GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2019
May 06 2019 - 4:01PM
- Epidiolex U.S. Q1 net sales of $33.5m - -
Positive Phase 3 pivotal results in Tuberous Sclerosis Complex,
sNDA submission expected in Q4 2019 - - Conference call today at
4:30 p.m. EDT -
GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the
Group), the world leader in the science, development and
commercialization of cannabinoid prescription medicines, announces
financial results for the first quarter ended March 31, 2019.
“We are pleased to report a strong launch of
Epidiolex in the US and continue to be encouraged by the level of
support for this medicine from patients, caregivers and healthcare
professionals. As the first and only plant-derived CBD medicine
approved by the FDA, Epidiolex offers a novel treatment option for
patients with Lennox-Gastaut Syndrome and Dravet syndrome, two
highly treatment-resistant forms of childhood-onset epilepsy”,
stated Justin Gover, GW’s Chief Executive Officer. “In addition, we
are delighted to report today positive results from a Phase 3 trial
in patients with seizures associated with Tuberous Sclerosis
Complex, and are excited at the prospect of expanding the use of
Epidiolex to these high need patients in the future.”
OPERATIONAL HIGHLIGHTS
- Darren Cline appointed U.S. Chief Commercial Officer
- Epidiolex® (cannabidiol)
- U.S. commercial update
- Q1 Net sales of $33.5m
- Over 7,600 patients have received Epidiolex prescriptions since
launch
- Over 1,900 physicians have generated dispensed prescriptions
since launch
- Pharmacy distribution network now includes over 145
distribution points
- Approximately 75 percent of 900 patients in expanded access
program and open label extension now transitioned to commercial
product. Remaining patients expected to transition by end of
Q2.
- Rapid and encouraging payor coverage decisions
- Over 90 percent of all U.S. lives now covered – 65 percent of
which have either Prior Authorization (PA) to indication or less
restrictive
- New commercial coverage determination recently announced by
United HealthCare, OptumRx and Prime Therapeutics
- 99 percent of State Fee-for-Service Medicaid lives now have a
coverage determination with 67 percent of covered lives having
either PA to indication or less restrictive
- 7 States covering Epidiolex without restrictions
- Approximately 90 percent of Managed Medicaid lives have a
coverage determination with 40 percent having a PA to indication or
less restrictive
- Target physician coverage
- The sales organization has to date interacted with about 70
percent of the over 5,000 target healthcare professionals including
all Level 3 and 4 epilepsy centers
- European regulatory and pre-launch progress
- CHMP opinion expected mid-2019
- Launches expected in major five European markets by end of
2019
- Manufacturing
- Commercial manufacturing and supply chain running smoothly
- Production capacity sufficient to meet expected demand in both
U.S. and Europe
- Clinical trials
- Positive results in Phase 3 trial in Tuberous Sclerosis Complex
- Primary efficacy measure achieved with both Epidiolex doses
compared to placebo
- sNDA submission expected in Q4 2019
- IND open for pivotal Phase 3 trial in Rett Syndrome with
expected start in Q2 2019
- Life-cycle management
- Several new formulations of CBD in development including
modified oral solution, capsule and intravenous formulation
- 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
- Key favorable patent grants by USPTO related to the use of CBD
in epilepsy
- Patents align directly with new Epidiolex FDA label and listed
in “Orange Book”
- Patent expiry dates to 2035
- Additional patent applications under review, including patents
related to the use of Epidiolex in TSC
- Pipeline progress
- Sativex® (nabiximols)
- FDA meeting in December 2018 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
- 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 has commenced recruitment
- Open label study in Rett syndrome and seizures has
commenced
FINANCIAL HIGHLIGHTS
- Cash and cash equivalents at March
31, 2019 were $521.7 million compared to $591.5 million as of
December 31, 2018
- Revenue for the quarter ended March
31, 2019 was $39.2 million compared to $3.0 million for the quarter
ended March 31, 2018
- Net loss for the quarter ended
March 31, 2019 was $50.1 million compared to $69.5 million for the
quarter ended March 31, 2018
- Closed transaction to sell Rare
Pediatric Disease Priority Review Voucher for $105 million on April
5, 2019. The sale will be reflected in our Q2 2019 results
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the quarter ending March 31, 2019 financial
results today at 4:30 pm EDT. 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: 47716.
