epidiolex in childhood epilepsy and expect these
trials to recruit rapidly with a view to reporting initial top-line
data around the end of 2015. The new data presented at the American
Academy of Neurology has only served to reinforce our confidence in
the potential for Epidiolex to become an important advance in the
field of treatment-resistant epilepsy," stated Justin Gover, GW's
Chief Executive Officer. "With our successful follow-on offering,
GW is in a strong position to continue to prepare for a NDA
submission to the FDA in 2016 and to make necessary preparations
toward a successful commercial launch."
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to
discuss the 2015 second quarter and half year financial results
today at 8:00 a.m. EDT / 1:00 p.m. BST. To participate in the
conference call, please dial 877-407-8133 (toll free from the U.S.
and Canada), or 0800-756-3429 (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 #13609474.
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 27 countries
outside the United States. GW is also advancing an orphan drug
program in the field of childhood epilepsy with a focus on
Epidiolex®, which is in Phase 3 clinical development for the
treatment of Dravet syndrome and the treatment of Lennox-Gastaut
syndrome. GW has a deep pipeline of additional cannabinoid product
candidates which includes Sativex in Phase 3 clinical development
as a potential treatment of pain associated with advanced cancer,
as well as compounds in Phase 1 and 2 clinical development for
glioma, type 2 diabetes, and schizophrenia. For further
information, please visit www.gwpharm.com.
Note regarding expanded access studies
Expanded access studies are uncontrolled, carried out by
individual physician investigators independent from GW, and not
always conducted in strict compliance with Good Clinical Practices,
all of which can lead to a treatment effect which may differ from
one seen in placebo-controlled trials. Data from these studies
provide only anecdotal evidence of efficacy for regulatory review,
although they may provide supportive safety information for
regulatory review. These studies contain no control or comparator
group for reference and are not designed to be aggregated or
reported as study results. Moreover, data from such small numbers
of patients may be highly variable. Such information, including the
statistical principles that the independent physician investigators
have chosen to apply to the data, may not reliably predict data
collected via systematic evaluation of the efficacy in
company-sponsored clinical trials or evaluated via other
statistical principles that may be applied in these trials.
Reliance on such information may lead to Phase 2 and/or Phase 3
clinical trials that are not adequately designed to demonstrate
efficacy and could delay or prevent GW's ability to seek approval
of Epidiolex.
Forward-looking statements
This news release contains forward-looking statements that
reflect GW's 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 clinical benefits of Sativex® and
Epidiolex® and the safety profile and commercial potential of
Sativex and Epidiolex. Forward-looking statements involve risks and
uncertainties. Actual events could differ materially from those
projected in this news release and depend on a number of factors,
including (inter alia), the success of 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, Epidiolex and other
products by consumer and medical professionals. A further list and
description of risks and uncertainties associated with an
investment in GW can be found in GW's filings with the U.S.
Securities and Exchange Commission. 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: |
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GW Pharmaceuticals plc |
(Today) +44 20 3727
1000 |
Stephen Schultz, VP Investor Relations |
917 280 2424 / 401 500 6570 |
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FTI Consulting (Media
Enquiries) |
|
Ben Atwell / Simon Conway / John Dineen
(UK) |
+ 44 20 3727 1000 |
Robert Stanislaro (U.S.) |
212 850 5657 |
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Trout Group, LLC (U.S. investor
relations) |
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Todd James / Chad Rubin |
646 378 2900 |
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GW Pharmaceuticals plc |
Condensed consolidated income
statement |
Three months ended 31 March
2015 |
|
|
Three months ended |
Three months
ended |
Three months ended |
|
31 March |
31 March |
31 March |
|
2015 |
2015 |
2014 |
|
$000's |
£000's |
£000's |
Revenue |
9,432 |
6,351 |
7,527 |
Cost of sales |
(958) |
(645) |
(640) |
Research and development expenditure |
(22,812) |
(15,362) |
(11,885) |
Management and administrative expenses |
(5,635) |
(3,794) |
(1,851) |
Net foreign exchange gain/(loss) |
6,156 |
4,145 |
(243) |
|
|
|
|
Operating loss |
(13,817) |
(9,305) |
(7,092) |
Interest income |
105 |
71 |
26 |
Interest expense |
(28) |
(19) |
(19) |
|
|
|
|
Loss before tax |
(13,740) |
(9,253) |
(7,085) |
Tax benefit |
2,605 |
1,754 |
1,889 |
|
|
|
|
Loss for the period |
(11,135) |
(7,499) |
(5,196) |
|
|
|
|
|
|
|
|
Loss per share – basic and
diluted |
(4.8c) |
(3.2p) |
(2.5p) |
All activities relate to continuing operations.
