JAZZ - Jazz Plans To Expand Epidiolex To Other Forms of Epilepsy
After the market closed on Tuesday, Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced financial results for the second quarter of 2021 and affirmed non-GAAP adjusted financial guidance for 2021. Jazz also said that it plans to expand the use of GW Pharmaceutical’s drug Epidiolex to other forms of epilepsy.
Total revenues increased 34% to $751.8 Million in the second quarter of 2021 versus $562 million in 2020. This beat the Yahoo Finance average analyst estimate for $735 million. The GAAP net income (loss) for the second quarter of 2021 was ( $363.3 million ), or ($6.11) per diluted share, compared to $114.8 million , or $2.06 per diluted share, for the second quarter of 2020. The non-GAAP adjusted net income for the second quarter of 2021 was $240 .6 million, or $3.90 per diluted share, compared to $207 .3 million, or $3.71 per diluted share, for the second quarter of 2020. The average analyst estimate was $3.42. The average price target is $207 and the stock was moving higher in early trading to $171.
“As we enter what we expect to be a period of sustained growth, I have never been more excited about the future for Jazz. The recent approval and launches of Xywav and Rylaze exemplify Jazz today. We are rapidly establishing ourselves as an innovative biopharmaceutical company with expanding R&D capabilities and substantial commercial prowess, underscored by our consistent execution across the business. The addition of the GW cannabinoid platform and related pipeline complement and enhance our own growing R&D capabilities, accelerating our ability to improve the lives of patients,” said Bruce Cozadd , chairman, and chief executive officer of Jazz Pharmaceuticals. “We have now executed four of five planned product launches since the beginning of 2020 and look forward to our anticipated launch of Xywav in idiopathic hypersomnia later this year, a critical step forward for these underserved patients. With 41% of our second quarter net product sales from recently launched or acquired products, we are well on track to meet our revenue diversification targets while driving significant shareholder value.”
Epidiolex Expansion
In the second quarter, Jazz recorded net product sales of $109.5 million for Epidiolex and believes it could become a blockbuster drug. The company said that this represented revenue from the close of the GW transaction on May 5 through the end of the quarter. On an unaudited pro forma basis full second-quarter net product sales were $155.9 million, a 32% increase over the same quarter of 2020. Jazz believes that as COVID restrictions ease in the US, there will be an upturn in patients visiting their physicians, which will drive additional growth of Epidiolex with new patient starts. In addition, Jazz said the European launch is progressing well with favorable pricing and access to date and reimbursement in place in four of the five largest markets. The company also expects to initiate a Phase 3 pivotal trial of Epidiolex for Epilepsy with Myoclonic-Atonic Seizures (EMAS), also known as Doose syndrome, in the first half of 2022. EMAS represents the fourth target indication for Epidiolex.
Robert Iannone — Executive Vice President, Research and Development and Chief Medical Officer said on the earnings call, “Epidiolex is currently approved in three refractory seizure disorders and we expect to initiate a registrational trial in a fourth, epilepsy with myoclonic-atonic seizures or EMAS in the first half of 2022. Patients diagnosed with EMAS, which is also known as Doose syndrome experienced generalized myoclonic-atonic seizures. The onset of EMAS occurs commonly in the first five years of life with the mean age of onset being three years.”
He added, “The trial provides the opportunity to study Epidiolex in a fourth childhood-onset epileptic encephalopathy at a very high unmet need. EMAS is characterized by generalized myoclonic-atonic seizures and this trial will provide the first randomized controlled clinical data with Epidiolex in this seizure-type, which we believe will provide a more fulsome view of the potential effectiveness at Epidiolex in treating a broad range of seizure disorders.”
Outlook
Jazz Pharmaceuticals is reaffirming its previously communicated full year 2021 non-GAAP financial guidance and updating its 2021 GAAP guidance. Revenue is affirmed at $3.02 Billion to $3.18 Billion The non-GAAP adjusted EPS is in the range of $13.40 to $14.70 per share. The company said the guidance includes the addition of GW from the date of close to year-end, approximately eight months. “We have updated our GAAP guidance primarily to reflect the impact of the UK Tax Act, which was enacted in June following our guidance update.”