GW Pharmaceuticals plc Reports Fiscal First Quarter 2018 Financial Results and Operational Progress
February 05 2018 - 4:00PM
-
Epidiolex®
(cannabidiol) NDA and MAA applications accepted for review
–- NDA PDUFA goal date scheduled for June 27, 2018
-- Conference call today at 4:30 p.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, announces financial
results for the first quarter ended 31 December 2017.
“With the Epidiolex regulatory applications
accepted for review in both the US and Europe, and an assigned
mid-year FDA decision date, 2018 is expected to be an exciting year
for our Company with an anticipated first U.S. approval and launch.
The commercial teams are making great progress toward launching
Epidiolex with full conviction,” stated Justin Gover, GW’s Chief
Executive Officer. “We also continue to see a significant flow of
clinical data from the Epidiolex program through both medical
meetings such as the American Epilepsy Society and in publication
including our recent Lennox-Gastaut syndrome results in The Lancet.
Beyond Epidiolex, we expect to progress a number of important
pipeline programs during 2018 that have the potential to offer
additional value.”
OPERATIONAL HIGHLIGHTS
- Epidiolex (CBD) orphan epilepsy program in Dravet syndrome,
Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and
infantile spasms (IS)• Regulatory: • NDA for the
adjunctive treatment of seizures associated with LGS and Dravet
syndrome accepted for priority review with planned PDUFA goal date
of June 27, 2018 • European submission accepted for
review by the EMA. Expected decision in Q1
2019• Clinical data: • First Phase 3 LGS trial
published in The Lancet • Second Phase 3 LGS trial
publication anticipated in H1 2018• Clinical trials
• Phase 3 trial in Tuberous Sclerosis Complex ongoing with
data expected H2 2018 • Second Phase 3 trial in Dravet
syndrome enrollment complete with data expected H2 2018
• Part A of two-part Phase 2/3 trial in Infantile Spasms
underway• Manufacturing • FDA GMP inspections
scheduled• Expanded access program and open label
extension: • Over 2,000 patients now have been exposed
to Epidiolex treatment • 97 percent of patients who
complete Phase 3 trials have entered long term
extension• Commercial: • Head of U.S. Sales
appointed, completing the full U.S. commercial leadership
team • Active discussions in U.S. with a wide variety
of payors and insurance programs • EU commercial
footprint now in place in five major European
markets• Life-cycle management • Several new
formulations of CBD in development including modified liquid
formulations, a solid dose form and an intravenous
formulation• Intellectual property • Several
patent applications related to the use of CBD in certain forms of
epilepsy being prosecuted with expected Track One decisions in Q2
2018 • Additional patent applications being filed as
new data is generated
- Pipeline progress• CBDV in epilepsy • Data
from CBDV Phase 2 partial-onset epilepsy study in adults expected
in Q1 2018• CBDV in Autism Spectrum Disorders •
10-patient investigator-initiated expanded access program for
seizures associated with autism underway •
Investigator-led 100 patient placebo-controlled trial in autism
spectrum disorder due to commence in Q2 2018 • Open
label study in Rett syndrome due to commence in Q2 2018 and Phase 2
placebo-controlled trial in Rett syndrome due to commence in Q3
2018 • Orphan Drug Designation from FDA for CBDV for
the treatment of Rett syndrome• Sativex®
(nabiximols) • US development and
commercialization rights reacquired – plans underway to commence US
pivotal trial in MS spasticity• CBD:THC in Glioblastoma
• Pivotal clinical development program plans under
development• Neonatal Hypoxic-Ischemic Encephalopathy (NHIE)
intravenous CBD program • Phase 1 trial complete
• Orphan Drug and Fast Track Designations granted from FDA
and EMA
- Board appointments• Three new independent members
appointed to Board of Directors.
FINANCIAL HIGHLIGHTS
- Revenue for the three months ended 31 December 2017 of £5.7
million ($7.7 million) compared to £2.1 million for the three
months ended 31 December 2016.
- Loss for the three months ended 31 December 2017 of £47.0
million ($63.3 million) compared to £15.6 million for the three
months ended 31 December 2016.
