GW Pharmaceuticals plc Reports Fourth Quarter and Year-End 2019 Financial Results and Operational Progress
February 25 2020 - 4:01PM
GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the
science, development, and commercialization of cannabinoid
prescription medicines, today announces financial results for the
fourth quarter and full-year ended December 31, 2019.
“2019 was an exceptional and transformative year
for GW, led by the successful launch of Epidiolex in the US and
approval in Europe. The positive impact this medicine has had on
thousands of patients and their families provides a compelling
foundation for continued growth in 2020,” said Justin Gover, GW’s
Chief Executive Officer. “We also expect 2020 to be an important
year for our growing and developing product pipeline beyond
Epidiolex as we build on our world leadership in cannabinoid
science. We are focused on advancing nabiximols in the US in
several indications and clinical programs with other potential
products whilst continuing to bring Epidiolex to more patients in
the US and Europe.”
OPERATIONAL HIGHLIGHTS
- Significant progress with Epidiolex (cannabidiol)
- Total net product sales of Epidiolex of $104.5 million for the
fourth quarter and $296.4 million for the full year
- U.S. commercial update
- 2020 focus on broadening prescriber base, expanding payer
coverage, entering long term care segment, and expected launch of
TSC indication
- European launch underway
- German commercial launch in Q4 2019
- Secured positive NICE recommendation in the UK with commercial
launch in Q1 2020
- Commercial launches in France, Spain and Italy expected later
this year, following pricing and reimbursement
- Clinical progress with further indications – broadening
addressable market
- Tuberous Sclerosis Complex (TSC) sNDA filed with FDA earlier
this month and MAA submission to EMA expected in Q1 2020
- Phase 3 trial in Rett Syndrome recruiting
- Several new formulations of CBD advancing into additional Phase
1 studies in 2020, including modified oral solution, and
capsule
- Improved intellectual property rights and exclusivity
- In addition to orphan exclusivity, 9 granted patents listed in
“Orange Book” and align directly with Epidiolex FDA label with
expiry dates to 2035
- Epidiolex composition patent application recently
published
- 2 new allowed patents broadly covering use in LGS and Dravet
syndrome
- Additional patent applications under review, including patents
related to the use of Epidiolex in TSC and other indications
- Pipeline progress
- Nabiximols (Sativex® outside of the US)
- Multiple Sclerosis spasticity -3 positive Phase 3 trials
completed in Europe
- US pivotal clinical program expected to commence in Q2 2020 to
augment existing data package
- Spinal cord injury spasticity - clinical program expected to
commence in H2 2020
- PTSD – clinical program expected to commence in H2 2020
- Schizophrenia (GWP42003)
- Positive Phase 2a trial published and Phase 2b trial expected
to commence H1 2020
- CBDV in autism
- 30-patient open label study in autism underway. Initial data
expected in 2020.
- Investigator-led 100 patient placebo-controlled trial in autism
underway
- Open label study in Rett syndrome and seizures underway
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program
- Phase 1b safety study in patients underway
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
FINANCIAL HIGHLIGHTS
- Total revenue for the quarter ended December 31, 2019 was
$109.1 million compared to $6.7 million for the quarter ended
December 31, 2018
- Net loss for the quarter ended December 31, 2019 was $24.9
million compared to a net loss of $71.9 million for the quarter
ended December 31, 2018
- Cash and cash equivalents at December 31, 2019 were $536.9
million compared to $591.5 million as of December 31, 2018
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast 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: 33178.
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. The Company’s
lead product, EPIDIOLEX® (cannabidiol) oral solution CV, is
commercialized in the U.S. by its U.S. subsidiary Greenwich
Biosciences for the treatment of seizures associated with
Lennox-Gastaut syndrome or Dravet syndrome in patients two years of
age or older. This product has received approval in the European
Union under the tradename EPIDYOLEX®. The Company has submitted a
supplemental New Drug Application to the U.S. Food and Drug
Administration (FDA) to expand the indication for Epidiolex to
include seizures associated with Tuberous Sclerosis Complex, for
which it has reported positive Phase 3 data, and is carrying out a
Phase 3 trial in Rett syndrome. The Company has a deep pipeline of
additional cannabinoid product candidates, in particular
nabiximols, for which the Company is advancing multiple late-stage
clinical programs in order to seek FDA approval in the treatment of
spasticity associated with multiple sclerosis and spinal cord
injury, as well as for the treatment of PTSD. The Company has
additional cannabinoid product candidates in Phase 2 trials for
autism 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®/EPIDYOLEX®
(cannabidiol) oral solution CV and Sativex® (nabiximols), and the
safety profile and commercial potential of both medicines.
