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GW Pharmaceuticals Conference Call Highlights


GW Pharmaceuticals (NASDAQ: GWPH) reported its third quarter earnings. Shares of the company are down 4 percent.

Below are some key highlights from its conference call.

Growth and Performance Prospects:

• It is no exaggeration to say that GW's business has transformed over the last year, principally as a result of the rapid advance of our Epidiolex program to treat orphan syndromes in the field of childhood epilepsy.
• During 2014, we have raised significant capital from US investors in support of this program, commenced treatment of approximately 200 children, obtained encouraging clinical data, and commenced formal clinical development of Epidiolex in the United States.
• This program falls into three areas; company-sponsored developments, FDA authorized expanded access INDs to independent investigators, and collaborations with various US states.
• First, with respect to company-sponsored activities, we're focusing our efforts on Dravet syndrome and Lennox-Gastaut syndrome for which we have received orphan drug designations from the FDA.
• During last year, we have held meetings with the FDA, finalized clinical trial protocols, set-up clinical trial sites participation in our trials.
• Most recently, the first Phase 2/3 Dravet syndrome trial has commenced and we remain on track to commence additional Phase 3 trials in the first quarter of 2015.
• Second, with respect to the expanded access program, we have seen a significant expansion of the number of patients authorized by FDA for treatment, which now totals approximately 410 patients.
• Of these, about 200 children and young adults are now receiving Epidiolex at 11 clinical trial sites in the United States, and new patients continue to be enrolled on a weekly basis.
• And third, two US states, Georgia and New York announced initiatives this year to collaborate with GW on separate Epidiolex clinical trials in epilepsy and progress towards the start of these programs is advancing.
• Underpinning all of this activity is a support we have received from investors this past year, including our successful offerings in January and June, raising net proceeds after expenses of $212 million.
• Which has resulted in a cash balance of approximately $267 million at the end of our financial year.
• This funding allows GW to continue to accelerate this epilepsy program as we enter 2015 and begin to prepare for future commercial launch.
• Beyond Epidiolex, GW Sativex program which has received Fast Track designation from the FDA for the treatment of chronic cancer pain also continue to progress in 2014.
• Recruitment is now complete in the first of our two pivotal Phase 3 trials. We are on course to report top line results from this first trial in early 2015.
• The second Phase 3 trial is expected to complete recruitment in the first quarter of 2015 with data expected follow in the second quarter.

Financial Metrics:

• Reporting a loss before tax for 2014 of GBP19.6 million or $31.7 million;
• Compared to the prior year that's an increase to our reported loss of GBP9.2 million.
• As you would expect the driver of the increased loss is growth in R&D spend primarily as it is related with our epilepsy program.
• In addition, we plan to increase spend on US commercial operations in preparation for future commercialization of Epidiolex.
• We therefore expect our net cash outflow from operating activities to increase approximately GBP50 million or $78 million.
• In addition, capital expenditure is expected to increase to around GBP22 million or $35 million as we complete construction of our Sativex manufacturing facility in preparation for anticipated US launch and expand the Epidiolex growing and manufacturing capacity.

Posted-In: conference callEarnings News


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