GW Pharmaceuticals plc Reports Second Quarter and Half-Year 2016 Financial Results and Operational Progress
May 05 2016 - 7:00AM
- Positive Phase 3 Epidiolex pivotal
trial in Dravet syndrome -- Initial LGS Phase 3
pivotal data expected in June -- Conference call
today at 9:00 a.m. EDT, 2:00 p.m. BST -
GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (AIM:GW) (the
Company or the Group), a biopharmaceutical company focused on
discovering, developing and commercializing novel therapeutics from
its proprietary cannabinoid product platform, announced financial
results for the second quarter and half-year ended 31 March 2016.
“Following positive results in our first Phase 3
trial of Epidiolex in Dravet syndrome, GW is now entering an
exciting new chapter as we start to prepare the Company’s first NDA
submission to the FDA and step up plans for Epidiolex
commercialization,” stated Justin Gover, GW’s Chief Executive
Officer. “The robust data from this first Phase 3 trial in Dravet
syndrome provides additional confidence for future clinical trials
of Epidiolex and we look forward to results from our Phase 3 trials
in Lennox-Gastaut syndrome in the near future. In addition, we
continue to expand our research through exploring further
indications for Epidiolex as well as ongoing Phase 2 clinical
programs for a number of our pipeline candidates.”
RECENT OPERATIONAL
HIGHLIGHTS
- Epidiolex® (CBD) orphan epilepsy program:
- Company sponsored Phase 3 development programs in Dravet
syndrome, Lennox-Gastaut syndrome (LGS) and Tuberous Sclerosis
Complex (TSC)
- Positive results in first Phase 3 Dravet syndrome trial
- Full publication of trial results expected in Q4 2016
- Second Phase 3 Dravet syndrome trial ongoing
- Pre-NDA meeting with FDA requested
- Two LGS Phase 3 trials fully enrolled; Data from first trial
expected in June
- 98% transition rate of eligible patients from pivotal Phase 3
trials to long term open label extension
- Phase 3 TSC trial commenced, Orphan Drug Designation received
from FDA
- Additional clinical development for Epidiolex expected to
commence in H2 2016
- Expanded access program:
- Recent updates at the American Academy of Neurology (AAN)
Annual Meeting showing consistent treatment effect and safety
profile in state-sponsored clinical programs from Alabama and
Georgia
- Over 900 children and young adults authorized for treatment by
FDA under Expanded Access Treatment INDs and 6 U.S. State
programs
- Advanced clinical programs in multiple cannabinoid pipeline
product candidates:
- CBDV Phase 2 partial-onset epilepsy study in adults ongoing.
Part A complete and Part B underway with data expected Q1 2017
- CBDV pre-clinical research ongoing within field of autism
spectrum disorders. Initial clinical evaluation is expected to
commence in H2 2016, with Phase 2 trials expected to commence in Q1
2017
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
Phase 1 clinical program expected to commence in Q4 2016
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
- THCV Phase 2 study in type-2 diabetes completed - data expected
in Q2/3 2016
- THC:CBD Phase 1b/2a study for the treatment of Recurrent
Glioblastoma Multiforme (GBM) fully enrolled with data expected in
Q4 2016
- Orphan Drug Designation granted from FDA and EMA
- Sativex® Phase 2 study in spasticity due to cerebral palsy
ongoing with data expected Q4 2016
- Pre-clinical progress addressing a number of areas of unmet
need including autism spectrum disorders, Duchenne muscular
dystrophy, glioma, ovarian and pancreatic cancers
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at 31 March 2016 of £192.7 million
($276.8 million) compared to £234.9 million as at 30 September
2015
- Revenue for the six months ended 31 March 2016 of £6.3 million
($9.1 million) compared to £14.3 million for the six months ended
31 March 2015. This decrease primarily reflects the expected
reduction in R&D fees associated with the conclusion of partner
funded Sativex Phase 3 cancer pain trials
- Loss for the six months ended 31 March 2016 of £34.5 million
($49.6 million) compared to £10.9 million for the six months ended
31 March 2015
Conference Call and Webcast
Information
GW Pharmaceuticals will host a conference call
and webcast to discuss the second quarter and half-year 2016
financial results today at 9:00 a.m. EDT / 2:00 p.m. BST. To
participate in the conference call, please dial 877-407-8133 (toll
free from the U.S. and Canada) 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 90 days. Replay Numbers: (toll free):1-877-660-6853,
(international):1-201-612-7415. For both dial-in numbers please use
conference ID # 13636232.