|
|
|
|
GW Pharmaceuticals plc |
Condensed consolidated income
statement |
Six months ended 31 March
2015 |
|
|
Six months ended |
Six months
ended |
Six months ended |
|
31 March |
31 March |
31 March |
|
2015 |
2015 |
2014 |
|
$000's |
£000's |
£000's |
Revenue |
21,261 |
14,317 |
15,015 |
Cost of sales |
(1,803) |
(1,214) |
(998) |
Research and development expenditure |
(45,274) |
(30,487) |
(21,037) |
Management and administrative expenses |
(6,826) |
(4,597) |
(3,126) |
Net foreign exchange gain/(loss) |
12,146 |
8,179 |
(479) |
|
|
|
|
Operating loss |
(20,496) |
(13,802) |
(10,625) |
Interest income |
170 |
114 |
56 |
Interest expense |
(58) |
(39) |
(39) |
|
|
|
|
Loss before tax |
(20,384) |
(13,727) |
(10,608) |
Tax benefit |
4,191 |
2,823 |
2,596 |
|
|
|
|
Loss for the period |
(16,193) |
(10,904) |
(8,012) |
|
|
|
|
|
|
|
|
Loss per share – basic and
diluted |
(6.8c) |
(4.6p) |
(4.1p) |
All activities relate to continuing operations.
|
Consolidated statement of
comprehensive loss |
For the six months ended 31 March
2015 |
|
|
Six months
ended 31 March
2015 £000's |
Six months ended 31 March 2014
£000's |
Loss for the
period |
(10,904) |
(8,012) |
Items that may be reclassified
subsequently to profit or loss |
|
|
Exchange differences on retranslation
of foreign operations |
(36) |
-- |
Other comprehensive loss for
the period |
(36) |
-- |
Total comprehensive loss for
the period |
(10,940) |
(8,012) |
|
|
GW Pharmaceuticals plc |
Condensed consolidated statement
of changes in equity |
Six months ended 31 March 2015
|
|
|
Called-up |
Share |
|
|
|
|
share |
premium |
Other |
Accumulated |
|
|
capital |
account |
reserves |
deficit |
Total |
|
£000's |
£000's |
£000's |
£000's |
£000's |
Balance at 1 October
2013 |
178 |
84,005 |
20,184 |
(68,965) |
35,402 |
Issue of share capital |
34 |
57,333 |
-- |
-- |
57,367 |
Expense of new equity issue |
-- |
(577) |
-- |
-- |
(577) |
Exercise of share options |
1 |
1,708 |
-- |
-- |
1,709 |
Exercise of warrants |
3 |
5,284 |
(922) |
922 |
5,287 |
Share-based payment transactions |
-- |
-- |
-- |
566 |
566 |
Loss for the period |
-- |
-- |
-- |
(8,012) |
(8,012) |
|
|
|
|
|
|
Balance at 31 March
2014 |
216 |
147,753 |
19,262 |
(75,489) |
91,742 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 1 October
2014 |
237 |
220,551 |
19,260 |
(81,464) |
158,584 |
Issue of share capital |
-- |
59 |
-- |
-- |
59 |
Exercise of share options |
-- |
379 |
-- |
-- |
379 |
Share-based payment transactions |
-- |
-- |
-- |
806 |
806 |
Loss for the period |
-- |
-- |
-- |
(10,904) |
(10,904) |
Other comprehensive loss |
-- |
-- |
(36) |
-- |
(36) |
|
|
|
|
|
|
Balance at 31 March
2015 |
237 |
220,989 |
19,224 |
(91,562) |
148,888 |
|
|
|
|
|
|
|
|
GW Pharmaceuticals plc |
Condensed consolidated balance
sheets |
As at 31 March 2015 |
|
As at 31 March |
As at 31
March |
As at 30 September |
|
2015 |
2015 |
2014 |
|
|
|
|
Non-current assets |
$000's |
£000's |
£000's |
Goodwill |
7,736 |
5,210 |
5,210 |
Other intangible assets |
85 |
57 |
-- |
Property, plant and equipment |
32,381 |
21,805 |
11,639 |
Deferred tax asset |
310 |
208 |
277 |
|
40,512 |
27,280 |
17,126 |
|
|
|
|
Current assets |
|
|
|
Inventories |
6,646 |
4,475 |
4,777 |
Taxation recoverable |
4,050 |
2,728 |
5,251 |
Trade receivables and other assets |
4,101 |
2,761 |
1,857 |
Cash and cash equivalents |
220,719 |
148,632 |
164,491 |
|
235,516 |
158,596 |
176,376 |
|
|
|