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 including Tuberous Sclerosis Complex (TSC) andRett
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 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-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/Andrew Ward |
+44 (0) 20 727 1000 |
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share data)
(unaudited)
|
|
March 31, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash
equivalents |
|
$ |
521,669 |
|
|
$ |
591,497 |
|
Accounts receivable,
net |
|
|
19,251 |
|
|
|
4,192 |
|
Inventory |
|
|
48,559 |
|
|
|
33,030 |
|
Prepaid expenses and
other current assets |
|
|
19,389 |
|
|
|
17,903 |
|
Total current
assets |
|
|
608,868 |
|
|
|
646,622 |
|
Property, plant, and
equipment, net |
|
|
102,029 |
|
|
|
90,832 |
|
Operating lease
assets |
|
|
20,077 |
|
|
|
— |
|
Goodwill |
|
|
6,959 |
|
|
|
6,959 |
|
Deferred tax
assets |
|
|
8,584 |
|
|
|
8,720 |
|
Other assets |
|
|
3,040 |
|
|
|
2,935 |
|
Total assets |
|
$ |
749,557 |
|
|
$ |
756,068 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
10,794 |
|
|
$ |
9,796 |
|
Accrued
liabilities |
|
|
59,782 |
|
|
|
52,477 |
|
Current tax
liabilities |
|
|
1,730 |
|
|
|
2,384 |
|
Other current
liabilities |
|
|
5,651 |
|
|
|
1,559 |
|
Total current
liabilities |
|
|
77,957 |
|
|
|
66,216 |
|
Long-term
liabilities: |
|
|
|
|
|
|
|
|
Finance lease
liabilities |
|
|
5,801 |
|
|
|
5,690 |
|
Operating lease
liabilities |
|
|
16,374 |
|
|
|
— |
|
Other liabilities |
|
|
9,696 |
|
|
|
10,082 |
|
Total long-term
liabilities |
|
|
31,871 |
|
|
|
15,772 |
|
Total liabilities |
|
|
109,828 |
|
|
|
81,988 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’
equity: |
|
|
|
|
|
|
|
|
Ordinary shares par
value £0.001; 368,613,440 shares |
|
|
|
|
|
|
|
|
outstanding as of March 31, 2019; 366,616,688 sharesoutstanding as
of December 31, 2018 |
|
|
567 |
|
|
|
564 |
|
Additional paid-in
capital |
|
|
1,593,056 |
|
|
|
1,581,144 |
|
Accumulated
deficit |
|
|
(879,004 |
) |
|
|
(828,940 |
) |
Accumulated other
comprehensive loss |
|
|
(74,890 |
) |
|
|
(78,688 |
) |
Total stockholders’
equity |
|
|
639,729 |
|
|
|
674,080 |
|
Total liabilities and
stockholders’ equity |
|
$ |
749,557 |
|
|
$ |
756,068 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share amounts) (unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
Revenues |
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
38,974 |
|
|
$ |
2,812 |
|
Other revenue |
|
|
273 |
|
|
|
229 |
|
Total revenues |
|
|
39,247 |
|
|
|
3,041 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
Cost of product
sales |
|
|
5,131 |
|
|
|
1,625 |
|
Research and
development |
|
|
30,375 |
|
|
|
43,485 |
|
Selling, general and
administrative |
|
|
55,078 |
|
|
|
26,173 |
|
Total operating
expenses |
|
|
90,584 |
|
|
|
71,283 |
|
Loss from
operations |
|
|
(51,337 |
) |
|
|
(68,242 |
) |
Interest income |
|
|
2,087 |
|
|
|
759 |
|
Interest expense |
|
|
(265 |
) |
|
|
(325 |
) |
Foreign exchange
loss |
|
|
(1,114 |
) |
|
|
(640 |
) |
Loss before income
taxes |
|
|
(50,629 |
) |
|
|
(68,448 |
) |
Income tax (benefit)
expense |
|
|
(565 |
) |
|
|
1,013 |
|
Net loss |
|
$ |
(50,064 |
) |
|
$ |
(69,461 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share, basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic and diluted |
|
|
369,823 |
|
|
|
340,252 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GW PHARMACEUTICALS
PLCCONSOLIDATED STATEMENTS OF CASH
FLOWS(in thousands)
(unaudited)
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
2018 |
|
Cash flows from
operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(50,064 |
) |
|
$ |
(69,461 |
) |
Adjustments to
reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Foreign exchange
loss |
|
|
797 |
|
|
|
873 |
|
Stock-based
compensation |
|
|
11,142 |
|
|
|
6,859 |
|
Depreciation and
amortization |
|
|
2,417 |
|
|
|
2,307 |
|
Deferred income
taxes |
|
|
— |
|
|
|
2,128 |
|
Changes in operating
assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable,
net |
|
|
(14,998 |
) |
|
|
(320 |
) |
Inventory |
|
|
(14,295 |
) |
|
|
672 |
|
Prepaid expenses and
other current assets |
|
|
(874 |
) |
|
|
(492 |
) |
Other assets |
|
|
659 |
|
|
|
(3 |
) |
Accounts payable |
|
|
1,998 |
|
|
|
652 |
|
Current tax
liabilities |
|
|
(654 |
) |
|
|
(2,684 |
) |
Accrued
liabilities |
|
|
6,328 |
|
|
|
(7,005 |
) |
Other current
liabilities |
|
|
191 |
|
|
|
1,103 |
|
Long-term
liabilities |
|
|
(1,029 |
) |
|
|
(30 |
) |
Net cash used in
operating activities |
|
|
(58,382 |
) |
|
|
(65,401 |
) |
Cash flows from
investing activities |
|
|
|
|
|
|
|
|
Additions to property,
plant and equipment |
|
|
(12,087 |
) |
|
|
(6,056 |
) |
Additions to
capitalized software |
|
|
(199 |
) |
|
|
(338 |
) |
Net cash used in
investing activities |
|
|
(12,286 |
) |
|
|
(6,394 |
) |
Cash flows from
financing activities |
|
|
|
|
|
|
|
|
Proceeds from exercise
of stock options |
|
|
773 |
|
|
|
1 |
|
Payments on finance
leases |
|
|
(179 |
) |
|
|
(72 |
) |
Payments on landlord
financing obligation |
|
|
(138 |
) |
|
|
(137 |
) |
Net cash provided by
(used in) financing activities |
|
|
456 |
|
|
|
(208 |
) |
Effect of exchange rate
changes on cash |
|
|
384 |
|
|
|
11 |
|
Net increase (decrease)
in cash and cash equivalents |
|
|
(69,828 |
) |
|
|
(71,992 |
) |
Cash and cash
equivalents at beginning of period |
|
|
591,497 |
|
|
|
559,227 |
|
Cash and cash
equivalents at end of period |
|
$ |
521,669 |
|
|
$ |
487,235 |
|
|
|
|
|
|
|
|
|
|
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