GW Pharmaceuticals plc Reports Fiscal Fourth Quarter and Year-End 2018 Financial Results and Operational Progress
- Epidiolex® (cannabidiol) oral solution (CV), first
- Conference call today at
“We are proud to have recently launched Epidiolex, the first and only
OPERATIONAL HIGHLIGHTS
- Epidiolex
- Commercial:
- Epidiolex launched on
November 1st in the U.S. and now available by prescription - Sales organization actively engaging with clinicians
- Awareness and interest high amongst patients and physicians
- Physician education programs providing strong support for initial introduction into clinics
- Patient and clinician websites active pre and post-launch
- Epidiolex demand coming from both major centers of excellence and local epilepsy clinics
- Active engagement with U.S. payors ongoing
- Epidiolex now covered on growing number of formularies
- U.S. supply chain distribution network operational and filling prescriptions
- Commercial footprint in place in 5 major European markets in preparation for 2019 European launches
- Epidiolex launched on
- Regulatory:
- DEA rescheduled Epidiolex to Schedule V
- Scheduling decision specific to
FDA approved CBD
- Scheduling decision specific to
- European submission under review by the EMA with decision expected in Q1 2019
- DEA rescheduled Epidiolex to Schedule V
- Clinical trials
- Positive results in second Dravet syndrome Phase 3 trial
- Primary endpoint achieved in both Epidiolex doses (10 mg/kg/day and 20 mg/kg/day) compared to placebo
- Both Epidiolex doses also demonstrated statistically significant improvements versus placebo in all key secondary endpoints
- Phase 3 trial in
Tuberous Sclerosis Complex fully recruited with data expected H1 2019- sNDA submission expected in H2 2019
- IND submitted for pivotal Rett Syndrome study with expected start in H1 2019.
- Positive results in second Dravet syndrome Phase 3 trial
- Manufacturing
- Commercial Epidiolex product shipments to the U.S. ongoing and sufficient to meet expected demand
- Continued investment in expanded facilities to meet anticipated long-term demand
- Expanded access program and open label extension:
- Approximately 1,000 patients in these programs to be transitioned to commercial product during first half of 2019
- Life-cycle management
- Several new formulations of CBD in development including capsule and modified oral solution
- Exclusivity
- 7-year orphan exclusivity confirmed by
FDA , 6-month pediatric extension expected - Key favorable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam
- Includes two new patents related to the treatment of drop seizures
- Patents align directly with new Epidiolex FDA label and listed in Orange Book
- Patent expiry dates to 2035
- Additional patent applications under review and being filed as new data is generated
- 7-year orphan exclusivity confirmed by
- Commercial:
- Pipeline progress
- Sativex® (nabiximols)
- Initial U.S. target indication: Multiple Sclerosis spasticity
- Three positive Phase 3 trials completed in
Europe FDA meeting expected in December to determine optimal regulatory pathway in the U.S
- Three positive Phase 3 trials completed in
- U.S. development and commercialization rights wholly owned by GW
- Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
- Initial U.S. target indication: Multiple Sclerosis spasticity
- CBDV
- 10-patient investigator-initiated expanded access program for seizures associated with autism underway
- Initial data on 5 patients to be presented at
American Epilepsy Society Annual Meeting shows encouraging signals on seizures and autism-related outcomes
- Initial data on 5 patients to be presented at
- Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q4 2018
- Open label study in Rett syndrome and seizures due to commence Q1 2019
- 10-patient investigator-initiated expanded access program for seizures associated with autism underway
- CBD:THC in Glioblastoma
- Phase 2 study showed significant increase in median survival for patients taking CBD:THC of 662 days compared to 369 days on placebo
- Orphan Drug Designation from both
FDA and EMA for CBD:THC to treat glioblastoma
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- Phase 1 trial complete
- Orphan Drug and Fast Track Designations granted from
FDA and EMA - Phase 2 trial expected to start in H1 2019
- Sativex® (nabiximols)
FINANCIAL HIGHLIGHTS (U.S. GAAP)
- Cash and cash equivalents at
September 30, 2018 were$354.9 million compared to$322.2 million as ofSeptember 30, 2017 - Revenue for the year ended
September 30, 2018 was$12.7 million compared to$8.6 million for the year endedSeptember 30, 2017 - Net loss for the year ended
September 30, 2018 was$295.2 million compared to$170.5 million for the year endedSeptember 30, 2017 - October equity financing resulted in net proceeds of
$324.2 million
Conference Call and Webcast Information
About
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.
