GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the Quarter Ended December 31, 2018
February 26 2019 - 4:01PM
– Epidiolex® (cannabidiol) oral
solution (CV), first FDA-approved plant-derived cannabinoid
medicine, launched in the U.S. in November to high awareness and
demand –
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 quarter ended December 31, 2018.
“We are pleased by the high level of physician
and patient demand for Epidiolex, and by the number of payors that
have already made favorable coverage determinations for the
product. With US launch taking place part way through the quarter,
the two month selling period at the end of 2018 was primarily aimed
at setting the commercial wheels in motion for the 2019 launch
year. As we move into the New Year, prescription growth trajectory
has been highly encouraging and we believe that we are on track to
deliver a successful market introduction of this important new
treatment,” stated Justin Gover, GW’s Chief Executive Officer. “In
addition to the US launch, we look forward to a positive regulatory
decision in Europe in the next few months, results of a Phase 3
trial in Tuberous Sclerosis Complex, and a number of advances in
the pipeline.”
OPERATIONAL HIGHLIGHTS
• Epidiolex® (cannabidiol)
- U.S. launch progressing to plan- First plant-derived
cannabinoid pharmaceutical ever approved by FDA and first ever
approved medicine in the U.S. for Dravet syndrome- Net sales for
Nov 1 - Dec 31 launch period of $4.7m- Approximately 4,500 new
patient enrolment forms in first two month selling period- Over 500
physicians have generated dispensed prescriptions in first two
month selling period- Filled prescription growth trend in January
2019 shows approximately 150 percent growth over December 2018-
Demand coming from major centers of excellence and local epilepsy
clinics- Pharmacy distribution network expanded from initial 5
specialty pharmacies to over 130 distribution points- Approximately
900 expanded access program and open label extension patients
expected to migrate to commercial product by end of Q2 2019
- Rapid and encouraging payor coverage decisions- Over 80 percent
of all commercial lives (145 million) now have a coverage
determination with 60 percent of these lives covered with either no
Prior Authorization (PA) or PA to label- 99 percent of State Fee
for Service Medicaid lives now have a coverage determination-
Approximately 90 percent of Managed Medicaid lives have a coverage
determination
- Target physician coverage- The sales organization has to date
interacted with about 70 percent of the 5,000 target physicians
including all Level 3 and 4 epilepsy centers
- European progress- European submission under review by the EMA
with a CHMP recommendation expected in Q2 2019- Commercial
footprint in place in initial 5 major European markets and active
preparations well underway for pricing and reimbursement to support
2019 European launches
- Manufacturing- Commercial manufacturing and supply chain
running smoothly- Production capacity sufficient to meet expected
demand in both U.S. and Europe- Continued investment in
manufacturing expansion program to meet anticipated long-term
demand
- Clinical trials- Second Dravet syndrome Phase 3 trial
successful and incorporated into EMA regulatory process- Phase 3
trial in Tuberous Sclerosis Complex fully recruited with data
expected in Q2 2019 ♦ sNDA expected in Q4 2019-
IND open for pivotal Phase 3 trial in Rett Syndrome. Expected start
Q2 2019.
- Life-cycle management- Several new formulations of CBD in
development including modified oral solution, capsule and
intravenous formulation. PK data expected in 2019.
- Exclusivity- 7 years of orphan exclusivity confirmed by FDA,
6-month pediatric extension expected. 10 years of orphan
exclusivity in Europe with 2 year pediatric extension- 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 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)- FDA meeting in December resulted in
regulatory pathway in the U.S. ♦ Initial U.S.
target indication: Multiple Sclerosis spasticity
♦ Single Phase 3 pivotal study expect to commence in Q4 2019-
U.S. development and commercialization rights wholly owned by GW-
Over 10 placebo-controlled trials already completed in other
indications, representing significant U.S. lifecycle management
opportunities
- CBDV- Initial data from 5 patient expanded access program
in patients with seizures and autism presented at American Epilepsy
Society Annual Meeting suggest that CBDV is well tolerated and has
potential as an AED/behavioral/cognitive medicine in the
autism/epilepsy population- Company sponsored IND open for
30-patient open label study in autism- Investigator-led 100 patient
placebo-controlled trial in autism spectrum disorder to commence in
H1 2019- Open label study in Rett syndrome and seizures due to
commence H1 2019
FINANCIAL HIGHLIGHTS
- Fiscal year now changed to begin
January 1, 2019
- Cash and cash equivalents at
December 31, 2018 were $591.5 million compared to $354.9 million as
of September 30, 2018
- Revenue for the quarter ended
December 31, 2018 was $6.7 million compared to $4.0 million for the
quarter ended December 31, 2017
- Net loss for the quarter ended
December 31, 2018 was $71.9 million compared to $61.8 million for
the quarter ended December 31, 2017
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the quarter ending December 31, 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
Replay ID: 44354.
