GW Pharmaceuticals plc Reports First Quarter 2016 Financial Results and Operational Progress
February 10 2016 - 7:00AM
-Three Phase 3 Epidiolex clinical trials
fully recruited above target sample size – on track for initial
data in March 2016-
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, announces financial
results for the first quarter ended 31 December 2015.
“We are on track to report topline data from
four Epidiolex Phase 3 trials in the months ahead and remain very
excited at the transformational potential of these data for GW. The
treatment effect data from our expanded access program provide a
solid basis for confidence in the outcome of these trials and the
potential for Epidiolex to make a meaningful difference to the
lives of patients with Dravet syndrome and Lennox-Gastaut
syndrome,” stated Justin Gover, GW’s Chief Executive Officer. “We
are looking forward to an active 2016, that, in addition to the
Epidiolex Phase 3 data, is expected to include our first NDA
filing, expansion of our U.S. commercial organization, and ongoing
data read-outs from a number of clinical pipeline programs.”
RECENT OPERATIONAL
HIGHLIGHTS
- Epidiolex® (CBD) childhood epilepsy program:
- Company sponsored Phase 3 development programs in Dravet
syndrome and Lennox-Gastaut syndrome (LGS)
- First Phase 3 Dravet syndrome trial fully enrolled above
original target sample size (120 randomized), data expected March
2016
- Second Phase 3 Dravet syndrome trial ongoing, data expected H2
2016
- Both LGS Phase 3 trials fully enrolled above original target
sample sizes (171 for 2-arm, 225 for 3-arm randomized), data
expected Q2 2016
- 97% transition rate of eligible patients from Phase 3 trials to
long term open label extension
- NDA submission with FDA expected Q4 2016
- Phase 3 Tuberous Sclerosis Complex trial due to commence Q1
2016
- Additional clinical development for Epidiolex expected to
commence in H2 2016
- Expanded access program
- Recent data update at the American Epilepsy Society December
2015 Annual Meeting showing promising safety and effectiveness
consistent with prior updates
- Over 375 children and young adults on treatment at 22 U.S.
clinical sites
- 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:
- THCV Phase 2 study in type-2 diabetes data expected Q2
2016
- THC:CBD Phase 1b/2a study for the treatment of Recurrent
Glioblastoma Multiforme (GBM) fully enrolled with data expected in
mid-2016
- Orphan Drug Designation granted from FDA and EMA
- Sativex® Phase 2 study in spasticity due to cerebral palsy
ongoing with data expected H2 2016
- CBDV Phase 2 partial-onset epilepsy study in adults ongoing.
Part A complete and Part B underway with data expected around the
end of 2016
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
Phase 1 clinical program expected to commence in H2 2016
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
- Clinical trials within the field of autism spectrum disorders
expected to commence in H2 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
- Revenue for the three months ended 31 December 2015 of £3.7
million ($5.4 million) compared to £8.0 million for the three
months ended 31 December 2014
- Loss for the three months ended 31 December 2015 of £17.7
million ($26.2 million) compared to £3.4 million for the three
months ended 31 December 2014
- Cash and cash equivalents at 31 December 2015 of £219.3 million
($324.1 million) compared to £234.9 million as at 30 September
2015
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the first quarter 2016 financial results
today at 8:00 a.m. EST / 1:00 p.m. GMT. 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 90 days. Replay Numbers: (toll
free):1-877-660-6853, (international):1-201-612-7415. For both
dial-in numbers please use conference ID # 13629628.
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 and
Lennox-Gastaut syndrome and which is also expected to enter Phase 3
clinical trials in the treatment of 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 |
GW Pharmaceuticals plcCondensed consolidated income
statementThree months ended 31 December 2015 and 2014
| |
|
Three months ended |
Three months ended |
Three months ended |
| |
|
31 December |
31 December |
31 December |
| |
Notes |
|
2015 |
|
2015 |
|
2014 |
| |
|
$000’s |
£000’s |
£000’s |
|
Revenue |
2 |
|
5,418 |
|
|
3,667 |
|
|
7,965 |
|
| Cost of sales |
|
|
(1,015 |
) |
|
(687 |
) |
|
(569 |
) |
| Research and development
expenditure |
3 |
|
(35,668 |
) |
|
(24,139 |
) |
|
(15,126 |
) |
| Sales, general and
administrative expenses |
|
|
(5,356 |
) |
|
(3,625 |
) |
|
(802 |
) |
| Net foreign exchange
gain |
|
|
5,321 |
|
|
3,601 |
|
|
4,034 |
|
| |
|
_______ |
_______ |
_______ |
| Operating
loss |
|
|
(31,300 |
) |
|
(21,183 |
) |
|
(4,498 |
) |
| Interest income |
|
|
93 |
|
|
63 |
|
|
44 |
|
| Interest expense |
|
|
(28 |
) |
|
(19 |
) |
|
(20 |
) |
| |
|
_______ |
_______ |
_______ |
| Loss before
tax |
|
|
(31,235 |
) |
|
(21,139 |
) |
|
(4,474 |
) |
| Tax benefit |
4 |
|
5,079 |
|
|
3,437 |
|
|
1,068 |
|
| |
|
_______ |
_______ |
_______ |
| Loss for the
period |
|
|
(26,156 |
) |
|
(17,702 |
) |
|
(3,406 |
) |
|
|
|
_______ |
_______ |
_______ |
|
|
|
|
|
|
| Loss per share –
basic and diluted |
5 |
(10.0c) |
(6.8p) |
(1.4p) |
All activities relate to continuing
operations.
