GW Pharmaceuticals plc Reports First Quarter 2017 Financial Results and Operational Progress
February 07 2017 - 7:00AM
-
Epidiolex® NDA
submission and launch preparation on track -- New
Positive Phase 2 glioma data further demonstrates value of
cannabinoid pipeline - - Conference call
today at 8:30 a.m. EST -
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, announced financial
results for the first quarter ended 31 December 2016.
“As we look forward to 2017, our primary focus
is on completing the Epidiolex NDA, which we expect to submit to
the FDA in the middle of this year. With three positive Phase 3
trials delivered in 2016, we remain confident in the prospects for
Epidiolex’s approval and are accelerating our preparations for a
highly successful launch,” stated Justin Gover, GW’s Chief
Executive Officer. “Beyond Epidiolex, the value of GW’s cannabinoid
platform is further illustrated by promising new clinical data in
the field of oncology and we continue to advance a number of
additional clinical programs that will yield data this year.”
OPERATIONAL HIGHLIGHTS
•
Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome,
Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and
infantile spasms (IS) |
•
Regulatory: |
• NDA
submission for both Dravet and LGS indications expected mid
2017 |
•
Preparations advancing for expected EU regulatory submission in H2
2017 |
•
Clinical: |
•
Positive results in a pivotal Phase 3 Dravet syndrome trial and in
two pivotal Phase 3 LGS trials |
•
Substantial new data presented at the American Epilepsy Society
Annual Meeting in December 2016 |
•
Manufacturing scale-up on track to deliver significant commercial
launch inventory |
• Pre-NDA
CMC meeting held with FDA in November 2016 |
•
Successful UK regulatory GMP inspection of GW manufacturing
facility in December 2016. On track for FDA GMP inspection
anticipated in H2 2017 |
•
Expanded access program and open label extension: |
• Over
1,200 patients now on Epidiolex treatment |
• 97
percent of patients who complete Phase 3 trials have entered long
term extension |
•
Commercial: |
• US
commercial team build well underway and pre-launch preparations
advancing well |
• EU
commercial team now being established |
•
Follow-on indications: |
• Phase 3
trial in TSC ongoing |
• Two
part Phase 3 trial in IS commenced in December 2016 |
•
Intellectual Property: |
• Patent
portfolio being prosecuted with claims directed to the use of CBD
in the treatment of epilepsy seizure subtypes and epilepsy
syndromes |
|
• THC:CBD
for Glioma |
•
Positive Phase 2 placebo-controlled data in Recurrent Glioblastoma
Multiforme (GBM) (see separate announcement issued today) |
• Orphan
Drug Designation from FDA and EMA |
•
Multiple relevant patents granted or in process |
|
• Other
cannabinoid pipeline product candidates: |
• CBDV
Phase 2 partial-onset epilepsy study in adults ongoing. Part A
complete and Part B underway with data expected H2 2017 |
• CBDV
pre-clinical research ongoing within field of autism spectrum
disorders. Phase 2 trials expected to commence in H2 2017 |
• Orphan
Drug Designation from FDA for CBDV for the treatment of Rett
syndrome |
•
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program |
• Phase 1
trial commenced in October 2016 |
• Orphan
Drug and Fast Track Designations granted from FDA and EMA |
|
FINANCIAL HIGHLIGHTS
• Revenue
for the three months ended 31 December 2016 of £2.1 million ($2.5
million) compared to £3.7 million for the three months ended 31
December 2015 |
|
• Loss
for the three months ended 31 December 2016 of £15.6 million ($19.3
million) compared to £17.7 million for the three months ended 31
December 2015 |
|
• Cash
and cash equivalents at 31 December 2016 of £360.2 million ($444.6
million) compared to £374.4 million as at 30 September 2016 |
|
Solely for the convenience of the reader, the above balances
have been translated into U.S. dollars at the rate on 31 December
2016 of $1.23429 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
Information
GW Pharmaceuticals will host a conference call
and webcast to discuss the first quarter 2017 financial results
today at 8:30 a.m 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, (international):1-919-882-2331. For both
dial-in numbers please use conference ID # 13654672.
