GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the Second Quarter Ended June 30, 2019
August 06 2019 - 4:01PM
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 second quarter ended June 30, 2019.
“We are pleased to report a strong second
quarter of sales of Epidiolex in the US, reflecting high demand by
US patients, increased prescribing by healthcare providers, and
ongoing progress in payor coverage determinations. With the recent
positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to
submit an sNDA by the end of 2019 with the goal of expanding the
Epidiolex label and market opportunity to include both children and
adult patients with TSC, a highly treatment-resistant condition,”
stated Justin Gover, GW’s Chief Executive Officer. “In Europe, we
are pleased to have recently received the positive opinion from the
CHMP which clears the way for an expected approval in October. Our
European commercial organization is in place and will be ready to
launch in the first European markets upon approval, making this
important new treatment option available to deserving European
patients.”
OPERATIONAL HIGHLIGHTS
- Epidiolex® (cannabidiol)
- U.S. commercial update
- Q2 Net sales of $68.4M; $101.9M net sales in the first half of
2019
- Over 12,000 patients have received Epidiolex prescriptions
since launch
- Over 2,500 physicians have generated dispensed prescriptions
since launch
- Pharmacy distribution network delivering median time to fill a
first prescription in approximately 2 weeks
- Vast majority of patients who have received Epdiolex remain on
therapy
- Transition of 900 patients in expanded access program and open
label extension to commercial product complete
- Strong payor coverage
- Approximately 93 percent of all Commercial, Medicaid and
Medicare lives in the US have a coverage determination, of which
65% are PA to indication or less restrictive
- European launch update
- Positive CHMP opinion with European Commission approval
expected in early October
- Q4 launches expected in France, Germany and UK; Spain and Italy
launches to follow in 2020
- Early Access Program in Europe for Dravet syndrome and LGS
patients now includes over 800 patients registered across 5 major
EU countries
- Manufacturing
- Commercial manufacturing and supply chain running smoothly
- Production capacity sufficient to meet expected demand in both
U.S. and Europe
- Clinical trials
- Phase 3 trial in Rett Syndrome now recruiting
- 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 expected
- Key favorable patent grants by USPTO related to the use of CBD
in epilepsy
- 9 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
- Pipeline progress
- Sativex® (nabiximols)
- Initial U.S. target indication: Multiple Sclerosis spasticity
- Clinical program expected to commence in Q4 to augment existing
pivotal data package
- No new oral anti-spasticity treatments developed in the field
for over 20 years
- Novel mechanism of action
- Potential “pipeline in a product” with over 10
placebo-controlled trials already completed in other
indications
- CBDV
- Potential both within field of autism and epilepsy
- IND open for 30-patient open label study in autism expected to
begin recruitment by the end of 2019
- Investigator-led 100 patient placebo-controlled trial in autism
spectrum disorder has commenced recruitment
- Open label study in Rett syndrome and seizures ongoing
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD
program
- Phase 1 trial complete in healthy volunteers
- Safety study in patients expected to commence in Q4
- Orphan Drug and Fast Track Designations granted from FDA and
EMA
FINANCIAL HIGHLIGHTS
- Revenue for the quarter ended June
30, 2019 was $72.0 million compared to $3.3 million for the quarter
ended June 30, 2018
- Cash and cash equivalents at June
30, 2019 were $583.7 million compared to $591.5 million as of
December 31, 2018
- Closed on sale of Rare Pediatric
Priority Review Voucher in the quarter and recognized net proceeds
of $104.1 million as a gain on the sale of an intangible asset
- Net income for the quarter ended
June 30, 2019 was $79.7 million compared to a net loss of $84.0
million for the quarter ended June 30, 2018
Conference Call and Webcast
InformationGW Pharmaceuticals will host a conference call
and webcast to discuss the quarter ending June 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: 51890.