Condensed consolidated statement of comprehensive loss
For
the three months ended 31 December 2015 and 2014
|
|
Three months ended 31
December2015 £000’s |
Three months ended31 December 2014 £000’s |
| Loss for the
period |
|
(17,702 |
) |
|
(3,406 |
) |
|
Items that may be reclassified subsequently to profit or
loss |
|
|
| Exchange differences on
retranslation of foreign operations |
|
(53 |
) |
|
(6 |
) |
|
Other comprehensive loss for the period |
|
(53 |
) |
|
(6 |
) |
|
Total comprehensive loss for the period |
|
(17,755 |
) |
|
(3,412 |
) |
GW Pharmaceuticals plcCondensed consolidated statement of
changes in equityThree months ended 31 December 2015 and 2014
|
|
|
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 |
- |
62 |
|
- |
|
|
- |
|
|
62 |
|
| Share-based payment
transactions |
- |
- |
|
- |
|
|
269 |
|
|
269 |
|
| Loss for the period |
- |
- |
|
- |
|
|
(3,406 |
) |
|
(3,406 |
) |
| Other comprehensive
loss |
- |
- |
|
(6 |
) |
|
- |
|
|
(6 |
) |
| |
_________ |
_________ |
________ |
__________ |
________ |
| Balance at 31
December 2014 |
237 |
220,672 |
|
19,254 |
|
|
(84,601 |
) |
|
155,562 |
|
| |
_________ |
_________ |
________ |
__________ |
________ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
| Balance at 1
October 2015 |
261 |
349,275 |
|
19,189 |
|
|
(123,455 |
) |
|
245,270 |
|
| Exercise of share
options |
2 |
562 |
|
- |
|
|
- |
|
|
564 |
|
| Share-based payment
transactions |
- |
- |
|
- |
|
|
1,306 |
|
|
1,306 |
|
| Loss for the period |
- |
- |
|
- |
|
|
(17,702 |
) |
|
(17,702 |
) |
| Deferred tax attributable
to unrealized share option gains |
- |
- |
|
- |
|
|
(74 |
) |
|
(74 |
) |
| Other comprehensive
loss |
- |
- |
|
(53 |
) |
|
- |
|
|
(53 |
) |
| |
_________ |
_________ |
________ |
__________ |
________ |
| Balance at 31
December 2015 |
263 |
349,837 |
|
19,136 |
|
|
(139,925 |
) |
|
229,311 |
|
|
|
_________ |
_________ |
________ |
__________ |
________ |
GW Pharmaceuticals plcCondensed consolidated balance sheetsAs at
31 December 2015 and 30 September 2015
|
|
|
As at31 December |
As at31 December |
As at30 September |
| |
|
|
2015 |
|
2015 |
|
2015 |
| |
|
|
|
|
| Non-current
assets |
|
$000’s |
£000’s |
£000’s |
| Intangible assets -
goodwill |
|
|
7,698 |
|
|
5,210 |
|
|
5,210 |
|
| Other intangible
assets |
|
|
408 |
|
|
276 |
|
|
245 |
|
| Property, plant and
equipment |
|
|
46,469 |
|
|
31,449 |
|
|
28,733 |
|
| Deferred tax asset |
|
|
572 |
|
|
387 |
|
|
418 |
|
| |
|
_________ |
__________ |
__________ |
| |
|
|
55,147 |
|
|
37,322 |
|
|
34,606 |
|
| |
|
_________ |
__________ |
__________ |
| Current
assets |
|
|
|
|
| Inventories |
|
|
6,934 |
|
|
4,693 |
|
|
4,756 |
|
| Taxation recoverable |
|
|
24,056 |
|
|
16,281 |
|
|
12,641 |
|
| Trade receivables and
other assets |
|
|
7,793 |
|
|
5,274 |
|
|
2,873 |
|
| Cash and cash
equivalents |
|
|
324,057 |
|
|
219,313 |
|
|
234,872 |
|
| |
|
_________ |
__________ |
__________ |
|
|
|
|
362,840 |
|
|
245,561 |
|
|
255,142 |
|
|
|
|
_________ |
__________ |
__________ |
| Total
assets |
|
|
417,987 |
|
|
282,883 |
|
|
289,748 |
|
| |
|
_________ |
__________ |
__________ |
| Current
liabilities |
|
|
|
|
| Trade and other
payables |
|
|
(48,561 |
) |
|
(32,865 |
) |
|
(24,022 |
) |
| Current tax
liabilities |
|
|
(359 |
) |
|
(243 |
) |
|
(366 |
) |
| Obligations under finance
leases |
|
|
(167 |
) |
|
(113 |
) |
|
(111 |
) |
| Deferred revenue |
|
|
(5,706 |
) |
|
(3,862 |
) |
|
(3,269 |
) |
| |
|
_________ |
__________ |
__________ |
|
|
|
|
(54,793 |
) |
|
(37,083 |
) |
|
(27,768 |
) |
| |
|
|
|
|
| Non-current
liabilities |
|
|
|
|
| Trade and other
payables |
|
