GW Pharmaceuticals plc Reports Fiscal Third Quarter 2018 Financial Results and Operational Progress
August 07 2018 - 04:01PM
-
Epidiolex®
(cannabidiol) oral solution approved by FDA and on track to
be launched in Fall -- Conference call today at
4:30 p.m. ET -
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the development and commercialization
of cannabinoid prescription medicines, announces financial results
for the third quarter ended 30 June 2018.
“The recent FDA approval of Epidiolex represents
a major medical advance for patients with Lennox-Gastaut Syndrome
and Dravet syndrome. We anticipate rescheduling to be completed
within 90 days of FDA approval and for product launch to take place
in the Fall,” stated Justin Gover, GW’s Chief Executive Officer.
“In preparation for launch, we have now completed the hiring of our
U.S. sales organization and are engaged with patient organizations,
physicians and managed care organizations/payors. This approval has
been a transformative event for GW, not only opening a new chapter
as a commercial-stage company, but also validating and reinforcing
our world leadership in cannabinoid science, and the potential of
our product pipeline.”
OPERATIONAL HIGHLIGHTS
- Epidiolex (cannabidiol)
- Regulatory:
- FDA approval for the treatment of seizures associated with LGS
or Dravet syndrome
- Epidiolex rescheduling expected within 90 days of FDA
approval
- European submission under review by the EMA with decision
expected in Q1 2019
- FDA issuance of a priority review voucher (PRV) for
Epidiolex.
- Manufacturing
- Commercial product being manufactured and prepared for shipping
to the U.S.
- Continued investment in expanded facilities to meet anticipated
long-term demand
- Commercial:
- U.S. sales organization fully recruited comprising two national
directors, eight regional managers plus 66 Neurology Account
Managers
- Active engagement with U.S. payors ongoing with clinical
presentations to plans that cover over 80% of covered lives in the
U.S.
- U.S. supply chain platform in place which will employ a closed
model distribution network of five Specialty Pharmacy Providers
(SPP’s)
- Commercial footprint in place in 5 major European markets in
readiness for 2019 European launches
- Epilepsy Clinical trials
- Three Phase 3 clinical trials published - two in The New
England Journal of Medicine and one in The Lancet
- Phase 3 trial in Tuberous Sclerosis Complex ongoing with data
expected H1 2019
- Autism
- Decision to expand target indications for Epidiolex beyond
epilepsy to autism. IND expected to be submitted for pivotal Rett
Syndrome study in Q4 18.
- Expanded access program and open label extension:
- Over 2,000 patients now have been exposed to Epidiolex
treatment
- Life-cycle management
- Several new formulations of CBD in development including
modified oral solution, capsule and an intravenous formulation
- Exclusivity
- 7-year orphan exclusivity confirmed by FDA, 6-month pediatric
extension expected
- Key favorable patent grants by USPTO related to the use of CBD
in epilepsy, including claims for the treatment of relevant seizure
types associated with LGS and Dravet syndrome, as well as the use
of CBD with clobazam
- Patents align directly with new Epidiolex FDA label and to be
listed in Orange Book
- Patent expiry dates to 2035
- Additional patent applications under review and being filed as
new data is generated
- Pipeline progress
- Sativex® (nabiximols)
- U.S. development and commercialization rights wholly owned by
GW
- Initial U.S. target indication: Multiple Sclerosis spasticity.
Three positive Phase 3 trials completed in Europe
- Plans to meet with FDA in H2 18 to determine MS spasticity
regulatory pathway in the U.S.