- Cash and cash equivalents at 31 December 2017 of £414.8 million
($559.2 million) compared to £241.2 million as at 30 September
2017.
Solely for the convenience of the reader, the
above balances have been translated into U.S. dollars at the rate
on 31 December 2017 of $1.3482 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 first quarter 2018 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 or 919-882-2331 (international). For both
dial-in numbers please use conference ID # 13675963 and PIN:
24706.
About GW Pharmaceuticals plc and
Greenwich Biosciences
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, along with its U.S.
subsidiary Greenwich Biosciences, is advancing an orphan drug
program in the field of childhood epilepsy with a focus on
Epidiolex (cannabidiol), for which GW has submitted an NDA to the
FDA and an MAA with the EMA for the adjunctive treatment of LGS and
Dravet syndrome. The Company continues to evaluate Epidiolex in
additional epilepsy conditions and currently has ongoing clinical
trials in Tuberous Sclerosis Complex and Infantile Spasms. GW
commercialized the world’s first plant-derived cannabinoid
prescription drug, Sativex® (nabiximols), which is approved for the
treatment of spasticity due to multiple sclerosis in numerous
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 gliobastoma,
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 4 December 2017. 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 |
Sam Brown (U.S. Media Enquiries) |
|
Mike Beyer |
312 961 2502
|
EU Media
Enquiries:FTI Consulting |
|
Ben Atwell |
+44 (0) 203 727
1000 |
GW Pharmaceuticals plc |
Condensed consolidated income statement |
Three months ended 31 December 2017 and 2016 |
|
|
|
Three months ended |
Three
months ended |
Three months ended |
|
|
31 December |
31 December |
31 December |
|
|
2017 |
2017 |
2016 |
|
|
$000’s |
£000’s |
£000’s |
Revenue |
|
7,728 |
|
|
5,732 |
|
|
2,056 |
|
Cost of sales |
|
(1,190 |
) |
|
(883 |
) |
|
(715 |
) |
Research and
development expenditure |
|
(40,818 |
) |
|
(30,276 |
) |
|
(24,914 |
) |
Sales, general and
administrative expenses |
|
(23,445 |
) |
|
(17,390 |
) |
|
(6,684 |
) |
Net foreign exchange
(loss)/gain |
|
(3,442 |
) |
|
(2,553 |
) |
|
11,815 |
|
Operating
loss |
|
(61,167 |
) |
|
(45,370 |
) |
|
(18,442 |
) |
Interest expense |
|
(320 |
) |
|
(237 |
) |
|
(90 |
) |
Interest and other
income |
|
1,621 |
|
|
1,202 |
|
|
273 |
|
Loss before
tax |
|
(59,866 |
) |
|
(44,405 |
) |
|
(18,259 |
) |
Tax
(expense)/benefit |
|
(3,433 |
) |
|
(2,546 |
) |
|
2,663 |
|
Loss for the
period |
|
(63,299 |
) |
|
(46,951 |
) |
|
(15,596 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share
– basic and diluted |
|
(20.3c) |
(15.0p) |
(5.2p) |
Loss per ADS –
basic and diluted(1) |
|
(243.6c) |
(180.0p) |
(62.4p) |
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
|
312.1 |
|
|
302.7 |
|
All activities relate to continuing
operations.(1) Each ADS represents 12 ordinary shares.
