GW Pharmaceuticals plc Reports Third Quarter 2016 Financial Results and Operational Progress
August 09 2016 - 7:00AM
- Positive Phase 3 Epidiolex pivotal
trial in Lennox-Gastaut Syndrome (LGS) - -
Positive FDA pre-NDA meeting - NDA for Dravet syndrome and LGS on
track for H1 2017 submission -
-Conference
call today at 8:30 a.m. EDT, 1:30 p.m. BST -
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, announced financial
results for the third quarter ended 30 June 2016.
“We have now reported two positive Phase 3
trials for Epidiolex and are on track for an NDA filing that
includes both the Dravet syndrome and Lennox-Gastaut Syndrome
indications. We believe that these Phase 3 data show that Epidiolex
has the potential to provide a robust and clinically meaningful
reduction in seizures in these highly treatment-resistant
populations together with an acceptable safety and tolerability
profile,” stated Justin Gover, GW’s Chief Executive Officer. “Our
recent successful financing has provided GW with the necessary
capital to move forward with confidence in preparing to execute a
highly successful launch.”
RECENT OPERATIONAL
HIGHLIGHTS
- Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome,
Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and
infantile spasms (IS)
- Phase 3 development programs:
- Positive results in first Phase 3 Dravet syndrome trial
- Positive results in first Phase 3 LGS trial
- Data presentations expected at upcoming American Epilepsy
Society Annual Meeting in December
- Positive Dravet syndrome Pre-NDA meeting held with FDA
- NDA on track for H1 2017 submission for both Dravet and LGS
indications
- Data from second LGS trial expected at end of Q3
- Second Phase 3 Dravet syndrome trial ongoing
- Phase 3 trial in TSC ongoing
- Phase 3 trial in IS to commence in Q4 2016
- Expanded access program and open label extension:
- Over 1,000 patients now on Epidiolex treatment under Expanded
Access Treatment INDs, U.S. State programs, and open label
extension trial
- 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 H1 2017
- CBDV pre-clinical research ongoing within field of autism
spectrum disorders. Initial open-label clinical evaluation expected
to commence in H2 2016, with Phase 2 trials expected to commence in
H1 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
- THC:CBD Phase 1b/2a study for the treatment of Recurrent
Glioblastoma Multiforme (GBM) fully enrolled with data expected in
Q4 2016
- Sativex® Phase 2 study in children with spasticity due to
cerebral palsy fully enrolled with data expected Q4 2016
- THCV Phase 2 study in type 2 diabetes completed, primary
endpoint not achieved
FINANCIAL HIGHLIGHTS
- Loss for the nine months ended 30 June 2016 of £46.7 million
($62.2 million) compared to £32.3 million for the nine months ended
30 June 2015. This increased loss primarily reflects investment in
the Epidiolex Phase 3 pivotal trials program.
- Cash and cash equivalents at 30 June 2016 of £191.2 million
($254.3 million) compared to £234.9 million as at 30 September
2015. Subsequently in July 2016 a follow-on offering raised total
net proceeds after expenses of $273.1 million (£206.4
million).
Conference Call and Webcast
Information
GW Pharmaceuticals will host a conference call
and webcast to discuss the third quarter 2016 financial results
today at 8:30 a.m. EDT / 1:30 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 # 13642862.
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,
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 plcCondensed consolidated income
statementThree months ended 30 June 2016
| |
|
30 June |
30 June |
30 June |
| |
Notes |
|
2016 |
|
2016 |
|
2015 |
| |
|
$000’s |
£000’s |
£000’s |
|
Revenue |
2 |
|
3,097 |
|
|
2,329 |
|
|
8,629 |
|
| Cost of sales |
|
|
(946 |
) |
|
(711 |
) |
|
(721 |
) |
| Research and development
expenditure |
3 |
|
(34,058 |
) |
|
(25,609 |
) |
|
(20,841 |
) |
| Sales, general and
administrative expenses |
|
|
(7,452 |
) |
|
(5,603 |
) |
|
(2,984 |
) |
| Net foreign exchange
gain/(loss) |
|
|
14,883 |
|
|
11,190 |
|
|
(8,851 |
) |
| |
|
_______ |
_______ |
_______ |
| Operating
loss |
|
|
(24,476 |
) |
|
(18,404 |
) |
|
(24,768 |
) |
| Interest income |
|
|
130 |
|
|
98 |
|
|
46 |
|
| Interest expense |
|
|
(24 |
) |
|
(18 |
) |
|
(21 |
) |
| |
|
_______ |
_______ |
_______ |
| Loss before
tax |
|
|
(24,370 |
) |
|
(18,324 |
) |
|
(24,743 |
) |
| Tax benefit |
4 |
|
8,125 |
|
|
6,109 |
|
|
3,318 |
|
| |
|
_______ |
_______ |
_______ |
| Loss for the
period |
|
|
(16,245 |
) |
|
(12,215 |
) |
|
(21,425 |
) |
|
|
|
_______ |
_______ |
_______ |
|
|
|
|
|
|
| Loss per share –
basic and diluted |
5 |
(6.1c) |
(4.6p) |
(8.5p) |
All activities relate to continuing
operations.