- Over 20 placebo-controlled trials already completed in other
indications, representing significant U.S. lifecycle management
opportunities
- CBDV
- 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 Q3 18
- Open label study in Rett syndrome and seizures due to commence
Q3 18
- CBD:THC in Glioblastoma
- Recent data presented from the Phase 2 study showed significant
increase in median survival for patients taking CBD:THC of 662 days
compared to 369 days on placebo
- Pivotal clinical development program plans under
development
- Orphan Drug Designation from both FDA and EMA for CBD:THC to
treat glioblastoma
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program
- Phase 1 trial complete
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
- Phase 2 trial in planning
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at 30 June 2018 of £334.0 million
($440.2 million) compared to £241.2 million as at 30 September
2017
- Revenue for the nine months ended 30 June 2018 of £10.7 million
($14.2 million) compared to £6.1 million for the nine months ended
30 June 2017
- Loss for the nine months ended 30 June 2018 of £136.7 million
($180.2 million) compared to £90.3 million for the nine months
ended 30 June 2017
Solely for the convenience of the reader, the
above balances have been translated into U.S. dollars at the rate
on 30 June 2018 of $1.31792 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 2018 financial results
today at 4:30 pm ET. 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 Replay ID: 35897.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.Founded in 1998, GW is the
world leader in the development and commercialization of
cannabinoid prescription medicines. The Company’s lead product,
EPIDIOLEX® (cannabidiol) oral solution, received U.S. FDA approval
in June 2018 and is under review by European regulators.
Previously, GW commercialized the world’s first plant-derived
cannabinoid prescription drug, Sativex® (nabiximols) in Europe and
is now advancing plans to develop this medicine in the US. The
Company has a deep pipeline of additional cannabinoid product
candidates which includes compounds in development for epilepsy,
autism, glioblastoma, and schizophrenia. For further information,
please visit www.gwpharm.com.
Forward-looking statementsThis
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 EPIDIOLEX (cannabidiol)
oral solution and the safety profile and commercial potential of
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 and 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 (U.S.) |
917 280 2424 / 401 500 6570 |
|
|
U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
|
Christy CurranMike Beyer |
615 414 8668312 961 2502 |
|
|
EU Media Enquiries:FTI
Consulting |
|
Ben
AtwellSimon Conway |
+44
(0) 3727 1000 |
|
|
GW
Pharmaceuticals plcCondensed consolidated income statementThree
months ended 30 June 2018 and 2017 |
|
|
|
|
|
|
|
30 June |
30 June |
30 June |
|
|
2018 |
2018 |
2017 |
|
|
$000’s |
£000’s |
£000’s |
Revenue |
|
3,457 |
|
|
2,623 |
|
|
2,412 |
|
Cost of sales |
|
(1,741 |
) |
|
(1,321 |
) |
|
(1,110 |
) |
Research and
development expenditure |
|
(24,503 |
) |
|
(18,592 |
) |
|
(27,936 |
