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

February, 25 2020 04:01 PM GW Pharmaceuticals Plc

- 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 and CARLSBAD, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- 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 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. 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

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

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

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

Company Name:	GW Pharmaceuticals Plc
Stock Symbol:	GWPH
Market:	NASDAQ
Website:	gwpharm.com

Twitter