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 28 countries outside the United States. GW is
advancing an orphan drug program in the field of childhood epilepsy
with a focus on Epidiolex® (cannabidiol), which is in Phase 3
clinical development for the treatment of Dravet syndrome,
Lennox-Gastaut syndrome and Tuberous Sclerosis Complex. GW has a
deep pipeline of additional cannabinoid product candidates which
includes compounds in Phase 1 and 2 trials for glioma, type 2
diabetes, schizophrenia and epilepsy. For further information,
please visit www.gwpharm.com.
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 herein 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:
| GW Pharmaceuticals plc |
|
| Stephen Schultz, VP Investor Relations |
401 500
6570 |
| |
|
| FTI Consulting (Media Enquiries) |
|
| Ben Atwell / Simon Conway |
+ 44 20
3727 1000 |
|
|
|
|
FleishmanHillard (U.S. Media) |
|
| Paddi
Hurley / Adam Silverstein |
212 453 2382 / 917 697 9313 |
| GW
Pharmaceuticals plc |
| Condensed
consolidated income statement |
| Three months
ended 31 March 2016 |
| |
| |
| |
|
Three months ended |
Three months ended |
Three months ended |
| |
|
31 March |
31 March |
31 March |
| |
|
2016 |
2016 |
2015 |
| |
|
$000’s |
£000’s |
£000’s |
|
Revenue |
|
|
3,805 |
|
|
2,649 |
|
|
6,351 |
|
| Cost of sales |
|
|
(779 |
) |
|
(542 |
) |
|
(645 |
) |
| Research and development
expenditure |
|
|
(36,988 |
) |
|
(25,749 |
) |
|
(15,362 |
) |
| Sales, general and
administrative expenses |
|
|
(4,657 |
) |
|
(3,242 |
) |
|
(3,794 |
) |
| Net foreign exchange
gain |
|
|
6,448 |
|
|
4,488 |
|
|
4,145 |
|
| |
|
_______ |
_______ |
_______ |
| Operating
loss |
|
|
(32,171 |
) |
|
(22,396 |
) |
|
(9,305 |
) |
| Interest income |
|
|
188 |
|
|
131 |
|
|
71 |
|
| Interest expense |
|
|
(23 |
) |
|
(16 |
) |
|
(19 |
) |
| |
|
_______ |
_______ |
_______ |
| Loss before
tax |
|
|
(32,006 |
) |
|
(22,281 |
) |
|
(9,253 |
) |
| Tax benefit |
|
|
7,827 |
|
|
5,449 |
|
|
1,754 |
|
| |
|
_______ |
_______ |
_______ |
| Loss for the
period |
|
|
(24,179 |
) |
|
(16,832 |
) |
|
(7,499 |
) |
|
|
|
_______ |
_______ |
_______ |
|
|
|
|
|
|
| Loss per share –
basic and diluted |
|
(9.2c) |
(6.4p) |
(3.2p) |
| |
| All
activities relate to continuing operations. |
| |
| Condensed
consolidated statement of comprehensive loss |
| For the
three months ended 31 March 2016 |
| |
Three months |
Three months |
| |
ended |
ended |
| |
31 March |
31 March |
| |
2016 |
2015 |
|
|
£000’s |
£000’s |
| Loss for the
period |
|
(16,832 |
) |
|
(7,499 |
) |
|
Items that may be reclassified subsequently to profit or
loss |
|
|
| Exchange differences on
retranslation of foreign operations |
|
(46 |
) |
|
(30 |
) |
|
Other comprehensive loss for the period |
|
(46 |
) |
|
(30 |
) |
|
Total comprehensive loss for the period |
|
(16,878 |
) |
|
(7,529 |
) |
| |
| GW
Pharmaceuticals plc |
| Condensed
consolidated income statement |