) |
Sales, general and
administrative expenses |
|
(35,158 |
) |
|
(26,677 |
) |
|
(11,751 |
) |
Net foreign exchange
gain/(loss) |
|
21,825 |
|
|
16,560 |
|
|
(8,410 |
) |
Operating
loss |
|
(36,120 |
) |
|
(27,407 |
) |
|
(46,795 |
) |
Interest expense |
|
(303 |
) |
|
(230 |
) |
|
(266 |
) |
Interest and other
income |
|
1,452 |
|
|
1,102 |
|
|
456 |
|
Loss before
tax |
|
(34,971 |
) |
|
(26,535 |
) |
|
(46,605 |
) |
Tax
(expense)/benefit |
|
(734 |
) |
|
(557 |
) |
|
6,247 |
|
Loss for the
period |
|
(35,705 |
) |
|
(27,092 |
) |
|
(40,358 |
) |
|
|
|
|
|
Loss per share
– basic and diluted |
|
(10.5c |
) |
|
(8.0p |
) |
|
(13.3p |
) |
Loss per ADS –
basic and diluted(1) |
|
(126.0c |
) |
|
(96.0p |
) |
|
(159.6p |
) |
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
|
338.6 |
|
|
303.9 |
|
|
|
|
|
|
|
|
|
|
All activities relate
to continuing operations.(1) Each ADS represents 12 ordinary
shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed consolidated
statement of comprehensive lossFor the three months ended 30 June
2018 and 2017 |
|
|
|
30 June2018
£000’s |
30 June2017 £000’s |
Loss for the
period |
(27,092 |
) |
(40,358 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange gain/(loss) on
retranslation of foreign operations |
959 |
|
(508 |
) |
Other comprehensive gain/(loss) for the
period |
959 |
|
(508 |
) |
Total comprehensive loss for the period |
(26,133 |
) |
(40,866 |
) |
|
|
|
|
|
|
|
|
|
|
GW
Pharmaceuticals plcCondensed consolidated income statementNine
months ended 30 June 2018 and 2017 |
|
|
|
|
|
|
|
30 June |
30 June |
30 June |
|
|
2018 |
2018 |
2017 |
|
|
$000’s |
£000’s |
£000’s |
Revenue |
|
14,154 |
|
|
10,740 |
|
|
6,095 |
|
Cost of sales |
|
(4,440 |
) |
|
(3,369 |
) |
|
(2,512 |
) |
Research and
development expenditure |
|
(107,608 |
) |
|
(81,650 |
) |
|
(80,007 |
) |
Sales, general and
administrative expenses |
|
(81,321 |
) |
|
(61,704 |
) |
|
(27,725 |
) |
Net foreign exchange
loss |
|
(801 |
) |
|
(608 |
) |
|
(583 |
) |
Operating
loss |
|
(180,016 |
) |
|
(136,591 |
) |
|
(104,732 |
) |
Interest expense |
|
(923 |
) |
|
(700 |
) |
|
(509 |
) |
Interest and other
income |
|
4,783 |
|
|
3,629 |
|
|
1,042 |
|
Loss before
tax |
|
(176,156 |
) |
|
(133,662 |
) |
|
(104,199 |
) |
Tax
(expense)/benefit |
|
(4,014 |
) |
|
(3,046 |
) |
|
13,878 |
|
Loss for the
period |
|
(180,170 |
) |
|
(136,708 |
) |
|
(90,321 |
) |
|
|
|
|
|
Loss per share
– basic and diluted |
|
(54.7c |
) |
|
(41.5p |
) |
|
(29.8p |
) |
Loss per ADS –
basic and diluted(1) |
|
(656.4c |
) |
|
(498.0p |
) |
|
(357.6p |
) |
|
|
|
|
|
Weighted
average ordinary shares outstanding (in millions) – basic and
diluted |
|
|
|
329.6 |
|
|
303.4 |
|
|
|
|
|
|
|
|
|
|
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 2018 and 2017 |
|
|
|
|
|
|
30 June2018
£000’s |
30 June2017 £000’s |
Loss for the
period |
(136,708 |
) |
(90,321 |
) |
Items that may be reclassified subsequently to profit or
loss |
|
|
Exchange gain/(loss) on
retranslation of foreign operations |
19 |
|
(267 |
) |
Other comprehensive gain/(loss) for the
period |
19 |
|
(267 |
) |
Total comprehensive loss for the period |
(136,689 |
) |
(90,588 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
