Exhibit 99.1

 

 

GW Pharmaceuticals plc Reports Fourth Quarter and Year-End 2019 Financial Results and Operational Progress

- Total revenue of $109.1 million for the fourth quarter and $311.3 million for the full year -

- Total Epidiolex^® net product sales of $104.5 million for the fourth quarter and $296.4 million for the first full year of sales-

- Conference call today at 4:30 p.m. EST -

London, UK and Carlsbad, CA, February 25, 2020 – 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

 

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Significant progress with Epidiolex (cannabidiol)

 

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Total net product sales of Epidiolex of $104.5 million for the fourth quarter and $296.4 million for the full year

 

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U.S. commercial update

 

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2020 focus on broadening prescriber base, expanding payer coverage, entering long term care segment, and expected launch of TSC indication

 

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European launch underway

 

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German commercial launch in Q4 2019

 

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Secured positive NICE recommendation in the UK with commercial launch in Q1 2020

 

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Commercial launches in France, Spain and Italy expected later this year, following pricing and reimbursement

 

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Clinical progress with further indications – broadening addressable market

 

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Tuberous Sclerosis Complex (TSC) sNDA filed with FDA earlier this month and MAA submission to EMA expected in Q1 2020

 

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Phase 3 trial in Rett Syndrome recruiting

 

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Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution, and capsule

 

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Improved intellectual property rights and exclusivity

 

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In addition to orphan exclusivity, 9 granted patents listed in “Orange Book” and align directly with Epidiolex FDA label with expiry dates to 2035

 

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Epidiolex composition patent application recently published

 

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2 new allowed patents broadly covering use in LGS and Dravet syndrome

 

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Additional patent applications under review, including patents related to the use of Epidiolex in TSC and other indications

 

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Pipeline progress

 

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Nabiximols (Sativex® outside of the US)

 

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Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe

 

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US pivotal clinical program expected to commence in Q2 2020 to augment existing data package

 

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Spinal cord injury spasticity - clinical program expected to commence in H2 2020

 

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PTSD – clinical program expected to commence in H2 2020

 

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Schizophrenia (GWP42003)

 

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Positive Phase 2a trial published and Phase 2b trial expected to commence H1 2020

 

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CBDV in autism

 

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30-patient open label study in autism underway. Initial data expected in 2020.

 

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Investigator-led 100 patient placebo-controlled trial in autism underway

 

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Open label study in Rett syndrome and seizures underway

 

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Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program

 

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Phase 1b safety study in patients underway

 

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Orphan Drug and Fast Track Designations granted from FDA and EMA

FINANCIAL HIGHLIGHTS

 

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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

 

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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

 

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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 Information

GW 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.

 

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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 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^®/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
Stephen Schultz, VP Investor Relations		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
Ex-U.S. media enquiries
Ben Atwell, FTI Consulting		+44 (0)203 727 1000

 

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GW PHARMACEUTICALS PLC

CONDENSED 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

 

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GW PHARMACEUTICALS PLC

CONDENSED 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

 

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GW PHARMACEUTICALS PLC

CONSOLIDATED 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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