GW Pharmaceuticals plc Reports Fiscal Third Quarter 2017 Financial Results and Operational Progress
August 07 2017 - 4:05PM
-
Epidiolex® NDA
submission process underway - - Conference
call today at 4:30 p.m. EDT -
GW Pharmaceuticals plc (NASDAQ:GWPH) (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
2017.
“I am pleased to report the NDA submission process for Epidiolex is
now underway with the final sections of the submission expected to
be completed in October. With a clear view now towards our
anticipated approval, we are making excellent progress with
preparations to ensure a highly successful launch in 2018,” stated
Justin Gover, GW’s Chief Executive Officer. “Following the recent
publication of our first Phase 3 trial in The New England Journal
of Medicine, we look forward to additional Epidiolex data
publications and presentations in the second half of the year. In
addition to Epidiolex, we continue to keep focus on our growing and
innovative cannabinoid pipeline where we have advanced a number of
additional exciting clinical programs.”
OPERATIONAL HIGHLIGHTS
• Epidiolex (CBD) orphan epilepsy program in Dravet syndrome,
Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and
Infantile Spasms (IS)
- Regulatory progress: - NDA rolling submission for both
Dravet and LGS indications underway. Pre-clinical module
submitted; Clinical module submission in progress; CMC module
submission expected in October- EMA pre-submission meetings held.
Expected EU regulatory submission in Q4 2017
- Further clinical progress: - Phase 3 Dravet syndrome trial
published in The New England Journal of Medicine - Quality of
Life in Childhood Epilepsy published in Epilepsia - Phase 3
trial in Tuberous Sclerosis Complex ongoing - Part A of two-part
Phase 3 trial in Infantile Spasms ongoing - Numerous abstracts
submitted to American Epilepsy Society annual meeting
- Manufacturing scale-up on track to deliver significant
projected commercial launch inventory:- Preparations on track for
FDA GMP inspection anticipated in early 2018
- Expanded access program and open label extension:- Over 1,500
patients now exposed to Epidiolex treatment - 97 percent of
patients who complete Phase 3 trials have entered long term
extension
- Commercial progress:- U.S. pre-launch commercial leadership
team in place - Full team of epilepsy specialist Medical and
Scientific Liaisons (MSLs) in place with significant medical
education initiatives underway and major presence at key target
congresses - EU commercial team build-out underway and
increasing presence at European congresses
- Strengthened Epidiolex exclusivity:- 14 distinct patent
families in prosecution relating to the use of CBD in the treatment
of epilepsy; decisions expected for several patents towards end
2017 and H1 2018- 6 patents published in the last quarter claiming
various methods of treatment using CBD
- Life-cycle management: - Several new formulations of CBD in
Phase 1 trials
• Progressed cannabinoid pipeline product candidates
- CBDV Phase 2 partial-onset epilepsy study in adults fully
enrolled. Data expected end 2017/early 2018
- CBDV in field of autism spectrum disorders: - Expanded access
IND granted by FDA for 10 patients with autism - Open label study
in Rett syndrome and Phase 2 placebo-controlled trial in planning
for H1 2018 - Orphan Drug Designation from FDA for CBDV for the
treatment of Rett syndrome
- CBD:THC in Glioblastoma:- Positive survival data from Phase 2
study presented recently at ASCO; further follow-up demonstrates
continued increased survival in the CBD:THC arm
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program:- Phase 1 trial complete- Orphan Drug and Fast Track
Designations granted from FDA and EMA
• Management appointments
- Dr. Volker Knappertz appointed Chief Medical Officer
- Douglas Snyder appointed Chief Legal Officer
- Prof. Ben Whalley appointed as Director of Research
FINANCIAL HIGHLIGHTS
• Cash and cash equivalents at 30 June 2017 of £284.1
million ($369.5 million) compared to £374.4 million as at 30
September 2016
• Revenue for the nine months ended 30 June 2017 of £6.1
million ($7.9 million) compared to £8.6 million for the nine months
ended 30 June 2016
• Loss for the nine months ended 30 June 2017 of £90.3
million ($117.5 million) compared to £46.7 million for the nine
months ended 30 June 2016
Solely for the convenience of the reader, the
above balances have been translated into U.S. dollars at the rate
on 30 June 2017 of $1.30081 to £1. These translations should not be
considered representations that any such amounts have been, could
have been or could be converted into U.S. dollars at that or any
other exchange rate as at that or any other date.
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the third quarter 2017 financial results
today at 4:30 pm EST. 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):1-877-481-4010. For both dial-in numbers please use
conference ID # 13667808 and PIN: 19259.