Condensed consolidated statement of comprehensive
loss
For the three months ended 30 June 2016
|
|
30
June2016£000’s |
30 June2015£000’s |
| Loss for the
period |
|
(12,215 |
) |
|
(21,425 |
) |
|
Items that may be reclassified subsequently to profit or
loss |
|
|
| Exchange gain on
retranslation of foreign operations |
|
266 |
|
|
16 |
|
|
Other comprehensive gain for the period |
|
266 |
|
|
16 |
|
|
Total comprehensive loss for the period |
|
(11,949 |
) |
|
(21,409 |
) |
| |
|
|
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated income
statementNine months ended 30 June 2016
| |
|
30 June |
30 June |
30 June |
| |
Notes |
|
2016 |
|
2016 |
|
2015 |
| |
|
$000’s |
£000’s |
£000’s |
|
Revenue |
2 |
|
11,497 |
|
|
8,645 |
|
|
22,945 |
|
| Cost of sales |
|
|
(2,580 |
) |
|
(1,940 |
) |
|
(1,935 |
) |
| Research and development
expenditure |
3 |
|
(100,406 |
) |
|
(75,497 |
) |
|
(51,328 |
) |
| Sales, general and
administrative expenses |
|
|
(16,584 |
) |
|
(12,470 |
) |
|
(7,581 |
) |
| Net foreign exchange
gain/(loss) |
|
|
25,640 |
|
|
19,279 |
|
|
(672 |
) |
| |
|
_______ |
_______ |
_______ |
| Operating
loss |
|
|
(82,433 |
) |
|
(61,983 |
) |
|
(38,571 |
) |
| Interest income |
|
|
388 |
|
|
292 |
|
|
161 |
|
| Interest expense |
|
|
(70 |
) |
|
(53 |
) |
|
(60 |
) |
| |
|
_______ |
_______ |
_______ |
| Loss before
tax |
|
|
(82,115 |
) |
|
(61,744 |
) |
|
(38,470 |
) |
| Tax benefit |
4 |
|
19,942 |
|
|
14,995 |
|
|
6,140 |
|
| |
|
_______ |
_______ |
_______ |
| Loss for the
period |
|
|
(62,173 |
) |
|
(46,749 |
) |
|
(32,330 |
) |
|
|
|
_______ |
_______ |
_______ |
|
|
|
|
|
|
| Loss per share –
basic and diluted |
5 |
(23.7c) |
(17.8p) |
(13.4p) |
All activities relate to continuing
operations.
Condensed consolidated statement of comprehensive
loss
For the nine months ended 30 June 2016
|
|
30
June2016£000’s |
30 June2015£000’s |
| Loss for the
period |
|
(46,749 |
) |
|
(32,330 |
) |
|
Items that may be reclassified subsequently to profit or
loss |
|
|
| Exchange gain/(loss) on
retranslation of foreign operations |
|
166 |
|
|
(20 |
) |
|
Other comprehensive gain/(loss) for the
period |
|
166 |
|
|
(20 |
) |
|
Total comprehensive loss for the period |
|
(46,583 |
) |
|
(32,350 |
) |
| |
|
|
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated statement of
changes in equityNine months ended 30 June 2016
|
|
|
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 |
22 |
|
127,812 |
|
|
- |
|
|
- |
|
|
127,834 |
|
| Expense of new equity
issue |
- |
|
(307 |
) |
|
- |
|
|
- |
|
|
(307 |
) |
| Exercise of share
options |
2 |
|
1,139 |
|
|
- |
|
|
- |
|
|
1,141 |
|
| Share-based payment
transactions |
- |
|
- |
|
|
- |
|
|
1,161 |
|
|
1,161 |
|
| Loss for the period |
- |
|
- |
|
|
- |
|
|
(32,330 |
) |
|
(32,330 |
) |
| Other comprehensive
loss |
- |
|
- |
|
|
(20 |
) |
|
- |
|
|
(20 |
) |
| |
_________ |
_________ |
________ |
__________ |
________ |
| Balance at 30 June
2015 |
261 |
|
349,195 |
|
|
19,240 |
|
|
(112,633 |
) |
|
256,063 |
|
| |
_________ |
_________ |
________ |
__________ |
________ |
| |
|
|
|
|
|
| |
|
|
|
|
|
| |
|
|
|
|
|
| Balance at 1
October 2015 |
261 |
|
349,275 |
|
|
19,189 |
|
|
(123,455 |
) |
|
245,270 |
|
| Exercise of share
options |
2 |
|
633 |
|
|
- |
|
|
- |
|
|
635 |
|
| Share-based payment
transactions |