GW
Pharmaceuticals plcCondensed consolidated statement of changes in
equityNine months ended 30 June 2018 and 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 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at 1
October 2017 |
304 |
|
|
556,570 |
|
|
18,822 |
|
|
(297,521 |
) |
|
278,175 |
|
Exercise of share
options |
2 |
|
|
- |
|
|
- |
|
|
- |
|
|
2 |
|
Issue of share
capital |
33 |
|
|
223,037 |
|
|
- |
|
|
- |
|
|
223,070 |
|
Expense of new equity
issue |
- |
|
|
(911 |
) |
|
- |
|
|
- |
|
|
(911 |
) |
Share-based payment
transactions |
- |
|
|
- |
|
|
- |
|
|
15,742 |
|
|
15,742 |
|
Loss for the
period |
- |
|
|
- |
|
|
- |
|
|
(136,708 |
) |
|
(136,708 |
) |
Deferred tax
attributable to unrealized share option gains |
- |
|
|
- |
|
|
- |
|
|
2,202 |
|
|
2,202 |
|
Other comprehensive
gain |
- |
|
|
- |
|
|
19 |
|
|
- |
|
|
19 |
|
Balance at 30
June 2018 |
339 |
|
|
778,696 |
|
|
18,841 |
|
|
(416,285 |
) |
|
381,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
GW Pharmaceuticals plcCondensed consolidated balance sheetsAs
at 30 June 2018 and 30 September 2017 |
|
|
|
|
|
|
|
As at30 June |
As at30 June |
As at30 September |
|
|
2018 |
|
2018 |
|
2017 |
Non-current
assets |
|
$000’s |
£000’s |
£000’s |
Goodwill |
|
6,866 |
|
|
5,210 |
|
|
5,210 |
|
Other intangible
assets |
|
2,855 |
|
|
2,166 |
|
|
1,049 |
|
Property, plant and
equipment |
|
65,768 |
|
|
49,903 |
|
|
43,666 |
|
Deferred tax asset |
|
11,287 |
|
|
8,564 |
|
|
6,282 |
|
|
|
86,776 |
|
|
65,843 |
|
|
56,207 |
|
Current
assets |
|
|
|
|
Inventories |
|
26,333 |
|
|
19,981 |
|
|
4,244 |
|
Taxation
recoverable |
|
2,499 |
|
|
1,896 |
|
|
20,072 |
|
Trade receivables and
other assets |
|
23,367 |
|
|
17,730 |
|
|
11,217 |
|
Cash and cash
equivalents |
|
440,190 |
|
|
334,005 |
|
|
241,175 |
|
|
|
492,389 |
|
|
373,612 |
|
|
276,708 |
|
Total
assets |
|
579,165 |
|
|
439,455 |
|
|
332,915 |
|
Current
liabilities |
|
|
|
|
Trade and other
payables |
|
(52,876 |
) |
|
(40,121 |
) |
|
(33,119 |
) |
Current tax
liabilities |
|
(2,558 |
) |
|
(1,941 |
) |
|
(838 |
) |
Obligations under
finance leases |
|
(282 |
) |
|
(214 |
) |
|
(205 |
) |
Deferred revenue |
|
(1,074 |
) |
|
(815 |
) |
|
(2,307 |
) |
|
|
(56,790 |
) |
|
(43,091 |
) |
|
(36,469 |
) |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Trade and other
payables |
|
(11,602 |
) |
|
(8,803 |
) |
|
(9,256 |
) |
Obligations under
finance leases |
|
(6,053 |
) |
|
(4,593 |
) |
|
(4,755 |
) |
Deferred revenue |
|
(1,815 |
) |
|
(1,377 |
) |
|
(4,260 |
) |
Total
liabilities |
|
(76,260 |
) |
|
(57,864 |
) |
|
(54,740 |
) |
Net
assets |
|
502,905 |
|
|
381,591 |
|
|
278,175 |
|
|
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
447 |
|
|
339 |
|
|
304 |
|
Share premium
account |
|
1,026,255 |
|
|
778,696 |
|
|
556,570 |
|
Other reserves |
|
24,831 |
|
|
18,841 |
|
|
18,822 |
|
Accumulated
deficit |
|
(548,628 |
) |
|
(416,285 |
) |
|
(297,521 |
) |
Total
equity |
|
502,905 |
|
|
381,591 |
|
|
278,175 |
|
|
|
|
|
|
|
|
|
|
|
|
GW
Pharmaceuticals plcCondensed consolidated cash flow statementsFor
the nine months ended 30 June 2018 and 2017 |
|
|
|
|
|
|
|
Nine months ended |
|