About EPIDIOLEX® (cannabidiol) oral solution
EPIDIOLEX, the first prescription, plant-derived cannabinoid medicine in
Important Safety Information
CONTRAINDICATION: HYPERSENSITIVITY
EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product.
WARNINGS & PRECAUTIONS
Hepatocellular Injury:
EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Transaminase and bilirubin levels should be obtained prior to starting treatment, at one, three, and six months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury.
Somnolence and Sedation:
EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants.
Suicidal Behavior and Ideation:
Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness.
Withdrawal of Antiepileptic Drugs:
As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus.
Adverse Reactions:
The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed.
Pregnancy:
EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry.
Drug Interactions:
Moderate or strong inhibitors or inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam) or others. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary.
Drug Abuse:
EPIDIOLEX is a Schedule V controlled substance and has a low potential for abuse.
Indications:
EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) in patients 2 years of age and older.
Please refer to the EPIDIOLEX full Prescribing Information for additional important information.
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 the safety profile and commercial potential of EPIDIOLEX. 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
Enquiries:
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publicrelations@gwpharm.com | ||
U.S. Media Enquiries: |
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GW PHARMACEUTICALS PLC CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except per share amounts) |
||||||||
Three Months Ended September 30, | ||||||||
2018 | 2017 | |||||||
Revenues | ||||||||
Product net sales | $ | 2,343 | $ | 2,368 | ||||
Other revenue | 77 | 82 | ||||||
Total revenues | 2,420 | 2,450 | ||||||
Operating expenses | ||||||||
Cost of product sales | 1,399 | 1,344 | ||||||
Research and development | 28,943 | 30,149 | ||||||
Selling, general and administrative | 52,685 | 19,371 | ||||||
Total operating expenses | 83,027 | 50,864 | ||||||
Loss from operations | (80,607 | ) | (48,414 | ) | ||||
Interest income, net | 986 | 440 | ||||||
Foreign exchange (loss) gain | (823 | ) | (5,201 | ) | ||||
Loss before income taxes | (80,444 | ) | (53,175 | ) | ||||
Income tax expense (benefit) | (565 | ) | 678 | |||||
Net loss | $ | (79,879 | ) | $ | (53,853 | ) | ||
Net loss per common share, basic and diluted | $ | (0.23 | ) | $ | (0.18 | ) | ||
Weighted average common shares outstanding, basic and diluted | 341,302 | 306,263 | ||||||
GW PHARMACEUTICALS PLC CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||
Years Ended September 30, | ||||||||
2018 | 2017 | |||||||
Revenues | ||||||||
Product net sales | $ | 10,469 | $ | 7,957 | ||||
Other revenue | 2,268 | 672 | ||||||
Total revenues | 12,737 | 8,629 | ||||||
Operating expenses | ||||||||
Cost of product sales | 5,986 | 4,521 | ||||||
Research and development | 153,736 | 112,249 | ||||||
Selling, general and administrative | 141,818 | 58,020 | ||||||
Total operating expenses | 301,540 | 174,790 | ||||||
Loss from operations | (288,803 | ) | (166,161 | ) | ||||
Interest income, net | 2,396 | 1,112 | ||||||
Foreign exchange (loss) gain | (4,963 | ) | (6,442 | ) | ||||
Loss before income taxes | (291,370 | ) | (171,491 | ) | ||||
Income tax expense (benefit) | 3,797 | (1,032 | ) | |||||
Net loss | $ | (295,167 | ) | $ | (170,459 | ) | ||
Net loss per common share, basic and diluted | $ | (0.88 | ) | $ | (0.56 | ) | ||
Weighted average common shares outstanding, basic and diluted | 333,936 | 305,826 | ||||||