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 is advancing an
orphan drug program in the field of childhood epilepsy with a focus
on Epidiolex (cannabidiol), for which GW has commenced a rolling
NDA submission with the FDA for the treatment of Dravet syndrome
and Lennox-Gastaut syndrome. The Company continues to evaluate
Epidiolex in additional epilepsy conditions and currently has
ongoing Phase 3 clinical trials in Tuberous Sclerosis Complex and
Infantile Spasms. 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 30 countries
outside the United States. The Company 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 timing and outcomes of regulatory or
intellectual property decisions, 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 including the most recent Form
20-F filed on 5 December 2016. 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.
|
|
GW
Pharmaceuticals plcCondensed consolidated income statementThree
months ended 30 June 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
30 June |
|
|
30 June |
|
|
30
June |
|
|
|
2017 |
|
|
2017 |
|
|
2016 |
|
|
|
$000’s |
|
|
£000’s |
|
|
£000’s |
|
Revenue |
|
3,138 |
|
|
2,412 |
|
|
2,329 |
|
Cost of sales |
|
(1,444 |
) |
|
(1,110 |
) |
|
(711 |
) |
Research and
development expenditure |
|
(36,339 |
) |
|
(27,936 |
) |
|
(25,609 |
) |
Sales, general and
administrative expenses |
|
(15,286 |
) |
|
(11,751 |
) |
|
(5,603 |
) |
Net foreign exchange
(loss) / gain |
|
(10,940 |
) |
|
(8,410 |
) |
|
11,190 |
|
|
|
|
|
|
|
|
Operating
loss |
|
(60,871 |
) |
|
(46,795 |
) |
|
(18,404 |
) |
Interest income |
|
593 |
|
|
456 |
|
|
98 |
|
Interest expense |
|
(346 |
) |
|
(266 |
) |
|
(18 |
) |
|
|
|
|
|
Loss before
tax |
|
(60,624 |
) |
|
(46,605 |
) |
|
(18,324 |
) |
Tax benefit |
|
8,126 |
|
|
6,247 |
|
|
6,109 |
|
|
|
|
|
|
Loss for the
period |
|
(52,498 |
) |
|
(40,358 |
) |
|
(12,215 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share
– basic and diluted |
|
(17.3c) |
(13.3p) |
(4.6p) |
Loss per ADS –
basic and diluted(1) |
|
(207.6c) |
(159.6p) |
(55.2p) |
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
|
303.9 |
|
|
262.9 |
|
|
All
activities relate to continuing operations. |
(1) Each
ADS represents 12 ordinary shares |
Condensed
consolidated statement of comprehensive loss |
For the three months
ended 30 June 2017 |
|
|
|
|
|
|
30
June2017£000’s |
30 June2016£000’s |
Loss for the
period |
(40,358 |
) |
(12,215 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange (loss)/gain on
retranslation of foreign operations |
(508 |
) |
266 |
|
Other comprehensive (loss)/gain for the
period |
(508 |
) |
266 |
|
Total comprehensive loss for the period |
(40,866 |
) |
(11,949 |
) |
GW
Pharmaceuticals plc |
Condensed
consolidated income statement |
Nine months
ended 30 June 2017 |
|
|
|
30 June |
|
30 June |
|
30
June |
|
|
|
2017 |
|
2017 |
|
2016 |
|
|
|
$000’s |
|
£000’s |
|
£000’s |
|
Revenue |
|
7,928 |
|
6,095 |
|
8,645 |
|
Cost of sales |
|
(3,268 |
) |
(2,512 |
) |
(1,940 |
) |
Research and
development expenditure |
|
(104,074 |
) |
(80,007 |
) |
(75,497 |
) |
Sales, general and
administrative expenses |
|
(36,065 |
) |
(27,725 |
) |
(12,470 |
) |
Net foreign exchange
(loss) / gain |
|
(757 |
) |
(583 |
) |
19,279 |
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(136,236 |
) |
(104,732 |
) |
(61,983 |
) |
Interest income |
|
1,355 |
|
1,042 |
|
292 |
|
Interest expense |
|
(662 |
) |
(509 |
) |
(53 |
) |
|
|
|
|
|
|
|
|
Loss before
tax |
|
(135,543 |
) |
(104,199 |
) |
(61,744 |
) |
Tax benefit |
|
18,053 |
|
13,878 |
