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GW Pharmaceuticals plc (GWPH) reported preliminary, unaudited net product sales for the fourth quarter and full-year 2019 and key priorities for 2020. The cannabis-based biotech firm said that it expects total net product sales to be approximately $108 million for the fourth quarter and approximately $309 million for the year ending December 31, 2019.

The bulk of the fourth quarter sales for GW Pharmaceuticals comes from the epileptic drug Epidiolex, which are expected to be roughly $104 million for the fourth quarter and approximately $296 million for the full year. The company said that official results were expected to be posted on February 25th. Cash and cash equivalents on December 31, 2019, were approximately $536 million.

“Our fourth quarter and full year results for 2019 reflect an exceptional launch year for Epidiolex. We are proud of the positive impact this medicine has already had on thousands of patients and believe that this past year provides a compelling foundation for continued success in 2020,” said Justin Gover, GW’s Chief Executive Officer. “Our goal in 2020 is not only to continue to drive Epidiolex growth but also to leverage our world leadership in cannabinoid science to advance our pipeline. In particular, we see significant market opportunity for nabiximols in several indications in the US and will be progressing multiple late stage clinical programs in 2020.”

Looking Ahead

GW Pharmaceuticals said that looking ahead it would work towards broadening the prescriber base for Epidiolex and work with insurance companies to reduce restrictions to the drug.

Build on positive experiences from existing physicians to increase prescribing to appropriate patients. It will also submit and try to obtain approval of the Tuberous Sclerosis Complex indication in both the U.S. and Europe, which would significantly expand the target population. Launches are also planned for five major European countries (Germany, France, UK, Spain, and Italy).

Pipeline

The company also outlined the following items planned for the year:

• Commence Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
• Continue to explore CBDV in autism through a combination of open-label and investigator-led placebo controlled clinical trials with data from one or more of these programs in 2020
• Execute NHIE clinical program utilizing an intravenous formulation of cannabidiol

British biotech firm GW Pharmaceuticals pls (NASDAQ: GWPH) second-quarter net sales of $68.4 million of the company’s cannabis-related drug Epidiolex, which is prescribed for children with rare epilepsy diseases. For the first half of 2019, GW Pharmaceuticals has sold $109 million of the drug. The good news sent the stock higher by over 10% in aftermarket trading to lately trade near $170.

“We are pleased to report a strong second quarter of sales of Epidiolex in the US, reflecting high demand by US patients, increased prescribing by healthcare providers, and ongoing progress in payor coverage determinations. With the recent positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to submit an sNDA by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition,” stated Justin Gover, GW’s Chief Executive Officer. “In Europe, we are pleased to have recently received the positive opinion from the CHMP which clears the way for an expected approval in October. Our European commercial organization is in place and will be ready to launch in the first European markets upon approval, making this important new treatment option available to deserving European patients.”

The company delivered $72.0 million in revenue for the quarter ending June 30, 2019 versus $3.3 million for last year’s quarter for the same time period. Net income for the quarter was $79.7 million versus a net loss of $84.0 million for last year’s quarter. The cash and cash equivalents on June 30, 2019, were $583.7 million.

GW Pharma also reported that over 12,000 patients have received Epidiolex prescriptions since launch and over 2,500 physicians have generated dispensed prescriptions. It is taking approximately two weeks for pharmacies to fill the prescription for a first time user. The company also said that the vast majority of patients who have received Epdiolex remain on therapy and that 900 patients had transitioned in expanded access programs. 93% of the patients had insurance coverage.

The company said that they expect fourth-quarter launches in France, Germany, and the UK for Epidiolex. Spain and Italy launches will follow in 2020. The Early Access Program in Europe for Dravet syndrome and LGS patients now includes over 800 patients registered across 5 major EU countries.

GW Pharmaceuticals (NASDAQ: GWPH) reported mixed second-quarter results on Tuesday after the market close, as revenue came in ahead of consensus but earnings expectations missed the mark by a wide margin.

U.K.-based GW Pharmaceuticals said it lost $3.12 a share on $3.35 million in sales, though the company mentioned the positive outcome of the Epidioled FDA Advisory Committee meeting during the quarter as one of the highlights.

GW’s CEO Justin Gover said that the company’s clinical data demonstrate a bright future for the company.

“The strength and consistency of the clinical data, together with the public presentations that featured very moving personal stories of the challenges associated with managing these difficult forms of epilepsy, led to a unanimous vote in support of approval,” Gover said in a statement. “With our late June FDA decision date nearing, our commercial team is busy preparing to launch Epidiolex in the second half of this year.”

Analysts compiled by Seeking Alpha expected the company to lose $2.48 a share on $3.03 million in revenue during the quarter.

Shares were falling 0.9 percent in after-hours trading to $143.25.

Epidiolex is the company’s pending drug for a number of health issues, including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS).

Gover noted that if Epidiolex is approved, it would be a huge boon for the company’s cannabinoid platform.

“Should Epidiolex be approved, we believe that this will signal a major vote of confidence in GW’s cannabinoid platform to discover and develop prescription medicines that meet exacting regulatory standards and will serve us to accelerate a number of important pipeline programs that have the potential to offer additional value,” he added.

GW, with a market cap approaching $4 billion, is one of the largest pure-play publicly traded cannabis companies. The company said it ended the quarter with $487.2 million in cash.

The company describes itself as “a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform.”

In addition to the financial results, GW said it had submitted Eipidiolex to the European Medicines Agency during the quarter and expects a decision in the first quarter of 2019.

It also received pre-approval from the DA for its cGMP inspection and did not receive any 483 citations. GW also submitted the second Phase 3 LGS trial for publication, with a paper expected to be released “shortly.” The phase 3 trial for the Tuberous Sclerosis Complex is expected to have data in the first half of 2019.

Shares of GW have bucked the broader downturn in cannabis-related equities in recent months. The Green Market Report Cannabis Company Index fell 21.9 percent in the first quarter, as regulatory concerns, especially in the U.S., weighed on investors’ minds.

GW shares have gained roughly 8 percent since the start of the year and more than 35 percent over the past year, outpacing the gain seen in the broader NASDAQ and S&P 500.