| Six months
ended 31 March 2016 |
| |
| |
| |
|
Six months ended |
Six months ended |
Six
months ended |
| |
|
31 March |
31 March |
31 March |
| |
|
2016 |
2016 |
2015 |
| |
|
$000’s |
£000’s |
£000’s |
|
Revenue |
|
|
9,073 |
|
|
6,316 |
|
|
14,317 |
|
| Cost of sales |
|
|
(1,765 |
) |
|
(1,229 |
) |
|
(1,214 |
) |
| Research and development
expenditure |
|
|
(71,664 |
) |
|
(49,888 |
) |
|
(30,487 |
) |
| Sales, general and
administrative expenses |
|
|
(9,864 |
) |
|
(6,867 |
) |
|
(4,597 |
) |
| Net foreign exchange
gain |
|
|
11,618 |
|
|
8,089 |
|
|
8,179 |
|
| |
|
_______ |
_______ |
_______ |
| Operating
loss |
|
|
(62,602 |
) |
|
(43,579 |
) |
|
(13,802 |
) |
| Interest income |
|
|
279 |
|
|
194 |
|
|
114 |
|
| Interest expense |
|
|
(50 |
) |
|
(35 |
) |
|
(39 |
) |
| |
|
_______ |
_______ |
_______ |
| Loss before
tax |
|
|
(62,373 |
) |
|
(43,420 |
) |
|
(13,727 |
) |
| Tax benefit |
|
|
12,765 |
|
|
8,886 |
|
|
2,823 |
|
| |
|
_______ |
_______ |
_______ |
| Loss for the
period |
|
|
(49,608 |
) |
|
(34,534 |
) |
|
(10,904 |
) |
|
|
|
_______ |
_______ |
_______ |
|
|
|
|
|
|
| Loss per share –
basic and diluted |
|
(18.9c) |
(13.2p) |
(4.6p) |
| |
| All
activities relate to continuing operations. |
| |
| Condensed consolidated statement of comprehensive loss |
| For the six months ended 31 March 2016 |
| |
Six months |
Six months |
| |
ended |
ended |
| |
31 March |
31 March |
| |
2016 |
2015 |
|
|
£000’s |
£000’s |
| Loss for the
period |
|
(34,534 |
) |
|
(10,904 |
) |
|
Items that may be reclassified subsequently to profit or
loss |
|
|
| Exchange differences on
retranslation of foreign operations |
|
(99 |
) |
|
(36 |
) |
|
Other comprehensive loss for the period |
|
(99 |
) |
|
(36 |
) |
|
Total comprehensive loss for the period |
|
(34,633 |
) |
|
(10,940 |
) |
| |
| GW
Pharmaceuticals plc |
| Condensed
consolidated statement of changes in equity |
| Six months
ended 31 March 2016 |
| |
| |
|
|
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 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 |
|
| |
_________ |
_________ |
________ |
__________ |
________ |
| |
|
|
|
|
|
| |
|
|
|
|
|
| |
|
|
|
|
|
| Balance at 1
October 2015 |
261 |
349,275 |
|
19,189 |
|
|
(123,455 |
) |
|
245,270 |
|
| Exercise of share
options |
2 |
623 |
|
- |
|
|
- |
|
|
625 |
|
| Share-based payment
transactions |
- |
- |
|
- |
|
|
3,164 |
|
|
3,164 |
|
| Loss for the period |
- |
- |
|
- |
|
|
(34,534 |
) |
|
(34,534 |
) |
| Deferred tax attributable
to unrealized share option gains |
- |
- |
|
- |
|
|
4 |
|
|
4 |
|
| Other comprehensive
loss |
- |
- |
|
(99 |
) |
|
- |
|
|
(99 |
) |
| |
_________ |
_________ |
________ |
__________ |
________ |
| Balance at 31
March 2016 |
263 |
349,898 |
|
19,090 |
|
|
(154,821 |
) |
|
214,430 |
|
|
|
_________ |
_________ |
________ |
__________ |
________ |
| |
| GW
Pharmaceuticals plc |
| Condensed
consolidated balance sheets |
| As at 31
March 2016 |