- |
|
- |
|
|
- |
|
|
5,900 |
|
|
5,900 |
|
| Loss for the period |
- |
|
- |
|
|
- |
|
|
(46,749 |
) |
|
(46,749 |
) |
| Deferred tax attributable
to unrealized share option gains |
- |
|
- |
|
|
- |
|
|
366 |
|
|
366 |
|
| Other comprehensive
gain |
- |
|
- |
|
|
166 |
|
|
- |
|
|
166 |
|
| |
_________ |
_________ |
________ |
__________ |
________ |
| Balance at 30 June
2016 |
263 |
|
349,908 |
|
|
19,355 |
|
|
(163,938 |
) |
|
205,588 |
|
|
|
_________ |
_________ |
________ |
__________ |
________ |
| |
|
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated balance sheetsAs at
30 June 2016
|
|
|
As at30 June |
As at30 June |
As at30 September |
| |
Notes |
|
2016 |
|
2016 |
|
2015 |
| Non-current
assets |
|
$000’s |
£000’s |
£000’s |
| Goodwill |
|
|
6,929 |
|
|
5,210 |
|
|
5,210 |
|
| Other intangible
assets |
|
|
749 |
|
|
563 |
|
|
245 |
|
| Property, plant and
equipment |
|
|
51,266 |
|
|
38,548 |
|
|
28,733 |
|
| Deferred tax asset |
|
|
2,506 |
|
|
1,884 |
|
|
418 |
|
| |
|
_________ |
__________ |
__________ |
| |
|
|
61,450 |
|
|
46,205 |
|
|
34,606 |
|
| |
|
_________ |
__________ |
__________ |
| Current
assets |
|
|
|
|
| Inventories |
6 |
|
5,955 |
|
|
4,478 |
|
|
4,756 |
|
| Taxation recoverable |
|
|
18,912 |
|
|
14,220 |
|
|
12,641 |
|
| Trade receivables and
other assets |
7 |
|
5,204 |
|
|
3,913 |
|
|
2,873 |
|
| Cash and cash
equivalents |
|
|
254,252 |
|
|
191,177 |
|
|
234,872 |
|
| |
|
_________ |
__________ |
__________ |
|
|
|
|
284,323 |
|
|
213,788 |
|
|
255,142 |
|
|
|
|
_________ |
__________ |
__________ |
| Total
assets |
|
|
345,773 |
|
|
259,993 |
|
|
289,748 |
|
| |
|
_________ |
__________ |
__________ |
| Current
liabilities |
|
|
|
|
| Trade and other
payables |
8 |
|
(43,514 |
) |
|
(32,719 |
) |
|
(24,022 |
) |
| Current tax
liabilities |
|
|
- |
|
|
- |
|
|
(366 |
) |
| Obligations under finance
leases |
10 |
|
(153 |
) |
|
(115 |
) |
|
(111 |
) |
| Deferred revenue |
9 |
|
(3,028 |
) |
|
(2,277 |
) |
|
(3,269 |
) |
| |
|
_________ |
__________ |
__________ |
|
|
|
|
(46,695 |
) |
|
(35,111 |
) |
|
(27,768 |
) |
| |
|
|
|
|
| Non-current
liabilities |
|
|
|
|
| Trade and other
payables |
8 |
|
(11,211 |
) |
|
(8,430 |
) |
|
(8,445 |
) |
| Obligations under finance
leases |
10 |
|
(6,658 |
) |
|
(5,006 |
) |
|
(1,540 |
) |
| Deferred revenue |
9 |
|
(7,791 |
) |
|
(5,858 |
) |
|
(6,725 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
liabilities |
|
|
(72,355 |
) |
|
(54,405 |
) |
|
(44,478 |
) |
| |
|
_________ |
__________ |
__________ |
| Net
assets |
|
|
273,418 |
|
|
205,588 |
|
|
245,270 |
|
|
|
|
_________ |
__________ |
__________ |
| |
|
|
|
|
|
Equity |
|
|
|
|
| Share capital |
|
|
350 |
|
|
263 |
|
|
261 |
|
| Share premium account |
|
|
465,353 |
|
|
349,908 |
|
|
349,275 |
|
| Other reserves |
|
|
25,741 |
|
|
19,355 |
|
|
19,189 |
|
| Accumulated
deficit |
|
|
(218,026 |
) |
|
(163,938 |
) |
|
(123,455 |
) |
| |
|
_________ |
__________ |
__________ |
| Total
equity |
|
|
273,418 |
|
|
205,588 |
|
|
245,270 |
|
| |
|
_________ |
__________ |
__________ |
GW Pharmaceuticals plcCondensed consolidated cash flow
statementsFor the nine months ended 30 June 2016
|
|
Nine months ended |
Nine months ended |
Nine months ended |
|
|
30 June |
30 June |
30 June |
|
|
|
2016 |
|
2016 |
|
2015 |
|
|
$000’s |
£000’s |