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), which is in Phase 3 clinical
development for the treatment of Dravet syndrome, Lennox-Gastaut
syndrome, 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 31 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 31 December 2016 and 2015
|
|
Three months ended |
|
Three months ended |
|
Three
months ended |
|
|
|
31
December |
|
31 December |
|
31
December |
|
|
|
2016 |
|
2016 |
|
2015 |
|
|
|
$000’s |
|
£000’s |
|
£000’s |
|
Revenue |
|
2,538 |
|
2,056 |
|
3,667 |
|
Cost of sales |
|
(883 |
) |
(715 |
) |
(687 |
) |
Research and
development expenditure |
|
(30,751 |
) |
(24,914 |
) |
(24,139 |
) |
Sales, general and
administrative expenses |
|
(8,250 |
) |
(6,684 |
) |
(3,625 |
) |
Net foreign exchange
gain |
|
14,583 |
|
11,815 |
|
3,601 |
|
|
|
_________ |
|
_________ |
|
_________ |
|
Operating
loss |
|
(22,763 |
) |
(18,442 |
) |
(21,183 |
) |
Interest income |
|
337 |
|
273 |
|
63 |
|
Interest expense |
|
(111 |
) |
(90 |
) |
(19 |
) |
|
|
_________ |
|
_________ |
|
_________ |
|
Loss before
tax |
|
(22,537 |
) |
(18,259 |
) |
(21,139 |
) |
Tax benefit |
|
3,287 |
|
2,663 |
|
3,437 |
|
|
|
_________ |
|
_________ |
|
_________ |
|
Loss for the
period |
|
(19,250 |
) |
(15,596 |
) |
(17,702 |
) |
|
|
_________ |
|
_________ |
|
_________ |
|
|
|
|
|
|
Loss per share
– basic and diluted |
|
(6.4c) |
(5.2p) |
(6.8p) |
Loss per ADS –
basic and diluted(1) |
|
(76.8c) |
(62.4p) |
(81.6p) |
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
302.7 |
|
261.4 |
|
All activities relate to continuing
operations.(1) Each ADS represents 12 ordinary shares.
Condensed consolidated statement of comprehensive
loss
For the three months ended 31 December 2016 and 2015
|
Three months ended31
December2016 £000’s |
|
Three months ended31 December2015£000’s |
|
Loss for the
period |
(15,596 |
) |
(17,702 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange gain/(loss) on
retranslation of foreign operations |
418 |
|
(53 |
) |
Other comprehensive gain/(loss) for the
period |
418 |
|
(53 |
) |
Total comprehensive loss for the period |
(15,178 |
) |
(17,755 |
) |
|
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated statement of
changes in equityThree months ended 31 December 2016 and 2015
|
|
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 |
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 |
|
|
_________ |
_________ |
________ |
__________ |
________ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
- |
- |
- |
|
2,166 |
|
2,166 |
|
Loss for the
period |
- |
- |
- |
|
(15,596 |
) |
(15,596 |
) |
Deferred tax
attributable to unrealized share option gains |
- |
- |
- |
|
(255 |
) |
(255 |
) |
Other comprehensive
income |
- |
- |
418 |
|
- |
|
418 |
|
|
_________ |
_________ |
________ |
_________ |
________ |
Balance at 31
December 2016 |
304 |
556,565 |
19,956 |
|
(191,512 |
) |
385,313 |
|
|
_________ |
_________ |
________ |
_________ |
________ |
GW Pharmaceuticals plcCondensed consolidated balance sheetsAs at
31 December 2016 and 30 September 2016
|
|
As at31 December |
|
As at31 December |
|
As at30
September |
|
|
|
2016 |
|
2016 |
|
2016 |
|
Non-current
assets |
|
$000’s |
|
£000’s |
|
£000’s |
|
Intangible assets -
goodwill |
|
6,431 |
|
5,210 |
|
5,210 |
|
Other intangible
assets |
|
1,206 |
|
977 |
|
629 |
|
Property, plant and
equipment |
|
46,647 |
|
37,792 |
|
38,947 |
|
Deferred tax asset |
|
5,351 |
|
4,335 |
|
3,873 |
|
|
|
_________ |
__________ |
__________ |
|
|
59,635 |
|
48,314 |
|
48,659 |
|
|
|
_________ |
__________ |
__________ |
Current
assets |
|
|
|
|
Inventories |
|
5,722 |
|
4,636 |
|
4,248 |
|
Taxation
recoverable |
|
29,272 |
|
23,716 |
|
21,322 |
|
Trade receivables and
other assets |
|
8,488 |
|
6,877 |
|
4,556 |
|
Cash and cash
equivalents |
|
444,649 |
|
360,247 |
|
374,392 |
|
|
|
_________ |
__________ |
__________ |
|
|
488,131 |
|
395,476 |
|
404,518 |
|
Assets held for
sale |
|
1,122 |
|
909 |
|
- |
|
|
|
_________ |
__________ |
__________ |
Total
assets |
|
548,888 |
|
444,699 |
|
453,177 |
|
|
|
_________ |
__________ |
__________ |
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(45,093 |
) |
(36,534 |
) |
(31,170 |
) |
Current tax
liabilities |
|
(909 |
) |
(736 |
) |
(883 |
) |
Obligations under