|
(12,620 |
) |
|
(8,541 |
) |
|
(8,445 |
) |
| Obligations under finance
leases |
|
|
(2,234 |
) |
|
(1,512 |
) |
|
(1,540 |
) |
| Deferred revenue |
|
|
(9,510 |
) |
|
(6,436 |
) |
|
(6,725 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
liabilities |
|
|
(79,157 |
) |
|
(53,572 |
) |
|
(44,478 |
) |
| |
|
_________ |
__________ |
__________ |
| Net
assets |
|
|
338,830 |
|
|
229,311 |
|
|
245,270 |
|
|
|
|
_________ |
__________ |
__________ |
| |
|
|
|
|
|
Equity |
|
|
|
|
| Share capital |
|
|
389 |
|
|
263 |
|
|
261 |
|
| Share premium account |
|
|
516,919 |
|
|
349,837 |
|
|
349,275 |
|
| Other reserves |
|
|
28,275 |
|
|
19,136 |
|
|
19,189 |
|
| Accumulated
deficit |
|
|
(206,753 |
) |
|
(139,925 |
) |
|
(123,455 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
equity |
|
338,830 |
229,311 |
245,270 |
| |
|
_________ |
_________ |
_________ |
| |
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated cash flow
statementsFor the three months ended 31 December 2015 and 2014
|
|
Three months ended |
Three months ended |
Three months ended |
|
|
31 December |
31 December |
31 December |
|
|
|
2015 |
|
2015 |
|
2014 |
|
|
$000’s |
£000’s |
£000’s |
|
Loss for the period |
|
(26,156 |
) |
|
(17,702 |
) |
|
(3,406 |
) |
|
Adjustments for:Interest incomeInterest expenseTax benefit |
(93)28(5,079) |
(63)19(3,437) |
(44)20(1,068) |
|
Depreciation of property, plant and equipmentAmortization of
intangible assetsNet foreign exchange gainsIncrease/(decrease) in
provision for inventories |
1,08821(5,559)10 |
73614(3,762)7 |
492-(4,068)(29) |
|
Share-based payment charge |
|
1,930 |
|
|
1,306 |
|
|
269 |
|
|
|
__________ |
__________ |
__________ |
|
|
|
(33,810 |
) |
|
(22,882 |
) |
|
(7,834 |
) |
|
Decrease in inventories |
|
83 |
|
|
56 |
|
|
157 |
|
|
Increase in trade receivables and other assets |
|
(3,548 |
) |
|
(2,401 |
) |
|
(192 |
) |
|
Increase in trade and other payables and deferred revenue |
|
11,292 |
|
|
7,642 |
|
|
1,689 |
|
|
Income taxes paid |
|
(541 |
) |
|
(366 |
) |
|
- |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from operating activities |
|
(26,524 |
) |
|
(17,951 |
) |
|
(6,180 |
) |
|
|
__________ |
__________ |
__________ |
|
Investing activities |
|
|
|
|
Interest received |
|
103 |
|
|
70 |
|
|
42 |
|
|
Purchases of property, plant and equipment |
|
(2,633 |
) |
|
(1,782 |
) |
|
(5,897 |
) |
|
Purchases of intangible assets |
|
(176 |
) |
|
(119 |
) |
|
- |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from investing activities |
|
(2,706 |
) |
|
(1,831 |
) |
|
(5,855 |
) |
|
|
__________ |
__________ |
__________ |
|
Financing activities |
|
|
|
|
Proceeds on exercise of share options |
|
833 |
|
|
564 |
|
|
62 |
|
|
Proceeds of new equity issue |
|
- |
|
|
- |
|
|
59 |
|
|
Interest paid |
|
(30 |
) |
|
(20 |
) |
|
(23 |
) |
|
Repayments of obligations under finance leases |
|
(38 |
) |
|
(26 |
) |
|
(28 |
) |
|
|
__________ |
__________ |
__________ |
|
Net cash inflow from financing activities |
|
765 |
|
|
518 |
|
|
70 |
|
|
|
__________ |
__________ |
__________ |
|
Effect of foreign exchange rate changes on cash and cash
equivalents |
|
5,475 |
|
|
3,705 |
|
|
4,068 |
|
|
|
__________ |
__________ |
__________ |
|
Net decrease in cash and cash equivalents |
|
(22,990 |
) |
|
(15,559 |
) |
|
(7,897 |
) |
|
Cash and cash equivalents at beginning of the period |
|
347,047 |
|
|
234,872 |
|
|
164,491 |
|
|
|
__________ |
__________ |
__________ |
|
Cash and cash equivalents at end of the
period |
324,057 |
219,313 |
156,594 |
|
|
__________ |
__________ |
__________ |
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