GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the Third Quarter Ended September 30, 2019
November 05 2019 - 4:00PM
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the discovery, development and
commercialization of cannabinoid prescription medicines, announces
financial results for the third quarter ended September 30, 2019.
“In this first year of launch, we are pleased to
report continued Epidiolex revenue growth in the US. Receptivity to
the introduction of this breakthrough treatment continues to be
highly encouraging as a result of positive physician and patient
experiences as well as strong payer coverage,” stated Justin Gover,
GW’s Chief Executive Officer. “We see significant opportunity for
the short, medium and long term and believe that all the
fundamentals are in place to make Epidiolex a very successful
brand. We can expect to see additional momentum from Europe as well
as the launch of the Tuberous Sclerosis indication during 2020. On
top of this, GW is ideally placed to consolidate its leadership in
cannabinoid science through advancing several mid and late stage
pipeline programs in the months ahead.”
OPERATIONAL HIGHLIGHTS
- Epidiolex® (cannabidiol)
- U.S. commercial update
- Q3 Net sales of $86.1M; $188.0M net sales in the first three
quarters of 2019
- Over 15,000 patients have received Epidiolex prescriptions
since launch
- Over 3,000 physicians have generated dispensed prescriptions
since launch
- Strong payor coverage with approximately 93 percent of all
Commercial, Medicaid and Medicare lives in the US having a coverage
determination, of which 65 percent are PA to indication or less
restrictive
- European launch update
- European Commission approval in September 2019
- Commercialization underway in France and Germany
- UK NICE guidance expected in Q4 2019; Spain and Italy launches
to follow in 2020
- Early Access Program now includes over 1,100 patients across 5
major EU countries, and over 400 physicians from 250 top epilepsy
centers
- New Indications
- Tuberous Sclerosis Complex
- TSC Phase 3 data to be presented at American Epilepsy Society
annual meeting in December 2019
- TSC sNDA expected to be filed with FDA in early 2020, approval
decision expected mid-2020
- TSC EMA submission expected in Q1 2020
- Rett Syndrome
- Phase 3 trial in Rett Syndrome recruiting
- Life-cycle management
- Several new formulations of CBD in development including
modified oral solution, capsule and intravenous formulation
- PK data generated in 2019 supports advancing multiple new
formulations into additional Phase 1 studies in 2020
- Exclusivity
- 7 years of orphan exclusivity confirmed by FDA, plus 6-month
pediatric extension expected. 10 years of orphan exclusivity in
Europe plus 2 year pediatric extension expected
- 9 granted patents listed in “Orange Book” and align directly
with Epidiolex FDA label
- Patent expiry dates to 2035
- Additional patent applications under review, including patents
related to the use of Epidiolex in TSC and other indications
- Patent application recently published indicating that Epidiolex
is more efficacious than synthetic CBD in pre-clinical epilepsy
models based on the key difference that Epidiolex comprises up to 2
percent of other cannabinoids.
- Pipeline progress
- Sativex® (nabiximols)
- Initial U.S. target indication: Multiple Sclerosis spasticity
- 3 positive Phase 3 trials completed in Europe
- Clinical IND open, FDA feedback received on clinical plan
- Clinical program expected to commence in Q1 2020 to augment
existing pivotal data package
- Clinical program in additional indications in planning for
2020-2021
- CBDV
- IND open for 30-patient open label study in autism expected to
commence Q4 19. Initial data in 2020.
- Investigator-led 100 patient placebo-controlled trial in autism
underway
- Open label study in Rett syndrome and seizures ongoing
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program
- Phase 1b safety study in patients expected to commence in
Q4
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
- Schizophrenia (GWP42003)
- Positive Phase 2a trial published
- Phase 2b trial expected to commence H1 2020
FINANCIAL HIGHLIGHTS
- Revenue for the quarter ended
September 30, 2019 was $91.0 million compared to $2.4 million for
the quarter ended September 30, 2018
- Cash and cash equivalents at
September 30, 2019 were $554.7 million compared to $591.5 million
as of December 31, 2018
- Net loss for the quarter ended
September 30, 2019 was $13.8 million compared to a net loss of
$79.9 million for the quarter ended September 30, 2018
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the quarter ending September 30, 2019
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: 54868.