|
14,995 |
|
|
|
|
|
|
|
|
|
Loss for the
period |
|
(117,490 |
) |
(90,321 |
) |
(46,749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share
– basic and diluted |
|
(38.7c) |
|
(29.8p) |
|
(17.8p) |
|
Loss per ADS –
basic and diluted(1) |
|
(464.4c) |
|
(357.6p) |
|
(213.6p) |
|
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
303.4 |
|
262.3 |
|
|
All
activities relate to continuing operations. |
(1) Each
ADS represents 12 ordinary shares |
Condensed
consolidated statement of comprehensive loss |
For the nine months
ended 30 June 2017 |
|
|
|
|
|
|
30
June2017£000’s |
|
30 June2016£000’s |
|
Loss for the
period |
(90,321 |
) |
(46,749 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange (loss)/gain on
retranslation of foreign operations |
(267 |
) |
166 |
|
Other comprehensive (loss)/gain for the
period |
(267 |
) |
166 |
|
Total comprehensive loss for the period |
(90,588 |
) |
(46,583 |
) |
GW
Pharmaceuticals plc |
Condensed
consolidated statement of changes in equity |
Nine months
ended 30 June 2017 |
|
|
|
|
|
|
|
|
|
Share |
|
|
|
|
Share |
premium |
Other |
|
Accumulated |
|
|
|
capital |
account |
reserves |
|
deficit |
|
Total |
|
|
£000’s |
£000’s |
£000’s |
|
£000’s |
|
£000’s |
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 1
October 2016 |
302 |
556,477 |
19,538 |
|
(177,827 |
) |
398,490 |
|
Exercise of share
options |
2 |
88 |
- |
|
- |
|
90 |
|
Share-based payment
transactions |
- |
- |
- |
|
8,141 |
|
8,141 |
|
Loss for the
period |
- |
- |
- |
|
(90,321 |
) |
(90,321 |
) |
Deferred tax
attributable to unrealized share option gains |
- |
- |
- |
|
(251 |
) |
(251 |
) |
Other comprehensive
loss |
- |
- |
(267 |
) |
- |
|
(267 |
) |
|
|
|
|
|
|
Balance at 30
June 2017 |
304 |
556,565 |
19,271 |
|
(260,258 |
) |
315,882 |
|
GW
Pharmaceuticals plc |
Condensed
consolidated balance sheets |
As at 30
June 2017 |
|
|
|
As at30 June |
|
As at30 June |
|
As at30
September |
|
|
|
2017 |
|
2017 |
|
2016 |
|
Non-current
assets |
|
$000’s |
|
£000’s |
|
£000’s |
|
Goodwill |
|
6,777 |
|
5,210 |
|
5,210 |
|
Other intangible
assets |
|
1,232 |
|
947 |
|
629 |
|
Property, plant and
equipment |
|
53,122 |
|
40,838 |
|
38,947 |
|
Deferred tax asset |
|
6,944 |
|
5,338 |
|
3,873 |
|
|
|
|
|
|
|
|
|
|
|
68,075 |
|
52,333 |
|
48,659 |
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Inventories |
|
5,354 |
|
4,116 |
|
4,248 |
|
Taxation
recoverable |
|
16,860 |
|
12,961 |
|
21,322 |
|
Trade receivables and
other assets |
|
12,926 |
|
9,937 |
|
4,556 |
|
Cash and cash
equivalents |
|
369,539 |
|
284,084 |
|
374,392 |
|
|
|
|
|
|
|
|
|
|
|
404,679 |
|
311,098 |
|
404,518 |
|
Assets held for
sale |
|
1,182 |
|
909 |
|
- |
|
|
|
|
|
|
|
|
|
Total
assets |
|
473,936 |
|
364,340 |
|
453,177 |
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Trade and other
payables |
|
(34,652 |
) |
(26,639 |
) |
(31,170 |
) |
Current tax
liabilities |
|
(1,131 |
) |
(870 |
) |
(883 |
) |
Obligations under
finance leases |
|
(263 |
) |
(202 |
) |
(211 |
) |
Deferred revenue |
|
(3,007 |
) |
(2,312 |
) |
(2,686 |
) |
|
|
|
|
|
|
|
|
|
|
(39,053 |
) |
(30,023 |
) |
(34,950 |
) |
|
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
|
Trade and other
payables |
|
(11,830 |
) |
(9,094 |
) |
(9,423 |
) |
Obligations under
finance leases |
|
(6,253 |
) |
(4,807 |
) |
(4,959 |
) |
Deferred revenue |
|
(5,898 |
) |
(4,534 |
) |
(5,355 |
) |
|
|
|
|
|
|
|
|
Total
liabilities |
|
(63,034 |
) |
(48,458 |
) |
(54,687 |
) |
|
|
|
|
|
|
|
|
Net
assets |
|
410,902 |
|
315,882 |
|
398,490 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