Nine months ended |
|
Nine months ended |
|
30 June |
|
30 June |
|
30 June |
|
2018 |
|
2018 |
|
2017 |
|
$000’s |
|
£000’s |
|
£000’s |
Loss for the period |
(180,170 |
) |
|
(136,708 |
) |
|
(90,321 |
) |
Adjustments for: |
|
|
|
|
|
Interest and other income |
(4,783 |
) |
|
(3,629 |
) |
|
(1,042 |
) |
Interest expense |
923 |
|
|
700 |
|
|
509 |
|
Tax expense/(benefit) |
4,014 |
|
|
3,046 |
|
|
(13,878 |
) |
Depreciation of property, plant and equipment |
6,190 |
|
|
4,697 |
|
|
3,781 |
|
Impairment of property, plant and equipment |
- |
|
|
- |
|
|
95 |
|
Reversal of impairment of property, plant and equipment |
- |
|
|
- |
|
|
(216 |
) |
Amortization of intangible assets |
480 |
|
|
364 |
|
|
168 |
|
Net foreign exchange losses |
800 |
|
|
607 |
|
|
583 |
|
(Decrease)/increase in provision for inventories |
(477 |
) |
|
(362 |
) |
|
80 |
|
Decrease in deferred signature fees |
(4,169 |
) |
|
(3,163 |
) |
|
(1,097 |
) |
Share-based payment charge |
20,743 |
|
|
15,742 |
|
|
8,141 |
|
Loss on disposal of property, plant and equipment |
149 |
|
|
113 |
|
|
605 |
|
|
(156,300 |
) |
|
(118,593 |
) |
|
(92,592 |
) |
(Increase)/decrease in inventories |
(20,789 |
) |
|
(15,774 |
) |
|
52 |
|
Increase in trade receivables and other assets |
(3,033 |
) |
|
(2,301 |
) |
|
(1,914 |
) |
Increase/(decrease) in trade and other payables and deferred
revenue |
9,305 |
|
|
7,061 |
|
|
(1,279 |
) |
Research and development tax credits received |
26,509 |
|
|
20,114 |
|
|
21,679 |
|
Income taxes paid |
(2,562 |
) |
|
(1,944 |
) |
|
(1,277 |
) |
Net cash outflow from operating activities |
(146,870 |
) |
|
(111,437 |
) |
|
(75,331 |
) |
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest received |
2,205 |
|
|
1,673 |
|
|
970 |
|
Purchases of property, plant and equipment |
(22,399 |
) |
|
(16,996 |
) |
|
(12,989 |
) |
Purchase of intangible assets |
(1,730 |
) |
|
(1,313 |
) |
|
(468 |
) |
Net cash outflow from investing activities |
(21,924 |
) |
|
(16,636 |
) |
|
(12,487 |
) |
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds on exercise of share options |
3 |
|
|
2 |
|
|
91 |
|
Proceeds of new equity issue |
293,987 |
|
|
223,070 |
|
|
- |
|
Expenses of new equity issue |
(1,201 |
) |
|
(911 |
) |
|
(134 |
) |
Interest paid |
(923 |
) |
|
(700 |
) |
|
(729 |
) |
Repayment of fit out funding |
(384 |
) |
|
(291 |
) |
|
(748 |
) |
Repayment of obligations under finance leases |
(202 |
) |
|
(153 |
) |
|
(160 |
) |
Net cash inflow/(outflow) from financing
activities |
291,280 |
|
|
221,017 |
|
|
(1,680 |
) |
Effect of foreign exchange rate changes on cash and cash
equivalents |
(144 |
) |
|
(114 |
) |
|
(810 |
) |
Net increase/(decrease) in cash and cash
equivalents |
122,342 |
|
|
92,830 |
|
|
(90,308 |
) |
Cash and cash equivalents at beginning of the period |
317,848 |
|
|
241,175 |
|
|
374,392 |
|
Cash and cash equivalents at end of the
period |
440,190 |
|
|
334,005 |
|
|
284,084 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GW Pharmaceuticals (NASDAQ:GWPH)
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From Feb 2024 to Mar 2024
GW Pharmaceuticals (NASDAQ:GWPH)
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From Mar 2023 to Mar 2024