£000’s |
|
Loss for the period |
|
(62,173 |
) |
|
(46,749 |
) |
|
(32,330 |
) |
|
Adjustments for: |
|
|
|
|
Interest income |
|
(388 |
) |
|
(292 |
) |
|
(161 |
) |
|
Interest expense |
|
70 |
|
|
53 |
|
|
60 |
|
| Tax
benefit |
|
(19,942 |
) |
|
(14,995 |
) |
|
(6,140 |
) |
|
Depreciation of property, plant and equipment |
|
3,359 |
|
|
2,526 |
|
|
1,670 |
|
|
Amortization of intangible assets |
|
56 |
|
|
42 |
|
|
2 |
|
| Net
foreign exchange (gains)/losses |
|
(25,777 |
) |
|
(19,382 |
) |
|
672 |
|
|
(Decrease)/increase in provision for inventories |
|
(60 |
) |
|
(45 |
) |
|
13 |
|
|
Profit on disposal of property, plant and equipment |
|
- |
|
|
- |
|
|
(1 |
) |
|
Share-based payment charge |
|
7,847 |
|
|
5,900 |
|
|
1,166 |
|
|
|
__________ |
__________ |
__________ |
|
|
|
(97,008 |
) |
|
(72,942 |
) |
|
(35,049 |
) |
|
Decrease in inventories |
|
430 |
|
|
323 |
|
|
- |
|
|
Decrease/(Increase) in trade receivables and other assets |
|
76 |
|
|
57 |
|
|
(171 |
) |
|
Increase in trade and other payables and deferred revenue |
|
4,354 |
|
|
3,274 |
|
|
5,715 |
|
|
|
__________ |
__________ |
__________ |
|
Cash used in operations |
|
(92,148 |
) |
|
(69,288 |
) |
|
(29,505 |
) |
|
Income taxes paid |
|
(1,529 |
) |
|
(1,150 |
) |
|
- |
|
|
Research and development tax credits received |
|
17,663 |
|
|
13,281 |
|
|
5,415 |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from operating activities |
|
(76,014 |
) |
|
(57,157 |
) |
|
(24,090 |
) |
|
|
__________ |
__________ |
__________ |
|
Investing activities |
|
|
|
|
Interest received |
|
386 |
|
|
290 |
|
|
154 |
|
|
Purchases of property, plant and equipment |
|
(8,319 |
) |
|
(6,255 |
) |
|
(14,136 |
) |
|
Purchase of intangible assets |
|
(483 |
) |
|
(363 |
) |
|
(59 |
) |
|
Proceeds from sales of property, plant and equipment |
|
- |
|
|
- |
|
|
2 |
|
|
|
__________ |
__________ |
__________ |
|
Net cash outflow from investing activities |
|
(8,416 |
) |
|
(6,328 |
) |
|
(14,039 |
) |
|
|
__________ |
__________ |
__________ |
|
Financing activities |
|
|
|
|
Proceeds on exercise of share options |
|
845 |
|
|
635 |
|
|
1,141 |
|
|
Proceeds of new equity issue |
|
- |
|
|
- |
|
|
127,834 |
|
|
Expenses of new equity issue |
|
- |
|
|
- |
|
|
(307 |
) |
|
Interest paid |
|
(70 |
) |
|
(53 |
) |
|
(63 |
) |
|
Repayment of fit out funding |
|
(319 |
) |
|
(240 |
) |
|
- |
|
|
Capital element of finance leases |
|
(130 |
) |
|
(98 |
) |
|
(228 |
) |
|
|
__________ |
__________ |
__________ |
|
Net cash inflow from financing activities |
|
326 |
|
|
244 |
|
|
128,377 |
|
|
|
__________ |
__________ |
__________ |
|
Effect of foreign exchange rate changes on cash and cash
equivalents |
|
25,993 |
|
|
19,546 |
|
|
(691 |
) |
|
|
__________ |
__________ |
__________ |
|
Net (decrease)/increase in cash and cash
equivalents |
|
(58,111 |
) |
|
(43,695 |
) |
|
89,557 |
|
|
Cash and cash equivalents at beginning of the period |
|
312,363 |
|
|
234,872 |
|
|
164,491 |
|
|
|
|
__________ |
|
__________ |
|
__________ |
|
Cash and cash equivalents at end of the
period |
|
254,252 |
|
|
191,177 |
|
|
254,048 |
|
|
|
|
__________ |
|
__________ |
|
__________ |
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Aug 2024 to Sep 2024
GW Pharmaceuticals (NASDAQ:GWPH)
Historical Stock Chart
From Sep 2023 to Sep 2024
