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Globe Newswire 26-Feb-2019 4:01 PM
– Epidiolex® (cannabidiol) oral solution (CV), first FDA-approved plant-derived cannabinoid medicine, launched in the U.S. in November to high awareness and demand –
– GW moves to a new fiscal year-end beginning January 1, 2019 –
– Conference call today at 4:30 p.m. EST –
LONDON and CARLSBAD, Calif., Feb. 26, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group)), the world leader in the development and commercialization of cannabinoid prescription medicines, announces financial results for the quarter ended December 31, 2018.
"We are pleased by the high level of physician and patient demand for Epidiolex, and by the number of payors that have already made favorable coverage determinations for the product. With US launch taking place part way through the quarter, the two month selling period at the end of 2018 was primarily aimed at setting the commercial wheels in motion for the 2019 launch year. As we move into the New Year, prescription growth trajectory has been highly encouraging and we believe that we are on track to deliver a successful market introduction of this important new treatment," stated Justin Gover, GW's Chief Executive Officer. "In addition to the US launch, we look forward to a positive regulatory decision in Europe in the next few months, results of a Phase 3 trial in Tuberous Sclerosis Complex, and a number of advances in the pipeline."
OPERATIONAL HIGHLIGHTS
• Epidiolex® (cannabidiol)
• Pipeline progress
FINANCIAL HIGHLIGHTS
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending December 31, 2018 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: 44354.
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 and currently has an ongoing clinical trial in tuberous sclerosis complex (TSC). 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-K filed on 29 November 2018. 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 |
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Christy Curran Mike Beyer |
615 414 8668 312 961 2502 |
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EU Media Enquiries: FTI Consulting |
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Ben Atwell/Andrew Ward | +44 (0) 20 727 1000 |
GW PHARMACEUTICALS PLC
CONSOLIDATED BALANCE SHEETS
(Unaudited; in thousands)
December 31, | September 30, | |||||||
2018 | 2018 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 591,497 | $ | 354,913 | ||||
Accounts receivable, net | 4,192 | 2,122 | ||||||
Inventory | 33,030 | 19,061 | ||||||
Prepaid expenses and other current assets | 17,903 | 14,615 | ||||||
Total current assets | 646,622 | 390,711 | ||||||
Property and equipment, net | 90,832 | 82,381 | ||||||
Goodwill | 6,959 | 6,959 | ||||||
Deferred tax assets | 8,720 | 7,334 | ||||||
Other assets | 2,935 | 3,150 | ||||||
Total assets | $ | 756,068 | $ | 490,535 | ||||
Liabilities and stockholders' equity | ||||||||
Accounts payable | $ | 9,796 | $ | 9,741 | ||||
Accrued liabilities | 52,477 | 46,739 | ||||||
Current tax liabilities | 2,384 | 1,385 | ||||||
Other current liabilities | 1,559 | 804 | ||||||
Total current liabilities | 66,216 | 58,669 | ||||||
Long-term liabilities | ||||||||
Capital lease liabilities | 1,454 | 1,535 | ||||||
Build-to-suit financing obligation | 4,236 | 4,378 | ||||||
Other liabilities | 10,082 | 10,794 | ||||||
Total long-term liabilities | 15,772 | 16,707 | ||||||
Total liabilities | 81,988 | 75,376 | ||||||
Stockholders' equity: | ||||||||
Ordinary shares par value £0.001; 366,616,688 shares outstanding as | ||||||||
of December 31, 2018; 340,246,840 shares outstanding as of | ||||||||
September 30, 2018 | 564 | 530 | ||||||
Additional paid-in capital | 1,581,144 | 1,246,857 | ||||||
Accumulated deficit | (828,940 | ) | (757,034 | ) | ||||
Accumulated other comprehensive (loss) income | (78,688 | ) | (75,194 | ) | ||||
Total stockholders' equity | 674,080 | 415,159 | ||||||
Total liabilities and stockholders' equity | $ | 756,068 | $ | 490,535 |
GW PHARMACEUTICALS PLC
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in thousands, except per share amounts)
Three Months Ended December 31, | ||||||||
2018 | 2017 | |||||||
Revenues | ||||||||
Product net sales | $ | 6,617 | $ | 2,220 | ||||
Other revenue | 37 | 1,772 | ||||||
Total revenues | 6,654 | 3,992 | ||||||
Operating expenses | ||||||||
Cost of product sales | 1,829 | 1,171 | ||||||
Research and development | 29,086 | 36,195 | ||||||
Selling, general and administrative | 49,083 | 25,174 | ||||||
Total operating expenses | 79,998 | 62,540 | ||||||
Loss from operations | (73,344 | ) | (58,548 | ) | ||||
Interest income | 2,449 | 604 | ||||||
Interest expense | (295 | ) | (314 | ) | ||||
Foreign exchange (loss) gain | (982 | ) | 160 | |||||
Loss before income taxes | (72,172 | ) | (58,098 | ) | ||||
Income tax (benefit) expense | (266 | ) | 3,718 | |||||
Net loss | $ | (71,906 | ) | $ | (61,816 | ) | ||
Net loss per common share, basic and diluted | $ | (0.20 | ) | $ | (0.20 | ) | ||
Weighted average common shares outstanding, basic and | ||||||||
diluted | 366,458 | 313,730 |
GW PHARMACEUTICALS PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in thousands)
Three Months Ended December 31, | ||||||||
2018 | 2017 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (71,906 | ) | $ | (61,816 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Foreign exchange loss (gain) | 742 | (180 | ) | |||||
Stock-based compensation | 9,683 | 5,592 | ||||||
Depreciation and amortization | 2,534 | 2,163 | ||||||
Deferred income taxes | (1,265 | ) | (1,152 | ) | ||||
Other | — | 8 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (2,125 | ) | (223 | ) | ||||
Inventory | (14,460 | ) | 378 | |||||
Prepaid expenses and other current assets | (3,635 | ) | (516 | ) | ||||
Other assets | (47 | ) | (166 | ) | ||||
Accounts payable | (1,211 | ) | (1,802 | ) | ||||
Current tax liabilities | 878 | 4,898 | ||||||
Accrued liabilities | 5,942 | 3,004 | ||||||
Other current liabilities | 93 | (2,071 | ) | |||||
Long-term liabilities | 317 | 325 | ||||||
Net cash used in operating activities | (74,460 | ) | (51,558 | ) | ||||
Cash flows from investing activities | ||||||||
Additions to property, plant and equipment | (18,687 | ) | (7,748 | ) | ||||
Additions to capitalized software | (63 | ) | (993 | ) | ||||
Proceeds from disposal of property, plant and equipment | — | — | ||||||
Net cash used in investing activities | (18,750 | ) | (8,741 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of ordinary shares, net of issuance costs | 324,638 | 297,932 | ||||||
Proceeds from exercise of stock options | — | 1 | ||||||
Payments on build-to-suit financing obligation | — | (26 | ) | |||||
Payments on capital leases | (40 | ) | (39 | ) | ||||
Payments on landlord financing obligation | (130 | ) | (125 | ) | ||||
Net cash provided by (used in) financing activities | 324,468 | 297,743 | ||||||
Effect of exchange rate changes on cash | 5,326 | (551 | ) | |||||
Net increase (decrease) in cash and cash equivalents | 236,584 | 237,073 | ||||||
Cash and cash equivalents at beginning of period | 354,913 | 322,154 | ||||||
Cash and cash equivalents at end of period | $ | 591,497 | $ | 559,227 |