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’s lead product,
EPIDIOLEX (cannabidiol oral solution) is commercialized in the US
by its U.S. subsidiary Greenwich Biosciences for the treatment of
seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet
syndrome in patients two years of age or older. This product has
received approval in Europe under the tradename EPIDYOLEX. The
Company continues to evaluate EPIDIOLEX in additional rare
conditions including Tuberous Sclerosis Complex (TSC) and Rett
syndrome. 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 advancing a late stage program in order to seek FDA
approval. The Company has a deep pipeline of additional cannabinoid
product candidates which includes compounds in Phase 1 and 2 trials
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 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-KT filed on 26 February 2019. 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/Mike Trace |
+44 (0) 203 727 1000 |
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|
|
|
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share data)
(unaudited)
|
|
September 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
554,682 |
|
|
$ |
591,497 |
|
Accounts
receivable, net |
|
|
41,818 |
|
|
|
4,192 |
|
Inventory |
|
|
69,288 |
|
|
|
33,030 |
|
Prepaid
expenses and other current assets |
|
|
32,196 |
|
|
|
17,903 |
|
Total current assets |
|
|
697,984 |
|
|
|
646,622 |
|
Property,
plant, and equipment, net |
|
|
110,161 |
|
|
|
90,832 |
|
Operating
lease assets |
|
|
20,438 |
|
|
|
— |
|
Goodwill |
|
|
6,959 |
|
|
|
6,959 |
|
Deferred tax
assets |
|
|
8,425 |
|
|
|
8,720 |
|
Other
assets |
|
|
3,884 |
|
|
|
2,935 |
|
Total assets |
|
$ |
847,851 |
|
|
$ |
756,068 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
6,934 |
|
|
$ |
9,796 |
|
Accrued
liabilities |
|
|
81,704 |
|
|
|
52,477 |
|
Current tax
liabilities |
|
|
— |
|
|
|
2,384 |
|
Other
current liabilities |
|
|
6,627 |
|
|
|
1,559 |
|
Total current liabilities |
|
|
95,265 |
|
|
|
66,216 |
|
Long-term
liabilities: |
|
|
|
|
|
|
|
|
Finance
lease liabilities |
|
|
5,297 |
|
|
|
5,690 |
|
Operating
lease liabilities |
|
|
17,007 |
|
|
|
— |
|
Other
liabilities |
|
|
10,627 |
|
|
|
10,082 |
|
Total long-term liabilities |
|
|
32,931 |
|
|
|
15,772 |
|
Total liabilities |
|
|
128,196 |
|
|
|
81,988 |
|
Commitments
and contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock
- Ordinary shares par value £0.001; |
|
|
570 |
|
|
|
564 |
|
370,937,744 shares outstanding as of September 30, 2019; |
366,616,688 shares outstanding as of December 31, 2018 |
Additional
paid-in capital |
|
|
1,619,649 |
|
|
|
1,581,144 |
|
Accumulated
deficit |
|
|
(813,013 |
) |
|
|
(828,940 |
) |
Accumulated
other comprehensive loss |
|
|
(87,551 |
) |
|
|
(78,688 |
) |
Total stockholders’ equity |
|
|
719,655 |
|
|
|
674,080 |
|
Total liabilities and stockholders’ equity |
|
$ |
847,851 |
|
|
$ |
756,068 |
|
|
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except per share
amounts) (unaudited)
|
|
Three
Months Ended |
|
|
Nine
Months Ended |
|
September 30, |
September 30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
90,849 |
|
|
$ |
2,343 |
|
|
$ |
201,312 |
|
|
$ |
8,249 |
|
Other revenue |
|
|
122 |
|
|
|
77 |
|
|
|
944 |
|
|
|
496 |
|
Total revenues |
|
|
90,971 |
|
|
|
2,420 |
|
|
|
202,256 |
|
|
|
8,745 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
8,150 |
|
|
|
1,399 |
|
|
|
19,901 |
|
|
|
4,815 |
|
Research and development |
|
|
36,301 |
|
|
|
28,943 |
|
|
|
99,143 |
|
|
|
117,541 |
|
Selling, general and administrative |
|
|
64,178 |
|
|
|
