- 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 -
CARLSBAD, Calif., May 06, 2019 (GLOBE NEWSWIRE) -- 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 epilepsyâ€, 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.â€
OPERATIONAL HIGHLIGHTS
FINANCIAL HIGHLIGHTS
Conference Call and Webcast
Information
GW 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 statements
This 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 Curran Mike Beyer |
615 414 8668 312 961 2502 |
| EU Media Enquiries: FTI Consulting |
|
| Ben Atwell/Andrew Ward | +44 (0) 20 727 1000 |
GW PHARMACEUTICALS PLC
CONDENSED 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 shares outstanding 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 PLC
CONDENSED 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 PLC
CONSOLIDATED 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 | ||||