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 and has received a positive
opinion from the Committee for Medicinal Products for Human Use
(CHMP). 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 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, 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/Andrew Ward |
+44 (0) 20 727 1000 |
|
|
GW PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED BALANCE SHEETS(in thousands, except
share data) (unaudited) |
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
583,683 |
|
|
$ |
591,497 |
|
Accounts receivable, net |
|
|
32,113 |
|
|
|
4,192 |
|
Inventory |
|
|
60,042 |
|
|
|
33,030 |
|
Prepaid expenses and other
current assets |
|
|
21,693 |
|
|
|
17,903 |
|
Total current assets |
|
|
697,531 |
|
|
|
646,622 |
|
Property, plant, and equipment,
net |
|
|
107,332 |
|
|
|
90,832 |
|
Operating lease assets |
|
|
18,739 |
|
|
|
— |
|
Goodwill |
|
|
6,959 |
|
|
|
6,959 |
|
Deferred tax assets |
|
|
8,726 |
|
|
|
8,720 |
|
Other assets |
|
|
3,490 |
|
|
|
2,935 |
|
Total assets |
|
$ |
842,777 |
|
|
$ |
756,068 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
11,757 |
|
|
$ |
9,796 |
|
Accrued liabilities |
|
|
66,434 |
|
|
|
52,477 |
|
Current tax liabilities |
|
|
— |
|
|
|
2,384 |
|
Other current liabilities |
|
|
5,757 |
|
|
|
1,559 |
|
Total current liabilities |
|
|
83,948 |
|
|
|
66,216 |
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Finance lease liabilities |
|
|
5,536 |
|
|
|
5,690 |
|
Operating lease liabilities |
|
|
15,139 |
|
|
|
— |
|
Other liabilities |
|
|
9,262 |
|
|
|
10,082 |
|
Total long-term liabilities |
|
|
29,937 |
|
|
|
15,772 |
|
Total liabilities |
|
|
113,885 |
|
|
|
81,988 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock - Ordinary shares
par value £0.001; 370,621,184 shares outstanding as of June
30, 2019; 366,616,688 shares outstanding as of December 31,
2018 |
|
|
570 |
|
|
|
564 |
|
Additional paid-in capital |
|
|
1,607,346 |
|
|
|
1,581,144 |
|
Accumulated deficit |
|
|
(799,256 |
) |
|
|
(828,940 |
) |
Accumulated other comprehensive
loss |
|
|
(79,768 |
) |
|
|
(78,688 |
) |
Total stockholders’ equity |
|
|
728,892 |
|
|
|
674,080 |
|
Total liabilities and stockholders’ equity |
|
$ |
842,777 |
|
|
$ |
756,068 |
|
|
GW PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS(in
thousands, except per share amounts)
(unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product net sales |
|
$ |
71,489 |
|
|
$ |
3,094 |
|
|
$ |
110,463 |
|
|
$ |
5,906 |
|
Other revenue |
|
|
549 |
|
|
|
190 |
|
|
|
822 |
|
|
|
419 |
|
Total revenues |
|
|
72,038 |
|
|
|
3,284 |
|
|
|
111,285 |
|
|
|
6,325 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
6,620 |
|
|
|
1,791 |
|
|
|
11,751 |
|
|
|
3,416 |
|
Research and development |
|
|
32,467 |
|
|
|
45,113 |
|
|
|
62,842 |
|
|
|
88,598 |
|
Selling, general and administrative |
|
|
62,273 |
|
|
|
37,786 |
|
|
|
117,351 |
|
|
|
63,959 |
|
Total operating expenses |
|
|
101,360 |
|
|
|
84,690 |
|
|
|
191,944 |
|
|
|
155,973 |
|
Loss from operations |
|
|
(29,322 |
) |
|
|
(81,406 |
) |
|
|
(80,659 |
) |
|
|
(149,648 |
) |
Interest income |
|
|
2,310 |
|
|
|
999 |
|
|
|
4,397 |
|
|
|
1,758 |
|