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 EPIDIOLEX®/EPIDYOLEX®, Sativex® 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.
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 |
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|
Stephen Schultz, VP Investor Relations |
917 280 2424 / 401 500 6570 |
|
|
|
|
U.S. Media Enquiries:Sam Brown Inc.
Healthcare Communications |
|
|
Christy CurranMike Beyer |
615 414 8668312 961 2502 |
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| Ex-U.S. media
enquiries |
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|
Ben Atwell, FTI Consulting |
+44 (0)203 727 1000 |
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share
data)(unaudited)
|
|
|
December 31, |
|
|
December 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
Assets |
|
|
|
|
|
|
|
|
| Cash and cash equivalents |
|
$ |
536,933 |
|
|
$ |
591,497 |
|
| Accounts receivable, net |
|
|
48,883 |
|
|
|
4,192 |
|
| Inventory |
|
|
85,528 |
|
|
|
33,030 |
|
| Prepaid expenses and other
current assets |
|
|
28,292 |
|
|
|
17,903 |
|
|
Total current assets |
|
|
699,636 |
|
|
|
646,622 |
|
| Property, plant, and equipment,
net |
|
|
127,765 |
|
|
|
90,832 |
|
| Operating lease assets |
|
|
24,916 |
|
|
|
— |
|
| Goodwill |
|
|
6,959 |
|
|
|
6,959 |
|
| Deferred tax assets |
|
|
18,123 |
|
|
|
8,720 |
|
| Other assets |
|
|
4,850 |
|
|
|
2,935 |
|
|
Total assets |
|
$ |
882,249 |
|
|
$ |
756,068 |
|
| Liabilities and
stockholders’
equity |
|
|
|
|
|
|
|
|
| Accounts payable |
|
$ |
9,990 |
|
|
$ |
9,796 |
|
| Accrued liabilities |
|
|
99,374 |
|
|
|
52,477 |
|
| Current tax liabilities |
|
|
437 |
|
|
|
2,384 |
|
| Other current liabilities |
|
|
7,760 |
|
|
|
1,559 |
|
|
Total current liabilities |
|
|
117,561 |
|
|
|
66,216 |
|
| Long-term liabilities: |
|
|
|
|
|
|
|
|
| Finance lease liabilities |
|
|
5,573 |
|
|
|
5,690 |
|
| Operating lease liabilities |
|
|
21,650 |
|
|
|
— |
|
| Other liabilities |
|
|
11,431 |
|
|
|
10,082 |
|
|
Total long-term liabilities |
|
|
38,654 |
|
|
|
15,772 |
|
|
Total liabilities |
|
|
156,215 |
|
|
|
81,988 |
|
| Commitments and
contingencies |
|
|
|
|
|
|
|
|
| Stockholders’ equity: |
|
|
|
|
|
|
|
|
| Ordinary shares par value £0.001;
371,068,436 and 366,616,688 shares outstanding as of December
31, 2019 and 2018, respectively |
|
|
570 |
|
|
|
564 |
|
| Additional paid-in capital |
|
|
1,632,046 |
|
|
|
1,581,144 |
|
| Accumulated deficit |
|
|
(837,959 |
) |
|
|
(828,940 |
) |
| Accumulated other comprehensive
loss |
|
|
(68,623 |
) |
|
|
(78,688 |
) |
|
Total stockholders’ equity |
|
|
726,034 |
|
|
|
674,080 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
882,249 |
|
|
$ |
756,068 |
|
| |
|
|
|
|
|
|
|
|
GW PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except per share
amounts) (unaudited)
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
109,019 |
|
|
$ |
6,617 |
|
|
$ |
310,331 |
|
|
$ |
14,866 |
|
|
Other revenue |
|
|
57 |
|
|
|
37 |
|
|
|
1,001 |
|
|
|
533 |
|
|
Total revenues |
|
|
109,076 |
|
|
|
6,654 |
|
|
|
311,332 |
|
|
|
15,399 |
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
7,298 |
|
|
|
1,829 |
|
|
|
27,199 |
|
|
|
6,644 |
|
|
Research and development |
|
|
43,535 |
|
|
|
29,086 |
|
|
|
142,678 |
|
|
|
146,627 |
|
|
Selling, general and administrative |
|
|
78,351 |
|
|
|
49,083 |
|
|
|
259,880 |
|
|
|
165,727 |
|
|
Total operating expenses |
|
|
129,184 |
|
|
|
79,998 |
|
|
|
429,757 |
|
|
|
318,998 |
|
| Loss from operations |
|
|
(20,108 |
) |
|
|