| |
| |
|
|
|
As at31 March |
As at31 March |
As at30 September |
| |
|
2016 |
2016 |
2015 |
| Non-current
assets |
|
$000’s |
£000’s |
£000’s |
| Intangible assets -
goodwill |
|
|
7,484 |
|
|
5,210 |
|
|
5,210 |
|
| Other intangible
assets |
|
|
418 |
|
|
291 |
|
|
245 |
|
| Property, plant and
equipment |
|
|
49,439 |
|
|
34,416 |
|
|
28,733 |
|
| Deferred tax asset |
|
|
1,006 |
|
|
700 |
|
|
418 |
|
| |
|
_________ |
__________ |
__________ |
| |
|
|
58,347 |
|
|
40,617 |
|
|
34,606 |
|
| |
|
_________ |
__________ |
__________ |
| Current
assets |
|
|
|
|
| Inventories |
|
|
6,698 |
|
|
4,663 |
|
|
4,756 |
|
| Taxation recoverable |
|
|
31,415 |
|
|
21,869 |
|
|
12,641 |
|
| Trade receivables and
other assets |
|
|
4,847 |
|
|
3,374 |
|
|
2,873 |
|
| Cash and cash
equivalents |
|
|
276,791 |
|
|
192,684 |
|
|
234,872 |
|
| |
|
_________ |
__________ |
__________ |
|
|
|
|
319,751 |
|
|
222,590 |
|
|
255,142 |
|
|
|
|
_________ |
__________ |
__________ |
| Total
assets |
|
|
378,098 |
|
|
263,207 |
|
|
289,748 |
|
| |
|
_________ |
__________ |
__________ |
| Current
liabilities |
|
|
|
|
| Trade and other
payables |
|
|
(42,569 |
) |
|
(29,633 |
) |
|
(24,022 |
) |
| Current tax
liabilities |
|
|
(122 |
) |
|
(85 |
) |
|
(366 |
) |
| Obligations under finance
leases |
|
|
(164 |
) |
|
(114 |
) |
|
(111 |
) |
| Deferred revenue |
|
|
(3,792 |
) |
|
(2,640 |
) |
|
(3,269 |
) |
| |
|
_________ |
__________ |
__________ |
|
|
|
|
(46,647 |
) |
|
(32,472 |
) |
|
(27,768 |
) |
| |
|
|
|
|
| Non-current
liabilities |
|
|
|
|
| Trade and other
payables |
|
|
(12,462 |
) |
|
(8,675 |
) |
|
(8,445 |
) |
| Obligations under finance
leases |
|
|
(2,130 |
) |
|
(1,483 |
) |
|
(1,540 |
) |
| Deferred revenue |
|
|
(8,830 |
) |
|
(6,147 |
) |
|
(6,725 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
liabilities |
|
|
(70,069 |
) |
|
(48,777 |
) |
|
(44,478 |
) |
| |
|
_________ |
__________ |
__________ |
| Net
assets |
|
|
308,029 |
|
|
214,430 |
|
|
245,270 |
|
|
|
|
_________ |
__________ |
__________ |
| |
|
|
|
|
|
Equity |
|
|
|
|
| Share capital |
|
|
378 |
|
|
263 |
|
|
261 |
|
| Share premium account |
|
|
502,628 |
|
|
349,898 |
|
|
349,275 |
|
| Other reserves |
|
|
27,423 |
|
|
19,090 |
|
|
19,189 |
|
| Accumulated
deficit |
|
|
(222,400 |
) |
|
(154,821 |
) |
|
(123,455 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
equity |
|
308,029 |
214,430 |
245,270 |
| |
|
_________ |
__________ |
__________ |
| |
| GW Pharmaceuticals
plc |
| Condensed consolidated
cash flow statements |
| For the six months ended
31 March 2016 |
| |
| |
|
|
Six months ended |
Six months ended |
Six months ended |
|
|
31 March |
31 March |
31 March |
|
|
2016 |
2016 |
2015 |
|
|
$000’s |
£000’s |
£000’s |
|
Loss for the period |
|
(49,608 |
) |
|
(34,534 |
) |
|
(10,904 |
) |
|
Adjustments for: |
|
|
|
|
Interest income |
|
(279 |
) |
|
(194 |
) |
|
(114 |
) |
|
Interest expense |
|
50 |
|
|
35 |
|
|