Condensed consolidated statement of comprehensive
loss
Three months ended 31 December 2017 and 2016
|
Three monthsended31
December2017£000’s |
Three monthsended31 December2016£000’s |
Loss for the
period |
(46,951 |
) |
(15,596 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange (loss)/gain on
retranslation of foreign operations |
(187 |
) |
418 |
|
Other comprehensive (loss)/gain for the
period |
(187 |
) |
418 |
|
Total comprehensive loss for the period |
(47,138 |
) |
(15,178 |
) |
GW
Pharmaceuticals plc |
Condensed
consolidated statement of changes in equity |
Three
months ended 31 December 2017 and 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 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 1
October 2017 |
304 |
|
|
556,570 |
|
|
18,822 |
|
|
(297,521 |
) |
|
278,175 |
|
Issue of share
capital |
33 |
|
|
223,037 |
|
|
- |
|
|
- |
|
|
223,070 |
|
Expenses of new equity
issue |
- |
|
|
(903 |
) |
|
- |
|
|
- |
|
|
(903 |
) |
Share-based payment
transactions |
- |
|
|
- |
|
|
- |
|
|
4,127 |
|
|
4,127 |
|
Loss for the
period |
- |
|
|
- |
|
|
- |
|
|
(46,951 |
) |
|
(46,951 |
) |
Deferred tax
attributable to unrealized share option gains |
- |
|
|
- |
|
|
- |
|
|
469 |
|
|
469 |
|
Other comprehensive
expense |
- |
|
|
- |
|
|
(187 |
) |
|
- |
|
|
(187 |
) |
Balance at 31
December 2017 |
337 |
|
|
778,704 |
|
|
18,635 |
|
|
(339,876 |
) |
|
457,800 |
|
GW
Pharmaceuticals plc |
Condensed
consolidated balance sheets |
As at 31
December 2017 and 30 September 2017 |
|
|
|
|
|
|
|
|
|
|
|
|
As at31 December |
As at31 December |
As at30 September |
|
|
2017 |
2017 |
2017 |
Non-current
assets |
|
$000’s |
£000’s |
£000’s |
Intangible assets -
goodwill |
|
7,024 |
|
|
5,210 |
|
|
5,210 |
|
Other intangible
assets |
|
2,258 |
|
|
1,675 |
|
|
1,049 |
|
Property, plant and
equipment |
|
62,117 |
|
|
46,074 |
|
|
43,666 |
|
Deferred tax asset |
|
10,508 |
|
|
7,794 |
|
|
6,282 |
|
|
|
81,907 |
|
|
60,753 |
|
|
56,207 |
|
Current
assets |
|
|
|
|
|
|
|
|
Inventories |
|
5,344 |
|
|
3,964 |
|
|
4,244 |
|
Taxation
recoverable |
|
27,838 |
|
|
20,648 |
|
|
20,072 |
|
Trade receivables and
other current assets |
|
18,222 |
|
|
13,516 |
|
|
11,217 |
|
Cash and cash
equivalents |
|
559,227 |
|
|
414,795 |
|
|
241,175 |
|
|
|
610,631 |
|
|
452,923 |
|
|
276,708 |
|
Total
assets |
|
692,538 |
|
|
513,676 |
|
|
332,915 |
|
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(45,895 |
) |
|
(34,042 |
) |
|
(33,119 |
) |
Current tax
liabilities |
|
(6,017 |
) |
|
(4,463 |
) |
|
(838 |
) |
Obligations under
finance leases |
|
(280 |
) |
|
(208 |
) |
|
(205 |
) |
Deferred revenue |
|
(1,195 |
) |
|
(886 |
) |
|
(2,307 |
) |
|
|
(53,387 |
) |
|
(39,599 |
) |
|
(36,469 |
) |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Trade and other
payables |
|
(13,199 |
) |
|
(9,790 |
) |
|
(9,256 |
) |
Obligations under
finance leases |
|
(6,341 |
) |
|
(4,703 |
) |
|
(4,755 |
) |
Deferred revenue |
|
(2,405 |
) |
|
(1,784 |
) |
|
(4,260 |
) |
Total
liabilities |
|
(75,332 |
) |
|
(55,876 |
) |
|
(54,740 |
) |
Net
assets |
|
617,206 |
|
|
457,800 |
|
|
278,175 |
|
|
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
454 |
|
|
337 |
|
|
304 |
|
Share premium |
|