52,685 |
|
|
|
181,529 |
|
|
|
116,644 |
|
Total operating expenses |
|
|
108,629 |
|
|
|
83,027 |
|
|
|
300,573 |
|
|
|
239,000 |
|
Loss from
operations |
|
|
(17,658 |
) |
|
|
(80,607 |
) |
|
|
(98,317 |
) |
|
|
(230,255 |
) |
Interest income |
|
|
2,249 |
|
|
|
1,283 |
|
|
|
6,646 |
|
|
|
3,041 |
|
Interest expense |
|
|
(272 |
) |
|
|
(297 |
) |
|
|
(805 |
) |
|
|
(935 |
) |
Other income |
|
|
— |
|
|
|
— |
|
|
|
104,117 |
|
|
|
— |
|
Foreign exchange gain (loss) |
|
|
1,889 |
|
|
|
(823 |
) |
|
|
2,801 |
|
|
|
(5,123 |
) |
(Loss) income before income taxes |
|
|
(13,792 |
) |
|
|
(80,444 |
) |
|
|
14,442 |
|
|
|
(233,272 |
) |
Income tax
(benefit) expense |
|
|
(35 |
) |
|
|
(565 |
) |
|
|
(1,485 |
) |
|
|
79 |
|
Net (loss) income |
|
$ |
(13,757 |
) |
|
$ |
(79,879 |
) |
|
$ |
15,927 |
|
|
$ |
(233,351 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss)
income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.04 |
) |
|
$ |
(0.23 |
) |
|
$ |
0.04 |
|
|
$ |
(0.68 |
) |
Diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.23 |
) |
|
$ |
0.04 |
|
|
$ |
(0.68 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
372,246 |
|
|
|
341,302 |
|
|
|
371,286 |
|
|
|
340,675 |
|
Diluted |
|
|
372,246 |
|
|
|
341,302 |
|
|
|
376,985 |
|
|
|
340,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GW PHARMACEUTICALS
PLCCONSOLIDATED STATEMENTS OF CASH
FLOWS(in thousands)
(unaudited)
|
|
Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net income
(loss) |
|
$ |
15,927 |
|
|
$ |
(233,351 |
) |
Adjustments
to reconcile net income (loss) to net cash used in |
|
|
|
|
|
|
|
|
operating
activities: |
Foreign exchange (gain) loss |
|
|
(418 |
) |
|
|
5,097 |
|
Share-based compensation |
|
|
35,633 |
|
|
|
26,035 |
|
Depreciation and amortization |
|
|
7,096 |
|
|
|
7,127 |
|
Deferred income taxes |
|
|
— |
|
|
|
835 |
|
Gain from sale of priority review voucher |
|
|
(104,117 |
) |
|
|
— |
|
Other |
|
|
39 |
|
|
|
233 |
|
Changes in
operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(37,691 |
) |
|
|
(581 |
) |
Inventory |
|
|
(37,561 |
) |
|
|
(14,024 |
) |
Prepaid expenses and other current assets |
|
|
(14,869 |
) |
|
|
15,005 |
|
Other assets |
|
|
2,968 |
|
|
|
(398 |
) |
Accounts payable |
|
|
(1,161 |
) |
|
|
4,040 |
|
Current tax liabilities |
|
|
(601 |
) |
|
|
(4,844 |
) |
Accrued liabilities |
|
|
29,176 |
|
|
|
13,503 |
|
Other liabilities |
|
|
(1,943 |
) |
|
|
1,013 |
|
Net cash
used in operating activities |
|
|
(107,522 |
) |
|
|
(180,310 |
) |
Cash
flows from investing activities |
|
|
|
|
|
|
|
|
Proceeds from sale of priority review voucher |
|
|
104,117 |
|
|
|
— |
|
Additions to property, plant and equipment |
|
|
(29,915 |
) |
|
|
(23,614 |
) |
Additions to capitalized software |
|
|
(1,183 |
) |
|
|
(1,049 |
) |
Proceeds from disposal of property, plant and equipment |
|
|
- |
|
|
|
517 |
|
Net cash
provided by (used in) investing activities |
|
|
73,019 |
|
|
|
(24,146 |
) |
Cash
flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
2,878 |
|
|
|
619 |
|
Payments on finance leases |
|
|
(317 |
) |
|
|
(211 |
) |
Payments on landlord financing obligation |
|
|
(404 |
) |
|
|
(397 |
) |
Net cash
provided by financing activities |
|
|
2,157 |
|
|
|
11 |
|
Effect of
exchange rate changes on cash |
|
|
(4,469 |
) |
|
|
131 |
|
Net decrease
in cash and cash equivalents |
|
|
(36,815 |
) |
|
|
(204,314 |
) |
Cash and
cash equivalents at beginning of period |
|
|
591,497 |
|
|
|
559,227 |
|
Cash and
cash equivalents at end of period |
|
$ |
554,682 |
|
|
$ |
354,913 |
|
|
|
|
|
|
|
|
|
|
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