About GW Pharmaceuticals plc and
Greenwich Biosciences, Inc.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, has received U.S. FDA
approval for EPIDIOLEX (cannabidiol) oral solution for the
treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
or Dravet syndrome in patients two years of age or older and which
is now available by prescription in the U.S. The Company has
submitted a regulatory application in Europe for the adjunctive
treatment of seizures associated with LGS and Dravet syndrome. The
company continues to evaluate EPIDIOLEX in additional rare epilepsy
conditions and currently has an ongoing clinical trial in tuberous
sclerosis complex (TSC). 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 and for
which the company is now planning a U.S. Phase 3 trial. The Company
has a deep pipeline of additional cannabinoid product candidates
which includes compounds in Phase 1 and 2 trials for epilepsy,
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 Sativex (nabiximols) and the safety profile and
commercial potential of EPIDIOLEX and Sativex. 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 10-K filed on 29 November 2018. 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
Atwell/Andrew Ward |
+44 (0)
20 727 1000 |
|
GW PHARMACEUTICALS
PLCCONSOLIDATED BALANCE
SHEETS(Unaudited; in thousands)
|
|
December 31, |
|
|
September 30, |
|
|
|
2018 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
591,497 |
|
|
$ |
354,913 |
|
Accounts receivable,
net |
|
|
4,192 |
|
|
|
2,122 |
|
Inventory |
|
|
33,030 |
|
|
|
19,061 |
|
Prepaid expenses and other
current assets |
|
|
17,903 |
|
|
|
14,615 |
|
Total
current assets |
|
|
646,622 |
|
|
|
390,711 |
|
Property and equipment,
net |
|
|
90,832 |
|
|
|
82,381 |
|
Goodwill |
|
|
6,959 |
|
|
|
6,959 |
|
Deferred tax assets |
|
|
8,720 |
|
|
|
7,334 |
|
Other assets |
|
|
2,935 |
|
|
|
3,150 |
|
Total
assets |
|
$ |
756,068 |
|
|
$ |
490,535 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,796 |
|
|
$ |
9,741 |
|
Accrued liabilities |
|
|
52,477 |
|
|
|
46,739 |
|
Current tax
liabilities |
|
|
2,384 |
|
|
|
1,385 |
|
Other current
liabilities |
|
|
1,559 |
|
|
|
804 |
|
Total
current liabilities |
|
|
66,216 |
|
|
|
58,669 |
|
Long-term liabilities |
|
|
|
|
|
|
|
|
Capital lease
liabilities |
|
|
1,454 |
|
|
|
1,535 |
|
Build-to-suit financing
obligation |
|
|
4,236 |
|
|
|
4,378 |
|
Other liabilities |
|
|
10,082 |
|
|
|
10,794 |
|
Total
long-term liabilities |
|
|
15,772 |
|
|
|
16,707 |
|
Total
liabilities |
|
|
81,988 |
|
|
|
75,376 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Ordinary shares par value
£0.001; 366,616,688 shares outstanding as |
|
|
|
|
|
|
|
|
of December 31, 2018;
340,246,840 shares outstanding as of |
|
|
|
|
|
|
|
|
September 30, 2018 |
|
|
564 |
|
|
|
530 |
|
Additional paid-in
capital |
|
|
1,581,144 |
|
|
|
1,246,857 |
|
Accumulated deficit |
|
|
(828,940 |
) |
|
|
(757,034 |
) |
Accumulated other
comprehensive (loss) income |
|
|
(78,688 |
) |
|
|
(75,194 |
) |
Total
stockholders’ equity |
|
|
674,080 |
|
|
|
415,159 |
|
Total
liabilities and stockholders’ equity |
|
$ |
756,068 |
|
|
$ |
490,535 |
|
GW PHARMACEUTICALS
PLCCONSOLIDATED STATEMENTS OF
OPERATIONS(Unaudited; in thousands, except per
share amounts)
|
|
Three Months Ended December 31, |
|
|
|
2018 |
|
|
2017 |
|
Revenues |
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