1,049,849 |
|
|
778,704 |
|
|
556,570 |
|
Other reserves |
|
25,124 |
|
|
18,635 |
|
|
18,822 |
|
Accumulated
deficit |
|
(458,221 |
) |
|
(339,876 |
) |
|
(297,521 |
) |
|
|
|
|
|
|
|
|
|
|
Total
equity |
|
617,206 |
|
|
457,800 |
|
|
278,175 |
|
GW
Pharmaceuticals plc |
Condensed
consolidated cash flow statements |
For the
three months ended 31 December 2017 and 2016 |
|
|
|
|
|
|
|
|
|
|
Three monthsended |
Three
monthsended |
Three monthsended |
|
31 December |
31 December |
31 December |
|
2017 |
2017 |
2016 |
|
$000’s |
£000’s |
£000’s |
Loss for the period |
(63,299 |
) |
|
(46,951 |
) |
|
(15,596 |
) |
Adjustments for: |
|
|
|
Interest expense |
320 |
|
|
237 |
|
|
90 |
|
Interest and other income |
(1,621 |
) |
|
(1,202 |
) |
|
(273 |
) |
Tax expense/(benefit) |
3,433 |
|
|
2,546 |
|
|
(2,663 |
) |
Depreciation of property, plant and equipment |
2,069 |
|
|
1,535 |
|
|
1,059 |
|
Impairment of property, plant and equipment |
- |
|
|
- |
|
|
95 |
|
Amortization of intangible assets |
127 |
|
|
94 |
|
|
18 |
|
Net foreign exchange losses/(gains) |
3,442 |
|
|
2,553 |
|
|
(11,815 |
) |
Increase in provision for inventories |
36 |
|
|
27 |
|
|
28 |
|
Decrease in deferred signature fees |
(3,716 |
) |
|
(2,756 |
) |
|
(429 |
) |
Share-based payment charge |
5,564 |
|
|
4,127 |
|
|
2,166 |
|
Loss on disposal of property, plant and equipment |
5 |
|
|
4 |
|
|
557 |
|
|
(53,640 |
) |
|
(39,786 |
) |
|
(26,763 |
) |
Decrease/(increase) in inventories |
341 |
|
|
253 |
|
|
(416 |
) |
Increase in trade receivables and other current assets |
(465 |
) |
|
(345 |
) |
|
(1,974 |
) |
Increase in trade and other payables and deferred revenue |
219 |
|
|
162 |
|
|
5,613 |
|
Income taxes paid |
- |
|
|
- |
|
|
(450 |
) |
Research and development tax credits received |
232 |
|
|
172 |
|
|
- |
|
Net cash outflow from operating activities |
(53,313 |
) |
|
(39,544 |
) |
|
(23,990 |
) |
|
|
|
|
Investing activities |
|
|
|
Interest received |
684 |
|
|
507 |
|
|
138 |
|
Purchases of property, plant and equipment |
(8,785 |
) |
|
(6,516 |
) |
|
(1,376 |
) |
Purchases of intangible assets |
(562 |
) |
|
(417 |
) |
|
(220 |
) |
Net cash outflow from investing activities |
(8,663 |
) |
|
(6,426 |
) |
|
(1,458 |
) |
|
|
|
|
Financing activities |
|
|
|
Proceeds on exercise of share options |
- |
|
|
- |
|
|
90 |
|
Proceeds of new equity issue |
300,743 |
|
|
223,070 |
|
|
- |
|
Expenses of new equity issue |
(425 |
) |
|
(315 |
) |
|
(134 |
) |
Interest paid |
(320 |
) |
|
(237 |
) |
|
(247 |
) |
Repayments of fit out funding |
(127 |
) |
|
(94 |
) |
|
(564 |
) |
Repayments of obligations under finance leases |
(67 |
) |
|
(50 |
) |
|
(95 |
) |
Net cash inflow/(outflow) from financing
activities |
299,804 |
|
|
222,374 |
|
|
(950 |
) |
Effect of foreign exchange rate changes on cash and cash
equivalents |
(3,753 |
) |
|
(2,784 |
) |
|
12,253 |
|
Net increase/(decrease) in cash and cash
equivalents |
234,075 |
|
|
173,620 |
|
|
(14,145 |
) |
Cash and cash equivalents at beginning of the period |
325,152 |
|
|
241,175 |
|
|
374,392 |
|
|
|
|
|
Cash and cash equivalents at end of the
period |
559,227 |
|
|
414,795 |
|
|
360,247 |
|
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