|
Total assets |
276,028 |
185,876 |
193,502 |
|
|
|
|
Current liabilities |
|
|
|
Trade and other payables |
(23,493) |
(15,820) |
(12,376) |
Obligations under finance leases |
(221) |
(149) |
(126) |
Deferred revenue |
(5,875) |
(3,956) |
(4,827) |
|
(29,589) |
(19,925) |
(17,329) |
|
|
|
|
Non-current liabilities |
|
|
|
Trade and other payables |
(11,965) |
(8,057) |
(7,927) |
Obligations under finance leases |
(2,528) |
(1,703) |
(1,781) |
Deferred revenue |
(10,846) |
(7,303) |
(7,881) |
Total liabilities |
(54,928) |
(36,988) |
(34,918) |
|
|
|
|
Net assets |
221,100 |
148,888 |
158,584 |
|
|
|
|
|
|
|
|
Equity |
|
|
|
Share capital |
353 |
237 |
237 |
Share premium account |
328,169 |
220,989 |
220,551 |
Other reserves |
28,548 |
19,224 |
19,260 |
Accumulated deficit |
(135,970) |
(91,562) |
(81,464) |
|
|
|
|
Total equity |
221,100 |
148,888 |
158,584 |
|
|
|
|
|
|
GW Pharmaceuticals plc |
Condensed consolidated cash flow
statements |
For the six months ended 31 March
2015 |
|
|
Six months ended |
Six months ended |
Six months ended |
|
31 March |
31 March |
31 March |
|
2015 |
2015 |
2014 |
|
|
|
As restated1 |
|
$000's |
£000's |
£000's |
Loss for the period |
(16,193) |
(10,904) |
(8,012) |
Adjustments for: |
|
|
|
Interest income |
(170) |
(114) |
(56) |
Interest expense |
58 |
39 |
39 |
Tax benefit |
(4,191) |
(2,823) |
(2,596) |
Depreciation of property, plant and
equipment |
1,509 |
1,016 |
641 |
Amortisation of intangible assets |
3 |
2 |
-- |
Net foreign exchange gains |
(12,274) |
(8,265) |
(1,008) |
Increase/(decrease) in provision for
inventories |
19 |
13 |
(341) |
Loss on disposal of property, plant and
equipment |
2 |
1 |
-- |
Share-based payment charge |
1,197 |
806 |
566 |
|
|
|
|
|
(30,040) |
(20,229) |
(10,767) |
Decrease in inventories |
429 |
289 |
234 |
(Increase)/decrease in trade receivables and
other assets |
(1,342) |
(904) |
197 |
Increase in trade and other payables and
deferred revenue |
1,643 |
1,106 |
1,081 |
|
|
|
|
Cash used in operations |
(29,310) |
(19,738) |
(9,255) |
Research and development tax credits
received |
8,041 |
5,415 |
-- |
|
|
|
|
Net cash outflow from operating
activities |
(21,269) |
(14,323) |
(9,255) |
|
|
|
|
Investing activities |
|
|
|
Interest received |
167 |
113 |
71 |
Purchases of property, plant and
equipment |
(15,094) |
(10,165) |
(2,011) |
Purchase of intangible assets |
(88) |
(59) |
-- |
Proceeds from sales of property, plant and
equipment |
1 |
1 |
-- |
|
|
|
|
Net cash outflow from investing
activities |
(15,014) |
(10,110) |
(1,940) |
|
|
|
|
Financing activities |
|
|
|
Proceeds on exercise of share options |
563 |
379 |
1,708 |
Proceeds of new equity issue |
88 |
59 |
57,367 |
Expenses of new equity issue |
-- |
-- |
(577) |
Proceeds of warrant exercise |
-- |
-- |
5,287 |
Interest paid |
(65) |
(44) |
(37) |
Proceeds from fit out funding |
-- |
-- |
4,010 |
Capital element of finance leases |
(82) |
(55) |
(48) |
|
|
|
|
Net cash inflow from financing
activities |
504 |
339 |
67,710 |
Effect of foreign exchange rate changes on
cash and cash equivalents |
12,229 |
8,235 |
1,008 |
|
|
|
|
Net (decrease)/increase in cash and
cash equivalents |
(23,550) |
(15,859) |
57,523 |
Cash and cash equivalents at beginning of the
period |
244,269 |
164,491 |
38,069 |
|
|
|
|
Cash and cash equivalents at end of
the period |
220,719 |
148,632 |
95,592 |
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