finance leases |
|
(204 |
) |
(165 |
) |
(211 |
) |
Deferred revenue |
|
(3,096 |
) |
(2,508 |
) |
(2,686 |
) |
|
|
_________ |
__________ |
__________ |
|
|
(49,302 |
) |
(39,943 |
) |
(34,950 |
) |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Trade and other
payables |
|
(11,667 |
) |
(9,452 |
) |
(9,423 |
) |
Obligations under
finance leases |
|
(6,060 |
) |
(4,910 |
) |
(4,959 |
) |
Deferred revenue |
|
(6,271 |
) |
(5,081 |
) |
(5,355 |
) |
|
|
_________ |
__________ |
__________ |
Total
liabilities |
|
(73,300 |
) |
(59,386 |
) |
(54,687 |
) |
|
|
_________ |
__________ |
__________ |
Net
assets |
|
475,588 |
|
385,313 |
|
398,490 |
|
|
|
_________ |
__________ |
__________ |
|
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
375 |
|
304 |
|
302 |
|
Share premium
account |
|
686,963 |
|
556,565 |
|
556,477 |
|
Other reserves |
|
24,631 |
|
19,956 |
|
19,538 |
|
Accumulated
deficit |
|
(236,381 |
) |
(191,512 |
) |
(177,827 |
) |
|
|
_________ |
__________ |
__________ |
Total
equity |
|
475,588 |
385,313 |
398,490 |
|
|
_________ |
__________ |
__________ |
GW Pharmaceuticals plcCondensed consolidated cash flow
statementsFor the three months ended 31 December 2016 and 2015
|
Three monthsended |
|
Three monthsended |
|
Three
monthsended |
|
|
31
December |
|
31 December |
|
31
December |
|
|
2016 |
|
2016 |
|
2015 |
|
|
$000’s |
|
£000’s |
|
£000’s |
|
Loss for the period |
(19,250 |
) |
(15,596 |
) |
(17,702 |
) |
Adjustments for: |
|
|
|
Interest income |
(337 |
) |
(273 |
) |
(63 |
) |
Interest expense |
111 |
|
90 |
|
19 |
|
Tax benefit |
(3,287 |
) |
(2,663 |
) |
(3,437 |
) |
Depreciation of property, plant and equipment |
1,307 |
|
1,059 |
|
736 |
|
Impairment of property, plant and equipment |
117 |
|
95 |
|
- |
|
Amortization of intangible assets |
22 |
|
18 |
|
14 |
|
Net foreign exchange gains |
(14,583 |
) |
(11,815 |
) |
(3,762 |
) |
Increase in provision for inventories |
35 |
|
28 |
|
7 |
|
Decrease in deferred signature fees |
(530 |
) |
(429 |
) |
(289 |
) |
Share-based payment charge |
2,673 |
|
2,166 |
|
1,306 |
|
Loss on disposal of property, plant and equipment |
687 |
|
557 |
|
- |
|
|
__________ |
__________ |
__________ |
|
(33,035 |
) |
(26,763 |
) |
(23,171 |
) |
(Increase)/decrease in inventories |
(513 |
) |
(416 |
) |
56 |
|
Increase in trade receivables and other assets |
(2,436 |
) |
(1,974 |
) |
(2,401 |
) |
Increase in trade and other payables and deferred revenue |
6,929 |
|
5,613 |
|
7,931 |
|
Income taxes paid |
(555 |
) |
(450 |
) |
(366 |
) |
|
__________ |
__________ |
__________ |
Net cash outflow from operating activities |
(29,610 |
) |
(23,990 |
) |
(17,951 |
) |
|
__________ |
__________ |
__________ |
Investing activities |
|
|
|
Interest received |
170 |
|
138 |
|
70 |
|
Purchases of property, plant and equipment |
(1,698 |
) |
(1,376 |
) |
(1,782 |
) |
Purchases of intangible assets |
(272 |
) |
(220 |
) |
(119 |
) |
|
__________ |
__________ |
__________ |
Net cash outflow from investing activities |
(1,800 |
) |
(1,458 |
) |
(1,831 |
) |
|
__________ |
__________ |
__________ |
Financing activities |
|
|
|
Proceeds on exercise of share options |
111 |
|
90 |
|
564 |
|
Expenses of new equity issue |
(165 |
) |
(134 |
) |
- |
|
Interest paid |
(305 |
) |
(247 |
) |
(20 |
) |
Repayments of fit out funding |
(696 |
) |
(564 |
) |
- |
|
Repayments of obligations under finance leases |
(117 |
) |
(95 |
) |
(26 |
) |
|
__________ |
__________ |
__________ |
Net cash (outflow)/inflow from financing
activities |
(1,172 |
) |
(950 |
) |
518 |
|
|
__________ |
__________ |
__________ |
Effect of foreign exchange rate changes on cash and cash
equivalents |
15,123 |
|
12,253 |
|
3,705 |
|
|
__________ |
__________ |
__________ |
Net decrease in cash and cash equivalents |
(17,459 |
) |
(14,145 |
) |
(15,559 |
) |
Cash and cash equivalents at beginning of the period |
462,108 |
|
374,392 |
|
234,872 |
|
|
__________ |
__________ |
__________ |
Cash and cash equivalents at end of the
period |
444,649 |
|
360,247 |
|
219,313 |
|
|
__________ |
__________ |
__________ |
Enquiries:
GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations
401 500 6570
Sam Brown (U.S. Media Enquiries)
Mike Beyer
312 961 2502
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