39 |
|
| Tax
benefit |
|
(12,765 |
) |
|
(8,886 |
) |
|
(2,823 |
) |
|
Depreciation of property, plant and equipment |
|
2,212 |
|
|
1,540 |
|
|
1,016 |
|
|
Amortisation of intangible assets |
|
39 |
|
|
27 |
|
|
2 |
|
| Net
foreign exchange gains |
|
(12,034 |
) |
|
(8,377 |
) |
|
(8,265 |
) |
|
(Decrease)/increase in provision for inventories |
|
(66 |
) |
|
(45 |
) |
|
13 |
|
|
Loss on disposal of property, plant and equipment |
|
- |
|
|
- |
|
|
1 |
|
|
Share-based payment charge |
|
4,545 |
|
|
3,164 |
|
|
806 |
|
|
|
__________ |
__________ |
__________ |
|
|
|
(67,906 |
) |
|
(47,270 |
) |
|
(20,229 |
) |
|
Decrease in inventories |
|
200 |
|
|
138 |
|
|
289 |
|
|
Increase in trade receivables and other assets |
|
(715 |
) |
|
(498 |
) |
|
(904 |
) |
|
Increase in trade and other payables and deferred revenue |
|
3,086 |
|
|
2,148 |
|
|
1,106 |
|
|
|
__________ |
__________ |
__________ |
|
Cash used in operations |
|
(65,335 |
) |
|
(45,482 |
) |
|
(19,738 |
) |
|
Income taxes paid |
|
(1,284 |
) |
|
(894 |
) |
|
- |
|
|
Research and development tax credits received |
|
- |
|
|
- |
|
|
5,415 |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from operating activities |
|
(66,619 |
) |
|
(46,376 |
) |
|
(14,323 |
) |
|
|
__________ |
__________ |
__________ |
|
Investing activities |
|
|
|
|
Interest received |
|
267 |
|
|
186 |
|
|
113 |
|
|
Purchases of property, plant and equipment |
|
(6,687 |
) |
|
(4,655 |
) |
|
(10,165 |
) |
|
Purchases of intangible assets |
|
(214 |
) |
|
(149 |
) |
|
(59 |
) |
|
Proceeds from sales of property, plant and equipment |
|
- |
|
|
- |
|
|
1 |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from investing activities |
|
(6,634 |
) |
|
(4,618 |
) |
|
(10,110 |
) |
|
|
__________ |
__________ |
__________ |
|
Financing activities |
|
|
|
|
Proceeds on exercise of share options |
|
898 |
|
|
625 |
|
|
379 |
|
|
Proceeds of new equity issue |
|
- |
|
|
- |
|
|
59 |
|
|
Interest paid |
|
(50 |
) |
|
(35 |
) |
|
(44 |
) |
|
Repayment of obligations under finance leases |
|
(79 |
) |
|
(55 |
) |
|
(55 |
) |
|
|
__________ |
__________ |
__________ |
|
Net cash inflow from financing activities |
|
769 |
|
|
535 |
|
|
339 |
|
|
|
__________ |
__________ |
__________ |
|
Effect of foreign exchange rate changes on cash and cash
equivalents |
|
11,881 |
|
|
8,271 |
|
|
8,235 |
|
|
|
__________ |
__________ |
__________ |
|
Net decrease in cash and cash equivalents |
|
(60,603 |
) |
|
(42,188 |
) |
|
(15,859 |
) |
|
Cash and cash equivalents at beginning of the period |
|
337,394 |
|
|
234,872 |
|
|
164,491 |
|
|
|
__________ |
__________ |
__________ |
|
Cash and cash equivalents at end of the
period |
276,791 |
192,684 |
148,632 |
|
|
__________ |
__________ |
__________ |
GW Pharmaceuticals (NASDAQ:GWPH)
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From Aug 2024 to Sep 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Sep 2023 to Sep 2024