Interest expense |
|
|
(268 |
) |
|
|
(313 |
) |
|
|
(533 |
) |
|
|
(638 |
) |
Other income |
|
|
104,117 |
|
|
|
— |
|
|
|
104,117 |
|
|
|
— |
|
Foreign exchange gain (loss) |
|
|
2,026 |
|
|
|
(3,660 |
) |
|
|
912 |
|
|
|
(4,300 |
) |
Income (loss) before income taxes |
|
|
78,863 |
|
|
|
(84,380 |
) |
|
|
28,234 |
|
|
|
(152,828 |
) |
Income tax (benefit) expense |
|
|
(885 |
) |
|
|
(369 |
) |
|
|
(1,450 |
) |
|
|
644 |
|
Net income (loss) |
|
$ |
79,748 |
|
|
$ |
(84,011 |
) |
|
$ |
29,684 |
|
|
$ |
(153,472 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.21 |
|
|
$ |
(0.25 |
) |
|
$ |
0.08 |
|
|
$ |
(0.45 |
) |
Diluted |
|
$ |
0.21 |
|
|
$ |
(0.25 |
) |
|
$ |
0.08 |
|
|
$ |
(0.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
371,712 |
|
|
|
340,457 |
|
|
|
370,776 |
|
|
|
340,355 |
|
Diluted |
|
|
377,435 |
|
|
|
340,457 |
|
|
|
376,674 |
|
|
|
340,355 |
|
|
GW PHARMACEUTICALS PLCCONSOLIDATED
STATEMENTS OF CASH FLOWS(in thousands)
(unaudited) |
|
|
|
Six Months Ended June 30, |
|
|
|
2019 |
|
|
2018 |
|
Cash flows from operating
activities |
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
29,684 |
|
|
$ |
(153,472 |
) |
Adjustments to reconcile net
income (loss) to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Foreign exchange loss |
|
|
882 |
|
|
|
3,930 |
|
Share-based compensation |
|
|
23,330 |
|
|
|
16,426 |
|
Depreciation and amortization |
|
|
4,808 |
|
|
|
4,720 |
|
Deferred income taxes |
|
|
— |
|
|
|
1,407 |
|
Gain from sale of priority review voucher |
|
|
(104,117 |
) |
|
|
- |
|
Other |
|
|
21 |
|
|
|
148 |
|
Changes in operating assets and
liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
(27,924 |
) |
|
|
(423 |
) |
Inventory |
|
|
(27,070 |
) |
|
|
2,501 |
|
Prepaid expenses and other current assets |
|
|
(6,819 |
) |
|
|
22,139 |
|
Other assets |
|
|
1,542 |
|
|
|
(249 |
) |
Accounts payable |
|
|
3,488 |
|
|
|
3,156 |
|
Current tax liabilities |
|
|
619 |
|
|
|
(3,458 |
) |
Accrued liabilities |
|
|
13,887 |
|
|
|
3,599 |
|
Other liabilities |
|
|
(2,192 |
) |
|
|
1,265 |
|
Net cash used in operating
activities |
|
|
(89,861 |
) |
|
|
(98,311 |
) |
Cash flows from investing
activities |
|
|
|
|
|
|
|
|
Proceeds from sale of priority review voucher |
|
|
104,117 |
|
|
|
- |
|
Additions to property, plant and equipment |
|
|
(22,515 |
) |
|
|
(14,675 |
) |
Additions to capitalized software |
|
|
(1,017 |
) |
|
|
(983 |
) |
Net cash provided by (used in)
investing activities |
|
|
80,585 |
|
|
|
(15,658 |
) |
Cash flows from financing
activities |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options |
|
|
2,878 |
|
|
|
2 |
|
Payments on finance leases |
|
|
(250 |
) |
|
|
(143 |
) |
Payments on landlord financing obligation |
|
|
(273 |
) |
|
|
(271 |
) |
Net cash provided by (used in)
financing activities |
|
|
2,355 |
|
|
|
(412 |
) |
Effect of exchange rate changes
on cash |
|
|
(893 |
) |
|
|
(4,906 |
) |
Net decrease in cash and cash
equivalents |
|
|
(7,814 |
) |
|
|
(119,287 |
) |
Cash and cash equivalents at
beginning of period |
|
|
591,497 |
|
|
|
559,227 |
|
Cash and cash equivalents at end
of period |
|
$ |
583,683 |
|
|
$ |
439,940 |
|
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