(73,344 |
) |
|
|
(118,425 |
) |
|
|
(303,599 |
) |
|
Interest income |
|
|
1,818 |
|
|
|
2,449 |
|
|
|
8,464 |
|
|
|
5,490 |
|
|
Interest expense |
|
|
(282 |
) |
|
|
(295 |
) |
|
|
(1,087 |
) |
|
|
(1,230 |
) |
|
Other income |
|
|
— |
|
|
|
— |
|
|
|
104,117 |
|
|
|
— |
|
|
Foreign exchange loss |
|
|
(5,073 |
) |
|
|
(982 |
) |
|
|
(2,272 |
) |
|
|
(6,105 |
) |
|
Loss before income taxes |
|
|
(23,645 |
) |
|
|
(72,172 |
) |
|
|
(9,203 |
) |
|
|
(305,444 |
) |
| Income tax expense (benefit) |
|
|
1,301 |
|
|
|
(266 |
) |
|
|
(184 |
) |
|
|
(187 |
) |
|
Net loss |
|
$ |
(24,946 |
) |
|
$ |
(71,906 |
) |
|
$ |
(9,019 |
) |
|
$ |
(305,257 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.07 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.88 |
) |
|
Diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
372,447 |
|
|
|
366,458 |
|
|
|
371,580 |
|
|
|
347,123 |
|
|
Diluted |
|
|
372,447 |
|
|
|
366,458 |
|
|
|
371,580 |
|
|
|
347,123 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GW PHARMACEUTICALS
PLCCONSOLIDATED STATEMENTS OF CASH
FLOWS(in thousands)
(unaudited)
|
|
|
Year Ended December 31, |
|
|
|
|
2019 |
|
|
2018 |
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
| Net loss |
|
$ |
(9,019 |
) |
|
$ |
(305,257 |
) |
| Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
Foreign exchange loss |
|
|
2,709 |
|
|
|
5,839 |
|
|
Stock-based compensation |
|
|
48,030 |
|
|
|
35,718 |
|
|
Depreciation and amortization |
|
|
9,240 |
|
|
|
9,661 |
|
|
Deferred income taxes |
|
|
(9,698 |
) |
|
|
(430 |
) |
|
Gain from sale of priority review voucher |
|
|
(104,117 |
) |
|
|
— |
|
|
Other |
|
|
39 |
|
|
|
233 |
|
| Changes in operating assets and
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(44,623 |
) |
|
|
(2,706 |
) |
|
Inventory |
|
|
(51,125 |
) |
|
|
(28,484 |
) |
|
Prepaid expenses and other current assets |
|
|
(9,831 |
) |
|
|
11,370 |
|
|
Other assets |
|
|
3,888 |
|
|
|
(445 |
) |
|
Accounts payable |
|
|
805 |
|
|
|
2,829 |
|
|
Current tax liabilities |
|
|
(963 |
) |
|
|
(3,966 |
) |
|
Accrued liabilities |
|
|
43,110 |
|
|
|
19,445 |
|
|
Other liabilities |
|
|
(1,914 |
) |
|
|
1,423 |
|
| Net cash used in operating
activities |
|
|
(123,469 |
) |
|
|
(254,770 |
) |
| Cash flows from investing
activities |
|
|
|
|
|
|
|
|
|
Proceeds from sale of priority review voucher |
|
|
104,117 |
|
|
|
— |
|
|
Additions to property, plant and equipment |
|
|
(40,386 |
) |
|
|
(42,301 |
) |
|
Additions to capitalized software |
|
|
(2,102 |
) |
|
|
(1,112 |
) |
|
Proceeds from disposal of property, plant and equipment |
|
|
— |
|
|
|
517 |
|
| Net cash provided by (used in)
investing activities |
|
|
61,629 |
|
|
|
(42,896 |
) |
| Cash flows from financing
activities |
|
|
|
|
|
|
|
|
|
Proceeds from issuance of ordinary shares, net of issuance
costs |
|
|
— |
|
|
|
324,637 |
|
|
Proceeds from exercise of stock options |
|
|
2,878 |
|
|
|
620 |
|
|
Payments on finance leases |
|
|
(389 |
) |
|
|
(251 |
) |
|
Payments on landlord financing obligation |
|
|
(543 |
) |
|
|
(527 |
) |
| Net cash provided by (used in)
financing activities |
|
|
1,946 |
|
|
|
324,479 |
|
| Effect of exchange rate changes
on cash |
|
|
5,330 |
|
|
|
5,457 |
|
| Net increase (decrease) in cash
and cash equivalents |
|
|
(54,564 |
) |
|
|
32,270 |
|
| Cash and cash equivalents at
beginning of period |
|
|
591,497 |
|
|
|
559,227 |
|
| Cash and cash equivalents at end
of period |
|
$ |
536,933 |
|
|
$ |
591,497 |
|
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