|
|
|
Share capital |
|
395 |
|
304 |
|
302 |
|
Share premium
account |
|
723,985 |
|
556,565 |
|
556,477 |
|
Other reserves |
|
25,068 |
|
19,271 |
|
19,538 |
|
Accumulated
deficit |
|
(338,546 |
) |
(260,258 |
) |
(177,827 |
) |
|
|
|
|
|
|
|
|
Total
equity |
|
410,902 |
|
315,882 |
|
398,490 |
|
|
|
|
|
|
|
|
|
GW
Pharmaceuticals plc |
Condensed
consolidated cash flow statements |
For the
nine months ended 30 June 2017 |
|
|
Nine months ended |
|
Nine months ended |
|
Nine
months ended |
|
|
30
June |
|
30 June |
|
30
June |
|
|
2017 |
|
2017 |
|
2016 |
|
|
$000’s |
|
£000’s |
|
£000’s |
|
Loss for the period |
(117,490 |
) |
(90,321 |
) |
(46,749 |
) |
Adjustments for: |
|
|
|
|
|
|
Interest income |
(1,355 |
) |
(1,042 |
) |
(292 |
) |
Interest expense |
662 |
|
509 |
|
53 |
|
Tax benefit |
(18,053 |
) |
(13,878 |
) |
(14,995 |
) |
Depreciation of property, plant and equipment |
4,918 |
|
3,781 |
|
2,526 |
|
Impairment of property, plant and equipment |
124 |
|
95 |
|
- |
|
Reversal of impairment of property, plant and equipment |
(281 |
) |
(216 |
) |
- |
|
Amortization of intangible assets |
219 |
|
168 |
|
42 |
|
Net foreign exchange losses/(gains) |
758 |
|
583 |
|
(19,382 |
) |
Increase/(decrease) in provision for inventories |
104 |
|
80 |
|
(45 |
) |
Decrease in deferred signature fees |
(1,427 |
) |
(1,097 |
) |
(881 |
) |
Share-based payment charge |
10,590 |
|
8,141 |
|
5,900 |
|
Loss on disposal of property, plant and equipment |
787 |
|
605 |
|
- |
|
|
|
|
|
|
|
|
|
(120,444 |
) |
(92,592 |
) |
(73,823 |
) |
Decrease in inventories |
68 |
|
52 |
|
323 |
|
(Increase)/decrease in trade receivables and other assets |
(2,490 |
) |
(1,914 |
) |
57 |
|
(Decrease)/increase in trade and other payables and deferred
revenue |
(1,664 |
) |
(1,279 |
) |
4,155 |
|
|
|
|
|
|
|
|
Cash used in operations |
(124,530 |
) |
(95,733 |
) |
(69,288 |
) |
Income taxes paid |
(1,661 |
) |
(1,277 |
) |
(1,150 |
) |
Research and development tax credits received |
28,200 |
|
21,679 |
|
13,281 |
|
|
|
|
|
|
|
|
Net cash outflow from operating activities |
(97,991 |
) |
(75,331 |
) |
(57,157 |
) |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Interest received |
1,262 |
|
970 |
|
290 |
|
Purchases of property, plant and equipment |
(16,896 |
) |
(12,989 |
) |
(6,255 |
) |
Purchase of intangible assets |
(609 |
) |
(468 |
) |
(363 |
) |
|
|
|
|
|
|
|
Net cash outflow from investing activities |
(16,243 |
) |
(12,487 |
) |
(6,328 |
) |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds on exercise of share options |
118 |
|
91 |
|
635 |
|
Expenses of new equity issue |
(174 |
) |
(134 |
) |
- |
|
Interest paid |
(948 |
) |
(729 |
) |
(53 |
) |
Repayment of fit out funding |
(973 |
) |
(748 |
) |
(240 |
) |
Repayment of obligations under finance leases |
(208 |
) |
(160 |
) |
(98 |
) |
|
|
|
|
|
|
|
Net cash (outflow)/inflow from financing
activities |
(2,185 |
) |
(1,680 |
) |
244 |
|
|
|
|
|
|
|
|
Effect of foreign exchange rate changes on cash and cash
equivalents |
(1,053 |
) |
(810 |
) |
19,546 |
|
|
|
|
|
|
|
|
Net decrease in cash and cash equivalents |
(117,472 |
) |
(90,308 |
) |
(43,695 |
) |
Cash and cash equivalents at beginning of the period |
487,011 |
|
374,392 |
|
234,872 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of the
period |
369,539 |
|
284,084 |
|
191,177 |
|
|
|
|
|
|
|
|
Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
401 500 6570
Sam Brown (U.S. Media Enquiries)
Christy Curran
615 414 8668
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