6,617 |
|
|
$ |
2,220 |
|
Other revenue |
|
|
37 |
|
|
|
1,772 |
|
Total revenues |
|
|
6,654 |
|
|
|
3,992 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
1,829 |
|
|
|
1,171 |
|
Research and development |
|
|
29,086 |
|
|
|
36,195 |
|
Selling, general and
administrative |
|
|
49,083 |
|
|
|
25,174 |
|
Total operating expenses |
|
|
79,998 |
|
|
|
62,540 |
|
Loss from operations |
|
|
(73,344 |
) |
|
|
(58,548 |
) |
Interest income |
|
|
2,449 |
|
|
|
604 |
|
Interest expense |
|
|
(295 |
) |
|
|
(314 |
) |
Foreign exchange (loss) gain |
|
|
(982 |
) |
|
|
160 |
|
Loss before income taxes |
|
|
(72,172 |
) |
|
|
(58,098 |
) |
Income tax (benefit) expense |
|
|
(266 |
) |
|
|
3,718 |
|
Net loss |
|
$ |
(71,906 |
) |
|
$ |
(61,816 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share, basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding, basic
and |
|
|
|
|
|
|
|
|
diluted |
|
|
366,458 |
|
|
|
313,730 |
|
GW PHARMACEUTICALS
PLCCONSOLIDATED STATEMENTS OF CASH
FLOWS(Unaudited; in thousands)
|
|
Three Months Ended December 31, |
|
|
|
2018 |
|
|
2017 |
|
Cash flows from
operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(71,906 |
) |
|
$ |
(61,816 |
) |
Adjustments to reconcile
net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Foreign
exchange loss (gain) |
|
|
742 |
|
|
|
(180 |
) |
Stock-based
compensation |
|
|
9,683 |
|
|
|
5,592 |
|
Depreciation
and amortization |
|
|
2,534 |
|
|
|
2,163 |
|
Deferred
income taxes |
|
|
(1,265 |
) |
|
|
(1,152 |
) |
Other |
|
|
— |
|
|
|
8 |
|
Changes in operating
assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts
receivable, net |
|
|
(2,125 |
) |
|
|
(223 |
) |
Inventory |
|
|
(14,460 |
) |
|
|
378 |
|
Prepaid
expenses and other current assets |
|
|
(3,635 |
) |
|
|
(516 |
) |
Other
assets |
|
|
(47 |
) |
|
|
(166 |
) |
Accounts
payable |
|
|
(1,211 |
) |
|
|
(1,802 |
) |
Current tax
liabilities |
|
|
878 |
|
|
|
4,898 |
|
Accrued
liabilities |
|
|
5,942 |
|
|
|
3,004 |
|
Other
current liabilities |
|
|
93 |
|
|
|
(2,071 |
) |
Long-term
liabilities |
|
|
317 |
|
|
|
325 |
|
Net cash used in operating
activities |
|
|
(74,460 |
) |
|
|
(51,558 |
) |
Cash flows from
investing activities |
|
|
|
|
|
|
|
|
Additions to
property, plant and equipment |
|
|
(18,687 |
) |
|
|
(7,748 |
) |
Additions to
capitalized software |
|
|
(63 |
) |
|
|
(993 |
) |
Proceeds
from disposal of property, plant and equipment |
|
|
— |
|
|
|
— |
|
Net cash used in investing
activities |
|
|
(18,750 |
) |
|
|
(8,741 |
) |
Cash flows from
financing activities |
|
|
|
|
|
|
|
|
Proceeds
from issuance of ordinary shares, net of issuance costs |
|
|
324,638 |
|
|
|
297,932 |
|
Proceeds
from exercise of stock options |
|
|
— |
|
|
|
1 |
|
Payments on
build-to-suit financing obligation |
|
|
— |
|
|
|
(26 |
) |
Payments on
capital leases |
|
|
(40 |
) |
|
|
(39 |
) |
Payments on
landlord financing obligation |
|
|
(130 |
) |
|
|
(125 |
) |
Net cash provided by (used
in) financing activities |
|
|
324,468 |
|
|
|
297,743 |
|
Effect of exchange rate
changes on cash |
|
|
5,326 |
|
|
|
(551 |
) |
Net increase (decrease) in
cash and cash equivalents |
|
|
236,584 |
|
|
|
237,073 |
|
Cash and cash equivalents
at beginning of period |
|
|
354,913 |
|
|
|
322,154 |
|
Cash and cash equivalents
at end of period |
|
$ |
591,497 |
|
|
$ |
559,227 |
|
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