GW PHARMACEUTICALS PLC CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) |
||||||||
September 30, | ||||||||
2018 | 2017 | |||||||
Assets | ||||||||
Cash and cash equivalents | $ | 354,913 | $ | 322,154 | ||||
Accounts receivable, net | 2,122 | 1,367 | ||||||
Inventory | 19,061 | 5,669 | ||||||
Prepaid expenses and other current assets | 14,615 | 35,392 | ||||||
Total current assets | 390,711 | 364,582 | ||||||
Property and equipment, net | 82,381 | 63,175 | ||||||
Goodwill | 6,959 | 6,959 | ||||||
Deferred tax assets | 7,334 | 6,805 | ||||||
Other assets | 3,150 | 1,401 | ||||||
Total assets | $ | 490,535 | $ | 442,922 | ||||
Liabilities and stockholders’ equity | ||||||||
Accounts payable | $ | 9,741 | $ | 7,757 | ||||
Accrued liabilities | 46,739 | 33,656 | ||||||
Current tax liabilities | 1,385 | 1,119 | ||||||
Other current liabilities | 804 | 2,377 | ||||||
Total current liabilities | 58,669 | 44,909 | ||||||
Long-term liabilities | ||||||||
Capital lease liabilities | 1,535 | 1,741 | ||||||
Build-to-suit financing obligation | 4,378 | 4,611 | ||||||
Other liabilities | 10,794 | 10,838 | ||||||
Total long-term liabilities | 16,707 | 17,190 | ||||||
Total liabilities | 75,376 | 62,099 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Stockholders’ equity: | ||||||||
Ordinary shares par value £0.001; 340,246,840 and 304,439,740 shares issued as of September 30, 2018 and 2017, respectively |
530 | 482 | ||||||
Additional paid-in capital | 1,246,857 | 916,726 | ||||||
Accumulated deficit | (757,034 | ) | (461,867 | ) | ||||
Accumulated other comprehensive (loss) income | (75,194 | ) | (74,518 | ) | ||||
Total stockholders’ equity | 415,159 | 380,823 | ||||||
Total liabilities and stockholders’ equity | $ | 490,535 | $ | 442,922 | ||||
GW PHARMACEUTICALS PLC CONSOLIDATED STATEMENTS OF CASH FLOWS (in thousands) |
||||||||
Years Ended September 30, | ||||||||
2018 | 2017 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (295,167 | ) | (170,459 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Stock-based compensation | 31,627 | 15,479 | ||||||
Depreciation and amortization | 9,290 | 7,054 | ||||||
Loss on disposal of assets | 241 | 1,554 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (804 | ) | (277 | ) | ||||
Inventory | (13,646 | ) | 5 | |||||
Prepaid expenses and other current assets | 19,406 | (3,191 | ) | |||||
Other assets | (564 | ) | - | |||||
Accounts payable | 2,238 | 3,171 | ||||||
Income taxes | (263 | ) | (3,713 | ) | ||||
Accrued liabilities | 16,507 | 1,253 | ||||||
Other current liabilities | (1,546 | ) | (11 | ) | ||||
Long-term liabilities | 813 | 161 | ||||||
Net cash used in operating activities | (231,868 | ) | (148,974 | ) | ||||
Cash flows from investing activities | ||||||||
Additions to property, plant and equipment | (31,362 | ) | (19,285 | ) | ||||
Additions to capitalized software | (2,042 | ) | (812 | ) | ||||
Proceeds from disposal of property, plant and equipment | 517 | - | ||||||
Net cash used in investing activities | (32,887 | ) | (20,097 | ) | ||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of ordinary shares, net of issuance costs | 297,931 | - | ||||||
Proceeds from exercise of stock options | 621 | 122 | ||||||
Payments on build-to-suit financing obligation | (113 | ) | (105 | ) | ||||
Payments on capital leases | (163 | ) | (156 | ) | ||||
Payments on landlord financing obligation | (522 | ) | (1,074 | ) | ||||
Net cash provided by (used in) financing activities | 297,754 | (1,213 | ) | |||||
Effect of exchange rate changes on cash | (240 | ) | 8,993 | |||||
Net increase (decrease) in cash and cash equivalents | 32,759 | (161,291 | ) | |||||
Cash and cash equivalents at beginning of period | 322,154 | 483,445 | ||||||
Cash and cash equivalents at end of period | $ | 354,913 | 322,154 | |||||
Source: GW Pharmaceuticals plc